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Food
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Prior Notice Final Rule pp 66298-66382
[Federal Register: November 7, 2008 (Volume 73, Number 217)] [Rules and Regulations] [Page 66297-66382] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07no08-13] [[Page 66297]] ----------------------------------------------------------------------- III. Comments on the IFR FDA received 320 timely submissions in response to the IFR. To make it easier to identify comments and FDA's responses to the comments, the word ``Comment'' will appear in parentheses before the description of the comment, and the word ``Response'' will appear in parentheses before FDA's response. A summary follows which includes a description of the appropriate section in the final rule. A. General Comments (Comments) Most comments generally support the intent of the Bioterrorism Act and FDA's efforts to implement its provisions with the IFR. Some comments commend FDA for revising certain proposed requirements to address the needs of international trade by shortening timeframes, reducing the amount of information required to be submitted, and adding a reasonable amount of flexibility for the submission of prior notice based on the mode of transportation in the IFR. However, several comments assert that the agency has misinterpreted the Bioterrorism Act and some comments suggest that the final rule should be more consistent with the existing trade practices established in accordance with CBP. (Response) FDA drafted the IFR in response to the comments to the proposed rule, the needs of international trade, and the continued threat of international terrorism and other significant risks to public health posed by imported food. We also drafted the final rule accordingly. (Comments) Several comments support the graduated enforcement policy the agency used to implement the [[Page 66298]] IFR, noting that this policy facilitated the transition into compliance with the prior notice requirements. Comments ask that FDA provide a similar transition period after publication of the final rule during which time submitters may become familiar with new requirements, understand the new procedures and adjust business processes and practices. (Response) After publication of the IFR, FDA published guidance that included a transition period during which we emphasized education to achieve compliance (the December 2003 Prior Notice Interim Final Rule CPG) (68 FR 69708, December 15, 2003). FDA agrees that implementing a graduated enforcement policy using enforcement discretion has assisted submitters to become accustomed to the new requirements. The new requirements of the final rule will not take effect until 180 days after publication. Since the final rule retains most of the requirements found in the IFR, and with the 180-day delay in effective date, we are not implementing a graduated enforcement policy for implementing the final rule. FDA and CBP have issued elsewhere in this issue of the Federal Register a new CPG (hereinafter the Prior Notice Final Rule Draft CPG) that explains our proposed policies for enforcing violations of this final rule. The draft CPG describes the circumstances under which FDA and CBP should typically consider not taking any regulatory action, the types of violations FDA and CBP intend to focus on, and other enforcement policies. (Comments) Several comments thank FDA for providing an opportunity to provide comments on the provisions of the IFR after a period of active FDA/CBP enforcement. (Response) FDA agrees that providing several comment periods following publication of the IFR has permitted affected stakeholders an additional opportunity to offer specific and informed comments on the new requirements. (Comments) One comment requests that FDA clarify that prior notices submitted to FDA will not be subject to public disclosure under the Freedom of Information Act (5 U.S.C. 552, et seq.) (FOIA) because information contained in a prior notice is confidential business information. Alternatively, the comment requests that FDA develop policies to protect confidential business information contained in prior notices from public disclosure. (Response) FDA does not believe this is necessary. FDA already has relatively detailed regulations, in 21 CFR part 20, governing the disclosure of information under FOIA, including the disclosure of confidential business information. Likewise, the agency's general policies, procedures, and practices relating to the protection of confidential information received from third parties apply to information received under prior notice. We do not believe rules, policies, or procedures specific to prior notice are needed. (Comments) One comment states that during the period of enforcement discretion, various ports of arrival took different approaches to enforcement and suggests that FDA ensure that all ports and all officials act in a similar fashion to achieve a consistent enforcement posture. The comment also suggests that FDA and CBP conduct ``cross- training'' of their officials staffing FDA or CBP help desks. (Response) All prior notice field operations and procedures are directed by the FDA Prior Notice Center (PNC). The PNC works to ensure a consistent implementation and enforcement program. Since the initial implementation of the prior notice rule, FDA staff has received additional training and guidance on prior notice requirements. (Comments) Several comments acknowledge the efforts of CBP and FDA to work together to achieve the common goal of securing the imported food supply. In particular, comments congratulate FDA for coordinating with CBP to allow transmission of FDA-required information through the ABI to CBP's ACS. In addition, comments support the integration and cooperation of both agencies in utilizing CBP's targeting system to efficiently and rapidly spot anomalies in freight crossing our borders; reducing the FDA proposed timeframes for submission of prior notice in the advance electronic information requirements; and the commissioning of CBP staff to conduct examinations and investigations. One comment requests that CBP and FDA ensure that there are adequate resources at ports of arrival to mitigate anticipated delays at border crossings when the rule is enforced. Several comments anticipated that trade would collapse on December 12, 2003, when the new regulations took effect. (Response) FDA and CBP are continuously coordinating efforts to receive, review, and respond to prior notice submissions. We further note that trade continued without significant interruption on December 12, 2003, or anytime after that implementation date. Rather, the implementation of the prior notice requirements was relatively smooth. (Comments) Several comments acknowledge the importance and value of FDA's educational outreach efforts to the trade industry through scheduled outreach and education sessions, port-specific flyers, foreign government training and Web site communications, especially those that summarize certain compliance data. The comments also applaud the unprecedented efforts the FDA has made in this regard. (Response) FDA and CBP will continue outreach and education efforts as resources permit. See section III.M entitled ``Outreach and Enforcement'' later in this document for further discussion on this subject. (Comments) Several comments commend FDA for its efforts in developing the prior notice regulation in an efficient and effective manner, reaching out to affected stakeholders for input and comment, and acknowledge the tremendous effort put forth by the agency in the development of the regulation. Other comments state that the rule lacked real world international business input and will have both business and government unable to function because of the amount of paperwork generated, which will not stop a terrorist attack. In particular, one comment notes that tracing a grower of a particular shipment is impossible in many instances. (Response) FDA and CBP systems have been able to manage the millions of prior notice submissions received, reviewed, and responded to since December 12, 2003. The agencies strove to implement the requirements in the Bioterrorism Act in a manner that required only that information deemed necessary and appropriate to ensure FDA could meet its statutory obligation to receive, review and respond to prior notices and target those shipments needing inspection upon arrival in the United States. Based on FDA's and CBP's experience since December 2003, the agencies have revised some of the requirements in the IFR and eliminated some of the information we no longer deem necessary (e.g., HTS codes). FDA notes that the grower of a food in its natural state is required only when known. (Comments) One comment suggests that the prior notice IFR is ``functionally redundant'' because prior notice has long been a part of FDA protocol long before the Bioterrorism Act. (Response) While FDA agrees that most of the information required by the IFR has been submitted to FDA via CBP processes for decades, the information has not been required prior to arrival of the food, making prior notice a new, unique, and valuable process.
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(Comments) One comment suggests that the IFR was unduly costly,
ill-considered and generally more harmful than useful. An additional
comment believes that the prior notice requirements would restrict
trade more than necessary and hopes that the United States will
implement the Bioterrorism Act in the least trade-restrictive manner.
Another comment states that despite efforts to comply with the new
requirements, massive problems seem to constantly occur. Another
comment complains about accessibility to the Web site, cost and time of
the submission procedures, language barriers, and complexity of the
information requested.
(Response) FDA disagrees. The prior notice process, which allows
submission of the required information via either ABI/ACS or PNSI, has
been relatively smooth. Although there were some technical problems
encountered during the early implementation phase, FDA believes that
the graduated enforcement process coupled with the vigorous education
and outreach efforts by both the government and the industry have
supported a relatively smooth transition to the new procedures and have
improved compliance with the new requirements. FDA also has considered
its international trade obligations under various World Trade
Organization agreements, North America Free Trade Agreement, and other
international agreements throughout the rulemaking development
processes for both the IFR and this final rule. Both rules are
consistent with our international obligations.
(Comments) Some comments believe there is a disincentive towards
product diversification when exporting articles of food to the United
States because the prior notice requirements put them at a competitive
disadvantage compared to shipments that originate in the United States.
(Response) The requirement for prior notice was established by
Congress with the passage of the Bioterrorism Act to improve the
ability of the United States to prevent, prepare for, and respond to
bioterrorism and other public health emergencies. Section 307 of the
Bioterrorism Act requires prior notice of all food imported or offered
for import into the United States. FDA is aware of the international
trade obligations of the United States and has considered these
obligations throughout the rulemaking process for this final rule and
the IFR preceding it. Both are consistent with these international
obligations. FDA and CBP have actively explored ways to reduce the
burden on industry to the extent feasible while fulfilling the
Bioterrorism Act mandates. Accordingly, we have made a number of
changes in the final rule that minimize the impact of prior notice
requirements on the food being imported or offered for import into the
United States. We also note that the registration requirement applies
to domestic facilities, as well as foreign facilities, and that the
registration provisions in the Bioterrorism Act contain certain
exclusions that apply only to foreign facilities. (See e.g., 21 CFR
1.226(a), which exempts from the requirement to register a foreign
facility, if food from such facility undergoes further manufacturing/
processing (including packaging) by another facility outside the United
States; no similar exclusion applies to facilities within the Unites
States.)
(Comments) Other comments suggest that the IFR failed to include a
provision that would ensure that high risk imports arrive at ports
staffed by FDA inspection personnel and notes that this could be
accomplished by designating particular ports of entry for accepting
high risk products or requiring importers of such products to provide
longer notice to ensure adequate inspection coverage.
(Response) FDA disagrees. Section 307 of the Bioterrorism Act
specifically prohibits FDA from limiting the port of entry by stating,
``Nothing in this section may be construed as a limitation on the port
of entry for an article of food.'' We also disagree that certain
shipments require longer timeframes for submission of prior notice to
ensure adequate inspection coverage. Under a Memorandum of
Understanding (MOU) between FDA and CBP, published on January 7, 2004
(69 FR 924), FDA has commissioned thousands of CBP officers in ports
and other locations to conduct, on FDA's behalf, investigations and
examinations of imported foods. This helps ensure that there is
adequate inspection coverage, including at ports where FDA does not
currently have personnel.
B. Comments on the Legal Authority
(Comments) One comment requests that FDA delegate authority to the
U.S. Department of Agriculture (USDA), as it has with CBP, to enable
USDA to implement prior notice requirements on products where the USDA
shares jurisdiction.
(Response) FDA disagrees. FDA has not delegated its authority under
section 801(m) of the act to CBP, although FDA has commissioned CBP
officers in ports and other locations to conduct, on FDA's behalf,
investigations and examinations of imported foods. FDA recognizes that
there are some products over which both FDA and USDA have jurisdiction.
For example, both FDA and USDA's Animal and Plant Health Inspection
Service (APHIS) regulate the importation of fruits and vegetables into
the United States, although the goal of APHIS' regulation is to
safeguard U.S. agriculture and natural resources from the risks
associated with the plant pests. Nonetheless, FDA does not believe that
there is a need to have USDA implement the prior notice requirements
for products for which we share jurisdiction, nor do we believe that
doing so would lead to an efficient enforcement of the prior notice
requirements. The Bioterrorism Act mandates that advance notice be
given to FDA for any article of food that is being imported or offered
for import into the United States and that the Secretary receive,
review, and appropriately respond to such notifications. To accomplish
this, FDA established the PNC that operates 24 hours a day, 7 days a
week, to receive, review, and respond to these notices as they are
submitted. The purpose of prior notice is to enable FDA to conduct
inspections of imported foods at U.S. ports upon arrival and target
foods that may pose a significant risk to public health, based on the
information submitted.
Prior Notice is submitted electronically to FDA through either
Customs' ABI/ACS or FDA's PNSI. Regardless of the mode of transmission,
the prior notice information will undergo both a validation process and
a screening in FDA's Operational and Administrative System for Import
Support (OASIS) for food safety and security criteria. If the FDA
system does not indicate that further evaluation of or action on the
notice or article of food is necessary for prior notice, the system
will transmit a message through OASIS to the ABI/ACS interface for CBP
that the article of food may be conditionally released. However, if
additional evaluation of the prior notice information is necessary,
personnel at the FDA's PNC will access the information provided and
determine if that information suggests the potential for a significant
risk to public health.
FDA personnel are able to make this determination by using their
experience of imported foods, utilizing the expertise within the Center
for Food Safety and Nutrition (CFSAN), the Center for Veterinary
Medicine (CVM), the inspectional information obtained by the Office of
Regulatory Affairs (ORA), and utilizing the expertise of CBP staff who
are co-located with the PNC. If FDA determines that a potential health
risk is present, FDA or CBP will
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examine the food or take other appropriate action.
Evaluations of imported articles of food are made on an article-of-
food by article-of-food basis. CBP and FDA are continuously working
together to incorporate further intelligence gained from this process.
The recent addition of USDA personnel to assist in the sharing of
information affecting the safety and security of imported foods will
help further this effort.
FDA does note that food items that are under the exclusive
jurisdiction of the USDA are not subject to the requirements of prior
notice. (See the discussion on Sec. 1.277 (scope), discussed infra.)
(Comments) Another comment suggests that to be consistent with the
Bioterrorism Act, FDA should permit an alternative to prior notice for
administrative flexibility. The comments suggest that this could be
accomplished by including in the final rule a provision which states,
``Other measures as appropriate that provide an equivalent level of
assurance of compliance with the requirements of this part.''
(Response) FDA disagrees. Section 801(m) of the act requires the
submission of prior notice for all food imported or offered for import
into the United States, except as outlined in Sec. 1.277(b). FDA is to
use that information to determine whether it should inspect the food
upon arrival in the United States. Compliance with prior notice,
therefore, means providing the required information within the
specified timeframes. No other ``measures'' would ``provide an
equivalent level of assurance of compliance'' with the prior notice
requirements.
C. What Definitions Apply to This Subpart? (Sec. 1.276)
Section 1.276 of the IFR provides definitions for the following
terms: The act, calendar day, country from which the article
originates, country from which the article is shipped, FDA Country of
Production, food, grower, international mail, no longer in its natural
state, port of arrival, port of entry, registration number, shipper,
United States, and you. FDA received no comments on the definitions for
the act, calendar day, country from which the article originates, FDA
Country of Production, grower, and United States, and thus, the final
rule retains the definitions for these terms that were in the IFR.
Although no comments were received on the definitions for ``country
from which the article is shipped,'' ``registration number,'' and
``you,'' we made minor revisions to these definitions. We also added a
definition for the term, ``full address,'' although we did not get any
comments on this term.
1. The Act (Sec. 1.276(a))
The final rule defines ``the act'' to mean ``the Federal Food,
Drug, and Cosmetic Act.''
2. Calendar Day (Sec. 1.276(b)(1))
The final rule defines ``calendar day'' to mean ``every day shown
on the calendar.''
3. Country From Which the Article Originates (Sec. 1.276(b)(2))
The final rule defines ``country from which the article
originates'' to mean ``FDA Country of Production.''
4. Country From Which the Article is Shipped (Sec. 1.276(b)(3))
The final rule defines ``country from which the article is
shipped'' to mean ``the country in which the article of food is loaded
onto the conveyance that brings it to the United States or, in the case
of food sent by international mail, the country from which the article
is mailed.'' For clarity, we revised the last phrase of this definition
to change, ``the country in which the article will be mailed'' to ``the
country from which the article is mailed.''
5. FDA Country of Production (Sec. 1.276(b)(4))
The final rule defines ``FDA Country of Production'' to mean, for
an article of food that is in its natural state, the country where the
article of food was grown, including harvested or collected and readied
for shipment to the United States. If an article of food is wild fish,
including seafood that was caught or harvested outside the waters of
the United States by a vessel that is not registered in the United
States, the FDA Country of Production is the country in which the
vessel is registered. If an article of food that is in its natural
state was grown, including harvested or collected and readied for
shipment, in a Territory, the FDA Country of Production is the United
States. For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a vessel, the
FDA Country of Production is the country in which the vessel is
registered. If an article of food that is no longer in its natural
state was made in a Territory, the FDA Country of Production is the
United States.
6. Full Address (Sec. 1.276(b)(6))
The IFR did not have a definition for the term, ``full address.''
However, we added this term to the final rule for clarity since this
term is used throughout the rule. The final rule defines ``full
address'' to mean ``the facility's street name and number; suite/unit
number, as appropriate; city; Province or State as appropriate; mail
code as appropriate; and country.''
7. Grower (Sec. 1.276(b)(7))
The final rule defines ``grower'' to mean ``a person who engages in
growing and harvesting or collecting crops (including botanicals),
raising animals (including fish, which includes seafood), or both.''
8. Registration Number (Sec. 1.276(b)(13))
The final rule defines ``registration number'' to mean ``the
registration number assigned to a facility by FDA under section 415 of
the act (21 U.S.C. 350d) and subpart H of this part.'' FDA made a minor
change in this definition in the final rule by adding the phrase ``to a
facility'' after the word ``assigned'' to clarify that FDA assigns
registration numbers by facility.
9. United States (Sec. 1.276(b)(15))
The final rule defines ``United States'' to mean ``the Customs
territory of the United States (i.e., the 50 States, the District of
Columbia, and the Commonwealth of Puerto Rico), but not the
Territories.''
10. You (Sec. 1.276(b)(16))
The final rule defines ``you'' to mean ``the person submitting the
prior notice, i.e., the submitter or the transmitter, if any.'' We made
a minor change to this definition by simplifying the last phrase of the
definition to ``i.e., the submitter or the transmitter, if any.''
FDA received comments on the definitions for the following terms in
the IFR: food, international mail, no longer in its natural state, port
of arrival, and shipper. FDA also received comments that recommend that
FDA include additional definitions for the following terms in the IFR:
Carrier, manufacturer, trip number, and ultimate consignee. FDA
responds to these comments in the following paragraphs.
11. Food (Sec. 1.276(b)(5))
The IFR defines ``food'' as having the meaning given in section
201(f) of the act, except that it does not include food contact
substances as defined in section 409(h)(6) of the act (21 U.S.C.
348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u). Examples of
food include fruits, vegetables, fish, including seafood,
[[Page 66301]]
dairy products, eggs, raw agricultural commodities for use as food or
as components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods,
candy, and canned foods.
(Comments) One comment asks FDA to define food contact substances,
which are exempt from the requirements of prior notice, to include
secondary direct food additives. The comment reasons that secondary
direct food additives, many of which are food processing aids, meet the
criteria for food contact substances as defined in section 409(h)(6) of
the act (21 U.S.C. 348(h)(6)). The comment further reasons that
secondary direct food additives meet the criteria that FDA used in the
registration IFR to exclude food contact materials from the
requirements of the registration IFR as they are not ``food for
consumption'' in that ``they are not intentionally eaten for their
taste, aroma, or nutritive value'' (68 FR 58894 at 58911).
(Response) Some secondary direct food additives meet the definition
of food contact substances as given in section 409(h)(6) of the act
and, therefore, would not be subject to the prior notice requirements
(Sec. 1.276(b)(5)(i)(A)). The comment, however, asks about secondary
direct food additives that are not food contact substances, for example
food processing aids. The IFR concluded that food processing aids that
are not food contact substances are subject to prior notice ``Whether a
food processing aid or `indirect additive' is subject to prior notice
depends upon whether such a substance is `food' under this rule. As
noted, for purposes of the interim final rule, `food' excludes `food
contact substances' as defined at section 409(h)(6) of the FD&C Act.
Among other things, unlike food processing aids and `indirect
additives,' `food contact substances' are not `intended to have any
technical effect in food,' [section 409(h)(6) of the act]. In addition,
`food' excludes pesticides as defined at 7 U.S.C. 136(u). Thus, if the
substance is not a pesticide and is intended to have a technical effect
in the food being processed, the substance is not exempt from the
definition of `food' under Sec. 1.276(b)(5) in the interim final rule.
This is a reasonable result in that such processing aids are
intentionally and directly added to `traditional' foods.'' (68 FR 58974
at 58986). We continue to hold this view. Thus, if a secondary direct
food additive is not a food contact substance but is a food processing
aid, then it would be subject to prior notice.
(Comments) Two comments ask the FDA to clarify the term,
``reasonably expected to be directed to a food use.'' One comment
states that seed produced by seed companies is intended to be used for
planting crops, but the production process inevitably results in
remnant or culled seed that is suitable for use as animal feed (and to
a far lesser degree, as food for human consumption), which generally is
sold by the seed company as such. The comment states that a similar
issue arises with some crops, such as onions, for which bulbs sold to
farmers may also be used as feed or, in limited cases, as food if they
are determined to be remnant or culled. The comment believes that FDA
should provide specific limitations on the definitions of ``reasonably
believes'' and ``reasonably expected'' that take into consideration
that the seed produced by seed companies is intended to be used for
planting crops, even though it is understood that there inevitably will
be some remnant seed and culls. Without such limitations, the comment
believes the rule is unreasonably broad, imposes a burden on seed
companies primarily marketing seeds for planting purposes that is out
of proportion to the protective goals of the act, and is subject to
widely varying interpretations. Another comment notes that the seed
industry's research and development activities generate very small
amounts of seed that may be found ``unsuitable'' for planting and end
up in the food supply, and similarly asks for clarification of the
``reasonably believes'' and ``reasonably expected'' language.
(Response) In the preamble to the IFR, we state that ``FDA will
consider a product as one that will be used for food if any of the
persons involved in importing or offering the product for import (e.g.,
submitter, transmitter, manufacturer, grower, shipper, importer, owner,
or ultimate consignee) reasonably believes that the substance is
reasonably expected to be directed to a food use'' (68 FR 58974 at
58987). The purpose of this statement was to explain when an article of
food would be subject to prior notice if it is capable of multiple
uses. The comments, and our experience with the IFR, have shown that
there is some confusion as to how to determine when a substance that is
capable of a food use and a nonfood use is a ``food'' for purposes of
prior notice. To clarify, we will consider such a substance to be
``food'' for the purpose of prior notice if it is reasonably likely to
be directed to a food use. This should make it clearer that, as
explained in the preamble to the IFR, the determination is not based on
the intended use of the article (68 FR 58974 at 58987).
In one of the comments, the seed will ``inevitably'' contain
remnant seed and culls that will be diverted to human or animal feed.
In this case, since at the time of import, the seed is reasonably
likely to be directed to a food use, prior notice is required. FDA
believes this is consistent with the purpose of the Bioterrorism Act.
With respect to the other comment about seeds found ``unsuitable'' for
planting, there is insufficient detail in the comment to determine
whether these seeds would be considered food.
Nonetheless, we note that the Prior Notice Final Rule Draft CPG,
announced elsewhere in this issue of the Federal Register, proposes an
enforcement policy regarding seeds for planting. Under the draft
policy, FDA and CBP would typically consider not taking any regulatory
action regarding seeds that will be used for cultivation. The policy
would apply when no more than a small portion of that seed is diverted
from cultivation to animal feed or other food use. It would not apply,
however, where the seed is used for the production of edible sprouts,
such as alfalfa seeds for the production of alfalfa sprouts.
(Comments) One comment states that the Bioterrorism Act regulations
do not present a means to provide FDA with certification that any of
the indicated persons (i.e., submitter, transmitter, manufacturer,
grower, shipper, importer, owner, or ultimate consignee) do not
reasonably believe that an item is reasonably expected to be directed
to a food use prior to arrival at a U.S. port. The comment further
states that there is no method to avoid classifying their products as
anything other than those flagged as FD4 \2\ articles requiring prior
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notice, thereby providing no means to avoid refusal of the goods upon
arrival because the prior notice was not filed.
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\2\ HTS codes are ``flagged'' in ACS as follows to indicate that
products are or may be under FDA jurisdiction:
FD0--Indicates that FDA has determined the article, even though
subject to FDA's laws and regulations, is acceptable for CBP release
without further presentation of prior notice or other entry
information to FDA.
FD1--Indicates that the article may be subject to FDA
jurisdiction, including FDA review under 801(a) of the act. For
products not subject to FDA jurisdiction, a filer can ``Disclaim''
product from FDA notification requirements.
FD2--Indicates that the article is under FDA jurisdiction and
review of entry information by FDA under section 801(a) of the act
will take place. However, the article is not ``food'' for which
prior notice information is required.
FD3--Indicates that the article may be subject to prior notice
under section 801(m) of the act and 21 CFR Part 1, subpart I. ,
e.g., the article has both food and nonfood uses.
FD4--Indicates that the article is ``food'' for which prior
notice is required under section 801(m) of the act and 21 CFR Part
1, subpart I.
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(Response) FDA disagrees. FDA is continuously reviewing the FD3 and
FD4 flags associated with HTS codes. The HTS codes are flagged to
indicate which products will (FD4) or may (FD3) require prior notice
and which product will or may require FDA review under section 801(a)
of the act for admissibility; all FDA-regulated products are covered,
not just foods. If you believe that an item has been incorrectly
flagged, you should contact the FDA and provide a statement that
explains your rationale. The designation will be reviewed and action
taken to correct the flag if deemed appropriate. With respect to the
comment about providing certification about the belief of the
``indicated persons,'' submitters may disclaim articles of food marked
FD3 if the article is not reasonably likely to be directed to a food
use by using an affirmation of compliance in ABI/ACS.
(Comments) Many comments address the FD flags associated with the
HTS codes. Two comments state that they are currently importing a
product that was flagged FD4, which requires that prior notice be
submitted for that article. However, the item is not an article of food
and the commenter would like the HTS code changed from a FD4 flag to a
FD3 flag. An additional comment had concerns about multiple use
products, where one use would require prior notice and another use
would not. Another comment states that there is no clear methodology
provided to disclaim an item beyond the initial FD3 designation. The
comment recommends that the agency outline the elements of a due
diligence protocol that would become part of the disclaimer process.
One comment suggested that the data elements in the prior notice
submission be amended to permit an affirmation that a substance is not
directed for a food use. This would avoid the article of food from
being refused if the prior notice was submitted for a category that
required prior notice. Another comment wants FDA to develop a method
that would allow the submitter or the transmitter to disclaim the need
for prior notice at the time of the prior notice transmission.
(Response) If there is a concern regarding the FD flags associated
with the HTS codes, you should contact FDA and provide a detailed
description of why you believe the HTS code is flagged incorrectly. FDA
and CBP are continuously reviewing and updating the FD flags associated
with the HTS codes. If you have questions regarding whether prior
notice is required for a particular article of food, contact the PNC
for assistance. Furthermore, we have established procedures in place to
disclaim articles of food the submitter believes does not require prior
notice. This can be accommodated by ABI/ACS as an affirmation of
compliance.
(Comments) One comment states that the list of HTS codes flagged
for prior notice (both FD3 and FD4) (as provided by Customs Admin
message 03-2605 dated October 31, 2003) contains 762 tariff numbers.
The comment asks if this is a definitive list at this point, especially
since FDA and CBP estimated the number to be around 2,000.
(Response) This is not a definitive list. FDA and CBP are
continuously reviewing and updating the FD flags associated with the
HTS codes. Guidance regarding the HTS flags is posted at
http://
www.cfsan.fda.gov/~dms/htsguid3.html. The lack of an FD3 or FD4
designation does not mean that prior notice is not required. If the
article of food fits the definition of food provided in Sec. 1.276 of
the final rule, then prior notice is required for that article of food.
(Final rule) Section 1.276(b)(5) of the final rule defines ``food''
as having the meaning given in section 201(f) of the act, except that
it does not include food contact substances as defined in section
409(h)(6) of the act (21 U.S.C. 348(h)(6)) or pesticides as defined in
7 U.S.C. 136(u). Examples of food include fruits, vegetables, fish,
including seafood, dairy products, eggs, raw agricultural commodities
for use as food or as components of food, animal feed (including pet
food), food and feed ingredients, food and feed additives, dietary
supplements and dietary ingredients, infant formula, beverages
(including alcoholic beverages and bottled water), live food animals,
bakery goods, snack foods, candy, and canned foods.
We revised this definition for clarity in the final rule by adding
the phrase, ``except as provided in paragraph (b)(5)(i) of this
section,'' in the first sentence; and reworded paragraph (b)(5)(i) to
read, ``For purposes of this subpart, food does not include:''.
12. International Mail (Sec. 1.276(b)(8))
The IFR defines ``international mail'' to mean foreign national
mail services. International mail does not include express carriers,
express consignment operators, or other private delivery services.''
(Comments) One comment asks FDA to define international mail to
include express carriers. Another comment asks FDA to clarify whether
sending an item by express delivery will be considered ``international
mail'' or ``express carrier.''
(Response) FDA declines to make the requested change. The IFR
defines ``international mail'' to mean ``foreign national mail
services'' and expressly excluded express carriers, express consignment
operators, or other private delivery services from the definition. We
retain this definition in the final rule but revised the wording to
make the definition easier to read, and to add the phrase, ``unless
such service is operating under contract as an agent or extension of a
foreign mail service,'' at the end of the definition. This phrase was
needed to clarify that a contractor working for a foreign mail service
also is included in the definition of ``international mail.''
International mail is a function of the foreign postal organizations of
sovereign countries who are members of the International Postal Union.
International mail shipments generally do not utilize any of the
electronic data transmission systems commonly used by express
consignment carriers and private delivery services.
(Final rule) Section 1.276(b)(8) of the final rule defines
``international mail'' to mean foreign national mail services.
International mail does not include express consignment operators or
carriers or other private delivery services unless such service is
operating under contract as an agent or extension of a foreign mail
service.
13. Manufacturer (Sec. 1.276(b)(9))
(Comments) Two comments request that we define the word
``manufacturer.'' One of these suggests that we define ``manufacturer''
to mean the last entity to conduct a processing operation; e.g.,
including bottling but excluding labeling.
(Response/Final rule) As discussed in section III.H.7.a of this
document, FDA agrees and has added a definition for manufacturer.
Section 1.276(b)(9) of the final rule defines manufacturer as the last
facility, as that word is defined in Sec. 1.227(b)(2) (in the
registration rule), that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any
similar activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
[[Page 66303]] manufacturing/processing is considered the manufacturer. 14. No Longer in Its Natural State (Sec. 1.276(b)(10)) The IFR defines ``no longer in its natural state'' to mean that ``an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.'' (Comments) One comment asks FDA to clarify the term, ``no longer in its natural state'' by expressly stating that seed for sowing or planting that are shucked, sorted and sized remain ``in their natural state'' for purposes of prior notice. Another comment believes that activities such as trimming, washing, waxing, and packaging of produce are part of normal harvesting activities and seeks to clarify that produce that has been trimmed, washed, waxed, and/or packaged is still ``in its natural state.'' (Response) The IFR defines ``no longer in its natural state'' as meaning ``an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.'' In the final rule, we are deleting the word ``waxed'' in the list of activities that render the food still in their natural state because this was included in error. After publishing the prior notice IFR, FDA issued guidance in the form of questions and answers to help clarify the prior notice requirements. In the second edition of ``Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2)'' (the prior notice question and answer guidance document) available at http://www.cfsan.fda.gov/~pn/pnqagui2.html, issued May 2004, under section B, Definitions, question 4.1 of the guidance, we discuss seeds. If the seed will be used only for sowing or planting, and not directed to food use, then no prior notice is required and, therefore, there is no need to determine whether the seeds are in their natural state for the purposes of prior notice. Regarding the other comments, the definition for ``no longer in its natural state'' in the final rule already states that trimmed or washed produce is still in its natural state, if those activities are attendant to harvest or collection. This same definition states that waxing and packaging are activities that render food no longer in its natural state. (Final Rule) Section 1.276(b)(10) of the final rule defines ``no longer in its natural state'' to mean that ``an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, or polished or packaged are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.'' 15. Port of Arrival (Sec. 1.276(b)(11)) The IFR defines ``port of arrival'' to mean ``the water, air, or land port at which the article of food is imported or offered for import into the United States, i.e., the port where the article of food first arrives in the United States. This port may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).'' (Comments) Two comments ask FDA to clarify what is meant by the term, ``port of arrival.'' One comment notes that notwithstanding the definition in the IFR, FDA representatives have stated that ``port of arrival'' means the first port where the articles of food are ``off- loaded'' and that if the articles remain on the vehicle or vessel, then the port of arrival definition has not been met for these and only these articles. Another comment reports being told by FDA representatives that when a ship arrives from Europe, only goods ``off loaded'' in that port must be given prior notice within the timeframes required. If the ship has food destined to be ``off loaded'' in other ports, prior notice must be filed for each port in accordance with the timeframes required by the regulations. The comments ask FDA to clarify this definition. (Response) FDA agrees to clarify the term, ``port of arrival,'' as it is a required data element in a prior notice and important for gauging the timeframes for prior notice submission. The interim final rule defined ``port of arrival'' as ``the water, air, or land port at which the article of food is imported or offered for import into the United States, i.e., the port where the article of food first arrives in the United States.'' In essence, the comments ask us to identify the point at which an article of food ``first arrives'' in the United States when the food is arriving by water. The preambles to the proposed rule and IFR explained that for FDA to be able to protect U.S. consumers from terrorism or other food- related emergencies, it was important for FDA to receive prior notice before the food covered by that notice is shipped around the country and potentially lost to government oversight (68 FR 5428 at 5431 and 68 FR 58974 at 58991). The preambles concluded that prior notice must be given before the food first physically appears in the United States so that FDA can inspect the food upon arrival. As noted in the comments, some shipments contain both food and nonfood cargo. If the carrier stops at multiple ports, the articles of food may remain on board at intermediate ports where nonfood articles are unloaded. The articles of food are then unloaded at one or more subsequent ports. When food is shipped via water and FDA has bioterrorism or other public health emergency concerns about the food, it would inspect the food at the point of unloading. This is because before the food is unloaded it would remain on the carrier either at a secured port under CBP authority or in open water, preventing intentional or unintentional diversion until unloading. The same is true for food shipped by air. When an article of food remains on board at one airport to be unloaded at a subsequent airport, FDA would not need to examine the food until the point where that food is unloaded. In contrast, when food is shipped via land, any articles of food
[[Page 66304]]
remaining on board would travel through the United Stated while outside
of secured ports and, therefore, could be potentially lost to
government oversight due to off-loading in noncontrolled areas.
Therefore, we believe that when an article of food is shipped via
water or air, the article ``first arrives'' at the port where it is
unloaded. When an article of food is shipped via land, the article
``first arrives'' at the port where it crosses the border. We are
revising the definition of ``port of arrival'' in the final rule to
clarify this distinction. We have added a statement that for an article
of food arriving by water or air, the port of arrival is the port of
unloading. For an article of food arriving by land, the definition now
states that the port of arrival is the port where the article of food
first crosses the border into the United States.
(Comments) One comment asks FDA to clarify the word ``port.'' The
comment asks whether the IFR applies to U.S. Navy ships returning to
``port'' or to a U.S. Naval Base from outside U.S. territorial waters.
The comment notes that U.S. Navy fleet ships always have been
considered U.S. territory. The comment also notes that the CPG states
that food entering and then leaving the ``port area'' is not subject to
prior notice and asks FDA to clarify the term, ``port area.''
(Response) FDA clarifies that the term, ``port,'' is not defined
but that ``port of arrival'' and ``port of entry'' are defined. The
term, ``port,'' as used in the rule relates to ports identified by CBP.
In 19 CFR 101.1 Definitions, ``Port and port of entry refer to any
place designated by Executive Order of the President, by order of the
Secretary of the Treasury, or by Act of Congress, at which a Customs
officer is authorized to accept entries of merchandise to collect
duties, and to enforce the various provisions of the Customs and
navigation laws. The terms `port' and `port of entry' incorporate the
geographical area under the jurisdiction of a port director.'' If CBP
changes this definition in the future, we will evaluate whether Sec.
1.276(b)(12) should be revised to incorporate those changes. Proposed
policies in the Prior Notice Final Rule Draft CPG, would apply to most
articles of food on U.S. Navy ships returning to ``port'' or a U.S.
Naval Base from outside U.S. territorial waters. One policy states that
FDA and CBP should typically consider not taking any regulatory action
when an article of food is imported or offered for import for an
official government purpose without prior notice, provided that a
Federal Government agency is the importer of record. Another states
that FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
noncommercial purposes with a noncommercial shipper without prior
notice. One of the examples of foods imported or offered for import
that may be covered by this policy is food in household goods,
including military transfers.
(Final rule) Section 1.276 (b)(11) of the final rule defines ``port
of arrival'' as ``the water, air, or land port at which the article of
food is imported or offered for import into the United States. For an
article of food arriving by water or air, this is the port of
unloading. For an article of food arriving by land, this is the port
where the article of food first crosses the border into the United
States. The port of arrival may be different than the port where
consumption or warehouse entry or foreign trade zone admission
documentation is presented to the U.S. Customs and Border Protection
(CBP).''
16. Shipper (Sec. 1.276(b)(14))
The IFR defines ``shipper'' to mean ``the owner or exporter of the
article of food who consigns and ships the article from a foreign
country or the person who sends an article of food by international
mail to the United States.''
(Comments) Two comments request that we clarify the IFR's
definition of ``shipper.'' One comment asks whether the shipper is the
person who physically loads the shipment for its final journey to the
United States, the company that has the business contract to export the
food to the U.S. importer, or someone in the middle who removes the
shipment from temporary storage for the initial phase of its entire
journey to the United States. Another comment asks for clarification as
to who is the shipper when the producer's shipping platform is involved
in the shipment--the transporter who takes responsibility for the whole
shipment or the producer's own facility (assuming that neither would be
classified as ``manufacturer'')?
(Response) In the IFR, we defined ``shipper'' based upon the
description of shipper as it is discussed in CBP's proposed rule
``Required Advance Electronic Presentation of Cargo Information'' (July
23, 2003, 68 FR 43574 at 43577). We have decided to continue to use
this definition in the final rule. In the examples cited in the
comments above, the shipper is considered to be the entity that
arranges or directs the shipment to be sent to the United States,
irrespective of who physically transports it. In the first example it
would be the company having the business contract to export the food;
in the second, assuming that the producer is sending the food to a firm
in the United States, they (the producer) would be the shipper. It
should also be noted that a firm may be both a shipper and a
manufacturer with respect to the same product if the product is shipped
from the point of manufacture to the United States. Moreover, we have
added the phrase, ``or express consignment operators or carriers or
other private delivery service,'' after the term, ``international
mail,'' in the definition of ``shipper'' to clarify that a shipper is
involved with various types of transactions, and not just international
mail shipments.
(Final rule) Section 1.276(b)(14) of the final rule defines shipper
to mean ``the owner or exporter of the article of food who consigns and
ships the article from a foreign country or the person who sends an
article of food by international mail or express consignment operators
or carriers or other private delivery service to the United States.''
17. Comments Requesting Additional Definitions
(Comments) Several comments request that we define additional terms
in the final rule, including: ``trip number,'' ``carrier,'' and
``ultimate consignee.''
(Response) FDA disagrees. FDA believes these terms are sufficiently
clear based on our experience since the initial implementation of the
prior notice IFR. FDA intends to interpret the ``ultimate consignee''
consistent with CBP's use of that term in regards to the entry of
merchandise, which is contained in paragraph 6.3 of Customs Directive
No. 3550-079A, June 27, 2001. As stated in that CBP Directive, ``if the
merchandise has not been sold or consigned to a U.S. party at the time
of entry or release, then the Ultimate Consignee at the time of entry
or release is defined as the proprietor of the U.S. premises to which
the merchandise is to be delivered.''
18. Summary of the Final Rule
Section 1.276 of the final rule defines the following terms: The
act, calendar day, country from which the article originates, country
from which the article is shipped, FDA Country of Production, food,
full address, grower, international mail, manufacturer, no longer in
its natural state, port of arrival, port of entry, registration number,
shipper, United States, and you.
[[Page 66305]] D. What is the Scope of this Subpart? (Sec. 1.277) Section 1.277(a) of the IFR states that the prior notice requirements apply to all food for humans and other animals that is imported or offered for import into the United States. This covers food for use, storage, or distribution in the United States, and includes food for gifts, trade and quality assurance/quality control samples, food for transshipment through the United States to another country, food for future export, and food for use in a U.S. Foreign Trade Zone (FTZ). Section 1.277(b) of the IFR sets out the exclusions from prior notice. It excludes food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States (i.e., for consumption by themselves, family and friends, not for sale or other distribution); food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States; food that is imported then exported without leaving the port of arrival until export; and meat food products, poultry products, and egg products that, at the time of importation, are subject to the exclusive jurisdiction of USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). FDA received many comments about Sec. 1.277(b), which are addressed in order of the exclusions covered in the IFR: Food for an individual's personal use when carried by or otherwise accompanying an individual; homemade food; food that is imported for immediate exportation; and foods under exclusive USDA/Food Safety and Inspection Service jurisdiction. The comments concerning requests for additional exclusions from the scope of the prior notice requirements are addressed by issue, beginning with general comments/requests. 1. Food for an Individual's Personal Use When Accompanied at Arrival Section 1.277(b)(1) of the IFR excludes food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States. The IFR explains that in this situation there was no ``shipper'' as that term is used in section 801(m) of the act. (Comments) One comment requests that FDA expand the exemption for food carried in to the United States for personal use to include all food products carried in personal baggage; or to allow declaration of entry to be made through existing general CBP entry declaration procedures. (Response) FDA disagrees. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the United States (e.g., food that is in his or her carry-on or checked baggage) when the food is for that individual's personal use (Sec. 1.277(b)(1)). This means that the food is for consumption by the individual or by the individual's family and friends and is not for sale or other distribution. If the food carried by or otherwise accompanying an individual is for commercial purposes, then prior notice requirements apply. As we explained in the IFR preamble, we do not believe that Congress intended for us to characterize travelers bringing food back from their travels in their personal baggage for their own use as ``shippers'' for purposes of section 801(m) of the act. When there is a commercial purpose involved, there is a ``shipper,'' i.e., the person or entity on whose behalf the traveler is bringing in the food. Thus, by its terms, section 801(m) of the act requires that food carried by or otherwise accompanying an individual arriving in the United States that is not for personal use be subject to prior notice. Moreover, we explained that we would potentially create a loophole that would defeat the purpose of the prior notice rule if we were to exempt all food products carried in personal baggage. (Final rule) Section 1.277(b)(1) of the final rule continues to state that the rule does not apply to food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States. 2. Homemade Food Sent as Personal Gift Section 1.277(b)(2) of the IFR excludes food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States. (Comments) No comments were received about this issue. (Final rule) Section 1.277(b)(2) is retained without change. 3. Food Imported Then Exported Without Leaving Port of Arrival Until Export Section 1.277(b)(3) of the IFR excludes food that is imported then exported without leaving the port of arrival until export. (Comments) One comment states that if food moves for immediate export \3\ (IE) out of the same port, it is not subject to prior notice. However, if the food moves on a T&E entry, prior notice is required. The comment provides a scenario where a shipment arrives at Los Angeles Harbor and then moves to Los Angeles Airport for export. Los Angeles Harbor and Los Angeles Airport are separate ports and each has its own port code assigned by CBP. The comment states that CBP considers this an IE entry. Similarly, the comment questioned if FDA considers this an IE entry as well, or if it is considered a T&E entry that requires prior notice. --------------------------------------------------------------------------- \3\ Food that is brought to a U.S. port but is then directly exported from that port of arrival is entered under a CBP IE entry and subject to the limitations of an IE bond. In essence, this food may not leave the port of arrival until export. --------------------------------------------------------------------------- (Response) If the food arrives in and is exported from the same port, then it is not subject to prior notice. FDA considers a port to be the same as defined by CBP in 19 CFR 101.1; i.e., the term ``port'' incorporates the geographical area under the jurisdiction of a port director. The geographical boundaries of the port of Los Angeles-Long Beach are described in 19 CFR 101.3(b)(1). While Los Angeles Harbor and Los Angeles Airport are separate for CBP management purposes, they are considered to be within the same port. Accordingly, IE entries may be filed for movements between Los Angeles Harbor and Los Angeles Airport followed by exportation of the goods. Similarly, because such movements would not leave the port of arrival until export, prior notice would not be required. (Comments) One comment suggests that articles of food imported and admitted into a FTZ in or adjacent to the port of arrival as ``zone restricted status'' merchandise, and then exported from the port of arrival under an IE entry, are sufficiently similar to an IE entry that the same restrictions as for an IE entry would apply if the food were refused admission under 801(m) of the act. The comment, therefore, recommends that these articles should be exempt from the prior notice requirements. (Response) The fact that food is for admission into an FTZ does not, by itself, mean that the food is not subject to the requirements of the prior notice regulation (Sec. 1.277(a)). In the first instance described in the comments, where the article of food is imported and admitted into an FTZ located in the port of arrival and then exported from the port of arrival, prior notice is not required (Sec. 1.277(b)(3)). In the second instance, where the article of food is imported and admitted into an FTZ
[[Page 66306]]
located adjacent to the port of arrival and then exported, prior notice
would be required since the food has left the port of arrival before
export and may not be subject to the limitations of an IE bond. An FTZ
adjacent to the port of arrival is considered to be outside the port of
arrival, and therefore not sufficiently similar to those IE entries
that have never left the port of arrival.
(Comments) Several comments ask that FDA exempt the airline
industry's food service from the requirements of prior notice. The
comments assert that there is no danger to the American public from
this operation. One comment suggests that leftover unopened cans of
soda, unopened small bottles of liquor (to be held in bonded storage)
or other ``dry-stores'' items on flights inbound to the United States
and intended for use on later flights should be exempt from prior
notice. In addition, the comment states that it is not possible to
determine at ``wheels up'' what will remain upon landing in the United
States. One comment states that it is impossible to provide detailed
information about leftover soda and liquor on incoming international
aircraft. One comment proposes the addition of the following exception
to Sec. 1.277(b): ``Food that is imported by a shipper operating an
aircraft in international air transportation, then exported by the same
shipper, [as] long as such food remains on board the aircraft at all
times from import to export.''
(Response) If the aircraft food is consumed on the international
flight or discarded and is not entered into the United States for use,
storage, or distribution or remains on board and is exported from the
same port into which it arrived, it is outside the scope of the
regulation and prior notice is not required. By contrast, prior notice
is required for in-flight food that is moved out of the port of arrival
to caterers for use on other international or domestic flights (Sec.
1.277).
(Comments) One comment questions whether wines manufactured in a
foreign country and present on a passenger ship that may cruise or dock
in the United States Territorial Sea require prior notice.
(Response) If the wine remains on the ship, it does not require
prior notice (Sec. 1.277(b)(3)). However, if the wine is offloaded
from the ship and leaves the port of arrival in the United States,
prior notice would be required.
(Comments) One comment asks that if wines are loaded onto a
passenger ship at a U.S. port, but such an article of food has been
previously imported into the U.S. to be exported or transshipped, does
the prior notice for such an article of food require the manufacturer's
registration number.
(Response) Prior notice is required for food imported or offered
for import into the United States before arrival and not when the food
is loaded onto a passenger ship in the United States.
(Final rule) Section 1.277(b)(3) is retained without change in the
final rule and excludes food that is imported then exported without
leaving the port of arrival until export.
4. Food Under the Exclusive Jurisdiction of USDA
The IFR in Sec. 1.277(b)(4), (b)(5), and (b)(6) excludes: Meat
food products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.); poultry products that at the time of
importation are subject to the exclusive jurisdiction of USDA under the
Poultry Products Inspection Act (21 U.S.C. 451 et seq); and egg
products that at the time of importation are subject to the exclusive
jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C.
1031 et seq). The IFR explains that these are excluded as directed in
the Bioterrorism Act.
(Comments) Comments state that live animals including cattle, pig,
chickens, etc. require prior notice, whereas prior notice is not
required for products exclusively regulated by the Federal Meat
Inspection Act. The comments recommend that animals regulated
exclusively by USDA/Veterinary Services such as live cattle, pigs, and
chickens be exempt from prior notice because USDA examines them upon
importation. One comment further suggests that live animals requiring
prior notice should be those animals regulated by FDA, such as turtles,
game animals, etc. Another comment asks whether prior notice is
required for livestock sent to the United States for recreational
purposes, but after a number of years are expected to be slaughtered
and enter the food chain as pet food. One comment asks that FDA exempt
breeder livestock not imported for immediate slaughter and remove
``FD3'' flags from HTS codes that cover breeder livestock to avoid
confusion at the ports of arrival regarding applicability of prior
notice requirements.
(Response) FDA disagrees. Live animals, such as poultry and cattle,
are food for purposes of prior notice (Sec. 1.276(b)(5)(ii)) if the
article of food is reasonably likely to be directed to a food use (see
discussion supra on the definition of food in section III.C.11). Note
that live food animals are not excluded from prior notice under section
801(m)(3)(B) of the act and Sec. 1.277(b)(4) or (b)(5) because live
food animals do not fall within the exclusive jurisdiction of USDA
under the Federal Meat Inspection Act or Poultry Products Inspection
Act. If the live animals are imported for a nonfood use (i.e., as a
pet, for show purposes, racing) and are not reasonably likely to be
directed to a food use, then prior notice is not required. USDA/
Veterinary Services inspects imported live animals for animal health,
not human health, purposes. An FD3 flag associated with breeder
livestock means that the livestock may be subject to prior notice
requirements. If the live animal is not reasonably likely to be
directed to a food use, then the HTS code may be disclaimed because
prior notice is not required.
(Comments) Some comments had a concern regarding USDA-regulated
products. One comment noted that USDA-regulated products were excluded
from the FDA prior notice rule, but that an HTS codes document released
on November 20, 2003, highlights a number of products that are
regulated by USDA. Another comment questions why cattle imported for
slaughter are coded FD4 and all other cattle are coded FD3 when the
importation of cattle is under the responsibility and jurisdiction of
USDA.
(Response) Only items that are under the exclusive jurisdiction of
the USDA are excluded from the requirements of prior notice. Articles
of food that are jointly regulated by FDA and USDA are subject to the
requirements of prior notice. Live animals raised for food, even though
not in their final, edible form, are considered to be food under the
act. United States v. Tomahara Enterprises Ltd., Food Drug Cosm. L.
Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live calves intended as veal are
food) and United States v. Tuente Livestock, 888 F. Supp. 1416 (S.D.
Ohio 1995) (live hogs are food).
(Final rule) Section 1.277(b)(4), (b)(5), and (b)(6) of the final
rule are retained without change and exclude meat food products that at
the time of importation are subject to the exclusive jurisdiction of
the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
poultry products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.); and egg products that at the time of
importation are subject to the exclusive jurisdiction of USDA under the
Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
[[Page 66307]] 5. Additional Exclusions Requested--General (Comments) One comment states that cough drops containing OTC (over-the-counter) Monograph active ingredients are regulated as an over-the-counter drug by the FDA, and therefore, are not subject to prior notice. However, CBP categorizes all cough drops, including ones regulated as drugs by the FDA, as candy subject to regulation by FDA as food. Therefore, due to this classification by CBP, cough drops would require prior notice. In addition, another comment asks if pharmaceuticals, such as over-the-counter drugs, are exempt from prior notice requirements. (Response) CBP classification does not identify foods requiring prior notice. However, CBP and FDA have worked together to provide indicators; i.e., flags associated with HTS codes to indicate which articles being imported may require prior notice submission. The FD3 flag indicates that the products categorized by that HTS code may require prior notice submission; those products categorized in those HTS codes flagged as FD3 that do not require prior notice submission may be disclaimed by the filer upon entry. On the other hand, the FD4 flag indicates that the products categorized by that HTS code require prior notice submission. FDA has published guidance regarding these flags and has published a list of the HTS codes with FD3 and FD4 flags. The guidance is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html and the list of codes is posted at http://www.cfsan.fda.gov/~pn/htscodes.html. The comment asks about such articles containing OTC monograph active ingredients. HTS Code 3004909176 (cough and cold preparations) would apply to, among other articles, cough suppressants that contain OTC monograph active ingredients. This HTS Code is not flagged for either FD3 or FD4, meaning that prior notice would not be required. Candies, which are food, would fall under different HTS Codes and would be subject to prior notice. (Comments) One comment recommends that FDA's food category codes for raw materials could be made more complete to cover the range of materials known to be used in products marketed as foods. The comment states that there are numerous CBP ``Customs Codes'' that do not contain the appropriate FD3 or FD4 codes and that this causes confusion among the industry with some groups interpreting the lack of an FDA code as meaning that that food ingredient was exempt from prior notice, even if the ingredient is known to be used in food. Other comments assume that ingredients lacking an FD3 or FD4 code that are best known as being active ingredients in drugs, but are also used in dietary supplements, are exempt from prior notice. The comment recommends that these codes should be made as complete as possible and that FDA should indicate that ingredients without a FD3 or FD4 code may still require prior notice. (Response) FDA and CBP continuously evaluate the HTS codes in order to attach the appropriate FD3 and FD4 designations. However, the lack of an FD3 or FD4 designation does not mean that prior notice is not required. If the article fits the definition of food provided in Sec. 1.276 of the final rule, then prior notice is required for that article of food. If you believe that an item has been incorrectly flagged, or is not currently flagged, but should be, you should contact the FDA and provide a statement with your suggestion and basis for the flag designation. (Comments) One comment believes that there is a conflict between the registration (21 CFR part 1, subpart H) and prior notice IFRs, where the former is based upon the intended use of food (i.e., consumption), and the latter applies to ``all'' food. The comment states that this has caused difficulties with the import process by: (1) Requiring foreign facilities to register in order to meet the prior notice requirements and (2) requiring drug and device establishments to register as food facilities in order to facilitate importation of intra-company articles. The comment believes this places an undue burden on drug and device establishments and hampers the importation process for articles not intended for use in food, as well as for food articles not intended for consumption. The comment suggests that section Sec. 1.277 be changed to read: ``This subpart applies to all food intended for consumption by humans and other animals * * *.'' In addition, the comment suggests that the HTS codes be modified to allow articles designated with a FD3 or FD4 code to be disclaimed, with rationale, depending on their intended use. (Response) FDA disagrees. FDA disagrees with changing Sec. 1.277 to read that prior notice is only required for food that is intended for consumption. In the preamble to the IFR, FDA noted that the determination of whether a substance is ``food'' is not a question of intended use (See 68 FR 58974 at 58987). Moreover, we do not believe that there is a conflict between the registration and prior notice requirements. Under the registration rule, in general, a facility engaged in the manufacturing/processing, packaging, or holding of food for consumption in the United States must be registered. Regardless of whether the facility that manufactured the food manufactured it for consumption in the United States, section 801(l) of the act prohibits food that is from an unregistered foreign facility from being delivered for distribution in the United States until the facility is registered. Thus, if the owners, operators, or agents in charge of facilities want to ensure these types of food are not subject to being held under section 801(l) of the act, they can register in accordance with section 415 of the act (21 U.S.C. 350d) (and if the food is for consumption in the United States, they must register unless the facility qualifies for an exemption). An importer can likewise ensure that food is not subject to being held under section 801(l) of the act by not importing or offering for import food that is from an unregistered foreign facility. Throughout this preamble to the final rule, we often use the phrase ``food is subject to being held'' in describing our enforcement of the registration requirement through prior notice. Under section 801(l) of the act, ``[i]f an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 415, such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered'' (emphasis added). In this situation, the article of food is being prevented from moving forward past the port of arrival because the food is from a foreign facility that has not registered. This situation is distinct from a situation where, after FDA reviews the prior notice information, the food is held upon arrival for examination because it may pose a significant risk to public health, usually referred to as a ``BT Hold.'' In addition, we do not believe that prior notice places an undue burden on the drug and medical device industry. Items designated with a FD4 code are all believed to be used exclusively in food, and therefore, require prior notice. Articles designated by a FD3 code can have food and nonfood uses. These items do not require prior notice if the use of the article does not fit the definition of food provided in Sec. 1.276 of
[[Page 66308]]
the final rule and may be disclaimed by the filer as such upon entry.
(Comments) One comment states that there is no facility
registration requirement for transshippers; however, goods processed
under CBP's Form CF7512 (T&Es and ITs) require a prior notice to be
filed. The comment notes that this cannot be accomplished without the
corresponding facility registration number. In addition, T&Es and ITs
do not have a designated submitter. The comment requests that T&E and
IT transactions be exempt from prior notice.
(Response) FDA disagrees that T&E or IT transactions should be
exempt from the requirements of prior notice. These articles of food
leave the port of arrival prior to exportation from the United States
or for subsequent movement through the United States prior to entry.
Under Sec. 1.281(a)(9) of the IFR, a shipper's (transshipper's)
registration number was not required for a facility associated with an
article of food if the article is imported for transshipment. Under the
final rule, if the shipper's identity is provided, the shipper's
registration number is optional. Therefore, the absence of a shipper's
registration number should not prevent submission of a prior notice
under either the IFR or final rule. Moreover, FDA disagrees with the
comment's implication that a prior notice requires a designated
submitter. Under Sec. 1.278 of the IFR and final rule, a prior notice
may be submitted by any person with knowledge of the required
information.
(Comments) Several comments request that FDA generally exempt
Canada and Mexico from submitting prior notice for food shipments. One
comment requests that FDA exempt Canada, in keeping with the nature of
cooperation and shared security risks between the United States and
Canada, in particular the 30 point border plan. The comment reasons
that Canadian origin food is easily traceable through existing Canadian
registration requirements, while already meeting or exceeding United
States standards in some instances. The comment further notes that the
legislation acknowledges the largest threat is from offshore, yet the
regulations most severely hit continental trade between the United
States, Canada, and Mexico. One comment suggests that the exemption
could be limited to shipments of food which are under similar security
controls, especially small quantity shipments of fish imported via
package delivery. Another comment asks that FDA exempt goods being
imported into the United States from companies which are inspected by
the Canadian Food and Inspection Agency.
(Response) FDA disagrees. While we welcome any additional
information that supports our ability to quickly review prior notice
submissions and determine which food to inspect at U.S. ports of
arrival, the Bioterrorism Act does not provide for blanket exclusions
based on the country from which the food is shipped or the country in
which the food originates. FDA currently is reviewing flexible
alternative programs (e.g., CBP's Customs-Trade Partnership Against
Terrorism (C-TPAT), which was adopted into law (still as a voluntary
system) by Subtitle B of Title II of the SAFE Port Act of 2006 (Public
Law 109-347), and Free and Secure Trade (FAST) (a voluntary program
authorized under 19 U.S.C. 1411) ) to determine their potential for
streamlining the prior notice review process, but notes that these
programs do not meet or affect the requirement to submit prior notice.
Moreover, FDA notes that many shipments from Canada and Mexico into the
United States in fact are transshipments from other countries, which
prior notice submissions identify with the FDA Country of Production
data element.
(Comments) One comment suggests that FDA create a relational
database to give unique identification numbers to an importer's
specific items. The comment states that this would speed submission,
reduce time to enter the data, and increase compliance with the
regulation. The comment reasons that most food importers will bring in
the same product, in the same package, from the same country, over and
over. Another comment suggests that a single weekly summary of all
shipments by a company to individual consumers or a summary of orders
received should be adequate for this type of commerce.
(Response) FDA disagrees. Not all importers consistently import the
same types of food. The Bioterrorism Act requires submission of prior
notice before an article of food is imported or offered for import into
the United States. A weekly summary as suggested by the comment would
not meet this requirement, as such a summary would not provide prior
(advance) notice before the article of food is imported or offered for
import. FDA notes, however, that a number of the software programs that
customs brokers use to file prior notice and entry submissions with
ABI/ACS do allow for repetitive information to be saved on the filer's
computer and used for future shipments, as appropriate. Similarly,
FDA's PNSI has been designed to accommodate repetitive information,
such that the basic prior notice information that will repeat on each
prior notice can be created and saved for use on subsequent prior
notices. A separate prior notice confirmation number is generated for
each article of food or recipient.
(Comments) One comment requests that FDA exempt highly perishable
food products. The comment states that highly perishable food products,
such as ice cream, must be delivered in a timely manner. A delay in the
delivery schedule due to holdups at the border could potentially ruin
these products, and customers inconvenienced by the time delay may
choose to stop importing them. A number of comments request that FDA
exempt fresh produce. Several comments note that produce is already
carefully monitored by CBP and placed on automatic quarantine for
mandatory inspection at the first port of arrival by USDA/CBP. Other
comments state that produce is already subject to 100 percent USDA
inspection and approval prior to release. Another comment requests that
produce be exempt from the requirement of prior notice because it
already meets the requirements of the Bioterrorism Act. The comment
reasons that the purpose of the prior notification to FDA is to provide
FDA with the information necessary to make a decision (prior to
arrival) for a possible physical inspection. The comment states that
the CBP Agriculture Specialist performs the physical inspection (or
reviews original documentation that confirms ``pre-inspection'').
Therefore, the comment reasons, importations of fresh produce are
already meeting the requirements of the Bioterrorism Act. The comments
further state that because prior notice is already given for produce,
the new procedure created by this new legislation will only increase
costs and cause extreme hardship for small business. An additional
comment states that their shipments are subject to four levels of
inspection: County, State, Federal, Customs and ``Bio Terrorist'' and
reasons that the redundancy is wasteful.
(Response) FDA disagrees. Highly perishable foods, like all other
foods that are covered by the final rule, are subject to prior notice
requirements. The timeframes are sufficiently short, allowing for
submission of prior notice as soon as 2, 4, or 8 hours before arrival
in the United States depending on mode of transportation. While the
Bioterrorism Act provides for an exclusion for certain types of food,
such as meat and meat food products subject to USDA's exclusive
jurisdiction, it does not exclude perishable foods generally
[[Page 66309]]
or foods jointly regulated by USDA and FDA.
As we explained in the IFR preamble, merely obtaining existing
information about the food from other agencies would not guarantee that
FDA has the information required by section 801(m) of the act's prior
notice requirements because there is wide variation in the purposes and
information required by other government programs (68 FR 58974 at
58992). Moreover, our ability to respond to bioterrorism incidents or
other food-related emergencies in a timely manner may be more difficult
if the information is not easily accessible.
(Comments) One comment recommends that the rule be amended to
include an exemption from prior notice for organizations that are
importing FD4 materials for nonfood uses.
(Response) FDA disagrees. Items designated with an FD4 code are all
believed to be used exclusively in food, and therefore, food
encompassed by an HTS code that is flagged FD4 is subject to prior
notice requirements. Moreover, as discussed previously, FDA provided
extensively its rationale for not limiting the prior notice
requirements to food for consumption in the United States. (See 68 FR
58974 at 58990 and 58991.) As FDA noted in the IFR, Congress did not
explicitly limit the prior notice requirement to articles of food that
are intended for consumption in the United States even though it could
have done so as shown in section 415 of the act (requirement to
register food facilities). If anyone believes that an HTS code has been
flagged FD4 in error, they can inform FDA and, if we agree, we will
change the flag accordingly.
(Comments) Two comments request that FDA exempt small businesses.
(Response) FDA disagrees. Prior notice is required for all FDA-
regulated food that is imported or offered for import. The Bioterrorism
Act does not provide for exclusions based upon the size or nature of
the firms or facilities associated with that importation.
(Comments) One comment asks FDA to permit an exemption from prior
notice, by importer number, to be recognized in ACS at the time of
entry transmission, to importers who demonstrate that their products
will not reasonably be expected to be directed to a food use.
(Response) FDA disagrees. Prior notice requirements are associated
with food, not the person manufacturing, growing, shipping, importing,
or owning the food. A product is food for purposes of prior notice if
the article of food is reasonably likely to be directed to a food use.
Prior notice is required for each article of food imported or offered
for import, and food imported or offered for import by or for select
importers will not be excluded from prior notice requirements. If an
importer does not import articles of food, then no ``exemption'' would
be needed since prior notice would not apply to such imports. The FD
flags associated with HTS codes are designed to help identify which
products will require prior notice. If an import is marked FD3 but it
is not food subject to prior notice, the importer can disclaim this
import and prior notice would not need to be submitted.
6. Additional Exclusions Requested--Special Programs (C-TPAT/FAST) and
Flexible Alternatives
In the explanation of the reduced timeframes and the relationship
of special programs to those timeframes, FDA stated in the IFR that the
``interim final rule provides for greatly reduced timeframes for foods
based on mode of transportation. These timeframes are what FDA has
determined are the minimum timeframes necessary to allow it to satisfy
the statutory mandate that the timeframes give the agency the time it
needs to `receive, review, and respond' to prior notices. However, FDA
is also interested in exploring flexible alternatives for submission of
prior notice for foods or firms covered by programs of other agencies,
such as C-TPAT, or imported by other agencies.'' (68 FR 58974 at
58995).
FDA and CBP reopened the comment period for the IFR in the Federal
Register of April 14, 2004 (69 FR 19763). On page 19764 of that
publication, FDA and CBP wrote ``In the prior notice [interim final
rule], we expressed interest in exploring flexible alternatives for
submission of prior notice for foods or firms covered by programs of
other agencies, such as CBP's Customs-Trade Partnership Against
Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or
food imported by other government agencies (68 FR 58974 at 58995). C-
TPAT is a government/business initiative to increase cargo security
while improving the flow of trade. Under this program, businesses must
conduct comprehensive self-assessments of their supply chain using the
security guidelines developed jointly with CBP, and they must
familiarize companies in their supply chain with the guidelines and the
program. These businesses must provide CBP with specific and relevant
information about their supply chains and security practices and
procedures. As C-TPAT members, companies may become eligible for
expedited processing and reduced inspections, but are not exempt from
advance electronic information requirements. (See CBP's advance
electronic information rule). FAST, an acronym for Free and Secure
Trade between the United States and Canada, and the United States and
Mexico, is an expedited-clearance system designed to improve border
security without slowing the flow of legitimate trade across the
northern and southern U.S. borders. FAST processing is available to
importers, carriers and foreign manufacturers (southern border) who
participate in C-TPAT and who use a FAST-registered driver. The
initiative builds on the same concepts that drove the rapid, post-9/11
construction and implementation of C-TPAT. FDA and CBP plan to assess
the feasibility of including the FAST timeframes in FDA's prior notice
final rule, as well as other flexible alternatives raised by comments.
To assist in this assessment, FDA and CBP requested comments on
several questions, including three regarding special programs (69 FR
19763 at 19764):
C-TPAT/FAST Questions:
(1) Should food products subject to FDA's prior notice requirements
be eligible for the full expedited processing and information
transmission benefits allowed with C-TPAT and FAST? If so, how should
this be accomplished?
(2) If the timeframe for submitting prior notice for food arriving
by land via road is reduced to 1 hour consistent with the timeframe in
the advance electronic information rule, would a shorter timeframe be
needed for members of FAST?
(3) Should the security and verification processes in C-TPAT be
modified in any way to handle food and animal feed shipments regulated
by FDA? If so, how?
The comments received addressing these issues are discussed in the
following paragraphs in order of the questions posed in the Federal
Register notice, beginning with comments addressing general issues
regarding C-TPAT and FAST.
a. General comments. (Comments) Numerous comments address special
trade programs, such as C-TPAT and FAST. These comments recommend that
FDA and CBP modify these CBP programs to reflect the criteria required
by FDA and to develop integrated data elements for low risk FAST/C-TPAT
shipments, which would meet both agencies' requirements. The comments
believe it is necessary to have harmonization between FDA and CBP for
``low-risk'' shippers.
[[Page 66310]]
Many comments contend that the IFR does not take into account the
Canada-United States Smart Border Plan (SBP). A key element of the SBP
is the FAST bilateral arrangements. Under the C-TPAT and the Canadian
Partnerships in Protection (PIP) programs, companies approved by both
countries have invested in specific counter-terrorism and supply-chain
integrity measures, and are therefore, accorded more expedited
treatment at the Canada-U.S. border in recognition of the lower risk
they present.
The comments recommend that FDA recognize foods imported under
these programs as low risk and to afford them benefits, such as reduced
information requirements for each shipment; reduced timeframes for
providing prior notice; reduced clearance time at the border; and
reduced number of verifications of information. The comments further
urge FDA and CBP to permit importers who are participants in C-TPAT and
FAST to comply with their prior notice obligations in a manner that
does not undermine the benefits of participation in these programs. The
comments contend that C-TPAT and FAST improve U.S. security on a number
of levels, including reducing the risk of bioterrorism, and help to
focus limited border resources on higher risk cargo. The comments
suggest that FDA and CBP therefore should be careful not to remove
incentives for participation in these programs by making importation of
food items more cumbersome than other types of entries. Otherwise, the
comments contend prior notice will dilute a key advantage offered to
FAST/C-TPAT participants, thereby weakening the incentive to join the
program. The companies participating in these programs have made a
substantial commitment to improving security by putting in place
appropriate security systems, and submitting to periodic review of
those systems by CBP.
The comments believe that these programs strengthen FDA's ability
to meet the objectives of the prior notice rule. They contend that this
is achieved in two ways: (1) Through the rigorous security screening
that participants must comply with in order to obtain a low-risk
status; and (2) by removing low-risk shipments from the queue, FAST/C-
TPAT work to shrink the number of shipments that must be screened,
thereby ``freeing up'' FDA officials to focus limited resources on
higher risk shipments.
One comment states that a firm having to manage its systems to
track C-TPAT products and non-C-TPAT products will incur increased
complexity, increased cost, and will be subject to making errors. This
comment suggests that firms who routinely send products across the
border could provide prior notice on a quarterly basis. The facility
would track the number of shipments each quarter and update FDA with
any changes to the anticipated amounts. These shipments would be
permitted to cross the border without waiting, but still could be
subjected to FDA or CBP inspection.
Another comment questions the cost, benefits, etc. of these
programs for small companies. In addition, a few comments address the
creation of similar programs and/or the expansion of the current
programs. One comment requests that FDA permit the use of Line Release
(i.e., an automated system designed to release and track repetitive
shipments) for food shipments arriving by rail. The comment states that
their member railroads participate in C-TPAT and it would be
discriminatory to permit the use of an expedited clearance system for
motor carriers, but not rail transportation.
One comment urges FDA to begin working with all interested parties
to identify criteria for qualification and participation in a program
like C-TPAT, FAST, and others as it applies to prior notice. The
comment suggests that participation might hinge on the submission and
verification of documentation evidencing the implementation of, and
continued adherence to, validated supply chain risk management
techniques. The comment believes that there would be mutual benefits of
such a program. FDA could reallocate its resources to closer review and
examination of shipments from those importers that do not participate
in the program and, thus, have not demonstrated the same level of
commitment to food safety and shipment security as participating
importers do. Program participants would benefit from the agency's
recognition of their commitment to safety and security, which
presumably would be reflected in more efficient and timely processing
of their entries at the border. In that regard, the comment suggests
that the agency consider extending to participating low risk importers
the option of submitting a single prior notice for all entries in a
mixed load container or truck. FDA product codes for all line entries
would continue to be available to FDA through FDA's existing OASIS
system.
Another comment hopes that the multiple U.S. agencies (FDA,
Department of Homeland Security, and USDA) could collectively address
this issue and develop a protocol for food products that are currently
ineligible for any FAST benefits.
A few comments request that C-TPAT should be open to all foreign
operators willing to participate and that companies participating in C-
TPAT should be exempt from the procedures under the Bioterrorism Act.
These comments encourage partnerships between the U.S. and E.U. similar
to C-TPAT, which would facilitate trade in food and feed between the
E.U. and U.S. and avoid delays at the U.S. border, especially with
respect to perishable products. In addition, one comment suggests that
food transporters should be allowed eligibility in C-TPAT and FAST to
ensure that all transporters operate on a level playing field.
One comment notes that C-TPAT is not currently offered to Canadian
manufacturers unless they are an Importer of Record for U.S. Customs'
purposes.
Finally, one comment expresses concern that any motor carrier who
is not Pre-Arrival Processing System (PAPS)-certified may be required
to present the prior notice confirmation number upon arrival at the
border, even if prior notice was submitted through ACS. The comment
states that truck drivers are generally unable to obtain the prior
notice confirmation number prior to arrival given the short distance
between Canada and the United States and the fact that prior notice is
not generally submitted until after the trucker has left with the load.
The comment states that requiring PAPS authorization as a way to avoid
delays is to mandate that truck companies become C-TPAT certified or
otherwise comply with the designation requirements. The comment notes
that this is not possible, sometimes for cost reasons alone. The
comment also has similar concerns regarding the PAPS-program at the
Southern border.
(Response) While FDA welcomes the additional information provided
by C-TPAT and FAST, these programs would require relatively significant
changes to be useful in helping us carry out the prior notice program.
The purpose of prior notice is to help identify food that potentially
poses a significant health risk to the American public and to deploy
resources to the port of arrival so that inspections can be conducted
before the shipment enters the United States. Information about the
manufacturing facility is used in conducting this risk assessment. The
C-TPAT assessment, however, does not always include the food
manufacturing/processing operations. Even when it does, C-TPAT focuses
on security risks
[[Page 66311]]
whereas the prior notice program considers all health and safety risks
to the food, such as unintentional contamination. Moreover, unlike PNC
reviewers, the CBP Supply Chain Specialists who conduct the validation
assessments for C-TPAT are not necessarily trained in assessing the
potential risks associated to food products and neither FDA nor CBP has
the resources to fund the extensive training that would be required to
do so. Because knowing that a firm participates in C-TPAT does not
assist FDA in conducting its food safety review, we have decided not to
provide special treatment in terms of reduced prior notice information
requirements or reduced timeframes based on C-TPAT participation.
It is important to note that participation in C-TPAT does not
affect the information requirements of CBP's advance electronic
information rules; the same information is required regardless of C-
TPAT participation. However, successful participation in C-TPAT does
affect the frequency of CBP cargo and trade examination. FDA likewise
uses a risk-based approach in selecting foods for examination at the
border for security and food safety reasons. FDA, thus, is continuing
to explore with CBP and industry use of these programs in making
decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions).
Comments addressing which foreign operators are eligible for
participation in FAST and C-TPAT are outside the scope of this rule.
CBP stated in a document entitled ``Frequently Asked Questions
Regarding Minimum Security Criteria for Importers,'' dated March 25,
2005, (CBP's March 25, 2005, Frequently Asked Questions (FAQ) document)
(available at http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/
security_criteria/criteria_importers/questions.xml (FDA has verified
the Web site address, but FDA is not responsible for any subsequent
changes to the Web site after this document publishes in the Federal
Register)), that ``C-TPAT remains a voluntary, incentive based
partnership. However, once a company commits to the C-TPAT program,
there are specific program requirements that must be adhered to by the
company to qualify for C-TPAT benefits, which are significant. C-TPAT
importers are six times less likely to undergo a security related cargo
examination, and four times less likely to be subject to a trade
related examination, than non-C-TPAT members. These significantly fewer
cargo examinations help save importers time and money, while leading to
a more predictable supply chain. CBP continues to explore additional
benefits, which can be afforded members who meet or exceed the minimum-
security criteria.''
The document also states that ``CBP employs a risk management
approach in screening and targeting, and such shipments, as well as
those from unknown or less established entities, receive higher
scrutiny from CBP. The agency does not disclose ATS targeting rules.''
(Comments) Several comments suggest that FDA should not establish a
duplicative program, but should incorporate additional factors or
criteria necessary for prior notice into existing programs.
(Response) FDA agrees that it is generally preferable not to
establish duplicative programs. Thus, while we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes, we will continue
exploring use of these programs in making decisions regarding which
products to inspect for the purposes of admissibility (801(a)
decisions).
b. Special programs.
i. Should food products subject to FDA's prior notice requirements
be eligible for the full expedited processing and information
transmission benefits allowed with C-TPAT and FAST? If so, how should
this be accomplished? (Comments) Numerous comments assert that
businesses that participate in the C-TPAT and FAST programs should be
eligible for processing/transmission benefits. These comments contend
that importers, carriers and drivers who have been approved for C-TPAT
and FAST already have been deemed to be ``low risk'' by CBP. Importers
and carriers have had to demonstrate supply chain security controls,
and drivers have been subjected to rigorous background screening.
Companies have made the security investments and have bolstered their
operations to provide the requisite security and integrity of their
trade transactions. The federal governments of the United States and
Canada have encouraged FAST participation on the grounds that it will
mean expedited border crossings and reduced information requirements.
By allowing food to move through the FAST ``stream'' in the same manner
as other products, FDA would demonstrate the commitment to
harmonization that industry has long encouraged and would provide an
incentive for additional participation in the C-TPAT and FAST programs.
In addition, the comments noted that if the primary benefits of the C-
TPAT program were removed, FDA would create a disincentive for C-TPAT
participation that would ultimately reduce the security of the articles
covered by the Bioterrorism Act. Finally, the comments note that these
benefits are necessary to avoid duplication and inconsistent
application of prior notice requirements for shipments that meet the
stringent FAST criteria.
(Response) FDA continues to use a risk-based approach for
determining which foods to inspect for the purposes of admissibility.
FDA will continue to work with CBP and acknowledges that the additional
information provided by C-TPAT participation could be helpful in this
risk-based assessment. In CBP's March 25, 2005, FAQ document cited
previously, CBP states that ``[u]nsolicited shipments will
understandably lie outside the capability of the importer to ensure
security. CBP employs a risk management approach in screening and
targeting, and such shipments, as well as those from unknown or less
established entities, receive higher scrutiny from CBP.'' FDA agrees
with this statement.
(Comments) Numerous comments provide suggestions on how to
accomplish processing/transmission benefits for C-TPAT and FAST
participants. Many of the comments cite a need for better harmonization
and streamlining between FDA and CBP. Suggestions from the comments
include:
<bullet> Enhance coordination between CBP and FDA, allowing trained
CBP/FDA officers to process food shipments through the FAST lane, and
allowing FAST importers using a FAST driver and carrier importing food
and/or feed products to submit prior notice to both the CBP and FDA
through the existing CBP/FDA interface.
<bullet> Allow for integrated targeting processes, including a
reduction in the risk targeting factors for food shipments, as well as
other product categories, which would translate into expedited
processing, reduced exams and other benefits for food import shipments
under the program.
<bullet> Integrate the CBP and FDA data systems to allow for one
filing of the required information. The C-TPAT certification process
delves into the critical aspects of a company's handling and
documentation procedures, and requires a company to demonstrate it has
good process controls in place throughout the supply chain.
<bullet> Modify the CBP and FDA systems for the receipt of advance
notice and prior notice to ``flag'' importation under
[[Page 66312]]
C-TPAT and FAST. These notices should receive priority attention for
entry and clearance purposes.
<bullet> Establish an MOU between FDA and CBP to allow the sharing
of necessary information with the understanding of the program
applicant.
<bullet> Implement a shorter prior notice timeframe for C-TPAT
members.
<bullet> Reduce data element reporting by virtue of having
successfully passed the C-TPAT validation process. Product information
(HTS code, product code, manufacturer's registration numbers, etc.)
should be part of the pre-filed information profiles under FAST.
Finally, one comment suggests the following:
(1) A statement of proof of acceptance (e.g., copy of acceptance
letter from CBP) into the C-TPAT and/or FAST programs;
(2) A detailed statement/description of policies and procedures in
place for meeting FDA prior notice requirements. This submission should
follow the format of the supply chain questionnaire information
submitted to CBP as part of the C-TPAT application process and should
be considered as an addendum to the original submission; and
(3) FDA should notify the importer in writing of: (a) its
acceptance/agreement with the importer's FDA prior notice procedures;
or (b) additional questions to be answered or data to be provided to
meet FDA requirements for acceptance into the FDA prior notice ``C-
TPAT/FAST'' program.
(Response) As we discussed previously, we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes. FDA, however, is
continuing to explore with CBP and industry use of these programs in
making decisions regarding which products to inspect for the purposes
of admissibility (801(a) decisions).
ii. If the timeframe for submitting prior notice for food arriving
by land via road is reduced to 1 hour consistent with the timeframe in
the advance electronic information rule, would a shorter timeframe be
needed for members of FAST? (Comments) One comment suggests that the
timeframe for submitting prior notice of one hour is fine, even for
express deliveries. Another comment believes that reducing the
timeframes for submission of prior notice would not sufficiently
expedite the clearance of product for participants of FAST. However, an
overwhelming majority of the comments favor reducing the timeframe for
FAST participants to 30 minutes. Under the CBP Advance Electronic
Information Rule, the time element for FAST participants is 30 minutes.
The comments state that to have two different time standards for the
same mode of transportation only serves to create confusion. The
comments believe that any harmonization of FDA and CBP security
programs would assist the orderly flow of trade at the border crossing
points.
The comments contend that the key premise behind the FAST program
is that low-risk parties should receive expedited treatment at the
border, freeing up enforcement resources to concentrate on parties of
higher or unknown risk, which is why the timeframes CBP adopted are
shorter for FAST than for other shipments. If FDA adopted the 30 minute
timeframe, it would demonstrate a commitment to harmonizing with CBP,
and prevent a situation whereby FAST requirements vary depending on the
type of commodity being transported. Finally, one comment believes that
to ensure consistency with FAST and CBP's Automated Commercial
Environment (ACE),\4\ prior notice should be required and calculated
from the port of entry and not the first point of arrival, as is
currently the case.
---------------------------------------------------------------------------
\4\ The ACE system will replace the current ABI/ACS, as well as
combine other CBP entry functions and transactions. Prior Notice
submissions will be compatible with ACE.
---------------------------------------------------------------------------
(Response) Harmonized timeframes could facilitate the orderly flow
of trade traffic at the borders. Advance screening of consistent
information also would aid in reducing the review time. However, as we
discuss later in section II.F of this document (``When must prior
notice be submitted to FDA? (Sec. 1.279)''), we are maintaining the
timeframes that are in the IFR. These timeframes represent the minimum
amount of time FDA needs to meet the statutory responsibility to
receive, review, and respond to prior notice submissions. Our
assessment of the timeframes and review times showed that we would not
be able to reduce the timeframes to correspond to those used by CBP for
land and air shipments.
iii. Should the security and verification processes in C-TPAT be
modified in any way to handle food and animal feed shipments regulated
by FDA? If so, how? (Comments) Four comments respond that the security/
verification processes of C-TPAT/FAST should be modified for food.
Fourteen comments respond that the process should not be modified for
food. Most comments suggest that the current validation processes are
sufficient and caution that additional FDA inspection would be
redundant. Many of these comments state that C-TPAT is a well-thought-
out program and that with its current security profile requirements and
present followup verification systems, the program is already well
suited to handle human and animal food shipments. The comments suggest
that FDA should rely on CBP's successful programs and avoid
``recreating the wheel'' or imposing new and potentially inconsistent
criteria on food companies. The comments further contend that food
safety and product integrity is already an integral part of the
industry's own internal policies, which have always been concerned and
accountable for the safety and security of their products without
regard to the more recent border security program. Therefore, companies
certified under C-TPAT have made the critical security investments and
have bolstered their operations to provide the requisite security and
integrity of their trade transactions, regardless of the commodities
(food or nonfood products) that are shipped. Another comment stresses
that FDA should not impose additional conditions of participation for
FAST members because the requirements for FAST participation imposed by
CBP provide adequate assurance that expedited clearance is appropriate.
(Response) FDA agrees with the statement in CBP's March 25, 2005,
FAQ document that says ``For C-TPAT to ensure its continued viability,
effectiveness, and relevance, the program must continue to evolve--as
the terrorist threat and the nature of global trade evolves. The
impetus for strengthening the existing security guidelines is to
provide more detail to the membership on the expectations of the
program, and to assist CBP in defining a more consistent baseline for
minimal program requirements and better-defined C-TPAT benefits.'' The
issue of how to modify the processes is discussed in the next comments
and responses.
(Comments) Numerous comments provide suggestions on how to modify
the security/verification processes of C-TPAT/FAST. These include:
<bullet> FDA should investigate security plans with actual physical
inspections of the facilities prior to allowing participation in the
programs.
<bullet> FDA should verify that other countries' regulatory systems
for food production and safety are equivalent to those of the United
States. The agency should also perform on-site audits and inspection of
production facilities
[[Page 66313]]
before a food manufacturer or carrier can be certified.
<bullet> It should be mandatory for food manufacturers to provide
notice concerning any changes in the manufacturing processes or
supplies, as well as those that may affect physical and personnel
security. In addition, the current requirements that manufacturers
periodically review the security commitment of their service providers
to detect weakness or potential weaknesses in security should be
altered to require that: (1) The review is conducted on an annual basis
and (2) a certification that the review has been conducted.
<bullet> FDA and CBP should work together, along with the trade
community, to identify potential areas where the C-TPAT security and
verification processes can or should be modified. CBP and FDA should
coordinate these processes to address the additional concerns of the
FDA in order to allow C-TPAT/FAST members expedited processing of food
and feed shipments in addition to CBP shipments.
<bullet> C-TPAT requirements should encompass any industry and food
specific security measures into C-TPAT's checklist.
<bullet> These processes must be more comprehensive. There are no
questions on the Supply Chain Security Profile Questionnaire to specify
the type of freight being hauled. In addition, there are no
opportunities in the questionnaire to indicate different locations to
which a company is shipping regularly, or insurance a company has to
cover those states.
(Response) FDA notes that CBP has continued to expand the C-TPAT
program, which now includes minimum security criteria for importers who
participate in C-TPAT. FDA also notes that as of July 10, 2006, CBP has
received over 11,000 C-TPAT applications of which 6,089 have been
certified and 2,973 have been validated (certified members provide a
complete security profile that is screened by CBP, while validated
members also undergo a complete validation of their security profile
that includes an on-site visit to the company to review the submitted
security profile, followed by a physical verification of security
measures). There are limited resources at this time to add new
significant program requirements to meet FDA's needs under the
Bioterrorism Act and verify that those procedures have been
incorporated. The two agencies will continue to explore the feasibility
of the approaches recommended in the comments in the future.
c. Flexible alternatives. In the Federal Register document to
reopen the comment period, FDA and CBP also requested comment on the
following questions regarding flexible alternatives (69 FR 19763 at
19764):
<bullet> If timeframes are reduced in FDA's prior notice final
rule, would other flexible alternatives for participants in FAST or for
food imported by other agencies be needed?
<bullet> In considering flexible alternatives for food imported by
other government agencies, what factors or criteria should FDA consider
when examining alternatives? Should participation be voluntary? If so,
should FDA consider inspection of companies in the supply chain from
the manufacturer to those who may hold the product, including reviews
of their security plans to determine what procedures are in place to
prevent infiltration of their facilities as a condition of
participation?
<bullet> In considering flexible alternatives for submission of
prior notice, should FDA consider additional means of ensuring that all
companies subject to the Registration of Food Facilities Interim Final
Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
<bullet> Are there conditions of participation that FDA should
consider; e.g., inspections of companies in the supply chain from the
manufacturer to those who may hold the product, or reviews of their
security plans to determine what procedures are in place to prevent
infiltration of their facilities?
<bullet> Should the food product category be considered as a
criteria or element of expedited prior notice processing or other
flexible alternatives? If so, should certain foods be excluded from
expedited prior notice processing? If so, what should be the basis for
determining which foods should be excluded?
<bullet> If FDA adopts reduced timeframes in the prior notice final
rule, should FDA phase in the shorter timeframes as CBP phases in the
advance electronic information rule?
<bullet> Should FDA offer a prior notice submission training
program for submitters and transmitters, including brokers, to ensure
the accuracy of the data being submitted?
This section will address the comments to each of those questions
introduced in the Federal Register of April 14, 2004, beginning with
general comments.
(Comments) One comment said that if the final rule is refined, then
it is not necessary to offer additional flexible alternatives. Several
comments state that any flexible alternatives should be incorporated
into existing programs because the duplication of security programs and
division of limited resources are not in the best interest of our
security goals and the protection of public health.
(Response) FDA believes that additional flexible alternatives
should be incorporated into existing programs when appropriate and
feasible. FDA will continue to work with CBP and acknowledges that the
additional information provided by other programs such as C-TPAT could
be helpful for purposes of admissibility decisions.
i. If timeframes are reduced in FDA's prior notice final rule,
would other flexible alternatives for participants in FAST or for food
imported by other agencies be needed? (Comments) Several comments
encourage incorporation of prior notice requirements into the C-TPAT
and FAST programs. Most comments caution that additional requirements
should not be added as separate programs, but that FDA should recognize
participants in the existing programs for expedited review and
processing of prior notice. One comment further suggests that
participation in C-TPAT and FAST should also ensure expedited 801(a)
admissibility processing. Another comment suggests that CBP be solely
responsible for administering both the FDA and CBP requirements of C-
TPAT and FAST.
(Response) As we discussed previously, we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes. FDA, however, is
continuing to explore with CBP and industry use of these programs in
making decisions regarding which products to inspect for the purposes
of admissibility (801(a) decisions).
FDA disagrees with the comment's suggestion that CBP be solely
responsible for administering both the FDA and CBP requirements for
these programs, as the expertise related to food safety and possible
additional participation requirements that address food safety resides
in FDA. Accordingly, FDA and CBP will continue to consider how to
administer FAST and C-TPAT programs so that they could apply to FDA
regulated products.
ii. In considering flexible alternatives for food imported by other
government agencies, what factors or criteria should FDA consider when
examining alternatives? Should participation be voluntary? If so,
should FDA consider
[[Page 66314]]
inspection of companies in the supply chain from the manufacturer to
those who may hold the product, including reviews of their security
plans to determine what procedures are in place to prevent infiltration
of their facilities as a condition of participation? (Comments/
Response) There were no comments addressing flexible alternatives for
food imported by other government agencies. However, FDA has considered
imported shipments of foods for official U.S. federal government use
and our draft policy for enforcing prior notice in these situations is
contained in the Prior Notice Final Rule Draft CPG that is announced
elsewhere in this issue of the Federal Register. Under the draft
policy, FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for an
official government purpose, provided that a Federal Government agency
is the importer of record.
(Comments) Many comments advise that voluntary participation
enhances the success of these programs.
(Response) C-TPAT is a voluntary, incentive based partnership. As
we continue exploring use of the C-TPAT and FAST programs in making
decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions), it will be based on the assumption
that participation should remain voluntary.
iii. In considering flexible alternatives for submission of prior
notice, should FDA consider additional means of ensuring that all
companies subject to the Registration of Food Facilities Interim Final
Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
(Comments) Several comments reiterate that it is not necessary for FDA
to provide flexible alternatives that exceed or augment CBP's existing
programs, including a requirement to have an updated and verified
registration on file with FDA. However, another comment believes that
companies eligible to participate in low-risk programs should have an
updated registration and that verification of that registration would
be useful in determining low-risk status. Another comment assumes that
verification of registration with FDA should have been conducted under
CBP's current validation aspect of the C-TPAT program.
(Response) FDA agrees that participants designated as low risk
should have an updated and verified registration of all facilities
subject to 21 CFR part 1, subpart H. FDA also agrees it would be
efficient to conduct the verification as part of the C-TPAT validation
process, but neither FDA nor CBP has the resources to do so at this
time.
iv. Are there conditions of participation that FDA should consider;
e.g., inspections of companies in the supply chain from the
manufacturer to those who may hold the product, or reviews of their
security plans to determine what procedures are in place to prevent
infiltration of their facilities? (Comments) Most comments suggest that
other conditions, such as inspection of other companies in the supply
chain would be unnecessary and a repetition of effort with little
return on investment. Another comment states that to begin a process of
examining the security plans and procedures of foreign food facilities
would be tremendously expensive, call into question the validity of the
prior notice and registration requirements already in place, and the
efficacy of the targeting tools FDA employs.
(Response) We agree that adding conditions for C-TPAT participation
and validating them to meet the purpose of the Bioterrorism Act would
be extremely expensive and potentially only benefit a small number of
those entities subject to this rule. We do not believe that this is the
best use of our limited resources at this time, particularly as we have
not experienced significant impacts on the flow of trade as a result of
the timeframes in the rule since the IFR took effect on December 12,
2003.
v. Should the food product category be considered as a criteria or
element of expedited prior notice processing or other flexible
alternatives? If so, should certain foods be excluded from expedited
prior notice processing? If so, what should be the basis for
determining which foods should be excluded? (Comments) While one
comment asserts that the food product category be considered an
important element of expedited processing, most other comments state
that no product category distinctions should be made. One comment
states that to allow items imported under food product categories to
qualify for expedited prior notice could easily lead to abuse of the
system intended to protect us from terrorist attack. Other comments
suggest that all food products be treated in the same manner and be
subject to the same regulations. Most comments state that no product
should be specifically included or excluded from participation, but
that the criteria for participation should be focused solely on
attributes of the company and a company's ability to meet the program
standards set by the particular government agency.
(Response) FDA agrees in part that no product category distinctions
should be made. However, FDA acknowledges that some foods are more
susceptible to terrorism and food safety problems than others,
regardless of the processes within the supply chain. But if we were to
make product category distinctions, such actions could be disruptive to
transportation (e.g., we may need to segregate products) and may make
such products targets for terrorism since such products may be eligible
for special (e.g., expedited) treatment.
vi. If FDA adopts reduced timeframes in the prior notice final
rule, should FDA phase in the shorter timeframes as CBP phases in the
advance electronic information rule? (Comments/Response) Comments
addressing phase-in of timeframes are found under the discussion of
Sec. 1.279 ``When must prior notice be submitted to FDA.''
vii. Should FDA offer a prior notice submission training program
for submitters and transmitters, including brokers, to ensure the
accuracy of the data being submitted? (Comments/Response) Most comments
support additional training for submitters and transmitters. Additional
discussion of training is found under section III. M (Outreach and
Enforcement) of this document.
7. Additional Exclusions Requested--Samples
(Comments) Numerous comments request an exclusion from the
requirements of prior notice for samples used in trade fairs, market
research, market testing, and laboratory analyses (i.e., quality
analysis/quality control (QA/QC) samples, scientific research,
compositional analyses, research and development, standard of identity
confirmation testing or quality comparison testing). The comments state
that QA/QC samples are clearly not destined for consumption and will
never enter the food chain or be consumed by the general public,
thereby placing samples in a low-risk category. In addition, the
comments note that these samples are often imported in very small
quantities for a specific purpose. Samples used for organoleptic
analyses will be consumed in very small quantities as part of the
analytic procedures in a laboratory setting. In the case of trade
samples, the comments contend that although the food will be consumed,
the consumption is minor and is contained within a controlled
environment, such as a test kitchen or trade booth.
[[Page 66315]]
In addition, the comments suggest some ways in which the burdens
for submitting prior notice for samples could be less cumbersome. These
recommendations include:
<bullet> Exempt all samples or some subset of samples, e.g.,
analytical, research, consumer complaint;
<bullet> Set a limit of the quantity of samples in each shipment
and do not require prior notice for quantities below this limit;
<bullet> Exempt samples from the requirement to provide the
manufacturer's registration number;
<bullet> Include a field in the prior notice in which a filer can
indicate that the item(s) is a sample, and eliminate certain data
elements if this field is flagged (i.e., registration number);
<bullet> Allow a single prior notice without registration numbers
for commingled shipments of many small sample items falling under the
same or similar FDA product codes;
<bullet> Allow shippers to provide a pre-approved list of customers
who may receive samples in a particular month, on a monthly basis in
lieu of filing individual prior notices;
<bullet> Specify procedures in the final rule for clearly
identifying samples, such as the inclusion of a statement on the airway
bill of lading that says: ``Quality Evaluation and Research and
Development Use Only--Resale Prohibited;'' and
<bullet> Provide a limited exemption for intra-corporate (within
the same company) samples.
One comment requests that FDA exempt foods for exhibit at trade
shows and food samples. The comment reasons that these foods are not
intended for consumption in the United States, but are imported for
``show'' and sampling at the trade shows, not for later general
consumption. The comment further reasons that the quantity involved
with each shipment is minuscule, usually no more than five hundred
consumer units, which is too small a quantity to pose a potential
national security threat.
Another comment states that there should be a de minimus provision
for samples from known shippers/importers that is ``cross-referenced''
by shipper facility registration, manufacturer facility registration,
importer facility registration, low value, and low weight.
(Response) Many samples of food, including those for test
marketing, are ``articles of food imported or offered for import,'' as
stated in section 801(m) of the act. If, however, the samples are items
that are in such early stages of research and development that they
cannot yet be considered food under Sec. 1.276(b)(5) of the final
rule, they would not be subject to prior notice requirements. In
addition, if the sample is in a form that is not an article of food,
such as a slurry of lettuce for pesticide analysis, then prior notice
requirements would not apply. But where a sample is food, as defined
under prior notice, the sample is not excluded from the final rule even
if it is imported or offered for import for quality assurance, research
or analysis purposes only, not for human or animal consumption and not
for resale. However, as outlined in the Prior Notice Final Rule Draft
CPG, FDA's and CBP's enforcement discretion policy would apply to these
foods, under which FDA and CBP should typically consider not taking any
regulatory action when there is no prior notice and the food is a
sample not intended for human or animal consumption.
Samples of food are considered to be for quality assurance,
research or analysis purposes, rather than human or animal consumption,
when they are in small quantities (i.e., quantities consistent with the
quality assurance, research, or analysis purposes) and the entire
sample is used up by the analysis, destroyed after analysis, or
destroyed following a reasonable retention period after analysis. The
analysis may include sensory examination, such as organoleptic
examination for determining tea quality or detecting the presence of
histamines. Evidence that an article of food is for quality assurance,
research, or analysis purposes only might include, among other
evidence, markings on the food and shipping documents.
FDA disagrees with the comments that suggest that prior notice
should only be required for food, including samples, that is intended
for consumption. In the preamble to the IFR, FDA discussed extensively
its rationale for not limiting the prior notice requirements to food
for consumption in the United States. (See 68 FR 58974 at 58990 and
58991.) This rationale still holds. FDA also disagrees with the
comments that state samples should be exempted from prior notice if the
consumption of the samples is minor and is contained within a
controlled environment, such as a test kitchen or trade booth, or the
quantity involved with each shipment is minuscule, such that it ``is
too small a quantity to pose a potential national security threat.''
The purpose of the Bioterrorism Act is not limited to terrorist
activity or other national security threats; its purpose is ``[t]o
improve the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health emergencies'' [emphasis
added]. (Public Law 107-188.) Moreover, we have had incidents where
small quantities of samples that had been consumed caused serious
illness or death. For example, in the preamble to the IFR, FDA noted
that ``in the summer of 2003, FDA received a report from a poison
control center in country T concerning the acute poisoning of 9 men
(one died) from ingestion of an herbal fermented wine. Symptoms
occurred within minutes. Reports indicated that this product may have
been exported to the United States in small quantities for test
marketing in restaurants. This underscores the importance of FDA
receiving prior notice of all food imported or offered for import.''
(68 FR 58974 at 58993.)
8. Additional Exclusions Requested--Mail
(Comments) One comment sought better information regarding the
sending of food products as international packages or bringing food
products into the United States personally in their baggage.
(Response) Information on the sending of food through international
mail can be found at:
http://www.cfsan.fda.gov/~pn/pnmail.html. Food
products for personal use brought into the United States that
accompanies an individual are not subject to the requirements of prior
notice (Sec. 1.277(b)(1)).
(Comment) One comment questions whether express couriers, such as
EMS, FEDERAL EXPRESS, DHL, and TNT, are considered ``international
mail.''
(Response) Section 1.276(b)(8) of the final rule defines
international mail to mean foreign national mail services and further
states that international mail does not include express consignment
operators or carriers or other private delivery services unless such
service is operating under contract as an agent or extension of a
foreign mail service. Therefore, if food items are shipped through one
of these services and the food items are not otherwise excluded from
prior notice requirements, prior notice is required.
(Comments) One comment questions if the rule applies to the
military postal service, which is a subsidiary of the United States
Postal Service that operates overseas.
(Response) If the military post offices are located outside of the
United States, as defined for the purposes of prior notice, articles of
food would be subject to the requirements of prior notice (Sec.
1.277(a)).
(Comments) One comment states that the costs and resource
implications of FDA applying this type of approach to single-piece,
person-to-person,
[[Page 66316]]
international mailings of manufactured food products may outweigh any
perceived benefits. FDA's current approach to prior notice forces the
U.S. Postal Service (USPS), FDA, and CBP to dedicate substantial
resources simply to attempt effective implementation of these
regulations. The comment asks that FDA: (1) Exempt these single-piece,
personal use mailings from prior notice; (2) allow CBP to continue
using its time-tested strategies for screening and selections of items
from mail shipments arriving at the first port of entry; (3) allow the
delivery of mail items containing food, even if the contents are not
accompanied by prior notice confirmation numbers to the U.S. address,
as long as the U.S. authorities find no problem with the contents at
border inspection; and (4) work in close coordination with CBP and USPS
to promote more clarity of understanding on the procedures for packages
where the majority of the contents are not food items. The comment
states that these policies will need to be uniformly applied, and also
must ensure that proper accountability is provided to the mailers and
recipients whose mailed items might have been refused, seized, or
destroyed.
Another comment requests an exemption for manufactured food
products that are sent via international mail for noncommercial
purposes. Some comments complain that the required data are very
complex for the average customer and the system is not very customer-
friendly, entries take a long time, and each single item has to have a
separate prior notice.
A few comments state that most of the required information, such as
the manufacturer's registration number, is not available to private
persons, and therefore, not available to international mail and mail by
express carriers. The comments note that this is particularly
problematic, since FDA does not provide information on registration of
facilities to private parties. The comments further note that a
business relationship between the buyer of the goods (e.g., a private
person), the mail service and the manufacturer will in general not be
present. In addition, the comments state that to file prior notice,
Internet access and knowledge of the English language is required. The
comments contend that mail users will have to bear unreasonable
disadvantages and unequal treatment. The comments argue that this seems
disproportionate because most shipments are of low value. Therefore,
the comments suggest that FDA simplify the prior notice requirements
through FDA's PNSI for mail users.
In addition, the comments suggest that: (1) Private persons should
be excluded from prior notice; (2) the requested information should be
limited to some key-information, such as the submitter and the type of
food; (3) all mail services, including express carriers, should fall
under the definition of ``international mail;'' and (4) FDA should
provide on their Web site dedicated information for companies and
consumers about international mail, in different languages.
(Response) The act does not exempt noncommercial shipments with a
noncommercial shipper. FDA explained this position in the preamble to
the IFR (See 68 FR 58992) and believes that this rationale is still
valid. However, under the Prior Notice Final Rule Draft CPG, when food
is purchased or otherwise acquired by an individual for nonbusiness
purposes and sent to an individual with a noncommercial shipper, FDA
and CBP would typically consider not taking regulatory action if prior
notice is not submitted. This proposed enforcement discretion policy
would be continued from the Prior Notice Interim Final Rule CPG.
Express consignment operators or carriers or other private delivery
services, unless such service is operating under contract as an agent
or extension of a foreign mail service, are not considered
international mail. (See Sec. 1.276(b)(8) of the final rule). The IFR
created a category for international mail because the rule imposed
slightly different requirements for such imports. For example, given
the nature of international mail imports, prior notice required the
planned date of mail instead of the anticipated arrival information; it
required the identification of the recipient instead of the importer,
owner, and consignee; and it did not require the mode of
transportation, carrier, planned shipment information, and hold
information. In addition, for international mail the prior notice must
be submitted before the article of food has been sent in order to allow
the prior notice confirmation number to accompany the package. We do
not believe these changes are relevant for shipments arriving by
express consignment operators or carriers or other private delivery
services. For example, if the express carrier submits the prior notice,
it will be able to include the mode of transportation, carrier, and
other data elements not included in the international mail category. In
situations where the submitter and/or transmitter is not the express
consignment operator or carrier, the final rule now allows the
submission of the express consignment operator or carrier tracking
number in lieu of anticipated arrival and certain planned shipment
information. Thus, we do not believe the final rule should be revised
to expand the definition of international mail to include express
consignment operators or carriers or other private delivery services.
FDA also does not agree the prior notice requirements should not
apply to low-value shipments, as neither the Bioterrorism Act nor
experience with samples support this approach. See FDA's responses to
comments previously under section III.D.7 of this document ``Additional
Exclusions Requested--Samples'' for further discussion on this point.
(Comments) A few comments suggest that FDA modify the existing
procedures for commercial shipments arriving by international mail. The
comments state that complying with the requirements of FDA's prior
notification procedure results in an unbearable workload for mail order
companies, which sometimes mail thousands of packages at one time, with
each package requiring a prior notice. The comments suggest that
manufacturers submit their company information and product information
for similar items once and then add the different recipients' addresses
at the end.
(Response) FDA's PNSI has been designed to accommodate repetitive
information so that the basic prior notice can be created and saved,
and each U.S. recipient can be added at the end of each subsequent
prior notice. A separate prior notice confirmation number is generated
for each article of food (and recipient). Similarly, a number of the
software programs that customs brokers use to file prior notice and
entry submissions with ABI/ACS do allow for repetitive information to
be saved on the filer's computer and used for future shipments, as
appropriate.
9. Additional Exclusions Requested--Gifts
(Comments) Several comments recommend that FDA expand the exemption
already provided for homemade food products sent as gifts (Sec.
1.277(b)(2)) or food items carried in for ``personal consumption''
(Sec. 1.277(b)(1)) to include all gifts, regardless of mode of
transportation, that are intended for personal use. Another comment
asks for clarification regarding food articles sent as gifts to persons
in the United States for personal consumption. This comment believes
that prior notice is only required for food articles that will be
[[Page 66317]]
distributed or traded in the United States.
(Response) If the food was made by an individual in his/her
personal residence and sent by that individual as a personal gift
(i.e., for nonbusiness reasons) to an individual in the United States,
prior notice is not required (Sec. 1.277(b)(2)). Other food products
sent by an individual and imported for noncommercial purposes with a
noncommercial shipper are not excluded from prior notice requirements.
FDA explained this position in the preamble to the IFR (See 68 FR
58992) and believes that this rationale is still valid. However, under
the Prior Notice Final Rule Draft CPG, when gifts are shipped by an
individual for nonbusiness reasons to an individual without prior
notice, FDA and CBP should typically consider not taking regulatory
action. This proposed policy would apply regardless of the mode of
transportation.
10. Additional Exclusions Requested--Low-Value
(Comments) Many comments request a de minimis exemption from prior
notice for all low value shipments (less than $200). The comments
assert that the prior notice requirements can be quite onerous for
small shipments and that low value shipments of prepared food sent from
and to individuals for their personal use are of little risk to the
U.S. food supply, especially relative to the individual size and large
number of commercial shipments entering the country. One comment states
that a low value exemption from prior notice for shipments under $200,
whether for personal or commercial use, would be consistent with CBP's
de minimis exemption. In addition, one comment states that foreign
individuals shipping low value gifts to the United States will not know
the Bioterrorism Act's requirements and will not be able to obtain the
manufacturer's phone and registration numbers. The comment states that
these numbers are not readily available to the consumer when products
are purchased in small quantities. One comment requests an exemption
for small dollar value mail-order sales to U.S. customers ($100 or
less) since the prior notice system is difficult and costly to
implement for this type of business.
(Response) FDA disagrees. Low-value shipments are clearly subject
to the terms of section 801(m) of the act as they are ``articles of
food imported or offered for import.'' Moreover, low-value articles of
food can pose the same threat level to the U.S. food supply as do
articles of food that cost more, as we explained in the IFR (68 FR
58974 at 58993). However, under the proposed enforcement discretion
policy, described in the Prior Notice Final Rule Draft CPG, when food
is sent by an individual for noncommercial purposes with a
noncommercial shipper without prior notice, regardless of the article's
value, FDA and CBP should typically consider not taking any regulatory
action.
(Comments) Two comments recommend that FDA consider incorporating
into the final rule a limited exemption for very small quantities of
food. One of those comments considers a small quantity to be under 80
pounds or less than 100 bottles.
(Response) FDA disagrees and will not place a weight or quantity
restriction on the requirements for prior notice. ``Small quantity''
shipments are clearly subject to the terms of section 801(m) of the act
as they are ``articles of food imported or offered for import.''
Similar to low-value articles of food, small quantity shipments can
pose the same threat level to the U.S. food supply as do articles of
food that arrive in larger quantities. If we were to exempt small
quantity food shipments, small quantities of poisoned food (with the
potential to do a high level of damage) could be imported into the
United States without prior notice, thereby negating the purpose of the
Bioterrorism Act.
11. Additional Exclusions Requested--Couriers
(Comments) One comment reports that many of the express couriers
refuse to do the necessary paperwork for shipments being sent via their
services. Therefore, the manufacturers are required to submit prior
notice. However, the manufacturer does not have the necessary
information needed to complete the form, such as flight number,
departure and arrival time, etc. The comment suggests that express
courier shipments should be treated in the same manner as mail
shipments.
(Response) FDA disagrees but has modified the rule to address the
underlying concern. Food imported or offered for import via these
private delivery services are subject to prior notice, which must be
submitted within the timeframe of the applicable mode of
transportation--water, air, or land (Sec. 1.279). In the prior notice
CPG published in November 2004 (November 9, 2004; 69 FR 64959), FDA and
CBP stated that they generally would consider not taking regulatory
action if the prior notice is inadequate because it does not include
the required anticipated arrival information and/or planned shipment
information and if, among other criteria, the prior notice includes the
shipment's tracking number in lieu of the required anticipated arrival
information and/or planned shipment information. A person shipping food
into the United States via an express courier will have access to the
tracking number to use in lieu of the flight number or other planned
shipment information. FDA has incorporated this policy in Sec. 1.281
of the final rule, which allows the submitter and/or transmitter to
submit the express consignment operator or carrier tracking number in
lieu of anticipated arrival and certain planned shipment information as
long as neither the submitter nor transmitter is the express
consignment operator or carrier and prior notice is submitted via PNSI.
12. Additional Exclusion Requested--Gift Packs
(Comments) One comment requests clarification of the interpretation
pertaining to gift baskets. The comment states it is unclear whether
prior notice is based upon the description of the entire gift basket as
an entity, which is currently the case for CBP entry processing, or on
the individual items within the basket. One comment asks FDA to exempt
gift baskets because they are ``no-risk.''
(Response) Under the final rule, a gift pack is not considered a
single article of food (e.g., a gift pack consisting of four articles
of food would require four prior notice submissions). This is because a
gift pack is not manufactured/processed as a single product, but is
packed by consolidating a variety of articles of food into a unit, with
or without other nonfood articles. However, FDA and CBP are proposing
to continue their enforcement discretion policy for gift packs, which
the agencies first announced in their March 2005 CPG (March 4, 2005; 70
FR 10657). Under that policy, ``FDA and Customs Border Protection (CBP)
staff should typically consider not taking regulatory action if there
is a prior notice violation because a single prior notice is submitted
for a gift pack and the identity of the facility that packed the gift
pack is submitted in lieu of the identity of the manufacturer(s),
provided that the gift pack is purchased or otherwise acquired by an
individual and imported or offered for import for nonbusiness
purposes.''
There is no CBP rule or regulation, nor is there a General Rule of
Interpretation (GRI) under which gift packs are classified. In the case
of ``gift packs'' that contain multiple products,
[[Page 66318]] CBP tries to classify the gift pack using the concept of a set. That is, if the products included in a gift pack are part of a common activity, the gift pack may be classified under the HTS code that is most applicable. However, CBP does not consider eating to be a common activity, even when all items in a gift pack are to be consumed. Therefore, unless there has been an applicable CBP ruling, entries of gift packs should be declared to CBP using the HTS code for each item included within the gift pack. This principle applies even when there are food and nonfood items in the pack (e.g., a soup mug and a can of soup) as well as for make-your-own gift packs (e.g., if you created a gift pack by personally selecting individual items from a list of available products). 13. Additional Exclusions Requested--Household Goods and Unaccompanied Baggage (Comments) Many comments suggest that the final rule exempt unaccompanied food that is included in a shipment of personal household goods, if the food is owned by and intended to be consumed by the shipper of the household goods, their family or friends, and if the food is not to be offered for sale or distribution. In addition, several comments suggest that food contained in unaccompanied baggage should be exempt from the requirements of prior notice. The comments state that the owner of the food never changes, and that there is no sale or transfer of the goods. The comments believe that shipping food items contained in household goods or unaccompanied baggage to the United States is equivalent to carrying the items in baggage for personal use. The comments further state that household goods are even more personal than food accompanying a traveler because although it travels from one personal residence to another, it remains part of the same household or home. The comments suggest that FDA not require as many data elements for these types of shipments, and allow a minimum amount of food/consumables to be imported without prior notice. The comments believe that it will be unnecessarily tedious and exhaustive for individuals to input the required information into the FDA PNSI, and that it is unreasonable to ask individuals to destroy or leave behind hundreds of dollars of canned goods. Additionally, one comment suggests that persons on duty in the United States as members of the armed forces of a North Atlantic Treaty Organization (NATO) or Partnership for Peace or civilian component attached to or employed by NATO Headquarters, Supreme Allied Commander Transformation Atlantic and their immediate families be granted an exemption from prior notice. The comment contends that these individuals have undergone an intense screening process prior to being selected for a NATO position. One comment requests that FDA exempt Department of Defense active duty military and civilian personnel unaccompanied baggage and household good shipments. (Response) Section 801(m) of the act does not authorize an exclusion from prior notice for food imported as part of unaccompanied baggage or food included as part of a shipment of personal household goods. Therefore, food contained in household goods and accompanied baggage are subject to prior notice requirements. However, a proposed enforcement discretion policy in the Prior Notice Final Rule Draft CPG would apply to most or all of the household goods and unaccompanied baggage shipments described in the comments. Under the proposed policy, FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for noncommercial purposes with a noncommercial shipper without prior notice. We consider food in household goods, including military and civilian transfers, to be food imported or offered for import for a noncommercial purpose. This enforcement discretion policy would be a continuation of the policy in effect since FDA issued the June 2004 Prior Notice Interim Final Rule CPG (June 29, 2004, 69 FR 38906). 14. Additional Exclusions Requested--Noncommercial Use (Comments) One comment asserts that shipments for personal consignment when sent from a business are, by definition, noncommercial, due to the fact they are purchased for personal use and not for resale. The comment suggests that FDA define noncommercial shipments to include any consignment to an individual for personal, noncommercial use, as exempt from the requirements of prior notice, regardless of whether the shipper is a business entity or an individual. (Response) FDA disagrees. As we described in the IFR, there is no basis in the statute for an exemption based on shipments that are for personal use, regardless of whether the shipper is a commercial or noncommercial (i.e., an individual) entity (68 FR 58974 at 58992). However, we are proposing an enforcement discretion policy in the Prior Notice Final Rule Draft CPG for food imported or offered for import for noncommercial purposes with a noncommercial shipper without prior notice, irrespective of the type of carrier. Under the proposed policy, FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for noncommercial purposes with a noncommercial shipper without prior notice. The noncommercial shipper, under this policy, would be an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for nonbusiness purposes). When a business ships a food, it is for a commercial or business purpose. The situation as described in this comment, therefore, would not meet the criteria covered by the enforcement discretion policy since the shipper is a business. (Comments) One comment requests that private persons should be excluded from the requirements of prior notice. The comment states that commercially-produced food imported for the personal use of an individual, even if included in a shipment of personal effects, should not require prior notice. (Response) Section 801(m) of the act does not authorize a broad exclusion from prior notice for food imported or offered for import by private persons. Therefore, food that is commercially produced that is imported for the personal use of an individual, as described in the comment, would be subject to this final rule. However, we are proposing an enforcement discretion policy in the Prior Notice Final Rule Draft CPG for food imported or offered for import for noncommercial purposes with a noncommercial shipper, irrespective of the type of carrier without prior notice. Under the proposed policy, FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for noncommercial purposes with a noncommercial shipper without prior notice. This policy would cover the food described in the comment, commercially produced food imported for the personal use of an individual, as long as the shipper is noncommercial. This enforcement policy would continue the policy initially announced in our June 2004 Prior Notice Interim Final Rule CPG. The draft CPG describes a noncommercial purpose as one where the food is purchased or otherwise acquired by an individual for nonbusiness purposes, and a noncommercial shipper is one where the shipper is an individual (e.g., the individual delivers the food to a post
[[Page 66319]]
office or common carrier for delivery to self, family member, or friend
for nonbusiness purposes, i.e., not for sale, resale, barter, business
use, or commercial use). Examples of foods imported or offered for
import that may be covered by this noncommercial category are: (1) Food
in household goods, including military and civilian transfers; (2) food
purchased by a traveler and mailed or shipped to the traveler's U.S.
address by the traveler, not the commercial establishment; and (3)
gifts purchased at a commercial establishment and shipped by the
purchaser, not the commercial establishment.
(Comments) One comment suggests that older wines already owned by a
U.S. individual and imported solely for personal consumption be exempt
from prior notice. Another comment provides an example of an individual
who owns a wine cellar overseas and arranges for cases of wine to be
sent to him/herself in the United States for personal consumption.
(Response) As discussed previously, there is no basis in section
801(m) of the act to exclude food imported or offered for import for
personal use. Although this importation is subject to the provisions of
this final rule, if the wine is imported or offered for import by an
individual for noncommercial purposes and shipped by himself to himself
using a noncommercial shipper without prior notice, the proposed
enforcement discretion policy in the Prior Notice Final Rule Draft CPG
would apply. Under the proposed policy, FDA and CBP generally should
typically consider not taking regulatory action when an article of food
is imported or offered for import for noncommercial purposes with a
noncommercial shipper without prior notice.
(Comments) One comment suggests that small shipments of nominal
value for personal, noncommercial use should be exempted from the
requirements of prior notice. The comment states that the express
industry handles many of these shipments now, which include purchases
from a growing number of Internet-based sellers. The comment asserts
that these small shipments for personal use do not qualify as a risk to
the domestic food supply, and should be exempt from prior notice.
(Response) As we discussed previously, section 801(m) of the act
does not authorize an exclusion for small quantity or low-value
shipments. FDA notes that under the Prior Notice Final Rule Draft CPG,
FDA and CBP should typically consider not taking regulatory action when
an article of food is imported or offered for import for noncommercial
purposes, such as small shipments for personal use, with a
noncommercial shipper without prior notice. However, this proposed
enforcement discretion policy would not extend to situations where the
shipper is a commercial entity (e.g., a retail store, an Internet
company, etc.).
15. Additional Exclusions Requested--U.S. Goods Returned
(Comments) A few comments request exemptions for unadulterated U.S.
goods being returned. The comments state that these items do not pose
an adequate threat to the nation's food supply. In addition, these
comments indicate that it is not possible to provide the manufacturer's
registration number for merchandise that was manufactured in the United
States and then exported overseas, where the merchandise can be
purchased and then shipped back to the United States. The comments
state that the original manufacturer in the United States will not
provide their registration number in these scenarios.
(Response) FDA disagrees. As discussed in the IFR, FDA believes
that, for the purpose of section 801(m) of the act, the phrase
``imported or offered for import into the United States'' applies to
articles of food of U.S. origin that are ``reimported'' back into the
United States (68 FR 58974 at 58990). FDA believes that this
interpretation, and the underlying rationale for it, are still valid.
We also believe, as explained in the IFR, that section 801(m) of the
act does not authorize us to exclude ``low-risk'' food shipments from
prior notice requirements (68 FR 58974 at 58993).
The inability to submit the manufacturing facility's registration
number is not a valid reason for excluding such a shipment from prior
notice requirements. However, we are revising Sec. 1.281(a)(6) of the
final rule to provide flexibility in submitting the identity of the
manufacturer. In addition to the name of the manufacturer, the
submitter may submit either the registration number, city, and country
of the manufacturer, or both the full address of the manufacturer and
the reason why the registration number is not provided.
(Comments) One comment requests that FDA provide clear direction
whether prior notice is required for food shipments of U.S. products
that are returned to the United States after refusal by a foreign
government.
(Response) FDA requires prior notice for an article of food that
has been exported from the U.S. and is being ``reimported'' back into
the U.S., as we consider such a shipment as being ``imported or offered
for import into the United States'' (Sec. 1.277(a)), regardless of
whether it was initially a U.S. export that was refused by a foreign
government. We would require prior notice for these shipments even if
entry is not required by CBP. In these cases, we recommend that prior
notice be submitted via PNSI.
16. Additional Exclusions Requested--In-Transit Shipments
(Comments) Several comments request that in-transit shipments be
excluded from the prior notice requirements. The comments express
concern that submitting prior notice for such shipments presents a
tremendous burden on industry. Companies may seek to avoid the
potential cost and disruption by diverting freight to other routes
rather than use transshipment facilities through U.S. territory for
destinations in Mexico and Canada.
The comments note that requiring prior notice for shipments not
intended for consumption in the United States appears to be beyond the
statutory authority provided by the Bioterrorism Act. The comments
reason that in-transit shipments are under strict CBP regulations and
control by the carrier with respect to movement and are secured by a
bond, and thus, the food cannot be diverted to enter the U.S. food
supply.
(Response) FDA disagrees. The IFR contains FDA's rationale and
legal support for determining that for the purpose of section 801(m) of
the act, the phrase, ``imported or offered for import into the United
States,'' applies to articles of food of U.S. origin that are
``reimported'' back into the United States, as well as to food that
transits the United States (See 68 FR 58974 at 58990). FDA continues to
believe this determination is correct and is not convinced it should be
revised. Moreover, the comment implies that these shipments should be
exempt from prior notice requirements since the shipments are under
strict CBP control and are secured by a bond, i.e., that these
shipments are low-risk. However, section 801(m) of the act does not
authorize an exemption for articles of food that are ``low risk'' or
covered by programs of other agencies, such as CBP or foreign
government regulatory authorities.
(Comments) One comment requests that the final rule exempt foreign-
to-foreign transit mail; i.e., mail shipments that simply transit the
United States for delivery in a third country. The comment reasons that
these items are not intended for U.S. consumption (i.e., not intended
for a U.S. recipient); represent the transfer of universal
[[Page 66320]]
service obligation mail between sovereign governmental entities; and
are items from foreign mailers who would not know when to submit the
required prior notice data as they do not always know whether their
mail dispatches will be transiting the United States.
(Response) As we explained in the IFR and elsewhere in this notice,
food that is not intended for U.S. consumption is still within the
scope of ``imported or offered for import'' (68 FR 58974 at 58991) and
is subject to prior notice requirements. However, we understand that in
the case of foreign-to-foreign mail, the sender does not have control
over the transportation route that the foreign-to-foreign shipment will
transit. Therefore, we are proposing an enforcement discretion policy
in the Prior Notice Final Rule Draft CPG that would address this
situation. Under that policy, FDA and CBP should typically consider not
taking any regulatory action when an article of food is imported or
offered for import via international mail without prior notice and
there is no U.S. recipient.
(Comments) Comments filed by express carriers request that FDA
exempt all non-U.S. destination shipments from the requirement to
provide prior notice. The comments note that the shipment is in the
custody of the express carrier at all times and the risk of diversion
from the highly-controlled environment in which express shipments move,
particularly in-bond shipments, is low. The comments also reason that
foreign shippers and foreign consignees do not submit the required
prior notice data because they are, by design, not aware that their
shipments will transit the United States on their way to a third
country because express carriers do not disclose flight routes of
packages either to shippers or consignees due to security concerns. If
prior notice must be submitted, express carriers will be required to
make the customers aware of routes, nullifying this simple but
effective security precaution.
(Response) As described in the previous comment, prior notice
applies to food imported or offered for import notwithstanding that the
food is not intended for U.S. consumption. However, we recognize that,
when shipping via express carrier or other private delivery service,
the sender does not have control over the transportation route that the
foreign-to-foreign shipment will transit. For example, a person in
Europe intends to mail an article of food to South America via an
express carrier. This person has no control over the package entering
the United States if the express carrier, for example, chooses to
consolidate shipments going to South America in Florida. The proposed
enforcement discretion policy in the Prior Notice Final Rule Draft CPG
states that FDA and CBP should typically consider not taking any
regulatory action when an article of food is imported or offered for
import and the carrier is an express consignment operator or carrier;
neither the submitter nor transmitter is the express consignment
operator or carrier; and the importer, owner, or recipient/consignee is
not located in the United States.
(Comments) Several comments request that FDA exempt shipments of
food that move from Canada to Canada under bond by rail through
Northern Maine. These comments note that such shipments moving by rail
in bond cannot be delivered to points within the United States, must
move from Canada to Canada, and that the food products in trailers on
rail cars cannot be diverted to enter the U.S. food supply. The
comments state that having to submit prior notice puts the U.S. rail
carriers at a competitive disadvantage when competing for Canadian rail
business. Other comments request that FDA exempt shipments of food that
move from Canada to Canada by marine and trucking companies. The
comments reason that their Canada to Canada in-transit shipments move
in sealed containers and that providing detailed information for
products that are never going to enter the U.S. food supply is a
hardship to U.S. businesses.
(Response) FDA disagrees. The Bioterrorism Act does not create any
exemptions for this situation and therefore, there is no basis for
excluding such business operations from prior notice requirements. The
preamble to the IFR provides our rationale for determining that food
that transits the United States falls under the scope of this rule (68
FR 58974 at 58990) and we continue to hold this view. Moreover, the
comment implies that these shipments should be exempt from prior notice
requirements because they pose a relatively low risk by moving by rail,
in bond, and/or under seal. Even if such food shipments are a low risk,
as discussed elsewhere in this notice, section 801(m) of the act does
not authorize a ``low risk'' exemption. However, the proposed guidance
in the Prior Notice Final Rule Draft CPG (which would continue the
policy established in the March 2005 revision to the Prior Notice
Interim Final Rule CPG) addresses imported food arriving from and
exiting to the same country. It describes the situations and conditions
under which FDA and CBP should typically consider not taking regulatory
action when prior notice is not submitted.
(Comments) Another comment suggests that the FDA work cooperatively
with CBP such that transshipments that follow the CBP transshipment
procedures are not required to enter additional information for FDA
prior notice purposes, and that shipments that may pose a risk are
identified through the CBP process. The comment also states that the
current requirements in the agreement for secure in-transit procedures
could be modified to meet the objective of the prior notice IFR to
prevent the entry of products that have been intentionally adulterated.
Shipments that follow the proposed secure in-transit procedures would
not be distributed in the United States and would be of minimal risk to
human or animal security and safety. The comment also suggests that FDA
can achieve certainty of safety of overseas shipments that are
transiting to the United States through Canada by conducting
examinations at the first point of arrival in North America and through
the expansion of existing bilateral harmonized risk screening and
lockout sharing systems to accommodate additional high-risk
commodities.
(Response) CBP's secure in transit procedures cannot substitute for
the submission of prior notice for in transit shipments because they do
not meet the requirements of the Bioterrorism Act, such as providing
FDA with certain specified information. The information in a prior
notice is necessary for FDA to determine whether it should examine the
food at the U.S. port of arrival. In addition, section 801(m) of the
act does not authorize an exemption for articles of food that are
covered by programs of other agencies, such as CBP, even if those
programs would ``prevent the entry of products that have been
intentionally adulterated.''
(Comments) One comment notes that there are many ocean containers
crossing into the United States for transshipment purposes and prior
notice is not being submitted. The comment asks how to ensure that
ocean containers that arrive in Canada or Mexico and cross into the
United States by rail have prior notice submitted in a timely fashion,
or submitted at all, when shippers are not always aware of when the
containers are due to cross or on which train.
(Response) FDA addressed this issue in the IFR when it allowed any
person with knowledge of the required information to submit prior
notice. In
[[Page 66321]]
Sec. 1.285 of the proposed prior notice rule (68 FR 5428, February 3,
2003), FDA provided that a purchaser or importer of an article of food
who resides or maintains a place of business in the United States or an
agent thereof was authorized to submit prior notice. FDA further
proposed that if the article of food is imported for in-bond movement
through the United States for export, the prior notice must be
submitted by the arriving carrier or, if known, the carrier making the
in-bond entry. Many comments to the proposed rule objected to the
limitation that only a person who resides or maintains a place of
business in the United States can submit the prior notice. In addition,
comments pointed out that under some circumstances, the U.S. importer
or purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice.
In response, FDA modified this provision in the IFR and removed the
restriction on who can submit prior notice. Accordingly, Sec. 1.278 of
the IFR provides that any person with knowledge of the required
information may submit prior notice to FDA. FDA has retained this
provision in the final rule.
17. Additional Exclusions Requested--Diplomatic Pouch
We have determined that prior notice does not apply to food in
diplomatic pouches because Art. 27(3) of The Vienna Convention on
Diplomatic Relations (1961) states that: ``The diplomatic bag shall not
be opened or detained.''
(Final Rule) Section 1.277(b)(7) of the final rule adds a new
exclusion to the rule: ``Articles of food subject to Art. 27(3) of The
Vienna Convention on Diplomatic Relations (1961), i.e., shipped as
baggage or cargo constituting the diplomatic bag.''
18. Additional Exclusions Requested--Seeds for Planting
(Comments) One comment requests that FDA exempt imported seed that
is destined solely for planting purposes, even if small amounts found
unsuitable for planting will end up in the food supply. The comment
also requests that the FD3 flags be removed from HTS codes that cover
seed for sowing or planting or, alternatively, to clarify that FD3
flagged HTS codes may be ``disclaimed'' at entry.
(Response) Whether seeds are subject to prior notice depends on
whether the seeds meet the definition of food. Some seeds, such as
sesame seeds for baking or as a garnish, are food for which prior
notice must be submitted to FDA before the seed is imported or offered
for import into the United States. Some seeds are capable of both food
and nonfood uses, such as seeds that are sometimes processed into
cooking oil and other times processed into industrial-use oil. As
discussed elsewhere in this document, FDA considers such seed to be
food for the purpose of prior notice if the seed is reasonably likely
to be directed to a food use. Even when seed is for a nonfood use, such
as seeds for growing flowers, if a small portion of that seed is
reasonably likely to be directed for use in animal feed, prior notice
would be required. Because seeds, including seeds for planting, may be
subject to prior notice under section 801(m) of the act, we believe
they are properly flagged as FD3.
Nonetheless, we note that the draft Prior Notice Final Rule CPG,
announced elsewhere in this issue of the Federal Register, proposes an
enforcement policy regarding seeds for planting. Under the draft
policy, FDA and CBP should typically consider not taking any regulatory
action regarding seeds that will be used for cultivation if they are
imported or offered for import without prior notice. The policy would
apply when no more than a small portion of that seed is diverted from
cultivation to animal feed or other food use. It would not apply,
however, where the seed is used for the production of edible sprouts,
such as alfalfa seeds for the production of alfalfa sprouts.
E. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
Section 1.278 of the IFR states that prior notice may be submitted
by any person with knowledge of the required information and identifies
this person as the submitter. The IFR also states that the submitter
also may use another person to transmit the required information on
his/her behalf and identifies the person who transmits the information
as the transmitter. The IFR also states that the submitter and
transmitter may be the same person.
(Comments) Several comments note that carriers often do not have
access to the information required to classify articles in the FDA
system (the commercial invoice and packing list) because it is
proprietary information that the owners of the goods will not want to
give to intermediaries in the transportation chain. Also, there is
confusion regarding who is responsible for submitting prior notice.
This causes particular problems for carriers of in-bond cargo
transiting the United States. The comment suggests that exempting in-
bond shipments from prior notice would allow carriers to move the
shipment without having to submit prior notice and permit the broker at
the port of entry, who does get the necessary documents, to properly
submit the prior notice. (Response) FDA disagrees that there is
confusion regarding who is responsible for submitting prior notice. The
IFR and this final rule expressly state in Sec. 1.278 that any person
with knowledge of the required information may submit the prior notice.
FDA provided this flexibility as to who could submit prior notice in
response to comments that FDA received on the proposed rule, which
urged FDA not to limit who could file prior notice to either a
purchaser or importer of an article of food who resides or maintains a
place of business in the United States or an agent thereof, or to the
arriving carrier or the carrier making the in-bond entry if the article
of food is imported for in-bond movement through the United States for
export. (See 68 FR 58974 at 58994.) Comments to the proposed rule also
pointed out that under some circumstances, the U.S. importer or
purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice. In response, FDA modified
this provision in the IFR and removed the limitation on who can submit
prior notice.
(Response) FDA disagrees that there is confusion regarding who is
responsible for submitting prior notice. The IFR and this final rule
expressly state in Sec. 1.278 that any person with knowledge of the
required information may submit the prior notice. FDA provided this
flexibility as to who could submit prior notice in response to comments
that FDA received on the proposed rule, which urged FDA not to limit
who could file prior notice to either a purchaser or importer of an
article of food who resides or maintains a place of business in the
United States or an agent thereof, or to the arriving carrier or the
carrier making the in-bond entry if the article of food is imported for
in-bond movement through the United States for export. (See 68 FR 58974
at 58994.) Comments to the proposed rule
[[Page 66322]]
also pointed out that under some circumstances, the U.S. importer or
purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice. In response, FDA modified
this provision in the IFR and removed the limitation on who can submit
prior notice.
Accordingly, Sec. 1.278 of the IFR provides that any person with
knowledge of the required information may submit prior notice to FDA.
FDA noted in the preamble to the IFR that any person may now take
responsibility for submitting prior notice for a particular article of
food, as long as that person can provide all the required information.
This person is referred to as the submitter in the IFR. The IFR also
states that the submitter may use another person to transmit the
required information to FDA. For ease of reference, the person who
transmits the prior notice is referred to as the transmitter in the
IFR. FDA has retained these provisions in the final rule. FDA further
notes that to the extent that there is confusion, the parties to the
transaction may want to consider a means for identifying which party is
responsible for submitting prior notice as part of their business
arrangements (e.g., within their contract).
(Comments) Several comments note that problems arise because the
IFR creates no particular obligation on any particular party within the
distribution system to submit prior notice. One comment states that
because prior notice can be submitted by any person who has the
information, there are many cases of duplicate prior notices filed by
different parties for the same shipment. Another comment suggests that
FDA select one party to be responsible, suggesting the appropriate
party would be either the exporter or the importer-broker.
(Response) Please see the response to the previous comments. FDA's
proposed rule did specify a limited class of individuals who could
provide prior notice and this limitation received significant adverse
comment. Accordingly, both the IFR and this final rule provide that any
person with knowledge of the required information may submit the prior
notice (Sec. 1.278). FDA notes that the parties to a transaction can
elect to take steps among them to identify which party should submit
the prior notice and ensure that the party submitting prior notice has
the appropriate and correct information.
(Comments) One comment suggests that it is improper for a carrier
to require the shipper to submit prior notice when the shipper is not
shipping goods into the United States, but the carrier unilaterally
moves the goods through their hub in the United States, thereby causing
the shipment to enter the United States. Another comment notes that the
data elements required in a prior notice are not available to the
shipper, inferring that it is not possible for a shipper to submit
prior notice.
(Response) Neither the IFR nor this final rule specifies who must
file prior notice. Rather, the rule provides that any person with
knowledge of the required information may submit prior notice to FDA.
Accordingly, it is not for FDA to say whether it is proper for a
carrier to require a shipper to submit prior notice as a condition of
shipment, as that is a matter between two contracting parties. We note
that the Prior Notice Final Rule Draft CPG proposes an enforcement
policy for foreign-to-foreign mail. Under the proposed policy, if there
is no prior notice FDA and CBP should typically consider not taking any
regulatory action in the case of international mail where the recipient
is not in the United States since the sender does not have control over
the transportation route that the foreign-to-foreign mail will transit.
(Comments) One comment asks whether there are any prior notice
obligations to fulfill if the exporter is not required to register with
the FDA under the Bioterrorism Act (21 CFR part 1, subpart H).
(Response) Prior notice and registration are separate obligations
under different regulations and with differing applicability. For
example, registration applies to facilities that manufacture, process,
pack or hold food that will be consumed by humans or animals in the
United States. By comparison, prior notice generally applies to FDA-
regulated food being imported or offered for import into the United
States, regardless of whether it will be consumed in the United States
and regardless of whether the exporter must register.
(Comments) One comment asks for clarification of the legal
responsibility of the submitter.
(Response) Among the requirements of the final rule, the prior
notice information must be accurate and timely. As described in Sec.
1.283, if an article of food is imported or offered for import and the
notice is inaccurate or untimely, the food is subject to refusal of
admission. Other consequences under the act for those who fail to
comply with the prior notice requirements, such as by submitting
inaccurate or untimely notice, are described in Sec. 1.284.
(Final rule) Section 1.278 of the final rule states that prior
notice may be submitted by any person with knowledge of the required
information and identifies this person as the submitter. The final rule
also states that the submitter may use another person to transmit the
required information on his/her behalf and identifies the person who
transmits the information as the transmitter. The final rule also
states that the submitter and transmitter may be the same person.
F. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
Section 801(m)(2)(A) of the act states that FDA shall by regulation
prescribe the time of submission of the notification in advance of
importation or the offering of the food for import, which period shall
be no less than the minimum amount of time necessary for the Secretary
to receive, review, and appropriately respond to such notification, and
any timeframe FDA adopts in the final rule must be justified under this
standard. Section 1.279(a) of the IFR requires FDA to receive prior
notice and confirm it for review no less than 2 hours before arriving
at the port of arrival by land via road, no less than 4 hours before
arriving at the port of arrival by air and land via rail, and no less
than 8 hours before arriving at the port of arrival by water. We
explained in the preamble to the IFR that the ``interim final rule
provides for greatly reduced timeframes for foods [from what we had
proposed] based on mode of transportation. These timeframes are what
FDA has determined are the minimum timeframes necessary to allow it to
satisfy the statutory mandate that the timeframes give the agency the
time it needs to `receive, review, and respond' to prior notices.'' (68
FR 58974 at 58995)
Under Sec. 1.279(b) of the IFR, prior notice may not be submitted
more than 5 calendar days before arrival, except in the case of food
imported or offered for import by international mail. Under Sec.
1.279(c) of the IFR, if the article of food is arriving by
international mail, the prior notice must be submitted before the food
is sent to the United States.
Section 1.279(d) of the IFR provides that the time of submission is
fixed and the prior notice time will start for purposes of determining
if prior notice is timely when the prior notice submission is confirmed
by FDA for
[[Page 66323]]
review. FDA will confirm a prior notice once all required information
has been submitted and confirmed as facially complete. For example, if
the information submitted failed to include an FDA Product Code, the
system will not provide a confirmation for that prior notice. The
transmitter has an opportunity to correct the rejected information.
When the information is corrected, transmitted, and determined to be
facially valid, the system will then notify the transmitter and provide
the prior notice confirmation number.
Under Sec. 1.279(e) of the IFR, the prior notice confirmation
number must accompany any article of food arriving by international
mail. Under Sec. 1.279(f), a copy of the confirmation (with the prior
notice confirmation number) must accompany any article of food carried
by or otherwise accompanying an individual (unless excluded under Sec.
1.277(b)(1)), and be provided to CBP or FDA upon arrival. Additionally,
under Sec. 1.279(g) the prior notice confirmation number must
accompany any article of food for which the prior notice was submitted
through the FDA PNSI when arriving in the United States and must be
provided to CBP and FDA upon arrival.
We further stated in the IFR's preamble that we also were
interested in exploring flexible alternatives for submission of prior
notice for foods or firms covered by programs of other agencies, such
as C-TPAT, or imported by other agencies. We explained that FDA and CBP
would publish a plan, including an implementation schedule, to achieve
the goal of a uniform, integrated system, and to coordinate timeframes
for import prior notice information while fulfilling the Bioterrorism
Act mandates for air and truck modes of transportation with timeframes
finalized by CBP when they finalize their rule entitled ``Required
Advance Electronic Presentation of Cargo Information'' (the Advance
Electronic Information Rule) (68 FR 58995). On December 5, 2003, CBP
issued the Advance Electronic Information Rule (68 FR 68140), which
requires CBP to receive, by way of a CBP-approved electronic data
interchange system, information pertaining to cargo before the cargo is
either brought into or sent from the United States by any mode of
commercial transportation (water, air, rail, or truck). The cargo
information required is that which is reasonably necessary to enable
high-risk shipments to be identified for purposes of ensuring cargo
safety and security and preventing smuggling under the laws enforced
and administered by CBP. The Advance Electronic Information Rule
implements the provisions of section 343(a) of the Trade Act of 2002,
as amended by the Maritime Transportation Security Act of 2002. The
relevant timeframes provided in the Advance Electronic Information Rule
are as follows:
<bullet> For arrival by land via road at ports that are fully
equipped to accommodate CBP's Advance Electronic Information Rule, no
later than 1 hour prior to the arrival of the truck at the border, or
for Free and Secure Trade (FAST) participants, 30 minutes;
<bullet> For arrival by land via rail at ports that are fully
equipped to accommodate CBP's Advance Electronic Information Rule, no
later than 2 hours prior to the arrival of the train at the border; For
arrival by air, no later than the departure time (``wheels up'') of the
aircraft from any foreign port or place in North America, including
locations in Mexico, Central America, South America (from north of the
Equator only), the Caribbean, and Bermuda, and from other areas into
ports that are fully equipped to accommodate CBP's Advance Electronic
Information Rule no later than 4 hours prior to the arrival of the
aircraft in the United States.
On April 14, 2004, FDA and CBP announced their ``Joint FDA-CBP Plan
for Increasing Integration and Assessing the Coordination of Prior
Notice Timeframes'' (69 FR 19765), which the agencies amended in August
2004 (http://www.cfsan.fda.gov/~pn/pnplan2.html). As stated in the plan
regarding the agencies' assessment of reduced timeframes ``FDA and CBP
continuously are assessing the completeness of prior notice submissions
received as well as the amount of time necessary to receive, review,
and respond to those submissions requiring a human review. However,
that process is not yet complete, as we are currently operating under
the enforcement policies outlined in the Prior Notice Compliance Policy
Guide (CPG). See Compliance Policy Guide Sec. 110.310--Prior Notice of
Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. (Issued December 15, 2003, and
revised June and August 2004; http://www.fda.gov/ora under Compliance
References.) We currently do not receive prior notice for all
shipments.''
In our plan, we also stated that we would assess existing
procedures and staffing needed to receive, review, and respond to the
prior notices submitted in accordance with the Prior Notice IFR;
identify what changes to work practices and staffing would be necessary
to determine if FDA could continue to receive, review, and respond to
all prior notice submissions with reduced timeframes for land and air
consistent with CBP's rule; and implement necessary changes and make
appropriate adjustments to ensure we could receive, review, and respond
to all prior notice submissions with reduced timeframes before issuing
the final rule, consistent with our obligation to ensure that any
timeframe selected is sufficient to receive, review, and respond to
prior notice submissions, as set out in section 801(m)(2)(A) of the
act. We also emphasized that ``the evaluation of whether to reduce the
timeframes for prior notice review will depend on the level of
compliance industry achieves during the assessment. If we are unable to
make such an assessment, our intended timeframe for issuing a prior
notice final rule may be delayed.''
Comments received on the prior notice IFR addressed the timeframes
required in the IFR, as well as integration of those timeframes with
the timeframes covered by CBP's advance electronic information rule.
Comments also covered the IFR's requirement that prior notice must be
submitted at least 5 days prior to arrival. We respond to the issue of
timeframes for submitting prior notice here, and respond to the other
questions raised in our Joint Implementation Plan and April 14, 2004,
reopening of the comment period later in this preamble.
1. IFR Timeframes (2, 4, and 8 hours)
(Comments) One comment asks FDA to permit prior notice to be
submitted at the port of entry, instead of at the port of arrival, in
order to align the prior notice process with long-standing, existing
CBP clearance processes and infrastructures at the port of entry. The
comment reasons that since according to FDA's own estimates, 80 to 90
percent of prior notice data will be filed by the ABI filer, it is
logical that prior notice should be filed at the same port where
clearance entry is filed. The comment also suggests that FDA may want
to consider a two-step process for submitting prior notice, under which
the CBP ``ACI data'' is accepted as the first step, filed at port of
arrival as part of the ``ACI data,'' followed by complete prior notice
in its current form, filed as a second step at the port of entry, i.e.,
concurrent with the clearance entry. Another comment suggests that to
ensure consistency with ACE, the prior notice should be required and
calculated from the port of entry and not the first point of arrival,
as is currently the case.
[[Page 66324]]
Another comment recommends that to fully achieve the FDA-CBP goal
of coordinating timeframes, FDA should adopt the ``point of entry,''
rather than the ``point of arrival'' in the United States to measure
the timeliness of the prior notice filing. CBP's ``point of entry'' is
well known to importers and its use for purposes of the Bioterrorism
Act not only will alleviate unnecessary confusion, but also will
facilitate the stream of U.S. commerce without compromising food
safety.
The comment also states that with the growing partnership between
FDA and CBP, FDA's concern regarding limited personnel should no longer
be an issue now that FDA and CBP collectively are using their
respective enforcement officials for this joint endeavor.
(Response) FDA discussed the ``port of entry/port of arrival''
issue extensively in the preamble to the IFR and is not persuaded by
the comments that its initial position should be changed (See 68 FR
58974 at 58988). The Bioterrorism Act established that prior notice be
provided by a specified period of time in advance of the time of the
importation of the article of food involved or the offering of the food
for import, which period shall be no less than the minimum amount of
time necessary for the Secretary to receive, review, and appropriately
respond to such notification, but may not exceed 5 days. That means
that prior notice must be submitted before the article of food arrives
in the United States. Moreover, we explained in the IFR that the
overall purpose of the Bioterrorism Act is to improve the ability of
the United States to prevent, prepare for, and respond to bioterrorism
and other public health emergencies, thereby making essential the
ability to examine or hold a suspect article of food when it first
arrives at a port of entry in the United States, rather than later at
the port where CBP will process the entry. Thus, the final rule uses
the term ``port of arrival'' rather than ``port of entry'' as the food
may not arrive at the port of entry until long after it has arrived in
the United States. In addition, CBP's advance electronic information
rule also requires notice in advance of ``arrival'' in the United
States, and not at ``entry.''
The IFR and final rule define ``port of arrival'' and ``port of
entry.'' Neither, however, use the terms ``point of arrival'' or
``point of entry.'' FDA could not find reference to ``point of entry''
in CBP rules or regulations.
FDA does agree that FDA's staffing at certain U.S. ports is much
less of an issue. Under an MOU between FDA and CBP signed by the
respective commissioners of both agencies on December 3, 2003, FDA has
commissioned thousands of CBP officers in ports and other locations to
conduct, on FDA's behalf, investigations and examinations of imported
foods. This unprecedented FDA-CBP collaboration significantly
strengthens the implementation of the Bioterrorism Act to ensure the
security of imported foods, particularly with respect to implementing
the prior notice rule. Building on FDA's and CBP's long history of
close cooperation, the MOU upgrades the two agencies' teamwork in
training, day-to-day operations, and information sharing. As part of
the MOU, FDA and CBP have provided specialized training for the
commissioned CBP employees who carry out this work, and both agencies
have expanded their existing cooperative arrangements to directly share
information affecting the safety and security of imported foods,
including co-locating FDA's PNC with CBP staff. Although the FDA and
CBP partnership benefits the prior notice process in many ways, this
partnership does not mean that the PNC no longer would have staffing
concerns such that the prior notice timeframes could be reduced, as the
comment implies. Please see the discussion later in this document
regarding ``Integration of FDA and CBP timeframes'' for further
discussion on reducing timeframes.
(Comments) One comment noted that the time difference between their
country and the United States makes it difficult for the agent to start
submitting prior notice immediately upon the receipt of necessary
information. Therefore, some food transported by air, as well as by
water, has actually missed the appointed timeframe. The comment
requests that prior notice be accepted until immediately before the
arrival of the food.
(Response) FDA disagrees. FDA's PNSI is available 24 hours a day to
submit prior notice. The timeframes established in the final rule are
the minimum amount of time that FDA needs to receive, review, and
respond to prior notice submissions.
2. Integration of FDA and CBP Timeframes
(Comments) One comment states that ``no shorter timeframes should
be allowed.'' However, the remainder of the comments addressing
consistency of timeframes between FDA and CBP recommend that FDA
timeframes for imported food arriving by air and land be reduced and be
consistent with those set forth by CBP in their advanced electronic
information rule. No comments recommend aligning the prior notice
timeframe for imported food arriving by water with the CBP advanced
electronic information rule timeframe of 24 hours prior to loading on
the vessel. The reasons for recommending that prior notice timeframes
be the same as CBP's advanced electronic information timeframes for
food arriving by air and land are that it would minimize the complexity
of the process by presenting a more streamlined flow of information and
avoid unnecessary duplication, result in fewer errors, provide better
compliance rates, allow for fewer disruptions at the border,
significantly reduce the burden on the trade community without creating
additional security risks, and allow operators at close border points
to load and verify truck loads and travel routes prior to submitting
notice. One comment suggested that there is no basis for concluding
that more time is needed for food shipments than for other shipments.
Another comment states that utilizing one system and one set of
timelines should provide adequate notice to FDA and improve compliance
with the prior notice requirements.
(Response) The timeframes established in the final rule represent
the minimum amount of time FDA needs to meet our statutory
responsibility to receive, review, and respond to prior notice
submissions. In accordance with our Joint Implementation Plan, we
evaluated the feasibility of conducting prior notice reviews in a
reduced time period in an effort to more closely harmonize the
submissions with CBP timeframes. As part of our assessment, we analyzed
data regarding prior notices we received in the first 9.75 months of
fiscal year (FY) 2005--specifically from prior notices received and
responded to by the PNC between October 1, 2004, and July 23, 2005.
Based on the results of our assessment, in the final rule we have
maintained the timeframes that are in the IFR:
<bullet> If the article of food is arriving by land by road, no
less than 2 hours before arriving at the port of arrival;
<bullet> If the article of food is arriving by land by rail, no
less than 4 hours before arriving at the port of arrival;
<bullet> If the article of food is arriving by air, no less than 4
hours before arriving at the port of arrival; and
<bullet> If the article of food is arriving by water, no less than
8 hours before arriving at the port of arrival.
FDA and CBP established these timeframes for the IFR based on the
information available at the time. By necessity, though, these
decisions regarding timeframes were not informed
[[Page 66325]]
by actual experience in operating the prior notice program. We now have
that experience, and the information gained during our assessment shows
that the minimum timeframes for submitting prior notices contained in
the IFR closely match the minimum time necessary for FDA to receive,
review, and respond to the prior notices. During the assessment period,
FDA was able to receive, review, and respond to almost all notices
within the established timeframes. In a relatively small number of
situations, FDA was not able to make a decision regarding whether to
inspect the food at the port of arrival by the end of the timeframe. In
these situations, when the food arrived at the port of arrival, it was
delayed while FDA completed its review. The number of such shipments,
however, has been relatively low, and the resulting impact on
government resources and the flow of traffic at ports has not been
significant. Thus, we do not believe we should increase the timeframes
to account for this relatively small number of outliers whose review
takes longer than the IFR's timeframes.
Our assessment also shows that, because the IFR's timeframes
closely match the minimum time necessary for FDA to receive, review,
and respond to the prior notices, those timeframes could not be
significantly reduced. If we were to change the timeframes to be
consistent with those of CBP's advance electronic information rule, not
only would this go against the statutory standard for setting the
timeframes, but it would also significantly increase the number of
shipments where FDA would not be able to decide whether it should
examine the food at the port of arrival by the end of the timeframe.
Based on current and projected staffing levels in the PNC, such
shipments would be delayed at the port of arrival until FDA has either
completed its review or decided to examine or not examine the food at
the port of arrival without the benefit of a complete review. FDA could
expend additional resources to increase capacity to review and reduce
the timeframe, but it would be at considerable cost to assist a small
number of shipments that have difficultly meeting these timeframes. In
the nearly 4 years since the end of the transition enforcement period
for the interim final rule, very few shipments have arrived without
prior notice and as such, the timeframes are both reasonable, and
economically efficient. The prior notice review process, information
from our assessment, and the consequences of reducing the timeframes
for conducting the prior notice review are discussed in more detail
below.
To implement the Prior Notice IFR, FDA established the PNC that
operates 24 hours a day, 7 days a week, all days of the year to
receive, review, and adequately responds to these notices as they are
submitted. PNC staff is also responsible for responding in real-time
(by e-mail, fax, or telephone) to inquiries they receive from affected
parties about pending prior notices and/or operational issues.
The purpose of prior notice is to help identify food that
potentially poses a significant health risk to the American public and
to deploy resources to the port of arrival so that inspections can be
conducted before the shipment ever enters the United States. Regardless
of whether a prior notice is submitted electronically to FDA through
CBP's ABI/ACS or FDA's PNSI, the prior notice information undergoes a
validation process and is then screened against food safety and
security criteria.
If the results of our initial validation indicate that the prior
notice requirements have been met and the results of our screening
indicate that the shipment does not appear to be a potential
bioterrorism or significant public health threat, the submission is
considered to have satisfied prior notice requirements and the
associated article of food is allowed to proceed for further
processing, including FDA admissibility review under section 801(a) of
the act. Alternatively, if the results of the initial screening of the
prior notice information indicate there is a potential bioterrorism or
other significant public health threat, the prior notice undergoes
additional intensive review by the PNC using other databases and
sources of information to determine whether the article of food should
be held at the port of arrival for examination or should be allowed to
proceed into 801(a) status for admissibility review. PNC personnel make
this determination using their experience with imported foods and the
expertise within FDA's CFSAN for human food or FDA's CVM for animal
feed, the inspectional information obtained by FDA's ORA, and the
expertise of CBP. FDA's goal is to complete its review within the 2, 4,
or 8 hour timeframe for submitting prior notice so that the review is
complete before the shipment arrives at the port of arrival. If the
intensive review takes longer than the timeframe and the shipment
arrives at the port of arrival, then FDA may delay the shipment at the
port of arrival until its review is completed. FDA could increase
staffing at the PNC in order to decrease timeframes, but the effect has
diminishing returns. When a shipment must undergo intensive review, PNC
staff members are reviewing databases and sorting through information
to determine whether the shipment poses a potential threat. Reviewing
one source of information leads to other sources of information to
investigate. It would not necessarily be effective to expend, for
example, five staff members on one intensive review at the start
because not all sources of information for review are known at the
beginning of an intensive review. Doubling or tripling staff, as
discussed in Option 2B of the Final Regulatory Impact Analysis of this
document, also would result in a significant amount of unused office
space and equipment during the slowest time periods. Staffing at
increased levels at all times would result in wasteful unproductive
staff waiting for shipments to arrive.
Moreover, the constant unpredictability of the submission times for
high risk prior notices requiring the shortest timeframe review (2
hours for food arriving by land via road) is a significant issue. The
exact busiest times are variable, and are very difficult to predict on
a daily basis. In addition, PNC targeting for high risk shipments also
varies based on contemporaneous targeting intelligence and changing
risk assessment strategies. Having constant two to three times the
number of staff to cover those short bursts of time when the highest
volume of high risk shipments, with the lowest timeframes are at their
peak would be inefficient and wasteful.
In addition, it has been suggested that the PNC reduce their time
frames and hold only those shipments it needs more time to review.
There are two very significant reasons why this would be impractical.
First, from a security perspective, doing so would result in holding
only potential high risk shipments at the border and would make PNC
targeting strategies widely visible and predictable to both those
involved in legitimate trade, and those with nefarious pursuits looking
to exploit weaknesses in U.S. food cargo security. Second, the holding
of high risk shipments at the port would cause logistical challenges
for port operators, and would almost certainly have a negative impact
on all food and nonfood shipments processed through those ports. In
contrast, with the current PN timeframes which have been in place for
more than 4[frac1s2] years, these logistical challenges have been
almost nonexistent, and PNC targeting strategies are virtually
transparent to the import trade.
[[Page 66326]]
The other factor to consider is the tremendous growth of imported
foods year to year (approximately 14 percent growth over the past 4
years), which far exceeds what FDA projected in the IFR. FDA has been
able to maintain the existing timeframes without adversely impacting
trade. Given that we continue to expect imports to increase in volume,
FDA does not believe that reducing timeframes is warranted. For all the
above reasons, FDA believes that its current and projected staffing
levels are sufficient and appropriate, and the timeframes are both
reasonable, and economically efficient.
FDA receives approximately 167,000 prior notices each week. The
distribution of prior notices by mode of transportation during our
assessment that were flagged by the initial screening and that received
an intensive prior notice review by the PNC is as follows:
| Truck | 27.6% |
| Car | 2.9% |
| Air | 17.6% |
| Rail | 0.8% |
| Sea | 39.2% |
| 11.1% | |
| Other | 0.8% |
As indicated, a significant portion (approximately 31 percent) of
the prior notices reviewed by the PNC on a daily basis are land/road
border entries, which under the IFR are subject to submission
timeframes of at least 2 hours before arrival. On average, during the
assessment period, the PNC conducted intensive security reviews on 225
to 250 prior notices per day from all modes of transportation, which
means that, on average, the PNC conducted intensive security reviews on
about 77 prior notices (31 percent of 250) each day that are subject to
the 2-hour timeframe. Moreover, the prior notices are not evenly
distributed over an 8 hour shift or 24-hour day. The actual dispersal
pattern of the prior notice submissions is not uniform; an overwhelming
majority of prior notice submissions arrive between a certain 12-hour
period.
The amount of time the PNC has needed for its intensive review has
ranged from 20 minutes to 315 minutes (5 hours and 25 minutes) from
when FDA received the prior notice and confirmed it for review. Using
data collected on articles of food arriving by land via truck and car
during our assessment period, the PNC expended an average of 61 minutes
to receive, review, and make a decision on whether or not a shipment
should be refused or held for examination under section 801(m) of the
act, or allowed to proceed into 801(a) status for admissibility review.
The PNC completed about 99 percent of its intensive reviews of prior
notices submitted for land/road border arrivals within 120 minutes of
receiving and confirming the prior notice for review. Only about 57
percent of the intensive reviews were completed within 1 hour. Reviews
for the remaining 43 percent (8,900 prior notices for the assessment
period, or more than 10,000 for FY 2005) took longer. If the timeframe
were set at 1 hour for these articles of food instead of the IFR's 2
hours, the PNC would have had to either delay the food at the port of
arrival until it completed its review or decide whether to examine the
food at the port or arrival without the benefit of a complete review,
based on current and projected staffing levels in the PNC.
FDA does not have data to accurately analyze the impact of changing
the timeframe to 30 minutes for FAST participants because FAST
membership is not one of the data elements that we currently require in
a prior notice submission. FDA instead did the analysis based on the
total number of prior notices submitted that the PNC could review based
on a timeframe of 30 minutes. The PNC completed less than 10 percent of
its intensive reviews of prior notices submitted for land/road border
arrivals within 30 minutes of receiving and confirming the prior notice
for review. If the timeframe for all articles of food arriving by land
by truck and car during our assessment period had been 30 minutes
(i.e., the timeframes for FAST participants) instead of 2 hours, the
PNC would not have completed approximately 68 percent of its intensive
reviews (over 14,000 during the assessment period, which equates to
approximately 16,000 for FY 2005 of the land/road border prior notices)
within the applicable timeframe. As a result, the PNC would have had to
either delay the food at the port of arrival until it completed its
review or decide whether to examine the food at the port of arrival
without the benefit of a complete review, based on current and
projected staffing levels in the PNC. This assessment is an
overestimate of the number of articles of food that would be eligible
for FAST timeframes, as we do not know how many articles of food
arriving in the United States subject to the prior notice requirements
are from FAST and C-TPAT participants. Moreover, there are other
impediments to integrating prior notice with the C-TPAT and FAST
programs. These are discussed in section III.D.6 of this document
(``Additional Exclusions Requested--Special Programs (C-TPAT/FAST) and
Flexible Alternatives'').
We also conducted a similar assessment on prior notices submitted
for articles of food arriving by air between October 1, 2004, and July
23, 2005. The IFR requires prior notices for these shipments to be
submitted and confirmed for review at least 4 hours before the food
arrives at the U.S. port of arrival. If the timeframes for articles of
food arriving by air during our assessment period had been reduced to
``wheels up,'' the PNC would not have completed approximately 21
percent of the intensive prior notice reviews for articles of food with
flight times less than 3 hours. These articles of food (2,700 for our
assessment period, or an estimated 3,230 for FY 2005) also would have
been subject to cargo delays and/or increased cargo examinations, based
on current and projected staffing levels in the PNC.
Neither FDA nor CBP have sufficient personnel or resources to
accommodate the number of additional cargo delays and/or food shipment
examinations that would result under either 60- or 30-minute timeframes
for articles of food arriving by land by road. This would include the
significant additional personnel and resources needed to track,
facilitate, and coordinate the evaluation and/or examination of the
delayed cargo. Coordination of the handling of delayed shipments is a
resource intensive process that can last for multiple days per
shipment, and includes communicating with both FDA and CBP personnel at
the border, and the brokers/filers and importers involved in the
shipment.
To handle the extra work, the PNC would need to shift its personnel
based on current and projected staffing levels in the PNC, resulting in
fewer staff being available to review prior notices for all categories
of shipments including shipments arriving by water. The PNC's current
approximate average time for the PNC intensive review for shipments
arriving by water is 5 hours, which is within the 8 hour submission
timeframe. We would expect, based on our assessment, that the time
taken away from prior notice review work for the increase in
coordination due to the increase in delays and examinations for
[[Page 66327]]
land and air shipments would increase the time needed to complete
intensive review of prior notices for shipments arriving by water by 25
percent at the minimum. As a result, over 7,000 shipments by water
during our assessment period (estimated as 7,370 for FY 2005) would
have been delayed at the port of arrival while the PNC completed its
intensive review and determined whether the shipment in fact presented
a significant health threat, based on current and projected staffing
levels in the PNC.
In setting the timeframes, the act provides that we may consider,
among other considerations, the effect on commerce (section
801(m)(2)(A) of the act). Assuming current and projected PNC resources,
lowering the timeframes to 60 or 30 minutes would likely result in
delays at the border, not only for those shipments delayed for
intensive review longer than the timeframe, but also for other
shipments passing through the port, especially at the busiest land
border ports where traffic lanes, parking, and inspection facilities
are extremely limited. In some ports, the lack of holding facilities
could result in an increase in trucks being turned around at the
border. As we have mentioned above, there have been a relatively small
number of situations where FDA was not able to make a decision
regarding whether to inspect the food at the port of arrival by the end
of the timeframe, causing a small number of shipments to be delayed
when it arrived at the port of arrival. Since the impact of these small
number of delays on trade has not been significant, continuing to
maintain that the current IFR timeframes is the most efficient use of
resources.
Thus, based on current and projected resources and other high-
priority activities FDA is addressing, reducing the timeframes would
lead to an increase in delays at the ports of arrival, causing FDA to
shift some resources away from conducting intensive reviews of prior
notices so they can conduct the coordination and other activities
necessary for these delayed shipments. The shift in resources away from
conducting intensive reviews would, in turn, further increase the
number of shipments that are delayed because FDA has not been able to
finish its intensive review within the applicable submission timeframe.
This ultimately would cause a delay in getting cargo to its final
destination, which would have an adverse impact on trade.
Moreover, the number of prior notices identified for intensive
review has increased over time, as intelligence and other risks are
identified. We expect the number of intensive reviews to continue to
increase relative to the assessment period, resulting in even more food
shipments that would be delayed or held for examination under shortened
timeframes.
We did not get any comments asking us to coordinate the timeframes
for articles of food arriving by water in our prior notice rule (8
hours before arrival) with those in CBP's rule (24 hours before
arrival). We received one comment asking us to reduce the time for
articles arriving by water. We stated in the preamble to the IFR ``In
determining the actual timeframes for submission of prior notice for
each mode of transportation, FDA considered the need to provide
sufficient time for the agency to review and respond to the information
submitted, as well as the current ability of the food industry to
provide the information required within the stated timeframe given the
differences in lead time before arrival among different modes of
transportation. We determined that information for shipments whose
transport time is measured in days or weeks (e.g., ocean shipments) is
available further in advance of arrival than shipments whose transport
time is measured in hours (e.g., land and air shipments.) Staggered
prior notice submission timeframes will allow FDA reviewers to direct
additional resources to shipments with short transport times and to
defer review of shipments with longer transport times. Based on these
considerations, FDA established the prior notice timeframes in the
interim final rule to associate with the mode of transportation.'' (69
FR at 58995). We continue to hold this view for shipments arriving by
water in light of our assessment for articles of food arriving by land
and air.
For all of the previously stated reasons, we did not reduce the
timeframes for submitting prior notice in the final rule for any mode
of transportation, as these timeframes still are the minimum amount of
time FDA needs to fulfill its statutory obligation to receive, review
and respond to prior notices while having the minimal impact on trade.
(Comments) One comment suggests that it would be preferable for FDA
to harmonize the prior notice timelines to the future ACE transmission
timelines, ensuring consistency and compliance of the trade community
and efficiencies in both agency and industry workforces.
(Response) FDA agrees that timeframes for submission of prior
notice may be further evaluated in light of new trade programs such as
ACE, when it is implemented and in effect. CBP is planning to bring its
ACE system on line in the next few years, which will accommodate prior
notice submissions and eliminate or change ABI/ACS and PNSI prior
notice submissions. FDA will continue to assess and pursue the
integration of timeframes as policies, processes, and strategic IT
systems are improved. FDA believes that the most opportune time for
coordinating timeframes will coincide with the startup of CBP's ACE. We
will determine at that time or after ACE is operational whether the
prior notice timeframes should and can be reduced further. Until that
time, the timeframes for submission of prior notice will remain the
same in the final rule as issued under the IFR (see Sec. 1.279).
3. Phase-In of FDA and CBP Timeframes
When FDA reopened the comment period for the IFR on April 14, 2004
(see 69 FR 19763), FDA asked Flexible Alternative Question 6: ``If FDA
adopts reduced timeframes in the prior notice final rule, should FDA
phase in the shorter timeframes as CBP phases in the advance electronic
information rule?''
(Comments) Most comments recommend integration of the phase-in of
reduced timeframes in association with CBP's schedule to promote
consistency between the programs, reduce errors, and minimize
disruption of supply chains through conflicting requirements. However,
one comment, in addition to recommending adherence to CBP's phase-in
schedule, also notes that they would not want FDA to delay adopting a
reduced timeframe for submitting prior notice merely because CBP is not
yet ready to implement the counterpart provisions of its advance notice
programs. In addition, they state that the deadlines are minimum
periods, and any shipper can provide more notice of imports, to FDA,
CBP or both, than the minimum timeframes in either regulation. They
recommend that FDA should shorten its lead times to match those in the
CBP regulations, even if the CBP requirements are not yet in place.
Another comment states that the phase-in plan, which is a port-by-port
implementation according to a time schedule, would be very problematic
to industry. The comment further explains that systems and operations
do not necessarily have the flexibility to switch on by individual site
or location and the current plan would introduce complication and
confuse the trade community. The comment recommends further discussion
with CBP and FDA as to development of a more viable and achievable
implementation plan.
(Response) This issue is moot, as the final rule retains the
timeframes
[[Page 66328]] established in the IFR, for the previously stated reasons. 4. Prior Notice Confirmation Number (Comments) One comment asks for clarification regarding when the prior notice confirmation number is required to accompany the food. (Response) The prior notice confirmation number must accompany any article of food arriving by international mail, when the food is carried by or otherwise accompanying an individual, or when the prior notice was submitted via FDA's PNSI. Under Sec. 1.279(e), the prior notice confirmation number must accompany any article of food arriving by international mail. Under Sec. 1.279(f), a copy of the confirmation (with the prior notice confirmation number) must accompany any article of food carried by or otherwise accompanying an individual (unless excluded under Sec. 1.277 (b)(1)), and be provided to CBP or FDA upon arrival. Additionally, under Sec. 1.279(g) the prior notice confirmation number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when arriving in the United States and must be provided to CBP and FDA upon arrival. (Comments) One comment asked FDA to confirm whether it is sufficient for an ocean carrier to have the prior notice confirmation number on arrival or whether they are required to have the actual prior notice confirmation also. (Response) Under Sec. 1.279(e), the prior notice confirmation number must accompany any article of food arriving by international mail. Additionally, under Sec. 1.279(g) the prior notice confirmation number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when arriving in the United States and must be provided to CBP and FDA upon arrival. Therefore, although a prior notice confirmation number is required, the final rule does not require that the actual prior notice confirmation has to be supplied for food arriving by ocean carrier. (Comments) One comment states that when food arrives in the United States, the carrier should present a copy of the prior notice confirmation and the food to CBP. The comment asks if the submitter should send the prior notice confirmation to the carrier company or to the vessel that transported the food to the United States. (Response) As stated previously, Sec. 1.279(e) requires the prior notice confirmation number to accompany any article of food arriving by international mail. Additionally, under Sec. 1.279(g) the prior notice confirmation number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when arriving in the United States and must be provided to CBP and FDA upon arrival. How persons importing or offering for import food into the United States choose to comply with this requirement is a private matter (e.g., persons may decide to specify these obligations in the contract between the exporting company and the carriers to ensure that the logistics are worked out in advance). (Comments) Comments stated that the data requirements should be reassessed to simplify and make the requirements more manageable. The comment states that one data element should link all information secured by prior notice, which would be beneficial for locating shipments in the event of a possible crisis. The comments suggest that FDA use bill of lading numbers as a single reference point because all shipments that are moved are repeatedly covered by this number. This would render the prior notice confirmation number currently used redundant. (Response) FDA does not agree that the waybill/Bill of Lading can be used as a single reference point for all shipments instead of the prior notice confirmation number. A Bill of Lading number is not always assigned to a shipment at the time of prior notice submission. For certain shipments, such as those sent by international mail, no Bill of Lading may exist. Thus, FDA has determined that it is better to use a unique confirmation number provided by the FDA system to transmitters. (Comments) One comment notes that a separate prior notice is required for each distinct food product and a prior notice confirmation number is returned for each prior notice. Therefore, if a shipment consists of multiple food products, the carrier would have multiple prior notice confirmations upon arrival. The comment states multiple prior notice confirmations do not align well with the commercial realities of international trade, where the focus is on the entire shipment, not the individual components. The comment recommends that FDA provide a prior notice confirmation number that encompasses the entire shipment. (Response) FDA disagrees. The carrier could be carrying articles of food for different submitters or recipients. If it was necessary to hold an article of food, the entire shipment would be held under the above scenario suggested by the comment. Under the final rule, the article of food that is subject to a hold can be offloaded and the rest of the shipment allowed to proceed. This would not be the case if there was only one prior notice confirmation number for the entire shipment. 5. 5-Day Maximum Pre-Arrival Limitation (Comments) Many comments requested that prior notice be allowed to be submitted more than 5 days before arrival. This would allow exporters to complete their documentation at the same time the bill of lading and health certification is usually completed in the case of food shipped by water. One comment contends that the 5 day limit does not reflect the variable and unpredictable nature of transport and does not reflect a risk-based approach to a potential bioterrorism threat. Another comment contends that the limitation of the timeframe to 5 days is problematic and is due to a misinterpretation of the statute. The comment asserts that the statutory language does not preclude a party from voluntarily providing prior notice more than 5 days in advance. The comment also maintains that 10 days prior to arrival would provide the necessary flexibility for their industry. A foreign government, apparently assuming that prior notice must be submitted by the foreign shipper or exporter, recommends that the time should be extended because it may take the shipment 2 weeks to reach a U.S. port. (Response) In response to the concerns raised by the comments, we have revised Sec. 1.279(b) to allow submission of prior notice more than 5 days before arrival (except for articles of food imported or offered for import by international mail). Specifically, this provision permits prior notice submissions to be submitted no more than 30 calendar days before the anticipated date of arrival for submissions made through ABI/ACS and no more than 15 calendar days before the anticipated date of arrival for submissions made through PNSI. Due to system limitations, the timeframes between ABI/ACS and PNSI are not identical. Also, because of the way ABI/ACS is programmed, when prior notice is submitted through ABI/ACS, the prior notice confirmation number cannot be provided more than 5 calendar days before the anticipated date of arrival. Please note that if any of the prior notice information, except the anticipated arrival information, the estimated quantity, or the planned shipment information, changes after FDA has confirmed the prior notice submission for review, the prior notice must be resubmitted, as provided by Sec. 1.282(a). The resubmission must be
[[Page 66329]] confirmed by FDA for review no less than 2, 4, or 8 hours before arriving at the port of arrival, with the minimum time depending on the mode of transportation (Sec. 1.279(a)). If prior notice is resubmitted, the previous prior notice should be cancelled (Sec. 1.282(b), (c)). 6. International Mail (Comments) There were no comments received regarding the timeframes established for prior notice covering food arriving by international mail. (Response) FDA retained the timeframes for submission of prior notice for food arriving by international mail that are in the IFR. (Final rule) The final rule at Sec. 1.279(a) requires that you must submit prior notice to FDA and the prior notice submission must be confirmed by FDA for review as follows: If the article of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival; if the article of food is arriving by land by rail, no less than 4 hours before arriving at the port of arrival; if the article of food is arriving by air, no less than 4 hours before arriving at the port of arrival; or if the article of food is arriving by water, no less than 8 hours before arriving at the port of arrival. Under Sec. 1.279(b), except in the case of an article of food imported or offered for import by international mail, prior notice may be submitted no more than 30 calendar days before the anticipated date of arrival for submissions made through ABI/ACS and no more than 15 calendar days before the anticipated date of arrival for submissions made through PNSI. Under Sec. 1.279(c), if the article of food is arriving by international mail, the prior notice must be submitted before the article of food is sent to the United States. Under Sec. 1.279(d), FDA will provide notification that the prior notice has been confirmed for review with a reply message that contains a prior notice confirmation number. The prior notice will be considered submitted and the prior notice review time will start when FDA has confirmed the prior notice for review. Under Sec. 1.279(e), the prior notice confirmation number must accompany any article of food arriving by international mail. The prior notice confirmation number must appear on the Customs Declaration that accompanies the package. We provide CN22 or CN23 or a U.S. equivalent as examples of the Customs Declaration. Under Sec. 1.279(f), a copy of the confirmation, including the prior notice confirmation number, must accompany any article of food that is subject to this subpart when it is carried by or otherwise accompanies an individual when arriving in the United States. The copy of the confirmation must be provided to CBP or FDA upon arrival. Under Sec. 1.279(g), the prior notice confirmation number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when the article arrives in the United States and must be provided to CBP or FDA upon arrival. G. How Must You Submit the Prior Notice? (Sec. 1.280) Section 1.280 of the IFR required that prior notice must be submitted electronically to FDA in the English language, except that an individual's name, the name of a company, and the name of a street may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet. The IFR provided for two methods of electronic submission of prior notice: (1) The CBP ABI/ACS; or (2) FDA PNSI at http://www.access.fda.gov. The IFR required submission of prior notice via FDA's PNSI for articles of food imported or offered for import by international mail, other transaction types that cannot be made through ABI/ACS, and articles of food that have been refused under section 801(m)(1) of the act and 21 CFR part 1, subpart I. The IFR also provided for contingencies if certain systems were not working, e.g., a custom broker's or self-filer's system, ABI/ACS, PNSI, or OASIS. The IFR required that prior notice must be submitted through PNSI if a custom broker's or self-filer's system or if the ABI/ACS interface is not working. The IFR also required that prior notice must be submitted via e-mail or fax if PNSI or OASIS is not working. The IFR did not exempt any specific categories of food articles from prior notice if systems are not performing. In August 2004, FDA and CBP published guidance covering a Contingency Plan for System Outages. This guidance can be accessed at http://www.cfsan.fda.gov/~pn/pndguid.html. Comments addressing contingencies will be discussed later in this section. Comments regarding how to submit prior notice are addressed according to issue: General comments; comments about the ABI/ACS and PNSI systems, including technical issues and security of the systems; and comments about contingencies. 1. General Comments (Comments) One comment suggests that FDA should have CBP collect and review all prior notices with one prior notice submission timeframe for all agencies. (Response) FDA disagrees. The Bioterrorism Act, while providing for the ability to commission other agencies to help implement the provisions of the Bioterrorism Act, specifies that the Secretary is to receive prior notice for all food imported or offered for import into the United States. FDA personnel are trained and knowledgeable about the risks and hazards involving food products under its jurisdiction and have the expertise to review the prior notice submissions. The integration of prior notice submission timeframes is discussed earlier in this document under the discussion for Sec. 1.279. (Comments) Several comments suggest allowing the option of submitting prior notice by fax or mail because not everyone has Internet capability, access to a computer, or proficiency in English. One comment asks that they be allowed to continue sending prior notice by fax (as is allowed during certain contingency situations). Several other comments suggest that international mail shippers are at a disadvantage because many mail customers have no access to the Internet, the pre-notification system is not customer-friendly, entries take a long time, and the data requirements are too complex and difficult for customers to determine. (Response) FDA does not agree that a process for manual transmission is needed, except on a contingency basis. FDA believes that persons engaged in international commerce have, or can get, access to the Internet. If the Internet is not accessible by the submitter, he or she can use a customs broker to submit prior notice through ABI/ACS or another person to transmit prior notice through the FDA PNSI. Allowing manual transmission would not give adequate time for FDA personnel to receive, review, and respond, unless the timeframes for prior notice in the final rule were greatly extended. Thus, manual transmission will be used only as a contingency alternative. FDA also notes that the data quality of manual systems is usually less than satisfactory, because no automated data validation takes place during data entry. The U.S. Government has a strong commitment to reducing paper-based processes and moving toward e-commerce for all business transactions. Accordingly, under the final rule, paper-
[[Page 66330]]
based submissions will not be allowed, except on a contingency basis.
In response to the comment that international mail shippers are
disadvantaged, FDA also notes that it has compliance policies to
address this situation. Its compliance policy under the IFR had been
that ``FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
non-commercial purposes with a non-commercial shipper'' without prior
notice. This applied to all such food subject to prior notice,
including food shipped by international mail. The Prior Notice Final
Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy.
(Comments) One comment suggests that instead of submitting prior
notice via PNSI, mail shippers be allowed to complete an alternate form
requiring minimal information that is similar to the Customs
Declaration form in the native language to be completed at the post
office. This comment argues that the current requirements are too
cumbersome for the average consumer. Similarly, another comment
suggests that FDA accept Customs Declaration Forms CN22 and CN23 in
lieu of submitting prior notice via PNSI for mail shippers. This
comment argues that such forms are much easier to complete and are
official documents prescribed by the Universal Postal Convention and
are used around the world. In the alternative, this comment suggests
that FDA accept data submitted by mail shippers via PNSI in a condensed
form determined by the foreign government's postal agency.
(Response) FDA disagrees. Section 801(m) of the act requires the
prior notice submission to contain certain data elements, such as the
identity of the article of food, manufacturer and shipper of the
article, grower, country from which the article originates, country
from which the article is shipped, and the anticipated port of entry of
the article. Customs Declaration Forms are not adequate substitutes for
providing this information to FDA since such forms do not typically
require this kind of comprehensive information. Likewise, allowing a
foreign government's postal agency to determine which information to
submit to FDA also does not guarantee that we will receive the
information required by section 801(m) of the act. Therefore, FDA has
not provided an alternative form of prior notice submission for food
arriving by mail for commercial purposes.
FDA again notes that it has compliance policies that address some
of the concerns raised by the comments. Its compliance policy under the
IFR had been that ``FDA and CBP should typically consider not taking
any regulatory action when an article of food is imported or offered
for import for non-commercial purposes with a non-commercial shipper''
without prior notice. This applied to all such food subject to prior
notice, including food shipped by international mail. The Prior Notice
Final Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy. FDA believes that
this proposed compliance policy should not be extended to food that is
imported or offered for import for commercial purposes or with a
noncommercial shipper without prior notice. Mail shipments associated
with a commercial purpose pose a higher risk with respect to ability to
reach a greater number of people, and most commercial entities already
are familiar with submitting information to FDA and CBP.
(Comments) One comment proposes a two-step process for filing prior
notice, whereby FDA would accept the same data submitted for CBP ABI to
satisfy the prior notice requirements at the first port of arrival.
Then, after accepting ABI data at the port of arrival, complete prior
notice data would be filed at the port of entry as step two of the
process. The comment contends that utilizing ABI data for prior notice
at the port of arrival would allow faster processing, which is a
significant issue considering FDA's concern about timely processing of
prior notice under a shorter time schedule. This more complete data
would be filed concurrent with the CBP clearance entry, and therefore
provide FDA with the level of data desired, while removing the issue of
time constraints under a reduced schedule measured against the port of
arrival.
(Response) FDA disagrees. The purpose of section 801(m) of the
Bioterrorism Act is to ensure that FDA has sufficient information
before arrival so it can determine what foods to inspect at the border.
Therefore, all information required for prior notice must be submitted
prior to arrival, not just a portion of the information.
Additional information may be required after arrival and for entry
admissibility decisions. That process is completed after arrival for
those foods offered for consumption in the United States. (See 68 FR
58974 at 58976 in the preamble to the IFR for additional discussion
about the relationship and differences between the prior notice
determination and the admissibility determination.)
(Comments) One comment suggests the agencies should synchronize the
different filing systems so as to ensure that all notices can be made
via Automated Manifest System (AMS). Other comments request FDA to
coordinate prior notice with CBP's AMS to eliminate duplication of data
submissions.
(Response) FDA disagrees. No interface currently exists between AMS
and the existing interface with FDA's OASIS through the ABI/ACS entry
processes, which means FDA does not have access to AMS data. FDA and
CBP have discussed interfacing with AMS for manifest data and
determined that the general cargo data in AMS are not suitable to
accommodate the detailed information requirements of section 801(m) of
the act. For example, AMS does not collect the country of origin. In
addition, its collection of the identities of the article of food and
its manufacturer differs from the way those are collected under the
prior notice interim final and final rules in such a way that the data
would not meet our needs in carrying out the purpose of section 801(m)
of the act.
(Comments) One comment urges FDA to upgrade its systems to coincide
with normal commercial flow times and recommends that FDA consider the
approach used by the Census Bureau, i.e., providing a range of
automated filing options for meeting electronic filing requirements by
offering an Internet application, a direct link for certified filers,
and a personal computer (PC)-based application.
(Response) FDA provides two methods for submitting prior notice:
One via ABI/ACS (a PC-based link for certified filers) and another via
PNSI (an Internet-based application). Prior notice is not required to
be filed at a specific time or during specific hours of the day, but
may be submitted 24 hours/day, 365 days of the year. The rule requires
FDA to receive the prior notice before the food arrives in the United
States, and the time frame is based on the mode of transportation (see
Sec. 1.279).
(Comments) One comment suggests that FDA participate in the
International Trade Data System (ITDS), which provides for one-window
filing of trade-related information by motor carriers and other parties
through CBP's ACE system, to more effectively execute its Bioterrorism
Act mission.
(Response) FDA is actively participating in the development of
CBP's ACE system and has long been a participant in the ITDS. However,
ACE is not yet a complete reality and prior
[[Page 66331]]
notice requirements have been in effect since December 12, 2003. FDA is
working with CBP and others in the international trade community to
ensure that the prior notice requirements are reflected in ACE once ACE
is fully operational.
(Comments) One comment notes that exporters use different kinds of
transmission formats to send prior notice-related information to
importers or brokers in the United States. The comment further states
that since none of its member companies have received any notice from
FDA requesting changes in content or formatting of the transmitted
information, they assume that FDA is satisfied with their industry's
approach to regulatory compliance. In the event that FDA requires a
change to format or content of the reporting now conducted, the comment
requests that FDA notify companies well in advance of any such
requested change.
(Response) FDA receives prior notice information via ABI/ACS or
PNSI. FDA expects that the transmitted information discussed in the
comment is submitted to FDA via one of these two methods in the proper
format. If the information is inaccurate, the food is subject to
refusal. Customs brokers are notified using typical procedures
regarding any changes relating to the rule that require an IT change to
ABI/ACS, including a 90-day lead time before implementation of the IT
change. FDA also provides tutorials on its Web site that explain
changes to PNSI (see http://www.cfsan.fda.gov/~pnts/pnsitut.html).
2. English Language
(Comments) Many comments suggest that FDA program PNSI in other
languages, such as Japanese, Korean, German, and Spanish. These
comments state that ``mail users'' must rely on PNSI to submit prior
notice, and in many cases, English may not be the native language for
many of these users and puts them at a disadvantage, e.g., foreign
filers experience higher burdens and are frequently being timed out of
PNSI because it takes them longer to complete a prior notice. One
comment argues that a reason for noncompliance of prior notice
requirements is the inability to understand English well enough to
submit prior notice via PNSI.
(Response) FDA agrees that a system available in multiple languages
would be advantageous for some users. However, the agency has assessed
the feasibility of providing and maintaining PNSI in multiple
languages, and has determined that the cost of developing translations
into one or more additional languages cannot be accommodated at this
time. The cost of updating the translations as new versions of the
system are developed would also be substantial. In addition, FDA notes
that other import documents required by FDA and by CBP must be filed in
English. Therefore, FDA does not plan to program PNSI in other
languages and the final rule will continue to require submission of
prior notice in the English language.
FDA and CBP nonetheless have taken into account many of the
concerns referenced in the comments. For example, the final rule does
not apply to homemade foods shipped from an individual to an individual
in the United States (see Sec. 1.277, Scope, discussed supra). In
addition, the agencies' compliance policy under the IFR had been that
``FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
non-commercial purposes with a non-commercial shipper'' without prior
notice. This applied to all such food subject to prior notice,
including food shipped by international mail. The Prior Notice Final
Rule Draft CPG, announced elsewhere in this issue of the Federal
Register, would continue that enforcement policy.
(Comments) One comment requests that other pieces of the prior
notice system also be available in other languages, such as the
tutorials for determining the FDA product code. Another comment
suggests that FDA provide foreign governments and trade organizations
with a detailed outline of the ``prior notice form'' with explanations
of the individual requirements so that they could be translated into a
foreign language and provided to affected companies.
(Response) While many of the documents regarding prior notice
requirements have been translated into other languages, the PNSI
tutorials (available at http://www.cfsan.fda.gov/~pnts/pnsitut.html)
and the FDA Harmonized Tariff Schedule Codes guidance (available at
http://www.cfsan.fda.gov/~dms/htsguid3.html) have not been translated.
FDA intends to continue translating these and other prior notice
documents as resources permit. Documents that are available in other
languages are posted at http://www.cfsan.fda.gov/~mow/internat.html.
Foreign governments and trade organizations are welcome to translate
these documents and provide them to affected companies.
3. Technical Issues Concerning Both Systems
(Comments) One comment suggests that both systems provide a link to
HTS codes.
(Response) FDA agrees. Both PNSI and ABI/ACS provide a link to HTS
codes. FDA also has provided guidance regarding HTS codes and a
companion list of HTS codes flagged with prior notice indicators. The
guidance is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html and
the updated list is posted at http://www.cfsan.fda.gov/~pn/
htscodes.html.
(Comments) One comment states that railroads will not load cargo
until a prior notice confirmation number is provided, and a prior
notice confirmation number cannot be provided without complete planned
shipment information, including a railcar number.
(Response) FDA notes that, while this situation seemed to be an
issue early in the implementation of the prior notice IFR, it is our
understanding and experience that the rail industry has now changed
business practices to address this concern. FDA received only one
comment on this issue and has not received any other feedback to
suggest this matter is still of concern. A check with a large rail
shipping company revealed that the restrictions for loading cargo are
not at issue; i.e. rail cars can be physically loaded with shipments
containing food prior to obtaining prior notice (Ref. 1). Therefore,
the prior notice filer does have the ability to obtain the rail car
number in order to file prior notice. The rail company did however
indicate that rail cars are not connected/added/attached to the U.S.
in-bound train until the rail company receives documentation that prior
notice has been filed.
(Comments) One comment states that the FDA Help Desk, and other
methods now established for resolution of operational issues, simply
are not yielding a workable ``fix'' to the ``kinks'' in the new PNSI/
ABI system. Another comment recommends the establishment of a system
for swift resolution of technical and operational problems for both
systems.
(Response) FDA agrees and has established an FDA Help Desk to deal
with technical issues involving PNSI. Questions and concerns about
operational, rather than technical, problems involving prior notice
should be directed to FDA's PNC. While the FDA PNC is available 24
hours a day, 7 days a week to respond to operational issues, it is not
equipped to resolve technical issues involving PNSI or ABI.
[[Page 66332]]
However, the PNC has a process in place to handle calls involving
technical issues and will forward those calls to the Help Desk. CBP
also has a well-established system of client representatives to deal
with technical problems involving ABI/ACS. CBP client representatives
are available to assist users with ABI issues. ABI operational issues
are the sole responsibility of CBP.
(Comments) One comment states that the systems go down from time to
time, and all the time-consuming entry-work has to be repeated.
(Response) PNSI has been enhanced to allow copying and saving of
prior notices within a Web entry and copying of a Web entry, with or
without the associated prior notices. Copying allows you to avoid
repetitive data entry for similar Web Entries and associated Prior
Notices. You also may cancel a Web Entry and then copy it, to correct
errors in a Web Entry you have already completed. Instructions for
copying a Web entry prior notice are available on FDA's Web site at
http://www.cfsan.fda.gov/~pn/pnstep2.html#copywe. ABI users are
responsible for their own software and its capability to save and/or
copy information that has not been transmitted.
(Comments) One comment urges FDA to harmonize their efforts with
CBP with respect to the prior notification of food articles and to work
with CBP to integrate its joint administration and enforcement of prior
notice for both CBP and FDA. One comment recommends that both the FDA
and CBP systems be simplified to allow for both a decrease in data
entry time and a more efficient method for multiple data entries.
(Response) FDA agrees and is continuously working with CBP to make
the administration and enforcement of prior notice as integrated and
efficient as possible. Both agencies recognize that ACE, when
initiated, will allow for a more harmonized process.
With respect to multiple data entries, PNSI does offer several
features that make prior notice data entry faster and reduce the amount
of redundant data entry, such as the Copy Web Entry feature, Copy Prior
Notice feature, and other shortcuts. Please refer to Time Saving Tips
from the FDA PNC for PNSI (http://www.cfsan.fda.gov/~pn/pntips.html)
for a description of these features. Many private ABI software programs
also have features that provide a means for multiple data entries.
(Comments) Several comments express concern about the timeliness of
receipt of the prior notice confirmation number. One comment states
that it can take an hour or more to receive the prior notice
confirmation number that is needed to move the cargo. Another comment
states that there have been several instances when the confirmation
response has been delayed and asks FDA to improve the timeliness of
this response.
(Response) Generally, for prior notice submission via PNSI, the
user should receive their confirmation number immediately upon
submission of the correctly completed form. For those prior notices
submitted via ABI on the anticipated date of arrival, users can expect
to receive a response message (confirmation number or rejection) within
15 minutes of submission. For ABI submissions submitted prior to the
anticipated date of arrival, users can expect to receive their response
message no later than midnight (Eastern Time) on the anticipated date
of arrival.
(Comments) One comment states that there are glitches in the
software that has been released. The comment notes that perfume is a
nonfood product that is subject to FDA's 801(a) jurisdiction, but it
does not require prior notice. However, in a procedures memorandum from
CBP, it appears that if you disclaim FDA in FD3, it is disclaimed for
all purposes. Similarly, if you acknowledge FDA jurisdiction in FD3,
then prior notice must be submitted whether or not the importation
involves food.
(Response) We have provided instructions describing how to disclaim
an article for prior notice, while still sending information required
for FDA 801(a) admissibility. The instructions were included in at
least four separate ABI Administrative Messages issued by CBP beginning
in March 2004 (e.g., Administrative Message 04-0586, dated March 24,
2004). If merchandise marked FD3 in the Tariff Record is subject to
prior notice and 801(a) reporting requirements, the required prior
notice and 801(a) information should be transmitted. In cases where
801(a) information is required, and prior notice information is not
required, filers should transmit the ``PN disclaimer'' (PND) and the
information required for 801(a). In this case, the PND Affirmation of
Compliance (AofC) code must be the first AofC code recorded (FD01
Record-Positions 20-22) in the ABI transmission. The PND affirmation
does not require a qualifier. If the merchandise marked FD3 represents
an article exempt from all FDA reporting requirements, the line should
be disclaimed using the FD0 marker in the OA Record,\5\ as has always
been done for FDA disclaims.
---------------------------------------------------------------------------
\5\ This is a ``Conditional Other Government Agency
Declaration'' input record that provides a code indicating that
there are/are not other government agency review requirements.
---------------------------------------------------------------------------
(Comments) One comment believes there is a problem with the in-bond
system. The comment states that if it is assumed that a shipment
arrives in Los Angeles, but is destined for in-bond travel to New York,
the shipment is subject to prior notice upon arrival. In order to
properly comply with CBP requirements, the arrival date is entered
based upon the expected arrival date in New York. The data exchange
between CBP and FDA is then triggered by the New York arrival date
rather than the Los Angeles arrival date. The comment is concerned that
prior notice could be transmitted in a timely manner to CBP, but be
held up due to computer programming, making the prior notice untimely.
The brokers have fixed this problem in the short term by inputting the
Los Angeles arrival date in both places for prior notice purposes and
then changing it after prior notice has concluded.
(Response) The anticipated arrival date is a requirement of prior
notice and is independent of CBP entry requirements. The Bioterrorism
Act requires submission of prior notice before the food arrives in the
United States, and not upon arrival as stated in the comment.
Therefore, in the example provided, prior notice is required before the
article of food arrives in Los Angeles notwithstanding any other CBP
entry requirements.
For ABI entries requiring prior notice, the filer must enter
separate dates for purposes of entry and prior notice. The filer enters
an anticipated arrival date at the entry header level for CBP. For
purposes of prior notice, the filer also enters the anticipated arrival
date as an affirmation of compliance code ``ADA.'' Therefore, there
should not be a problem with choosing which date to submit as raised by
the comment.
(Comments) One comment suggests that the systems provide a drop
down list of reasons that provide an explanation for the absence of the
registration number.
(Response) FDA agrees. In the November 2004 revision of the CPG
that explained how FDA intended to enforce the prior notice IFR, a list
of reasons was provided as Appendix 1, Reason Codes for Registration
Number of Manufacturer Not Provided. This list of reasons is available
in both PNSI and ABI/ACS, and the reasons are available as a drop down
menu in PNSI. ACS is
[[Page 66333]]
programmed in ``batch mode'' which does not lend itself to drop down
menus. CBP also has issued Administrative Messages to ABI filers in
December 2004 and March 2005 concerning these reason codes. The Prior
Notice Final Rule Draft CPG that is announced elsewhere in this issue
of the Federal Register provides an updated list of reasons to be used
in certain limited situations when the manufacturer's facility
registration number is not provided in a prior notice submission.
(Comments) One comment recommends that the required data elements
be identified so that shippers will know which elements are mandatory
and which are not.
(Response) In the preamble to the IFR, FDA provided a table of the
data elements for reference describing in which situations the
information is mandatory (68 FR 58974 at 58980). The preamble of this
final rule also contains table 2 which describes the information
requirements. FDA also notes that PNSI is programmed such that if a
data element does not apply, the data element is not requested during
the prior notice submission process.
(Comments) One comment states that when a prior notice confirmation
number is submitted to CBP and FDA, it is sometimes returned with a
different prior notice confirmation number. The comment asks why this
is and what happens to the original prior notice confirmation number.
(Response) FDA acknowledges that this problem occurred in the early
stages of prior notice; however, we have rectified the situation. When
we received a report concerning this prior notice confirmation number
problem, we immediately modified our software to prevent the reported
problem from reoccurring.
4. ABI/ACS Interface
(Comments) One comment states that the ABI system has been proven
to be the most efficient means for meeting the prior notice time
requirements.
(Response) FDA agrees that for many submitters, the ABI interface
is the most efficient means for providing prior notice, as it allows
the data to be saved and used for entry purposes. FDA also acknowledges
that not all submitters have a custom broker, nor does ABI accommodate
all transactions subject to prior notice (e.g., food imported by
international mail or inside personal baggage not for personal use).
Accordingly, the final rule continues to provide for electronic
submission of prior notice via either ABI/ACS or PNSI.
(Comments) One comment points out that some problems with
electronic submission of prior notice are being encountered by virtue
of the fact that not all brokers interact with FDA in a completely
electronic environment. ABI allows for the fully electronic
transmission of CBP and FDA data, but ``dual mode'' brokers must also
submit information to FDA in paper form. The comment recommends that
FDA encourage all brokers to participate in paperless electronic
processing.
(Response) ``Dual mode'' filers are those who must submit paper
entries when transmitting entry information for FDA admissibility
consideration. However, for prior notice, any customs broker or self-
filer, including ``dual mode'' filers, may transmit using ABI/ACS or
PNSI.
(Comments) One comment urges that for rail intermodal shipments
between points in Canada where the transportation transits the United
States, FDA should agree that data submitted to the CBP via AMS
constitutes advance notice under the FDA regulations.
(Response) FDA disagrees. Under section 801(m) of the act, FDA, not
CBP, must receive prior notice. Furthermore, no interface currently
exists between AMS and the existing interface with FDA's OASIS through
the ABI/ACS entry processes, which means FDA does not have access to
AMS data. FDA and CBP have discussed interfacing with AMS for manifest
data and determined that the general cargo data in AMS are not suitable
to accommodate the detailed information requirements of the prior
notice rule. For example, AMS does not collect the country of origin.
In addition, its collection of the identities of the article of food
and its manufacturer differs from the way those data points are
collected under the prior notice final rule in such a way that the data
would not meet our needs in carrying out the purpose of section 801(m)
of the act.
(Comments) One comment reports that foreign exporters are obliged
to use FDA's PNSI as they cannot register as users of CBP's ABI. The
comment contends that these exporters, not being able to combine prior
notice and a customs declaration for import in one operation, will be
in a disadvantaged position compared to U.S. importers because the
foreign exporter, after having completed his prior notice, will receive
a prior notice confirmation number, which he then has to transmit to
his U.S. importer or customs broker.
(Response) FDA disagrees. Prior notice may be submitted
electronically through either ABI/ACS or PNSI. Typically, ABI/ACS is
used by a person who contracts with a filer who is licensed and
approved by CBP to use ABI/ACS. The submitter provides the filer with
the information necessary to transmit a complete prior notice through
ABI/ACS to FDA. This process is often used to combine the prior notice
and entry processes and many importers and foreign exporters find this
to be the most advantageous process. FDA and CBP provided the ability
to use ABI/ACS in response to comments to the proposed rule. As
expected, the ABI/ACS process is used in around 83 percent of prior
notice transmissions. PNSI was developed for those submissions that
cannot be accommodated by ABI/ACS, and for those who choose not to use
a customs broker for prior notice submissions, and these transmissions
represent about 17 percent of the total prior notice submissions.
(Comments) One comment asks that the customs broker be allowed
access to all pertinent information by electronic means in order to
reduce the amount of paperwork required by the prior notice process.
(Response) The means by which the submitter provides the
transmitter with the required information is a matter of communication
between the submitter and transmitter. The final rule neither requires
nor precludes processes the parties select to handle these
communications.
(Comments) Several comments request that the agencies change the
process for resubmission of prior notice after the original prior
notice or entry has been cancelled and when prior notice is submitted
after the food is already in the United States. One comment asks that
the system interface be modified so that the resubmission automatically
cancels the original. Another comment suggests that in the case where
the foods are already in the United States and the CBP entry has had to
be cancelled and resubmitted, it should not be necessary to repeat the
prior notice filing; filing entry should be sufficient. Another
suggests that when the second entry is made, CBP allow for submission
of the previous prior notice confirmation number rather than the
creation of a new prior notice with an accompanying new prior notice
confirmation number. Other comments suggest that ABI submission of
prior notice be allowed for food in the United States. An additional
comment states that CBP entry can be made for articles of food that are
already in the United States without adequate prior notice. Another
comment recommends that FDA consider allowing the submission of prior
notice through the ABI interface even when that prior notice will not
be
[[Page 66334]]
timely. Finally, one comment suggests that a new prior notice should
not be required when errors are made and that an easier way should be
created to provide for corrections.
(Response) In the case of a prior notice submitted after the food
has arrived, the prior notice is inadequate because of no prior notice
and the food may be refused. The post-refusal prior notice (i.e., the
prior notice submitted after arrival) may only be submitted via PNSI
until such time as ACS or its successor system can accommodate such
transactions. The changes to the system requested by the comments
cannot be accommodated since such revisions would require programming
changes to ACS, which CBP is currently only maintaining, and not
enhancing since its replacement system (ACE) is being developed.
(Comments) One comment suggests that because errors in the ABI
system need to be corrected in a timely manner to facilitate
transmission of prior notice, CBP should be required to be available 24
hours a day, 7 days a week to allow for correction of these clerical
errors.
(Response) Inasmuch as the filer has submitted a certified summary
that the filer wishes to change, the cancellation of the entry is more
than just a simple correction to an ABI transmission. This change
requires review because it affects the integrity of cargo release.
Accordingly, any corrections to certified entry information must be
done during normal business hours.
(Comments) Several comments suggest that PNSI, in its validation
processes, should include a check to see if other notices are already
on file for the same article and that a warning message should be
established to indicate a duplicate prior notice is being filed.
(Response) FDA disagrees. The prior notice submission process
allows for transmission through either ABI/ACS or PNSI. The prior
notice confirmation number is unique to a transmission through either
system but cannot be matched against other transmissions at this time.
Programming PNSI to locate duplicate prior notices would require a
considerable amount of resources, which would yield minimal benefit
since the submitter would know about the duplicate submission after
transmitting the prior notice.
(Comments) Several comments request resolution of a PN/ABI system
interface obstacle that requires that CBP entry and prior notice be
made at the same time. The comment contends that prior notice must be
submitted before entry can be made (e.g., for quota class merchandise
subject to CBP ``live entry'' requirements) and current system
configurations can make it impossible to comply with both CBP and prior
notice requirements. The comment recommends that CBP and FDA create a
procedure in ABI/ACS that allows the CBP entry to be generated, but not
filed, at the time a prior notice is submitted.
Another comment states that filers are insisting on submitting the
entry information to CBP via ABI at the same time that they are
submitting the prior notice information to the FDA. This apparently
creates situations where the food is loaded and ready for shipment
before there is a form of electronic release and this situation negates
CBP's Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free
and Secure Trade (FAST) program requirements. The proximity of certain
border points means that although the timeframe has been met with CBP
for electronic release via CBP's PAPS, it is difficult to meet the
present timeframes of the prior notice as the filer takes a longer time
to submit both entries via ABI.
(Response) We disagree. Prior notice and entry need not be made at
the same time. Prior notice is a precondition of entry and must be made
first but may be done independently of the entry by use of FDA's PNSI
or CBP's ``WP'' transaction in ABI. These systems allow for an
independent submission of prior notice even if no entry has been filed.
The entry filer may then provide the prior notice confirmation number
to CBP as part of the entry. The entry will be validated in the CBP/FDA
interface and will be allowed if the prior notice has been completed.
The importer and filer may make a business decision to file the prior
notice with the entry, and FDA and CBP's systems can accommodate this
practice.
Because the entry and prior notice submissions may be completed
independently, the timeframes are dependent on how the parties at
interest choose to file entry and prior notice: The one-step (prior
notice with entry) or two-step (independent prior notice followed by
entry) process. This allows them to meet both timeframes, which
represent two agencies, two processes, and two different sets of
requirements.
(Comments) One comment contends that the lack of uniformity between
the PNSI and CBP requirements for transmission of carrier information
causes confusion to filers and FDA/CBP staff. The comment contends that
providing the Standard Carrier Abbreviated Code (SCAC) code for the
carrier in lieu of the carrier's name and country is only available
when transmitting via PNSI because the CBP system, which is how the
majority of prior notices are being transmitted, requires the name and
country and does not provide the SCAC option.
(Response) FDA disagrees. The SCAC or International Air
Transportation Association (IATA) codes can be transmitted via ABI/ACS
via an Affirmation of Compliance. The CBP requirement to provide the
name and country of the carrier is for purposes other than prior
notice.
(Comments) Several comments recommend an interface between the CBP
manufacturer identity (MID) codes and the FDA food facility
registration numbers. Specific recommendations include that: (1) CBP
allow the MID system to be updated via prior notice submissions; (2)
FDA develop an interface with CBP that allows for validation and
coordination of data between these two systems; (3) ABI provide a
notification to the filer if the information from the MID does not
match the facility registration information on file with FDA; and (4)
the agencies permit incorrect and duplicate MID information to be
corrected though a secure CBP system. Another comment recommends the
establishment of a system that validates data and resolves any conflict
between CBP and FDA data.
(Response) With respect to correcting and updating MIDs, CBP does
not believe it is possible to eliminate all differences between MIDs
and related FDA manufacturing facility registration numbers. The same
manufacturer may have numerous MIDs, and conversely, a MID may identify
more than one manufacturer due to the nature of the algorithm that is
employed.
With respect to the comment that asks that FDA develop an interface
with CBP to allow for validation and coordination of data, FDA and CBP
currently exchange facility data electronically as part of the prior
notice and 801(a) processes. CBP sends FDA the MID and facility
information (including registration number, when applicable). FDA
performs edits to ensure that the MID matches the firm represented by
the registration number. In certain cases, FDA will reject a prior
notice submission that does not match a MID submission. Filers will
receive an ABI rejection communication identifying the mismatch when
this occurs. Once the facility and all other required information has
been received and validated, FDA will confirm the prior notice
submission.
(Comments) Several comments suggest that when a prior notice is
transmitted via ABI/ACS and confirmed for review by FDA, the data
should be
[[Page 66335]]
moved from ACS to OASIS regardless of the estimated time of arrival
(ETA) date.
(Response) The ABI/ACS system is not configured to certify
information nor transfer information to FDA in real-time as PNSI does.
ACS is programmed to collect data in batch mode and does not transmit
the data to FDA instantaneously. Therefore, prior notices submitted via
PNSI will continue to receive a real-time system response when the
prior notice is confirmed for review by FDA. However, prior notices
submitted via ABI/ACS will continue to be transmitted in a batch mode
and to receive systematic confirmation responses in the pre-arranged
timeframes developed by CBP. For those prior notices submitted via ABI
on the anticipated date of arrival, users can expect to receive a
response message (confirmation number or rejection) within 15 minutes
of submission. For ABI submissions submitted prior to the anticipated
date of arrival, users can expect to receive a response message no
later than midnight (Eastern Time) on the anticipated date of arrival,
i.e., the message generally is sent before 11:59 p.m. on the day before
the anticipated date of arrival.
(Comments) Several comments state that although PNSI is designed to
not require changes in the location of the anticipated port of arrival
(thus allowing a shipment to be diverted to a port other than the
intended port of arrival transmitted in the prior notice), the CBP ABI
system precludes the CBP entry from being accepted at other than the
reported port of entry. When this occurs, the CBP entry and original
prior notice must be deleted and a new entry must be submitted with a
new prior notice creating a new timeframe. The comments recommend that
the requirement be consistently applied and that the ABI/ACS system be
revised to allow for changes to the port of entry without causing
cancellation of the CBP entry.
(Response) FDA disagrees. The prior notice rule does not require a
new prior notice when the anticipated port of arrival changes after the
prior notice has been confirmed for review by FDA. CBP does require
cancellation of entry documentation for entry purposes when the port of
entry changes. The cancellation of an electronic ABI entry for CBP
results in the cancellation of any associated prior notices filed with
the entry in ABI. Amending ABI/ACS to allow amendments, such as when
the port of entry changes, would entail substantial and costly
revisions to the system; such technical changes are not cost-effective
or a good use of limited resources given the development of the
Automated Commercial Environment, which will replace ACS.
(Comments) One comment recommends that for a short trial period,
the full prior notice edits, with warning messages, should be turned on
without rejection of CBP entry processing. The comment reasons that
this would be a method of alerting ABI/ACS transmitters to errors
without jeopardizing the movement of the food. Another comment suggests
that a significant reason for a high rate of noncompliance on data
submissions is the lack of the automated systems' capability to advise
filers of data inadequacies.
(Response) The systems provide for error messages to be transmitted
to filers that identify the reasons for errors in prior notice
submissions that can be determined during the data entry process (e.g.,
certain required data elements are missing or product code submitted is
invalid). Over time, the agencies have seen the prior notice rejection
rate go down. Both agencies have been providing industry with
information regarding error messages.
(Comments) One comment points out that the PNSI Web portal has
changed to allow multiple containers to be reported against a single
prior notice line but that CBP has not changed their specifications to
allow more than a single container to be reported on a prior notice
line in ABI. The comment recommends that this change to the FDA Web
portal be communicated to CBP so they may change their ABI
specifications.
(Response) ABI currently allows filers to submit multiple container
numbers per FDA line by sending multiple FD05 records containing
affirmation of compliance code ``CNO.'' The first affirmation goes in
the FD01 record, with subsequent affirmations in the FD05 record which
can be repeated as often as necessary. Filers are able to submit
multiple records using the affirmation of compliance code ``CNO'' and
provide a different container number in each record.
5. PNSI
(Comments) One comment suggests that to more effectively screen
shipments entering the United States, FDA must work to integrate OASIS
with the prior notice system.
(Response) FDA's OASIS has always been an integral part of the
prior notice process as OASIS provides for internal systematic
screening of prior notice submissions in order to assist the agency in
making a determination regarding inspection of the food at the border.
OASIS also provides for systematic screening to assist FDA in making
admissibility decisions.
(Comments) Several comments request extension of the time one is
permitted to be logged into a session using PNSI. Comments state that
it is difficult to complete entering data before the system times out.
Several comments suggest that completing the process in time was
difficult for many persons whose native language is not English.
(Response) For security reasons, PNSI is currently configured with
a 30-minute time-out. FDA notes that Internet commerce systems are
typically configured with a similar, or more stringent, time-out
setting. FDA also notes that the time-out setting applies only to a
period of user inactivity; no limit is set on the total amount of time
the user may be logged into a particular session, nor is there a limit
to the amount of time taken to prepare and save or submit a specific
Web entry or prior notice. Users are ``timed-out'' only if their
session remains inactive for longer than the time-out setting.
Users may also save their entry while it is partially completed.
The data are retained and will be available when the user logs back
into the system.
(Comments) Several comments express concern about the capacity of
the FDA computer systems to process the volume of submissions. These
comments suggest that the system needs additional capacity to meet the
loads expected when full enforcement is instituted. Several comments
also believe that performance issues (e.g., slow response) are
hampering their usage of the system.
(Response) FDA recognizes these concerns and is committed to
providing systems that will meet user needs. FDA designed the prior
notice systems to process a volume of users far in excess of the
projected usage. Prior to implementation, FDA thoroughly tested the
performance of its system against loads in excess of that anticipated.
These tests have shown the system capable of maintaining acceptable
response even at these loads. Currently, FDA handles approximately
167,000 prior notices each week and could handle a much higher volume
without a capacity problem.
Many factors influence the responsiveness of an Internet based
system, including factors beyond the FDA's control, such as the user's
computer system (hardware, software, and Internet connection) and
traffic on the Internet as a whole. Since prior notice was implemented
in December 2003, FDA has carefully monitored both PNSI and OASIS
system usage and
[[Page 66336]]
performance. During this period, no issues related to load on these
systems have been identified. FDA has worked to resolve specific
issues, such as hardware failures, which have hampered system
performance and availability for short periods.
FDA and CBP also have increased the capacity of the communications
link between their systems to ensure that additional bandwidth is
available for future increases in load. FDA continues to monitor its
system and to test for performance as the system is upgraded and
enhanced. Users may obtain current system status information for PNSI
at the FDA Industry Systems home page (http://www.access.fda.gov) and
are requested to contact the Help Desk if they encounter any
performance issues currently not identified on the system status page.
(Comments) Several comments recommend that FDA develop an alternate
system that supports batch submission of prior notices. The comments
suggest that a batch system would save submitters a vast amount of
input time and allow the agency faster processing capability. The
comments also assert that a batch system would reduce the costs
incurred due to double entry between the user's existing systems, e.g.,
for order entry and filing with FDA. One comment proposes that they be
given a defined quantity of registration numbers at their disposal for
printing onto their dispatch labels (presumably by registration number
they are referring to the prior notice confirmation number). The
comment says they would like a fully automated process, where all data
relevant for prior notice would be created and then transmitted
electronically to CBP and FDA, instead of the current procedure of
manual input of all details.
(Response) FDA agrees that a mechanism to facilitate batch/fully
automated filing would provide some advantage to certain filers.
However, FDA believes that the existing systems (PNSI and ABI)
currently provide substantial capabilities in this area. PNSI offers
several features that make prior notice data entry faster and reduces
the amount of redundant data entry such as the Copy Web Entry feature,
Copy Prior Notice feature and other shortcuts. Please refer to Time
Saving Tips from FDA's PNC for PNSI (http://www.cfsan.fda.gov/~pn/
pntips.html) for a description of these features. ABI software can
often provide similar copying features, depending on the ABI software
package used by the transmitter.
FDA also recognizes that the resources to develop and maintain an
additional system would be significant. Therefore, FDA is not prepared
to undertake the development of a batch system at this time; following
completion of any system upgrades that will be released in conjunction
with implementation of the final rule, FDA will reassess the need for
and feasibility of developing a batch submission system. FDA notes that
some submitters have created their own internal programs that are
designed to organize data in ``batch'' mode, which in turn submits
their prior notices to PNSI in rapid succession.
(Comments) One comment states that they frequently ship the same
article of food in multiple containers. The comment believes that since
there is only one article of food, only one prior notice should be
required. The comment notes that the FDA Web Portal only allows the
input of one container per prior notice; therefore, they have to submit
multiple prior notices instead of only one. The comment requests that
the FDA Web Portal be changed to allow for the input of multiple
containers per article of food.
(Response) FDA agrees. The FDA Web Portal has been changed to allow
multiple containers to be reported against a single prior notice line
in the above situation.
(Comments) One comment states that most of their orders contain
multiple food items in one box and the process of filing prior notice
in PNSI for each item is very time consuming because one can only enter
one item at a time. The comment suggests updating PNSI to allow users
to enter multiple items on one screen (i.e., the user creates a Web
entry for each shipment and the system then allows them to specify all
items in that shipment on one screen).
(Response) A prior notice contains information on not just the
article of food being imported, but also the facilities related to that
article such as the manufacturer, shipper, owner and ultimate
consignee. Since this information can be unique for each article, it
must be provided for each article individually. PNSI does offer several
features that make prior notice data entry faster and reduce the amount
of redundant data entry such as the Copy Web Entry feature, Copy Prior
Notice feature and other shortcuts. Please refer to Time Saving Tips
from FDA's PNC for PNSI (http://www.cfsan.fda.gov/~pn/pntips.html) for
a description of these features.
(Comments) One comment states that FDA's Web Portal does not accept
the input of CBP entry numbers. The comment further states that there
are times when an entry number is not required for an article of food
that requires prior notice. The comment questions why the FDA Web
Portal does not accept an entry number when a CBP entry is required and
known at the time of filing prior notice. Another comment recommends
that the Web Portal software be redesigned in order for filers to
receive the relevant entry identifier information with the prior notice
confirmation number.
(Response) FDA disagrees. PNSI does accept the CBP entry number. If
there is no entry number or other entry identifier, PNSI will provide a
system-generated entry identifier to the prior notice submission. We
also posted guidance on FDA's Web site at http://www.cfsan.fda.gov/~pn/
pnentgui.html that describes the entry types and the entry identifiers.
(See also discussion infra on the CBP entry identifier in section
III.H.5 of this document.)
(Comments) Several comments express concern about system outages
for PNSI and/or ABI. These comments suggest that one or both systems
had not been available for extended periods in the past or were
frequently unavailable. Comments also recommend that FDA provide an
alternate method, such as facsimile, for submission during periods when
the systems are not available. One comment notes that PNSI has not been
functioning properly. The comment states that the System Status update
pages indicates that the system is operating as ``normal,'' but the
system is really down.
(Response) FDA recognizes that system outages could have the
potential to disrupt trade. To minimize outages, FDA has built
redundancy into these computer systems (e.g., multiple servers and
backup systems) and, to the extent possible, combined planned
maintenance activities to be accomplished during a single outage.
Planned outages are scheduled for a timeframe with the minimum possible
impact to users and notice is provided as far in advance as possible,
allowing users to plan their access to the system. System status
information, including planned outages, is posted at http://
www.access.fda.gov and at http://www.cfsan.fda.gov/~furls/fisstat.html.
Users are requested to contact the Help Desk if any performance issues
not identified on the system status page are encountered.
FDA also provides alternate options for users to file prior notice
during system outages. Filers who use CBP's ABI/ACS system can utilize
PNSI when ABI, ACS, and/or OASIS are unavailable. In addition, FDA has
provided a method for filing via facsimile or e-mail when PNSI is
[[Page 66337]]
unavailable for an extended period (see the Contingency Plan for System
Outages at http://www.cfsan.fda.gov/~pn/pndguid.html). These
contingency plans are designed to ensure that the flow of trade is not
interrupted when system outages cannot be avoided (see also the
discussion on contingency plans below).
(Comments) One comment notes that companies continue to report
technical difficulties when using PNSI, including the inability to
access reliable technical advice through the hot-line. Another comment
indicates that the waiting time for the helpline is very long, with a
minimum wait time of 15 minutes.
(Response) FDA has made a number of enhancements and has fixed
several issues with earlier releases of PNSI. FDA also continues to
work to provide the best possible service addressing technical issues
through the Help Desk. Users are encouraged to continue to contact the
Help Desk for technical assistance. The Help Desk is available Monday
through Friday from 7:30 a.m. to 11 p.m. Eastern Time. Users may leave
a message or send e-mail at other times, which will be addressed on the
next business day.
(Comments) Several comments address the complexity of PNSI. The
comments state that the system requires the complete re-creation of all
data for each prior notice even when shipments are repetitive with
minimal variables in information; that the full address should not be
necessary for registered facilities; and that PNSI should allow
submitters to save and store data for replication or provide for self-
populating fields. One comment, however, notes that their users have
had relatively little problem using PNSI.
(Response) FDA continues to provide, to the extent possible, a
``user-friendly'' PNSI application. Several features have been added
since the initial release (PNSI 1.0) to assist users, including a
feature that allows users to copy individual prior notices and Web
Entries, with or without the associated prior notices. Where possible,
lists of standard values (e.g., entry types, SCAC & IATA Codes, firm
types, quantity and packaging descriptions) are provided to facilitate
entry of these values. These enhancements minimize the need for users
to enter repetitive information. Similar to the IFR, the prior notice
final rule does not require the full address in all cases. When a
registration number is provided, name, city and country can usually be
provided instead of the name and full address (e.g., Sec.
1.281(a)(6)). FDA continues to work to enhance the system, in response
to user comments, as well as to changing business requirements.
(Comments) One comment asks if PNSI will provide guidance on
formatting of the information for identification of the submitter,
transmitter, and manufacturer. The comment is concerned that PNSI may
only accept certain formatting, without providing guidance to the
submitter, thereby, causing problems with PNSI accepting and processing
prior notice.
(Response) PNSI is supported by several tutorials and help screens
which lead the user through correct inputting of data.
(Comments) Several comments address specific issues with the PNSI
software (potential ``bugs'') or suggestions for enhanced capabilities.
Examples include questions about the completeness of the lists of
values (drop-down lists), issues with browser settings and
compatibility, and suggestions for additional bar code printouts.
(Response) FDA welcomes user suggestions for improvements to the
PNSI system. Discrepancy reports are investigated thoroughly to ensure
the system meets both FDA's requirements and user needs to the extent
possible. Suggested improvements are also prioritized and reviewed by a
Change Control Board who continue to determine appropriate and feasible
improvements to the system. FDA encourages users to continue to contact
the Help Desk with any technical questions, issues, or suggestions.
(Comments) One comment suggests that PNSI should be revised to
create a view screen similar to the printed confirmation with all the
information in one place before submission. The comment also suggests
that when creating a prior notice for different commodities, the system
should not have all commodities default onto prior notice, but should
allow the user to use a check box to choose a commodity, rather than to
cancel the commodity.
(Response) FDA agrees. The PNSI software has been enhanced to
provide a screen that includes all of the information about the prior
notice prior to a transmitter completing the submission step. PNSI also
has been enhanced to allow copying of prior notices within a Web Entry
and copying of a Web Entry, with or without the associated prior
notices. A user thus can copy a Web Entry with all associated prior
notices, then use the cancel function to remove any prior notices not
required for the new entry.
FDA welcomes any additional comments or suggestions on how to
improve PNSI; these can be submitted to the Help Desk using the
telephone number or e-mail provided at http://www.cfsan.fda.gov/~furls/
helpf.html.
6. Security of the Systems
(Comments) One comment suggests that FDA create a mechanism whereby
interested parties may assert protection from public disclosure under
FOIA for information contained in prior notices that they believe is
confidential business information.
(Response) We believe that there is no need to create such a
mechanism because the agencies would review the prior notice
information to determine if it is protected by a FOIA exemption before
disclosure to the public.
(Comments) One comment states that in order to complete the PNSI
submission, several security settings on their respective computers had
to be disabled.
(Response) PNSI is designed to work with the browsers listed at
http://www.access.fda.gov/, using standard settings. PNSI requires that
the browser be set to accept cookies. FDA does not believe that these
settings present a security risk to users. Users are encouraged to
contact the Help Desk for assistance with specific issues regarding
access and system settings.
7. Contingency Plans
In Sec. 1.280(b), (c), (d), and (e) of the IFR, FDA requires that
if a custom broker's or self-filer's system is not working or if the
ABI/ACS interface is not working, prior notice must be submitted
through PNSI. It further states that if the PNSI is not working and/or
OASIS is not working, FDA will issue an Internet notification, and
submission of prior notice must be by e-mail or by facsimile to FDA.
FDA posts the e-mail or facsimile information on its Web site. The
prior notice information will only be accepted at the posted e-mail or
facsimile locations if FDA determines that PNSI or OASIS is not
working.
On August 12, 2004, FDA and CBP published guidance covering a
Contingency Plan for System Outages (see http://www.cfsan.fda.gov/~pn/
pndguid.html/). FDA and CBP identified seven potential system downtime
scenarios that could impact transmission, confirmation, and processing
of prior notice submissions and developed alternative submission
options for each of the identified scenarios.
(Comments) One comment states that FDA and CBP need to formulate
and communicate a realistic contingency plan for commercial
importations that takes into account CBP ABI downtime, FDA OASIS
downtime, and broker
[[Page 66338]]
downtime. Two comments express concern that contingency plans include a
dependency on PNSI and their experience has shown that PNSI was
intended for the casual importer and never intended for commercial
operations. The comment states that significant delays will be
experienced if 80 percent of the transactions are suddenly routed from
the ABI/ACS system to the PNSI system.
(Response) FDA is committed to providing systems that will meet
user needs. FDA designed PNSI to process a volume of users far in
excess of the projected usage, and tested performance at these volumes.
As noted previously, FDA and CBP published guidance covering a
Contingency Plan for System Outages (see http://www.cfsan.fda.gov/~pn/
pndguid.html/) and anyone may submit comment on it.
(Comments) One comment suggests that FDA and CBP provide guidance
that defines an appropriate timeframe to wait for prior notice
confirmation before assuming the system is down and/or that
resubmission is required.
(Response) Generally, for prior notice submissions via PNSI, the
user should receive a confirmation number immediately upon submission
of the correctly completed form. For those prior notices submitted via
ABI on the anticipated date of arrival, users can expect to receive a
response message (confirmation number or rejection) within 15 minutes
of submission. For ABI submissions submitted prior to the anticipated
date of arrival, users can expect to receive a response message no
later than midnight (Eastern Time) on the anticipated date of arrival,
i.e., the message generally is sent before 11:59 p.m. on the day before
the anticipated date of arrival.
The FDA/CBP Contingency Plan states that ``notice advising of any
available downtime specifics will be posted at http://
www.access.fda.gov, http://www.fda.gov, http://www.cfsan.fda.gov/
~furls/fisstat.html, and
http://www.cfsan.fda.gov/~pn/pnoview.html, and
through messages in ABI/ACS (see 21 CFR 1.280(d)).'' Section 1.280(c),
(d), and (e) of the IFR also lists three of these four Web sites to
advise of system downtimes, and specifies in what form prior notice
should be submitted during certain system outages (i.e., e-mail or
fax). In order to simplify the Web addresses for these notifications
and the instructions for submitting prior notice when PNSI or OASIS is
not working, the final rule has been revised by providing the outage
notification at one Web address (http://www.fda.gov). In order to
provide more flexibility to respond to various contingencies, the final
rule has also been revised by stating that FDA will accept prior notice
submissions in the format it deems appropriate during the system(s)
outage.
FDA has posted information on the Systems Status Web site located
at http://www.cfsan.fda.gov/~furls/fisstat.html regarding system
downtime that states ``Most problems will be temporary. Try accessing
the system again in 15 minutes.'' This site also provides information
about scheduled maintenance, which states that ``Periodically FDA
Industry Systems will need to undergo maintenance and upgrades. All
scheduled maintenance will take place on Saturdays 3 a.m. to 8 a.m.
Eastern Time (Saturday 8 a.m. to 1 p.m. GMT). If you are having trouble
accessing FDA Industry Systems during that time, please try again after
8 a.m. Eastern Time on Saturday (1 p.m. GMT).'' This site also provides
a status history of the system.
(Comments) One comment suggests that FDA should develop and publish
a form that could be used if it were ever necessary to file prior
notice by fax. The comment asserts that a form also would assist
importers in gathering the information necessary to file a prior notice
and also would clear up the confusion that currently exists in foreign
countries. The comment believes that it was obvious that FDA
contemplated issuing a form when it first proposed the prior notice
regulations and complains that no explanation has been given by FDA for
not producing the form.
(Response) FDA disagrees. A form to be used during contingencies is
posted on FDA's Web site only when an applicable system outage is
encountered. During a system outage when fax submissions are being
accepted, FDA will publish the fax telephone number for the PNC at
http://www.access.fda.gov, http://www.fda.gov, http://
www.cfsan.fda.gov/~furls/fisstat.html, and http://www.cfsan.fda.gov/
~pn/pnoview.html, as well as through messages in ABI/ACS. Fax
transmission is not allowed except when posted and submitted during
PNSI downtimes or specified emergencies. FDA believes that if the form
was available and posted even as a reference, there is the potential
for misuse or confusion. Our experience with use of the fax form is
that submitters will continue to fax the form even after they have been
instructed that the form will not be accepted.
(Comments) Some comments express concern that submission of all
prior notices relies on electronic systems (even the fax). The comments
suggest that the usual flow of goods should be allowed to continue
unhindered, with the paperwork sorted out afterwards. One comment
further suggests that rather than providing for PNSI as a contingency
system when ABI is down, prior notice submissions should function
according to all other submissions processed through ABI when CBP
declares either a ``national snow day'' or ``power outage.'' The
comment recommends that if ABI is not working, the shipment should be
allowed to proceed, pending later issuance of a prior notice
confirmation via ABI.
(Response) FDA does not agree that if ABI is not working the
shipment should be allowed to proceed. In that instance, prior notice
can, and therefore should, be submitted via PNSI.
In all contingency situations, except for power failure, some
electronic means of prior notice submission is required, either by
PNSI, e-mail, or fax. However, in the case of a localized or regional
power failure, the Contingency Plan guidance recommends that filers
should submit the required prior notice information to FDA at the port
of arrival, or if there is no FDA officer at a given port, to CBP via a
paper copy of the prior notice e-mail contingency form (FDA 3540) at
the time of cargo release.
(Comments) One comment explains that various companies are
organizing contingency plans whereby the prior notice confirmation
number will be included in the delivery order, which then will be faxed
to the office of the steamship line at the port of entry so that the
requisite paperwork is in hand when the product is offloaded from the
carrier. The comment further explains that this contingency plan takes
into account the unique circumstances posed by transporting goods by
steamship line insofar as the customs broker or purchaser may not
always be able to send the prior notice confirmation number to the
carrier prior to the carrier's arrival. The comment asserts that the
procedure satisfies FDA's requirements that the prior notice
confirmation number must accompany the food when it ``arrives in the
United States'' and be provided to CBP or FDA ``upon arrival.'' The
comment further urges FDA to include this course of action in its
guidance documents.
(Response) FDA agrees that the described scenario satisfies the
requirement under Sec. 1.279(g) that the prior notice confirmation
number must accompany any article of food for which the prior notice
was submitted through PNSI when the article arrives in the United
States and must be provided to
[[Page 66339]]
CBP or FDA upon arrival. FDA does not believe, however, that it is
necessary to include this specific business practice in its guidance
documents, as there are various means that private entities may choose
to use to comply with the regulation.
As described in the contingency plan guidance, if prior notice
already has been submitted via ABI/ACS prior to an interface outage,
and confirmation from FDA already has been received, then the submitter
may proceed with prior notice using the standard process under the
following scenarios:
<bullet> ACS, OASIS, and PNSI are all operational, but the link
between ACS and OASIS is down on FDA's or CBP's side of the system
interface;
<bullet> ACS, PNSI, and the link between ACS and OASIS are
operational, but OASIS is non-operational;
<bullet> ACS and the link between ACS and OASIS are operational,
but OASIS is non-operational and PNSI is non-operational or unavailable
due to Internet service interruptions;
<bullet> OASIS, PNSI and the link between ACS and OASIS are
operational but ACS is non-operational; or
<bullet> ACS is non-operational, PNSI is non-operational or
unavailable due to Internet service interruptions, and OASIS and the
link between ACS and OASIS are either operational or non-operational.
The standard process does not include presentation of the prior
notice confirmation number to FDA or CBP upon arrival if the prior
notice was submitted by ABI/ACS.
If prior notice already has been submitted via ABI/ACS and
confirmation from FDA has not been received prior to the interface
outage, FDA and CBP recommend that rather than resubmitting via PNSI,
submitters should provide to CBP officers, at the time of cargo
release, an endorsed (signed) copy of the ABI transmission or some
other evidence adequate to show that prior notice has been submitted
via ABI/ACS.
If prior notice has been submitted via PNSI prior to the system
outage and a confirmation number already has been received, the
confirmation number must accompany the article of food (Sec.
1.279(g)). In addition, FDA and CBP recommend that the submitter also
provide the PNSI confirmation page, including the prior notice
confirmation number and time stamp, to CBP officers for cargo release.
If the prior notice confirmation page is not provided, this may delay
cargo release while the CBP officer contacts FDA for verification of
the prior notice confirmation number(s) and time of submission.
(Final rule) The final rule in Sec. 1.280(a) requires that prior
notice must be submitted electronically to FDA in the English language,
except that an individual's name, the name of a company, and the name
of a street may be submitted in a foreign language. All information,
including these items, must be submitted using the Latin (Roman)
alphabet.
Section 1.280(a)(1) and (a)(2) of the final rule provides for two
methods of electronic submission of prior notice: (1) The CBP Automated
Broker Interface of the Automated Commercial System (ABI/ACS); or (2)
The FDA PN System Interface (PNSI) at http://www.access.fda.gov. We
corrected a reference in paragraph (a) to state that unless Sec.
1.280(c) applies, prior notice must be submitted through either ABI/ACS
or PNSI.
The final rule requires submission of prior notice via PNSI for
articles of food imported or offered for import by international mail,
and other transaction types that cannot be made through ABI/ACS. Prior
notice for articles of food that have been refused under section
801(m)(1) of the act must be submitted through PNSI until such time as
ACS or its successor system can accommodate such transactions.
The final rule also provides for contingencies if involved systems
were not working, e.g., a custom broker's or self-filer's system, ABI/
ACS, PNSI, or OASIS. The final rule requires that prior notice must be
submitted through PNSI if a customhouse broker's or self-filer's system
or if the ABI/ACS interface is not working. The final rule states that
if PNSI or OASIS is not working, FDA will post prominent notification
and instructions at http://www.fda.gov. FDA will accept prior notice
submissions in the format it deems appropriate during the system(s)
outage. The final rule does not exempt any specific categories of food
articles from prior notice if systems are not performing.
H. What Information Must Be in a Prior Notice? (Sec. 1.281)
The Bioterrorism Act requires the submission to the Secretary of a
notice providing the identity of each of the following: The article;
the manufacturer and shipper of the article; if known within the
specified period of time that notice is required to be provided, the
grower of the article; the country from which the article originates;
the country from which the article is shipped; and the anticipated port
of entry for the article.
The IFR requires in Sec. 1.281(a), (b), and (c) that specific
information be submitted in prior notice: Section 1.281(a) covers
general information requirements which apply to all shipments except
those arriving by international mail; section 1.281(b) covers limited
information requirements for food arriving by international mail; and
section Sec. 1.281(c) covers information requirements for food refused
under section 801(m) of the act (e.g., food that has already arrived in
the United States).
The preamble to the IFR discusses the term, ``an article of food,''
and states that ``the description of an `article' of food is not the
same as the definition of `food' in Sec. 1.276(b)(5). An `article'
refers to a single food that is associated with the same complete FDA
Product Code, the same package size, and the same manufacturer or
grower. These requirements are found in the information required in the
IFR in Sec. 1.281(a)(5), (a)(6), or (a)(7) and again in Sec. 1.281(b)
and (c)'' (68 FR 58974 at 59003).
The comments are discussed in order of the information requirement
in the IFR, beginning with comments generally addressing the
information requirements.
1. General Comments
(Comments) Several comments express concern that the IFR requires
significantly more information than the Bioterrorism Act requires and
ask that FDA reduce the number of data elements. One comment notes that
the Bioterrorism Act names only six or seven specific items that must
be provided. One comment indicates that the information required for
prior notice is far in excess of that required in the Codex Committee
on Food Import and Export Inspection and Certification Systems
Guidelines for Generic Official Certificate Formats and the Production
and Issuance of Certificates (CAC/GL 38-2001). One comment adds that
the required information far exceeds what is necessary to enable FDA to
identify articles of food that need to be inspected. Another comment
suggests that some of the information required for a prior notice is
already ``covered'' by the registration requirement of section 305 of
the Bioterrorism Act (see the Registration of Food Facilities Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 interim final rule, 21 CFR part 1, subpart H, confirmed 70 FR
57505, October 3, 2005), so FDA will already have this information.
Another comment suggests that the prior notice could be simplified,
thus reducing the possibility of errors and potential trade
disruptions, by quoting the registration number and only adding
information
[[Page 66340]]
specific to a particular shipment. One comment notes that CBP's data
fulfill FDA's needs; therefore, the IFR's duplicate system is a waste
of resources, and FDA should use CBP's system.
(Response) FDA disagrees with the comments that ask for a reduction
in the number of required data elements. FDA has selected those data
elements that will allow FDA to meet its statutory obligation to
receive, review, and respond to prior notices efficiently and
effectively. In addition to the Bioterrorism Act's requirements of the
identities of the article of food, the manufacturer and shipper, the
grower, if known, the country from which the article originates, the
country from which the article is shipped, and the anticipated port of
entry for the article, FDA determined that certain additional
information is required for efficient enforcement of the Bioterrorism
Act, primarily for the means of identifying the article of food and
effective enforcement of refusals. For example, the identification of
the individual and the firm, if applicable, submitting the prior notice
is needed so that FDA knows who is responsible for the information in
the prior notice and can communicate with them when necessary via mail,
phone, or e-mail. The information also is necessary to follow up when
audits, inspections, or enforcement are necessary. Therefore, FDA does
not agree with one of the comment's assertions that the prior notice
rule should only require the registration number and other information
specific to a particular shipment.
The goals of the Bioterrorism Act and the Codex Committee differ,
and thus, the requirements of the prior notice rule will differ from
that of the Codex Committee on Food Import and Export Inspection and
Certification Systems. The purpose of prior notice is to enable FDA to
conduct inspections of imported foods at U.S. ports upon arrival and
target foods that may pose a significant risk to public health, based
on the information submitted. The Codex Committee on Food Import and
Export Certification and Inspection Systems is charged with developing
principles and guidelines for food import and export certification and
inspection systems.
We also do not agree with the comment's assertion that FDA should
use CBP's data to fulfill FDA's needs under the Bioterrorism Act.
Information that is submitted at the time of CBP entry processing is
not useful for prior notice as this information can be submitted or
changed after the food has already arrived in the United States and
thus does not fulfill the express intent of the Bioterrorism Act that
FDA receive information about a shipment before it arrives in the
United States.
FDA also does not agree that some of the prior notice information
is already ``covered'' by the food facility registration requirement.
For example, facilities typically provide general product categories as
part of the registration process. This generalized information would
not provide the identity of the article being imported or offered for
import and, therefore, would not meet the prior notice requirements as
defined in section 801(m) of the act. Therefore, we do not agree that
some of the registration information could be used to meet the prior
notice information needs. Moreover, a facility's registration contains
all of the general food product categories the facility manufactures,
processes, packs or holds; and would not allow FDA to know specifically
which article of food is the subject of the prior notice, which
precludes an effective assessment of risk.
(Comments) Several comments recommend that the limited information
requirements associated with food arriving by international mail in
Sec. 1.281(b) be applied to all importations. One comment suggests
that by eliminating such data as the entry type and identifier, the
port of entry, the FDA Product code, and the HTS code, all prior
notices could be submitted via FDA's PNSI at an earlier time. The
comment further asserts that the requirement for these types of data is
the primary reason that 80 to 90 percent of prior notices are submitted
via ABI/ACS rather than PNSI. Another comment reasons that as the
manufacturer and facility identification numbers are not provided for
homemade food or postal shipments, the necessity of providing this
information for other types and modes should be examined. Another
comment recommends that the notification procedure should be
simplified, and that the data elements should be limited to the
minimum, such as the shipper's name and its contact point, the food
facility registration number, and food product codes.
(Response) FDA disagrees. The type of information required for
prior notice submissions of food arriving by international mail are
limited because of the process by which international mail enters the
United States. For international mail shipments, the IFR and the final
rule requires the identification of the U.S. recipient rather than the
importer, owner, or ultimate consignee because mail is sent only to a
U.S. recipient rather than the multiple entities that may be involved
in a traditional commercial importation. The final rule does not
require an entry identifier because international mail will always
receive a system-generated identifier, as international mail shipments
cannot be submitted via ABI/ACS. Because the port of entry and time and
date of entry are completely subject to the international mail process,
the IFR requires only that the submitter identify the date of shipment,
i.e., the date the food is shipped, which provides the most information
possible to satisfy the anticipated port of entry. Moreover, since
international mail is always in the custody of CBP until it is released
for delivery to the recipient, no additional shipment information is
necessary for communication between FDA and CBP.
FDA also disagrees that information, such as the entry type and
identifier, the port of entry, and the FDA Product Code should be
eliminated from the prior notice requirements. The anticipated port of
entry is specifically required by the statute and FDA has determined
that the best possible method of determining product identity is the
FDA Product Code. We have eliminated the HTS code in the final rule
because it has not been a necessary factor for enhancing communication
between FDA and CBP for the purpose of inspection at the port of
arrival. However, the entry type and identifier are critical elements
in communications between FDA and CBP so that the appropriate food is
either held at the port of arrival as appropriate, or allowed to
proceed.
FDA also disagrees with the suggestion that the manufacturer and
facility registration numbers are not provided for homemade food or
postal shipments and, therefore, should not be required for other types
of shipments. The IFR excludes homemade food from prior notice
requirements entirely, and this exclusion also is in the final rule.
Both the IFR and the final rule require submission of the identity of
the manufacturer and the manufacturer's registration number in the
prior notice for food arriving by international mail.
FDA agrees with the comments that prior notice requirements should
be limited to the minimum, and has selected those data elements that
will allow FDA to expeditiously meet its statutory obligation to
receive, review, and respond to prior notices. FDA, however, does not
agree with the comments that the shipper's name and its contact point,
the registration number of food facility, and food product codes are
the only data elements FDA needs to fulfill this mandate. In addition
to the Bioterrorism
[[Page 66341]]
Act requirements of the identities of the article of food, the
manufacturer and shipper, the grower, if known, the country from which
the article originates, the country from which the article is shipped,
and the anticipated port of entry for the article, FDA determined that
certain additional information is required for efficient enforcement of
the Bioterrorism Act, primarily for the means of identifying the
article of food and effective enforcement of refusals.
FDA also notes that it is not surprising that 80 to 90 percent of
prior notices are submitted via ABI/ACS. Numerous comments on the
proposed rule urged FDA to use the existing ACS-OASIS interface between
CBP and FDA to accept prior notice information. As stated in the IFR,
FDA and CBP agreed with the recommendation that the agencies provide a
single point of data entry for CBP and FDA for as many kinds of entries
as possible, and modified our systems to allow prior notice to be filed
by either CBP's ABI/ACS or FDA's PNSI beginning with the December 12,
2003, effective date of the IFR. FDA also noted at that time that it
expected approximately 90 percent of prior notice submissions for all
importations of foods to be transmitted by a customs broker or self-
filer through the ABI/ACS interface to FDA. (See 68 FR 58974 at 58976,
October 10, 2003.) Since implementation, this estimate has proven true,
as approximately 83 percent of all prior notices are filed through the
ABI/ACS interface.
(Comments) Several comments suggest that all prior notice
information requirements that are duplicative of information
requirements for CBP via AMS for Advanced Electronic Information or in
ABI/ACS for Entry should be eliminated. One comment recommends that
prior notice be aligned with CBP ``ACI'' rules, for both timing and
data elements. The comment believes that this could lead to a possible
reduction in data elements.
(Response) FDA disagrees. Information that is submitted for CBP
entry processing is not useful for prior notice as this information can
be submitted or changed after the food already has arrived in the
United States and prior notice is required before the food arrives.
Moreover, no interface currently exists between AMS and the
existing interface with FDA's OASIS through the ABI/ACS entry
processes, which means FDA does not have access to AMS data. FDA and
CBP have discussed interfacing with AMS for manifest data and
determined that the general cargo data in AMS are not suitable to
accommodate the detailed information requirements of section 801(m) of
the act. For example, its collection of the identities of the article
of food and its manufacturer differs from the way those are collected
under the prior notice interim final and final rules in such a way that
the data would not meet our needs in carrying out the purpose of
section 801(m) of the act.
(Comments) Many comments suggest that submitters consolidate
similar prior notices into one prior notice based on a variety of
reasons, e.g., one prior notice per consignee with all food products
consolidated; one prior notice per shipment with all information
consolidated; one prior notice per commodity regardless of the
quantity, size, color or species; one prior notice per bill of lading;
one prior notice per truck or conveyance and one prior notice for the
same food type regardless of brand.
(Response) The Bioterrorism Act requires notice for each article of
food and requires in that notice, for each article of food, certain
information. As stated in the IFR, an ``article'' refers to a single
food that is associated with the same complete FDA Product Code, the
same package size, and the same manufacturer or grower (68 FR 58974 at
59003). This is consistent with how entry is filed with CBP. An article
of food is a unique item related to a specific manufacturer or grower
and a specific process or size. All of these pieces of information are
critical for a risk-based assessment of the food. The ABI/ACS system
provides the capability to submit information for multiple food items
as lines in a single entry, when entry level information is consistent
for a number of articles in a shipment. For example, shipment level
information, such as estimated time of arrival, can be captured once
for all articles within a shipment. The ability to minimize data entry
by copying specific information from one article, or line, to another
depends upon the sophistication of the software being used by the
submitter to create the submission to CBP. The FDA PNSI allows for
simplified submission of similar articles of food by allowing the
submitter to easily repeat common information (e.g., FDA product code,
manufacturer, etc.) while entering different quantities (e.g., amount
and package size). Both systems thus significantly reduce the amount of
repetitive entry. The prior notice requirements in the IFR or the final
rule do not require the submission of the brand for the article of
food.
(Comments) One comment suggests that different programs should not
require different information requirements. The comment particularly
focuses on FAST and C-TPAT and recommends that prior notice submissions
for those participating in these programs should be subject to fewer
information requirements.
(Response) FDA disagrees. All of the information required in a
prior notice is necessary for determining what articles to inspect upon
arrival and otherwise carrying out section 801(m) of the act. The
information is initially screened electronically in order to expedite
the PNC's review. If less information is provided, regardless of
whether the food is covered by some other program, then the result of
that screening would be less reliable. This issue is discussed further
in section III.D.6.a of this document (``Additional Exclusions
Requested--Special Programs (C-TPAT/FAST) and Flexible Alternatives--
General Comments'')
(Comments) Two comments refer to submission of ``blanket'' prior
notices; one referencing repetitive shipments of analytical samples and
the other suggesting a summary of daily shipments.
(Response) FDA disagrees that it should change its approach from
the IFR. As stated in the preamble to the IFR (see 68 FR at 59003), an
article of food is a unique item related to a specific manufacturer or
grower and a specific process or size. All of these pieces of
information are critical for a risk-based assessment of the food. FDA
currently receives most of this information from customs brokers or
self-filers via ABI/ACS. The ABI/ACS system also provides the
capability to submit information for multiple food items as lines in a
single entry, when entry level information is consistent for a number
of articles in a shipment. For example, shipment level information,
such as estimated time of arrival, can be captured once for all
articles within a shipment. The ability to minimize data entry by
copying specific information from one article, or line, to another
depends upon the sophistication of the software being used to create
the submission to CBP. The FDA PNSI is designed to allow for simplified
submission of similar articles of food by allowing the submitter to
easily repeat common information (e.g., FDA product code, manufacturer,
etc.) while entering different quantities (e.g., amount and package
size). Both systems will thus significantly reduce the amount of
repetitive entry of information while preserving the identity of each
article of food. Moreover, the purpose of prior notice is for FDA to
receive, prior to arrival, information about each article of food being
imported or offered for
[[Page 66342]] import for the purpose of enabling such article to be inspected at ports of entry into the United States. Receiving blanket prior notices would not provide the necessary information nor would a daily summary, which by definition would be after-the-fact, not prior to arrival. 2. The Submitter In Sec. 1.281(a)(1), (b)(1), and (c)(1), the IFR requires submission of the name of the individual submitting the prior notice and his/her business address, telephone number, fax number, e-mail address, and the name and address of the submitting firm, if applicable. If a registration number is provided, city and country may be provided instead of the full address. (Comments) Several comments assert that it is duplicative and unnecessary to require not only the corporate name and address of the submitter but an individual's name, telephone number, fax number and e- mail address as well. The comments contend that this information already should exist in the FDA registration database and that the name of the submitting firm should be sufficient. The comments assert that in today's job market, individuals change jobs more frequently, thereby making the maintenance of this level of specificity in a database time consuming with minimal benefit. However, another comment states that the regulatory provisions in the prior notice IFR are silent regarding which person(s) will be contacted by FDA and/or CBP when an issue or problem arises regarding a prior notice and urge FDA to clarify that in refusal circumstances, the agency will contact the person who submitted the prior notice (i.e., the submitter or the transmitter.) The comment further states that by reason of his or her knowledge and/or access to the necessary information, as well as having the implicit authority and responsibility to properly file the prior notice, the submitter or transmitter typically will be in the best position to take corrective action as expeditiously as possible. (Response) FDA has determined that a fax number is not necessary for communication with the submitter. However, the identification of the individual and the firm, if applicable, submitting the prior notice is needed so that FDA knows who is responsible for the information in the prior notice and can communicate with them when necessary via mail, phone, or e-mail. The information submitted must provide sufficient information to enable FDA to communicate questions, concerns, or enforcement information with the submitter. See section III.J.1 of this document regarding inadequate prior notice (Sec. 1.283(a)(1)) for a discussion of communication of refusals. (Comments) One comment suggests that there should be an option to identify whether or not the submitter is C-TPAT certified. (Response) As we previously explained in the discussion under our assessment of timeframes (see section III.F of this document), C-TPAT participation will not affect timeframes, the amount of information required to be submitted under prior notice, or decisions made during the prior notice review process. Thus, the costs to submitters and the government of submitting such information would not provide benefits. FDA will continue to coordinate with CBP for administration of C-TPAT as it applies to FDA-regulated products, particularly as it relates to admissibility decisions under section 801(a) of the act. However, the prior notice final rule will not require that the submitter self- declare as C-TPAT certified or not C-TPAT certified. (Comments) One comment asks if it is possible for a submitter to have his/her legal residence in the country of origin. (Response) Neither the IFR nor the final rule limits the residence or location of the submitter. Section 1.278 of the final rule states that any person with the knowledge of the required information may submit a prior notice. (Final rule) The final rule requires in Sec. 1.281(a)(1), (b)(1), and (c)(1) the submission of the name of the individual submitting the prior notice and his/her business address, telephone number, and e-mail address, and the name and address of the submitting firm, if applicable. We reworded the last sentence of these paragraphs for clarity to state that if the business address of the individual submitting the prior notice is a registered facility, then the facility's registration number, city, and country may be provided instead of the facility's full address. 3. The Transmitter Section 1.281(a)(2), (b)(2), and (c)(2) of the IFR requires the submission of the identity of the transmitter, if different from the submitter. The IFR requires the name of the individual and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her business address, and phone number, fax number, and e-mail address. If a registration number is provided, city and country may be provided instead of the full address. (Comments) A comment states that the regulatory provisions in the prior notice IFR are silent regarding which person(s) will be contacted by FDA and/or CBP when an issue or problem arises regarding a prior notice and urges FDA to clarify that in refusal circumstances, the agency will contact the person who submitted the prior notice (i.e., the submitter or the transmitter.) The comment further states that due to his or her knowledge and/or access to the necessary information, as well as the implicit authority and responsibility for properly filing the prior notice, the submitter or transmitter typically will be in the best position to take corrective action as expeditiously as possible. (Response) FDA agrees. The identification of the individual or the firm, if applicable, transmitting the prior notice is needed so that FDA knows who is responsible for transmitting the information in the prior notice and can communicate with them when necessary via mail, phone, fax, or e-mail. Moreover, the information submitted must provide sufficient information to enable FDA to communicate questions, concerns, or enforcement information with the transmitter. See section III.J.1 of this document regarding inadequate prior notice (Sec. 1.283(a)(1)) for a discussion of communication of refusals. (Comments) Some comments ask if FDA would clarify what distinguishes the submitter from a transmitter and if it is possible for an authorized transmitter to have his/her legal residence in the USA. (Response) The submitter is any person with knowledge of the required information. The transmitter is the person who transmits the required information on behalf of the submitter. The submitter and transmitter may be the same person. (See Sec. 1.278) The final rule does not limit the residence or location of the transmitter. (Final rule) If the prior notice is transmitted by a person other than the submitter, the final rule in Sec. 1.281(a)(2), (b)(2), and (c)(2) requires the name of the individual and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her business address, telephone number, fax number, and e-mail address. We reworded the last sentence of these paragraphs for clarity to state that if the business address of the individual transmitting the prior notice is a registered facility, then the facility's registration number, city, and country may be provided instead of the facility's full address. 4. The CBP Entry Type Section 1.281(a)(3), (b)(3), and (c)(3) of the IFR require submission of the [[Continued on page 66343]] From the Federal Register Online via GPO Access [wais.access.gpo.gov] ] [[pp. 66343-66392]] Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 [[Continued from page 66342]]
[[Page 66343]]
entry type, which for Sec. 1.281(b)(3) will be a mail entry.
(Comments) Two comments ask for clarification of the CBP entry type
data element and request a list of all of the options for entry type.
(Response) FDA needs this information both for screening to
identify the appropriate articles for inspection and for communication
between the FDA and CBP staff at the port. Also, the entry type
determines which entry identifiers should be used (entry number, in-
bond number) to identify the shipment. In addition, the CBP entry type
tells us if the article of food is for consumption in the United States
or is for export or other uses.
Some examples of CBP entry types are: consumption entries,
warehouse entries, and temporary importation bond entries. Each of
these types has a designated CBP code. For prior notice submissions
made through ABI/ACS, the entry type will consist of the CBP entry code
specific for that type of entry; e.g., ``01'' for a consumption entry,
``21'' for a warehouse entry, ``23'' for a temporary importation bond
entry, etc. These codes are ones customs brokers and self-filers
provide to CBP at entry.
For prior notice submissions made through the FDA PNSI, applicable
entry types will be provided for selection in a drop-down menu; e.g.,
consumption, IT, T&E, mail, FTZ, etc. Explanations of the different
entry types are available on PNSI to help the transmitter choose the
right one. There also is guidance posted on FDA's Web site located at
http://www.cfsan.fda.gov/~pn/pnentgui.html that describes the entry
types and the entry identifiers (Sec. 1.281(a)(4) and (c)(3))
associated with those entry types.
(Final Rule) The final rule in Sec. 1.281(a)(3), (b)(3), and
(c)(3) requires submission of the entry type. For articles arriving by
international mail (Sec. 1.281(b)(3)), the entry type will always be a
mail entry.
5. The CBP Entry Identifier (e.g., the Customs ACS Entry Number or In-
Bond Number)
Sections 1.281(a)(4) and (c)(4) of the IFR require the submission
of the CBP entry identifier (e.g., CBP entry number or in-bond number),
if available. This requirement does not apply to articles arriving by
international mail, nor to those carried by or accompanying an
individual, unless entry is otherwise required by CBP and an associated
CBP entry identifier has been assigned. In these cases, the FDA PNSI
will apply a system-generated entry identifier.
(Comments) One comment suggests that PNSI should be modified to
allow for use of the house air waybill as a CBP identifier.
(Response) FDA disagrees. The CBP entry identifier information is
necessary for proper identification of the information in a prior
notice with the appropriate articles for inspection. The submission of
the entry identifier also is critical for matching the prior notice to
the corresponding CBP entry, which is necessary to assess the adequacy
of the prior notice when shipments arrive and are presented for review.
For in-bond entries and FTZ admissions, and for prior notices
submitted through the FDA PNSI, an entry identifier is critical for
matching the prior notice to the corresponding CBP entry if a
consumption entry is submitted so FDA and CBP can ensure that prior
notice requirements were satisfied. FDA does not agree that the
waybill/Bill of Lading can be used as a CBP identifier, nor do we
believe that there is a problem with obtaining a CBP identifier. If the
submitter does not have a CBP identifier, a system-generated entry
identifier can be provided upon request. The Airway Bill number and
Bill of Lading number is a separate data element found in the planned
shipment information (Sec. 1.281(a)(17)(i)). A Bill of Lading number
is not always assigned to a shipment at the time of prior notice
submission. For certain shipments, such as those sent by international
mail, no Bill of Lading may exist. Thus, FDA has determined that we
cannot allow for the use of the house air waybill number as a CBP
identifier.
(Comments) Two comments request clarification of the CBP entry
identifier data element and where it can be located.
(Response) For transmitters submitting prior notice with CBP entry
information through the ABI/ACS interface, the CBP entry number
assigned by CBP is also the entry identifier. For customs brokers or
self-filers submitting prior notice for a food entering the United
States as an IT entry, a T&E entry, or FTZ admission, the CBP in-bond
number or FTZ admission number assigned by CBP also is the entry
identifier. If prior notice is being submitted through PNSI, the entry
identifier will depend on the entry type and the reason for the Web
submission. If available to the transmitter (e.g., the prior notice is
for a CBP entry but the ABI/ACS interface is not available), the CBP
entry number must be used. When appropriate, the in-bond number must be
used as the entry identifier. If one of the entry identifiers described
above does not exist, the transmitter can request a system-generated
entry identifier.
There is guidance posted on FDA's Web site at http://
www.cfsan.fda.gov/~pn/pnentgui.html that describes the entry types and
the entry identifiers (Sec. 1.281(a)(4) and (c)(4)) associated with
those entry types.
(Final rule) The final rule requires in Sec. 1.281(a)(4) and
(c)(4) the CBP entry identifier (e.g., CBP entry number or in-bond
number), if available.
6. The Product Identity
Section 801(m)(1) of the Bioterrorism Act requires that a prior
notice must contain the identity of the article of food being imported
or offered for import. Section 1.281 (a)(5), (b)(4), and (c)(5) of the
IFR requires the identity of the article of food being imported or
offered for import, as follows: the complete FDA product code; the
common or usual name or market name; the estimated quantity of food
that will be shipped, described from largest container to smallest
package size; and the lot or code numbers or other identifier of the
food if required by the act or FDA regulations; e.g., low-acid canned
foods, at Sec. 113.60(c) (21 CFR 113.60(c)); acidified foods, at Sec.
114.80(b) (21 CFR 114.80(b)); and infant formula, at Sec. 106.90 (21
CFR 106.90).
(Comments) One comment suggests that the definition of ``article of
food'' should be amended to eliminate quantity and product code as
distinguishing factors that require a separate prior notice and that
separate prior notices should be based on the uniformity of entry level
food data. The comment further asserts that the integrity, or lack
thereof, of the food product will not be compromised based on the
product type, size and/or quantity.
(Response) FDA disagrees. FDA continues to believe that estimated
quantity, including base units and total quantity, is a necessary
component of product identity. This information is important for
communications with FDA and CBP staff at the border and for
examinations to determine whether the amount ordered matches the amount
received. For example, as discussed in the preamble to the IFR, if more
was received than was ordered, FDA guidance recommends an investigation
to determine the cause of the discrepancy as additional and unwanted
articles may have been added to intentionally contaminate the shipment
(68 FR 58974 at 59005). If less product is received than ordered or
than shipped, some of the product may have been intentionally diverted.
Moreover, the agency's risk-based decisions are based upon the food
type and size of that product as many foods are
[[Page 66344]]
processed differently and the health-based problems result from these
differences. For example, a manufacturer may have two different low
acid canned food (LACF) production lines that are used for filling and
sealing different size cans. A problem with pulling a vacuum on one
LACF line may cause the food in those size cans to become adulterated;
this would not apply to the cans sealed on the other LACF line. FDA
would be able to target shipments from this manufacturer for the size
cans that may similarly be adulterated. As stated previously, the PNSI
system also allows for automatic repeating of like information (e.g.,
identity of the manufacturer), which decreases repetitive entry of
information that is the same for multiple articles of food within a
shipment. This also can be accomplished with submission via ABI/ACS,
dependent on the filer's own software.
(Comments) One comment requests clarification of the interpretation
pertaining to gift packs. The comment asserts that CBP currently
processes gift packs according to the description of the entire gift
pack as an entity. The comment asks if prior notice is required on the
individual items within the gift pack. Another comment recommends that
FDA show flexibility and further develop policies that do not create
excessive costs for exporters who are shipping multiple food products
in the same package.
(Response) A gift pack may contain various articles of food subject
to prior notice requirements. In addition, a gift pack may also contain
various nonfood articles that are not subject to prior notice
requirements. A package with multiple food products, though not a gift
pack, is another example of various articles of food. A prior notice is
required for each article of food, even when multiple articles of food
are designated as a gift pack or are otherwise packaged together.
There is no CBP rule or regulation nor is there a General Rule of
Interpretation (GRI) under which gift packs are classified for tariff
purposes. In the case of ``gift packs'' that contain multiple products,
for entry purposes, CBP will try to classify the gift pack using the
concept of a set. That is, if the products included in a gift pack are
part of a common activity, the gift pack may be classified under the
HTS code that is most applicable. However, CBP does not consider eating
to be a common activity even when all items in a gift pack are to be
consumed. Therefore, unless there has been an applicable CBP ruling,
entries of gift packs should be declared to CBP using the HTS code for
each item included with the gift pack. This would apply even when there
are food and nonfood items in the pack; e.g. a soup mug and a can of
soup, as well as for make-your-own gift packs; e.g., if you created a
gift pack by selecting individual items from a list of available
products.
The final rule requires a prior notice submission for each article
of food. As we explained in the preamble to the IFR, an ``article''
refers to a single food that is associated with the same complete FDA
Product Code, the same package size, and the same manufacturer or
grower (68 FR 58974 at 59003). Moreover, the ``packer'' of a gift pack
is not the facility that manufactured/processed the food pack.
Therefore, each article of food in a gift pack must be covered by a
separate prior notice. However, the Prior Notice Final Rule Draft CPG,
published elsewhere in this issue of the Federal Register, describes
our proposed enforcement policy for gift packs purchased or otherwise
acquired by an individual and imported or offered for import for
nonbusiness purposes. This draft guidance states that for these types
of gift packs FDA and CBP staff should typically consider not taking
regulatory action if there is a prior notice violation because a single
prior notice is submitted for a gift pack and the identity of the
facility that packed the gift pack is submitted in lieu of the identity
of the manufacturer(s) and/or grower(s) for each article of food within
the gift pack.
(Comments) One comment states that the regulations should require a
separate prior notice for each HTS number in the container and that a
detailed description of the product is not necessary.
(Response) FDA disagrees. For prior notice to accomplish its
intended purpose and help FDA protect American consumers, a more
precise description of the product is necessary than that provided by
the HTS number. As we explained in the preamble to the IFR, although
the HTS codes are currently utilized by CBP and FDA to identify
generally which imports are subject to an FDA admissibility review,
these codes are often not sufficient to specifically identify a product
for FDA decisionmaking. For example, in many cases, the tariff code
does not describe how the product was processed (e.g., commercially
sterile or shelf-stable) or how the product is packaged. Thus, several
products that FDA considers different from each other (because these
differences affect the potential safety of the food) may be combined
under one HTS code. (See 68 FR 58974 at 59004.) Moreover, the HTS code
has never been sufficient for FDA admissibility decisions; at entry,
the FDA product code has been required on FDA-regulated products.
Therefore, the FDA product code should be familiar to most submitters
of prior notice. Prior notice requires that we now get this information
before arrival of the article of food into the United States.
(Comments) One comment asserts that FDA has issued an interim final
regulation that requires prior notice needlessly. The comment provides
an example of a container containing red wine, under 14 percent alcohol
and in multiple varietals and sizes from the same manufacturing
facility and asserts that multiple prior notice submissions should not
be required.
(Response) FDA disagrees. For prior notice to accomplish its
intended purpose and help FDA protect American consumers, a prior
notice must be submitted for each article of food. If the food is
identified by a single FDA product code, size, and manufacturer, then
only one prior notice is required. Currently there are only seven FDA
product code designations covering wine: White/still, red/still, rose/
still, naturally carbonated sparkling, artificially carbonated
sparkling, Champagne, and wine coolers. The identity of the size of the
article of food is covered under the requirement to submit the
estimated quantity of the article of food (see Sec. 1.281(a)(5)(iii),
(b)(4)(iii), and (c)(5)(iii)). In the previous example, although the
shipment contains only red wine from the same manufacturer, there are
different sizes of bottles within the container and each package size
requires a separate prior notice. The reason is that a problem in
sealing one size bottle of wine, but not the other size bottles, may
result in serious adverse health consequences. As we explained in the
preamble to the IFR, FDA believes that package size is necessary and
part of product identity. Moreover, the base unit of measure is a
characteristic of product identity and is thus necessary for effective
review of the prior notice information. Base unit is critical to
processing safety requirements and is particularly important when
evaluating the safety of low-acid canned foods (68 FR 58974 at 59005).
(Comments) One comment requests that a single prior notice should
cover one commodity and alternately suggests that a single prior notice
be required for each FDA Product Code. As an example, the comment
suggests that a separate prior notice is required for each size of
apples in a load with 10 sizes of apples representing one FDA Product
Code.
[[Page 66345]]
Another comment suggests that all products covered by the same FDA
product code should require a single prior notice entry.
(Response) A separate prior notice is required for each article of
food represented in a shipment or a load. In the example of different
sizes of apples, because apples are identified by one FDA Product Code,
and assuming that all the apples represent the same grower, if known,
and the remainder of the required information is the same for all the
apples, then one prior notice would be sufficient. However, if the
articles of food represent the same FDA product code but contain
different package sizes, then these are different articles of food and
a separate prior notice is required for each.
(Comments) One comment states that prior notice would need to be
submitted for each brand, and then each bottle size and format.
(Response) In response to comments to the proposed rule, FDA
determined that the brand is not critical for risk-based screening and
the IFR did not require identification of the brand of the article of
food. This determination has been retained in the final rule.
Identification of the size of the article of food is covered under the
requirement to submit the estimated quantity of the article of food
(see Sec. 1.281(a)(5)(iii), (b)(4)(iii), and (c)(5)(iii)).
a. The complete FDA product code. FDA's product code is a unique
numeric code currently used by FDA and customs brokers and self-filers
to describe food products, as well as other products regulated by FDA.
The IFR requires in Sec. 1.281(a)(5)(i), (b)(4)(i), and (c)(5)(i), the
complete FDA Product Code be submitted.
(Comments) Several comments ask for clarification about the
appropriate FDA product code to use for specific products and for
guidance concerning specific types of products. Several comments
request that the FDA Product Code Builder be translated into various
foreign languages. Two comments request clarification regarding the
appropriate product code for gift packs. One comment requests that
submitters be advised of the correct product code for foods subject to
prior notice requirements.
(Response) The final rule does not attempt to clarify appropriate
coding for specific products. The FDA product codes are frequently
updated, revised and changed. The active codes are available in the FDA
Product Code Builder at http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/
PCB.HTM. The FDA Product Code Builder also contains many synonyms for
foods covered by the same product code designations; e.g., Rice Flour
(FDA Product Code 02C-01) has the synonyms of Bot Gao (Vietnamese rice
flour), Harina De Arroz (Latin American rice flour), and Joshinko
(Japanese fine, white rice flour, used to make taffy-like sweets). At
this time due to resource constraints, FDA does not plan to translate
the FDA Product Code Builder into foreign languages. A product code
builder tutorial is available at http://www.cfsan.fda.gov/~pn/pcb-
tut.html.
As stated previously (see the discussion on the identity of the
article of food being imported or offered for import), a gift pack is
not a single article of food, but multiple articles of food packed
together. Each article of food in a gift pack must be covered by a
separate prior notice with an FDA product code for each article.
However, FDA is proposing an enforcement policy whereby FDA should
typically not take regulatory action if a single prior notice is
submitted for a gift pack. More details about this proposed enforcement
policy are described in the Prior Notice Final Rule Draft CPG,
published elsewhere in this issue of the Federal Register.
b. The common or usual or market name. The IFR in Sec.
1.281(a)(5)(ii), (b)(4)(ii), and (c)(5)(ii) requires the submission of
the common or usual name or market name of the article of food as an
element of the identity of the article of food. (See 21 CFR 102.5 for
additional information about common or usual names.)
(Comments) Several comments ask for clarification about the
appropriate common, usual, or market name to use for specific products
and for guidance concerning specific types of products. One comment
asks if a sufficient common, usual, or market name would be the name or
names of products listed in the FDA Product Code Builder.
(Response) The final rule does not attempt to clarify appropriate
common, usual, or market names for specific products. The FDA Product
Code Builder contains many synonyms, which are common, usual, or market
names, for foods covered by the same product code designations; e.g.,
FDA Product Code 16A--4 Ocean Perch is also known as Pacific Perch, Red
Perch, Red Rockfish, and Rosefish. Therefore, anyone needing
information about the appropriate common, usual or market name to use
should consult the FDA Product Code Builder, which is accessible at
http://www.cfsan.fda.gov/~pn/pcb-tut.html.
c. The estimated quantity of food. The IFR in Sec.
1.281(a)(5)(iii) and (b)(4)(iii) requires the estimated quantity of
food that will be shipped, described from largest container to smallest
package size and for articles of food that have been refused under
section 801(m) of the act in Sec. 1.281(c)(5)(iii), the quantity of
food that was shipped, described from largest container to smallest
package size.
(Comments) Several comments recommend elimination of the submission
of quantity for each article of food, and recommend that such
situations involving various sizes and quantities of similar articles
of food (e.g., same FDA product code and same manufacturer) be covered
by one prior notice submission.
(Response) FDA disagrees. FDA continues to believe that quantity is
a necessary component of product identity. FDA also believes that
package size is a necessary part of product identity. The base unit of
measure is a critical characteristic of product identity and is thus
necessary for effective review of the prior notice information. Base
unit also is critical to processing safety requirements and is
particularly important when evaluating the safety of low-acid canned
foods. Both base unit and total quantity (which includes knowing the
smallest ``package size'') are necessary for response (examination) and
communication with FDA and CBP staff at the port. As noted in FDA's
``Food Security Preventive Measures Guidance for Importers''
(``Guidance for Industry, Importers and Filers, Food Security
Preventive Measures Guidance,'' March 2003), these elements are also
critical for food security examinations to determine if the amount
ordered is the amount received. For example, if more was received than
was ordered, the guidance recommends an investigation to determine the
cause of the discrepancy, as additional and unwanted articles may have
been added to intentionally contaminate the shipment. If less is
received than ordered or than shipped, some of the food may have been
intentionally diverted. Both base unit and total quantity are currently
data elements that can be submitted via ABI/ACS to OASIS.
(Comments) One comment asks for clarification as to the
requirements in Sec. 1.281(a)(5)(iii) and (b)(4)(iii) for estimated
quantity and the requirement in Sec. 1.281(c)(5)(iii) for the actual
quantity.
(Response) The requirement for providing estimated quantity in
Sec. 1.281(a)(5)(iii) and (b)(4)(iii) apply to those prior notices
provided in accordance with the requirements in the final rule; i.e.,
those submitted before the food arrives at the port of arrival in
[[Page 66346]]
the United States as required in Sec. 1.279. The requirement for
providing the actual quantity in Sec. 1.281(c)(5)(iii) applies only to
those articles of food refused under section 801(m) of the act, i.e.,
prior notices submitted after the article of food has arrived at the
port of arrival without adequate prior notice and has been refused. In
this case, since the article of food already has arrived, the quantity
is set and the actual quantity can be determined and submitted in the
post-refusal prior notice.
(Comments) One comment asserts that a slide entitled ``Article of
Food vs. Shipment of Food'' in an FDA presentation about the IFR
provides a conflict of interpretation about the requirement to provide
the estimated quantity. The comment asserts that the illustration
suggests a separate prior notice is required for each and asks that FDA
clarify this presentation.
(Response) The illustration in question (see http://
www.cfsan.fda.gov/~dms/fsbtac17/sld014.htm) provides the following
example:
| Tuna | 24/12 oz. cans |
2,000 cases |
Company 1 |
| Tuna | 48/6 oz. cans |
1,000 cases |
Company 1 |
| Tuna | 24/12 oz. cans |
300 cases |
Company 2 |
| Tuna | 6/66 oz. cans |
2,400 cases |
Company 3 |
1 One shipment; 4 different products; 4 prior notices
FDA reiterates that the previously shown chart illustrates a
situation with four different articles of food, each requiring a
separate prior notice. The example provides three different
manufacturers of the canned tuna; thus, canned tuna from each of these
manufacturers requires a separate prior notice submission. Further, the
12 ounce (oz) cans and the 6 oz cans manufactured by Company 1 are
different sizes and thus are different articles of food. Accordingly,
each requires a separate prior notice submission.
The final rule continues to require submission of the estimated
quantity of food that will be shipped, described from largest container
to smallest package size. A prior notice will not be inadequate if the
estimated quantity changes between the confirmation of prior notice and
the time of arrival. Similar to the IFR, the final rule does not
require that a prior notice be cancelled and resubmitted if the
estimated quantity changes after confirmation.
d. The lot or code numbers or other identifier. The IFR in Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) requires the submission of
the lot or code numbers or other identifier of the food if required by
the act or FDA regulations; e.g., low-acid canned foods, at Sec.
113.60(c); acidified foods, at Sec. 114.80(b); and infant formula, at
Sec. 106.90.
(Comments) One comment requests clarification concerning when a lot
or code number or other identifier is required for an article of food.
(Response) The lot or code numbers are the identification numbers
or code of a production lot, which can more specifically identify a
product for screening and examination purposes and for communication
within FDA and with CBP and the manufacturer, etc. For example, recalls
involving serious health risks are often associated with a specific
production lot, such as counterfeit infant formula or under-processed
canned food. FDA screening can target these food products for
examination based on information of public health emergencies or
recalls in foreign countries.
FDA regulations require lot/code identifiers for certain foods.
Currently, low acid canned foods, acidified foods, and infant formula
are required to bear lot codes or other identifiers (see Sec.
113.60(c) (low-acid canned foods); Sec. 114.80(b) (acidified foods);
and Sec. 106.90 (infant formula low-acid canned foods)). The interim
final and final rules require lot/code or other identifiers only for
these kinds of articles of foods. Many other foods may have lot or code
identifiers that are not required by FDA regulation; submission of
these identifiers is optional under the final rule.
Submission of the required lot/code identifier is accommodated by
ABI/ACS as an affirmation of compliance or through PNSI as a production
identifier. ACS currently allows for submission of more than one
affirmation of compliance per article of food. PNSI also accepts more
than one lot identifier per article of food.
(Final rule) The final rule requires in Sec. 1.281(a)(5)(i),
(b)(4)(i), and (c)(5)(i) the complete FDA product code. The final rule
in Sec. 1.281(a)(5)(ii), (b)(4)(ii), and (c)(5)(ii) requires the
submission of the common or usual name or market name of the article of
food as an element of the identity of the article of food. The final
rule in Sec. 1.281(a)(5)(iii) and (b)(4)(iii) requires the estimated
quantity described from the largest container to the smallest package
size. For articles of food that have been refused under section 801(m)
of the act, the final rule in Sec. 1.281(c)(5)(iii) requires
submission of the quantity of food that was shipped, described from
largest container to smallest package size. The final rule in Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) requires the submission of
lot or code numbers or other identifiers for articles of food if
required to bear such numbers by the act or by FDA regulations.
7. Identity of the Manufacturer
Section 801(m)(1) of the act states that a prior notice must
contain the identity of the manufacturer of the article of food being
imported or offered for import. Section 1.281(a)(6), (b)(5), and (c)(6)
of the IFR requires that prior notice for an article of food that is no
longer in its natural state include the name and address of the
manufacturer and the registration number assigned to the facility that
is associated with the article of food. The IFR further states that a
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage, and export, or further manipulation and export.
The IFR also provides that if the article of food is sent by an
individual as a personal gift (i.e., for nonbusiness reasons) to an
individual in the United States, he or she may provide the name and
address of the firm that appears on the label under 21 CFR 101.5
instead of the name, address, and registration number of the
manufacturer. If a registration number is provided, city and country
may be provided instead of the full address.
FDA received many comments on the requirement to provide the name,
address and registration number, when applicable, as the identity of
the manufacturer. For ease in discussing these comments, we are
presenting the issues they raise into the following general categories:
<bullet> Does ``the manufacturer'' in section 801(m) of the act
mean the place where the food was actually manufactured or can it
include other entities? What if more than one entity was involved in
the manufacture of the article of food?
<bullet> Does FDA have the authority to require the registration
number of the manufacturer of the article of food being imported or
offered for import as a data element in prior notice?
<bullet> Assuming FDA can require the manufacturer's registration
number in a prior notice submission, should FDA continue to do so in
the final rule and/or should FDA provide an alternative means for
submitters to provide the identity of the manufacturer? and
[[Page 66347]]
<bullet> Questions Seeking Clarification.
a. Does ``the manufacturer'' in section 801(m) of the act mean the
place where the food was actually manufactured or can it include other
entities? What if more than one entity was involved in the manufacture
of the article of food? (Comments) Section 1.281(a)(6) of the IFR
requires the submission of the identity of the manufacturer of each
article of food no longer in its natural state. Several comments
recommend that the final rule define ``the manufacturer.'' Some
comments note that for ``gray market'' or ``parallel market''
importations (food purchased outside the manufacturer's distribution
chain and imported to the United States), the only identifiable product
information is that which is on the product itself. The comments
suggest that in lieu of the name, address, and registration number of
the manufacturer of the food, the prior notice submission should
include the name and address of the entity that appears on the label on
the food. A comment notes that while this information is not as
detailed as that required for other imports, it relieves importers of
``gray market'' foods from having to provide information that in most
instances would never be available to them. Other comments suggest that
shipments of gifts to individuals but with a commercial purpose, such
as business gifts to generate goodwill among colleagues, should be
permitted to reference the manufacturer's name and address as shown on
the label in lieu of the registration number of the manufacturer.
Several comments request that FDA provide guidance regarding how to
complete prior notice for imported food from multiple manufacturing
facilities. One comment suggests that the final rule should define the
manufacturer as the last entity to conduct a processing operation;
e.g., including bottling, but excluding labeling. Another comment
provides an example of wine that is produced and bottled at winery
``X'' and sent to winery ``B'' for labeling, which sends the wine to
another facility for storage, which then transfers the wine to the
freight forwarder ``F'' who stores and consolidates the wine with other
wines for shipment to the United States. Another comment provides an
example of fresh fruit that is processed in one facility in a foreign
country and then is transported to one or several other facilities that
re-palletize the fruit, resulting in a finished pallet containing boxes
that have been packaged at several packing facilities.
(Response) These comments address, directly or indirectly, the
meaning of ``the manufacturer'' in section 801(m) of the act. In
construing the prior notice provision of the Bioterrorism Act, FDA is
confronted with the question of whether Congress has directly spoken to
the precise question presented (``Chevron step one''). Chevron, U.S.A.,
Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984). To find no ambiguity,
Congress must have clearly manifested its intention with respect to the
particular issue. Young v. Community Nutrition Institute, 476 U.S. 974,
980 (1986). If Congress has spoken directly and plainly, the agency
must implement Congress's unambiguously expressed intent. Chevron, 467
U.S. at 842-843. If, however, the Bioterrorism Act is silent or
ambiguous as to the meaning of ``the manufacturer,'' FDA may define
this term in a reasonable fashion (``Chevron step two''). Chevron, 467
U.S. at 842-843; FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
132 (2000).
We have determined that in enacting section 801(m) of the act,
Congress did not clearly manifest its intention with respect to the
meaning of ``the manufacturer.'' When an article of food is made from
one or more raw ingredients, there could be several entities involved
in its manufacture. For example, boxed macaroni and cheese might
involve preparing the dried macaroni, preparing the dried cheese,
combining these materials, and packaging and labeling the finished
product. Where multiple steps are carried out by multiple entities, the
act does not directly and plainly set forth which entity or entities
Congress intended as the manufacturer to be submitted as part of the
prior notice. Another question regarding ``the manufacturer'' whose
answer is not clearly manifested in the act is whether the manufacturer
means the specific facility where the article is manufactured or the
entity that owns, or contracts with, the manufacturing facility.
Additionally, Congress did not plainly address whether the entity
listed on a product's label could be considered the manufacturer. The
entity listed on a product's label can be, as provided by 21 CFR 101.5,
the packer or distributor. Additionally, under that regulation, the
label may state the principal place of business of the manufacturer,
packer, or distributor in lieu of the actual place where the food was
manufactured or packed or is to be distributed, unless the statement
would be misleading.
For the reasons given in the following paragraphs, we have
determined that, for purposes of section 801(m) of the act, the phrase,
``the identity of the manufacturer,'' should be interpreted to mean the
place where the food was actually manufactured/processed (i.e., the
site-specific manufacturing facility). We believe that this
interpretation is reasonable and consistent with the goals of the
Bioterrorism Act.
In considering whether it is reasonable to interpret the
manufacturer as being the actual place where the food was manufactured,
we considered the language and purpose of the prior notice provision,
as well as the other provisions of the Bioterrorism Act. The purpose of
the Bioterrorism Act is ``to improve the ability of the United States
to prevent, prepare for, and respond to bioterrorism and other public
health emergencies'' (Public Law 107-188). The prior notice provision
contributes to this goal by providing the agency with the information
it needs to determine whether, due to significant concerns about an
article of imported food, it should inspect the food upon arrival in
the United States. Having the identity of the actual place where the
food was manufactured (i.e., the site-specific manufacturing facility)
will inform these risk-based decisions much better than having the
identity of the packer or distributor or even the name and address of
the manufacturer's principal place of business.
Information about the manufacturer contributes to FDA's inspection
decisions under prior notice in two principal ways. One way is that
when FDA receives intelligence regarding potential areas of concern
about food shipments, this intelligence is often linked to a site-
specific manufacturing facility. For example, FDA received intelligence
regarding alleged contamination with a harmful chemical substance of
certain imported food products from a certain specific foreign
manufacturing facility. FDA flagged shipments from this facility for
further PNC review, and subsequently recommended the examination and
sampling of several shipments from the site specific facility due to
the significant public health threat posed by the articles of food.
Because the identity of the site-specific manufacturing facility was
included in the prior notices, FDA was able to match the intelligence
with the relevant food shipments, without affecting the importation of
similar products from other manufacturers. If prior notice only
included the name and address listed on the label, FDA could not have
confidence that it could flag shipments of the food manufactured at the
specific facility, either for further PNC review or for inspection.
Matching a third-party distributor or packer with the actual
manufacturer that FDA wants to flag
[[Page 66348]]
based on intelligence would be very difficult and time consuming, and
may even be impossible to do with the information available to the
agency. If prior notice included the principal place of business of the
manufacturer (e.g., the corporate headquarters location) instead of the
site-specific manufacturing facility, FDA's ability to correctly target
shipments would not be much better. More often than not, when FDA
receives intelligence regarding a manufacturer, it is specific to the
site-specific manufacturing facility and not just the manufacturer's
corporate identity. In these situations, if the prior notice that has
been submitted contains only corporate-level information, FDA would
have to target every relevant shipment from every plant the firm owns
or contracts with, which could be dozens, or even hundreds. As a
result, much time would be spent unnecessarily reviewing many shipments
that may not be of interest but whose risk could not be discounted
based on the supplied manufacturer information.
The other way information about the manufacturer contributes to
FDA's inspection decisions under prior notice is the agency's use of
this information during its manual review of a prior notice. Regardless
of the reason a shipment is flagged for manual review by the PNC, the
identity of the manufacturer is one of the key elements FDA relies on
in further assessing the potential risk a shipment poses to the United
States. FDA does this by using the identity of manufacturer, as
provided in prior notice, to gather additional information from a
variety of sources, such as FDA's and other government agencies'
databases and research using publicly available information. For
example, FDA will often try to determine whether the article of food
being imported is consistent with the type or types of food the
facility usually makes and ships to the United States, whether the
facility's owners, agents, or workers have potential ties to security
concerns, and whether FDA has found problems with prior shipments from
the facility. The more closely that this information is tied with the
site-specific manufacturing facility, the more reliable the risk
assessment will be. If prior notice could include the name and address
of the firm on the label (in lieu of the site specific manufacturer),
and this firm is the product's distributor, then FDA would be able to
gather additional information about the distributor but not the
manufacturer. A risk assessment based on information concerning the
distributor would be much less meaningful than one based on the actual
manufacturer because the actual manufacturer has much more control over
the product's quality and security than the product's distributor.
For example, when researching the site-specific manufacturer listed
in a prior notice to investigate potential security concerns, FDA found
information in a government database suggesting the facility had ties
to terrorism. Based on this and other information, FDA decided to
examine the product covered by the prior notice. If the name and
address of a different firm, such as the distributor, had been provided
in the prior notice instead, it is unlikely that FDA's research would
have turned up this association and unlikely that this shipment would
have been flagged for inspection. In its experience under the IFR, when
prior notice has not included the identity of the actual manufacturer,
FDA has had to attempt to determine the site-specific manufacturer by
using alternative means such as inspection, contacting the submitter,
and/or contacting the firm listed on the label, a process that in some
cases has taken days and even weeks. The only other way to be sure that
the subject article of food is not a threat is to have the food stopped
and examined at the port of arrival to determine if it is a threat.
Stopping shipments while FDA conducts additional research or an
inspection would require significant agency resources and could create
inefficiencies for the agency, CBP, industry, and consumers as food
shipments back-up at the border.
Similarly, if the prior notice included the principal place of
business of the manufacturer rather than the specific manufacturing
facility, this information is likely to be too broad to be helpful,
particularly if it is a large company. Each manufacturing facility is
different, in terms of its employees, the food it manufactures for the
United States, its manufacturing processes, and its security standards
and procedures. One location of a company may have a higher standard
for the security of its employees and manufacturing processes than
another location. In those cases where the parent company owns or
contracts with multiple manufacturing facilities, FDA would have to
determine the risk associated with each of these facilities to ensure
our review is adequate. Because FDA is under strict timeframes to
review, assess risk, and respond to the prior notices, conducting such
wide-ranging research is not practical. Not only would this be
prohibitively time-consuming (which would have a detrimental impact on
trade), in many situations FDA may not be able to ascertain the
identity of each of the firm's manufacturing facilities. Alternatively,
FDA could attach a risk to the headquarters location, but doing so
would result in a less meaningful prior notice risk assessment and may
result in articles of food being assigned a lower or higher risk than
they should have based on the specific manufacturing facility.
Our interpretation of ``the manufacturer'' to mean the actual place
where the food was manufactured also furthers the purposes of the
Bioterrorism Act by helping to ensure that imported food is from
registered facilities. Under section 801(l) of the act, food that is
imported or offered for import is subject to being held if it ``is from
a foreign facility for which a registration has not been submitted to
[FDA] under section 415'' of the act. FDA checks the information about
the site-specific manufacturing facility provided in prior notice to
verify that facility's registration status. If the prior notice
provided only the name and address listed on the label of the food
rather than the actual manufacturing facility, FDA would have no
practicable means to readily determine whether the manufacturing
facility is registered. As explained previously, the name and address
on the label could be, for example, the distributor or the parent
company of the facility.
Collecting information regarding the manufacturing facility of an
imported product and its registration status goes back to well before
prior notice. As part of the admissibility review process for the
various types of imported goods it regulates, FDA collects, among other
information, the ``FDA Manufacturer'' and applicable registration
numbers. (See, for example, 70 FR 69576, November 16, 2005.)
The Bioterrorism Act expanded the registration requirement with
respect to food facilities. New section 415 of the act requires
domestic and foreign facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United States to be
registered with FDA, unless the facility is exempted. Under new section
801(1) of the act, food from a foreign facility that has not registered
under section 415 of the act is subject to being held until the foreign
facility has registered. It could be argued that FDA should make its
determination about the food manufacturing facility's registration
status as part of the entry and admissions process. The reason it is
necessary to make this determination at the time FDA is reviewing prior
notice
[[Page 66349]]
is that if the article of food is held under section 801(l) of the act,
it may not be delivered to the importer, owner, or consignee and cannot
be moved under bond under section 801(b) of the act. Operationally, the
only way to implement these movement restrictions is to conduct the
registration status review before entry is filed, which is when the
prior notice review is conducted.
The comments recommending that the prior notice rule be expanded to
allow the identity of the entity shown on the product label in lieu of
the identity of the manufacturer are generally based on the argument
that information about the manufacturer, especially its registration
number, is not always available to the submitter, such as when food is
purchased outside the manufacturer's distribution chain. The statute
indicates that Congress considered the issue of whether it would be
difficult or impossible to provide the identity of the manufacturer but
chose to require it nonetheless. Among the data required by prior
notice are the identity of the manufacturer and, for food in its
natural state, the identity of the grower, if known. Section 801(m) of
the act expressly provides that the identity of the grower does not
need to be submitted if it is not known within the prior notice
timeframes; however, the act does not include this exemption for the
identity of the manufacturer. This indicates that this information
about the manufacturer must be submitted regardless of any potential
difficulties in obtaining it. With respect to the comments that were
concerned about situations where the person submitting prior notice
does not know the registration number of the manufacturer, as discussed
elsewhere in this preamble, FDA and CBP are modifying the final rule
such that the identity of the manufacturer can be submitted as the name
of the manufacturer and either the registration number, city, and
country of the manufacturer, or both the full address of the
manufacturer and the reason the registration number is not provided.
Regarding situations where multiple steps are carried out by
multiple entities, we have determined that ``the manufacturer'' can
reasonably be interpreted to mean the last facility that manufactured/
processed the article. A facility is the last facility that
manufactured/processed the food if the food does not undergo further
manufacturing/processing, other than the addition of labeling or any
similar activity of a de minimis nature. This interpretation is based
on the definition of a foreign manufacturer under the food facility
registration provision, section 415(b)(3) of the act, and our
implementing rule, 21 CFR part 1, subpart H (see specifically
Sec. Sec. 1.227(b)(2) and 1.226(a)). It also is consistent with the
definition of FDA manufacturer collected as part of the entry and
admissibility process, which states that if more than one party
processed the article, then the manufacturer is the last party who
substantially transformed the product. (See, for example, 70 FR 69576,
November 16, 2005.)
Applying this definition to the example pertaining to wine in the
comments, the manufacturer for purposes of prior notice would be winery
``X'' since this is the facility that produced and bottled the wine.
The other facilities involved in this example perform either
manufacturing activities of a de minimis nature, such as labeling, or
other activities not related to manufacturing, such as storing and
consolidating the wine. Thus, although some of these facilities might
have to register with FDA as required by 21 CFR part 1, subpart H as
holders or packers of food intended for consumption in the United
States, the facilities in the example other than winery ``X'' are not
considered the last facility under the prior notice final rule's
definition of ``manufacturer.'' Regarding the comment on fresh fruit,
FDA assumes that the comment is using the term ``processed'' to mean an
activity (such as treatment against pests or polishing) that leaves the
food still in its natural state, as explained in the definition of ``no
longer in its natural state'' under Sec. 1.276(b)(10). Although
subsequent facilities palletize the fruit, these would not be
manufacturers because they only pack the food and packing is not
considered manufacturing/processing. Under this scenario, no
information for any manufacturers would be required for the prior
notice. Instead, under Sec. 1.281(a)(7) of the final rule, the prior
notice would require the name and address of the grower, if known.
Consistent with the interpretation that the identity of the
manufacturer requires site-specific information, we are removing the
provision in the IFR stating that if the article of food is sent by an
individual as a personal gift to an individual in the United States,
then the name and address of the firm that appears on the label could
be submitted instead of the identity of the facility that manufactured
the food. We note, however, that under the enforcement policy
contemplated in the Prior Notice Final Rule Draft CPG, FDA and CBP
would typically consider not taking regulatory action when no prior
notice is submitted with respect to gifts that are shipped by an
individual to an individual.
Given the importance of having the site-specific manufacturer, we
are also proposing a change to the CPG regarding the identity of the
manufacturer. The Prior Notice Interim Final Rule CPG had a policy that
covered situations where, after a good faith effort, the person
submitting prior notice did not know the name and address of the
facility that manufactured the food. It stated that if the submitter
provided certain alternative information, such as the identity of the
facility's headquarters, FDA and CBP should typically consider not
taking any regulatory action despite this noncompliance with the prior
notice requirements. The Prior Notice Final Rule Draft CPG does not
continue this policy because, as described above, FDA and CBP believe
that knowing the identity of the facility involved in the food's
production is critical to ensuring that FDA can effectively target food
for inspection at the border upon arrival and can effectively determine
whether food should be held because it is from an unregistered
manufacturing facility.
Accordingly, section 1.276(b)(9) of the final rule defines
manufacturer for the purpose of prior notice submission as the last
facility, as that word is defined in Sec. 1.227(b)(2), that
manufactured/processed the food. A facility is considered the last
facility even if the food undergoes further manufacturing/processing
that consists of adding labeling or any similar activity of a de
minimis nature. If the food undergoes further manufacturing/processing
that exceeds an activity of a de minimis nature, then the subsequent
facility that performed the additional manufacturing/processing is
considered the manufacturer. We have removed in the final rule the
option that was in the IFR to provide the label information in Sec.
101.5 instead of the name, address, and registration number of the
manufacturer for food sent by an individual as a personal gift (i.e.,
for nonbusiness reasons) to an individual in the United States. Unless
excepted elsewhere in the regulation, the identity of the manufacturer
must be submitted for an article of food that is no longer in its
natural state.
b. Does FDA have the authority to require the registration number
of the manufacturer of the article of food being imported or offered
for import as a data element in prior notice? (Comments) Many comments
state that the Bioterrorism Act does not require registration numbers
to be submitted in prior notice. Some comments further assert that the
statute clearly states that the ``identity of the manufacturer'' must
[[Page 66350]]
be included for prior notice but it does not allude to nor require the
registration number. Another comment explains that if Congress intended
FDA to require the registration number, it would have specifically
articulated this requirement as it did in section 321 of the
Bioterrorism Act for drug and device imports. The comment concludes
that the failure of the Congress to include registration numbers in the
enumerated statutory elements of prior notice is powerful evidence that
Congress did not intend for FDA to require it. Another comment states
that the act does not prescribe how the identity of the manufacturer
must be provided, and therefore Congress has not spoken to this issue.
Accordingly, FDA is entitled to deference in crafting a permissible
construction of the statutory requirements.
One comment notes that all wineries producing wine for consumption
in the United States are required under section 415 of the Bioterrorism
Act to provide to FDA their name, the street addresses of their
facilities and the trade names under which they do business. It further
states that as long as the importer provides the name and address of
the manufacturer of the wine, this will be sufficient for FDA to
identify whether the manufacturer is registered with the FDA, and that
additionally requiring the importer to furnish a registration number is
unnecessary to implement the Bioterrorism Act.
Another comment asserts that the obligation to verify that the
manufacturer of a food article imported or offered for import into the
United States is registered, or is required to do so, is an obligation
imposed upon the FDA by Congress under the Bioterrorism Act, not upon
the importer. The comment further asserts that for FDA to shift its
burden to importers who are not related to the facilities required to
be registered is, at the very least, unjust and certainly was not the
intent of Congress. The comment further states that FDA has the ability
and access to the information necessary to verify registration status
of manufacturers; unaffiliated importers do not. Another comment
asserts that FDA's overly broad interpretation of the prior notice
provision of the Bioterrorism Act results in an anticompetitive
business environment that is contrary to the spirit of the Bioterrorism
Act. Another comment emphasizes that to enforce the registration
requirement through the means of prior notice requirements, which
affect persons that are completely unrelated to the party responsible
for registering the facility, is inappropriate.
Another comment states that the U.S. Congress placed the burden
upon the FDA to ensure that a facility's owner, operator or agent in
charge complies with the registration requirements established under
the Bioterrorism Act and while it is reasonable for the FDA to request
that importers assist them in this task by asking for facility
registration numbers on prior notice submissions, the agency must not
condition lawful entry on the provision of this number that may, for a
variety of reasons, be unavailable to the importer.
Another comment claims that FDA has no jurisdiction to enforce the
registration requirements upon the affected foreign facilities. Another
comment asserts that domestic food manufacturers are not faced with
this dilemma because they are already within the United States, and
there are no equivalent requirements to verify that domestic foods are
produced at facilities that are properly registered with FDA.
(Response) FDA's position remains that it has the authority to
require the registration of the manufacturer as a data element in prior
notice. Under section 801(m) of the act, prior notice must include the
identity of the manufacturer. The manufacturer's registration number is
an identifier, just as, for example, Employer Identification numbers,
Social Security numbers, and driver's license numbers are regularly
used to help identify establishments and individuals. Such numerical
identifiers are much better for matching than name and address
information alone. For example, names and addresses often do not have
standardize formats, there can be alternative spellings and
abbreviations, and misspellings are not uncommon. In addition, many
facilities have similar names, even facilities in the same country or
city. Unique identifiers are all the more important given the high
volume of prior notices that FDA needs to process, FDA's goal of
processing them expeditiously, and the need to ensure that FDA can
accurately flag shipments of potential concern.
As contemplated by the Registration of Food Facilities rule, Sec.
1.241(c), FDA also uses the identity of the manufacturer collected as
part of prior notice to ensure that imported food is from registered
facilities. Section 801(l) of the act, which was enacted as part of the
Bioterrorism Act, states that if an article of food is being imported
or offered for import into the United States, and such article is from
a foreign facility for which a registration has not been submitted
under section 415 of the act, such article shall be held at the port of
entry for the article, and may not be delivered to the importer, owner,
or consignee of the article, until the foreign facility is so
registered. In the preamble to the IFR, we described how we would use
registration in concert with prior notice to carry out our
responsibilities under section 801(l) of the act ``Registration is
designed to work in concert with prior notice at the border, as
reflected in new section 801(l) of the FD&C Act, which provides that
food from facilities that must register may not be admitted into
distribution for consumption in the United States unless the relevant
facilities have been registered. To enforce section 801(l) of the FD&C
Act as intended by Congress, FDA has determined that it must review
registration status of manufacturers and shippers as part of prior
notice. The information provided by registration will allow FDA to
check prior notice submissions against registration data to confirm the
identity. Moreover, the information provided by prior notice
submissions can serve as a crosscheck as to whether these facilities
are registered as required and have provided the necessary updates * *
*. FDA does not agree that it should confirm registration without
requiring that the number be submitted. Each registered facility will
be assigned a unique registration number by FDA. Thus, the registration
number will help identify the manufacturer. Without a registration
number, it may be difficult to determine exactly which registered
facility to associate with the article: Different firms may have the
same or similar names and more than one firm may operate from a
particular location.'' (68 FR 58974 at 59001). FDA continues to believe
that it should use the information in prior notice to verify the
manufacturer's registration status, and that the registration number is
the simplest and fastest way for us to do this. FDA further notes that
it verifies the registration status of both domestic and foreign
facilities. FDA's procedures for enforcing the registration
requirements for domestic facilities are explained in FDA's
``Compliance Policy Guide--Guidance for FDA Staff, Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002.'' See http://www.cfsan.fda.gov/
~furls/cpgreg2.html.
c. Assuming FDA can require the manufacturer's registration number
in a prior notice submission, should FDA continue to do so in the final
rule and/or should FDA provide an alternative means for submitters to
provide the identity of the manufacturer other than
[[Page 66351]]
the registration number? (Comments) Several comments recommend
elimination of the registration number as a requirement for identifying
the manufacturer of a food no longer in its natural state. One comment
suggests that inclusion of a food facility registration number does not
ensure the legitimacy of the shipment and that a black market for
certain foods could result if registration numbers continue to be
required for prior notice. Many others comments recommend elimination
of the requirement for the manufacturer's registration number in
various situations:
<bullet> The food facility is not required to register because
ingredients or finished goods manufactured by it are not consumed in
the United States, and thus it has no registration number;
<bullet> The manufacturer that has gone out of business and does
not have a facility registration number;
<bullet> Samples for:
Any reason/any type of sample;
Any product samples not intended for public consumption or for
retail sale;
Quality control;
Research;
Analytical samples that are not intended for human or animal
consumption;
Quality assurance samples that will be used for taste testing or
quality control that includes human consumption;
<bullet> Fine wines;
<bullet> Registration numbers of the parties in possession of the
wine over the past 2 years;
<bullet> All wines and distilled spirits, when a registration
number is not available;
<bullet> Wine produced more than 5 years prior to the date of its
import (the year of production is typically indicated on the bottle's
label, and label approvals are required under U.S. Tax and Trade Bureau
regulations);
<bullet> All food produced prior to December 12, 2003;
<bullet> All food sent into the country for the personal
consumption of the recipient and not for business use or
redistribution;
<bullet> Gifts arriving in the United States from one individual to
another in a business setting; and
<bullet> Consumer-to-consumer shipments.
Some comments state that the requirement to provide the
manufacturer's registration number in the prior notice is overly
burdensome and unreasonable for some segments of the food industry. The
comments suggest that there are numerous legitimate reasons that food
companies may seek to import food products from manufacturers whose
registration number is unknown or which are not required to register
with FDA.
Other comments recommend alternatives to the requirement to submit
the manufacturer's registration number. The most commonly recommended
alternative to submission of the manufacturer's registration number is
to allow submitters to identify the manufacturer by providing the name
and address of the facility with an accompanying reason as to why the
registration number was not submitted. One comment specifically
recommends a drop-down menu that allows the submitter to explain the
reason for the lack of a registration number, such as ``product was not
obtained from the manufacturer.'' The comment reasons that this
optional approach allows FDA to continue to require registration
numbers, but does not per se invalidate a prior notice based on the
absence of this single piece of information. Another comment suggests
that the submitter affirm that it believes, to the best of its
knowledge, that the manufacturer is registered with FDA. One comment
recommends that only the manufacturer's name for a ``gray market'' food
should be sufficient for the prior notice when the submitter does not
know the manufacturer's registration number.
Another comment asserts that FDA must consider alternative means
for ensuring that all facilities subject to the Registration of Food
Facilities Rule (21 CFR part 1, subpart H) have an updated registration
on file with FDA that has been verified. The comment further suggests
that taking such action will allow the FDA to ensure that the
regulations are not implemented in a manner that prevents the lawful
import of safe and healthy food products based solely upon the
unavailability of the confidential facility registration number.
Several comments assert that confirmation that a facility is registered
can be made without obtaining the registration number of the facility.
One comment states that, though FDA has indicated that it wants the
new facility registration requirement to be enforced through the prior
notice regime, enforcement can be accomplished without requiring that
the facility registration numbers be included in the prior notice. With
the name and address of the manufacturer included, FDA can look up the
manufacturer in its database of registered manufacturers. If the
manufacturer has not registered, then the FDA could deny entry to the
articles of food in question. The manufacturers therefore already have
a strong incentive to register with the FDA, since that is the only way
their products can gain entry into the United States.
Other comments suggest inspection of a food shipment to ensure its
safety when the prior notice submission lacks the required registration
number, rather than refusal of that food as an acceptable alternative.
The comments state that this approach will avoid situations where
shipments are rejected while still preserving FDA's regulatory
discretion. Another comment states that importers who obtain food from
parties other than the original food manufacturers are willing to bear
the burden of increased inspections when they do not provide a
manufacturer's registration number in the prior notice. Other comments
agree that the manufacturer's registration number should be required in
prior notice submissions, but that the prior notice should not be
deemed inadequate (i.e., the food should not be refused under 801(m) of
the act) if the manufacturer is identified by name and address of the
facility and a reason for lack of submission of the manufacturer's
registration number is provided.
Another comment suggests that the final rule should be amended to
provide that the prior notice only need to include such information
about the manufacturers of older vintage wines that is readily
available to the importer, together with registration numbers for all
persons who have owned the wine and all facilities that have stored the
wine over the preceding 2 years.
One comment suggests that FDA permit the importation of quality
assurance samples that will be used for taste testing or quality
control that includes human consumption without the facility
registration number of the foreign manufacturer or processor. The
comment further suggests that in lieu of the registration number, the
prior notice should include the manufacturer's name and location along
with the identification of the person sending the samples.
While most comments state that the name and address of the
manufacturer could be submitted in prior notice, one comment states
that re-sellers will not normally supply the name of their supplier or
the name of the manufacturer of a particular product to their
customers. The comment asserts that supplying the name of the
manufacturer would allow that customer to circumvent the re-seller and
attempt to make direct contact with the supplier or manufacturer, thus
taking business away from the re-seller. Another comment states that if
only the
[[Page 66352]]
name of the manufacturer is submitted in a prior notice, the prior
notice should not be considered inadequate.
Other comments support requiring the registration number of the
original processor on prior notice submissions, particularly when a
third-party is exporting the product to the United States. One comment
further recommends that FDA should revise its rules regarding the use
of registration numbers in general, and in the prior notice rule in
particular, to protect legitimate buyers and distributors from
unauthorized ``gray market'' imports. Several comments suggest that the
manufacturer's registration number should be required and that only the
registration number be submitted, not the name and country.
Additionally, some comments suggest that if manufacturer and facility
registration numbers are provided and the numbers provided are specific
to a particular facility location, the requirement to complete the
address information should be removed to avoid duplication of
information.
(Response) To effectively implement the prior notice and
registration provisions in the Bioterrorism Act, the final rule
requires the registration number of the manufacturer or, if the
registration number is not provided, the facility's full address and
reason the registration is not provided. Reasons for not providing a
registration number include, for example, the manufacturing facility is
out of business; the manufacturing facility is a private residence and
thus is not a ``facility'' for the purposes of the registration
requirements; and the submitter is unable to determine the registration
number of the manufacturing facility.
Matching of facilities is vital for making an initial assessment on
the accuracy of the prior notice; assessing the risk of the associated
article of food based on the associated manufacturing facility, its
operations, and history of importations; and verifying registration
status. Without the registration number, PNC reviewers have to conduct
this matching using the name and address submitted in a prior notice.
Due to the potential for human error during data input or deviations in
the spelling or format of a facility's name, address or city, FDA may
incorrectly think it has found a match between the facility described
in the prior notice and a facility in the registration database.
Similarly, the facility described in the prior notice may be close, but
not exact, to several facilities listed in the registration database,
causing uncertainty as to which, if any, is the correct match. This is
complicated by the fact that the manufacturing facility submitted as
part of prior notice might not be registered. At best this matching
process may take significantly longer (depending on the number of
manufacturers, products, and other factors involved), impeding FDA's
ability to complete its review within the prior notice timeframes. At
worst, a facility mismatch will result in FDA conducting its risk
assessment based on incorrect information.
The information provided in a registration thus enables FDA to
better assess risk of the product itself, as it gives the PNC more
information upon which to base its assessment. PNC reviewers use the
registration information to verify whether the articles of food in the
shipment match the food product categories that the owner, operator, or
agent-in-charge of the facility listed in the site-specific facility's
registration with FDA. The registration information also provides
alternate names for a facility, lists the parent company and
subsidiaries of the facility, verifies addresses, and provides the
identity of the officers of the facility and/or their U.S. Agents. This
additional information may identify potential terrorist threats (e.g.,
a facility and/or facility official has ties with a terrorist
organization). Not providing the registration number in a prior notice
leads to prolonged or incomplete searches, which in turn could lead to
additional cargo delays or examinations at the port of arrival as the
PNC completes its intensive review (see earlier discussion under
timeframes). We also note that registered facilities generally do not
make their registration numbers public, so they generally have to be
obtained directly from the manufacturer or its designee during the
importation process as part of completing a prior notice. Thus it is
harder to falsify registration information than the facility's name and
address, deterring the submission of false manufacturer identification
information.
In some cases, the registration number of the manufacturer is not
available to the submitter, and therefore, we have revised the rule to
provide an alternate means for satisfying the requirement to provide
the identity of the site-specific manufacturer in prior notices. For
purposes of the prior notice final rule, the identity of the
manufacturer is the name of the manufacturer and either: (1) The
registration number, city, and country of the manufacturer or (2) both
the full address of the manufacturer and the reason the registration
number is not provided (see Sec. 1.281(a)(6), (b)(5), (c)(6)). One of
the following reasons may be submitted when no manufacturer
registration number is provided:
<bullet> Situations where the facility is out of business, as
stated in Sec. 1.235(a);
<bullet> Private residence, as stated in Sec. 1.227(b)(2);
<bullet> The facility is a restaurant, as defined in Sec.
1.227(b)(10), and qualifies for the restaurant exemption in Sec.
1.226(d);
<bullet> The facility is a retail food establishment, as defined in
Sec. 1.227(b)(11), and qualifies for the retail food establishment
exemption in Sec. 1.226(c);
<bullet> The facility is a nonprocessing fishing vessel, as stated
in Sec. 1.226(f);
<bullet> Nonbottled drinking water collection and distribution
establishment, as stated in Sec. 1.227(b)(2);
<bullet> The manufacturer satisfies the definition of ``farm'' in
Sec. 1.227(b)(3), and qualifies for the farm exemption in Sec.
1.226(b); or
<bullet> The submitter is unable to determine the registration
number of the manufacturer. The full address of the manufacturer has
been provided by the submitter.
The Prior Notice Final Rule Draft CPG that is announced elsewhere
in this issue of the Federal Register lists these reasons to use when
the registration number is not provided and describes our proposed
enforcement policies.
As discussed previously, without the registration number, it will
be more difficult and/or may take more time for us to verify the
identity of the manufacturing facility and its registration status and
to determine whether the article of food is subject to being held under
section 801(l) of the act. Thus, it is in the interest of the parties
involved in the import to provide the manufacturer's name and
registration number, and not simply the manufacturer's name and full
address, because the registration number will help us process the
shipment more expeditiously. The submitter should exercise a reasonable
amount of effort to obtain and provide the registration number before
using the reason ``the submitter is unable to determine the
registration number of the manufacturer.''
FDA does not agree with the comments asserting that the
registration number is sufficient by itself to ``identify'' a facility
in a prior notice submission. The additional information is needed to
verify that the registration number, which is comprised of eleven
digits, is accurate. Without additional information, there is a
significant possibility of typographical errors, leading to
misidentification of facilities, which could lead to foods being
stopped
[[Page 66353]]
at the port for inadequate prior notice and registration. There also is
the possibility of someone entering data in an attempt to ``guess'' at
a registration number. Having identifying information in addition to
the registration number helps prevent such guessing. Having this
confirmatory information also allows us to notify submitters of a
mismatch before the prior notice is accepted and confirmed for review,
which allows them to correct any inadvertent errors before the food
arrives at the port, where it otherwise may be subject to refusal for
an inadequate (inaccurate) prior notice.
If the prior notice does not contain either the manufacturer's
registration number or the reason and name and full address, the food
is subject to refusal of admission under section 801(m)(1) of the act
for failure to provide adequate prior notice, as the identity of the
manufacturer is incomplete. The food also may be subject to a hold
under section 801(l) of the act if the food is from a foreign
manufacturer that is not registered under section 415 of the act.
In response to comments from those who are importing food from a
facility that is not registered because food manufactured by it is not
intended to be consumed in the United States, FDA notes that these
shipments are subject to hold under 801(l) of the act. Under section
801(l) of the act, food is subject to being held if it is imported or
offered for import into the United States and it is from a foreign
facility that has not registered. This provision applies regardless of
whether the food was intended for consumption in the United States at
the time it was manufactured, for example where an article of food is
made in Country X for consumption in Country X, but is purchased by a
third party who re-labels the product for import and resale in the
United States.
(Comments) One comment recommends that inter-company gifts be
exempt from the requirement to provide the manufacturer's registration
number on the prior notice because these items have no commercial value
and are sent as business gifts. The comment suggests that FDA use the
same approach for business and nonbusiness gifts, by allowing a listing
of the manufacturer's name and address as it appears on the product's
label.
(Response) The provisions in the final rule regarding the
registration number are being revised, and these revised provisions
apply to both business and nonbusiness shipments. The final rule no
longer allows for submission of the name and address as it appears on
the label in any situation. However, the rule also is being changed
such that the submitter may submit either the manufacturer's
registration number, city, and country or both the manufacturer's full
address and the reason why the registration number is not provided.
d. Questions seeking clarification.
i. Designation of grower. (Comments) Two comments state that they
are exempt from the registration requirements because they are farms;
however, they want guidance regarding the steps these farms should
follow to ensure that their products move through the prior notice
system without delays at the port.
(Response) If the article of food is no longer in its natural
state, such that the identity of the manufacturer is required, the
submitter can submit a reason for why the registration number was not
provided; i.e., facility is a grower, meets farm exemption. These
reasons also are listed in the Prior Notice Final Rule Draft CPG
announced elsewhere in this issue of the Federal Register. If the
article of food is in its natural state, the identity of the
manufacturer is not required and the systems will know that they do not
need to verify the manufacturing facility's registration status.
ii. Manufacturer cancels registration. (Comments) A comment asks
what designation is appropriate for the scenario where at the time of
production the manufacturing/processing facility was legitimately
registered with the FDA, but cancelled its registration prior to the
importer submitting prior notice.
(Response) If the manufacturing facility still is operational, but
chooses to cancel its registration with FDA, then the food from this
facility is subject to refusal under 801(l) of the act. As stated
therein, ``If an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to [FDA], such
article shall be held at the port of entry for the article, and may not
be delivered to the importer, owner, or consignee of the article, until
the foreign facility is so registered.'' If the facility has canceled
its registration because it has gone out of business, then this reason
may be entered on the prior notice.
iii. Identity of manufacturer for samples. (Comments) One comment
states that there are some circumstances involving market survey and
consumer complaint samples where the manufacturing facility is unknown
to the submitter of prior notice and the manufacturing facility may not
have a registration number because it does not do business in the
United States. One comment provides the example of when shoppers are
hired to collect company trademark products, package these according to
company-established protocol, enclose purchase information and ship
these to designated laboratories in the United States. and the shoppers
often have no way of knowing the identity of the specific manufacturing
facility. One comment states that it is not likely that a
manufacturer's registration number would be available for competitive
product samples and for finished product samples used for evaluation
purposes, as well as for articles used for research and development
purposes. The comment states that the registration number does not fall
under the Freedom of Information Act and in some cases, the
manufacturer's facility may not be required to register since the
article of food was not intended for consumption in the United States.
Another comment provides the example of when a consumer expresses a
concern about either the quality or safety of a purchased food, and the
consumer is instructed to ship that product to the U.S.-based franchise
company laboratory for a timely analytical assessment.
(Response) We have revised the final rule such that the identity of
the manufacturer must include the name of the manufacturer and either
the registration number, city, and country of the manufacturer or both
the full address of the manufacturer and the reason the registration
number is not provided. Relevant to these comments, one of the reasons
for not providing the registration number is that the submitter is
unable to determine it. However, as described above, if the article of
food is from an unregistered facility, it is subject to being held
under section 801(l) of the act. Moreover, without the registration
number, it will be more difficult and/or may take more time for FDA to
verify the identity of the manufacturing facility and its registration
status. As a result, the food may be delayed until the verification is
completed.
While the final rule requires prior notice, including the identity
of the manufacturer, for shipments of samples, under the enforcement
policy proposed in the Prior Notice Final Rule Draft CPG, FDA and CBP
should typically consider not taking any regulatory action with respect
to prior notice violations when an article of food is imported or
offered for import for quality assurance, research or analysis purposes
only, not for human or animal consumption without prior notice.
iv. U.S. manufacturer of product being imported. (Comments) Two
[[Page 66354]]
comments express concern that FDA would reject a prior notice for
imported food that contains a U.S. manufacturing facility and that
facility's registration number.
(Response) Both ABI/ACS and PNSI accept the identity of a
manufacturing facility from any internationally recognized country
designation, including the United States. FDA recognizes that some food
imported into the U.S. is manufactured in the U.S., exported, and then
re-imported. Prior notice applies to these articles of food and
identification of the U.S. facility as the manufacturer is correct.
v. Require manufacturer to reveal or conceal the registration
number. (Comments) Two comments recommend that FDA compel manufacturers
to divulge their food facility registration numbers upon inquiry.
Another comment requests that FDA issue guidance stating that: FDA does
not require the registration number on commercial documents; the
inclusion of a registration number on commercial documents will not
facilitate clearance by CBP or FDA of the shipment; and FDA recommends
that companies reveal this confidential information once only in a
formal letter and ensure by all possible means that their customer
(e.g., distributor, importer, or customs broker) also respect the
confidentiality of this information. One comment cautions about
reported abusive and misleading declaration of a registration number in
a prior notice for shipments that are unconnected with the food
facility that actually owns that registration number. Another comment
suggests that FDA should revise both the prior notice and registration
rules to clarify that those doing business with the owner of a facility
should not and have no reason to demand the facility registration
number.
Several comments suggest that FDA provide a means for importers and
others to verify a facility's registration, even if such verification
does not disclose any information beyond affirmation or denial. One
comment suggests that FDA compare Manufacturer Identity (MID) data
submitted through ABI/ACS to the FDA Food Facility Registration
database and notify the transmitter of a MID mismatch while keeping
actual registration information secure. The comment reasons that this
process would give the submitter and transmitter of a prior notice a
noncompliance alert and also would alert the agency of possible
additional intensive review requirements even before the prior notice
submission has been completed. Another comment encourages the agency to
allow American importers to query a database that would do nothing more
than confirm whether the details provided are accurate. Another comment
suggests that FDA make the registration database available to
authorized customs brokers only.
(Response) FDA does not intend to direct registered food facilities
to divulge their registration numbers on documents or upon request.
However, FDA does agree that guidance regarding divulging registration
numbers and prior notice submissions may help to clarify the process,
and provided this guidance in our ``Guidance for Industry, Questions
and Answers Regarding Registration of Food Facilities Final Guidance''
available at http://www.cfsan.fda.gov/~dms/ffregui4.html.
vi. Exporting facility. (Comments) One comment requests that FDA
accommodate the importation of previously manufactured food products
that were purchased at retail outlets outside the United States and
recommends that FDA require only the registration number of the
exporting facility and information identifying the company responsible
for the product. The comment reasons that this information, along with
other identity information required by prior notice, should be
sufficient for FDA and CBP to make risk decisions about a particular
import.
(Response) FDA disagrees. The Bioterrorism Act requires the
identity of the manufacturer as well as the shipper. The identity of
the shipper or the exporting facility alone is not sufficient to
satisfy the requirements of the statute. The facility that manufactured
the food must be identified.
vii. Food imported or offered for import for transshipment,
storage, and export, or further manipulation and export. In the IFR, a
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage, and export, or further manipulation and export.
We have removed this exception in the final rule because we have
determined that section 801(m) of the act requires the identity of the
manufacturer for food imported or offered for import into the United
States, regardless of whether that food will be consumed in the United
States. Likewise, under section 801(l) of the act, food is subject to
being held if it is imported or offered for import into the United
States and it is from a foreign facility that has not registered. This
provision applies even if the food is not for consumption in the United
States. As noted previously, if the submitter is unable to determine
the registration number of the manufacturer, the submitter may provide
a reason along with the name and full address of the manufacturer.
(Final rule) Section 1.281(a)(6), (b)(5), and (c)(6) of the final
rule requires for an article of food that is no longer in its natural
state, the identity of the manufacturer, as follows: the name of the
manufacturer; and either the registration number, city, and country of
the manufacturer or both the full address of the manufacturer and the
reason the registration number is not provided.
8. The Grower, if Known
The Bioterrorism Act requires the submission of the identity of the
grower of the article, if that identity is known within the specified
period of time that notice is required to be provided. Section
1.281(a)(7), (b)(6), and (c)(7) of the IFR requires for an article of
food that is in its natural state, submission of the name and growing
location address of the grower, if known. If the submitter does not
know the identity of the grower or, if the article has been
consolidated, and the submitter does not know the identity of any of
the growers, the submitter may provide the name and address of the firm
that has consolidated the articles of food from different growers or
different growing locations.
(Comments) One comment asks that the requirement to identify the
grower not be mandatory in the final rule and suggests exempting the
growers and providing the information of growers on a voluntary basis.
Another comment asserts that it is virtually impossible to identify
each grower once grain is commingled at the country elevator.
(Response) The Bioterrorism Act requires the identity of the
grower, if known, in the submission of prior notice. Therefore, we
cannot eliminate the requirement to provide the identity of the grower
in all cases, as suggested by the comment. If the identity of the
grower is not known at the time of submission of the prior notice, and
the food has been consolidated, then the submitter may, but is not
required to, provide the name and address of the consolidator (Sec.
1.281(a)(7), (b)(6), and (c)(7)).
(Comments) Another comment states that a single shipment of fresh
fruit may represent hundreds of growers, all of whom are known by the
submitter of the prior notice. The comment asserts that requiring
submission of an individual prior notice for each article represented
by a single grower seems unnecessarily burdensome. The comment suggests
that in lieu of requiring identification of all
[[Page 66355]]
known growers in the prior notice, the rule should require the
submitter of the prior notice to retain a complete list of growers and
to make this list available to FDA for inspection and copying upon
request.
(Response) We do not agree. Periodic access, inspection, and
copying of a complete listing of all growers of an article of food does
not satisfy the requirement to identify the grower of the article of
food, if known, within the specified period of time that notice is
required to be provided. FDA responded to a similar comment in the
prior notice IFR and explained that FDA does not agree that a list
would satisfy the statutory requirement, as it would not tell FDA which
grower was associated with the particular article of food as envisioned
by the statute (68 FR 58974 at 59006). We affirm the view here.
(Comments) One comment requests that FDA reconsider the requirement
to submit the names of multiple growers, if known, in the prior notice.
The comment notes that submitters of prior notices must provide
separate notices for each grower in the case of consolidated shipments
(if the growers are known), which it asserts is onerous and costly for
exporters of consolidated shipments of horticulture products. The
comment believes that the proposed recordkeeping rules will cause the
names of the growers to be recorded and available and the prior notice
information is a duplication of effort. The comment asks that, for
consolidated shipments, FDA permit the submission of one prior notice
providing the name of the consolidator or one notice with the names of
all the growers.
(Response) FDA disagrees. Adding the capability to accept a list of
growers would add considerable complexity to both the data entry
software (PNSI and/or ABI) and the screening programs. FDA responded to
a similar comment in the prior notice IFR and explained that FDA does
not agree that a list would satisfy the statutory requirement, as it
would not tell FDA which grower was associated with the particular
article of food as envisioned by the statute (68 FR 58974 at 59006).
And as we explained in the previous response, periodic access,
inspection, and copying of a complete listing of all growers of an
article of food does not satisfy the requirement to identify the grower
of the article of food, if known, within the specified period of time
that notice is required to be provided. FDA notes that users of PNSI
can create a prior notice for one grower, copy that prior notice, and
edit just the grower information and the quantity and packaging
information, assuming the imports for each grower are distinctly
packaged.
(Final rule) Section 1.281(a)(7), (b)(6), and (c)(7) of the final
rule requires for an article of food that is in its natural state, the
submission of the name and growing location address of the grower, if
known. If the submitter does not know the identity of the grower or, if
the article has been consolidated and the submitter does not know the
identity of any of the growers, the name and address of the firm that
has consolidated the articles of food from different growers or
different growing locations may be submitted.
9. FDA Country of Production
The Bioterrorism Act requires the submission of the identity of the
country from which the article originates. The IFR in Sec.
1.281(a)(8), (b)(7) and (c)(8), requires that a prior notice contain
the FDA Country of Production of the article of food being imported or
offered for import into the United States. As set out in the IFR
definition at Sec. 1.276(b)(4), the FDA Country of Production is, for
an article of food in its natural state, the country where the article
of food was grown, including harvested or collected and readied for
shipment to the United States. If, however, an article of food is wild
fish, including seafood, that was caught or harvested outside the
waters of the United States by a vessel that is not registered in the
United States, the FDA Country of Production is the country in which
the vessel is registered. For a food that is no longer in its natural
state, the FDA Country of Production is the country where the article
of food was made. However, if an article of food is made from wild
fish, including seafood, that was made aboard a vessel, the FDA Country
of Production is the country in which the vessel is registered. The IFR
also provides that the FDA Country of Production of food grown and
harvested or collected or made in a U.S. Territory is the United
States.
(Comments) One comment asks what is required as the country of
production in a case where spirits are exported in bulk to a third-
country for local bottling and subsequent export from that third-
country for consumption in the United States.
(Response) For a food that is no longer in its natural state (e.g.
spirits), the FDA Country of Production is the country where the
article of food was made (e.g. bottled). For an article of food that
undergoes multiple manufacturing steps, as in this comment, the FDA
Country of Production would be country where the last facility performs
a manufacturing/processing step that exceeds an activity of a de
minimis nature.
(Final rule) The final rule retains without change the provisions
in Sec. 1.281(a)(8), (b)(7), and (c)(8) of the IFR.
10. Shipper
The Bioterrorism Act requires the submission of the identity of the
shipper of the article. The IFR at Sec. 1.281(a)(9), (b)(8), and
(c)(9) requires that the shipper be included in a prior notice. The IFR
defines shipper (Sec. 1.277(b)(12)) as the owner or exporter who
consigns and ships the article of food from a foreign country or the
person who sends an article of food in international mail to the United
States.
(Comments) One comment states that the FDA has augmented section
307 of the Bioterrorism Act to require not only supply chain party
identification but also the registration number of the shipper. The
comment further states that the requirement to submit the shipper's
registration number is easily met. There were no other comments
received on this issue.
(Response) We revised certain sections pertaining to the identity
of the shipper. The IFR required the registration number of the
shipper, if the shipper is required to be registered. The final rule
requires the identity of the shipper only if the shipper is different
from the manufacturer. Moreover, the final rule eliminates the
requirement to submit the registration number of the shipper, if the
shipper is required to be registered, and made the submission of the
registration number optional. The identity of the shipper in the final
rule is satisfied by submission of the name and full address of the
shipper.
(Final rule) The final rule in Sec. 1.281(a)(9), (b)(8), and
(c)(9) requires the name and full address of the shipper, if the
shipper is different from the manufacturer. If the address of the
shipper is a registered facility, the submitter may submit the
registration number of the shipper's registered facility.
FDA revised this requirement to require the shipper's information
only when the shipper is different from the manufacturer in order to
eliminate duplicative requirements. Moreover, we eliminated the
requirement to provide the registration number of the shipper, if the
shipper is required to be registered, and made the submission of the
registration number optional.
In the IFR, the shipper's registration number is not required for a
facility associated with an article of food if the article is imported
or offered for import for transshipment, storage, and export,
[[Page 66356]] or further manipulation and export. We have removed this exception in the final rule since the shipper's registration number is now optional. 11. The Country From Which the Article is Shipped The Bioterrorism Act requires the submission of the identity of the country from which the article is shipped. The IFR requires in Sec. 1.281(a)(10) and (c)(10) submission of the identity of the country from which the article is shipped. In Sec. 1.281(b)(9), the IFR requires submission of the identity of the country from which the article is shipped (i.e., mailed). (Comments) There were no comments received on this issue. (Final Rule) The final rule retains without change the provisions in Sec. 1.281(a)(10), (b)(9), and (c)(10) of the IFR. 12. Anticipated Arrival Information Section 1.281(a)(11) of the IFR requires the submission of anticipated arrival information to include the anticipated port of arrival and anticipated border crossing; the anticipated date on which the article of food will arrive at the anticipated port of arrival; and the anticipated time of that arrival. In Sec. 1.281(c)(11), the IFR requires the submission of the actual port of arrival. Anticipated arrival information is not required for food arriving by international mail. A prior notice will not be inadequate if the anticipated port of arrival, the anticipated date of arrival, or the anticipated time of arrival changes between the time of confirmation of prior notice and the time of arrival, as provided by Sec. 1.282(a) of the IFR. The anticipated arrival information must specify the anticipated port of arrival and, if there is more than one border crossing location within that port, the specific anticipated border crossing where the food will be brought into the United States. (Comments) One comment suggests the elimination of the anticipated arrival information as a data element. Another comment suggests that in light of the MOU between FDA and CBP, arrival data are no longer important, as CBP can provide the personnel to conduct the necessary inspections. (Response) Section 801(m) of the act requires the submission of the identity of the anticipated port of entry for the article of food, therefore, this data element cannot be eliminated. The anticipated time and date of arrival are needed for planning resources because it relates to when the food will first become available for examination at the border. The coordination procedures between FDA and CBP should not be construed to mean that arrival information is no longer important nor that we will not, whenever possible, conduct necessary inspections at the port. Moreover, FDA's working with CBP personnel does not negate our need for anticipated time and date of arrival since headquarters and field staff still need to know when articles of food plan to arrive. (Comments) One comment states that the arrival information should be linked to the ABI entry filing at the port of entry because the FDA prior notice requirement is inconsistent with the existing entry clearance processes of CBP. The comment contends that requiring prior notice at the port of arrival will result in severe disruption to flight schedules, with the possible consequence of aircraft offload for any affected food shipment for which prior notice was not submitted. (Response) FDA disagrees. The Bioterrorism Act requires notification about articles of food prior to arrival in the United States. Although prior notice and entry information can be submitted together through ABI/ACS, prior notice cannot be substituted by the entry process, which legally can occur well after the food has arrived in the United States. Since implementation of the IFR, FDA and CBP have noted no severe disruptions, including to flight schedules due to lack of prior notice of some articles of food within an aircraft, truck, or vessel load. FDA points out that in December 2003, CBP issued and began implementation of the Advance Electronic Cargo Information rule, which also requires information about cargo before it arrives in the United States and allows for prohibition of landing authorization if such information is not provided in advance of arrival. (See 19 CFR 122.12(c) (international airports), 19 CFR 122.14(d)(4) (landing rights airports); and 19 CFR 122.15(a) (user fee airports).) (Comments) One comment recommends that FDA ask CBP to change their ABI system to provide for port diversion functionality. The comment acknowledges that, although the FDA prior notice system is designed to allow a shipment to be diverted to a port other than the intended port of entry reported in the prior notice, CBP's ABI system precludes the CBP entry from being accepted at other than the reported port of entry. Another comment requests that when a prior notice is transmitted via either the Cargo or Border Cargo Selectivity application, the data should be moved from ACS to OASIS regardless of the estimated time of arrival date. (Response) Such changes to the ABI system are not feasible at this time given resource constraints, and the development of CBP's new Automated Commercial Environment. Moreover, CBP transfers information to FDA at 8 p.m. on the day before arrival for truck shipments and 9 p.m. on the day before arrival for air shipment. Information is transferred to FDA on the same day if that information is submitted the same day as anticipated arrival of the shipment. CBP and FDA believe that this is sufficient for meeting the timeframes for receipt, review, and response to prior notice submission. (Comments) Two comments address the difficulty of obtaining exact arrival information, including a specific time of arrival for air shipments, because many airlines are often closed at night. The comment also states that including a specific date and time for arrivals by ocean vessel is difficult. (Response) FDA disagrees. From FDA's standpoint, ``time of arrival'' relates to when the food will first become available for examination at the port. For vessels, this would be when the vessel docks in the port. For planes, this would be when the plane lands. For land vehicles, such as trucks, buses, and trains, this would be when they cross the border. FDA believes that someone involved in importing or offering for import an article of food has an indication of anticipated arrival into the United States of that food and can inform the submitter and/or transmitter of the prior notice. FDA also emphasizes that the information being requested is ``anticipated'' information, not ``exact'' or ``specific'' information as the comment incorrectly describes. (Final rule) FDA and CBP have determined that for the purposes of communication, the identity of the border crossing within the port of arrival is no longer necessary. Therefore, that information is not required in the final rule. The final rule requires in Sec. 1.281(a)(11) the anticipated arrival information, including the anticipated port of arrival, the anticipated date on which the article of food will arrive at the anticipated port of arrival, and the anticipated time of that arrival. If the article of food is arriving by express consignment operator or carrier, and neither the submitter nor transmitter is the express consignment operator or carrier, and the prior notice is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of the anticipated arrival information. This revision is being made because anticipated arrival
[[Page 66357]] information is often not available to people who ship food using an express consignment operator or courier (see also the discussion in section III.E of this document describing the shipper as it relates to who is authorized to submit prior notice). For food that has been refused under section 801(m) of the act, Sec. 1.281(c)(11) of the final rule requires the port of arrival. We revised this provision in the final rule to require the actual date on which the article of food arrived at the port of arrival. This information is important for shipments where no previous prior notice was filed so that FDA knows how long it has been since the refused food shipment arrived in the United States. For shipments where a previously refused prior notice was filed, the actual arrival date will help FDA to connect the refused prior notice to the post-refusal prior notice submission. Anticipated arrival information is not required for food arriving by international mail. 13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient In Sec. 1.281(a)(12) and (c)(12), the IFR requires the name and address of the importer. In Sec. 1.281(a)(13) and (c)(13), the IFR requires the name and address of the owner if different from the importer or ultimate consignee. In Sec. 1.281(a)(14) and (c)(14), the IFR requires the name and address of the ultimate consignee. However, the identity of the importer, owner, and ultimate consignee are not required for an article of food that is imported or offered for import for transshipment through the United States under a T&E entry. The identity of the importer, owner, or ultimate consignee is not required for an article of food that is imported or offered for import via international mail. Instead, Sec. 1.281(b)(11) of the IFR requires the name and address of the U.S. recipient. a. Importer. (Comments) There were no comments received on this issue. (Final rule) The final rule in Sec. 1.281(a)(12) and (c)(12) requires the name and full address of the importer. FDA continues to require the identity of the importer so that FDA can take steps to ensure that food refused admission under section 801(m) of the act is not delivered to the importer illegally. FDA is inserting the word ``full'' in front of ``address'' in the final rule to make clear that the complete address is required. Consequently, FDA also is revising the subsequent sentence of this paragraph to state that if the business address of the importer is a registered facility, then the facility's registration number also may be provided in addition to the facility's full address. Providing the registration number will facilitate FDA's review. The identity of the importer is not required for an article of food that is imported or offered for import for transshipment through the United States under a T&E entry. b. Owner. (Comments) One comment asks that FDA clarify what it means by owner and provide examples. (Response) In the preamble to the IFR, in response to a comment, we explained that the ``owner'' is the entity who owns the article of food at the time of arrival (68 FR 58974 at 59011). However, if a prior notice is given after the article is refused under section 801(m)(1) of the act, then the owner is the entity who owns the article of food at the time the prior notice is submitted (Id.). (Final rule) The final rule in Sec. 1.281(a)(13) and (c)(13) requires the name and full address of the owner if different from the importer or ultimate consignee. FDA is continuing to require the identity of the owner so that FDA can take steps to ensure that food refused admission under section 801(m) of the act is not delivered to the owner illegally. FDA is inserting the word ``full'' in front of ``address'' in the final rule to make clear that the complete address is required. Consequently, FDA is revising the subsequent sentence to state that if the business address of the owner is a registered facility, then the facility's registration number may be provided in addition to the owner's full address. The identity of the owner is not required for an article of food that is imported or offered for import for transshipment through the United States under a T&E entry. c. Ultimate consignee. (Comments) One comment states that the ultimate consignee, as defined by CBP (Customs Directive No. 3550- 079A), is not necessarily the party to whom the merchandise is delivered and asks who is the ultimate consignee for purposes of this rule. Another comment notes that there are a number of manufacturers in Canada who ship their product to public warehouses in the United States to have product available on a just-in-time basis for their customers. The comment states that at the time the product crosses the border, it is still the property of the manufacturer and it does not have a specific customer (consignee) in the United States other than the manufacturer because the consignee is still to be determined. The comment asks for guidance as to how to comply and fill out the prior notice for these types of shipments. (Response) FDA intends to interpret the ``ultimate consignee'' consistent with CBP's use of that term in regards to the entry of merchandise. In a case where a customer or consignee has not been identified, as described in the previous comment, the public storage warehouse where the merchandise will be delivered and stored should be identified as the ultimate consignee in the prior notice submission. (Final rule) Section 1.281(a)(14) and (c)(14) of the final rule requires the name and full address of the ultimate consignee. FDA is continuing to require the identity of the ultimate consignee so that FDA can take steps to ensure that food refused admission under section 801(m) of the act is not delivered to the ultimate consignee illegally. FDA is inserting the word ``full'' in front of ``address'' in the final rule to make clear that the complete address is required. Consequently, FDA is revising the subsequent sentence to state that if the business address of the ultimate consignee is a registered facility, then the facility's registration number also may be provided in addition to the facility's full address. The identity of the ultimate consignee is not required for an article of food that is imported or offered for import for transshipment through the United States under a T&E entry. d. U.S. recipient. (Comments) There were no comments received on this issue. (Final rule) The identity of the importer, owner, or ultimate consignee is not required for an article of food that is imported or offered for import via international mail. Instead, the final rule requires in Sec. 1.281(b)(11) the name and address of the U.S. recipient. FDA is continuing to require the identity of the U.S. recipient so that FDA can take steps to ensure that food refused admission under section 801(m) of the act is not delivered to the U.S. recipient illegally. 14. Mode of Transportation Section 1.281(a)(15) and (c)(15) of the IFR requires submission of the identity of the mode of transportation. (Comments) There were no comments received on this issue. (Final rule) The final rule retains without change the provisions in Sec. 1.281(a)(15) and (c)(15) of the IFR. The mode of transportation data element is necessary to calculate whether prior notice is timely, as well as for identification of the article of food at the time of arrival for the purposes of planning examinations and communicating with CBP for enforcement and examination.
[[Page 66358]] 15. Carrier Section 1.281(a)(16) and (c)(16) of the IFR requires the SCAC or IATA code of the carrier which is, or will be, carrying the article of food from the country from which the article is shipped to the United States, or if codes are not applicable, then the name and country of the carrier. (Comments) Several comments ask for clarification of identification of the carrier and provide examples of when the article of food is transferred from one carrier to another both prior to arrival in the United States and after arrival in the United States. (Response) In the prior notice proposed rule, we had proposed to require the identity of each carrier or transporter firm that transports the article of food from the country from which the article was shipped into the United States. We agree with the comments we received to the proposed rule that asked FDA to eliminate the requirement to identify multiple carriers, and revised the proposed provisions to require in the IFR the submission of the identity of the carrier that is or will be carrying the article of food from the country from which the article is shipped to the United States. In doing so, FDA acknowledged the suggestion that the only pertinent carrier is the one arriving at the U.S. port. The final rule clarifies that the carrier is the carrier which is, or will be, carrying the article of food from the country from which the article is shipped to the United States to the port of arrival. (Final rule) FDA and CBP have determined that identity of the country of the carrier is not necessary when the SCAC or IATA codes are not provided; the name alone of the carrier is sufficient for communication between the two agencies. However, FDA and CBP have determined that the license plate number of a privately owned vehicle as well as the State or Province that issued the license plate number is necessary for such communication. While identity of the license plate number and State or Province that issued the license is needed to identify the carrier of the food at the port of arrival, it is more properly categorized as part of the identity of the carrier than as part of the identity of the planned shipment information. Therefore, the requirement for the submission of the license plate number (and State or Province that issued the license) for food arriving by privately owned vehicle has been moved to Sec. 1.281(a)(16) and (c)(16). FDA has found that the identification of the privately owned vehicle as the carrier, when applicable, is such a critical factor in the identification of the article of food for examination and communication, that we have included this information in Sec. 1.281(a)(16) and (c)(16) of the final rule. Section 1.281(a)(16) and (c)(16) of the final rule requires the identity of the carrier by submission of the SCAC or IATA code of the carrier which is, or will be, carrying the article of food from the country from which the article is shipped to the United States to the port of arrival, or if these codes are not applicable, then the name of the carrier. If the carrier is a privately owned vehicle, the final rule requires the submission of the license plate number of the vehicle and the State or Province that issued the license plate number. Identification of the carrier is not required for an article of food that is imported or offered for import via international mail. Identification of the carrier is necessary to enable FDA and CBP to identify the appropriate article of food for inspection or holding when the food arrives in the United States. FDA notes that a carrier typically is a different firm than the shipper. The broker or self- filer currently submits carrier information to ABI/ACS when entry is made, and it later is transmitted to OASIS. 16. Planned Shipment Information In Sec. 1.281(a)(17) and (c)(17), the IFR requires submission of planned shipment information as it exists when the prior notice is submitted. FDA recognized that some of this information may change after the prior notice has been submitted and addressed this in the IFR in Sec. 1.282(a), which specifies when changes require resubmission to FDA. Many comments addressed the planned shipment information. These comments are discussed in order of appearance of the specific data elements in the IFR and preceded by a discussion of general comments. a. General comments. (Comments) One comment suggests that a complete list of ABI mandatory and optional data elements be immediately published via the CBP Administrative Message system. The comment asserted that some planned shipment information, such as the vessel carrier flag, is not necessary when the carrier code is submitted. (Response) The ``vessel carrier flag'' is not part of the planned shipment information. For food arriving by ocean vessel, the vessel name and voyage number are part of the planned shipment information. The preamble to the final rule contains a table of information required at the end of this section (table 2 of this document). Each information requirement listed in the table 2 of this document is annotated to indicate when that information is required. (Comments) One comment suggests an additional requirement for planned shipment information. The comment suggests that a number assigned through CBP's PAPS be required and that the PAPS number could be added after the prior notice is submitted, but before the truck arrives at the border. The comment asserts that this amendment of a confirmed prior notice, would greatly decrease a truck's waiting time at the border and aid in quickly clearing trucks through CBP. (Response) PAPS is a CBP border cargo release mechanism that utilizes barcode technology to expedite the release of commercial shipments. FDA at this time has no plans to utilize PAPS in reviewing prior notices or otherwise administering the prior notice program, and therefore, FDA is not adding the PAPS number as an additional data element. (Comments) One comment requests clarification as to whether the additional requirement for planned shipment information, as applicable (carrier, vessel name, voyage flight numbers and bill of lading number), will require a resubmission of prior notice when those details change due to transportation arrangements outside of the control of the supplier. (Response) When we issued the IFR, we recognized that some of this information may change after the prior notice has been submitted, and addressed this in Sec. 1.282(a) of the IFR, which specifies when changes require resubmission to FDA. If planned shipment information required in Sec. 1.281(a)(17) changes after you receive notice that FDA has confirmed your prior notice submission for review, you are not required by the IFR to resubmit prior notice. The final rule retains this provision. b. Airway bill number(s) and bill of lading number(s)--Sec. 1.281(a)(17)(i) and (c)(17)(i). (Comments) One comment stated that FDA should simplify the data requirements and make the requirements more manageable. The comment states that one data element should link all information secured by prior notice, which would be beneficial for locating shipments in the event of a possible crisis. The comment suggests that the waybill/bill of lading number be utilized as a single reference point because all shipments that are moved are repeatedly covered by this number.
[[Page 66359]]
(Response) FDA does not agree that the waybill/Bill of Lading can
be used as a single reference point for all shipments instead of the
prior notice confirmation number. A Bill of Lading number is not always
assigned to a shipment at the time of prior notice submission. For
certain shipments, such as those sent by international mail, no Bill of
Lading may exist. Thus, FDA has determined that it is better to use a
unique confirmation number provided by the FDA system to transmitters.
(Final rule) The Airway Bill number(s) or Bill of Lading number(s)
have been valuable information for identification, examination and
communication; however, this information is generally not available to
an individual submitter of an article of food that is arriving via
express consignment operator or carrier. The express consignment
operator or carrier tracking number is available to those individuals
who send an article of food via express courier. Therefore, we have
amended the final rule to allow the submission of the express
consignment operator or carrier tracking number in lieu of the Airway
Bill or Bill of Lading numbers when the article of food is arriving by
express consignment operator or carrier and the submitter is not the
express consignment operator or carrier.
Section 1.281(a)(17)(i) and (c)(17)(i) of the final rule requires
submission of the Bill of Lading number(s) or the Airway Bill
number(s), as applicable to the mode of transportation and when it
exists. This information is not required for an article of food that is
imported or offered for import via international mail or when carried
by or otherwise accompanying an individual when entering the United
States. For food arriving by express consignment operator or carrier
when the submitter is not the express consignment operator or carrier,
the tracking number may be submitted in lieu of the Bill of Lading or
Airway Bill number.
c. Vessel name and voyage number--Sec. 1.281(a)(17)(ii) and
(c)(17)(ii). (Comments) One comment asks the purpose of this
requirement because the vessel name and voyage number are provided to
other U.S. agencies, such as CBP and U.S. Coast Guard, at an even
earlier stage than required for the prior notice.
(Response) The planned shipment information is necessary to ensure
the effective enforcement of section 801(m) of the act. Submission of
the vessel name and voyage number in prior notice associates that
information with the article of food and enables FDA to effectively
communicate with CBP regarding examination of that article of food
prior to arrival of that food. It is one of the means that FDA and CBP
use to match the prior notice review to the food when it arrives at the
port; e.g., what conveyance is carrying the article of food. The final
rule will continue to require the vessel name and voyage number for
food arriving by ocean vessel. As we discussed in the preamble to the
IFR, while we are dedicated to increasing information sharing
capabilities with other agencies, it is generally difficult to have the
required information readily accessible if we need to coordinate with
other agencies or governments to obtain from them the information
necessary to respond to bioterrorism incidents or other food-related
emergencies (68 FR 58974 at 58992).
(Final rule) Section 1.281(a)(17)(ii) and (c)(17)(ii) of the final
rule requires submission of the vessel name and voyage number for food
arriving by ocean vessel, when they exist.
d. Flight number--Sec. 1.281(a)(17)(iii) and (c)(17)(iii).
(Comments) There were no comments received on this issue.
(Final rule) The final rule requires the flight number for food
arriving by air carrier. The flight number has been valuable
information for identification, examination and communication; however,
this information is generally not available to an individual submitter
of an article of food that is arriving via express consignment operator
or carrier. The express consignment operator or carrier tracking number
is available to those individuals who send an article of food via
express consignment operator or carrier. Therefore, Sec.
1.281(a)(17)(iii) and (c)(17)(iii) of the IFR have been amended to
allow the submission of the express consignment operator or carrier
tracking number in lieu of the flight number when the article of food
is arriving by express consignment operator or carrier and the
submitter is not the express consignment operator or carrier.
e. Trip number--Sec. 1.281(a)(17)(iv) and (c)(17)(iv). (Comments)
Several comments request clarification of the definition of trip
numbers. One comment reasons that the load tender numbers or manifest
numbers should be used as trip numbers for food arriving by truck
because loads are tendered to carriers with these numbers, and the
carrier uses the numbers for billing reference. Another comment reasons
that trip number appears to refer to a number that relates to the
particular trip or journey rather than the vehicle. Another comment
asserts that the trip number should identify the conveyance, everything
onboard a trailer or container entering the United States. One comment
recommends elimination of the mandatory requirement for trip number.
(Response) FDA disagrees. Land carriers use the ``Trip'' number to
signify a train number, bus route number, and/or a truck route number.
This number normally designates a repetitive route between two
locations (e.g., Washington, DC to New York, NY) and may signify the
specific truck, bus, or train route (e.g., Train <greek-i> 138 or Bus
<greek-i> 4411). This information is necessary for communication
between FDA and CBP, and thus, the final rule continues to require a
trip number for food arriving by truck, bus, or rail.
(Final rule) Section 1.281(a)(17)(iv) and (c)(17)(iv) of the final
rule requires submission of the trip number for food arriving by truck,
bus, or rail, as applicable to the mode of transportation and when it
exists. This information is not required for an article of food that is
imported or offered for import via international mail.
f. Container number(s)--Sec. 1.281(a)(17)(v) and (c)(17)(v).
(Comments) One comment suggests that FDA should allow for multiple
container submissions on one prior notice.
(Response) Multiple container numbers can be submitted for one
prior notice on screen via PNSI submission or through use of multiple
qualifiers for the Affirmation of Compliance code for container number
via ABI/ACS submission.
(Final rule) Section 1.281(a)(17)(v) and (c)(17)(v) of the final
rule requires the identification of container numbers for food arriving
as containerized cargo by water, air, or land, as applicable to the
mode of transportation and when it exists. This information is not
required for an article of food that is imported or offered for import
via international mail or when carried by or otherwise accompanying an
individual when entering the United States.
g. Car number--Sec. 1.281(a)(17)(vi) and (c)(17)(vi). (Comments)
No comments were received on this issue.
(Final rule) The final rule retains the provisions of the IFR and
requires submission of the identity of the car number for food arriving
by rail, when it exists. This information is not required for an
article of food that is imported or offered for import via
international mail or when carried by or otherwise accompanying an
individual when entering the United States.
h. License plate number and State or Province--Sec.
1.281(a)(17)(vii) and (c)(17)(vii). (Comments) No comments were
received on this issue.
[[Page 66360]]
(Final rule) FDA has determined that while identity of the license
plate number and State or Province that issued the license is needed to
identify the carrier of the food at the port of arrival, it is more
properly categorized as part of the identity of the carrier than as
part of the identity of the planned shipment information. Therefore,
the requirement for the submission of the license plate number (and
State or Province that issued the license) for food arriving by
privately owned vehicle has been moved to Sec. 1.281(a)(16) and
(c)(16). The final rule requires the submission of the license plate
number of the vehicle and the State or Province that issued the license
plate number, if the carrier is a privately owned vehicle. By including
the identification of the privately owned vehicle as a carrier
information requirement, when applicable, you must resubmit the prior
notice in accordance with this subpart (see Sec. 1.282) if the
privately owned vehicle information changes after the prior notice has
been confirmed by FDA for review. Identification of the license plate
number and State or Province that issued the license is not required
for an article of food that is imported or offered for import via
international mail.
i. Harmonized tariff schedule (HTS) codes--Sec. 1.281(a)(17)(viii)
and (c)(17)(viii). (Comments) One comment suggests the use of the HTS
codes in lieu of FDA product codes and asserts that the HTS codes
provide all the information that the FDA would need for prior notice.
(Response) The HTS codes often are not sufficient to specifically
identify a product for FDA decisionmaking. For example, in many cases,
the tariff code does not describe how the product was processed (e.g.,
commercially sterile or shelf-stable) or how the product is packaged,
which is indicated in the Process Indicator Code (PIC) element of FDA's
product code. Several products that FDA considers different from each
other (because these differences affect the potential safety of the
food) may be combined under one HTS code. Therefore, the HTS codes do
not provide all the information that is required to identify the food.
Additionally, at the time that FDA and CBP issued the IFR, we
believed that the HTS code was needed for communication between FDA and
CBP and that the identification of the HTS would assist CBP in the
efficient processing of prior notice through ACS. We also thought that,
for prior notices submitted through the FDA's PNSI, the HTS numbers
were needed to ensure that the data collected from the CBP entry when
it is transmitted through ABI/ACS could be matched to prior notice. We
have found that the HTS code is neither critical for communication with
CBP nor for identification of the food for examination purposes.
Accordingly, we have removed the requirement to submit the HTS code as
a part of prior notice planned shipment information.
(Comments) One comment suggests that FDA and CBP upgrade the flags
associated with HTS numbers. The comment also states that prior notice
cannot be submitted through ABI/ACS if the HTS code does not have a FDA
flag. One comment states that FDA should not rely solely upon HTS flags
to implement the prior notice requirements.
(Response) FDA agrees and monitors and updates the HTS flags.
Guidance about the HTS flags is posted at http://www.cfsan.fda.gov/
~dms/htsguid3.html. Prior notice can be submitted on any product
because of intended use, regardless of the HTS flag. Not having a FDA
flag associated with the HTS code does not prevent submission of prior
notice via ABI/ACS or PNSI.
(Final rule) Section 1.281(a)(17) and (c)(17) of the final rule
requires submission of the following planned shipment information, as
applicable, based on the mode of transportation:
<bullet> Bill of lading number(s), Airway bill number(s), or
express consignment operator or carrier tracking number when the
article of food is arriving by express consignment operator or carrier
and the submitter is not the express consignment operator or carrier
(not applicable to food carried by or otherwise accompanying an
individual);
<bullet> For food arriving by ocean vessel, vessel name and voyage
number;
<bullet> For food arriving by air carrier, flight number or the
express consignment operator or carrier tracking number when the
article of food is arriving by express consignment operator or carrier
and the submitter is not the express operator or carrier;
<bullet> For food arriving by truck, bus, or rail, the trip number;
<bullet> For food arriving as containerized cargo by water, air, or
land, the container number(s) (not applicable to food carried by or
otherwise accompanying an individual); and
<bullet> For food arriving by rail, car number (not applicable to
food carried by or otherwise accompanying an individual).
We also added the phrase ``to the mode of transportation and when
it exists'' after ``as applicable'' in the opening sentence of Sec.
1.281(a)(17) and (c)(17) to clarify that the data elements under
planned shipment information are applicable by mode of transportation
and when the data element exists. For example, rail car number,
container number, and train trip number may be applicable for rail
shipments, and vessel name, voyage number, and container number may be
applicable for food arriving by ocean vessel.
The final rule does not require that prior notice be cancelled and
resubmitted if this planned shipment information changes after FDA has
confirmed the prior notice for review. A prior notice will not be
inadequate if any of the planned shipment information changes between
the confirmation of prior notice and the time of arrival.
j. Refused articles. (Comments) One comment requests clarification
of the process for resubmission if a prior notice is refused for
reasons other than failure to satisfy prior notice requirements. The
comment asks once the failure is rectified, should companies use the
PNSI or ABI/ACS to resubmit the load for clearance?
(Response) A food may be refused under 801(m) of the act only if it
is imported or offered for import with inadequate prior notice; i.e.,
no prior notice, untimely prior notice, or inaccurate prior notice. To
resolve a refusal, prior notice or a revised prior notice must be
submitted via PNSI until such time as ACS or its successor system can
accommodate such transactions.
The following table 2 summarizes the information required under
Sec. 1.281(a), (b), and (c):
[[Page 66361]]
| Information | Transshipment | Carried By or Accompanying an Individual |
Food Not in Natural State |
Food in Natural State |
After Section 801(m) of the Act Refusal |
|
|---|---|---|---|---|---|---|
| §1.281 paragraph(s) | (a) and (c) | (a) | (a) | (a) | (b) | (c) |
| Submitter | Y | Y | Y | Y | Y | Y |
| Transmitter | Y | Y | Y | Y | Y | Y |
| Entry Type | Y | Y | Y | Y | Y | Y |
| Entry Identifier | Y | Y | Y | Y | N | Y |
| FDA Product Code | Y | Y | Y | Y | Y | Y |
| Common, usual, or market name |
Y | Y | Y | Y | Y | Y |
| Estimated Quantity | Y | Y | Y | Y | Y | Actual |
| Lot/Code # | Y | Y | Y | N | Y | Y |
| Manufacturer | Y | Y | Y | N | Y | Y |
| Grower, if known | Y | Y | N | Y | Y | Y |
| Grower, if known | Y | Y | N | Y | Y | Y |
| Country of Production | Y | Y | Y | Y | Y | Y |
| Shipper | Y | Y | Y | Y | Y | Y |
| Country from which article is shipped |
Y | Y | Y | Y | Y | Y |
| Port of arrival | Anticipated1 | Anticipated1 | Anticipated1 | Anticipated1 | N | Actual1 |
| Date of arrival | Anticipated1 | Anticipated1 | Anticipated1 | Anticipated1 | N | Actual |
| Time of arrival | Anticipated1 | Anticipated1 | Anticipated1 | Anticipated1 | N | N |
| Date of mailing | N | N | N | N | Anticipated | N |
| Importer | N | Y | Y | Y | N | Y |
| Owner | N | Y | Y | Y | N | Y |
| Ultimate consignee |
N | Y | Y | Y | N | Y |
| U. S. recipient | N | N | N | N | Y | N |
| Mode of transport | Y | Y | Y | Y | N | Y |
| Carrier | Y | Y | Y | Y | N | Y |
| Bill of lading/ airbill |
Planned1 | N | Planned1 | Planned1 | N | Actual1 |
| Vessel/Voyage | Planned | Planned | Planned | Planned | N | Actual |
| Flight # | Planned1 | Planned1 | Planned1 | Planned1 | N | Actual1 |
| Trip # | Planned | Planned | Planned | Planned | N | Actual |
| Container # | Planned | N | Planned | Planned | N | Actual |
| Car # | Planned | N | Planned | Planned | N | Actual |
| Hold information | N | N | N | N | N | Y |
1If the article of food is arriving by express consignment carrier or operator, and the submitter and/or transmitter is not the express consignment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of this information.
[[Page 66362]] I. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (Sec. 1.282) In Sec. 1.282 (a)(1) of the IFR, if any of the information required in Sec. 1.281(a) except the quantity information, the anticipated arrival information, or the planned shipment information, changes after FDA has confirmed the prior notice submission for review, you must resubmit prior notice. For food arriving by international mail, if any of the information required in Sec. 1.281(b), except the anticipated date of mailing, changes after FDA has confirmed the prior notice submission for review, you must resubmit prior notice. The IFR also states that the original prior notice should be cancelled in PNSI or if originally submitted via ABI/ACS, the entry should be deleted. (Comments) Some comments request that FDA revisit the concepts outlined in Sec. Sec. 1.289 through 1.294 of the proposed rule, which allowed amendments to be made to product identity, estimated quantity, and arrival information, without having to cancel the entry and resubmit the prior notice under a new entry. The comments contend that such amendments were acceptable and would not taint the adequacy of a prior notice or compromise food security, if the amendments are made within the applicable 2-, 4-, or 8-hour timeframes per mode of transportation at issue. The comments suggest that amendments allow for a degree of flexibility in the prior notice system and acknowledge a well-known fact in the industry that this type of information may change after prior notice has been submitted. Some comments suggest that allowing the submitter or filer to update or correct information provided in a prior notice will facilitate the steady flow of prior notice submissions, without jeopardizing the security and safety of the food supply. (Response) Unlike the proposed rule, the IFR does not allow for amendments relating to the product identity. After considering the comments on whether the final rule should allow amendments, and based on our experience with the IFR, we believe the approach in the IFR is sound. The reduced timeframes in the IFR, which are continued in the final rule, provide very little leeway in the time FDA has to receive, review, and respond to the prior notice submissions. Moreover, the timeframes are based, in part, on not receiving amendments because allowing amendments would increase the review time. In addition, ACS cannot accommodate changes in prior notice submissions that have been confirmed by FDA for review because CBP also needs finality so it can complete its own screening of the entry. Therefore, to keep the timeframes as short as possible, we are not permitting changes to prior notice without restarting the clock. Moreover, we believe that the prior notice information required by the final rule should be sufficiently fixed to be submitted within the timeframes. The final rule allows for estimates for some information-- estimated quantity, anticipated arrival information, and planned shipment information--and changes to any of these data elements does not require that the prior notice be resubmitted. (Comments) Some comments request that FDA create a mechanism to allow correction of errors in a manner that does not restart the prior notice clock. One comment requests the final rule provide for correction of errors within the timeframe of the 2-, 4-, or 8-hour deadline. The comments suggest that a streamlined process, possibly through electronic means, of making clerical corrections or correcting errors in timely filed prior notice should be a permanent feature of the integrated FDA-CBP process. Some comments contend that without the opportunity to correct the error post-submission, shippers may find their shipments frozen in an extended period of delay, which would frustrate the purpose of the FDA-CBP Integration Plan that is aimed at reducing such timeframes. Comments also suggest this would create an unintended legislative loop between the two regulatory frameworks meant by the Integration Plan to be seamlessly and efficiently integrated. Some comments object to the IFR's requirements because after the CBP entry or entry summary has been certified, there currently is no mechanism for making corrections, including corrections of simple clerical errors, without canceling the entry and submitting a new entry. Comments state that the requirement to cancel and resubmit a prior notice when submitted information changes or to correct a clerical error creates additional work in an already overburdened environment. According to the comments, in the air and truck environment where cargo is processed on weekends and at off-hour operations, CBP is unavailable to process these entry cancellations. The comments state that in such circumstances, cargo could be forced into refused status due to CBP's inability to act in a timely manner. Similarly, other comments state that many imported articles of food are time sensitive and must be shipped in a temperature controlled environment. The comments note that clerical errors in the prior notice may not be corrected, and if an error is discovered after a CBP entry is certified, the entry must be cancelled. According to the comments, if CBP is not available to cancel the entry (e.g., the shipment arrives over the weekend), the delay may cause the shipment to be destroyed. The comments request that FDA and CBP find a way to address this problem, either by allowing clerical revisions after the entry has been certified, permitting entry deletions under certain circumstances, or ensuring CBP availability on a 24 hours/7 days a week/365 days a year schedule. (Response) Because we reduced the timeframes for submitting prior notice in the IFR to the least amount of time that we need to meet our statutory responsibility to receive, review, and respond to prior notice submissions, the IFR did not provide for amendments or updates. The timeframes in the final rule also provide the least amount of time we need to receive, review and respond to prior notice submissions and therefore, the final rule also does not provide for amendments or updates. The use of ABI/ACS precludes amendments and updates without substantial and costly revisions to the system; such technical changes are not cost-effective or a good use of limited resources given the development of the Automated Commercial Environment, which will replace ACS. Changes to ABI/ACS submissions that have been electronically transmitted to FDA's OASIS and confirmed by FDA for review are not feasible because CBP also needs finality so it can complete its own screening of the entry. Changes to confirmed prior notice submissions, other than those relating to estimated quantity, anticipated arrival information, and planned shipment information, must be processed by resubmission of prior notice unless the article of food will not be offered for import or imported into the United States. The responsibility is on submitters to provide accurate prior notice to FDA, and we encourage affected parties to take appropriate measures to verify entries for accuracy before sending. FDA notes that both ABI and PNSI systems allow for correction of errors that are revealed by the systems' validation process. In PNSI, a PN confirmation number will not be provided if it detects errors in the submitted data. Moreover, FDA notes that if CBP is unavailable to cancel a prior notice, submitters can create and submit new
[[Page 66363]]
replacement entries and prior notices using either ABI or a combination
of ABI and PNSI even when the original entry has not yet been
cancelled. However, the submitter should cancel the previously
submitted inaccurate ABI entry (via request to CBP) at the first chance
possible to avoid subsequent administrative and operational problems
with entry release. This is a revision to the IFR in that Sec.
1.282(c) of the final rule uses the correct term ``cancel'' versus
``delete'' when describing what CBP should be requested to do in this
case. When an entry is ``deleted'' versus ``cancelled'' in ABI, the
filer is able to re-use the original entry number. However, PNSI will
reject a prior notice submission that attempts to re-use a previous
entry number. Therefore, we revised the final rule to provide for
cancellation of the entry, rather than deletion of an entry.
(Comments) Some comments request that FDA and CBP develop a process
for reviewing amendments that do not affect the security of the cargo
in less than the full eight hours, so that the shipments' release from
the port is not delayed unduly.
(Response) The requirements for amendments set forth in the
proposed rule were eliminated from the IFR. This final rule provides
that if required information (except estimated quantity, anticipated
arrival information, including the anticipated date of mailing, and
planned shipment information) changes after FDA has confirmed prior
notice for review, the prior notice should be cancelled and a prior
notice with the correct information must be submitted. The reduced
timeframes in the IFR, which are continued in the final rule, provide
very little leeway in the time FDA has to receive, review, and respond
to the prior notice submissions. Moreover, the timeframes are based, in
part, on not receiving amendments because allowing amendments would
increase the review time. In addition, ACS cannot accommodate changes
in prior notice submissions that have been confirmed by FDA for review
because CBP also needs finality so it can complete its own screening of
the entry. Because we are maintaining the IFR timeframes in the final
rule, it is difficult to accommodate amendments.
(Comments) Some comments state that changes to prior notice should
be required for material changes only. Materiality would need to be
determined.
(Response) We agree. The final rule requires that, if certain
required information changes after FDA has confirmed prior notice for
review, the prior notice should be cancelled and a prior notice with
the correct information must be submitted. Changes to other information
(i.e., estimated quantity, anticipated arrival information, and planned
shipment information) do not require the submitter to re-submit a
revised prior notice.
(Comments) Some comments suggest that entry deletions, rather than
cancellations, should be permitted for legitimate reasons.
(Response) FDA believes the comment misunderstands Sec. 1.282(c)
of the IFR because that provision states, ``If you submitted the prior
notice via ABI/ACS, you should cancel the prior notice via ACS by
requesting that CBP delete the entry'' (emphasis added). However, the
final rule now recommends that if you cancelled a prior notice
submitted via ABI/ACS, you should cancel the prior notice via ACS by
requesting that CBP cancel, rather than delete, the entry (Sec.
1.282(c)). When an entry is ``deleted'' versus ``cancelled'' in ABI,
the filer is able to re-use the original entry number. However, PNSI
will reject a prior notice submission that attempts to re-use a
previous entry number. Therefore, we revised the final rule to provide
for cancellation of the entry, rather than deletion of an entry.
(Comments) One comment requested clarification regarding whether
the additional requirement for planned shipment information as
applicable (carrier, vessel name, voyage flight numbers, and bill of
lading number) will necessitate a resubmission when those details
change due to transportation arrangements outside the control of the
supplier.
(Response) No. The final rule does not require resubmission of
prior notice if the planned shipment information changes after prior
notice has been submitted and confirmed for review by FDA.
(Comments) One comment notes that part of the process of completing
a prior notice is to obtain a CBP entry number, which many firms use a
customs broker to do. The comment states that this works well in most
cases, but can create problems for products arriving by boat. The
comment further states that of all the modes of transportation, boats
are the most unpredictable and can arrive earlier or later than
expected. Early arrivals pose a problem because of the 8 hour notice
period and the relatively short timeframe in which a company learns of
an impending early arrival. Given the fact that customs brokers may not
work a 24-hour, 7-day per week schedule, prior notice shipments that
arrive on the weekend, holiday, or after normal business hours will be
filed late and could be subject to civil penalties. The comment
recommends that the prior notice system allow custom entry numbers to
be updated after the customs entry has been filed by the customs
brokers and that any penalty considerations be deferred under these
circumstances.
(Response) The type of updates recommended by this comment is not
necessary because prior notice can be submitted without a customs entry
number. In the situation described, where prior notice must be
submitted before entry can be filed, prior notice may be submitted
using PNSI without a CBP entry identifier (e.g., a CBP entry number).
PNSI will provide a system-generated entry identifier. Once a customs
broker is secured during normal business hours to file the entry, the
prior notice confirmation number(s) can be given to the broker who can
affiliate the prior notice(s) to the customs entry via the ABI
submission.
(Comments) Some comments request clarification on what happens to
the food if the information relating to product identity, estimated
quantity, or anticipated arrival changes after prior notice is
submitted.
(Response) The final rule requires that if required information
(except estimated quantity, anticipated arrival information, including
the anticipated date of mailing, and planned shipment information)
changes after FDA has confirmed prior notice for review, the prior
notice must be resubmitted. As we explained in the preamble to the IFR,
``FDA proposed to allow changes to certain information in the prior
notice after a prior notice was submitted. * * *. Some comments stated
that if the timeframe for submitting prior notice was changed, i.e.,
shortened to 4 hours for land and air and 8 hours for water, then
amendments and updates would not be necessary. * * * FDA agrees with
the comments that state that if the deadline for submission of prior
notice were reduced, amendments and updates would not be necessary. FDA
has chosen timeframes that provide it with very little leeway in the
time it has to `receive, review and respond' to the prior notice
submissions. Thus, we concluded that we could no longer permit changes
to prior notice without restarting the clock. In addition, the use of
ABI/ACS precludes amendments and updates: changes to ABI/ACS
submissions that have been electronically transmitted to FDA's OASIS
and confirmed by FDA for review are not feasible because CBP also needs
finality so it can complete its own screening of the entry. Therefore,
the interim final rule does not allow for
[[Page 66364]]
changes to a prior notice after the transmitter has been notified that
FDA has confirmed the prior notice for review.'' (68 FR 58974 at 59013
and 59014)
We retain this view and therefore, changes in product identity
require resubmission of a prior notice with the correct information. We
do not require resubmission of a prior notice if the estimated
quantity, anticipated arrival information, including the anticipated
date of mailing, and planned shipment information changes, because
these data elements are not firm in the first place. Moreover, such
changes would not alter FDA's ability to review the prior notice or to
examine the food.
(Comments) Some comments request that FDA maintain the flexibility,
as provided by the IFR, to provide anticipated port arrival information
for date and time of arrival and point of crossing. The comments state
that this flexibility is critical for minimizing trade disruption and
note that times of arrival and entry locations often change and
importers need the flexibility to accommodate these unanticipated
changes without refiling entry information.
(Response) Section 1.281(a)(11), which requires anticipated arrival
information, has been revised in the final rule. The requirement to
provide the identity of the border crossing within the anticipated port
of arrival has been eliminated in the final rule. As with the IFR, in
the final rule, changes in anticipated port of arrival, anticipated
date of arrival, and anticipated time of arrival do not require
cancellation and resubmission of the prior notice.
(Comments) Some comments suggest that the requirement that all
prior notice data be transmitted via the PNSI portal after the prior
notice time limitations or refusal will increase the load on this
limited system. The comments state that the PNSI system capacity must
be dramatically increased before the August 2004 full enforcement
deadline in order to ensure that legitimate trade is not impacted due
to a failure of the system.
(Response) FDA does not agree that post-refusal prior notice
submissions have or will impact or overload PNSI. PNSI has operated
effectively since the IFR took effect and has sufficient capacity for
any increase in submissions after the effective date of this final
rule. FDA has carefully monitored both PNSI and OASIS system usage and
performance. No issues related to load on PNSI have been identified
since the IFR took effect. Until such time as ACS or its successor
system can accommodate such transactions, post-refusal prior notice
must be submitted via PNSI (see Sec. 1.280(a)(2)).
(Final Rule) Section 1.282 of the final rule requires that if
required information (except estimated quantity, anticipated arrival
information, including the anticipated date of mailing, and planned
shipment information) changes after FDA has confirmed prior notice for
review, the prior notice should be cancelled and a prior notice with
the updated information must be submitted.
J. What Happens to Food That Is Imported or Offered for Import Without
Adequate Prior Notice? (Sec. 1.283)
The IFR in Sec. 1.283 identifies consequences and procedures for
failure to provide adequate prior notice and describes the requirements
and procedures for various situations.
The comments received will be discussed below in the order each
issue appears in Sec. 1.283 of the IFR, proceeded by comments
generally addressing consequences.
1. General Comments
(Comments) Some comments suggest that enforcement actions should be
based on levels of culpability (e.g., negligent, grossly negligent, and
fraudulent), number of infractions, and seriousness of infractions.
(Response) FDA and CBP take various considerations, such as the
seriousness of the violation, into account when deciding whether to
take an enforcement action in response to violations of the prior
notice rule and, if so, what actions to take. For areas in which we
have established enforcement policies for prior notice, these are
contained in, and communicated to the public through a Compliance
Policy Guide (CPG). Elsewhere in this issue of the Federal Register, we
are announcing the availability of the Prior Notice Final Rule Draft
CPG, which describes our proposed enforcement policies for the final
rule.
(Comments) Some comments request clarification on the penalties for
inadvertent errors, such as clerical errors, in the prior notice
submission.
(Response) As described in the previous response, FDA and CBP take
into account the nature of the violation in determining how to respond
to prior notice violations. The validation process built into ABI and
PNSI should assist in catching inadvertent errors, such as clerical
errors, because the systems will not accept data with certain errors.
This validation process then allows the submitter to correct errors
before final submission of prior notice data.
(Comments) Some comments ask if there are any measures that
importers should undertake to avoid delays at the port of entry.
(Response) FDA advises that most delays based on inaccurate and
untimely submission of prior notice are avoidable and recommends that
importers focus on measures to increase accurate and timely submissions
of prior notice.
(Comments) Some comments state that the ``Category 3'' refusal and
fine provision is excessive for a shipment showing up at the border in
advance of the 2-hour timeframe elapsing and FDA should consider
lowering the penalty for this type of offense. Other comments request
clarification about what will happen to trucks that arrive too early,
i.e., will they be turned away or will they be allowed to wait in the
compound?
(Response) Section 1.283(a)(1)(iii) of the final rule provides that
if an article of food arrives early (i.e., before the prior notice time
has elapsed), its arrival will not be considered untimely if FDA
already has reviewed the prior notice, determined its response to the
prior notice, and advised CBP of that response. However, if FDA has not
reviewed the prior notice submission and responded to CBP before the
food arrives, the food is subject to refusal. As noted previously, in
determining whether to refuse the food, assess a CBP civil monetary
penalty, or take other regulatory action, we will take into account the
seriousness of the violation and other considerations. Trucks arriving
before FDA has processed the prior notice will be handled as
appropriate under the individual circumstances.
(Comments) Some comments state that the implementation plan for the
prior notice rule must include a contingency plan to ensure that border
traffic can still be cleared and does not come to a standstill as new
systems are put in place and problems are resolved. Comments point out
that it is essential for FDA and CBP to have appropriate mechanisms and
procedures in place (such as referral to a secondary inspection, where
appropriate) so that border congestion is not increased by the
application of the rules.
Some comments request clarification on arrangements between FDA and
CBP, the Canada Border Services Agency, and the bridge authorities to
address issues surrounding refusal of entry due to missing or
incomplete prior notice information. The comments indicate that the
relevant agencies on both sides of the border should have a plan in
place to deal with the inevitable
[[Page 66365]]
problems posed by larger volumes of returning trucks to ensure that
busy border crossings do not become a ``no man's'' land. Some comments
indicate that local staff at busy border crossings, such as the Peace
Bridge and Ambassador Bridge, have indicated that trucks will be turned
back for missing/incomplete prior notice if secure storage cannot be
arranged. Comments suggest that CBP could stamp a shipping document
(such as the bill of lading) ``Refused--BTA'' or implement procedures
that CBP had in place for refused trucks prior to the Bioterrorism Act.
Some comments suggest that carriers should be permitted a variety
of options when and if they are advised that one or more products
within a shipment have been refused due to a failure to have an
adequate prior notice. According to the comments, these options may
include, permission to hold the cargo at the border while the proper
information is submitted to the FDA and before mandatory notice of
intended destination for delivery; returning the cargo to the exporting
facility directly; holding the cargo at a designated carrier's closest
facility; and/or holding the cargo at a designated FDA holding
facility, not necessarily a general order bonded warehouse, near the
port of entry.
(Response) FDA and CBP have not experienced any major disruptions
in border traffic as a result of the implementation of the IFR in
December 2003. The agencies also have not made any significant
revisions to the IFR in this final rule that cause us to believe there
will be major disruptions in trade once the provisions in this final
rule take effect, particularly since we are providing a 180-day period
between publication of this rule and the effective date of its
provisions. This period of time should allow for full understanding by
affected parties of the requirements of the final rule.
We also note that the automated validation process in ABI and PNSI
will catch most missing and incomplete submissions before refusal
because the systems will not accept submissions with certain errors or
omissions. If refusal does occur, the carrier will have the option to
segregate refused food from the rest of the shipment (Sec.
1.283(a)(3)), the option to export after refusal with CBP concurrence
(Sec. 1.283(a)(5)), and the option to have refused food held at the
port of entry, unless directed otherwise by CBP or FDA (see Sec.
1.283(a)(1)).
(Comments) Some comments recommend establishing an electronic means
to resolve the refused admission status.
(Response) Both the IFR and the final rule provide for a response
to an 801(m) refusal to be provided to FDA by mail, e-mail, fax, or
courier. FDA will respond in kind, as we have not experienced any
problems as a result of this flexibility.
2. Inadequate Prior Notice (Sec. 1.283(a)(1))
(Comments) Several comments request that FDA notify the submitter,
filer, importer, or ultimate consignee, either in lieu of or in
addition to the carrier, about inadequacies in a prior notice
submission that result in refusal of the food. The comments state that
the carrier is not in a position to resolve the problem when the
article of food is refused. The comments note that the carrier has
temporary possession of the product, has minimal vested interest in the
shipment, particularly if is offloaded, and has little, if any,
resources or incentive to resolve the refusal. However, according to
the comments, the exporter, importer, or ultimate consignee has an
ownership interest in the refused food and a strong economic incentive
to resolve the refusal swiftly, or to export or destroy the refused
food if the prior notice defects cannot be corrected. The comments
state that delaying notification to the submitter, importer, and
ultimate consignee, unduly hinders the resolution of the problem.
One comment specifies that the filer of the prior notice, who is in
most cases the importer, supplier, owner of the merchandise, or a
representative of one of these entities, should be notified directly,
without any intermediate communication, so that the filer may promptly
take corrective action and mitigate any possible adverse regulatory and
commercial consequences. Some comments request that FDA or CBP notify
the General Order Manager (GOM) when a shipment has been rejected or
denied entry and also provide the rationale for that decision.
(Response) FDA disagrees. The IFR does not require FDA or CBP to
provide notice about a refusal, and we continue to believe this is
appropriate. As an operational matter, the carrier would have to be
notified of the refusal. The carrier can then notify others, such as
the entity that hired the carrier to transport the article of food,
that there is a problem with the prior notice. It would be resource-
intensive for FDA or CBP to assume responsibility for notifying various
other entities of the refusal. FDA notes that, although we collect the
contact information for the submitter and transmitter, which we could
use to contact parties about certain actions, including refusals,
routinely notifying these and other parties about a refusal would take
limited staff resources away from other functions, such as reviewing
prior notices. FDA will try to notify other parties (e.g., submitter),
in addition to the carrier, if feasible, and we often do contact these
other parties as resources allow. FDA notes that for the future
migration of ABI/ACS to the ITDS/ACE environment, FDA has requested the
ability to provide electronic prior notice ``refusal'' messaging. This
capability does not currently exist. If electronic prior notice refusal
messaging is in place, it would significantly reduce the resources
required to notify ITDS participants of these refusals.
(Comments) Some comments express concern that trucking companies
that pick up FDA-regulated freight in Canada or Mexico bound for the
United States cannot ascertain that the importer, shipper, or customs
broker has filed the appropriate prior notice. The comments ask what
form of proof FDA (or other border regulatory agencies) will consider
acceptable in order to release the motor carrier from responsibility if
the prior notice was not filed appropriately. The comments state that
it is not clear whether FDA will supply an official document that the
importer, shipper, or customs broker would issue to the motor carrier
to assure the carrier that prior notice has been filed.
(Response) Under Sec. 1.279(d) of the final rule, FDA notifies the
submitter when the prior notice has been confirmed for review, with a
message containing a prior notice confirmation number. Section 1.279(g)
of the final rule requires that the prior notice confirmation number
must accompany any article of food for which the prior notice was
submitted through PNSI when the article arrives in the United States
and must be provided to CBP or FDA upon arrival. To address the concern
in the comments, carriers may consider, as a matter of business
practice, requesting from their customers proof of confirmation of
prior notice submission prior to transporting the food to the United
States, even when there is no requirement to provide the confirmation
number to CBP or FDA upon arrival.
(Comments) Some comments request clarification on whether
information for FDA clearance will be allowed to be transmitted via
ABI, PNSI or either, for a shipment of food that will be entered after
the arrival of a vessel or an aircraft. Comments ask what error message
will be sent back to the transmitter for entry that is untimely filed,
e.g., will the transmitter receive a refused admission
[[Page 66366]]
status or some other error message? In addition, comments ask what the
mechanism is for communicating with the carrier on the disposition of
the prior notice. The comment states that carriers cannot view the FDA
``may proceed'' messages in CBP's AMS, and the ABI participant (usually
the customs broker) is responsible for communicating freight holds to
the various parties involved, including importers, container freight
stations (CFS), and truckers.
(Response) FDA clarifies that if an article of food subject to
prior notice requirements arrives in the United States and prior notice
has not been received for review by FDA in the timeframes prescribed in
the final rule, the food is subject to refusal under section 801(m) of
the act, unless FDA already reviewed the prior notice, determined its
response, and advised CBP of that response. See also the discussion
above regarding communication of refusal status.
(Comments) One comment requests clarification as to how
transmitters may confirm the validity and existence of registration
numbers provided by the shippers, importers, and carriers. The comment
states that the transmitter might bring in goods based on erroneous,
but good faith information.
(Response) FDA will identify anomalies in the initial submission of
registration numbers based on review of the information prior to
confirmation of receipt of the prior notice, and will respond
accordingly. If our subsequent review, after the prior notice is
confirmed for review, reveals problems with a submitted registration
number that causes the prior notice submission to be deemed inaccurate,
the food is subject to refusal under section 801(m) of the act.
Subsequent corrections to the submitted information can be provided by
resubmitting corrected information in a post-refusal prior notice (see
Sec. 1.283(c)).
If our subsequent review reveals problems with the submitted
registration number such that an article of food is from a foreign
facility that is not registered under section 415 of the act and 21
CFR, part 1, subpart H, and is imported or offered for import into the
United States, the food is subject to hold under section 801(l) of the
act. To resolve a hold, the facility must register and obtain a
registration number, and that number must be provided to FDA. This is
covered under Sec. 1.285(i) of the final rule.
As discussed in response to comments 157 and 158 in the preamble to
the Registration of Food Facilities Interim Final Rule (68 FR 58894 at
58931, October 10, 2003), section 305 of the Bioterrorism Act states
that FDA's list of registered facilities and registration documents FDA
receives under the rule are not subject to disclosure under FOIA.
Furthermore, section 305 of the Bioterrorism Act provides that any
information derived from the list of facilities or registration
documents that would disclose the identity or location of a specific
registered person is not subject to disclosure under FOIA. This does
not preclude the registered facility from disclosing its registration
number, such as to the submitter or others with whom it has a business
relationship.
(Comments) Some comments request that FDA clarify the penalties for
inadequate prior notice. One comment asks about the consequences when
foods are accidentally shipped without meeting the prior notice
requirements, i.e. can they be transshipped?
(Response) Prior notice is required for food imported or offered
for import into the United States, including shipments intended for
transshipment. If adequate prior notice is not provided, the food is
subject to refusal. Refused food must be held, in accordance with the
provisions of Sec. 1.283(a), unless CBP concurrence is obtained for
export and the food is immediately exported from the port of arrival
under CBP supervision. An article of food that has been refused is
considered general order merchandise and can only be moved under
appropriate custodial bond unless immediately exported under CBP
supervision. If the food is held at a secure facility outside of the
port, FDA must be notified of the location of the secure facility
before the food is moved there. Post-refusal prior notice can be
submitted as provided by Sec. 1.283(c).
We also note that CBP may seize goods imported contrary to law,
assess civil monetary penalties, including those under 19 U.S.C.
1595a(b) against every person who directs, assists, financially or
otherwise, or is in any way concerned in the importation of any
merchandise contrary to law, and refer violations for criminal
investigation and prosecution. Section 1.284 of the final rule lists
other consequences for failure to submit adequate prior notice. For
example, under 21 U.S.C. 335a, FDA can seek debarment of any person who
has been convicted of a felony relating to importation of food into the
United States or any person who has engaged in a pattern of importing
or offering for import adulterated food that presents a threat of
serious adverse health consequences or death to humans or animals.
(Comments) Some comments ask whether an entry of food would be
subject to detention if the product code does not precisely reflect the
nature of the product.
(Response) The final rule requires the submission of accurate
information that is submitted in the prior notice, including the
product code, which is required in Sec. 1.281 (a)(5)(i), (b)(4)(i),
and (c)(5)(i) of the final rule. If the product code does not
accurately identify the food, the food is subject to refusal. Section
1.283(a)(1)(ii) of the final rule states that if prior notice has been
submitted and confirmed by FDA for review, but upon review of the
notice or examination of the article of food, the notice is determined
to be inaccurate, the food is subject to refusal of admission under
section 801(m)(1) of the act.
3. Status and Movement of Refused Food (Sec. 1.283(a)(2))
(Comments) Some comments request that FDA clarify the process for
food that is refused and later deemed to be admissible.
(Response) Section 1.283 of the final rule identifies the
consequences and procedures for food that is refused because of
inadequate prior notice. If the refused food is not immediately
exported with CBP concurrence, it is considered general order
merchandise and must be held until adequate prior notice is submitted
and FDA has notified CBP and the transmitter that the food is no longer
refused because of inadequate prior notice. If in response to a request
for FDA review, FDA determines that the article is not subject to the
prior notice requirements or that the prior notice submission is
complete and accurate, it will notify the requester, the transmitter,
and CBP that the food is no longer subject to refusal under section
801(m)(1) of the act. A determination that an article of food is no
longer refused under section 801(m)(1) of the act is different than,
and may come before, determinations of admissibility under other
provisions of the act or other U.S. laws. Moreover, a determination
that an article of food is no longer refused under section 801(m)(1)
does not mean that it will be granted admission under other provisions
of the act or other U.S. laws (Sec. 1.283(g)). Further information
regarding the process may be found in the preamble to the IFR (68 FR
58974 at 59016 through 59022).
(Comments) Some comments state that the holding period for prior
notice should be no longer than the original required prior notice
timeframe. The comments contend that exceeding this
[[Page 66367]]
time period does not increase the safety to the public and may cause a
bottleneck for all freight movements if thousands of shipments are held
at their port of arrival. Comments suggest that, before the holding
period is fully implemented, FDA should determine the percentage of
shipments that are still not in conformity with the prior notice rule
and determine the potential for harming the movement of all freight
into and out of the United States when prior notice is fully
implemented.
(Response) Section 1.283(a)(2) of the final rule states that
refused food will be considered general order merchandise. In the first
instance, it is not within our control how long it will take the
parties associated with the article of food being held to satisfy the
prior notice requirements. Moreover, CBP regulations address the length
of time an imported product will be held in General Order (G.O.) Status
(19 CFR part 127). Section 1.283(a)(1) of the final rule states that
refused food that is not immediately exported must be held at the port
of entry unless directed by CBP or FDA. Accordingly, the final rule
does not require refused food to be held at the port of arrival unless
so directed by CBP or FDA. In Sec. 1.283(c)(3), we state that FDA will
try to review and respond to post-refusal prior notice submissions
within the prior notice timeframes.
(Comments) Some comments request that FDA establish procedures for
handling refused merchandise. The comments contend that secure storage
facilities and cargo movement procedures have not been established for
refused merchandise. According to the comments, there is no mechanism
to handle refused refrigerated or frozen shipments. The comments state
that perishable food that is held or is not properly stored may no
longer be commercially viable when it is released or sold at auction.
Comments also state that highly perishable shipments that are held past
their commercially viable time period and small shipments that have
little commercial value will quickly fill any warehouse, including any
G.O. warehouse, with no one to claim them. Other comments request that
FDA and CBP develop a joint operational plan for handling refused
merchandise with input from the importing and shipping industries.
Another comment states that directions on executing CBP 6043 Permit to
Transfer or CBP 7512 ``Restricted in-bond'' is needed to avoid major
congestion.
(Response) Section 1.283(a)(2)(i) of the final rule provides that
food refused under section 801(m)(1) of the act has ``General Order''
status. Under CBP laws and regulations, general order merchandise must
generally be held in a general order warehouse (19 CFR 127.1). CBP
regulations also empower the port director, if merchandise requires
specialized storage facilities that are unavailable in a bonded
facility, to direct the storage of the merchandise by the carrier or by
any other appropriate means (see 19 CFR 4.37(f), 122.50(f), or
123.10(f)). Additionally, fruit and other perishables may be held by
the port director in a bonded cold-storage warehouse for a reasonable
period, if it is probable that entry will be made at an early date (19
CFR 127.28(c)).
FDA and CBP believe that general order storage qualifies as secure
facilities for purposes of the Bioterrorism Act, as it is subject to
the requirements set forth at 19 CFR part 19. In particular, 19 CFR
19.9 contains controls that will ensure that refused food will be
adequately controlled while in storage and will not be released from
general order storage without CBP authorization.
FDA also emphasizes that refusal under section 801(m) of the act
occurs when no prior notice or inadequate or untimely prior notice is
submitted, as required under the Bioterrorism Act for articles of food
imported or offered for import into the United States. Costs and other
consequences described by the comments due to refusal for inadequate
prior notice should be avoided when adequate prior notice is submitted
to FDA. The final rule also outlines procedures for satisfying the
prior notice requirements after food has been refused and procedures
for requesting an FDA review of the refusal.
(Comments) One comment requests that FDA establish a clear
definition of ``perishable'' shipments. The comment states that
destroying or selling frozen, refrigerated, and fresh merchandise held
at a secure facility after 3 days, for inadequate prior notice, is
unreasonable and an excessive financial burden on international trade.
(Response) FDA does not agree that it is necessary or pertinent to
establish a definition of ``perishable'' for purposes of implementing
the prior notice requirements of the Bioterrorism Act, which requires
FDA to receive prior notice of food imported or offered for import into
the United States. Financial burdens associated with merchandise
directed to a secure facility because of inadequate, untimely or no
prior notice generally can be avoided by ensuring FDA receives adequate
prior notice in accordance with this final rule.
(Comments) Some comments request that FDA consider the ``port of
entry'' to be the port where legal entry is accomplished. The comments
state that these ports have facilities for proper food storage, as well
as the CBP and FDA processes and personnel to deal with any
irregularities. The comments point out that international shipments are
not legally ``entered'' with CBP at the port of arrival, but instead
are moved under bond to a subsequent port where CBP entry is made.
Further, shipments are not released at the port of entry until
clearance is obtained from CBP, and carriers are under a strict
obligation to retain control of shipments from the port of arrival to
the legal entry port. The comments note that under the IFR, shipments
of food will not be permitted to be moved from the port of first
arrival to the port of legal entry if prior notice is not provided or
is inadequate. According to the comments, express carriers may be
required to unload and reload entire planes in order to find one or two
shipments. The comments state that this is especially problematic
because proper facilities for the storage of food may not be available
at the ports of arrival. Comments further note that express consignment
operators have invested millions of dollars to construct and operate
dedicated sorting facilities that use state of the art automation and
scanning equipment. These facilities are far better suited to
identifying and detaining food shipments of concern to FDA than the
ramps or conventional air freight handling facilities commonly found at
the ports of arrival. Other comments state that there are no cold
storage facilities currently available in San Diego/Otay Mesa. The
comments contend that the Mexican authorities will not permit such
shipments to be returned to Mexico.
(Response) The IFR and the final rule at Sec. 1.283(a)(1) require
that food refused due to inadequate prior notice food must be held
within the port of arrival only if directed by CBP or FDA, and that
otherwise refused food must be held within the port of entry.
As we discussed in the preamble to the IFR, we defined ``port of
arrival'' and ``port of entry'' to provide flexibility to ensure that
``food that has been refused may move to the port of destination where,
for example the consumption or warehouse entry will be filed, unless
directed by CBP or FDA. Generally, we do not intend to hold shipments
at the border unless our assessment of the situation leads us to
believe it is warranted; e.g., the food may present a serious risk to
public health or that the prior notice violation is egregious.'' (See
68 FR 58974 at 58988.)
[[Page 66368]]
(Comments) One comment requests that FDA notify public food storage
warehouses when a shipment is being held, is not accepted for entry, or
when such shipments are released. The comment points out that the
warehouses receive shipments via multiple transport methods, store them
for multiple customers, and should be officially informed of the status
of the shipments, rather than relying on information from the owners of
the articles of food.
(Response) Under Sec. 1.283(a)(2), refused food shall not be
entered and shall not be delivered to the importer, owner, or
consignee. As discussed previously, FDA does not believe it should
modify the rule to require notice of the refusal to any specific entity
or entities. The entity moving the food to a warehouse can notify the
warehouse of the food's status, and the warehouse can likewise ask or
require that it be provided this information before accepting the food
for storage.
(Comments) Some comments state that the requirement in Sec.
1.283(a)(2)(ii) for carriers to notify FDA regarding delivery of
refused shipments within 24 hours of arrival and then to make delivery
immediately imposes an unreasonable burden on carriers.
(Response) We have changed the requirement to notify FDA of the
location where the food has been or will be moved from within 24 hours
of refusal to before the food is moved to that location. FDA needs this
information before the food is moved to verify that the facility where
the food is to be held is a secure facility. Moreover, because refused
food shall not be delivered to the importer, owner, or ultimate
consignee, before the food is moved, FDA needs to verify that the
secure facility is not owned by any of these parties.
For clarity and consistency, we also are changing the phrase
``designated location'' to ``secure facility'' in Sec. 1.283(a)(2)(ii)
and throughout the final rule. In addition, Sec. 1.283(a)(2)(ii) of
the IFR states that refused food must be moved under appropriate
custodial bond. We have revised this paragraph in the final rule to
state that the refused food must be moved under appropriate custodial
bond, unless immediately exported under CBP supervision. The final rule
also clarifies that the refused food may be held at the port of entry
or at a secure facility.
(Comments) Some comments request clarification on whether ``refused
goods'' will have to be exported or destroyed.
(Response) Articles of food that have been refused under section
801(m) of the act because of inadequate prior notice must be held until
prior notice requirements have been satisfied, unless the food is
immediately exported with CBP concurrence from the port of arrival. The
decision to export the refused food is not the responsibility of FDA or
CBP. If no prior notice submission or request for FDA review is
submitted in a timely fashion after a food is refused, the food will be
dealt with as set forth in CBP regulations relating to general order
merchandise. It may only be sold for export or destroyed as agreed to
by CBP and FDA.
(Comments) One comment requests clarification on the process for
designating a ``secure facility'' after a shipment of food is refused
admission status. The comment points out that the CF3461 entry document
currently designates a CBP exam site in box 29 and requests
clarification on whether refused goods will be sent automatically to
the designated CBP exam site or if arrangements can be made to
designate another facility.
(Response) FDA clarifies that a refusal under section 801(a) of the
act, relating to admissibility, differs from a refusal under section
801(m) of the act, relating to prior notice. A food refused under
section 801(m) of the act must be held within the port of entry for the
article of food unless directed to another location by CBP or FDA. If
CBP or FDA directs the food to be delivered to a secure facility, this
will not necessarily be the CBP exam site designated in box 29 of the
CF3461 entry document.
(Comments) Some comments ask if FDA will publish a list of approved
``secure facilities'' by port so that transmitters can designate these
facilities.
(Response) Early in our prior notice experience, FDA had indicated
that we would publish a list of secure facilities. However, our
experience has shown us that it is not practicable to maintain such a
list since the secure status of facilities changes very rapidly. While
we will not maintain such a list, FDA will verify whether a facility is
secure on a case-by-case basis.
(Comments) Some comments request that FDA and CBP jointly issue a
guidance document explaining in greater detail how they intend to hold
and store articles of food, particularly perishable food, refused
admission into the United States. One comment requests that FDA clarify
the process for food that is held and later deemed to be admissible.
(Response) FDA agrees and, as resources permit, will publish a
guidance document that will set out procedures for food refused for
failure to meet prior notice requirements.
(Comments) Some comments state that there are an insufficient
number of general order warehouses to store the food articles that have
been refused for noncompliance with these regulations.
(Response) FDA disagrees. Under CBP laws and regulations, general
order merchandise must generally be held in a general order warehouse
(19 CFR 127.1). However, in ports where there is no bonded warehouse
authorized to accept general order merchandise, CBP regulations also
empower the port director to direct the storage of the merchandise by
the carrier or by any other appropriate means (see 19 CFR 4.37(f),
122.50(f), or 123.10(f)). In addition, our experience has not shown
that there are an insufficient number of general order warehouses to
store food that has been refused under prior notice.
(Comments) Some comments state that FDA must delay full enforcement
of the prior notice regulations until it has done all that is necessary
to equip the U.S. ports to handle refused perishable goods.
(Response) FDA believes that the ports are equipped to handle
refused perishable goods. Since the IFR took effect, we have not been
aware of problems relating to perishable goods not being properly
maintained while being held at the ports.
(Comments) Some comments ask whether public storage warehouses will
be stuck with unsaleable food items or whether they will be compelled
to re-export at their own expense if the owner abandons a shipment that
is refused entry because of inadequate prior notice. Comments indicate
that a warehouse loses its lien abilities if a refused shipment is not
allowed in interstate/intrastate trade and is re-exported. Thus,
according to the comments, if the owner of the food does not pay
storage and handling for the product, the warehouse has no collateral
to compel payment. Comments also state that even if it does remain at
the warehouse and the owner declines payment, the product has been
refused entry so it cannot be sold to allow the warehouse to recoup its
charges.
(Response) Under the final rule, food refused under section 801(m)
of the act is considered to be general order merchandise and generally
must be held at a general order warehouse. If the refused food is not
immediately exported and if no prior notice is submitted or resubmitted
and no request for FDA review of the refusal is submitted, then the
food will be dealt with as set forth in CBP regulations relating to
general order merchandise (19 CFR part 127), except that, unless
otherwise agreed to by CBP and FDA,
[[Page 66369]]
the article may only be sold for export or destroyed (Sec.
1.283(a)(6)).
We made a minor change to the final rule by changing the last
phrase of Sec. 1.283(a)(6) from ``* * * except that the article may
only be sold for export or destroyed as agreed to by CBP and FDA'' to
``* * * except that, unless otherwise agreed to by CBP and FDA, the
article may only be sold for export or destroyed.'' This change was
needed because concurrence from FDA is not needed whenever a refused
article of food is sold for export or destroyed, and no prior notice is
submitted or resubmitted and no request for FDA review is submitted. We
are adding the phrase ``unless otherwise agreed to by CBP and FDA'' to
allow for the improbable (but not impossible) scenario when a refused
prior notice shipment would need to be transferred to another agency
for examination or investigation; in these cases, we would want
concurrence from both FDA and CBP.
(Comments) Some comments request that FDA revise the requirement to
store refused merchandise at local port facilities. One comment
indicates that this provision of the IFR does not make sense and does
not provide any measure of security or safety to the food supply. The
comment points out that, before the IFR, shipments were allowed to be
held at the importer's premises and suggested that this practice should
be allowed to continue. According to the comment, ports and land
borders do not have sufficient storage capacity to handle the possibly
overwhelming demand for space that will be needed when the prior notice
regulations are implemented.
(Response) FDA disagrees. Section 801(m)(2)(B) of the act
specifically requires that food refused under section 801(m) be held
and not delivered to the importer, owner, or consignee. The IFR and the
final rule require that refused food must be held within the port of
entry for the article unless directed to another location by CBP or
FDA. Therefore, an importer's premises, as suggested by the comment,
would not be appropriate since the Bioterrorism Act specifically
requires that the refused food not be delivered to the importer, owner,
or consignee. Nor would such a location be adequate because it also may
not be secure.
(Comments) Some comments object because shipments of food for which
prior notice has not been provided will not be permitted to be moved to
the port of entry. According to the comments, the operator will be
required to off-load these shipments and detain them at the port of
arrival until the prior notice is provided.
(Response) FDA disagrees. The IFR and the final rule require that
refused food must be held within the port of entry for the article
unless directed to another location by CBP or FDA. Thus, refused food
may be permitted to move to the port of entry; such food is not
required to be held at the port of arrival.
(Comments) Some comments express concern about the time it takes
for FDA to release food offered for import into the United States, and
request that FDA examine its inspection procedures and reduce the time
to clear and release the food. The comments indicate that some
shipments of food have been held at the port of entry for periods
ranging from 2 weeks to 2 months, which has a serious economic impact
on importers of perishable foods. The comments point out that there are
already additional costs associated with the IFR, such as fees charged
by custom brokers to file the prior notice. The comments further state
that the delays are adding more costs that importers must bear,
including the cost to store the food during this period, additional
freight charges, and costs incurred due to spoilage of perishable
products.
(Response) We know of no instance where a food has been held at any
port facility or secure location for an extended period of time as
described in the comment (2 weeks to 2 months) due to FDA's review of a
prior notice submission or due to FDA's refusal of food for failure to
provide adequate prior notice. Perhaps the comment actually is
referring to delays caused by FDA's admissibility review under section
801(a) of the act. Nevertheless, FDA will make every effort to minimize
the time necessary to perform prior notice assessments to minimize
delays in releasing shipments.
4. Segregation of Refused Foods (Sec. 1.283(a)(3))
(Comments) Some comments state that in an ``LTL'' (less-than-
truckload) environment, where an average trailer contains about 40
shipments, there is a potentially serious impact on several parties
when prior notice is not filed in a timely fashion for one of the
articles of food. The comments point out that the motor carrier's
potential loss of productivity from having equipment tied up when an
article of food has been denied entry or is being held has a serious
negative impact on the profitability of cross-border trucking
operators. According to the comments, this kind of down time has a
serious negative impact on truck drivers' compensation, when they are
paid based on miles driven, and greatly reduces the number of allowable
hours a driver is allowed to operate under Federal Motor Carrier Safety
regulations. The comments also indicate that holding a trailer at a
port of entry affects not only the motor carrier's operations, but also
all of the shippers, importers, and consignees whose goods are on
board. Some comments request that FDA require importers to provide
motor carriers with proof that prior notice was transmitted to FDA. The
comments state that currently FDA and CBP only suggest that motor
carriers require proof of prior notice filing from customers, but this
type of arrangement is not required by law or regulation. According to
the comments, because FDA system's acknowledgement of receipt of a
prior notice does not mean that the information received is correct or
complete, carriers are still left vulnerable to carrying goods that
could be turned back at the border. The comments indicate that this
type of action by FDA would tie up a carrier's equipment, negatively
affect driver wages, and have a serious effect on carrier productivity.
(Response) Financial burdens associated with refused food because
of inadequate or no prior notice generally can be avoided by ensuring
FDA receives adequate prior notice in accordance with this final rule.
For example, while the final rule requires only that the prior notice
confirmation number accompany any food for which the prior notice was
submitted through PNSI when the article arrives in the United States,
it does not preclude the carrier from requiring proof of confirmation
of prior notice submission prior to transporting the food to the United
States when prior notice is submitted through ABI/ACS. Moreover,
according to Sec. 1.283(a)(3) of the final rule, segregation may take
place to separate food that has not been placed under hold from food
refused for inadequate prior notice.
(Comments) Some comments request clarification on who is
responsible for the physical segregation of the refused food from the
rest of the shipment: The carrier, FDA or CBP, customs broker, or
importer. Comments also ask whether FDA or CBP officials will always
supervise the segregation.
(Response) The IFR at Sec. 1.283(a)(3) states that segregation may
take place to separate food that has not been placed under hold from
food refused for inadequate prior notice. The final rule clarifies this
paragraph by adding that other merchandise not subject to prior notice
requirements may be segregated from refused food.
[[Page 66370]]
The segregation may be done by any person as long as the refused
food is held as required and not delivered to the importer, owner, or
consignee. Neither FDA nor CBP is responsible for segregation. However,
the IFR and final rule state that FDA or CBP may supervise the
segregation. If FDA or CBP determine that supervision is necessary,
segregation must not take place without supervision.
(Comments) Some comments indicate that carriers should have the
option of unloading refused articles of food so they can deliver the
rest of their load without being detained any longer than necessary.
The comments point out that carriers do not have title or financial
interest in the goods they transport and they cannot provide
information to provide or correct an inadequate prior notice.
(Response) Carriers already have the option to segregate food so
that they can deliver the rest of their load. As discussed previously,
the IFR and the final rule at Sec. 1.283(a)(3) state that segregation
may take place to separate food that has not been placed under hold
from food refused for inadequate prior notice.
5. Costs (Sec. 1.283(a)(4))
(Comments) Some comments ask who is responsible for costs
associated with FDA verification of a shipment that is initially
refused and then it is later determined that the shipment's
documentation fulfills all requirements and complies with regulations;
i.e., the shipment was improperly refused.
(Response) Section 1.283(a)(4) of the final rule provides that
neither FDA nor CBP will be responsible for transportation, storage, or
other expenses resulting from refusal.
6. Export After Refusal (Sec. 1.283(a)(5))
(Comments) Some comments request clarification on procedures for
exporting fresh vegetables after refusal. The comments indicate that
some ports of arrival do not have cold storage facilities.
(Response) The procedures for exporting fresh vegetables after a
refusal under section 801(m) of the act are no different than other
exports, with the following qualifications: Food refused under section
801(m) must be immediately exported from the port of arrival with CBP
concurrence and under CBP supervision.
7. Post-Refusal Prior Notice Submissions (Sec. 1.283(c))
In Sec. 1.283(c)(2) of the final rule, FDA revised the text to
read ``the prior notice should be canceled'' instead of ``you should
cancel'' to indicate that the cancellation of the prior notice can be
done by CBP, upon request by the filer, if originally submitted in ABI/
ACS or by the transmitter if originally submitted in PNSI.
(Comments) Some comments object because the current ABI system
cannot accept prior notice after the articles of food arrive in the
United States. Instead, filers must use the PNSI system. The comments
suggest there is no valid reason for this limitation and request
modifications to allow filers to use the ABI system for submitting
prior notice, even after cargo has arrived in the United States. Other
comments request removal of edits for date sensitive prior notice in
ABI and PNSI. Some comments point out that if prior notice is
transmitted after the articles of food arrive, the filer must enter an
incorrect anticipated date of arrival, which is on or after the actual
date of arrival. According to the comments, this skews FDA information,
prevents FDA from determining whether prior notice was filed timely,
and gets the filer in the habit of submitting false information. The
comments also ask that if prior notice is submitted in this manner, how
FDA can determine if the date was filed timely or not? The comments
also state that because ABI will not accept prior notice on articles of
food that have already arrived, this leads to the more time consuming
filing of prior notice in PNSI and also leads to a corruption of the
correct data.
(Response) Prior notice submitted after the food has arrived in the
United States is a post-refusal submission. Under Sec. 1.280(a)(2) of
the IFR, post-refusal submission of prior notice must be completed via
PNSI. The final rule retains this provision, but re-worded the text to
state that post-refusal submissions must be submitted in PNSI until
such time as ACS or its successor system can accommodate such a
transaction. Post-refusal information requirements are found at Sec.
1.281(c). Among other data elements, a post-refusal submission requires
the location and address where the article of refused food will be or
is being held, the date the article has arrived or will arrive at that
location, and identification of a contact at that location (Sec.
1.281(c)(18)). The final rule now also requires the date the article of
food arrived at the port of arrival.
Post-refusal submissions cannot be submitted via ABI/ACS because
CBP's system cannot be modified at this time to accept information
about the location where the article of refused food will be or is
being held and the actual date of arrival of the article of refused
food. Amending ABI/ACS would entail substantial and costly revisions to
the system; such technical changes are not cost-effective or a good use
of limited resources given the development of the Automated Commercial
Environment, which will replace ACS.
PNSI programming changes should address the concern raised in the
comment about ``submitting false information.'' These same concerns
should not arise under the final rule since the final rule requires the
actual date of arrival for post-refusal submissions.
FDA made a minor change in the text of Sec. 1.283(a)(6) by
replacing the phrase, ``in a timely fashion,'' with the phrase, ``in
accordance with paragraph (d) of this section,'' to clarify that the
timeliness of a request for FDA review is found at paragraph (d). We
made a similar change in Sec. 1.285(g).
8. FDA Review After Refusal (Sec. 1.283(d))
(Comments) One comment requests that the final regulations make it
clear that the request for the review and/or the participation in the
review can be conducted by any of the parties named in Sec. 1.283(d)
of the IFR or by a designated representative, such as a customs broker,
freight forwarder, or attorney.
(Response) Section 1.283(d)(2) of the final rule provides that the
carrier, submitter, importer, owner, or ultimate consignee may submit a
written request asking FDA to review whether the article of food is
subject to the requirements of this subpart under Sec. 1.277. FDA has
added carrier in the final rule since the carrier is often the entity
notified of the refusal. Although not explicitly stated in the rule, a
designated representative of any of the parties listed (carrier,
submitter, importer, owner, and ultimate consignee) may act on behalf
of that party.
Furthermore, FDA revised Sec. 1.283(d)(1) to state that the
request for FDA review may include whether the information submitted in
a prior notice is complete, in addition to accurate. (In the IFR, we
also cited Sec. 1.276(b)(5), but we deleted it in the final rule
because it is redundant.) FDA revised Sec. 1.283(d)(5) to be
consistent with the changes made to Sec. 1.283(d)(1). In Sec.
1.283(d)(3), FDA revised the final rule to delete acceptance of
requests for review by mail and express courier. We are limiting
delivery to fax and e-mail to ensure that requests are expeditiously
received and directed to the appropriate staff.
[[Page 66371]] 9. International Mail (Sec. 1.283(e)) (Comments) Some comments request clarification on the disposition of mail for which prior notice is required, but is not provided. Comments also ask about the U.S. Postal Service's responsibilities for mail lacking prior notice. (Response) In the case of food arriving by international mail, if prior notice is inadequate or if the prior notice confirmation number is not affixed, the article will be held by CBP for 72 hours for FDA inspection and disposition. If the article is refused and there is a return address, the parcel may be returned to the sender. If there is no return address or the food in the shipment appears to present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA does not respond within 72 hours of the CBP hold, CBP may return the parcel back to the sender or, if there is no return address, destroy the parcel, at FDA expense. Under the prior notice final rule, only FDA and CBP have responsibilities for the destruction or return of refused foods that arrive via international mail. FDA revised Sec. 1.283(e) and Sec. 1.285(k) in the final rule to change the word ``stamped `No Prior Notice--FDA Refused''' to ``marked `No Prior Notice--FDA Refused''' to more accurately describe the marking that is placed on international mail packages arriving with inadequate prior notice or without the prior notice confirmation number affixed as required. In certain cases, the package cannot be stamped and a label/sticker is placed on the package. We also note that the Prior Notice Final Rule Draft CPG proposes an enforcement policy for foreign-to-foreign mail. Under the proposed policy, if there is no prior notice FDA and CBP should typically consider not taking any regulatory action in the case of international mail where the recipient is not in the United States since the sender does not have control over the transportation route that the foreign- to-foreign mail will transit. 10. Prohibitions on Delivery and Transfer (Sec. 1.283(f)) (Comments) Some comments ask whether CBP will put a manifest ``hold'' on food cargo until the prior notice confirmation is received. The comments state that, at the present time, cargo can be moved inland on an IT or T&E entry without FDA review. The comments ask if FDA will remind the transmitters that products should remain intact until a ``may proceed'' message is received. The comments further ask if ocean carriers will be advised of the FDA status of the articles of food when the shipment involves ``doors moves'' beyond 50 miles from the port of entry. (Response) Food arriving as an IT or T&E entry is subject to FDA review of prior notice before it arrives in the United States. Food that arrives with no prior notice is subject to refusal and must be held within the port of entry for the article unless directed to another location by CBP or FDA. Food that is refused under section 801(m) of the act is considered G.O. merchandise and cannot be entered or delivered to the importer, owner, or consignee. For clarity, FDA revised Sec. 1.283(f)(2) of the final rule to state that an article of food refused under section 801(m)(1) of the act may not be transferred by any person from the port or other designated secure facility. 11. Relationship to Other Admissibility Decisions (Sec. 1.283(g)) (Comments) Some comments request that FDA integrate the section 801(m) and the section 801(a) clearance processes and develop mechanisms to expedite the release of imported food for sale and use in domestic commerce. One comment states that currently numerous shipments that are offered for import are cleared for section 801(m), but are held pending section 801(a) review. The comments indicate that little is gained if shipments with adequate prior notice under section 801(m) are permitted to move promptly across the borders of the United States, only to encounter delays arising from the release process under section 801(a). The comments further note that in many cases, the shipments held for section 801(a) review are eventually released without another further examination or sampling. The comments suggest that a concurrent section 801(a) and section 801(m) review would eliminate rework, decrease unnecessary holds on shipments, and decrease the burden on both the importing community and FDA. Another comment also suggests that FDA integrate the prior notice information collection system with the existing OASIS (section 801(a) of the act) information management system as fully as possible. The comment states that these systems currently function separately, essentially creating two sequential FDA reviews. The comment believes that by merging these systems and resources, food security would be enhanced and productivity for FDA and the industry will be improved. In addition, the comment states that such a merger would be a natural extension of the ongoing integration efforts with CBP. (Response) FDA does not agree that doing the OASIS review under section 801(a) of the act concurrently with the prior notice review under section 801(m) of act would reduce the burden on the industry or FDA. Under section 801(m), prior notice for imported food shipments must be provided to FDA before the arrival, and an article of food is subject to refusal of admission if adequate prior notice has not been provided. Section 801(m) also provides that refused food must be held until adequate notice is given and may not be delivered to the importer, owner, or consignee. Thus, the refusal standard under section 801(m) is based on whether the requisite information has been provided in a timely fashion. The refusal standard in section 801(a) of the act is based on, among other things, whether the article appears to be adulterated or misbranded. Admissibility decisions under section 801(a) may be made after entry has been made. Thus, if prior notice is adequate, requests for further information, examination, or sampling of the food that is necessary to determine admissibility under section 801(a) may occur. The article of food need not be held at the port for FDA to accomplish its section 801(a) review. Because the section 801(m) review must occur prior to arrival, concurrent section 801(a) and section 801(m) reviews also would have to occur prior to arrival. FDA also notes that section 801(a) reviews typically take longer to complete than section 801(m) reviews. FDA believes such a concurrent process would be inefficient and impractical and would likely increase congestion at the ports of arrival. Thus, FDA generally intends to continue with its current practice of reviewing prior notice prior to arrival to decide whether to inspect the food at the time of arrival, based on information that suggests that the food is a potential significant risk to public health, and to allow shipments to proceed beyond the point of arrival to conduct section 801(a) reviews. (Comments) One comment asks FDA to clarify expectations at the port regarding ``may proceed'' decisions. The comment notes that the IFR indicates that ``the system will transmit a message back through OASIS to ABI/ACS interface for CBP that the article of food may be conditionally released.'' The comments continue to state that the IFR indicates that staff operating ``24 hours a day, seven days a week'' will review at the port of arrival or closest examination site. The comment notes that this implies decisions were to be
[[Page 66372]]
made at the port of entry. However, companies have reported that since
December 12, 2003, conditional release messages have not consistently
been received at entry. The comment asks that FDA clarify when this
message should be received and the implications for companies that
enter the United States within the ``release.''
(Response) The IFR states, ``If the FDA system does not indicate
that further evaluation of or action on the notice or article of food
is necessary for prior notice purposes, the system will transmit a
message back through the OASIS to ABI/ACS interface for CBP that the
article of food `may be conditionally released under section 801(b) of
the act.' However, if additional evaluation of the prior notice
information is necessary, FDA headquarters staff, operating 24 hours a
day, 7 days a week, will review and assess the information and may
initiate an examination or other action by FDA or CBP of the article of
food at the port of arrival or elsewhere, or in the case of rail
shipments, within the confines of the closest appropriate examination
site.'' (68 FR 58974 at 58976) The IFR clearly states that the
conditional release message is sent from FDA to CBP, not to any other
person. This is to ensure that CBP staff will know when the food
arrives if prior notice has been satisfied and that no further
examination by FDA is necessary. This conditional release does not
provide information about FDA's section 801(a) admissibility decision.
Further, the IFR clearly states that FDA headquarters staff operates 24
hours a day, 7 days a week and will review the prior notice and make
the decision regarding further action on the prior notice submission.
FDA and CBP do not intend to change these procedures for implementation
of the final rule.
(Comments) One comment encourages FDA to consider low risk status
to expedite its section 801(a) deliberations.
(Response) FDA does use a risk based approach when making prior
notice and admissibility decisions. FDA screening under section 801(a)
is separate from the subject of the final rule, FDA's screening under
section 801(m) of the act. Therefore, this comment is outside the scope
of the final rule.
(Final rule) Section 1.283 of the final rule describes the
consequences for an article of food that is imported or offered for
import with inadequate prior notice. The final rule sets out procedures
for resolving the inadequacy as well as for the movement and status of
the refused food.
K. What Are the Other Consequences of Failing to Submit Adequate Prior
Notice or Otherwise Failing to Comply With This Subpart? (Sec. 1.284)
Section 1.284 of the IFR provides that failure of a person who
imports or offers for import an article of food to submit prior notice
is a prohibited act under section 301(ee) of the act (21 U.S.C.
331(ee)) and sets out the civil, criminal, and debarment actions that
the United States may bring against persons who are responsible for the
commission of a prohibited act.
(Comments) One comment states that many of the mistakes made during
the initial implementation of the prior notice IFR can be attributed to
difficulties with both government and industry computer systems. The
comment indicates that such mistakes should not be part of an
importer's record.
(Response) FDA acknowledges that some mistakes in prior notice
submissions may have occurred because changes were needed in PNSI and
CBP's ABI/ACS or because industry needed to develop appropriate
software to facilitate the submission of prior notice. During the
initial implementation of the IFR that extended for more than 8 months
after the IFR took effect, FDA and CBP exercised enforcement discretion
to accommodate that situation. During this period, the two agencies
focused their resources on education to achieve compliance with the
prior notice requirements, escalating imposition of civil monetary
penalties, and ultimately refusal of shipments. This final rule will
take effect 180 days after today's publication date to allow affected
parties time to understand the requirements that differ from those in
the IFR, and make appropriate changes, including changes that may be
needed to filers' software. In enforcing prior notice, we will continue
to take into account the circumstances, such as whether a violation is
due to mistakes that can be attributed to difficulties in government
and industry computer systems during initial implementation.
(Comments) Some comments request clarification on the penalties
that apply for food that arrives without proper prior notice. Some
specifically request clarification of civil monetary penalties and an
explanation of the mechanism and criteria for application of these
penalties. One comment notes that, in the absence of clearly defined
procedures for assessing penalties, the current policy of liquidated
damages would apply, which has always been unacceptable with the
community and sureties.
(Response) CBP, in consultation with FDA, may assess civil monetary
penalties under 19 U.S.C. 1595a(b) against any person who directs,
assists, financially or otherwise, or is in any way concerned in the
importation of any merchandise contrary to law. During the early
implementation phase, FDA recommended to CBP that civil monetary
penalties (CMPs) be assessed only to those parties who failed to submit
prior notice. The parties were notified via e-mail regarding their
failure to submit prior notice before FDA recommended CMPs. As of May
2008, CBP has pursued CMPs on a total of 29 PNC related cases. Any CMPs
that CBP brings are subject to the administrative proceedings described
in 19 U.S.C. 1618 and 19 CFR part 171. Furthermore, liquidated damages
would not apply in the case of prior notice violations because no bond
obligations would vest under the basic importation bond.
(Comments) Some comments note that there are few options available
in the current penalty structure to assist FDA in enforcing compliance
other then civil and criminal charges. Comments suggest that some form
of monetary consequences, in lieu of civil and criminal charges, should
be available to allow FDA more flexibility in application.
(Response) Section 1.284 of the final rule provides consequences of
failing to comply with the requirements for submitting prior notice.
These are the primary enforcement options, aside from refusal of the
food, available to FDA under the Federal Food, Drug, and Cosmetic Act.
In addition, CBP can seize goods imported contrary to law, assess civil
monetary penalties or take other enforcement action, including referral
to U.S. Immigration and Customs Enforcement (ICE), as provided for
under its laws in lieu of or in addition to refusal of the food or
other civil and criminal penalties.
(Comments) Some comments suggest that failure to provide prior
notice in a timely fashion should result in refused entry and the
movement of the food to a secure facility where the prior notice can be
secured. The comments state that failure to enter U.S. commerce should
be considered a sufficient deterrent and that monetary penalties would
be counterproductive. The comments suggest that this arrangement would
avoid instances where businesses find themselves unable to trade or
constantly in situations of being in violation, and consequently
subject to criminal action.
(Response) FDA does not agree that refusal and movement of the food
to a secure facility will provide a sufficient
[[Page 66373]]
deterrent in all cases. CBP may assess civil monetary penalties under
19 U.S.C. 1595a(b) and will, in consultation with FDA, continue to
assess those penalties when warranted. FDA may further use the civil,
criminal, and debarment provisions provided by the Bioterrorism Act.
These statutory penalties are used only when warranted, and to date
have been used relatively infrequently.
(Comments) One comment notes that importers receive conflicting
information as to the enforcement guidelines at individual crossing
points and/or from individual FDA and CBP enforcement officers. The
comment recommends extension of the full enforcement date, which would
allow FDA and CBP to upgrade their current training efforts with the
officers at all ports of entry to ensure uniform and consistent
enforcement of the IFR.
(Response) FDA and CBP will continue to coordinate staff training
and industry outreach activities to ensure consistent enforcement of
the final rule. FDA believes that the effective date of 180 days after
publication of the final rule provides sufficient time to communicate
and implement changes to the final rule. As we establish enforcement
policies, these will be made publicly available through our compliance
policy guides. These policies and other information about the final
rule may be found through links on FDA's Web site at http://
www.fda.gov. FDA notes that the communication issues experienced when
the prior notice IFR initially took effect have been addressed and we
generally have found the prior notice process to be proceeding
smoothly.
(Comments) Some comments state that serious inconsistencies in
interpretation or application of the prior notice requirements at
multiple ports have caused confusion, delayed shipments, and increased
shipment costs. Examples provided by the comments include: the shifting
percentage of shipments that are physically held at the port due to
incomplete or inaccurate prior notice submissions during the initial
phases of enforcement, varying information regarding whether the
carrier must be in possession of the actual prior notice confirmation
number at the time of arrival regardless of whether the submission was
made via an ABI transmission, conflicting information as to whether
submissions of bonded freight will be allowed through the ABI system,
and failure to notify importers of specific errors pertaining to their
submissions. Some comments request that FDA establish a national office
with authority to resolve various field and port interpretations and
actions. Comments note the importance of a timely resolution to
disputes because of the potential financial impact to commerce if food
shipments are detained needlessly.
(Response) The initial source for resolving all perceived conflicts
is the final rule, and related information, including the responses to
comments in this preamble, the Prior Notice Final Rule CPG, and the
Prior Notice of Imported Food Questions and Answers, which may be found
through links on FDA's Web site at http://www.fda.gov. FDA's PNC, which
directs all prior notice activities, has been operating since the prior
notice IFR took effect on December 12, 2003. The PNC is available 24
hours a day, 7 days a week, and 365 days a year to answer questions and
resolve, as appropriate, operational concerns. The PNC can be reached
at 866-521-2297 for calls originating in the United States and 703-621-
7728 for calls originating from outside the United States. In addition,
FDA notes that based on the current PNC call/inquiry volume levels as
compared to those experienced during the initial 18 months of
implementation, repetitive prior notice submitters have now been
experiencing fewer difficulties in submitting prior notice.
(Comments) One comment requests that FDA outline what actions will
be taken against a company that is not complying with prior notice
requirements, but has committed the error only by acting on incorrect
advice from an FDA representative. The comment wants to know what
recourse is available to industry when a company faces large fines due
to inaccurate FDA guidance.
(Response) The PNC is responsible for resolution of these actions,
on a case-by-case basis. The advice that a submitter may have received
from an agency representative is considered when determining whether an
enforcement action is warranted. FDA notes that under the proposed
enforcement policy in the Prior Notice Final Rule Draft CPG, we intend
to take into consideration the circumstances surrounding a violation,
including the seriousness of the violation and flagrant and repeat
violations.
(Comments) One foreign government agency requests access to the
quantity and identity of the industries that are not complying with the
prior notice IFR so that they could help bring these industries into
compliance. The comment suggests creating a mechanism to notify foreign
governments of any noncompliance related to the Bioterrorism Act to
enable them to provide a faster and more efficient response.
(Response) FDA has established mechanisms for working cooperatively
with foreign government regulatory authorities on issues of mutual
concern, including matters relating to compliance with the prior notice
regulations. When requested and as resources allow, FDA/PNC personnel
have continued to participate in briefings for foreign governments and
organizations and at industry trade meetings. These have included
presentations to European Community visitors to the United States,
joint FDA-Canadian Food Inspection Agency import meetings, and other
foreign government and industry outreach events widely attended by both
industry and other government agencies, e.g., WESCCON (Western Cargo
Conference). FDA continues to work with foreign governments to develop
more efficient and effective communications. In addition, information
about compliance with prior notice requirements is posted at http://
www.cfsan.fda.gov/~pn/pnsum.html.
(Comments) Some comments request that FDA provide a sufficient
period of time for implementation of the final rule so that affected
parties can prepare for any changes in the rule.
(Response) FDA agrees and is providing 180 days after publication
of the final rule, which should be sufficient time for implementing
changes necessary to comply with the final rule.
(Comments) One comment states that FDA and CBP categorize some
articles of food differently; i.e., some articles that are ``drugs''
for FDA purposes are classified by CBP as ``foods.'' The comment
indicates that such products should not be denied entry or assessed
monetary penalties and suggests that the final rule provide for
immediate release and cancellation of monetary penalties for such
articles that are not ``food,'' as defined by the FDA.
(Response) FDA does not agree that a change in the final rule would
alleviate the concern expressed by the comment. The scope of the final
rule is stated explicitly in Sec. 1.277. Situations involving
discrepancies between FDA and CBP classification of an imported article
as a food or drug are best resolved on a case-by-case basis as they
arise. However, because FDA and CBP have worked closely to identify and
resolve such issues, the agencies believe that such situations will be
rare. In cases of doubt, the submitter should contact the PNC to
determine whether a product is an article of food subject to prior
notice requirements.
[[Page 66374]]
FDA uses a list of HTS codes to indicate which products FDA
believes prior notice is or may be required under the prior notice
regulations. FDA has provided this list to CBP so that CBP can ``flag''
the HTS codes in its entry systems to screen for foods for which prior
notice to FDA is required and to ensure that, as appropriate, prior
notice has been provided. FDA publishes this list to inform the food
industry which HTS codes have been ``flagged'' in CBP entry systems
with prior notice indicators. Guidance about the HTS flags is posted at
http://www.cfsan.fda.gov/~dms/htsguid3.html.
(Comments) One comment suggests that FDA consider the importer's
circumstances when denying entry or assessing penalties. The comment
states that, although it is reasonable to expect a company whose
principal business is importing food to abide by regulations applicable
to food imports, companies that rarely import food products will likely
have greater difficulty in complying with the requirements. The comment
further states that although these companies should be required to
comply before their entries are released, blanket denials of entry or
assessments of monetary penalties are not appropriate.
(Response) Elsewhere in this issue of the Federal Register, we are
announcing our Prior Notice Final Rule Draft CPG which describes our
policies for enforcing prior notice. Under the CPG, we are proposing to
take into consideration the circumstances surrounding a violation,
including the seriousness of the violation and flagrant and repeat
violations.
(Final rule) Section 1.284 of the final rule states that the
importing or offering for import into the United States of an article
of food in violation of the requirements of section 801(m) of the act,
including the requirements of this subpart, is a prohibited act under
section 301(ee) of the act and sets out the civil, criminal, and
debarment actions that the United States may bring against persons who
are responsible for the commission of a prohibited act.
L. What Happens to Food That is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under Subpart H
of This Part? (Sec. 1.285)
Section 1.285 of the IFR outlines the consequences for food
arriving at the port of arrival from facilities that are not registered
as required under section 415 of the act and 21 CFR part 1, subpart H.
These are similar to provisions in the IFR for handling food that is
refused for inadequate prior notice. The IFR states that if an article
of food from a foreign manufacturer that is not registered as required
under section 415 of the act and subpart H is imported or offered for
import into the United States, the food is subject to being held at the
port under section 801(l) of the act and refusal under section 801(m)
of the act and Sec. 1.283 for failure to provide adequate prior
notice. Under the IFR, the failure to provide the correct registration
number of the foreign manufacturer, if registration is required under
section 415 of the act and 21 CFR part 1, subpart H, renders the
identity of that facility incomplete for purposes of prior notice.
(Comments) Several comments state that FDA should increase
inspections of imported food when they arrive at the port, rather than
denying admission based on lack of the manufacturer's registration
number.
(Response) If the prior notice does not include a registration
number, it can instead include the full address of the manufacturer and
the reason why the registration number is not provided. In this
situation, the article of food will not be refused admission solely
because of the lack of the manufacturer's registration number. We agree
with the comments it is appropriate to consider the fact that the
registration number is not provided in determining whether FDA should
inspect the food, either upon arrival or as part of the admissions
process.
While an article of food will not be refused admission solely
because of the lack of the manufacturer's registration number, the food
is nonetheless subject to being held under section 801(l) of the act if
the manufacturer has not registered under section 415 of the act. It
may take FDA more time to determine the registration status of the
manufacturer if the name and full address, but not the registration
number, is provided as part of prior notice. Thus, if the registration
number is not provided, this may delay the food at the border until
this verification is completed.
(Comments) Some comments state that, although the prior notice
regulations clearly indicate that the manufacturer's registration
number is required on the prior notice, even for U.S. Goods Returned,
they do not expressly indicate that refusal will result when the
registration number is not provided. Rather, according to the comments,
Sec. 1.285(a) of the regulations only indicates that articles of food
arriving from an unregistered foreign facility will be subject to
refusal, as will articles of food arriving with an inaccurate
registration number in the prior notice. In more general terms, under
Sec. 1.283(a)(1)(ii), articles of food arriving with an ``inaccurate''
prior notice are subject to the same possibility of refusal upon
arrival. The comments state that the language of the regulations does
not guarantee refusal, but provides for flexibility and discretionary
enforcement. Comments suggest that FDA should not refuse entries for
which the importer does not know and cannot determine the registration
number.
(Response) As discussed in the previous response, if the prior
notice does not include a registration number, it can instead include
the full address of the manufacturer and the reason why the
registration number is not provided. In this situation, the article of
food will not be refused admission solely because of the lack of the
manufacturer's registration number, although the food is nonetheless
subject to being held under section 801(l) of the act if the
manufacturer has not registered under section 415 of the act.
Because this is a change from the IFR, in the final rule we have
deleted the text in ' 1.285(a) that states that failure to provide the
manufacturer's registration number renders the identity of the facility
incomplete for purposes of prior notice. We have also clarified the
text in ' 1.285(b) by removing the phrase ``imported or offered for
import from a foreign facility that is not registered as required under
section 415 of the act'' because it is redundant.
As part of our effort to develop policies for enforcing prior
notice and section 801(l) of the act, we are publishing the Prior
Notice Final Rule Draft CPG, announced elsewhere in this issue of the
Federal Register.
(Final rule) Section 1.285 of the final rule describes the
consequences and processes for food imported or offered for import in
the United States that is from a facility that is not registered under
section 415 of the act and 21 CFR part 1, subpart H. The food is
subject to being held and cannot be delivered to any importer, owner,
or consignee.
FDA also made other minor changes in this section.
<bullet> We revised the requirement in Sec. 1.285(c)(2) to notify
FDA of the location where the food has been or will be moved from
within 24 hours of refusal to before the food is moved to the hold
location. FDA needs this information before the food is moved to verify
that the facility where the food is to be held is a secure facility.
Moreover, because refused food shall not be delivered to the importer,
owner, or ultimate consignee, before the food is moved, FDA needs to
verify that the
[[Page 66375]]
hold location is not owned by any of these parties. In addition, Sec.
1.285(c)(2) of the IFR states that food under hold must be moved under
appropriate custodial bond. We have revised this paragraph in the final
rule to state that the refused food must be moved under appropriate
custodial bond, unless immediately exported under CBP supervision. The
final rule also clarifies that the refused food may be held at the port
of entry or at a secure facility.
<bullet> We revised Sec. 1.285(g) for clarity by adding the word,
``number,'' after the word, ``registration.'' We also changed the last
phrase of Sec. 1.285(g) from ``* * * except that the article may only
be sold for export or destroyed as agreed to by CBP and FDA'' to ``* *
* except that, unless otherwise agreed to by CBP and FDA, the article
may only be sold for export or destroyed.'' Similar to Sec.
1.283(a)(6), this change was needed because concurrence from CBP and
FDA is not needed whenever an article of food placed under hold under
section 801(l) of the act is sold for export or destroyed, and no
registration number or request for FDA review is submitted. We are
adding the phrase ``unless otherwise agreed to by CBP and FDA'' to
allow for the improbable (but not impossible) scenario when such a
shipment would need to be transferred to another agency for examination
or investigation; in these cases, we would want concurrence from both
FDA and CBP.
<bullet> In Sec. 1.285(h), we added the phrase, ``is not for
personal use,'' after the phrase, ``food carried by or otherwise
accompanying an individual arriving in the United States,'' because if
it is for personal use, then it is not subject to prior notice as
provided by Sec. 1.277(b)(1).
<bullet> We deleted references and provisions in Sec. 1.285(i) and
(l) relating to refusals, because the process for resolving a prior
notice submission for an article of food from a facility that is not
registered as required is based on holds under section 801(l) of the
act and not refusals under section 801(m) (see discussion above for
Sec. 1.285(a)). Under Sec. 1.285(i)(2), we are allowing submission of
the notification resolving the hold by fax and e-mail only, and
deleting the option to submit the notification by mail and express
courier. We also made other minor revisions to this Sec. 1.285 to
simplify the text.
<bullet> We revised Sec. 1.285(j)(2) of the final rule to allow
the carrier to submit a request for review after hold. Under Sec.
1.285(j)(3), we revised the final rule to allow submission of the
request for review after hold by fax and e-mail only, and deleted the
option to submit the notification by mail and express courier.
M. Outreach and Enforcement
As discussed in the IFR, FDA directed outreach to both domestic and
international stakeholders after publication of the IFR (68 FR 58974).
Our outreach activities included many methods of communication:
<bullet> Dissemination of materials to guide affected domestic and
international food facilities through the new processes established to
implement prior notice requirements;
<bullet> Numerous domestic and international outreach meetings to
the food industry, trade organizations, and State and foreign
government regulators;
<bullet> A series of videoconferences and a satellite downlink
video broadcast to more than 1,000 sites around the world;
<bullet> Materials provided for and events targeted to the media;
<bullet> Presentations by FDA officials and exhibits at
professional and trade conferences and meetings to inform industry and
State and local government representatives of the new requirements;
<bullet> Presentations by USDA's Foreign Agricultural Service (FAS)
and U.S. embassy officials who disseminated materials and answered
questions in various countries;
<bullet> Cooperative arrangements with CBP and other Federal
agencies to ensure that information on the interim final regulations
and their requirements is disseminated to affected companies and
individuals; and
<bullet> Issuance of several guidance documents (all available on
the Internet) that explain the prior notice requirements, including,
``Prior Notice of Imported Food: Questions and Answers,'' ``What You
Need to Know About Prior Notice of Imported Food Shipments,'' and
numerous Web-based tutorials for PNSI. Many of these guidance documents
are available in foreign languages; e.g., Arabic, French, Hindi,
Japanese, Malay, Portuguese, and Spanish.
Specifics regarding each of these activities are included on FDA's
Web site. In addition, FDA also provided training in new or revised
procedures for its field personnel, as well as CBP field personnel. FDA
included an initial transition period in the December 2003 prior notice
CPG for more than 8 months, during which the agencies emphasized
education to achieve compliance, rather than refusal of articles of
food with inadequate prior notice.
Shortly after publication of the IFR, FDA began disseminating at
U.S. ports flyers and posters summarizing the new requirements and
informing representatives of affected entities how to provide prior
notice to FDA. We also provided (and continue to provide) online
assistance and the FDA Help Desk to deal with technical issues
involving PNSI after the IFR became effective.
When FDA reopened the comment period on the IFR in the Federal
Register of April 14, 2004, under discussion of Flexible Alternatives
in question 7, we asked: ``Should FDA offer a prior notice submission
training program for submitters and transmitters, including brokers, to
ensure the accuracy of the data being submitted?'' Many comments
address various issues concerning outreach and enforcement. Discussion
of these issues by subject follows, proceeded by a discussion of
general issues.
1. General Outreach and Enforcement Issues
(Comments) Several comments acknowledge that the outreach
activities conducted by FDA and CBP were of tremendous assistance to
affected persons with the implementation of the PNSI and encourage
continued communication between the trade community and FDA and CBP.
Several other comments state that FDA and CBP's outreach efforts were
ineffective and encourage continued efforts toward education and
outreach.
(Response) FDA received praise from the Small Business
Administration for our efforts to address regulatory flexibility and
the impact on small business of the interim final rule. FDA and CBP
will continue outreach efforts to affected industry and other
governments, as resources allow. These efforts will focus on changes to
and implementation of the final rule. The PNC also will continue to
answer questions and provide technical assistance upon request, and FDA
and CBP will issue and update guidance as policies change or need
clarification.
2. Prior Notice Submission Training Program From Flexible Alternative
Question 7
(Comments) Many comments believe that a training program will
improve the accuracy of the data being submitted under the regulations
and that a training program would resolve many of the other problems
being encountered with the present rules. One comment suggests that,
following a detailed analysis of compliance issues, FDA should target
its training to specific problems and their solutions, and to entities
new to the process. One comment suggests that FDA offer a training
program for brokers and other transmitters and submitters. Other
[[Page 66376]]
comments recommend that specific outreach and training should be
conducted for each mode of transportation. Another comment cautions
that the FDA and CBP should have resources to implement an educational
campaign before initiating another training and outreach program.
(Response) FDA and CBP will conduct training focused on changes
between the final rule and the IFR. Depending on resources, the
education and outreach may take the form of public meetings, Web-based
interactive training, or posting on our Web sites of guidance and other
outreach materials. As resources permit, we also may translate our
guidance and other outreach materials into other languages.
3. Requests for Additional Outreach
(Comments) There were many comments that request additional
outreach and training, as well as some comments that suggest specific
outreach programs, such as:
<bullet> Providing an expanded program that would educate and train
all stakeholders, including substantially more and varied educational
programs before the full enforcement of the IFR, and escalating
training efforts in the area of shipper and carrier education and
compliance;
<bullet> Establishing an effective mechanism for disseminating
answers to specific questions to affected persons;
<bullet> Providing enforcement guidance that addresses specific
enforcement issues, such as enforcement of the food facility
registration requirements at the time of prior notice submission and
describing enforcement procedures in detail;
<bullet> Providing guidelines on the procedures to submit prior
notice either via FDA's PNSI or CBP's ABI, such as instructions on
cancellation or change of a prior notice and descriptions on what is
meant by identifying goods by the common, usual or market name;
<bullet> Explaining procedures of the rule in foreign languages and
establishing point of contacts in foreign countries;
<bullet> Publicizing the rule to individual Americans who will
travel abroad, and making compliance with it a simple, practicable, and
straight forward process;
<bullet> Providing a Web-based tutorial;
<bullet> Using CBP's ABI Administrative Messages to announce
changes in PNSI;
<bullet> Establishing an FDA and CBP agency-industry working group
and/or a more formal advisory committee with representatives of various
industry groups;
<bullet> Improving staffing on the ``hotline'' and/or creation of
an exclusive Help Line staffed with individuals with the requisite
technical expertise and the ability to resolve operational problems as
they arise;
<bullet> Creating dedicated e-mail addresses within FDA to which
specific questions can be addressed and/or specific e-mail addresses
for different technical and operations areas;
<bullet> Providing prompt information to submitters regarding
inadequacies or inaccuracies in prior notice, including shipment level
feedback to the filer; and
<bullet> Holding public meetings before the final rule takes effect
to ensure that all affected parties understand the rule and can be
heard.
(Response) We will provide outreach and training on the final rule
as resources permit. At a minimum, we will provide guidance and
instructions on the process for filing prior notice on our Web site.
This guidance, along with detailed instructions on the use of PNSI,
including step-by-step help, is available at http://www.cfsan.fda.gov/
~furls/helpf.html.
We agree with the recommendation to establish an effective
mechanism for disseminating answers to specific questions to industry,
and have issued guidance documents for each of the rules we have issued
to implement the authorities in the Bioterrorism Act that provide our
response to the frequently asked questions (FAQs), including the prior
notice IFR. We anticipate doing the same for this final rule. These
guidance documents are designed to help affected parties comply with
the legal requirements established by the various rules. We intend to
issue additional guidance as new questions arise and as resources
permit.
In terms of providing enforcement guidance, in December 2003, FDA
and CBP issued a CPG that stated that, until August 12, 2004, the two
agencies generally would utilize communication and education strategies
with escalating imposition of civil monetary penalties rather than
refusal of shipments. The two agencies revised the CPG in June 2004,
August 2004 (August 16, 2004, 69 FR 50389), November 2004, March 2005,
and November 2005 (November 14, 2005, 70 FR 69160), as our enforcement
policies changed and evolved. Published elsewhere in this issue of the
Federal Register is a notice of availability for the Prior Notice Final
Rule Draft CPG, which describes FDA's and CBP's proposed policies for
enforcing this final rule. A copy of the CPG may be found at http://
www.fda.gov/ora under ``Compliance References.''
Generally, FDA enforcement procedures regarding imports are
provided in FDA's Regulatory Procedures Manual, Chapter 9. This
guidance is posted at http://www.fda.gov/ora/compliance_ref/rpm_new2/
ch9/default.htm.
FDA agrees, in part, with the recommendation about providing user
guidelines and has provided guidance and instructions on the process
for filing prior notice. This guidance, along with detailed
instructions on the use of the PNSI, including step-by-step help, is
available at http://www.cfsan.fda.gov/~furls/helpf.html. Instructions
for contacting FDA with questions about prior notice are also available
at that Web site.
FDA cannot provide specific instructions on the use of ABI software
to file prior notice, as that software is developed and made available
through private vendors. Users should contact their vendor for specific
instructions on the use of their ABI software. CBP does regularly issue
to filers ABI Administrative Messages which provide instruction and
guidance regarding submission of prior notice through ABI/ACS.
As part of our outreach efforts for the prior notice IFR, we issued
a number of documents explaining the requirements of the IFR and/or
PNSI and provided them on our Web site in English and one or more other
languages, including:
<bullet> FDA Industry Systems, Index of Help Pages at
http://
www.cfsan.fda.gov/~furls/helpol.html) (also available in Spanish);
<bullet> HELP: Getting Started: Create New Account Quick Start
Guide) (also available in Spanish);
<bullet> OUTREACH: Overview of Prior Notice Interim Final Rule
(Slide Presentation) (also available in Arabic, French, Malay and
Spanish);
<bullet> Booklet: What You Need to Know About Prior Notice of
Imported Food Shipments (also available in French and Spanish); and
<bullet> Fact Sheet on the Interim Final Rule--Prior Notice of
Imported Food Shipments (also available in French, Malay, Polish,
Portuguese, Spanish, Arabic, Chinese, Hindi, and Japanese).
We also have an ``FDA Food and Cosmetic International/Foreign
Language Documents and Videos,'' which is a list of all food (and
cosmetic) documents that have been translated and the languages in
which they are available on our Web site at http://www.cfsan.fda.gov/
~mow/internat.html. Many of the documents describing prior notice
requirements and guidance have been translated into foreign languages.
FDA does not currently maintain staff in foreign countries.
However, FDA has
[[Page 66377]]
developed the Beyond our Borders initiative, which includes plans to
build an on-the-ground presence for FDA in Asia, Europe, Latin America,
and the Middle East. In March of 2008, we received approval from the
U.S. Department of State to establish eight full time permanent FDA
positions at U.S. diplomatic posts in the People's Republic of China,
pending authorization from the Chinese government. Furthermore, CBP,
U.S. Department of State, and USDA Food Agricultural Service staff are
located at U.S. Embassies in many foreign countries. These U.S.
government entities frequently provided assistance to foreign
stakeholders, including foreign government officials and private
companies, in understanding the requirements of various U.S.
regulations, including those provided in our Bioterrorism Act
regulations. We will routinely update these U.S. officials abroad about
changes to and implementation of this prior notice final rule.
As resources permit, we also will continue to translate guidance
documents and system instructions into other languages.
FDA agrees with the comment requesting publicizing the rule to
individual Americans who will travel abroad, and making compliance with
it a simple, practicable, and straight forward process. CBP Publication
<greek-i> 0000-0512, revised January 13, 2005, Know Before You Go--
Regulations for U.S. Residents, is posted at http://www.cbp.gov/xp/
cgov/travel/vacation/kbyg/. This publication is the primary CBP
guidance document concerning import regulations targeted to travelers
and contains information about the prior notice final rule's
requirements for importation of food. In addition to providing
information about prior notice requirements, the publication also
provides a link to FDA's Web site at http://www.fda.gov/oc/
bioterrorism/bioact.html.
FDA also agrees with the comment that requests us to provide a Web-
based tutorial. Since October 2003, FDA has provided a PNSI tutorial in
the form of step-by-step help on its Web site (http://
www.cfsan.fda.gov/~furls/helpf.html). FDA welcomes any additional
comments or suggestions on how to improve the help information; these
can be submitted to the PNC using the phone number or e-mail provided
on that Web page.
FDA and CBP agree that operational issues impacting ABI filers
should be announced using Administrative Messages, and intend to
continue to use that system, as we have routinely done since December
2003. When appropriate, information about the PNSI system will also be
announced both on the FDA Web site and through CBP's Administrative
Messages.
CBP also has established avenues of communication with trade
working groups and ensures FDA's participation when the subject for
discussion is prior notice. FDA does not plan to establish a formal
advisory committee to address prior notice.
FDA agrees with the comment to improve help desk staffing, as
resources permit. Our Web site contains a tutorial on how to submit a
registration for a facility subject to the requirements at 21 CFR part
1, subpart H. In addition, the PNC staff can answer questions about how
to submit prior notice. Questions regarding clarification of the rule
that are not addressed in this preamble or existing publications should
be submitted to FDA at industry@fda.hhs.gov. We will generally not
provide an individual response to these questions, but will answer them
in Question and Answer Guidance Documents so the information will be
broadly available.
FDA has included features in PNSI to inform submitters of many
types of inadequacies in the information provided, such as missing
required fields. FDA also has coordinated with CBP to provide prompt
messaging back to users when Prior Notice is filed through ACS. FDA
notes that certain inaccuracies cannot be identified electronically,
but could be detected in an intensive prior notice review (e.g., the
packaging of an actual shipment (12 oz cans of tuna fish) does not
match the prior notice data submitted for that shipment (e.g., 6 oz
cans of tuna fish)).
With respect to holding public meetings to provide an opportunity
for parties to voice their opinions on the IFR, FDA and CBP published
the IFR on October 10, 2003, and opened the comment period through
December 24, 2003. We reopened the comment period from April 14, 2004,
through July 13, 2004. We reviewed 320 timely comments that raised
multiple issues, and have considered those comments as we developed
this final rule. We also held numerous outreach meetings both
domestically and abroad--in person and by video conferencing--to
explain the requirements of the IFR to affected parties and answer
questions of clarification to ensure all were able to provide
meaningful comment to FDA and CBP. The comment period was the time for
all parties to be heard on the provisions of the IFR. While the
agencies welcome discussion and wanted to ensure that all stakeholders
understand their obligations under the statute and the IFR, the comment
period ended July 13, 2004, and the agencies did not consider comments
submitted outside of the open comment periods.
(Comments) Several comments recommend that FDA provide feedback to
the industry detailing areas of noncompliance and compliance. One
foreign government stated its willingness to work with FDA to increase
the level of industry compliance within their country through outreach
and education activities. It requests that FDA provide it on a timely
basis detailed information concerning noncompliance by their industry.
Another comment suggests that FDA could post on its Web site a
description of the types of errors most commonly observed in filed
prior notices.
(Response) We agree, and have been posting on our Web site summary
information about submission of prior notice, including data on the
types of errors. See http://www.cfsan.fda.gov/~pn/pnsum.html. We stated
that this information will also be analyzed to help FDA take
appropriate enforcement action when necessary. FDA presented the
Summary Information in two categories: (1) General interest--
Information about the number and types of prior notices that are being
submitted, and which systems are being used to submit them; and (2)
Specific requirements--Information about submission of the required
information. We provided an initial posting of the summary information
and two subsequent updates. The August 2004 update included some
summary information from December 2003 through April 2004 and some
snapshots of activity in July 2004, along with information on specific
information requirements such as registration number and carrier
information.
We also posted information summarizing the number of facilities
registered pursuant to 21 CFR part 1, subpart H at: http://
www.cfsan.fda.gov/~furls/ffregsum.html. This summary includes a
breakdown of the number of registered facilities by country and U.S.
State.
4. Enforcement Timeframe
(Comments) Many comments state that because FDA and CBP have not
informed prior notice submitters of specific deficiencies in their
submissions, FDA must extend the enforcement date of the rule to allow
more time to communicate errors and allow adequate time to fix them.
One comment suggests that the agencies should develop and implement a
notice-
[[Page 66378]]
specific informational system that provides detailed feedback to
submitters when a prior notice is deemed to be noncompliant. Another
comment states that exporters should be advised of noncompliant
shipments in order to take corrective action prior to the shift to full
enforcement. One comment believes that part of the phase-in period
should include a feedback program to let brokers know which importers
and corresponding transactions are handled with inadequate or no prior
notice. The comment states that this program should be developed in
conjunction with the industry to define measurements (history profile
and/or transactional), and determine what the notification process
should be. One comment encourages FDA to expeditiously publish a notice
that it intends to continue outreach and delay enforcement of the
regulation so that the business community may have a greater
opportunity for education, training, and continued dialogue with the
agencies. Other comments recommend a delay in the final phase of
enforcement until all systems are fully operational.
(Response) FDA disagrees. The obligation to comply with applicable
regulations is on the parties subject to a regulation as specified
therein; FDA does not have an obligation to inform all prior notice
submitters of specific deficiencies in their submissions before
beginning enforcement of a rule. FDA and CBP, however, were cognizant
of the potential effect the prior notice IFR could have on trade and
thus, after publication of the IFR, FDA published guidance that
included a transition period during which we emphasized education to
achieve compliance, rather than general refusal of noncompliant
shipments (the December 2003 Prior Notice Interim Final Rule CPG) (68
FR 69708). In addition, during the prior notice transition periods from
April 2004 through April 2005, we provided compliance summaries that
informed submitters, and those who transmit on their behalf, of the
major areas of deficiencies with respect to missing data elements.
These represented the general deficiencies we were seeing in prior
notice submissions during the educational transition period (see http:/
/www.cfsan.fda.gov/~pn/pnsum.html). The compliance summaries also
generally described the deficiencies in prior notices that are not
confirmed for review (e.g., failure to provide a valid registration
number). However, we do not plan to communicate submission deficiencies
to other than the submitter and transmitter. FDA believes that the
effective date of 180 days after publication of the final rule provides
sufficient time for the business community to become familiar with all
the provisions of the final rule. Moreover, we plan to conduct outreach
after publication of the final rule to affected industry and other
governments, as resources allow. These efforts will focus on changes to
the final rule. Given the delayed effective date, the fact that the
changes in the final rule are not very extensive, and the public's
experience in complying with the IFR, FDA believes there is no need for
a phased-in enforcement approach similar to what was done for the IFR.
(Comments) One comment states that if FDA discovers that a large
number of problems are experienced during the grace period between
publication of this final rule and the effective date, FDA should
consider extending the effective date, especially for first time
offenders.
(Response) FDA believes that the 180 day delay in effective date is
adequate for affected parties to become familiar with all the
provisions in the Prior Notice Final Rule. While we do not anticipate
extending the effective date past 180 days, we intend to take into
account the circumstances of the violation in enforcing the final rule.
5. Enforcement Penalties
(Comments) One comment requests that the agencies publish
procedures that clearly define what types of penalties will be issued
for failure to comply under Sec. 1.284 and to whom they will be
issued.
(Response) Sections 1.283 and 1.284 of the final rule describe the
consequences for failing to submit adequate prior notice or otherwise
failing to comply with the final rule. We believe these adequately
describe the types of penalties. The Prior Notice Final Rule Draft CPG
describes our proposed enforcement policies, and states, for example,
that we intend to focus our resources on more serious violations and
repeat or flagrant violations.
Civil monetary penalties, which are issued by CBP, may also be
assessed in response to a prior notice violation. CBP has posted a
variety of publications that explain both the administrative process
for fines, penalties, forfeitures, and liquidated damages, such as:
``What Every Member of the Trade Community Should Know About: Customs
Administrative Enforcement Process: Fines, Penalties, Forfeitures and
Liquidated Damages,'' which is posted at: http://www.cbp.gov/
linkhandler/cgov/trade/legal/informed_compliance_pubs/icp052.ctt/
icp052.pdf, and ``What Every Member of the Trade Community Should Know
About: Mitigation Guidelines: Fines, Penalties, Forfeitures and
Liquidated Damages,'' which is posted at http://www.cbp.gov/
linkhandler/cgov/trade/legal/informed_compliance_pubs/icp069.ctt/
icp069.pdf. (FDA has verified the Web site addresses, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
N. The Joint FDA-CBP Plan for Increasing Integration and Assessing the
Coordination of Prior Notice Timeframes
We stated in the preamble to the IFR (68 FR 58974 at 58995) that
FDA and CBP would publish a plan, including an implementation schedule,
to achieve the goal of a uniform, integrated system and to coordinate
prior notice timeframes for air and truck modes of transportation with
timeframes finalized by CBP when they finalize their rule entitled
``Required Advance Electronic Presentation of Cargo Information,'' all
while fulfilling the Bioterrorism Act mandates. For this reason, as
well as to obtain comments on other aspects of the rule, we issued an
IFR, with an opportunity for public comment for 75 days. Moreover, to
ensure that those who comment on this IFR would have had the benefit of
actual experience with the systems, timeframes, and data elements, FDA
also stated it intended to reopen the comment period for an additional
30 days to coincide with the issuance of the plan by FDA and CBP
relating to timeframes. We extended this comment period twice on April
14, 2004, and May 18, 2004, thereby providing an opportunity for
affected persons to comment for 165 days.
In April 2004, FDA and CBP announced the Joint Food and Drug
Administration-Customs and Border Protection Plan for Increasing
Integration and Assessing the Coordination of Prior Notice Timeframes
(the Plan).
The comments addressing the Plan are discussed in the following
paragraphs. Comments addressing our assessment of reducing the prior
notice timeframes are found earlier in section III.F (``When must prior
notice be submitted to FDA?'' (Sec. 1.279)) of this document. We
respond to the other questions (e.g., special programs and flexible
alternatives) raised in our April 14th reopening of the comment period
in sections III.D (``What is the Scope of this subpart?'' (Sec.
1.277)) and III.M (Outreach and Enforcement) of this document.
[[Page 66379]] 1. Increased Integration FDA and CBP have increased their integration and are continuing to do so in the following ways: <bullet> Co-location of all FDA Prior Notice staff with CBP's targeting staff; <bullet> Further refinement to FDA's targeting rule sets in CBP's targeting system, coupled with additional training in targeting techniques; <bullet> Continued targeting support from CBP and other Federal law enforcement analysts; and <bullet> Enhancement of communications and cooperation with CBP to facilitate information exchange and to ensure expeditious access and examination of food shipments FDA has decided to inspect upon arrival. (Comments) One comment suggests that FDA should consider performing the OASIS review concurrently with the ``FDA BTA review'' to eliminate duplicative work and burdens on both the importing community and FDA. Another comment suggests that FDA coordinate the prior notice procedure with FDA's ``Hold Intact Notice'' so that FDA can avail itself of the opportunity to identify in advance shipments for inspection, sampling or detention, or permit the shipment to pass and be delivered without delay. (Response) FDA disagrees. As we previously explained in an earlier response in section III.J.11 of this document, FDA does not agree that doing the OASIS review under section 801(a) of the act concurrently with the prior notice review under section 801(m) of act would be beneficial to industry or FDA. Because the section 801(m) review must occur prior to arrival, concurrent section 801(a) and section 801(m) reviews also would have to occur prior to arrival. FDA believes such a concurrent process would be inefficient and impractical and would likely increase congestion at the ports of arrival. (Comments) Comments state that co-locating FDA PNC staff with CBP's targeting staff is a positive step because the two agencies' personnel are both accountable for the risk analysis process, and thus, both agencies' personnel can easily interact and share information, leading to increased efficiencies and integration of the risk analysis process. (Response) FDA agrees and has co-located the PNC with CBP's targeting staff. (Comments) Comments strongly support further refinement of FDA's targeting rule sets in order to maintain and improve the risk analysis system to flag specific shipments for security concerns. Comments further support the continuing plan to target shipments for which little is known, while maintaining expedited processing for those shipments and importers that are well known and have provided FDA and CBP with the means by which they can assure general compliance. These comments also argue that products subject to FDA's prior notice requirements should be eligible for full expedited processing and information transmission benefits allowed with C-TPAT, FAST, and any other similar programs established in the future. One comment specifically encourages FDA and CBP to incorporate the current information contained within these programs and allow for the removal of the maximum number of flags within the risk analysis system for those companies that demonstrate their compliance by participation in these additional security programs. (Response) FDA agrees that refining our targeting rule sets helps to improve both agencies' risk analysis systems. As we discussed previously, FDA has decided not to consider any special programs, such as C-TPAT and FAST, in implementing the prior notice rule. (Comments) All the comments favor initiatives to provide additional training of FDA staff in targeting techniques that will increase the efficiency and effectiveness of the border crossing systems. One comment particularly notes that additional training should be targeted towards those individuals and issues that will provide measurable additional value to the prompt and efficient release of compliant cargo. (Response) Any effective targeting technique allows for the identification of food likely to be at risk for adulteration based on a scientific risk assessment. Targeted training will be provided, as resources permit. (Comments) Comments support enhanced communications and cooperation with CBP to facilitate information exchange and ensure fast access to foods that are subject to prior notice holds. Comments state that this will be critical to the food industry, as any delays will translate into added costs and inefficiencies to their current supply chain. One comment encourages FDA and CBP to integrate technologies used for implementing the Bioterrorism Act with NEXUS, US VISIT, FAST, C-TPAT, and other programs at the border. (Response) FDA agrees that exchanging information between the agencies is important to evaluation of and response to food safety and security challenges. (Comments) One comment encourages FDA and CBP to work with their Canadian counterparts to ensure that information is shared and technologies are working in parallel to make crossing the border seamless, efficient, and safe. (Response) FDA agrees that exchange of information between its international counterparts, when feasible, is critical to evaluation and response to food safety and security challenges. (Comments) One comment notes that FDA recently announced the signing of an MOU with CBP to commission CBP officers in ports and other locations to conduct investigations and examinations of imported foods on behalf of FDA. The comment questions whether this would have any consequences on the selections for controls by CBP officials stationed in EU ports. (Response) Investigation and examination of food as a result of prior notice is conducted upon or after arrival of the food in the United States. Therefore, the MOU should not have any consequences on CBP operations at EU ports. 2. General Comments on the Plan The Plan as announced in April 2004 and revised in November 2004 outlines the following: <bullet> From November 1, 2004, to January 3, 2005, we plan to assess existing procedures and staffing needed to receive, review, and respond to the prior notices submitted in accordance with the Prior Notice IFR (i.e., 2 hours before arrival by land by road; 4 hours before arrival by air or by land by rail; and 8 hours before arrival by water). <bullet> From January 4, 2005, to February 3, 2005, we intend to identify what changes to work practices and staffing would be necessary to determine if FDA could continue to receive, review, and respond to all prior notice submissions with reduced timeframes (e.g., 1 hour/30 minutes before arrival by land by road; 2 hours before arrival by land by rail; and by ``wheels up'' for flights originating in North and Central America, South America (north of the Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival by air). <bullet> From February 4, 2005, to May 3, 2005, we plan to implement necessary changes and make appropriate adjustments to ensure we could receive, review, and respond to all prior notice submissions with reduced timeframes. Under the Bioterrorism Act, any timeframe must be sufficient to receive, review, and respond to prior notice submissions, as set out in section 801(m)(2)(A) of the act (21 U.S.C. 801(m)(2)(A)). The agencies emphasized that the evaluation of whether to reduce
[[Page 66380]]
the timeframes for prior notice review will depend on the level of
compliance industry achieves during the assessment.
(Comments) Numerous comments concur with the proposed joint FDA-CBP
plan for increasing integration of both agencies' activities, as this
would eliminate the requirement for importers to maintain two different
timeframes for submission of data. One comment concurs with the joint
plan and states that it would minimize procedures and costs for firms.
One comment states that it was confident that, with proper planning and
development, additional integration of the security processes and the
differing timeframes can be coordinated through the actions outlined in
the published joint plan.
(Response) FDA agrees that increased integration of activities,
including timeframes when appropriate and feasible, would be
advantageous, provided FDA still is able to meet its statutory
obligation to receive, review, and respond to prior notice. As
discussed previously (see section III.F, When must prior notice be
submitted to FDA? (Sec. 1.279)), FDA conducted an assessment of FDA
response times with reduced timeframes and determined that if it
changed the prior notice timeframes to be consistent with those of
CBP's advance electronic information rule, the agency would not have
adequate time to receive, review, and respond to the prior notices.
Moreover, commerce actually would be adversely impacted by shorter
prior notice timeframes for submission, because this would
significantly increase the number of shipments where FDA would not be
able to decide whether it should examine the food at the port of
arrival by the end of the timeframe. Such shipments would be delayed at
the port of arrival until FDA has either completed its review or
decided to examine or not examine the food at the port or arrival
without the benefit of a complete review. Accordingly, FDA has retained
the timeframes in the IFR.
(Comments) One comment requests that FDA explain why the maritime
transportation timeframe was not considered in the joint plan.
(Response) FDA did not include the maritime transportation
timeframe because the CBP advance electronic information timeframe for
cargo arriving by water is 24 hours, which is significantly greater
than the time established by the prior notice IFR for this mode of
transportation (8 hours before arrival).
(Comments) One comment suggests that assessment of the resources
encompass all potential resources available at the port, including
those of the Department of Homeland Security (DHS) in order to make
better use of DHS resources at the border. Another comment states that
any assessment taken up during this timeframe must take into account
the problems inherent in the current systems, as well as the fact that
not all submissions will be properly prepared or followed up on, as
this could potentially translate into current practices or staffing
appearing to be inadequate when, in fact, they may not be.
Another comment asserts that some border crossings were not
designed for today's traffic volumes or the post 9-11 environment and
recommends that these physical resources be included in the assessment
of existing procedures. This comment also encourages CBP to audit
staffing levels at border crossings to determine if additional staff is
needed.
(Response) FDA agrees that any assessment must take into account
the availability of all resources, including those resources of
agencies with which we maintain MOU or other agreements covering
inspection and sample collection, which can, or should, be devoted to
the receipt, review, and response of prior notice. Accordingly, DHS
resources are used in implementing this rule, as described elsewhere in
this preamble.
(Comments) Two comments noted that they are experiencing
significant delays on shipments that cross the border on Fridays due to
FDA's limited hours on that day. The comments are concerned about
uncertainty regarding transit times and that customers' date-sensitive
orders will not be received on time. Another comment noted that waiting
times due to traffic volume has increased at the bridge at Detroit
because of the inability to move prior notice shipments through the
tunnel. The comment states that these delays have made it very
difficult to deliver to U.S. facilities that do not operate 24 hours
and that these delays will continue to cost exporters and importers and
may cause U.S. processing facilities to have unplanned downtime due to
a lack of raw material. Another comment notes that different FDA
locations ask for more information than the Bioterrorism regulations or
systems can process, thereby holding up shipments that move freely at
other border crossing locations.
(Response) Prior notice is submitted electronically through ABI/ACS
or PNSI. There is no ability for individual ports to require different
information as part of the prior notice submission process. The PNC
directs all prior notice activities for FDA and ensures consistent
review of submitted prior notices. If industry is having difficulties
with a specific port, they should contact the PNC to have the issues
resolved. FDA believes it is likely that the concerns raised in the
comments relate to admissibility decisions being made under section
801(a) of the act, which is a separate review than the one made under
section 801(m) of the act, as described previously.
(Comments) One comment states that FDA personnel should be assigned
to all arrival ports, particularly those where high risk shipments may
arrive.
(Response) FDA does not have the personnel to cover all possible
ports of arrival. Accordingly, under the authority of section 314 of
the Bioterrorism Act, FDA and CBP signed an MOU in December 2003 that
allowed FDA to commission thousands of CBP officers in ports and other
locations to conduct, on FDA's behalf, investigations and examinations
of imported foods. This FDA-CBP collaboration significantly strengthens
the implementation of the Bioterrorism Act to assure the security of
imported foods. The MOU enables FDA to work more efficiently with CBP
and builds upon FDA's and CBP's long history of close cooperation.
Additionally, the MOU enhances the two agencies' teamwork in training,
day-to-day operations, and information sharing. As part of the MOU, FDA
and CBP provide specialized training for the commissioned CBP employees
who will carry out this work, and both agencies have expanded their
existing cooperative arrangements to directly share information
affecting the safety and security of imported foods. (See http://
www.fda.gov/oc/bioterrorism/moucustoms.html.)
(Comments) One comment states that there were connection problems
with FDA's computer system, perhaps as a result of submission overloads
to the system, with session ``timeouts'' occurring. The comment notes
that it is crucial that an infrastructure with the capacity to deal
with the information being required by FDA be in place in order for
stakeholders to meet the requirements of prior notice.
(Response) As discussed in section III.G, How must you submit the
prior notice? (Sec. 1.280), FDA has carefully monitored both PNSI and
OASIS system usage and performance since prior notice was implemented
in December 2003. During this period, no issues related to load on
these systems have been identified. Both systems have experienced
occasional outages (including planned down times for maintenance and
upgrades). During
[[Page 66381]]
these outages, messages between the CBP and FDA systems are held in a
queue, resulting in a backlog. Initially, we did experience some
difficulties when trying to clear the queue after returning to normal
operations, but these issues have been resolved. FDA and CBP also have
increased the capacity of the communications link between their systems
to ensure that additional bandwidth is available for future increases
in load. FDA continues to monitor the production system and to test for
performance as the system is upgraded and enhanced.
(Comments) One comment suggests that FDA and CBP take the
integrated timeframes further and require only one notification that
should meet both FDA and CBP requirements and prevent confusion and
delays in the case of a bioterrorism event.
(Response) FDA disagrees. The Bioterrorism Act and the Trade Act
have different statutory requirements. In implementing these laws, the
agencies require different information and use different targeting and
screening tools. FDA and CBP have discussed interfacing with AMS (the
module of ACS through which carriers, port authorities, or service
bureaus transmit electronically the cargo declaration portion of the
inward foreign manifest to CBP) for manifest data and determined that
the general cargo data in AMS are not suitable to accommodate the
detailed information requirements of section 801(m) of the act. For
example, AMS does not collect the country of origin. In addition, its
collection of the identities of the article of food and its
manufacturer differs from the way those are collected under the prior
notice interim final and final rules in such a way that the data would
not meet our needs in carrying out the purpose of section 801(m) of the
act.
(Comments) One comment asserts that it is redundant for FDA to
repeat a feasibility analysis of submission timeframes because CBP has
clearly addressed those issues. Another comment proposes that FDA
accelerate the schedule for implementing the joint plan, and make this
evaluation with CBP as quickly as possible. One comment supports the
plan and suggested that any short term assessment take into account the
problems involved with the current systems. Another comment expresses
concern that full enforcement of the IFR will be in effect during the
proposed review period and that consequently, industry will be placed
in the difficult position of trying to comply with timeframe
requirements that are not synchronized. Another comment suggests that
other reasons for noncompliance, such as the need for additional
discretion on data and education, be included in the evaluation.
In response to the agencies' statement that the evaluation of
timeframes will depend on the level of compliance industry achieves
during the assessment, one comment asserts that it is not appropriate
for the agencies to place the burden of compliance entirely on the
trade. The comment further states that the trade's ability to provide
the information required also depends on the systems working properly,
the efficiencies of the government personnel involved, the educational
outreach levels and the feedback individual importers receive in
relation to their current processes. These are areas that are
controlled and managed by the agencies, so they also must be considered
when assessing the probability of reducing timeframes. One comment
expresses concern that the implementation schedule of the Plan may be
delayed due to industry noncompliance with the IFR. Another comment
asserts that this lack of communication from the agencies to submitters
regarding errors could negatively impact the assessment of compliance
of the trade and subsequently, the agencies' decisions regarding the
trade's future ability to provide a high level of compliance.
(Response) FDA disagrees. The obligation to comply with applicable
regulations is on the parties subject to a regulation as specified
therein; FDA does not have an obligation to inform all prior notice
submitters of specific deficiencies in their submissions before
beginning enforcement of a rule. Nonetheless, after publication of the
IFR, FDA published guidance that included a transition period during
which we emphasized education to achieve compliance, rather than
general refusal of noncompliant shipments (the December 2003 Prior
Notice Interim Final Rule CPG) (68 FR 69708). In addition, we have
provided compliance summaries that inform submitters, and those who
transmit on their behalf, of the major areas of deficiencies, in
general, that we were seeing in prior notice submissions during this
educational transition period (see http://www.cfsan.fda.gov/~pn/
pnsum.html), and generally advise the submitter of deficiencies in
prior notices that are not confirmed for review (e.g., failure to
provide a valid registration number). Moreover, FDA and CBP believe
that the level of compliance was sufficiently high during the
assessment period. The assessment period began almost a year after the
IFR went into effect. During that time, we resolved initial problems
with the government's prior notice systems and processes. Our extensive
outreach and focus on education instead of refusals and other
enforcement actions helped ensure that industry submission rates were
at or near 100 percent for most prior notice information by November
2004. In certain circumstances, such as with the manufacturer's
registration number, FDA and CBP continued to provide flexible
enforcement. With these measures, prior notice was operating smoothly
during the assessment period.
(Comments) One comment fully supports this process and encourages
FDA to provide for any changes that may be needed to allow the timing
reductions that are critical to economic prosperity. The comment
suggests that once the program has been operational for a time, and the
systems glitches worked out from past experience, the assessment would
translate into a faster processing time.
(Response) As stated previously, the prior notice timeframes must
ensure that we have sufficient time to receive, review, and respond to
the prior notice.
(Comments) Several comments encourage both agencies to ensure that
they allow for the proper communications with the trade prior to
planning for or implementing any changes as a result of the previously
mentioned assessments, so that the interests of all parties involved
can be assessed and the best changes can be implemented. One comment
requests that sufficient resources be allocated by FDA and CBP to
implement the Plan.
(Response) The IFR included an extended public comment period, and
comments were received and reviewed during the development of this
final rule. We also held numerous outreach meetings both domestically
and abroad--in person and by video conferencing--to explain the
requirements of the IFR to affected parties and answer questions of
clarification to ensure all were able to provide meaningful comment to
FDA and CBP. The final rule will not take effect until 180 days
following publication. The agencies plan additional outreach and
guidance during that 180-day period.
(Comments) Some comments request that FDA issue a final prior
notice rule only after there has been a period of full enforcement
followed by an additional comment period. These comments argue that
both FDA and industry need the benefit of experience with active and
full enforcement before fine-tuning the prior notice regulation into a
final rule.
[[Page 66382]]
Comments suggest that FDA reopen the comment period for 60 days after
full enforcement has been in place for 90 to180 days or for at least 6
months. In the interim, the comments recommend that the rule should be
maintained as an IFR for a longer period of time with phased
implementation, as one comment suggests, while developing the final
rule.
(Response) FDA reopened the comment period for a total period of
almost 6 months to allow parties an opportunity to provide meaningful
comment based on their experiences in complying with the IFR. FDA also
extended the initial eight-month transition period from August 2004 to
November 2004 for several of the data elements that our review
indicated had higher error submission rates while continuing
educational outreach activities. The implementation date for this final
rule is 180 days after publication. The IFR remains in effect until the
time the final rule takes effect. No comment period is associated with
the publication of the final rule.
(Comments) One comment urges the FDA to build into the final rule
the capability to administratively amend the prior notice provisions
quickly, if needed. The comment notes that this would be particularly
important for imports from any country with which the FDA has reached a
bilateral arrangement. This arrangement would serve as the basis for
having different (e.g., more efficient, effective, or risk based) prior
notice requirements. The comment further notes that this ability to
administratively amend the rule would be important so that FDA could
adjust procedures quickly and efficiently to reflect actual reductions
in risks through such arrangements.
(Response) FDA disagrees. The Bioterrorism Act requires that FDA
receive prior notice for every article of food imported or offered for
import into the United States. There are no exceptions based on the
country of production or the country from which the article of food is
shipped.
To the extent that FDA and CBP believe that changes in our policies
related to enforcing this final rule are needed, we will announce those
as revisions to the Prior Notice Final Rule Compliance Policy Guide, a
draft of which we are announcing elsewhere in this issue of the Federal
Register.
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Prior Notice Final Rule
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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