[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Rules and Regulations]
[Page 58975-59077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc03-18]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 02N-0278]
RIN 0910-AC41
Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim
final regulation that requires the submission to FDA of prior notice of
food, including animal feed, that is imported or offered for import
into the United States. The interim final rule implements the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act), which requires prior notification of imported
food to begin on December 12, 2003, even in the absence of a final
regulation. The interim final rule requires that the prior notice be
submitted to FDA electronically via either the Bureau of Customs and
Border Protection (CBP) Automated Broker Interface (ABI) of the
Automated Commercial System (ACS) or the FDA Prior Notice System
Interface (FDA PN System Interface). The information must be submitted
and confirmed electronically as facially complete by FDA for review no
more than 5 days and no less than 8 hours (for food arriving by water),
4 hours (for food arriving by air or land/rail), and 2 hours (for food
arriving by land/road) before the food arrives at the port of arrival.
Food imported or offered for import without adequate prior notice is
subject to refusal and, if refused, must be held.
DATES: This interim final rule is effective December 12, 2003. Submit
written or electronic comments by December 24, 2003.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Deborah Ralston, Office of Regulatory
Affairs, Office of Regional Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-6230.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Current Process--Admissibility Determinations Under Section
801(a) of the FD&C Act
B. Process After December 12, 2003--Prior Notice Determination
Followed by Admissibility Determination
II. Overview of the Interim Final Rule and Significant Changes Made
to the Proposed Rule
A. ``What Definitions Apply to This Subpart?'' (Section 1.276
Proposed as Sec. 1.277)
B. ``What is the Scope of This Subpart?'' (Section 1.277
Proposed as Sec. 1.276)
C. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278
Proposed as Sec. 1.285)
D. ``When Must Prior Notice Be Submitted to FDA?'' (Section
1.279 Proposed as Sec. 1.286)
E. ``How Must You Submit Prior Notice?'' (Section 1.280 Proposed
as Sec. 1.287)
F. ``What Information Must Be in a Prior Notice?'' (Section
1.281 Proposed as Sec. 1.288)
G. ``What Must You Do If Information Changes After You Have
Received Confirmation of a Prior Notice From FDA?'' (Section 1.282
Proposed Sec. Sec. 1.289 to 1.294)
H. ``What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice?'' (Section 1.283 Proposed as Sec.
1.278)
I. ``What Are the Other Consequences of Failing to Submit
Adequate Prior Notice or Otherwise Failing to Comply With This
Subpart?'' (Section 1.284 Proposed as Sec. 1.278)
J. ``What Happens to Food That Is Imported or Offered for Import
from Unregistered Facilities That Are Required to Register Under 21
CFR Part 1, Subpart H?'' (Section 1.285)
III. Comments on the Proposed Rule
A. General Comments and Outreach
B. Foreign Trade Issues
C. ``What Definitions Apply to This Subpart?'' (Section 1.276
Proposed as Sec. 1.277)
D. ``What Is the Scope of This Subpart?'' (Section 1.277
Proposed as Sec. 1.276)
E. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278
Proposed as Sec. 1.285)
F. ``When Must Prior Notice Be Submitted to FDA?'' (Section
1.279 Proposed as Sec. 1.286)
G. ``How Must You Submit Prior Notice?'' (Section 1.280 Proposed
as Sec. 1.287)
H. ``What Information Must Be in a Prior Notice?'' (Section
1.281 Proposed as Sec. 1.288)
I. ``What Must You Do If Information Changes After You Have
Received Confirmation of a Prior Notice From FDA?'' (Section 1.282
Proposed as Sec. Sec. 1.289 to 1.294)
J. ``What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice?'' (Section 1.283) and ``What Are the
Other Consequences of Failing to Submit Adequate Prior Notice or
Otherwise Failing to Comply With This Subpart?'' (Sec. 1.284
Proposed as Sec. 1.278)
K. ``What Happens to Food That Is Imported or Offered for Import
From Unregistered Facilities That Are Required to Register Under
Section 415 of the FD&C Act, 21 U.S.C. 350d and 21 CFR Part 1,
Subpart H?'' (Section 1.285)
IV. Issuance of an Interim Final Rule and Effective Date; Comments
V. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
1. Need for Regulation
2. Interim Final Rule Coverage
3. Regulatory Options Considered
4. Summary of Options
5. Benefits
B. Small Entity Analysis (or Final Regulatory Flexibility
Analysis)
1. Number of Establishments Affected
2. Costs per Entity
3. Additional Flexibility Considered
C. Unfunded Mandates
D. Small Business Regulatory Enforcement Fairness Act (SBREFA)
Major Rule
VI. Paperwork Reduction Act of 1995
VII. Analysis of Environmental Impact
VIII. Federalism
IX. References
I. Background
In the Federal Register of February 3, 2003 (68 FR 5428), the
Department of Health and Human Services (FDA) and the Department of
Treasury (U.S. Customs Service) issued a joint notice of proposed
rulemaking requiring submission to FDA of prior notice of human and
animal food that is imported or offered for import into the United
States. The events of September 11, 2001, had highlighted the need to
ensure that FDA had additional tools to help prevent a food-related
bioterrorism event or other public health emergency. Congress responded
by passing the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), which
was signed into law on June 12, 2002. The Bioterrorism Act includes a
provision in Title III (Protecting Safety and Security of Food and Drug
Supply), Subtitle A'Protection of Food Supply, section 307, which
changes when FDA will receive certain information about imported foods
by requiring the Secretary of Health and Human Services (the
Secretary), after consultation with the Secretary of the Treasury, to
issue an implementing regulation by December 12, 2003, to require prior
notification to FDA of food that is imported or offered for import into
the United States. Under
[[Page 58975]]
the Homeland Security Act of 2002 (Pub. L. 107-296), the Secretary of
the Treasury has delegated all relevant Customs revenue authorities to
the Secretary of Homeland Security who has, in turn, delegated them to
the Commissioner of the Bureau of Customs and Border Protection (CBP or
Customs). Thus, we are issuing this interim final rule jointly with the
Secretary of Homeland Security.
Section 307 of the Bioterrorism Act amends the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding section 801(m) (21 U.S.C.
381(m)) and amending section 301 (21 U.S.C. 331). (In the regulation
itself, which is codified in Title 21 of the Code of Federal
Regulations, the Federal Food, Drug, and Cosmetic Act is referred to as
``the act.'' Thus, when the regulation is quoted in this preamble the
term ``the act'' will be used to refer to the Federal Food, Drug, and
Cosmetic Act. However, in this preamble we refer to the Federal Food,
Drug, and Cosmetic Act as ``the FD&C Act'' in the preamble to
distinguish it from the Bioterrorism Act.)
The Bioterrorism Act also requires FDA to issue regulations
requiring certain food establishments to register with FDA (section
305), directs FDA to issue regulations regarding maintenance of certain
records (section 306), and grants FDA the authority to administratively
detain food (section 303). FDA has published proposed rules
implementing section 305 of the Bioterrorism Act (68 FR 5378, February
3, 2003), section 303 of the Bioterrorism Act (68 FR 25242, May 9,
2003), and section 306 of the Bioterrorism Act (68 FR 25188, May 9,
2003). The interim final rule implementing the food facility
registration requirements is published elsewhere in this issue of the
Federal Register.
A. Current Process--Admissibility Determinations Under Section 801(a)
of the FD&C Act
Section 801(a) of the FD&C Act sets out current standards and
procedures for FDA review of imports under its jurisdiction. Section
801(a) provides for examination of imports and also authorizes FDA to
refuse admission of imports that appear, from examination or otherwise,
to be, inter alia, adulterated or misbranded. When an FDA-regulated
product is imported, generally customs brokers submit entry information
to CBP on behalf of the importers of record. CBP then provides entry
information to FDA to enable admissibility decisions to be made. Under
CBP authorities, entry of the merchandise can be made up to 15 days
after arrival.
CBP regulations provide for different kinds of entries. Commonly,
merchandise is the subject of an entry for consumption or warehouse
(i.e., unrestricted, general use) under a basic importation and entry
bond at the port of arrival. A warehouse entry is a CBP entry procedure
as described in 19 CFR part 144. It allows imported product (with some
restrictions) to be entered without payment of duty, provided it is
kept in a bonded warehouse and not distributed. CBP authorities also
allow for an Immediate Transportation or IT entry of merchandise for
transportation under a custodial bond from the port of arrival to
another port where the consumption or warehouse entry will be made or
the product will be admitted into a foreign trade zone (FTZ) located
outside of the port area. In addition, if the merchandise is going to
an FTZ in the port area, FTZ admission documents are presented to CBP.
Finally, a transportation and exportation (or T&E) entry may be filed
if the merchandise is to be transshipped from the port of arrival
through the United States to another port for export.
FDA currently receives electronic information about entries from
CBP through CBP's ABI of the ACS. FDA receives this information through
its Operational and Administrative System for Import Support (OASIS).
The entry types currently transmitted through the ABI/ACS interface
with OASIS include consumption entries and warehouse entries but not IT
entries, T&E entries, or admissions into FTZs. The customs broker or
self-filer electronically submits entry information to ABI/ACS,
including: The identification of the product by the Harmonized Tariff
Schedule (HTS) code; the entry type; the entry number (including both
the ACS line number and the FDA line number); the arrival date; the
port; the port of unlading; the carrier code; the vessel name and
voyage, flight or trip number; importer and ultimate consignee; the
quantity; value; country of origin; bill of lading or airway bill
number; the manufacturer; the importer of record; and the ultimate
consignee. The HTS codes are flagged to indicate which products will
require FDA review; all FDA-regulated products are covered, not just
foods. The additional information that is currently transmitted through
the ABI/ACS interface to FDA includes: The FDA manufacturer; the FDA
shipper, the FDA Country of Production (country of origin); the
complete FDA product code; a description of the food in common business
terms; the quantity for each FDA line, and, as ``Affirmations of
Compliance,'' information specific to certain products, such as the
Food Canning Establishment (FCE) Number.\1\ CBP regulations do not
mandate electronic transmission of entry information; therefore, some
entries are filed in paper. If a ``paper'' entry is filed, it is
customary for CBP to require that copies of entry documentation by
submitted to FDA. The entry documents contain the same information as
the electronic filing, typically the information required on CBP's
Entry/Immediate Delivery (CF3461), and a copy of the foreign invoice.
The paper entries may be presented at the time of arrival or after.
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\1\ Affirmations of Compliance are data elements that a customs
broker or self-filer currently uses when transmitting certain
information to FDA through ABI/ACS to OASIS. Each provides a
mechanism to indicate (or affirm) compliance with a specific FDA
regulatory requirement.
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After information is transmitted from ABI/ACS, OASIS performs
additional validations on the data. If no corrections from the customs
broker or self-filer are needed, it screens the entry information
against FDA admissibility criteria. If the FDA electronic review
determines that further evaluation of the information or article of
food is not necessary, the system transmits a message back through the
FDA/CBP interface that the article of food ``may proceed without FDA
examination.'' If further evaluation is necessary, FDA staff will
review the entry information and may request additional information
necessary to make an admissibility determination or may examine or
sample the product. Section 801(b) of the FD&C Act provides for the
release of FDA regulated products to the importer or owner, under bond,
before the FDA admissibility decision is made. Accordingly, FDA
examination may take place at a location to which the product has been
moved. Because there are no restrictions on movement, the product may
be at the border, within the confines of a port, at a public storage
facility in the vicinity of the importer, or at the ultimate
consignee's warehouse. Finally, if the FDA electronic review indicates
that the product appears ``by examination or otherwise'' to be subject
to refusal of admission under section 801(a) of the FD&C Act (e.g.,
appears to be adulterated or misbranded), the FDA reviewer will
evaluate the entry information based on FDA guidance, take appropriate
action, and notify the importer as well as the customs broker.
Under current laws and regulations, FDA may receive the information
about some food imports some days after the food has arrived in the
United States,
[[Page 58976]]
has been moved from the port of arrival, and has been delivered to the
ultimate consignee. While FDA may ultimately receive electronic entry
notification of IT entries when the consumption entry is later filed,
FDA does not receive electronic notification with information about
food entered for transshipment for export or when the food is admitted
to an FTZ.
The admissibility standard in section 801(a) of the FD&C Act
largely focuses on whether the article of food appears to have been
safely produced, contains no contaminants or illegal additives or
residues, and is properly labeled. Section 801(a) provides that an
article of food is subject to refusal of admission if it ``appears,
from physical examination or otherwise': (1) To have been manufactured,
processed, or packed under insanitary conditions; (2) to be forbidden
or restricted in sale in the country in which it was produced or from
which it was exported; or (3) to be adulterated or misbranded. The food
adulteration and misbranding provisions (sections 402 and 403 of the
FD&C Act) set out most of the FD&C Act's safety and labeling standards
for foods.
B. Process After December 12, 2003--Prior Notice Determination Followed
by Admissibility Determination
Section 801(m) provides that an article of food is subject to
refusal of admission if adequate prior notice has not been provided to
FDA. Thus, the refusal standard in section 801(m) focuses in the first
instance on whether the requisite information has been provided in a
timely fashion, while the refusal standard in section 801(a) focuses on
whether the article was safely produced, contains no contaminants or
illegal additives or residues, and is properly labeled.
By adding the prior notice requirement to the FD&C Act, Congress,
in the Bioterrorism Act, changed when information about FDA-regulated
food imports must be provided to FDA and what happens if the
information is not provided. The prior notice provisions require that
notice must be provided on imported food shipments to FDA before
arrival. If adequate notice is not provided, section 801(m) of the FD&C
Act provides that the food is subject to refusal, and that refused food
must be held until adequate notice is given and may not be delivered to
the importer, owner, or consignee. The stated purpose of requiring
notice of imported food shipments before arrival in the United States
is to enable FDA to conduct inspections of imported food at U.S. ports
(see section 801(m)(1) of the FD&C Act). Thus, FDA intends to use prior
notice information to make decisions about which inspections to conduct
at the time of arrival. Currently, we intend to focus on conducting
these inspections when our information suggests the potential for a
significant risk to public health.
As explained in greater detail in the following paragraphs, FDA and
CBP are coordinating FDA's new prior notice requirements with CBP's and
FDA's existing entry requirements to the greatest extent possible.
Thus, the interim final rule allows prior notice to be submitted
electronically to FDA through either ABI/ACS or the FDA Prior Notice
(PN) System Interface. The HTS codes will be flagged within ABI/ACS to
indicate which HTS codes contain foods subject to prior notice
requirements. In addition, the ABI/ACS interface will provide a new
transaction for transmission of prior notice information on IT and T&E
entries, and FTZ admissions, e.g., the types of entries of which FDA
was not aware or did not know about until many days after arrival in
the United States. This will allow for FDA electronic screening and FDA
staff evaluation of the information so that FDA can assess, before the
food arrives, whether to inspect and to be prepared to conduct that
inspection upon arrival.
FDA expects 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. FDA estimates that
only 10 percent (or less) of the total importations cannot be
accommodated by the ABI/ACS interface and, therefore, will be submitted
via the FDA PN System Interface.
In addition to requiring submission of the information currently
sent to FDA for admissibility determinations, information identifying
the grower (if known), the country from which the article is shipped,
and anticipated arrival information is also required for prior notice.
If all of the prior notice information is transmitted through the ABI/
ACS interface, no additional transmission of information for
admissibility determinations under section 801(a) of the FD&C Act will
be necessary. If prior notice is submitted through the FDA PN System
Interface, additional transmission through ABI/ACS may be necessary for
CBP purposes and FDA's admissibility evaluation.
Regardless of the mode of transmission, the prior notice
information will undergo both a validation process and screening in
OASIS for food safety and security criteria. After the validation step
is complete, the prior notice will be confirmed by FDA for review and a
reply message sent to the transmitter indicating the prior notice has
been received and confirmed for FDA review. The form of this reply
messaging depends upon the mode of initial transmission: ABI/ACS or FDA
PN System Interface. The clock starts for determining if prior notice
was timely when this prior notice confirmation message is sent by FDA.
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.
In addition, the OASIS system review will determine if further
staff evaluation of the article of food is necessary for admissibility
determinations under section 801(a) of the FD&C Act (e.g., subject to
the guidance in an import alert). If so, FDA staff in the appropriate
district office will take action, which, in addition to the review and
evaluation of the submitted information or other documentation, could
include an examination of the article of food for admissibility
purposes. This admissibility examination may take place at the border
but may also take place at an examination site, a public warehouse, or
other appropriate locations. If FDA determines that refusal under
section 801(a) of the FD&C Act is appropriate, it will follow
appropriate procedures.
II. Overview of the Interim Final Rule and Significant Changes Made to
the Proposed Rule
The highlights of this interim final rule are described briefly in
the following paragraphs and are discussed in more detail later in the
preamble.
A. ``What Definitions Apply to This Subpart?'' (Section 1.276 Proposed
as Sec. 1.277)
[sbull] The term ``the act'' was not changed.
[sbull] The term ``calendar day'' was not changed.
[[Page 58977]]
[sbull] The term ``country from which the article originates'' was
added and defined as ``FDA Country of Production.''
[sbull] The term ``country from which the article of food was
shipped'' was revised to ``country from which the article is shipped.''
[sbull] The term ``FDA Country of Production'' replaces the term
``originating country.'' For an article of food that is in its natural
state, the FDA Country of Production is 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 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 FDA Country of Production
is the country where the article was made; except that, if an article
of food is made from wild fish 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.
[sbull] The term ``food'' has been redefined. The new definition
excludes ``food contact substances'' as defined in section 409(h)(6) of
the FD&C Act (21 U.S.C. 348(h)(6)) and ``pesticides'' as defined in 7
U.S.C. 136(u).
[sbull] The term ``grower'' has been added to the interim final
rule. It means a person who engages in growing and harvesting or
collecting crops (including botanicals), raising animals (including
fish, which includes seafood), or both.
[sbull] The term ``international mail'' has been added to the
interim final rule. The term ``international mail'' means foreign
national mail services, but not express carriers, express consignment
operators, or other private delivery services.
[sbull] The term ``no longer in its natural state'' has been added
to the interim final rule. The term means 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. However, 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 the prior notice interim final rule. Likewise,
whole fish headed, eviscerated, or frozen attendant to harvest are
still in their natural state for purposes of the prior notice interim
final rule.
[sbull] The term ``port of entry'' has been defined, as having the
meaning given in 19 CFR 101.1.
[sbull] The term ``port of arrival'' has been added to the interim
final rule. The interim final rule 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.''
[sbull] The term ``registration number'' has been added to the
interim final rule. Registration number refers to the registration
number assigned by FDA under section 415 of the FD&C Act, 21 U.S.C.
350d, and 21 CFR part 1, subpart H.
[sbull] The term ``shipper'' has been added to the interim final
rule. The interim final rule defines ``shipper'' as ``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.''
[sbull] The term ``United States'' has been added to the interim
final rule. It defines ``United States'' as the Customs territory of
the United States, i.e., ``the 50 States, the District of Columbia, and
the Commonwealth of Puerto Rico.''
[sbull] The term ``you'' has been revised to reflect the removal of
limitations on who is authorized to submit prior notice.
B. ``What is the Scope of This Subpart?'' (Section 1.277 Proposed as
Sec. 1.276)
This provision has been revised. Section 1.277(a) clarifies that
the interim final rule applies 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. FTZ.
Section 1.277(b) 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 the U.S. Department of Agriculture (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.).
C. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278
Proposed as Sec. 1.285)
This provision has been revised. The interim final rule has been
revised to remove the restriction that the submitter be the U.S.
importer or purchaser. The interim final rule provides that any person
with knowledge of the required information may submit prior notice or
have it transmitted on their behalf.
D. ``When Must Prior Notice Be Submitted to FDA?'' (Section 1.279
Proposed as Sec. 1.286)
This provision has been revised. FDA had proposed that all
information required in the prior notice be submitted to FDA no later
than 12 noon of the calendar day before the day the article of food
arrived at the border crossing in the port of entry. Under the interim
final rule, prior notice must be submitted to FDA and confirmed for FDA
review no less than 2 hours before arrival by land via road, no less
than 4 hours before arrival by air and land via rail, and no less than
8 hours before arrival by water. If the article of food is arriving by
international mail, the prior notice must be submitted before the food
has been sent to the United States and the parcel must be accompanied
by confirmation of FDA receipt of prior notice. With the exception of
prior notice for international mail, prior notice may not be submitted
more than 5 calendar days before the anticipated date of arrival at the
anticipated port of entry. When an article of food that is carried by
or otherwise accompanies an individual is subject to prior notice, the
prior notice must be submitted within the timeframe established for the
mode of transportation, and the food must be accompanied by a copy of
the FDA confirmation including the PN Confirmation Number. Because we
[[Page 58978]]
reduced the timeframes for submitting prior notice in the interim final
rule to the minimum amount of time that we need to meet our statutory
responsibility to receive, review, and respond to prior notice
submissions, the interim final rule does not provide for amendments or
updates to the prior notice. However, as discussed in more detail in
section D, FDA and CBP will be actively exploring ways to reduce prior
notice timeframes, while fulfilling the Bioterrorism Act mandates.
E. How Must You Submit Prior Notice? (Section 1.280 Proposed as Sec.
1.287)
FDA proposed that prior notice, amendments, and updates be
submitted electronically to FDA through the FDA PN System. The interim
final rule provides that prior notice must be submitted electronically,
in English (except an individual's name, the name of a company, or the
name of a street), through either CBP's ABI/ACS or the FDA PN System
Interface. All information must be submitted using the Latin (Roman)
alphabet. The interim final rule eliminates submission of duplicative
information to FDA by those who can file import entry information
through ABI/ACS. FDA and CBP are upgrading and interfacing their
respective electronic systems so that information required for prior
notice can be submitted through ABI/ACS. Information required by the
interim final rule also can be submitted through the FDA PN System
Interface. The interim final rule also provides that if a customs
broker's of self-filer's system is not working or if ABI/ACS is not
working, prior notice must be submitted through the FDA PN System
Interface. If the FDA PN System Interface or OASIS is not operating,
prior notice information must be submitted by e-mail, or by fax to the
FDA, but not in person.
F. What Information Must Be in a Prior Notice? (Section 1.281 Proposed
as Sec. 1.288)
The interim final rule requires the following information to be
submitted in the prior notice:
[sbull] Submitter (name of individual, individual's telephone, fax,
e-mail, name/address of submitting firm);
[sbull] Transmitter, if different than submitter (name of
individual, individual's telephone, fax, e-mail, name/address of
transmitting firm);
[sbull] Entry type;
[sbull] CBP entry identifier, such as the CBP entry number or in-
bond number;
[sbull] The identity of the article of food as follows: The
complete FDA product code; the common or usual name or market name; the
estimated quantity described from largest container to the smallest
package size; and the lot or code numbers or other identifier of the
food if required by the FD&C Act or FDA regulations;
[sbull] Manufacturer, for food no longer in its natural state
(name, address, registration number, except that the requirement to
provide registration number does not apply to an article of food that
is imported for transshipment or other export;
[sbull] Grower, if known, for an article of food that is in its
natural state (name and growing location);
[sbull] Consolidator may voluntarily be provided by the submitter,
at the submitter's option, if the grower is not known (name and
address);
[sbull] FDA Country of Production;
[sbull] Shipper (name, address, registration number; except that
the requirement to provide registration number does not apply to an
article of food that is imported for transshipment or other export;
[sbull] The country from which the article is shipped;
[sbull] Anticipated arrival information (port of arrival and
crossing location within that port, date, and time) or, if the food is
imported by international mail, the anticipated date of mailing;
[sbull] The name and address of the importer, owner, and ultimate
consignee, unless the shipment is imported or offered for import for
transshipment through the United States under a T&E entry, or, if the
food is imported by international mail, the U.S. recipient (name and
address);
[sbull] Mode of transportation;
[sbull] Carrier (SCAC/Standard Carrier Abbreviated Code or IATA/
International Air Transportation Association code or, if codes are not
applicable, the name and country of the carrier) (except for food
imported by international mail);
[sbull] Planned shipment information as applicable (except for food
imported by international mail), including 6-digit HTS code; and
[sbull] If the article of food is under hold for failure to submit
prior notice or submit an adequate prior notice, the location where it
is being held, the date the article has arrived or will arrive at the
location, and the name of a contact individual at the location.
FDA eliminated from the interim final rule telephone and fax
numbers and e-mail addresses for most firms, entry line numbers, trade
or brand name, and consumption entry information (port of entry/
anticipated date of entry for Customs purposes). FDA revised
information requirements regarding the quantity, lot/code identifier,
manufacturer, grower, and carrier in the interim final rule. FDA added
mode of transportation and planned shipment information to the interim
final rule. In the interim final rule, registration numbers are
required only for manufacturer and shipper, if the shipper is a
facility that is required to be registered under section 415 of the
FD&C Act (21 U.S.C. 350d) and 21 CFR part 1, subpart H, for that
article of food. For clarity, the interim final rule segregates the
information required for food arriving by international mail (Sec.
1.281(b)) and also segregates the information required for food refused
under section 801(m) of the FD&C Act (Sec. 1.281(c)).
Table 1A, which appears later in this preamble, describes the
information required in prior notice.
G. ``What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA?'' (Section 1.282 Proposed as
Sec. Sec. 1.289 to 1.294)
This provision has been revised in the interim final rule. The
proposed rule allowed one product identity amendment for certain
product identity information that was not known at the time of
submission and for arrival updates. Product identity amendments could
be submitted up to 2 hours before arrival at the border. Arrival
updates were required if the port of entry changed or if the time of
arrival was expected to be more than 3 hours later or 1 hour earlier
than the anticipated time of arrival.
The interim final rule does not provide for product identity
amendments or arrival updates. Because we reduced the timeframes for
submitting prior notice in the interim final rule to the least amount
of time that we need to meet our statutory responsibility to receive,
review, and respond to prior notice submissions, the interim final rule
does not provide for amendments or updates. The interim 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 correct information must be submitted.
H. ``What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice?'' (Section 1.283 Proposed as Sec.
1.278)
FDA revised the proposed rule to provide for more specificity, to
clarify
[[Page 58979]]
the status of refused food, and to provide a mechanism for FDA review
after refusal. In the interim final rule, FDA identifies the
consequences and procedures for the following situations:
1. Inadequate Prior Notice (No, Inaccurate, or Untimely Prior Notice)
Unless immediately exported with CBP concurrence, an article of
food that is refused for inadequate prior notice shall be held in
accordance with Sec. 1.283.
2. Status and Movement of Refused Food
[sbull] A refused food is considered general order merchandise
under section 490(a) of the Tariff Act of 1930, as amended (19 U.S.C.
1490(a)).
[sbull] The refused food must be moved under an appropriate
custodial bond. FDA must be notified of the location where the food has
been or will be moved within 24 hours of refusal. If the food is held,
it must be taken directly to the designated location within 48 hours,
shall not be entered, and shall not be delivered to any importer,
owner, or ultimate consignee.
3. Segregation of Refused Foods
If a refused food is part of a shipment that contains other
articles, the refused food may be segregated from the rest of the
shipment within the port of arrival or at the hold location if
different.
4. Costs
Neither FDA nor CBP are liable for transportation, storage, or
other expenses resulting from refusal.
5. Export After Refusal
A refused food may be exported with CBP concurrence and supervision
(unless CBP or FDA has administratively detained or seized the article
under other authority).
6. No Post-Refusal Submission or Request for Review
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.
7. Food Carried by or Otherwise Accompanying an Individual
For food that is not for personal use, if the article of food is
refused because prior notice is inadequate or the individual cannot
provide FDA or CBP with a copy of the PN confirmation, the article may
be held at the port or exported. If the individual cannot make
arrangements for holding or export, the food may be destroyed.
8. Post-Refusal Prior Notice Submissions
If an article of food is refused for no or inaccurate prior notice,
the prior notice must be submitted or corrected and resubmitted to FDA
and confirmed by FDA for review.
9. FDA Review After Refusal
After refusal, only the submitter, importer, owner, or ultimate
consignee may submit a written request asking FDA to review whether the
article is subject to the requirements of this subpart under Sec.
1.276(b)(5) and Sec. 1.277, or whether the prior notice submission is
accurate. The interim final rule also sets out procedures and
timeframes for the review process.
10. International Mail
In the case of food arriving by international mail, if prior notice
is inadequate or if the PN Confirmation Number is not affixed, the
article will be held by CBP for 72 hours for FDA inspection and
disposition. If refused and there is a return address, the parcel may
be returned to 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.
11. Prohibitions on Delivery and Transfer
A refused article of food may not be delivered outside of the port
where the article is held and may not be delivered to the importer,
owner, or ultimate consignee or transferred by any person from the port
or secure facility until FDA has examined the prior notice, determined
the adequacy of the prior notice, and notified CBP and the transmitter
that the article is no longer refused. After this notification by FDA
to CBP and transmitter, entry may be made in accordance with law and
regulation.
12. Relationship to Other Admissibility Provisions
A determination that an article of food is no longer subject to
refusal under section 801(m)(1) of the FD&C Act is different than, and
may come before, determinations of admissibility under other provisions
of the FD&C Act or other U.S. laws. A determination that an article of
food is no longer subject to refusal under section 801(m)(1) of the
FD&C Act does not mean that it will be granted admission under other
provisions of the FD&C Act or other U.S. laws.
I. What Are the Other Consequences of Failing to Submit Adequate Prior
Notice or Otherwise Failing to Comply With This Subpart? (Section 1.284
Proposed as Sec. 1.278)
The interim final rule provides that failure of a person who
imports or offers to import an article of food to submit prior notice
is a prohibited act under section 301(ee) of the FD&C 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.
J. What Happens to Food That Is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under 21 CFR Part
1, Subpart H? (Section 1.285)
The interim final rule also sets out the consequences concerning
what happens at the border to food from facilities that are not
registered as required under section 415 of the FD&C Act and 21 CFR
part 1, subpart H. These are similar to provisions in the interim final
rule for dealing with food that is refused for inadequate prior notice.
Table 1A of this document shows the information required by
sections 1.281(a), (b), and (c). For clarity, the table also identifies
under what circumstances certain information is not required, e.g.,
registration numbers when the article of food is imported or offered
for import for transshipment, storage and export, or further
manipulation and export.
BILLING CODE 4160-01-P
[[Page 58980]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.074
BILLING CODE 4160-01-C
III. Comments on the Proposed Rule
FDA received approximately 470 timely responses containing one or
more comments in response to the proposed rule. To make it easier to
identify comments and responses to the comments, the word ``Comments''
will appear before the description of the comment, and the word
``Response'' will appear before our response. A summary follows which
includes a description of the appropriate section in the interim final
rule.
A. General Comments and Outreach
(Comments) Some comments suggest revision of section 307 of the
Bioterrorism Act. Other comments recommend that FDA repropose the rule
or not implement the rule.
(Response) Changes to the statute are beyond the scope of this
rulemaking. Postponing implementation of or not implementing the rule
is not viable under section 307(c) of the Bioterrorism Act, which not
only directs the FDA to ``promulgate proposed and final regulations for
the requirement of
[[Page 58981]]
providing notice in accordance with section 801(m)'' by December 12,
2003, but also provides that an 8 hour prior notice requirement takes
effect on this date even if FDA has not promulgated regulations that
are in effect by this deadline. However, we are publishing this rule as
an interim final rule and are, accordingly, soliciting comment on its
provisions.
(Comments) Most comments generally support the protections of the
food supply provided under the Bioterrorism Act. Although comments
recommend that the final rule be amended to reflect more accurately
industry practices, other comments suggest the regulation should be
strengthened to ensure that FDA has all of the information required to
identify foods that may pose a health or security threat. Some comments
argue that FDA already has access to information currently submitted to
CBP to allow for identification and quick interdiction of foods that
may pose a health or security threat. Other comments question how the
final rule would enhance FDA's ability to improve food safety and
whether the benefits outweigh the costs.
(Response) Through section 307 of the Bioterrorism Act, Congress
amended the FD&C Act to require the submission to FDA of a notice
providing information regarding food before its importation into the
United States. Congress also required FDA to issue implementing
regulations to be effective not later than December 12, 2003. Thus, a
postponement of the rule is not an option. Although FDA is aware that
the prior notice regulation will affect industry, Congress determined
the need for prior notice by passing the Bioterrorism Act. Prior notice
of imported food will give FDA better information about the food
earlier, enabling FDA to review and respond to the information before
the arrival of the food at the border. Prior notice also will give FDA
information with which it will be able to better focus its inspection
resources. Section V of this preamble, Analysis of Economic Impacts,
discusses the benefits of this interim final rule in detail. To address
many of the concerns raised by the comments, FDA has made significant
modifications in the interim final rule. However, we are publishing
this rule as an interim final rule and are, accordingly, soliciting
comment on its provisions.
(Comments) Some comments ask that FDA provide clear guidance and
training to industry and agency field personnel about the procedures
for implementing the regulation.
(Response) FDA conducted extensive outreach on the proposed prior
notice rule, including having relevant FDA staff attend 6 international
meetings and over 100 domestic meetings to ensure that affected parties
were aware of the Bioterrorism Act prior notice requirements. On
January 29, 2003, FDA held a public meeting (via satellite downlink) to
discuss both the registration and prior notice proposed rules (see 68
FR 1568, January 13, 2003) or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
Nearly 1,000 participants in North and South
America and the Caribbean viewed that live broadcast. The meeting was
later re-broadcast to Europe, Asia, Africa, and the Pacific. FDA has
also posted transcripts of the broadcast in English, French, and
Spanish on the agency's Web site.
FDA plans similar outreach efforts directed to both domestic and
international stakeholders after publication of the interim final rule
implementing the registration and prior notice provisions of the
Bioterrorism Act. Outreach will include many methods of communication:
[sbull] Dissemination of materials to guide affected domestic and
international food facilities through the new processes established to
implement the registration and prior notice requirements;
[sbull] Domestic outreach meetings to State regulators and
industry;
[sbull] A satellite downlink video broadcast and a series of
videoconferences to various regions of the world;
[sbull] Materials and events for the media;
[sbull] International outreach to food trading partners;
[sbull] 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; and
[sbull] 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.
More specifics regarding each of these will be included in FDA's
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov. In addition, FDA also plans training in
new or revised procedures for its field personnel, as well as CBP field
personnel. FDA will also provide guidance on enforcement to its staff
containing the agency's policies on injunctions, prosecution, and
debarment related to failure to provide timely and accurate prior
notice, as well as the agency's policies regarding refusals under
section 801(m)(1) of the FD&C Act and holds under section 801(l). As
described in greater detail later, FDA intends to include a transition
period in this guidance, during which it will emphasize education to
achieve compliance. Guidance documents are available to the public, and
FDA will shortly publish a notice of availability in the Federal
Register.
FDA will notify the World Trade Organization (WTO) of this interim
final rule. Shortly after publication of this interim final rule, FDA
will begin 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. Online assistance and a help desk
will be available when the interim final rule becomes effective.
B. Foreign Trade Issues
(Comments) Some comments questioned the consistency of the proposed
regulation with U.S. obligations under various WTO agreements, NAFTA,
and other international agreements.
(Response) FDA is aware of the international trade obligations of
the United States and has considered these obligations throughout the
rulemaking process for this regulation and the interim final regulation
is consistent with these international obligations.
(Comments) Some comments asserted that the proposed regulation is
burdensome, confusing, costly, disproportionate, discriminatory, and
will have a negative impact on foreign trade.
(Response) In drafting the proposed rule, FDA considered how best
to structure the proposed rule consistent with the statutory mandates
of the Bioterrorism Act and, at the same time, to reduce the costs
associated with compliance. As discussed in more detail in the
following paragraphs, FDA has carefully considered comments received
regarding the burden imposed by the proposed rule, including its
effects on international trade. Furthermore, based on the comments
received on the proposed requirements, FDA has made a number of
significant changes that minimize the impact of prior notice
requirements on the food industry. These changes include removing
restrictions on who can submit prior notice; allowing submission to be
made either through ABI/ACS (the existing mechanism for filing entry
information with CBP) or the FDA PN System Interface (the FDA PN Web
system described in the proposed rule); reducing the timeframes for
submission of prior notice and tying them to mode
[[Page 58982]]
of transport; and streamlining the information requirements.
C. ``What Definitions Apply to This Subpart?'' (Section 1.276 Proposed
as Sec. 1.277)
1. The Act (Sec. 1.276(a))
The proposed rule defined ``the act'' as the Federal Food, Drug,
and Cosmetic Act. The proposed rule also applies the definitions of
terms in section 201 of the act (21 U.S.C. 321) to such terms as used
in the proposed rule.
(Comments) FDA did not receive comments on the definition of ``the
act.''
(Response) We did not change the definition in the interim final
rule. We have clarified that the definitions in the FD&C Act do not
apply if a term is defined differently in the interim final rule.
(Interim final rule) Section 1.276(a) of the interim final rule
defines ``the act'' as the Federal Food, Drug, and Cosmetic Act.
Section 1.276(b) provides the definitions in the FD&C Act apply unless
a term is defined differently in the interim final rule.
2. Calendar Day (Sec. 1.276(b)(1))
The proposed rule defined ``calendar day'' as ``every day shown on
the calendar.''
(Comments) FDA did not receive comments on the definition of
``calendar day.''
(Response) We did not change the definition in the interim final
rule.
(Interim final rule) ``Calendar day'' is defined in Sec.
1.276(b)(1) of the interim final rule as ``every day shown on the
calendar.''
3. Country From Which the Article Originates (Sec. 1.276(b)(2))
Section 801(m)(1) of the FD&C Act requires that ``the country from
which the article originates'' be identified in a prior notice. The
proposed rule used the term ``originating country'' and defined it as
``the country from which the article of food originates.''
(Comments) Comments were received on the proposed definition of
``originating country.'' These comments are addressed under ``FDA
Country of Production,'' which is the term that FDA has chosen in the
interim final rule to replace ``originating country.''
(Response) The term ``the country from which the article
originates'' has been added to the interim final rule to refer back to
the statutory language.
(Interim final rule) ``Country from which the article originates''
is defined as ``FDA Country of Production.''
4. Country From Which the Article Is Shipped (Sec. 1.276(b)(3))
The proposed rule defined ``country from which the article of food
was shipped'' as ``the country in which the article of food was loaded
onto the conveyance that brings it to the United States.'' A conveyance
is the means of transportation, e.g., ship, truck, car, van, plane,
railcar, etc., not the shipping container that can be moved from a ship
to a truck to a train. FDA requested comment on whether the phrase
``country from which the article of food was shipped'' should include
the countries of intermediate destination.
(Comments) Several comments support identifying countries of
intermediate destination, noting that it would be desirable to have
this information to support product tracing. One states that even if a
food product were merely shipped through another country without
further manufacturing/processing, the potential for tampering would
still exist. This comment is concerned that, without information on
every intermediate country, FDA would lack the ability to trace food
for potential contamination back through the distribution chain.
Another comment supports providing the countries of intermediate
destination. It states that, except in the case of sealed containers,
the manufacturer cannot control manipulation that occurs in countries
of intermediate destination.
Several comments state that the information required in a prior
notice should not include countries of intermediate destination. Other
comments note that: An imported article may pass through a number of
ports or stops in a variety of countries and never be unloaded; a U.S.
importer in most cases has no control of which ports or stops a carrier
may make; and exporters cannot guarantee which ports the ship will
enter or pass through on its way to a U.S. port. Another comment states
the information would not be necessary for sealed containers because
alteration or absence of a seal alerts the owner to tampering, but it
may be necessary for bulk or unpackaged products. Most of the comments
that object conclude that submission of additional countries of
intermediate destination would be unreasonable and burdensome and would
not improve the safety and security of the food supply.
(Response) Section 801(m)(l) of the FD&C Act uses the singular
``country'' when it directs submission of the identity of the country
from which the article is shipped, not the plural ``countries.'' Thus,
FDA has concluded that the text of the statute dictates that the
definition be singular. The interim final rule thus retains the
proposed definition of the term ``country from which the article was
shipped.''
(Comments) One comment states that the proposed definition of
``country from which the article of food was shipped'' is clear and
suggests that it be maintained. Several commenters suggest that
``country from which the article of food was shipped'' should be
defined as the country from which the goods were ``exported'' to the
United States as that phrase is used in the CBP regulations defining
``country of export.''
Other comments suggest that FDA's definition failed to take into
account the following considerations: That ocean and air carriers
routinely use ``feeder'' vessels/aircraft to move cargo from the
country of origin to a ``gateway'' for transfer to a larger vessel or
aircraft that will transport the cargo to its final destination; and
that ocean vessels frequently discharge containers destined for the
United States in Canada where they are transferred to a motor carrier
for transport to the United States. The comments conclude that the
proposal, if implemented, would confuse importers and require them to
attempt to obtain the cargo routing from master carriers. They suggest
that FDA require instead the reporting of the last country in which a
product was stored if that is different from the country in which it
was produced (the country of production).
(Response) Section 801(m)(1) of the FD&C Act requires that prior
notice submissions identify ``the country from which the article is
shipped.'' ``Country of export'' is not a term formally defined in
CBP's regulations.
We acknowledge that food may pass through more than one country
before it reaches the United States. However, we do not believe that
this practice changes the definition dictated by the statutory
language. Several examples may be helpful. In one scenario, a shipper
in country A arranges for a food manufactured in country B to be
transported to the United States via country C. The food arrives in
country C on an ocean vessel and is transferred to a truck that brings
it to the U.S. port of arrival. In this first scenario, the country
from which the article is shipped is country C.
In a second scenario, a shipper in country A arranges for a food
manufactured in country B to be transported to the United States by a
ship that is loaded in country B but stops in country C and then
continues to the United States where the food is discharged. In this
second scenario, the country from which the article is
[[Page 58983]]
shipped is country B. In a third scenario, if the food was transferred
to a different vessel in country C, the country from which the article
is shipped is country C.
(Interim final rule) Section 1.276(b)(3) of the interim final rule
defines ``country from which the article is shipped'' as ``the country
in which the article of food is loaded onto the conveyance that brings
it to the United States.'' We changed the term from ``country from
which the article was shipped'' to ``country from which the article is
shipped'' to accurately reflect the language of the statute.
5. FDA Country of Production and Originating Country (Sec.
1.276(b)(4))
The proposed rule defined ``originating country'' as ``the country
from which the article of food originates,'' which means the country
where the article of food was grown and harvested, or if processed,
where the article of food was produced.
(Comments) Many comments regarding the definition of ``originating
country'' suggest that FDA use the ``country of origin'' definition
used by CBP, or the standard rules of origin used by CBP, USDA, and
associations such as the WTO.
(Response) Section 801(m)(1) of the FD&C Act requires prior notice
submissions to FDA identify ``the country from which the article
originates.''
We have not changed the definition of ``originating country'' to
align it with ``country of origin'' as that term is defined by CBP. CBP
defines ``country of origin'' at 19 CFR 134.1(b) as follows:
the country of manufacture, production, or growth of any article of
foreign origin entering the United States. Further work or material
added to an article in another country must effect a substantial
transformation in order to render such other country the ``country
of origin'' within the meaning of this part; however, for a good of
a NAFTA country, the NAFTA Marking Rules will determine country of
origin.
In rulings, CBP has further defined ``country of origin'' and
substantial transformation to identify the country of growth of the
main ingredient in a processed food rather than the country of
production of ``the article [of food]'' (emphasis added) in the form it
is being imported into the United States. For example, a CBP ruling
identified the country of origin as the United States where beans were
rehydrated and canned in the Dominican Republic, but grown and dried in
the United States (Ref. 1). For purposes of the prior notice provisions
of the FD&C Act, the ``article of food'' is canned beans, not dried
beans. From a food safety standpoint, FDA is most interested in knowing
where the article of food was processed and canned. We believe that it
best serves the language and the purposes of section 801(m)(l) of the
FD&C Act to define the term to focus on the country of production of
the specific article of food that is being shipped to the United
States. To avoid confusion between FDA's prior notice requirements and
CBP requirements, the interim final rule uses the term ``FDA Country of
Production'' instead of the term ``originating country'' or ``country
from which the article originates.'' ``FDA Country of Production'' is
already familiar to customs brokers and self-filers using ABI/ACS
interface with OASIS.
(Comments) One comment suggests that ``EU'' (European Union) be
acceptable for use as an originating country.
(Response) FDA disagrees. Section 801(m) of the FD&C Act requires
identification of ``the country from which the article originates''
(emphasis added). Accordingly, for purposes of this provision, each
sovereign country must be identified when declared as part of the prior
notice submission.
(Comments) Several comments suggest that the definition of
``country of origin'' for fish be the country in which the vessel is
flagged or in which the fish was last processed. Another comment asks
FDA to use the definition of ``country of origin'' being used by USDA's
Agricultural Marketing Service for fish and seafood.
(Response) We generally agree. The proposed rule relied in part on
USDA's proposed definition as set out in USDA guidance published in the
Federal Register on October 11, 2002, and is based on the Farm Security
and Rural Investment Act of 2002 (commonly known as the 2002 Farm
Bill), as amended. As set out in Sec. 1.276(b)(4) of the interim final
rule, if an article of food is wild fish that is still in its natural
state and 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 the article of food is made from wild fish aboard a vessel, the FDA
Country of Production is the country in which the vessel is registered.
(Comments) Several comments express concern that the proposed
definition, ``[o]riginating country means the country from which the
article of food originates,'' does not take into consideration the
producer, processor, vessel or common carrier feeder and consolidation
practices in which components of the shipment may be composites or
commingled from more than one country. One comment asks that FDA
describe when the country of canning would be the originating country,
and when it would not. One comment suggests that decaffeinating or
blending coffee be considered processing and that decaffeinated or
blended coffee be considered as processed food for the purposes of
prior notice.
(Response) Some of these comments appeared to confuse the proposed
definition of ``country from which the article of food was shipped''
with the proposed definition of ``originating country,'' another reason
why we decided to use the term ``FDA Country of Production.'' As
explained above in the discussion of ``the country from which the
article is shipped,'' the two countries will sometimes be different.
When determining which country is the FDA Country of Production, the
focus should be on the production of the specific article of food. For
example, if the article of food is raw, whole, unpeeled carrots, the
FDA Country of Production is the country where the carrots were grown
and harvested. If the article of food is raw peeled and chopped carrots
or canned carrots, the FDA Country of Production is the country where
the carrots were peeled and chopped or canned. As a general matter, for
canned foods, the FDA Country of Production should be the country where
food was canned. Similarly, we consider decaffeinated coffee to be no
longer in its natural state and the FDA Country of Production would be
the country in which the coffee was decaffeinated.
(Interim final rule) Section 1.276(b)(4) of the interim final rule
defines the ``FDA Country of Production'' for an article of food that
is in its natural state, as 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. For an
article of food that is no longer in its natural state, the FDA country
of production is defined as 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
[[Page 58984]]
a Territory, the FDA Country of Production is the United States.
6. Food (Sec. 1.276(b)(5))
The proposed rule defined ``food'' as having the meaning given in
section 201(f) of the FD&C Act. The proposed rule provided examples of
food including:
fruits, vegetables, fish, dairy products, eggs, raw agricultural
commodities for use as food or components of food, animal feed,
including pet food, food and feed ingredients and additives,
including substances that migrate into food from food packaging and
other articles that contact food, dietary supplements and dietary
ingredients; infant formula, beverages, including alcoholic
beverages and bottled water, live food animals (such as hogs and
elk), bakery goods, snack foods, candy, and canned foods.
a. Food packaging and other food contact substances.
(Comments) We received several comments on the subject of food
contact substances, including packaging. The comments ask that FDA
clarify the definition of ``food'' because the proposed rule included
as examples of food not only those items traditionally understood as
food, but also items that come into contact with and may migrate into
food during processing or packaging. In particular, the comments ask
that food packaging and components of food packaging, other food
contact articles (such as food processing equipment and components of
such equipment, glassware, dishware, cutlery, kitchen appliances), and
so-called indirect additives (including those applied to food contact
surfaces) be excluded from the final rule's definition of ``food.''
In support, the comments contend the legislative history of the
prior notice provisions establish that Congress did not intend to apply
prior notice requirements to these substances even though they can be
food within the meaning of section 201(f) of the FD&C Act. In addition,
some point to language in section 415 of the FD&C Act (21 U.S.C. 350d)
relating to registration and language in section 414(b) of the FD&C Act
relating to recordkeeping (21 U.S.C. 350c). Finally, some comments
argued that an overly broad definition of ``food'' would dilute the
government's resources, thereby hampering the government's opportunity
to achieve the protective goals of the Bioterrorism Act.
(Response) We expressly included food packaging and other food
contact materials in the proposed definition, with the result that
prior notice would have been required for food packaging and other food
contact materials and their components (see 68 FR 5428 at 5430). The
breadth of the proposed definition of ``food'' was based on both the
statutory definition in section 201(f)(3) of the FD&C Act, which
defines articles used as components of food as ``food,'' as well as the
case law interpreting the definition, including Natick Paperboard v.
Weinberger, 525 F.2d 1103 (1st Cir. 1975) (paperboard containing PCBs
intended for food use is adulterated food; U.S. v. Articles of food * *
* 688 Cases * * * of Pottery (Cathy Rose), 370 F. Supp. 371 (E.D. Mi.
1974) (ceramic pottery that leaches lead is adulterated food).
The comments on food contact substances raise the question of what
Congress intended ``food'' to mean for purposes of prior notice. In
construing the prior notice provision of the Bioterrorism Act, FDA is
confronted with two questions. First, has Congress 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 ``food,'' FDA may define ``food'' 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)).
The agency has determined that, in enacting section 801(m) of the
FD&C Act, Congress did not speak directly and precisely to the meaning
of ``food.'' As noted, the FD&C Act has a definition of ``food'' at
section 201(f). It may be a reasonable assumption that, when the term
``food'' is used in the FD&C Act, section 201(f) applies. However,
although there may be ``a natural presumption that identical words used
in different parts of the same act are intended to have the same
meaning [citation omitted], * * * the presumption is not rigid * * *.''
(Atlantic Cleaners & Dyers, Inc. v. U.S., 286 U.S. 427, 433 (1932);
(accord: U.S. v. Cleveland Indians Baseball Co., 532 U.S. 200, 213
(2000)). Thus, the same word may be given different meanings, even in
the same statute, if Congress intended different interpretations or if
such different interpretations are reasonable (at step 2) (Atlantic
Cleaners & Dryers, Inc., supra).
Even before the Bioterrorism Act amendments, the term ``food'' was
not defined identically throughout the FD&C Act. For example, in
construing the parenthetical ``(other than food)'' in section
201(g)(1)(C) of the FD&C Act, the Seventh Circuit Court noted that
Congress meant to exclude only ``articles used by people in the
ordinary way that most people use food--primarily for taste, aroma, or
nutritive value'' and not all substances defined as food by section
201(f) (Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir.
1983)). Similarly, section 409(h)(6) of the FD&C Act defines a ``food
contact substance'' as ``any substance intended for use as a component
of materials used in manufacturing, packing, packaging, transporting,
or holding food if such use is not intended to have any technical
effect in such food'' (emphasis added). This definition makes sense
only if ``food'' in this context excludes materials that contact food
because components of food contact materials are plainly intended to
have a technical effect in such materials.\2\
---------------------------------------------------------------------------
\2\ FDA's long-standing interpretation of the FD&C Act's
definition of color additive, section 201(t), is an additional
example of where ``food'' is used more narrowly than as defined in
section 201(f). A color additive is defined in section 201(t) of the
FD&C Act as a substance that ``when applied to a food * * * is
capable * * * of imparting color thereto * * *.'' The agency's food
additive regulations distinguish between color additives and
``colorants,'' the latter being used to impart color to a food-
contact material (21 CFR 178.3297(a); see also 21 CFR 70.3(f)).
Thus, ``food'' as it appears in the statutory definition of color
additive, necessarily excludes food contact materials.
---------------------------------------------------------------------------
Thus, in this larger statutory context, FDA has evaluated section
801(m) of the FD&C Act to determine whether the meaning of the word
``food'' is ambiguous. In conducting this Chevron step one analysis,
all of the traditional tools of statutory interpretation are available
to determine whether the language Congress used is ambiguous
(Pharmaceutical Research & Manufacturers of America v. Thompson, 251 F.
3d 219, 224 (D.C. Cir. 2001)). Beginning with the language of the
statute, in section 801(m) of the FD&C Act, ``food'' is used to
describe which subset of FDA-regulated articles are subject to prior
notice:
In the case of an article of food that is being imported or
offered for import into the United States, the Secretary, after
consultation with the Secretary of the Treasury, shall by regulation
require, for the purpose of enabling such article to be inspected at
ports of entry into the United States, the submission to the
Secretary of a notice * * * (emphasis added).
The Bioterrorism Act is silent as to the meaning of ``food.'' Congress
did not specify whether it intended the definition in section 201(f) of
the FD&C Act to apply, one of the other
[[Page 58985]]
possibilities noted above, or another meaning. Where, as here, the
statutory language on its face does not clearly establish Congress's
intent, it is appropriate to consider not only the particular statutory
language at issue, but also the language and design of the statute as a
whole (Martini v. Federal Nat'l Mortgage Association, 178 F. 3d 1336,
1345 (D.C. Cir. 1999), citing K Mart Corp. v. Cartier, Inc., 486 U.S.
281 (1988)). Indeed, the analysis should not be confined to the
specific provision in isolation, because the meaning or ambiguity of a
term may be evident only when considered in a larger context (FDA v.
Brown & Williamson Tobacco Corp., supra at 132 (2000)).
Consistent with this instruction, FDA has considered other parts of
the Bioterrorism Act in assessing whether the meaning of ``food'' in
section 801(m) of the FD&C Act ambiguous. In particular, FDA has
considered the language of section 415 of the FD&C Act. The
Bioterrorism Act's registration provision is one piece of several
enacted by Congress to enhance the safety of the U.S. food supply.
Registration is designed to work in concert with prior notice. This is
reflected in the Bioterrorism Act's amendment of section 801 of the
FD&C Act to provide that food from an unregistered foreign facility be
held at the port when imported or offered for import (section 801(l) of
the FD&C Act). The information provided by registration will allow FDA
to cross-check prior notice submissions against registration data to
confirm the identity of manufacturers and others who are required to
register. Furthermore, the information provided by prior notice
submissions can serve as a cross-check as to whether firms are
registered as required and have been providing the necessary updates.
As explained in the preamble to the interim final registration rule
published elsewhere in this issue of the Federal Register, FDA has
concluded that the meaning of the term ``food'' in section 415 of the
FD&C Act is ambiguous. First, the use, in section 415(a)(1) of the FD&C
Act, of the phrase ``for consumption'' after the word ``food'' creates
an ambiguity because it could be read to suggest that ``food'' within
the context of the section 415 registration requirement only refers to
food that is ordinarily thought of as ``consumed.'' By modifying the
term ``food,'' Congress apparently intended to limit the term ``food''
to something less than the broad definition in section 201(f) of the
FD&C Act. In addition, in section 415(b)(1) of the FD&C Act, when
defining ``facility'' for purposes of section 415, Congress expressly
exempted ``farms; restaurants; other retail food establishments;
nonprofit food establishments in which food is prepared for or served
directly to the consumer * * *.'' These exemptions do not make clear
whether Congress intended them to cover only food that is ordinarily
eaten at some point by consumers primarily for taste, aroma, or
nutritive value or whether, for example, a retail food establishment
could include retailers of food contact materials, such as retail
cookware stores.
The legislative history of section 415 of the FD&C Act also
supports the conclusion that Congress did not speak directly to the
meaning of ``food'' in that Bioterrorism Act provision. Such history is
appropriately consulted at Chevron step one (Atherton v. FDIC, 519 U.S.
213, 228-29 (1997)). In particular, the Conf. Rept. to H.R. 3448, which
became the Bioterrorism Act, explains what Congress intended by
``retail food establishments,'' which is used to create an exemption
from registration.
The Managers intend that, for the purposes of this section, the
term 'retail food establishments' includes establishments that
store, prepare, package, serve, or otherwise provide articles of
food directly to the retail consumer for human consumption, such as
grocery stores, convenience stores, cafeterias, lunch rooms, food
stands, saloons, taverns, bars, lounges, catering or vending
facilities, or other similar establishments that provide food
directly to a retail consumer.
(H. Conf. Rept. No. 481, 107th Cong., 2d Sess., 133 (2002)). Similarly,
the Conf. Rept. notes that the term ``non-profit food establishments''
includes not-for-profit establishments in which food is prepared for,
or served directly to the consumer, such as food banks, soup kitchens,
homebound food delivery services, or other similar charitable
organizations that provide food or meals for human consumption'' (Id.
at 133-34). Notably, the examples provided by Congress for both types
of exempt food establishments are not those that generally sell or
distribute food contact materials. Accordingly, the legislative history
of section 415 of the FD&C Act creates additional ambiguity as to the
meaning of ``food.''
This ambiguity in the word ``food'' is further underscored by the
legislative history of section 801(m) of the FD&C Act. For example, the
Conf. Rept. states that the prior notice provision is to be construed
not to apply to ``packaging materials if, at the time of importation,
such materials will not be used for or in contact with food * * *''
(see H. Conf. Rept. No. 481, 107th Cong., 2d Sess., 136 (2002)). This
statement implies that Congress was not relying on the definition of
food in section 201(f) of the FD&C Act. For example, the statement
could be read to mean that the term ``food'' does not include packaging
or other materials that contact food.
Having concluded that the meaning of ``food'' in section 801(m) of
the FD&C Act is ambiguous, FDA has considered how to define the term to
achieve a ``permissible construction'' of the prior notice provision
(Chevron, USA, Inc. v. NRDC, Inc., supra at 843). In conducting this
Chevron step two analysis, the agency has considered the same
information evaluated at step one of the analysis (Bell Atlantic
Telephone Co. v. FCC, 131 F. 3d 1044, 1049 (D.C. Cir. 1997); Chevron
U.S.A., Inc. v. FERC, 193 F. Supp. 2d 54, 68 (D.D.C. 2002)). FDA has
determined that it is permissible, for purposes of the prior notice
provision, to exclude food contact materials from the definition of
``food.''
Restricting ``food'' to substances other than food contact
materials is consistent with the legislative history of the prior
notice provision relating to food packaging and other food contact
substances. In addition, it is consistent with the ``food for
consumption'' language in section 415(a)(1) (FD&C Act) of the
registration provision. That is, foods that are ``consumed'' are
generally those eaten for their taste, aroma, or nutritive value. In
addition, excluding food contact materials from ``food'' in this
regulation is consistent with the exemptions in section 415(b)(1) of
the FD&C Act, as well as the legislative history of section 415.
As discussed in the following paragraphs in responses to other
comments, FDA has also interpreted ``food'' for purposes of section
801(m) of the FD&C Act to exclude pesticides as that term is defined
under 7 U.S.C. 136(u). Accordingly, FDA has determined that a
reasonable interpretation of ``food'' for purposes of section 801(m) of
the FD&C Act is as follows and has revised Sec. 1.276(b)(5) of this
interim final rule to provide:
Food has the meaning given in section 201(f) of the act, except
for purposes of this subpart, 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.
[[Page 58986]]
Importantly, FDA still considers food packaging and other food
contact substances to be ``food'' within the meaning of section 201(f)
of the FD&C Act when they, or their components, migrate into other
food. Therefore, these items are still ``food'' for purposes of the
other provisions of section 801 of the FD&C Act (with the exception of
section 801(l), which shares the same definition of food as section
801(m)). Accordingly, although not subject to the section 801(m) of the
FD&C Act requirement of prior notice, food packaging materials and
other food contact substances will remain, as they have been, subject
to determinations of admissibility under section 801(a) of the FD&C
Act.
b. Food processing aids. (Comments) One comment argues that food
processing aids and ``indirect food additives'' should not be
considered food for purposes of section 801(m) of the FD&C Act.
According to the commenter, these substances resemble food contact
substances, which Congress, as evidenced by the prior notice
legislative history of food contact substances, did not expect FDA to
subject to prior notice.
(Response) 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
4091(h)(6) of the FD&C 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.
c. Antimicrobial pesticides. (Comments) One comment expresses
concern about including antimicrobial pesticides within the scope of
this regulation. The comment states that pesticides are imported
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), not the FD&C Act, and are subject to Environmental Protection
Agency (EPA) approval before they are admitted to the United States.
The comment asks that FDA clarify that this regulation is not
applicable to antimicrobial pesticides with FDA and/or EPA approved
food contact uses. The comment states that including antimicrobial
pesticides within the scope of this regulation would impose unnecessary
burdens on antimicrobial pesticide registrants, without enhancing the
protection of the food supply.
(Response) As discussed previously, the meaning of ``food'' in
section 801(m) of the FD&C Act is ambiguous. Therefore, FDA may define
``food'' in a reasonable manner. FDA believes that excluding pesticides
from the definition of food is reasonable. Pesticides, including those
used in or on food for human or animal use, are comprehensively
regulated by the Federal Government. Under FIFRA, 7 U.S.C. 136 et seq.,
all pesticides (both food and nonfood use) are registered with EPA. As
part of the registration process, establishments in which pesticides
are produced must register with EPA (40 CFR 167.3 and 167.20). As part
of the importation process, prior notice of pesticide shipments must be
provided to EPA (19 CFR 12.112).
Importantly, the Federal regulatory scheme for pesticides was
substantially revised in 1996 by the Food Quality Protection Act (FQPA)
(Pub. L. 104-170), and EPA's authority over pesticides was consolidated
and expanded. As a result of FQPA, pesticides and their residues are
subject to substantial and comprehensive regulation by EPA. Where
another Federal agency has the types of specific and comprehensive
authority described previously to regulate the safety of a substance,
FDA believes that it is appropriate to interpret ``food'' in section
801(m) of the FD&C Act as not including that substance. Accordingly,
FDA has revised the definition of ``food'' in Sec. 1.276(b)(5) to
exclude pesticides as defined by FIFRA.
d. Chemicals (Comments) One comment seeks clarification as to
whether chemicals are considered ``food.'' The comment expects that
chemicals intended for human consumption will likely be included in the
requirements for prior notice.
(Response) We are not sure exactly what substances or products the
comment refers to; ``chemicals'' is a very broad term. Unless excluded
because they are food contact substances or pesticides, chemicals that
are ``used for food or drink'' or are ``used for components of any such
articles'' are ``food'' under section 201(f) of the FD&C Act and the
definition in the interim final rule (Sec. 1.276(b)(5)). If the
substance is used in some applications that make the substance ``food''
and some that do not, the principles applicable to further processing
and multi-use substances, set out in the following paragraphs, apply.
e. Live animals. (Comments) Two comments address inclusion of live
animals. One comment urges FDA to exempt live food animals from this
regulation, as it will have far-reaching impacts on all Canadian
farmers who export live food animals to the United States. The other
comment asks for clarification as to how prior notice applies to live
food animals imported for further processing, such as finishing.
(Response) As discussed previously, the meaning of ``food'' in
section 801(m) of the FD&C Act is ambiguous. Therefore, FDA may define
``food'' in a reasonable manner. FDA believes that it is reasonable to
interpret ``food'' in section 801(m) of the FD&C Act to include live
animals. Such inclusion is consistent with the explicit reference to
animals in the statutory standard, ``serious adverse health
consequences or death to humans or animals'' in section
801(m)(2)(B)(ii) of the FD&C Act--the provision that relates to FDA
review of prior notices submitted for food refused for lack of adequate
prior notice. In addition, it is consistent with the legislative
history of section 801(m) of the FD&C Act that refers only to the
exclusion of food contact substances. Moreover, the products of live
food animals are an integral part of the food consumed in the United
States, and thus, it is logical to protect the raw materials (i.e., the
live animals) by including them under the Bioterrorism Act's
safeguards. Finally, the inclusion of live animals in the definition of
``food'' is consistent with the reasonable interpretation of the
registration provision, section 415 of the FD&C Act. Accordingly, the
interim final rule's definition of ``food'' includes live food animals.
Defining ``food'' to include live animals is also consistent with the
case law interpreting the term ``food'' in the broader context of the
FD&C Act. See United States v. Tuente Livestock, 888 F. Supp. 1416
(S.D. Ohio, 1995).
f. Articles for further processing or capable of multiple uses.
(Comments) Some comments ask that FDA clarify that the definition of
``food'' does not include substances that are not edible, but may be
further processed to be rendered edible, for example, crude vegetable
oils, crude petroleum, and minerals such as phosphates which may be
refined and processed into food ingredients such as glycerin and
phosphoric acid. The comments state that where bulk commodities have
potential food and nonfood uses, there should be an exemption from
import notification where these commodities have not been sufficiently
refined to be
[[Page 58987]]
directly used as food ingredients without further processing or
refining.
Another comment notes that gelatin is used for food,
pharmaceutical, and technical applications and seeks assistance with
establishing a labeling protocol to distinguish between edible gelatin,
pharmaceutical gelatin, and technical gelatin. Some comments state FDA
should require prior notice only for food intended for consumption and
ask FDA to specify the articles that would be considered ``food.'' The
comments also state that some imports have both food and nonfood uses
and that prior notice should only be required for imports that will be
used as a food. In addition, one comment strongly urges FDA to remove
indirect food contact colors (i.e., material used to color food contact
material) from the requirements of prior notice. The comment indicates
that food contact colors are often prepared in bulk and then shipped to
companies that can use these pigments in both food and nonfood
applications. The process of manufacturing color pigments could be many
steps removed from the process of actually using these products in food
packaging. Therefore, the decision to use the product in food may not
be made until after the pigment has entered commerce.
(Response) For purposes of the interim final rule, ``food'' has the
definition in section 201(f) of the FD&C Act except that ``food contact
substances'' as defined at section 409(h)(6) of the FD&C Act and
``pesticides'' as defined at 7 U.S.C. 136(u) are excluded from
``food.'' Under section 201(f) of the FD&C Act, ``food'' means
``articles used for food or drink'' (section 201(f)(1)) and articles
``used for components of any such article'' (section 201(f)(3)). The
determination of whether a substance is ``food'' is not a question of
intended use (Nutrilab v. Schweiker, 713 F.2d. 335, 337 (7th Cir.
1983); U.S. v. 52 Drums Maple Syrup, 110 F.2d 914, 915 (2d Cir. 1940);
U.S. v. Technical Egg Products, 171 F.Supp. 326, 328 (N.D. Ga. 1959)).
Courts interpreting the ``food'' definition in the FD&C Act have held
that articles at both ends of the food continuum are ``food'' for
purposes of the FD&C Act (U.S. v. O.F. Bayer & Co., 188 F.2d 555 (2d.
Cir. 1951); U.S. v. Tuente Livestock, 888 F. Supp. 1416 (S.D. Ohio,
1995) (live animals for food use are ``food'' under the FD&C Act); U.S.
v. Technical Egg Products, supra, 171 F.Supp. at 328 (rotten eggs are
``food'')). Thus, FDA believes that an item may be food even if the
food is not yet in the form in which it will be used for food. 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.
If the substance can be used in some applications that make the
substance ``food'' and some that do not, the same principles apply.
With respect to gelatin and other substances that may exist in multiple
grades, including food grade, FDA will consider an article 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.
Finally, as set forth previously, the interim final rule excludes
food contact substances from the definition of ``food.'' Thus, when
substances to color food contact substances or their components are
imported, they are not subject to prior notice. However, colors used in
such substances are still subject to regulation as food under section
201(f) of the FD&C Act for purposes of other provisions of the FD&C
Act.
(Interim final rule) In the interim final rule (Sec. 1.276(b)(5)),
``food'' has the meaning given in section 201(f) of the FD&C Act,
except for purposes of this rule, 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.
7. Grower (Sec. 1.276(b)(6))
Although the statute and proposed rule used the term grower, the
proposed rule did not define the term. However, FDA solicited comments
on whether the term ``grower'' includes a harvester or collector of
wild products, e.g., some fish and botanicals.
(Comments) A comment states that although harvesters or collectors
of wild botanicals do not grow botanicals and should be differentiated
from growers for certain purposes, these can be included in the term
``grower'' consistent with the congressional intent in Sec. 307 of the
Bioterrorism Act to identify the direct source of the agricultural raw
commodity.
(Response and interim final rule) FDA agrees. Accordingly, we have
defined ``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. International Mail (Sec. 1.276(b)(6))
Although the proposed rule applied to food imported or offered for
import by mail, see, e.g., 68 FR 5436, the proposed rule did not define
``international mail.''
(Comments) There were no comments received concerning any
definition of ``international mail.''
(Response and interim final rule) The interim final rule imposes
slightly different requirements relating to prior notice for food
arriving by international mail. Thus, FDA determined that a definition
of ``international mail'' would be helpful. The interim final rule
defines ``international mail'' to mean ``foreign national mail
services.'' It also expressly excludes express carriers, express
consignment operators, or other private delivery services from this
definition.
9. No Longer In Its Natural State (Sec. 1.276(b)(8))
Section 801(m)(1) of the FD&C Act requires that the identity of the
manufacturer be submitted as part of a prior notice. However, the
proposed rule did not define ``manufacturer'' or address what
constituted the product of a manufacturer versus the product of a
grower.
(Comments) Comments raised questions concerning when a manufacturer
must be identified for an article of food.
(Response) These comments are discussed under the heading ``What
Information Must be in a Prior Notice.'' However, as a result of the
comments, we determined that a definition of when food would be ``no
longer in its natural state'' would be helpful to clarify when the
identity of a manufacturer versus the identity of a grower must be
provided in a prior notice.
(Interim final rule) The interim final rule (Sec. 1.276(b)(8)),
defines the term ``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,
[[Page 58988]]
pasteurizing, homogenizing, mixing, formulating, bottling, milling,
grinding, extracting juice, distilling, labeling, or packaging.
However, 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 the
prior notice interim final rule. Likewise, whole fish headed,
eviscerated, or frozen attendant to harvest are still in their natural
state for purposes of the prior notice interim final rule.
10. Port of Arrival (Sec. 1.276(b)(9)) and Port of Entry (Sec.
1.276(b)(10))
The proposed rule defined ``port of entry'' 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 food first arrives
in the United States.''
(Comments) Many comments suggest harmonizing with, or adopting, the
CBP definition for ``port of entry.'' In the opinion of two comments,
the CBP definition is consistent with congressional intent and the FDA
departure from the CBP definition is unsupported. Many of these
comments state the two definitions would cause confusion in the import
community and could delay proper prior notice. Other comments suggest
changing the FDA definition of ``port of entry'' to the ``port of
arrival.'' Another comment suggests defining ``port of entry'' as the
entering point of a country where the merchandise is checked by
official authorities. Two comments state that defining ``port of
entry'' as the port of arrival would change business practices by
essentially stopping the use of CBP ``in-transit'' (i.e., IT) entries
under bond to inland ports.
(Response) Section 801(m)(2)(A) of the FD&C Act states that FDA's
implementing regulations must require that the notice ``be provided by
a specified period of time in advance of importation of the article
involved * * *.'' The stated purpose of section 801(m)(1) is ``enabling
[articles of food] to be inspected at ports of entry into the United
States * * *.'' Moreover, the overall purpose of the Bioterrorism Act
is ``[t]o improve the ability of the United States to prevent, prepare
for, and respond to bioterrorism and other public health emergencies.''
(Pub. L. 107-188.) The ability to examine or, if necessary, 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, will most effectively serve this overall purpose. Thus, to
ensure that there is clarity that prior notice must be provided in
advance of arrival, we are defining the term ``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 addition, we are adopting the CBP definition of ``port of
entry'' to allow flexibility when designating where refused merchandise
will be held. The CBP ``Port of entry'' definition states:
The terms ``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. (The
Customs ports in the Virgin Islands, although under the jurisdiction of
the Secretary of the Treasury, have their own Customs laws (48 U.S.C.
1406(i)). These ports, therefore, are outside the Customs territory of
the United States and the ports thereof are not ``port of entry''
within the meaning of these regulations) (19 CFR 101.1).
This flexibility will 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. We intend to implement prior notice,
both in terms of determining what warrants a refusal in the first
place, and in terms of determining which shipments may move to the port
of destination, in a risk-based way.
(Comments) Other comments state rail transportation would be
especially affected because inbound trains often are not required to
stop at the U.S. border but proceed to inland terminals.
(Response) As explained later, rail shipments that have been
refused admission per section 801(m)(1) of the FD&C Act are considered
to have the status of general order merchandise. In many cases, it will
be operationally difficult to stop an entire train because an article
of food on it has been refused admission because of inadequate prior
notice. Under CBP regulation, general order merchandise may be stored
by the carrier or as the CBP port director may direct (see 19 CFR
123.10(f)). Moreover, in situations involving shipments by rail, FDA
and CBP have the discretion to allow the movement of the cargo from the
border crossing to the nearest point where it can be safely and
securely held. We intend, whenever possible, to examine articles of
food arriving by rail at the appropriate examination site closest to
the border. However, if the shipment might pose an immediate danger to
public health and safety, an article of food arriving by train may be
held at the border pending resolution of the situation.
(Interim final rule) The interim final rule, Sec. 1.276(b)(9)
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, i.e., the port where the article of food first arrives in the
United States,'' (Sec. 1.276(b)(9)). This port may be different from
the port where consumption or warehouse entry or FTZ admission
documentation is presented to CBP. The interim final rule (Sec.
1.285(b)(10)) also defines port of entry as follows:
11. Registration Number (Sec. 1.276(b)(11))
Although the term appears in several places in the proposed rule,
the term ``registration number'' was not defined.
(Comments) No comments addressed the definition or meaning of
``registration number.''
(Response) To clarify that the term refers to registration of food
facilities, the interim final rule defines ``registration number'' as
the registration number assigned by FDA under section 415 of the FD&C
Act and 21 CFR part 1, subpart H, Sec. 1.276(b)(11). Specific comments
addressing when a registration number is required and other aspects of
providing registration numbers as information submitted in prior notice
are addressed later in this preamble--see ``What Information Must be in
a Prior Notice?'.
12. Shipper (Sec. 1.276(b)(12))
Section 801(m)(1) of the FD&C Act requires that the ``shipper of
the article'' be provided in a prior notice submission. The proposed
rule included the shipper as required information in a prior notice,
but did not define the term ``shipper.''
(Comments) FDA received no comments concerning the meaning of this
term.
(Response) In the proposed rule, we described the ``shipper'' as
``the person who arranges for a shipment to get to its first
destination in the United States * * *. The shipper is usually a
foreign firm that is located or maintains an address in the country
from which the
[[Page 58989]]
article was shipped.'' (68 FR 5437). However, in drafting the interim
final rule, we have realized that this description was not written in a
way that was useful in identifying the shipper in the case of food
imported by international mail. Accordingly, we have revised the
description of the ``shipper'' and included it in the definitions to
make it easier to find.
The definition is based on the description of ``shipper'' used by
CBP in their proposed rule, ``Required Advance Electronic Presentation
of Cargo Information,'' published in the Federal Register on July 23,
2003 (68 FR 43574 at 43577), which is similar to, but clearer than, the
description we used in the preamble to the proposed prior notice rule.
(Interim final rule) The interim final rule (Sec. 1.276(b)(12)),
defines ``shipper'' as ``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.''
13. United States (Sec. 1.267(b)(13))
Although the term appears in several places in section 801(m) of
the FD&C Act itself, the proposed rule did not contain a definition of
``United States.''
(Comments) A comment seeks clarification whether the prior notice
regulation applies to food imported into Guam, the U.S. Virgin Islands,
the Northern Mariana Islands, and other U.S. Territories.
(Response) This comment raises the question of what the term
``United States'' means for purposes of section 801(m) of the FD&C Act.
In construing the prior notice provision of the Bioterrorism Act, FDA
is confronted with two questions. First, has Congress 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 ``United
States,'' FDA may define ``United States'' 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)). The agency has
determined that, in enacting section 801(m) of the FD&C Act, Congress
did not speak directly and precisely to the meaning of ``United
States.''
The FD&C Act does apply to Guam, the U.S. Virgin Islands, the
Northern Mariana Islands, and other U.S. Territories. Section 201(a)(1)
of the FD&C Act (21 U.S.C. 321 (a)(1)) defines the term ``State'' to
mean any State or Territory of the United States, the District of
Columbia, and the Commonwealth of Puerto Rico. The term ``Territory''
is defined to mean any Territory or possession of the United States,
including the District of Columbia, and excluding the Commonwealth of
Puerto Rico and the Canal Zone, section 201(a)(2) of the FD&C Act (21
U.S.C. 321(a)(2)). However, the terms ``State'' and ``Territory'' are
not used in section 801(m) of the FD&C Act.\3\ Instead, section 801(m)
of the FD&C Act deals with ``articles imported or offered for import
into the United States,'' (section 801(m)(1)).
---------------------------------------------------------------------------
\3\ The terms ``State'' and ``Territory'' are key to the FD&C
Act's definition of ``interstate commerce,'' which is, in turn, key
to many of the FD&C Act's general inspection and enforcement
provisions, see, e.g., sections 301, 304, and 704 (21 U.S.C. 331,
334, and 374). However, while articles that ``are imported or
offered for import into the United States,'' section 801(m)(1) of
the FD&C Act, are in ``interstate commerce,'' see, e.g., U.S. v.
2,998 Cases * * * First Phoenix Group, Ltd, 64 F.3d 984 (5th Cir.
1995), the term ``interstate commerce'' does not appear in section
801(m).
---------------------------------------------------------------------------
The term ``United States'' is not defined in the FD&C Act's general
definitions in section 201. Nor is it defined in section 801(m) of the
FD&C Act. It is defined for purposes of section 702(a) of the FD&C Act
(21 U.S.C. 372(a)), which provides:
In the case of a food packed in the Commonwealth of Puerto Rico
or a Territory [FDA] shall attempt to make inspection of such food
at the first point of entry within the United States * * *. For the
purposes of this subsection, the term 'United States' means the
States and the District of Columbia.
This definition in section 702(b) seems to imply that, in other places
in the FD&C Act, the term ``United States'' would include all
Territories. However, in section 801(m) of the FD&C Act, the term
``United States'' appears as part of the phrase ``for purposes of
enabling inspection of such [food] articles at the ports of entry into
the United States'' (emphasis added). As defined by CBP, ``port of
entry'' means ports within the part of the United States that has been
denominated as the ``Customs territory of the United States.'' (19 CFR
101.1 and 101.3). Notably, though, the Territories are not considered
part of the Customs territory of the United States. CBP defines
``Customs territory of the United States'' to ``include[] only the
States, the District of Columbia, and Puerto Rico.'' (19 CFR 101.1).
Because of this reference to ``the ports of entry into the United
States,'' FDA has concluded that the term ``United States'' is best
interpreted in section 801(m) of the FD&C Act to be the Customs
territory of the United States and include only the 50 States, the
District of Columbia, and Puerto Rico, but not the U.S. Territories and
possessions. Defining the ``United States'' to be the Customs territory
of the United States will maximize FDA's ability to coordinate prior
notice with the CBP entry process, as CBP entry is made for articles
from the Territories when they arrive in the Customs territory of the
United States. Thus, section 801(m) of the FD&C Act does not apply to
articles of food imported or offered for import into Guam, the U.S.
Virgin Islands, the Northern Mariana Islands, and other U.S.
Territories; section 801(m) does apply, however, when articles of food
are imported or offered for import from the Territories into the United
States as defined by Sec. 1.276(b)(11) of the interim final rule.
(Interim final rule) The interim final rule (Sec. 1.276(b)(13)),
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 any other part of the United
States.
14. You (Sec. 1.276(b)(14))
The proposed rule defined ``you,'' based on who was authorized to
submit prior notice, as ``the purchaser or importer of an article of
food who resides or maintains a place of business in the United States,
or an agent who resides or maintains a place of business in the United
States acting on the behalf of the U.S. purchaser or importer or the
arriving carrier * * *'' or, if known, the in-bond carrier.
(Comments) No comments were received concerning the definition of
``you.'' However, comments were received about who may submit prior
notice.
(Response) Discussion of those comments and our responses are found
in the section ``Who is Authorized to Submit Prior Notice?'' FDA
decided, based on revisions to who may submit prior notice, to revise
the definition of ``you.'' The interim final rule clarifies that
``you'' means the persons (i.e., individuals and firms) submitting or
transmitting the prior notice. The submitter is responsible for the
prior notice. The persons who send the prior notice are transmitters.
If the submitter sends the prior notice, he or she is both
[[Page 58990]]
the submitter and transmitter. FDA notes that all messages sent via the
FDA PN System Interface will be sent to the transmitter. If prior
notice is submitted via ABI/ACS, all messaging goes to the customs
broker or self-filer via ABI/ACS.
(Interim final rule) The interim final rule (Sec. 1.276(b)(14)),
defines ``you'' as the person submitting the prior notice (the
``submitter'') or the person transmitting prior notice information on
behalf of the submitter (the ``transmitter'').
13. Summary of the Interim Final Rule
The interim final rule defines the following terms:
[sbull] The act;
[sbull] Calendar day;
[sbull] Country from which the article originates;
[sbull] Country from which the article is shipped;
[sbull] FDA Country of Production;
[sbull] Food;
[sbull] Grower;
[sbull] International mail;
[sbull] No Longer in Its Natural State;
[sbull] Port of arrival;
[sbull] Port of entry;
[sbull] Registration Number;
[sbull] Shipper;
[sbull] United States; and
[sbull] You.
D. ``What Is the Scope of This Subpart?'' (Section 1.277 Proposed as
Sec. 1.276)
FDA proposed that the prior notice requirements apply to food for
humans and other animals that is imported or offered for import into
the United States. The proposed rule specified that this included food
that is imported or offered for import into U.S. FTZs, for consumption,
storage, immediate export from the port of entry, transshipment through
the United States to another country, or import for export. The
proposed rule said that prior notice did not apply to food carried by
an individual in that individual's personal baggage for that
individual's personal use, meat food products, poultry products, and
egg products that are subject to the exclusive jurisdiction of USDA.
(Comments) Some comments state that the prior notice requirements
should not apply to food that is brought across the U.S. border but not
for consumption in the United States. In particular, the comments focus
on food exported from the port of arrival, food imported for
transshipment and export from another port, and food imported for
further processing and export. The comments argue that Congress did not
envision that the prior notice requirements would cause importers to
give notice of food not for consumption within the United States and
that notice of such food would not give FDA any useful or actionable
information. One comment states that the Bioterrorism Act repeatedly
refers to ``offered for import into the United States'' and concludes,
based on this phrase, that prior notice should apply only to food for
consumption by the citizens of the United States. One comment points to
statutory language that stipulates ``for human and animal
consumption.'' Based on this language, the comment argues that FDA
would exceed its statutory authority by requiring prior notice for
shipments not intended for consumption within the United States.
Another comment states that prior notice should not apply to food of
U.S. origin, especially if it was simply transshipped through another
country then ``re-imported'' into the United States.
(Response) These comments on scope raise the question of what
Congress intended the phrase ``imported or offered for import into the
United States'' to mean for purposes of section 801(m) of the FD&C Act.
In construing the prior notice provision of the Bioterrorism Act, FDA
is confronted with two questions. First, has Congress 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 ``imported
or offered for import into the United States,'' FDA may interpret the
phrase 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)).
The agency has determined that, in enacting section 801(m) of the
FD&C Act, Congress did not speak directly and precisely to the meaning
of ``imported or offered for import into the United States.'' For the
reasons in the following paragraphs, FDA has determined that, for
purposes of section 801(m) of the FD&C Act, the phrase ``imported or
offered for import into the United States'' can reasonably be
interpreted to apply to articles that are brought into the United
States for consumption in the United States, for transshipment through
the United States and export to another country, for further processing
in the United States and export, and articles of U.S. origin that are
``re-imported'' back into the United States. We have also determined
that the phrase ``imported or offered for import into the United
States'' can reasonably be interpreted to exclude articles that are
brought to the United States for the purpose of being exported without
ever leaving the port of arrival until export.
Neither the Bioterrorism Act nor the FD&C Act defines this phrase.
Moreover, courts that have considered the meaning of ``import'' or
similar terms in other statutes have not always arrived at the same
conclusions: Sometimes ``import'' means simply to bring in, but other
times ``import'' means to bring in with the intent to unlade or enter
(Procter & Gamble Manufacturing Co. v. U.S., 19 C.C.P.A. 415, 422
(C.C.P.A. 1932) (to import ``may mean to bring goods within the
jurisdictional limits of the country * * *; or it may mean the time
when it is withdrawn from the warehouse and enters the commerce of the
country''); compare, e.g., Canton R. Co. v. Rogan, 340 U.S. 511, 514-15
(1951) (``to import means to bring into the country''); Brown v.
Maryland, 25 U.S. 419, 426, 437-38 (1827) (``What, then, are `imports'?
The lexicon informs us, they are `things imported.' If we appeal to
usage for the meaning of the word, we shall receive the same answer.
They are the articles themselves which are brought into the country.'')
with United States v. Watches, Watch Parts, Calculators & Misc. Parts,
692 F. Supp. 1317, 1321 (S.D. Fla. 1988); United States v. Commodities
Export Co., 14 C.I.T. 166, 169-70 (Ct. Int'l Trade 1990) (``once goods
are within the jurisdictional limits of the United States with the
intent to discharge, they are imports under this definition''); United
States v. Boshell, 14 U.S. Cust. App. 273, 275-77 (Ct. Cust. App. 1922)
(``The common ordinary meaning of the word `import' is to bring in.
Imported merchandise is merchandise that has been brought within the
limits of a port of entry from a foreign country with intention to
unlade, and the word `importation' as used in tariff statutes, unless
otherwise limited, means merchandise to which that condition or status
has attached'')).
In considering what is a reasonable interpretation, we considered
the language and purpose of section 801(m) of the FD&C Act, as well as
the other provisions of the Bioterrorism Act and section 801 of the
FD&C Act. Section 801(m)(1) of the FD&C Act states, ``In the case of an
article of food that is
[[Page 58991]]
being imported or offered for import into the United States, the
Secretary * * * shall by regulation require * * * the submission to the
Secretary of a notice * * *.'' FDA notes that Congress did not
explicitly limit this provision to articles of food that are intended
for consumption in the United States. However, such limiting language
does appear in section 415 of the FD&C Act, which requires certain food
facilities to register with the agency. This shows that when Congress
crafted the Bioterrorism Act, it knew how to impose the limitation
sought by the comments. But neither section 801(m) of the FD&C Act nor
its legislative history contains language suggesting this limitation.
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.'' The prior notice provision
furthers this goal by enhancing the agency's ability to inspect
imported food upon arrival in the United States. Excluding from prior
notice food that is brought into the United States for transshipment or
further processing, rather than consumption, would run counter to the
purpose of the Bioterrorism Act. Articles entered at the port or
arrival under T&E entries with the stated intent to transship and
export may be diverted for consumption in the United States and thus
remain here rather than leave from another port. Some of this diversion
is legitimate; under CBP regulations, importers may change their minds
and file a superseding consumption entry. In addition, unscrupulous
importers may file a T&E entry instead of a consumption entry to avoid
paying duties on foods for consumption in the United States.
Unscrupulous importers may also file a T&E entry instead of a
consumption entry to try to avoid FDA review of their merchandise:
generally, FDA does not receive any notice of these kinds of entries
from CBP because these entries are not filed through ABI/ACS.
If we were to interpret ``imported or offered for import'' to
exclude those entries, we could be creating a significant potential gap
in section 801(m) of the FD&C Act's coverage. An importer could simply
bring in an article of food under a T&E entry without giving prior
notice and then, as allowed by CBP regulations, file a consumption or
other entry. Thus, this exclusion would create a loophole that could be
exploited by those who want to avoid giving prior notice, even for
articles of food that are for consumption in the United States. Given
the stated purposes of the Bioterrorism Act and of section 801(m) of
the FD&C Act, FDA has concluded that it is reasonable to interpret
``imported or offered for import into the United States'' to include
articles of food entered for transshipment and exportation.
Section 801(a) of the FD&C Act sets out the basic admissibility
procedure and standards for foods, drugs, devices, and cosmetics,
``which are being imported or offered for import into the United
States.'' As with section 801(m) of the FD&C Act, nothing in section
801(a) limits its requirements just to articles that are intended for
consumption in the United States. Indeed, section 801(d)(3) of the FD&C
Act exempts from section 801(a)'s admissibility standards certain
drugs, devices, food additives, color additives, and dietary
supplements if these items are intended at the time of ``importation''
for further processing or incorporation into a product that will be
exported. This exemption is only necessary if the phrase ``imported or
offered for import'' in section 801(a) includes the bringing into the
country of some types of goods that are for processing but not
consumption in the United States. Thus, in the context of section
801(a) of the FD&C Act, ``imported or offered for import into the
United States'' applies to more than food intended for consumption in
the United States. Finally, section 801(d)(1) of the FD&C Act, which
limits the circumstances under which U.S.-made drugs can be imported
back into the United States, makes it clear that the phrase ``im