[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]               
[Page 64959-64961]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0554]

 
Compliance Policy Guide Regarding Prior Notice of Imported Food 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised Compliance Policy Guide (CPG) entitled 
``Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides 
written guidance to FDA's and Customs and Border Protection's (CBP's) 
staff on enforcement of section 307 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) and the agency's implementing regulations, which require prior 
notice for food imported or offered for import into the United States. 
The CPG has been revised to provide additional guidance to FDA and CBP 
staff regarding prior notice submissions that do not provide 
information about the identity of the manufacturing facility of food no 
longer in its natural state, articles of food imported or offered for 
import by express courier, prior notice submission time frames, and 
lastly, gift packs purchased or otherwise acquired by an individual and 
imported or offered for import for nonbusiness purposes.

DATES: This guidance is final and effective on November 8, 2004. 
However, you may submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the guidance 
may be sent.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), 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. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of 
Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 703-621-7809.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of revised CPG section 110.310 
entitled ``Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.'' This 
revised guidance is issued with CBP concurrence and explains to FDA and 
CBP staff the new FDA and CBP policies on enforcement of section 307 of 
the Bioterrorism Act and its implementing regulations, which require 
prior notice to FDA of all food imported or offered for import into the 
United States (68 FR 58974, October 10, 2003 (codified at 21 CFR part 
1, subpart I, 1.276 through 1.285)). The original CPG was published 
December 2003, and was revised June 2004 to include additional guidance 
regarding food imported or offered for import for noncommercial 
purposes with a noncommercial shipper. In August 2004, the CPG was 
revised to provide additional guidance regarding food imported or 
offered for import for quality assurance, research or analysis purposes 
only, not for human or animal consumption and not for resale. We (FDA) 
also revised the CPG in August to extend until November 1, 2004,\1\ our 
enforcement discretion policy concerning certain violations related to 
the registration number of the manufacturing facility and the shipper, 
the airway bill number or bill of lading number, and the name and 
address of the ultimate consignee.
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    \1\ This date was extended to November 7, 2004.
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A. Identity of the Manufacturer

    FDA is revising the CPG to provide additional guidance regarding 
prior notice submissions that do not provide information to identify 
the manufacturing facility of an article of food (i.e., the specific 
facility that manufactured the food). This information is required for 
food that is no longer in its natural state. FDA and CBP intend to 
exercise broad enforcement discretion when this information is required 
but is not provided, under the following circumstances:
    (1) If, after a good faith effort, the person submitting prior 
notice does not know the registration number of the facility that 
manufactured the food and the facility is required to be registered, 
that person instead provides the name and full address of the facility 
that manufactured the food.
    (2) If, after a good faith effort, the person submitting prior 
notice does not know either the registration number or the name and 
full address of the facility that manufactured the food, that person 
instead provides the name and full address of the headquarters of the 
facility that manufactured the food.
    (3) If, after a good faith effort, the person submitting prior 
notice does not know either the information described in (1) about the 
facility that manufactured the food, or in (2) about the headquarters 
of the facility that manufactured the food, that person instead 
provides the name and full address of the invoicing firm.
    FDA is taking these steps to provide additional flexibility in 
filing prior notice to various kinds of importers while the final prior 
notice rule is under development. However, if the facility that 
manufactured the food is a foreign facility that is required to be 
registered and either its registration number is not provided or the 
name and address of a different facility (i.e., the manufacturing 
facility's headquarters or the invoicing firm) is provided, then it 
will be more difficult and/or may take more time for FDA and CBP to 
verify the identity of the manufacturing facility and its registration 
status and to determine whether the article of food is subject to being 
held under section 801(l) of the Federal Food, Drug, and Cosmetic Act 
(the act). As a result, if an article of food is imported or offered 
for import with the manufacturer's name and full address, or the name 
and address of the manufacturing facility's headquarters or the 
invoicing firm, instead of the manufacturer's name and registration 
number, and if FDA has concerns that the food may pose a serious health 
threat, then the food may be delayed at the port of arrival until the 
verification is completed. Moreover, as with other types of prior 
notice violations, FDA may consider the failure to provide required 
information about the manufacturer as a factor in determining whether 
and where to examine the article of food. Under all circumstances,

[[Page 64960]]

FDA and CBP intend to reject prior notice submissions unless the prior 
notice includes a valid registration number or an appropriate reason 
code selected from among those provided in the Prior Notice System 
Interface (PNSI) and the Automated Broker Interface of the Automated 
Commercial System (ABI/ACS). Rejected submissions are not confirmed for 
FDA review.
    This change to our enforcement discretion policy pertains to all 
prior notice submissions, including but not limited to the following: 
(1) Food carried by or otherwise accompanying an individual that is not 
for personal use; (2) food arriving by international mail that is not 
food imported or offered for import for noncommercial purposes with a 
noncommercial shipper; and (3) food imported or offered for import for 
quality assurance, research or analysis purposes only, not for human or 
animal consumption or resale.
    Please note that the enforcement discretion policy for identity of 
manufacturer does not apply to the requirement to provide the 
registration number assigned to the shipper's facility that is 
associated with the article of food, if applicable (see 21 CFR 
1.281(a)(9) and (b)(8)).

B. Express Courier

    FDA also is revising the CPG to provide additional guidance 
regarding food imported or offered for import by an express courier. 
The term ``express courier'' is being used as the term ``express 
consignment operator or carrier'' is defined by CBP at 19 CFR 128.1(a) 
and includes, for example, Federal Express and United Parcel Service. 
If prior notice is inadequate because it does not include the required 
anticipated arrival information and/or planned shipment information, 
FDA and CBP should typically consider not taking any regulatory action 
if the article of food is imported or offered for import via an express 
courier, the person submitting prior notice is not the express courier, 
prior notice is submitted via the PNSI, and the prior notice includes 
the shipment's tracking number instead of the required anticipated 
arrival information and/or planned shipment information. CBP and the 
Transportation Security Administration have advised express couriers to 
not reveal to the public certain arrival information. FDA and CBP 
believe that the tracking number instead of the planned shipment 
information may provide a means of more accurately determining the 
arrival information and intend to explore this option while developing 
the final rule.

C. Time Frame

    FDA is revising the CPG to allow prior notice to be submitted more 
than 5, but less than 10 days before the anticipated date of arrival of 
the food at the anticipated port of arrival (see 21 CFR 1.279(b)). FDA 
will typically consider not taking any regulatory action if there is a 
prior notice violation because the prior notice was submitted more than 
5 calendar days before the anticipated date of arrival, provided that 
the following occurs: (1) The prior notice was submitted less than 10 
calendar days before the anticipated date of arrival; and (2) the prior 
notice was submitted through the PNSI.
    FDA is taking these steps to provide additional flexibility in 
submitting prior notice while the final prior notice rule is under 
development. FDA and CBP believe that 10 days before the anticipated 
date of arrival of the food is sufficient time for a carrier to assure 
that prior notice has been confirmed for FDA review before loading the 
food. FDA also believes that this extended period will not impact its 
ability to receive, review, and respond to prior notice submissions of 
food, although a time period greater than 10 days may be problematic. 
FDA has limited this guidance to prior notice submissions by PNSI 
because of the way the ABI/ACS is programmed; when prior notice is 
submitted through ABI/ACS, the prior notice confirmation number cannot 
be provided more than 5 calendar days before the anticipated date of 
arrival.
    FDA recognizes that if any information in the prior notice 
submitted via PNSI changes except the anticipated arrival information, 
the estimated quantity, or the planned shipment information, after FDA 
has confirmed the prior notice submission for review, the prior notice 
should be cancelled and must be resubmitted.

D. Gift Pack Purchased or Otherwise Acquired by An Individual and 
Imported or Offered for Import for Nonbusiness Purposes

    Another change to the CPG relates to gift packs purchased or 
otherwise acquired by an individual and imported or offered for import 
for nonbusiness purposes. FDA and CBP staff should typically consider 
not taking regulatory action if there is a prior notice violation 
because a single prior notice is submitted for a gift pack and the 
identity of the facility that packed the gift pack is submitted instead 
of the identity of the manufacturer, provided that the gift pack is 
purchased or otherwise acquired by an individual and imported or 
offered for import for nonbusiness purposes. The policy applies 
irrespective of where the individual who purchased or otherwise 
acquired the gift pack lives, irrespective of the type of carrier, and 
irrespective of whether it involves a commercial or noncommercial 
shipper. The CPG provides information to FDA and CBP staff about what 
constitutes a nonbusiness purpose, the identity of a gift pack by FDA 
product code and examples of gift packs.

E. Policies Contained in the Previous Version of the CPG

    Please note that beginning November 8, 2004, FDA and CBP staff 
should typically consider taking enforcement action including refusal 
and/or assessment of Civil Monetary Penalties when the prior notice is 
inadequate, except the circumstances described in the revised CPG. 
FDA's enforcement discretion policies in the version of the CPG issued 
in August 2004 concerning certain violations related to the 
registration number of the shipper, the airway bill number or bill of 
lading number, and the name and address of the ultimate consignee will 
end on November 7, 2004, with the exception of the airway bill number 
or bill of lading number for prior notice submissions by individuals 
who are not the express courier (see section I.B of this document). 
Therefore, beginning November 8, 2004, FDA and CBP staff should 
typically consider taking enforcement action including refusal and/or 
assessment of Civil Monetary Penalties when the prior notice is 
inadequate because the registration number for the shipper is required 
but is not provided; the airway bill number or bill of lading number is 
not provided or is invalid (except as noted in section I.B of this 
document); or the name and address of the ultimate consignee is 
inaccurate because it contains the name and address of the express 
consignment operator or consolidator instead of the ultimate consignee.
    FDA is issuing this document as level 1 guidance consistent with 
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115). 
The revised CPG section 110.310 is being implemented on November 8, 
2004, without prior public comment, under Sec.  10.115(g)(2), because 
the agency has determined that prior public participation is not 
feasible or appropriate. This document revises policies that are due to 
take effect on November 8, 2004, so it is urgent that the agencies 
explain their new enforcement policies before that date.

[[Page 64961]]

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance 
document. Submit two copies of written comments, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of the revised CPG is available on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora under ``Compliance References.''


    Dated: October 28, 2004.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-24872 Filed 11-4-04; 8:57 am]

BILLING CODE 4160-01-S