[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://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://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