[Federal Register Volume 69, Number 72 (Wednesday, April 14, 2004)]
[Rules and Regulations]
[Pages 19763-19765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0278]


Prior Notice of Imported Food Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 30 
days the comment period for FDA's prior notice interim final rule (IFR) 
that published in the Federal Register of October 10, 2003 (68 FR 
58974). The prior notice interim final rule requires the submission to 
FDA of prior notice of food, including animal feed, that is imported or 
offered for import into the United States. FDA is taking this action 
consistent with its statement in the preamble of the prior notice IFR 
(68 FR 58974 at 59023) that it would reopen the comment period for an 
additional 30 days in March 2004, to ensure that those who comment on 
this interim final rule would have had the benefit of our outreach and 
education efforts and would have had some experience with the systems, 
timeframes, and data elements of the prior notice system.

DATES: Submit written or electronic comments by May 14, 2004.

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://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: May D. Nelson, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1722.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 10, 2003, FDA issued an IFR to implement new section 
801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 381(m)), added by section 307 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), 
which required prior notification of imported food to begin on December 
12, 2003. The prior notice IFR requires the submission to FDA of prior 
notice of food, including animal feed, that is imported or offered for 
import into the United States (68 FR 58974). The interim final rule 
requires that the prior notice be submitted to FDA electronically via 
either the 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) (21 CFR 1.280). 
Food imported or offered for import without adequate prior notice is 
subject to refusal and, if refused, must be held (21 CFR 1.283).
    Under section 801(m)(2)(A) of the FD&C Act, FDA is to choose 
timeframes that ``shall be no less than the minimum amount of time 
necessary for the Secretary [of Health and Human Services] to receive, 
review, and appropriately respond to such notification* * *'' Using 
this standard, the prior notice IFR requires that 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 (21 CFR 1.279). However, when we issued the interim 
final rule, FDA committed to exploring ways to increase integration of 
advance electronic notification processes with CBP and to reduce prior 
notice timeframes. Indeed, we stated in the preamble to the interim 
final rule (68 FR 58974 at 58995) that, by March 12, 2004, FDA and CBP 
would publish a plan, including an implementation schedule, to achieve 
the goal of a uniform, integrated system and to coordinate timeframes 
for import prior notice information while fulfilling the Bioterrorism 
Act mandates for air and truck modes of transportation with timeframes 
finalized by CBP when they finalize their rule entitled ``Required

[[Page 19764]]

Advance Electronic Presentation of Cargo Information.''
    For this reason, as well as to obtain comments on other aspects of 
the rule, we issued this rule as an interim final rule, with an 
opportunity for public comment for 75 days. Moreover, to ensure that 
those who comment on this interim final rule would have had the benefit 
of actual experience with the systems, timeframes, and data elements, 
FDA also stated it intended to reopen the comment period for an 
additional 30 days in March 2004, coinciding with the issuance of the 
plan by FDA and CBP relating to timeframes.
    In light of the significance of the prior notice IFR, in December 
2003 FDA and CBP issued a compliance policy guide (CPG) that describes 
our strategy for maintaining an uninterrupted flow of food imports 
while implementing the prior notice requirements of the Bioterrorism 
Act. (See Compliance Policy Guide Sec. 110.310--``Prior Notice of 
Imported Food Under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002;'' Availability (68 FR 69708, 
December 15, 2003), http://www.cfsan.fda.gov/guidance.html). The prior 
notice CPG states that until August 12, 2004, FDA and CBP intend to 
primarily emphasize educating the affected firms and individuals. 
During this period, the agencies intend to utilize communication and 
education initiatives, escalating imposition of civil monetary 
penalties, and ultimately refusal of imported food shipments. Upon 
issuance of the CPG, both agencies stated that they expected affected 
firms and individuals to demonstrate a good faith effort at compliance 
while the transitional policy was in place.

II. Comments

    We previously issued this rule as an interim final rule, with an 
opportunity for public comment for 75 days. Moreover, to ensure that 
those who comment on this interim final rule would have had the benefit 
of actual experience with the systems, timeframes, and data elements, 
FDA also stated it intended to reopen the comment period for an 
additional 30 days in March 2004. Accordingly, we are seeking comments 
on all aspects of the prior notice IFR.
    In the prior notice IFR, we expressed interest in exploring 
flexible alternatives for submission of prior notice for foods or firms 
covered by programs of other agencies, such as CBP's Customs-Trade 
Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade 
(FAST) program, or food imported by other government agencies (68 FR 
58974 at 58995).
    C-TPAT is a government/business initiative to increase cargo 
security while improving the flow of trade. Under this program, 
businesses must conduct comprehensive self-assessments of their supply 
chain using the security guidelines developed jointly with CBP, and 
they must familiarize companies in their supply chain with the 
guidelines and the program. These businesses must provide CBP with 
specific and relevant information about their supply chains and 
security practices and procedures. As C-TPAT members, companies may 
become eligible for expedited processing and reduced inspections, but 
are not exempt from advance electronic information requirements. (See 
CBP's Required Advance Electronic Presentation of Cargo Information 
Final Rule (the advance electronic information rule) (68 FR 68140)).
    FAST, an acronym for Free and Secure Trade between the United 
States and Canada, and the United States and Mexico, is an expedited-
clearance system designed to improve border security without slowing 
the flow of legitimate trade across the northern and southern U.S. 
borders. FAST processing is available to importers, carriers and 
foreign manufacturers (southern border) who participate in C-TPAT and 
who use a FAST-registered driver. The initiative builds on the same 
concepts that drove the rapid, post-9/11 construction and 
implementation of C-TPAT.
    FDA and CBP plan to assess the feasibility of including the FAST 
timeframes in FDA's prior notice final rule, as well as other flexible 
alternatives raised by comments. To assist in this assessment, FDA and 
CBP request comment on the following questions:
C-TPAT/FAST Questions:
    1. Should food products subject to FDA's prior notice requirements 
be eligible for the full expedited processing and information 
transmission benefits allowed with C-TPAT and FAST? If so, how should 
this be accomplished?
    2. If the timeframe for submitting prior notice for food arriving 
by land via road is reduced to 1 hour consistent with the timeframe in 
the advance electronic information rule, would a shorter timeframe be 
needed for members of FAST?
    3. Should the security and verification processes in C-TPAT be 
modified in any way to handle food and animal feed shipments regulated 
by FDA? If so, how?
    Any membership in C-TPAT or FAST, or any benefit received as a 
result of membership will not be affected by commenting in this 
rulemaking.
Flexible Alternative Questions:
    1. If timeframes are reduced in FDA's prior notice final rule, 
would other flexible alternatives for participants in FAST or for food 
imported by other agencies be needed?
    2. In considering flexible alternatives for food imported by other 
government agencies, what factors or criteria should FDA consider when 
examining alternatives? Should participation be voluntary? If so, 
should FDA consider inspection of companies in the supply chain from 
the manufacturer to those who may hold the product, including reviews 
of their security plans to determine what procedures are in place to 
prevent infiltration of their facilities as a condition of 
participation?
    3. In considering flexible alternatives for submission of prior 
notice, should FDA consider additional means of ensuring that all 
companies subject to the registration of food facilities interim final 
rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have 
an updated registration on file with FDA that has been verified?
    4. Are there conditions of participation that FDA should consider, 
e.g., inspections of companies in the supply chain from the 
manufacturer to those who may hold the product, reviews of their 
security plans to determine what procedures are in place to prevent 
infiltration of their facilities?
    5. Should the food product category be considered as a criteria or 
element of expedited prior notice processing or other flexible 
alternatives? If so, should certain foods be excluded from expedited 
prior notice processing? If so, what should be the basis for 
determining which foods should be excluded?
    6. If FDA adopts reduced timeframes in the prior notice final rule, 
should FDA phase in the shorter timeframes as CBP phases in the advance 
electronic information rule?
    7. Should FDA offer a prior notice submission training program for 
submitters and transmitters, including brokers, to ensure the accuracy 
of the data being submitted?
    To be timely, interested persons must submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments on 
the prior notice IFR as indicated in the DATES section of this 
document. Two copies of any mailed comments are to be submitted by 
commenting entities; individuals may submit one copy. Comments are to 
be identified with the docket number

[[Page 19765]]

found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    As noted, this regulation was effective on December 12, 2003. We 
will address comments received during this reopened comment period and 
the previous comment period that closed on December 24, 2003, and will 
confirm or amend the interim final rule in a final rule. We, however, 
will not address any comments that have been previously considered 
during this rulemaking.

    Dated: March 24, 2004.
Lester M. Crawford,
Acting Commissioner for Food and Drugs.

    Dated: April 6, 2004.
Robert C. Bonner,
Commissioner, Customs and Border Protection.
[FR Doc. 04-8517 Filed 4-9-04; 4:51 pm]
BILLING CODE 4160-01-S