FDA Reopens Comment Period for its Interim Final Rule on Prior Notice of Imported Food

(On October 10, 2003, the FDA published an interim final rule requiring the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S. See ITT's Online Archives or 10/16/04 news, 03101610, for previous BP summary on FDA's interim final rule which mentions FDA's intention to reopen the interim final rule comment period at a later date.)

Comments Requested on All Aspects of Rule, Including C-TPAT/FAST Options

Comment period reopened for a number of reasons. FDA states it is reopening the comment period on all aspects of its October 10, 2003 interim final rule for a number of reasons:

o The FDA is interested in exploring flexible alternatives for the submission of prior notice for foods or firms covered by programs of other agencies, such as U.S. Customs and Border Protection's (CBP's) Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or food imported by other government agencies.

o The reopening of the comment period coincides with the issuance of the FDA and CBP joint plan relating to timeframes for the submission of prior notice, among other things. (See today's ITT, 04041405, for BP summary of this FDA/CBP joint plan.)

o To ensure that those who comment on the rule would have had the benefit of FDA outreach and education efforts and would have had some experience with the systems, timeframes, and data elements of the prior notice system.

Series of questions regarding flexible alternatives, such as C-TPAT and FAST. In addition, FDA states that it plans, along with CBP, to assess the feasibility of including the FAST timeframes in the FDA's prior notice final rule, as well as other flexible alternatives raised by comments.

To assist in this assessment, FDA and CBP are requesting comments on a series of questions related to C-TPAT/FAST and other flexible alternatives, including (partial list):

Should food products be subject to FDA's prior notice requirements be eligible for the full expedited processing and information transmission benefits allowed with C-TPAT and FAST?

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 timeframes are reduced in FDA's prior notice rule, would other flexible alternatives for participants in FAST or for food imported by other agencies be needed?

Should food product category be considered as a criteria or element of expedited prior notice processing or other flexible alternatives?

Should FDA offer a prior notice submission training program for submitters and transmitters, including brokers, to ensure the accuracy of the data being submitted?

(See FDA notice for complete list of C-TPAT/FAST and other flexible alternatives-related questions.)

FDA Will Address Comments and Confirm/Amend Interim Final Rule in Final Rule

FDA notes that it will address comments received in 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.

However, FDA states that it will not address any comments that have been previously considered during this rulemaking.

- written or electronic comments due by May 14, 2004

FDA contact -

May D. Nelson (301) 436-1722

Reopening of comment period on prior notice interim final rule (FR Pub 04/14/04, D/N 2002N-0278) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-8517.pdf.