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On May 18, 2004, Customs and Border Protection (CBP) announced a delay until June of the implementation of Phase 3 of Enforcement of 21 CFR 1.283(a) and 1.285(a), (b) covered by FDA's Compliance Policy Guide "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
On June 3, 2004, in an Administrative Message entitled "OGA-FDA BTA Phase III Implementation - June 4, 2004", CBP notified Automated Broker Interface (ABI) filers that "ABI edits for Phase 3 of the BTA will be turned on at or about 6:00 am EDT on June 4."
A CBP press release of June 2, 2004, also announced that "The Phase III implementation will hold goods, which have not given prior notification, at the port of entry or at a FDA registered secure facility. The carrier will have the opportunity to voluntarily export the items if compliance with the BTA cannot be accomplished in a timely manner or at all. The exception is for transportation and exportation entries which require that prior notice be filed at the port of arrival before movement can be authorized. Prior to June 4th FDA and CBP have made numerous presentations to foreign government officials and domestic and foreign industry members. CBP and FDA have sponsored live satellite broadcasts, videoconferences around the world, and coordinated a massive distribution of outreach materials, all of which described the rules and the plan to enforce them." The complete CBP press release is located at http://www.cbp.gov/xp/cgov/newsroom/press_releases/06022004_2.xml.
The delay of implementation of Phase III does not imply an automatic delay of the final stage of enforcement of prior notice requirements on August 12, 2004. Submitters and transmitters of prior notice should also realize that prior notice submission periods before the shipment arrival should take into account any possible time needed to deal with corrections required by either ABI or by FDA. Simply submitting prior notice within the minimum 2, 4, or 8 hour window may not allow sufficient time to review any ABI or FDA rejection messages, correct rejected data, and submit corrected prior notice sufficiently in advance of arrival to avoid refusal.
Reminder -- The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) is launching a Summer Integrated Program in Food Safety Risk Analysis on the University of Maryland College Park campus. The Summer Integrated Program offers participants the opportunity to take from one to seven courses in a single trip. People can enroll in individual courses or in course clusters at a significant discount. Whether people join the program as a cluster resident or just for specific classes, they will meet and interact with food safety professionals from around the world. For more information please visit http://www.jifsan.umd.edu/sip2004/sipgovaca.cfm
For questions contact: Judy Quigley, JIFSAN Conference and Communications Coordinator, , 301-405-1696.
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Food Safety and Security Staff E-mail: |
Office Number: (301) 436-2277· FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/ |