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FDA Issues New Edition of Guidance For Industry on Interim Final Rule on Registration of Food Facilities

Date: Jan 27, 2004


The Food and Drug Administration on Jan. 12, 2004 issued a revised version of Questions and Answers Regarding the Registration of Food Facilities (for full text, click here.). This revision modifies the first edition of the FDA's guidance issued Dec. 4, 2003.

These documents were designed to provide guidance on implementing the Bioterrorism Act's requirement that domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with FDA. According to the Introduction to the revised edition, the first edition of the Q&A document was issued as guidance under 21 CFR 10.115. Edition 2 includes answers to new inquiries on the implementation of the interim final rule on registration of food facilities. It takes effect immediately because FDA determined that prior public participation "is not feasible or appropriate."

The guidance describes the FDA's current thinking on the topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.

The revisions address questions such as whether washing lettuce, applying pesticide to a crop, or placing stickers on fruit amounts to "processing," requiring registration of an otherwise exempt farm. The guidance also makes clear that post offices, express couriers, and truck terminals that have packages containing food on their premises are not required to register as food facilities.

Other Guidance Documents
This Question and Answer Guidance is the latest in a line of documents issued in the past few weeks to provide guidance to the food industry.

On Dec. 11, 2003, FDA and the U.S. Bureau of Customs and Border Protection (CBP) issued a compliance policy guide (for full text, click here.) that deals with enforcement of the requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) that FDA receive prior notification of all human and animal food, drinks and dietary supplements imported to the United States. A second rule required that all facilities that manufacture, process, pack or hold food for consumption in the U.S. register with FDA. Both rules, announced Oct. 10 (for In the News item,click here.), took effect Dec. 12.

Even though import notification is not required for food-contact substances, the policy guide may be of interest to those who also market direct additives.

FDA and CBP explained they expected a "good faith" effort at compliance. The policy guide specified that during the next eight months, the two agencies will rely on educating the affected firms and individuals. During this interim period, they will use communication and education initiatives, escalating imposition of civil monetary penalties, and ultimately refusal of shipments, according to the joint press release (for full text, click here.).

The phase-in period will end Aug. 12, 2004. "The goal of the transition policy is to provide complete clarity and education about the new import requirements, and achieve a higher level of U.S. food security without disrupting trade," according to FDA Commissioner Mark B. McClellan. During the phase-in period, FDA and CBP will use civil monetary penalties and refusals only in response to "repetitive, flagrant, and other serious violations," the agencies said.

The policy guide makes clear, however, that FDA and CBP will continue their surveillance of food imports to ensure they are safe and comply with other U.S. requirements. Furthermore, the transitional policy does not affect the agencies' ability to initiate other actions to protect U.S. consumers. From Dec. 12, 2003 on, they said, enforcement of the Bioterrorism Act "will be carried out, on a round-the-clock, 7 days a week basis, by hundreds of FDA and CBP employees."

FDA also issued a question and answer document as guidance for industry on the prior notice rule (for full text, click here.)

Delay in Recordkeeping, Food Shipment Detention Rules
FDA in December also announced a delay in finalizing the last two rules under the Bioterrorism Act, involving the establishment and maintenance of records related to food, and administrative detention of food shipments that could harm the health of humans or animals. The two proposals received numerous comments from concerned stakeholders that the agency needs to finish analyzing and consider before issuing the final regulations, FDA explained. FDA Commissioner Mark B. McClellan said "we want all FDA bioterrorism regulations to be examples of a government that communicates with stakeholders in order to craft clearly understood rules that protect consumers without creating undue burden on the industry."

While that work is being completed, FDA said it can use authorities granted by the Bioterrorism Act to detain foods and obtain records in advance of issuing final rules. The proposed rule on administrative detention of foods or animal feed had no mandated deadline, but Congress had directed that the rule on recordkeeping be completed by Dec. 12.