Food facilities that operate on a seasonal basis may include the dates they are open for business when registering with FDA.

The agency's proposed rule on the registration of food manufacturing, processing, packing or holding facilities notes the registration form will include a section where operators of seasonal facilities can supply the dates their facilities are open.

The form also will allow facilities that deal with numerous types of food products to check a "most/all food products" category box when registering.

The accommodations in the rule respond to comments sent by industry and consumer advocacy groups during FDA's drafting of the regulation. The proposed rule also notes that multiple buildings on a single campus may register as one facility; the Council for Responsible Nutrition had broached the topic in its comments (¹ Also see "CFSAN Bioterrorism Regs Should Include Grandfather Clause – CHPA" - Pink Sheet, 9 September, 2002., p. 12).

FDA's Center for Food Safety & Applied Nutrition issued the rule, which is slated for publication in the Feb. 3 Federal Register, under the mandate of the Public Health Security & Bioterrorism Preparedness & Response Act of 2002. The act was signed into law last June (² 'The Tan Sheet' June 17, 2002, In Brief).

The bioterrorism law additionally requires FDA to issue regs addressing the establishment and maintenance of records and the administrative detention of suspicious shipments; the two regs are due out in March. A fourth rule dealing with the prior notice of food imports also is scheduled to appear in the Feb. 3 Federal Register (see ³ Also see "Food Import Prior Notice Proposed Rule Allows Amendments, Not Appeals" - Pink Sheet, 3 February, 2003. ).

"Registration is one of several tools that will enable FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving FDA information about all facilities that manufacture, process, pack or hold food for consumption" in the U.S., ⁴ the proposed rule states.

The reg will go into effect Dec. 12, 60 days after the finalized version is scheduled to be published on Oct. 12. Any facility that opens after the rule takes effect must register prior to commencing operations. Any changes to data included on the registration form must be reported to the agency within 30 days.

All domestic and foreign facilities that manufacture, process, pack or hold food must register with FDA. For domestic sites, registration must be completed by the facility's owner or operator; foreign sites may have an approved agent register for them.

Exempt facilities include: retail stores; restaurants; nonprofit locations that prepare or serve food directly to consumers; facilities regulated by the U.S. Department of Agriculture; certain fishing vessels; and farms. Foreign facilities that send food to other sites outside the U.S for further processing or packaging before it enters the country are exempt from registration as well.

Information registrants would be required to provide includes the firm's name, full address, phone and fax numbers, email addresses (if available), as well as all trade names for the facility, its associated food products and its parent company. Similar information also should be provided for an emergency contact and a foreign facility's U.S. agent.

Information the proposed rule currently designates as optional includes food categories the facility deals with (such as dietary supplement or infant formula), which the reg notes would be "necessary for a quick, accurate and focused response to a bioterrorist incident or other food-related emergency."

Although registration via surface mail is an option, the agency strongly encourages facilities to register electronically. "FDA will be able to accept electronic registration from anywhere in the world 24 hours a day, seven days a week through a link on FDA's internal Web site," the rule says.

The reg adds that electronic registration will be quicker and error-proof, because the FDA database will not issue a registration number and confirmation page until all of the mandatory fields are completed.

Registration will be free of charge and must be done in English. The agency predicts approximately 400,000 facilities will register under the program.

Failure to register may lead to the filing of either a civil or criminal suit against the offending facility, the rule states. Foreign companies that fail to comply could see their food shipments detained at the port of entry, the regulation adds.

Electronic Facility Registration Encouraged In FDA Bioterrorism Reg

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