Interim final bioterrorism rules enter Federal Register

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Related tags: Regulation, Fda

The US Food and Drug Administration will publish two of the major
interim final regulations implementing the Public Health Security
and Bioterrorism Preparedness and Response Act in the Federal
Register today.

The US Food and Drug Administration (FDA) will publish two of the major interim final regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act in the Federal Register today.

The first rule requires all domestic and foreign food facilities that manufacture and process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The regulation is designed to allow the FDA and customs officials to better target inspections. The agency said it expects to receive about 25,000 notifications about incoming shipments each day.

The second requires advance notice of any shipment of food to be imported into the country. About 420,000 facilities are expected to register under this requirement. Final rules to implement new record-keeping requirements were not announced.

Industry associations are working to alert trade to the requirements, which take effect on December 12, 2003, in accordance with the Bioterrorism Act. They will however be enforced with discretion through the prior notice system for four months, while FDA educates stakeholders on the laws.

The interim final rules do contain some amendments to the proposals published this year. The timeframes for advance notice of incoming shipments have been reduced to minimize unnecessary costs so that importers are required to give notice two hours before arrival of food by land by road, four hours before arrival by air or by land via rail, or eight hours before arrival by water. They could be reduced further in the future as part of a plan to coordinate border-management activities more efficiently, said FDA.

The definition of foods now also excludes food contact substances.

Industry associations have however voiced concern that members are not sufficiently prepared for the rules, and with only 65 days to go before implementation, many trade groups have been trying to boost awareness of the implications.

"Companies need to immediately focus on these new requirements, particularly those companies that import food products or ingredients,"​ warned CEO of the National Nutritional Foods Association (NNFA) David Seckman. He added that NNFA will be reviewing the preamble to these rules to help members comply with the new obligations.

Speaking at SupplySide West last week, president of the American Herbal Products Association (AHPA) Michael McGuffin said his organisation was concentrating on educating firms outside the US, who are less likely to be fully aware of the regulation requirements.

NNFA has published the interim final rules and additional information about the Bioterrorism Act on its website​. It is also organising a presentation on the implications of the Bioterrorism Act. To register, go here​.

At the same time FDA is also to conduct national and international meetings and other programs in coming weeks to provide full information about the rules. The agency is holding a satellite downlink public meeting​ on October 28 to discuss the two rules.

"We have listened carefully to what stakeholders said about the proposals,in order to develop rules that are both workable and feasible,"​ Dr Mark McClellan, FDA commissioner said yesterday. "The rules we are announcing today are intended to fulfill our goal of making the food supply safer and more secure without hindering trade."

Registrations, which can be submitted electronically, via the Internet, or by surface mail or fax, will be accepted from October 16. There is no fee associated with registration.

The FDA​ is requesting further public comment on the rules.

Related topics: Regulation

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