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Two FDA Bioterrorism Rules Exempt Food Contact Substances

October 10 the Food and Drug Administration (FDA) issued interim final rules governing registration of food facilities and prior notice of imported food shipments. See 68 Fed. Reg. 58894 and 68 Fed. Reg. 58974, respectively. The rules, which will go into effect December 12, 2003, were promulgated pursuant to the Public Health Security and Bioterrorism and Preparedness and Response Act of 2002.

The good news for converters and their suppliers is the rules now exempt food contact substances, but they will have a significant impact on customers in the food industry.

Both rules changed significantly from proposals FDA issued in February. The most important change for the converting industry is that FDA explicitly exempts food contact substances from both the facility registration and prior notice rules. In particular, FDA revised the definition of “food” in both rules, clarifying that “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act) with the following exceptions: (1) food contact substances as defined in section 409(h)(6) of the Act,1 and (2) pesticides.

The result is the food packaging industry, along with ingredient suppliers, is exempt from complying with both the facility registration and prior notice rules. However, because many segments of the food industry still must comply with the rules, it is important for converters to understand the requirements.

The interim final rule on registration of food facilities generally requires the registration of domestic and foreign facilities that manufacture/process, pack, or hold food for consumption in the US.

Facilities subject to the registration rule must register with FDA no later than December 12. Registrations must be completed by the facility's owner, operator, or agent in charge, or an individual authorized by the owner, operator, or agent in charge. The rule provides several means by which facilities subject to the rule may register, including:

  • Electronic registration via the Internet — Registrations may be submitted electronically via the Internet at www.fda/furls beginning October 16 at 6:00 p.m. eastern standard time.
  • Registration via fax or mail — Registrants also may register by fax or mail, e.g., in situations where an electronic means of registration is not available. A registrant wishing to register by mail must call FDA at 877/FDA-3882 to request a copy of the form.
  • Registration via CD-ROM — The interim final rule also explains that FDA will accept multiple submissions in CD-ROM format.

The interim final rule on prior notice of imported food shipments requires prior notice of food imported or offered for import into the US be provided to FDA. Any person with knowledge of the required information may submit prior notice or have it transmitted on his/her behalf.

Pursuant to the interim final rule, all prior notices must be submitted electronically to FDA either through CBP's ABI/ACS or the FDA PN System Interface. All information contained in the notice must be in English, except for an individual's name, the name of a company, and the name of a street, which may be submitted in a foreign language.

Notice must be received and confirmed electronically by FDA not more than five days prior to arrival, and as specified by the mode of transportation set forth below, no fewer than:

  • two hours prior to arrival by land by road
  • four hours prior to arrival by air or by land by rail
  • eight hours prior to arrival by water.

For an article of food carried by or otherwise accompanying an individual, if the food is subject to the rule, the time frame for providing notice is consistent with the mode of transportation used. A copy of the FDA confirmation also must accompany the food.

1Section 409(h)(6) of the Act defines “food contact materials” as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.”


Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; This email address is being protected from spambots. You need JavaScript enabled to view it.; PackagingLaw.com.

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