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FDA Issues Interim Final Bioterrorism Regulations

October 9, 2003

In a briefing held today, the Food and Drug Administration (“FDA”) announced the release of its interim final regulations on food facility registration (Docket No. 2002N-0276) and prior notice of food imports (Docket No. 2002N-0278) (“the Regulations”).

The Regulations, and related fact sheets, are now available on the FDA’s web site. The Regulations will be published in tomorrow’s Federal Register.

The Regulations, which will be effective and enforceable on December 12, 2003, reflect FDA responses to some of the 350 comments submitted by industry after the release of the proposed regulations in February 2003.

According to today’s briefing, in order to allow time for facilities to register by the December 12th deadline, the FDA will begin accepting online registrations on October 16, 2003, at 6:00 p.m. (EST). The FDA strongly encourages electronic registration, but will also accept paper registrations.

The FDA made clear that the interim final regulations will become effective on December 12, 2003. The FDA is expected, however, to exercise its enforcement discretion during the initial implementation phase of the Regulations.

Once the Regulations are published in the Federal Register, a seventy-five (75) day comment period will begin. The FDA anticipates issuing final regulations in the spring of 2004.

FDA Outreach Programs

In connection with its issuance of the Regulations, the FDA will offer several outreach opportunities to industry, starting with a public meeting via satellite on October 28, 2003 from 1:00 p.m.-3:00 p.m. (EST). [Details on viewing the satellite downlink public meeting are available in the FDA’s October 1 Federal Register notice (68 Fed. Reg. 56600)]. The FDA has invited interested parties to submit questions on the regulations prior to this meeting. Parties interested in submitting questions may do so directly, in accordance with the instructions set forth in the FDA’s October 1 notice, or they may submit their questions to us for subsequent transmission to the FDA.

How To Find Out More

If you would like more specific information on FDA’s new regulations on food facility registration (Docket No. 2002N-0276) and prior notice of food imports (Docket No. 2002N-0278), and how they will effect the importation of food products, please contact us and we will add you to our FDA Import Regulation news service.

Please contact George Tuttle, III, at if you have any questions regarding FDA Bioterrorism Regulations or other Customs law matters.

George R. Tuttle, III is an attorney with the Law Offices of George R. Tuttle in San Francisco. The information in this article is general in nature and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered such.


Copyright 2005 by Tuttle Law Offices.

All rights reserved. Information has been obtained from sources believed to be reliable. However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.


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