FDA Regulation & Compliance
President Bush signed into law June 12, 2002 the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or "The Act"). This new legislation provided Food and Drug Administration (FDA) with new authority for protecting the nation's food supply against terrorist acts and other public health threats. The proposed regulation as published in the Federal Register has four main provisions which apply to domestic and imports to the United States; Registration, Prior Notice, Administrative Detention and Record Keeping. The final rule, which FDA plans to publish by October 12, 2003, will implement sections of "The Act" by December 12, 2003. Non-Compliance can result in civil and criminal penalties being imposed by the federal government. Read the FDA frequently asked questions.
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[08.12.2004] FDA Issues Guidance Document |
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[06.03.2004] U.S. Customs and Border Protection Moves to Implement the Bioterrorism Act |
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[12.11.2003]FDA and CBP Announce Their Transitional Compliance Policy on Food Imports Under the Bioterrorism Act |
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[12.05.2003] Federal Register Notice--Advance Cargo Information,Trade Act 2002, Section 343(a) [Download the pdf] |
Food and Drug Frequently Asked Questions
Who must submit prior notice?
- Purchaser or importer (or agent) who resides or maintains a place of business in the United States.
When must prior notice be submitted?
- See Federal Register pending Rules and Regulation.
What information must be included in the prior notice?
- See Federal Register pending Rules and Regulation.
How is the prior notice to be submitted?
- FDA and Customs and Border Protection (CBP) announced May 27, 2003 that they are working together to integrate and streamline the submission of the FDA's prior notice requirements of the Bioterrorism Act by modifying Customs Automated Commercial System (ACS). FDA and CBP are developing a system that will be less burdensome on the trade while at the same time fulfilling the mandates of the Bioterrorism Act.
Will immediate acknowledgement of the submission be provided?
- Yes, FDA plans that an acknowledgement will be issued with the time and date.
May the prior notice be amended or updated?
- Yes, under the proposed rule, amendments are accepted once, under specified, limited circumstances, for information regarding product specificity or quantity that did not exist at the time the original prior notice was submitted.
What are the consequences of submitting no or inadequate prior notice?
- The product shall be refused admission into the United States.
Who will submit the information?
- Importers/Customs Brokers, in most instances, should be able to submit the required Prior Notice information to the FDA via ACS.
Who must register their warehouses and/or facilities?
- Domestic and foreign facilities that manufacture process, pack, or hold food for human or animal consumption in the United States.
What date must facilities be registered with FDA?
- Facilities must be registered with the FDA by December 12, 2003.
Who must keep records?
- Domestic manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers of food intended for consumption in the United States.
- Foreign facilities that manufacture/process pack or hold food for human or animal consumption in the United States.
- Whether or not the food enters interstate commerce.
When does the record keeping period begin?
- At the time the activity begins.
What is the record keeping retention period?
- Perishable foods not intended for processing into nonperishable foods must be retained for one hour from the date created.
- Animal food, including pet food, retained for one year from the date created.
- Records for all other foods must be retained for two years from the date created.
Is electronic record keeping acceptable?
When will record keeping regulations begin?
- With the exception of "small businesses" 6 months after the publication date of the final rule in the Federal Register.
What is the fine for non-compliance?
- First conviction = 1 year in prison, $1,000 fine or both, subsequent convictions - 3 years in prison, $10,000 fine, or both and intent to defraud or mislead - 3 years in prison, $10,000 fine, or both.
Who receives a copy of the detention order?
- The owner, operator, or agent in charge of the place where the article of food is located.
When does a detention order terminate?
- FDA will issue a detention termination notice releasing the article of food to any person who received the detention order. If FDA fails to issue a detention termination notice and the 30-day detention period expires, the detention order is deemed to be terminated.
