FDA Recordkeeping Rule To Enhance The Security Of The U.S. Food Supply

Medical Letter on the CDC & FDA
January 21, 2005

Email this page

U.S. Food and Drug Administration (FDA) has issued final regulations on the establishment and maintenance of records to protect the U.S. human food and animal feed supply in the event of credible threats of serious adverse health consequences or death to humans or animals.

FDA also issued draft guidance to FDA staff and industry, which details the internal procedures the agency will follow before requesting access to records.

"Publication of this recordkeeping rule represents a milestone in U.S. food safety and security," said Secretary of U.S. Health and Human Services (HHS) Tommy G. Thompson. "There is more work to do yet, but our nation is now more prepared than ever before to protect the public against threats to the food supply."

This final regulation implements section 306 of the Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002), which directs the HHS secretary to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records identify the immediate previous source of all food received, as well as the immediate subsequent recipient of all food released.

"These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Dr. Lester M. Crawford, acting FDA commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."

The final regulation is the fourth regulation designed to increase the safety and security of the U.S. human and animal food supply under the authority of the Bioterrorism Act.

The record retention period for human foods ranges from 6 months-2 years depending on the shelf life of the food. Records for animal food, including pet food, must be retained for 1 year. The maximum record retention requirement for transporters of all types of food is 1 year.

Records must be retained at the establishment where the activities covered in the records occurred or at a reasonable accessible location. To minimize the burden on food companies affected by the final rule, companies may keep the required information in any format, paper or electronic. All businesses covered by this rule must comply within 12 months from the date the rule is published in the Federal Register, except small and very small businesses. Small businesses (11-499 full-time equivalent employees - FTEs) must comply within 18 months from this date, and very small businesses (10 or fewer FTEs) have to comply within 24 months from this date.

When the FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records or other information to which the FDA has access must be available for inspection and copying as soon as possible, not to exceed 24 hours from time of receipt of the official request. The records-access authority applies both to records required to be established and maintained by the final rule, or any other records a covered entity may keep to comply with federal, state, or local law or as a matter of business practice.

The Bioterrorism Act allows the FDA to bring a civil action in federal court to enjoin the persons who fail to comply with this rule. FDA also can seek criminal actions in federal court to prosecute persons who fail to establish and maintain records, as required by the final rule.

NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving this information for research and educational purposes.

Subscribe via rss

Global Food Challenge
IATP explains the policies that have caused the food crisis and the solutions we need.

Green Chemistry
The Green Chemistry revolution is making safer products and protecting human health and the environment.

Local Foods
IATP analyzes the key policy and marketplace issues driving local food systems.

NAFTA
NAFTA leaves a huge footprint on the U.S. and the world. As Washington gears up for the debate, IATP analyzes what's at stake.

Water
From ethanol to privatization, water is a hot issue in trade and agriculture worldwide. Trade Observatory has document and headline collections dedicated to water issues.

Think Forward
by IATP staff

Profiles of over 90 agribusiness companies, including their products, management, corporate geneaology and profit margins.