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FDA Issues Final Recordkeeping Rule of the Bioterrorism Act

Date: Feb 01, 2005


On Dec. 9, 2004, the U.S. Food and Drug Administration has issued final regulations requiring food companies and allied industries to establish and maintain records to protect against threats to human food and animal feed in the United States (69 Fed. Reg. 71562). The new rule implements the recordkeeping requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Recordkeeping is just one of four components of the Bioterrorism Act designed to protect our food supply. The other three that have already been issued are (1) registration of foreign and domestic food facilities; (2) prior notice of food shipments imported into the U.S.; and (3) administrative detention of suspected foods.

The regulations require "persons that manufacture, process, pack, transport, distribute, receive, hold, or import food" to establish and maintain records that identify the immediate previous source of all food received, as well as the immediate subsequent recipient of all food released. Rapid access to such information, will allow FDA to determine the source and cause of credible threats that can cause serious adverse health consequences or death to humans or animals. The agency also expects this rule will help it quickly notify consumers and/or facilities that might be affected. The rule applies mostly to traditional food manufacturers and packers, but nonetheless sweeps others involved in the food supply within its gambit. For example, transporters of food are brought fully within its scope, including foreign transporters.

The rule also applies to packaging material manufacturers, suppliers and contract packagers, as follows:

  • Manufacturers of finished containers that come in contact with food and who also put the food directly into the finished containers are required to establish and maintain records.
  • Manufacturers of finished containers that come in contact with food, but who do not actually put the food into the containers, are required only to make existing records available to FDA with respect to the container.
  • Manufacturers of food contact materials that are not the finished container that contacts food are only required to make existing records available to FDA upon request.
  • Manufacturers of food packaging that bears the label but is never directly in contact with food (such as secondary packaging) are completely exempt from the recordkeeping requirements.

Records must be available for inspection and copying as soon as possible, not to exceed 24 hours from the time of receipt of FDA's official written request. To minimize the burden on food companies, the required information may be kept in paper or electronic format. The record retention period for human food ranges from six months to two years, depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum length for retention of records by transporters for all types of food is one year.

Businesses must comply within 12 months of publication of the rule in the Federal Register, except small and very small businesses. Small businesses (11-499 full-time employees) must comply within 18 months, and very small businesses (1-10 full-time employees) must comply within 24 months.

Used with permission. Copyright FOOD & DRUG PACKAGING, February, 2005.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.