FDA's New Bioterrorism Regulation: Establishment and Maintenance of Records

The U.S. Food and Drug Administration (FDA) has issued new regulations as authorized by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act). The new regulations require establishment and maintenance, for not longer than two years, of records by any party (excluding farms, restaurants and certain others) who manufactures, process, pack, transport, distribute, receive, hold, or import food.

These records will allow the FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The records must be made available to FDA upon demand within 24 hours. Compliance is required beginning December 9, 2005, and not later than December 9, 2006, depending on size of the company.

The following Questions and Answers are excerpted from FDA reference material:

Who must establish and maintain records?
Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S.; and persons who place food directly in contact with its finished container. For these regulations, the term "persons" includes individuals, partnerships, corporations, and associations.

How is food defined for purposes of this regulation?
The FDA defines food as articles used for food or drink for both humans and animals, including chewing gum and articles used for food components. See the FDA Web site (http://www.fda.gov) for additional information and a list of examples.

Who is excluded entirely or in part from these regulations?
Farms; Foreign persons, except those that transport food in the U.S.; Restaurants; Persons conducting activities with food within the exclusive jurisdiction of the U.S. Dept. of Agriculture; Persons who manufacture, process, pack, store, or import for personal consumption are all exempted from these regulations.
Some entities are exempted from the requirement to establish and maintain the new records required by the BTA, but are still subject to the record availability requirements of existing records.
To review the complete list of exemptions, please visit http://www.fda.gov.

What records must be established and maintained?
In general, transporters and non-transporters must maintain records to identify the immediate previous and immediate subsequent sources of the shipments, along with names and addresses of those entities, and descriptions of the food items, including lot numbers if used. In addition, records must also include the date received, the date released, quantity and type of packaging. For complete information on the data elements required, please visit http://www.fda.gov.

How must the records be maintained?
FDA specifies the information a covered entity must keep but does not specify the form in which the records must be maintained. The records may be kept in any format, paper or electronic, provided they contain all the required information. The regulations do not require duplication of existing records, if these records contain all the required information.

How long must the records be retained?
The rule requires records to be created when food is received, released or transported except to the extent the information is contained in existing records. The retention period ranges from 6 months to 2 years, depending on fresh or perishable foods, and transporter or non-transporter.

What are the record availability requirements?
When 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, the required records must be available for inspection and photocopying or other means of reproduction as soon as possible, not to exceed 24 hours from time of receipt of the official request.

How does FDA intend to make a request to access or copy records under the Bioterrorism Act?
Once FDA makes the necessary determination following the specified procedures, an investigator or other FDA personnel, upon presentation of credentials, will submit a written notice, FDA 482 - Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA's legal authority to obtain these records. FDA may request additional records related to the implicated food article at a later time under the same authority.

What will happen if the required records are not established and maintained?
The Bioterrorism Act makes failure to establish and maintain the required records or failure to make them available to FDA a prohibited act. The Federal government can bring a civil or criminal action in Federal court against any party that commits a prohibited act.

When is compliance with the recordkeeping regulation required?
The first compliance date is December 9, 2005, for large businesses. Small businesses (11-499 full-time equivalent employees (FTEs)) must comply by June 9, 2006, and very small businesses (10 or fewer FTEs) must comply by December 9, 2006.

Where can I get more information?
The FDA Web site (http://www.fda.gov) has extensive information on the new recordkeeping provisions, and additional information on other provisions of the Bioterrorism Act of 2002.