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FDA
May 2003
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) requires the Secretary of Health and Human Services to issue final regulations by December 12, 2003, that would establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that must be kept by these regulations are those that are needed by the Secretary for inspection to allow the Secretary 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. This proposed regulation would implement this recordkeeping authority in the Bioterrorism Act.
Who must establish and maintain records under the proposal? Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. and foreign facilities that manufacture, process, pack or hold food intended for human or animal consumption in the U.S.
Who is excluded from these regulations? Farms; restaurants; non-profit operations that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing; and persons regulated exclusively by the U.S. Department of Agriculture under various statutes. A foreign facility is excluded if food from it undergoes further manufacturing/processing (including packaging) by another facility outside the U.S. The facility is not exempted from recordkeeping if the processing or packaging activities of the subsequent facility are limited to the affixing of a label to a package or other de minimis activity. The facility that conducts the de minimis activity also must establish and maintain records. Retail food operations also are exempted from maintaining records on immediate subsequent recipients when foods are sold directly to consumers. However, retail facilities with fewer than 10 employees that are located in the same general location as a farm, and sell unprocessed food grown on that farm or another farm located in the same general physical location are excluded from the requirement to establish and maintain records on both immediate previous sources and immediate subsequent recipients. This exemption also applies to processed foods such as baked goods, jams, jellies, and maple syrup so long as all the ingredients were grown or raised on that farm. In addition, persons who manufacture, process, pack, transport, distribute, receive, hold or import pet food who are not subject to the recordkeeping provisions of the animal proteins prohibited in ruminant feed regulation (21 CFR 589.2000) are, with respect to pet food records, excluded from the requirement to establish and maintain records on both immediate previous sources and subsequent recipients.
What records must be established and maintained? For manufacturers, processors, packers, distributors, receivers, holders and importers of food (that is, persons other than transporters), the records would have to:
1.The name of the firm and the responsible individual who had the food before you and their address, telephone number, and, if available fax number and e-mail address, and the date you received it.
2. The name of the firm and the responsible individual who had the food immediately after you and their address; telephone number, and, if available, fax number and e-mail address, and the date you delivered it.
3. The type of food, including brand name and specific variety; lot number or other identifier if available, quantity, and type of packaging.
4. Identification of each and every mode of transportation used (e.g., company truck, private carrier, rail, air, etc.) and the individual responsible from when the food was first received until it was delivered.
How must the records be maintained? FDA is specifying the information a covered entity must keep but not specifying 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.
Can existing records be used to satisfy the requirements of these regulations? The proposed regulations do not require duplication of existing records, if these records contain all the required information.
How long must the records be retained? The proposed rule would require records to be created when food is received, released or transported. Records for perishable foods not intended for processing into non-perishable foods, as well as records for animal food including pet food, would have to be retained for one year from the date they were created. Records for all other foods would have to be retained for two years after the date they were created.
Where must the records be retained? At the establishment where the activities covered in the records occurred (onsite) or at a reasonably accessible location.
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, any records or other information to which FDA has access must be available for inspection and photocopying or other means of reproduction within 4 hours if the request is made between 8:00 am and 6:00 pm, Monday through Friday, or within 8 hours if the request is made at any other time.
What records are excluded from these proposed regulations? Recipes, financial data, pricing data, personnel data, research data and sales data are excluded from these requirements. FDA is proposing to define recipe as the quantitative formula used in the manufacturing of the food product, but not the identity of the individual ingredients of the food. If finalized as proposed, FDA would have access to the records containing the ingredients used in a food product, but would not have access to the quantities of the ingredients used to make a product.
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 action in Federal court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who commit a prohibited act.
When would the recordkeeping requirements take effect? You do not have to comply with the proposed rule. However, there are certain statutory provisions regarding access to records and other information by FDA that are already in effect. You do have to comply with these statutory provisions. After considering comments FDA receives on the proposed rule, FDA will publish a final rule. The proposed rule would require all businesses, except small and very small businesses, to comply with the final rule 6 months from its publication rule in the Federal Register. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication of the final rule, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from publication of the final rule.
How to Comment on Proposed Regulations: Under U.S. law, proposed regulations are published in the Federal Register to provide interested parties with an opportunity to submit comments, e.g., suggestions to make the proposal more effective or less burdensome, questions regarding the agency's data or assumptions, submission of information the agency may not have, etc. FDA will consider all timely comments that it receives as it develops the final recordkeeping rule, which will be published in the Federal Register. Regularly updated information on this regulatory proposal and how to comment on it can be accessed electronically at http://www.fda.gov/oc/bioterrorism/bioact.html.
Comments on this proposed regulation, Establishment and Maintenance of Records (Docket Number 02N-0277), will be accepted until July 8, 2003. Written comments on the proposal can be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can be sent electronically to www.fda.gov/dockets/ecomments or as an e-mail to fdadockets@oc.fda.gov. Please ensure that you include in your submission the docket number that applies to your comment: Recordkeeping - Docket No. 02N-0277.
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Federal Register: Establishment
and Maintenance of Records