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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues Recordkeeping Regulation Under Bioterorrism Act, Completing the Requirements of Law

by Jon F. Scheid, Editor
FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 6

In early December, the Food and Drug Administration (FDA) issued the final regulation about the recordkeeping requirements under the Bioterrorism Act of 2002, the fourth set of regulations the act requires.

The recordkeeping rule requires persons who handle food, including feed and pet food, to maintain records that indicate the source of the food or ingredients and the destination for the products. These are the records that FDA inspectors will need to have to investigate credible threats of bioterrorism.

The other three rules apply to registration of firms, prior notice of food shipments imported or offered for import into the United States, and detention of products that FDA authorities believe pose a threat of injury.

Records rule

According to the recordkeeping rule, which was published December 6, 2004, “persons who manufacture, process, pack, transport, distribute, receive, hold, or import food” are required to establish and maintain records that identify the immediate previous source of all foods received, and that identify the subsequent recipient of the food product.

How long the records must be maintained depends on the type of food product. Records about animal feed and pet food must be maintained for a year, which corresponds to the time feed

manufacturers are required to keep records under the BSE feed rule.

Companies employing 500 persons or more must comply with the rule within a year of its publication. Mid-sized firms with between 11 and 499 employees must comply within 18 months.

And small firms employing 10 or fewer persons must comply within 24 months.

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 final rule requires that firms make records available to FDA inspectors as soon as possible, but in no case more than 24 hours after receiving the request. Draft guidance for FDA staff exercising records access authority has been published and can be accessed at http://www.cfsan.fda. gov/~dms/secgui12.html.

The regulation requires firms to create records when they receive food or feed, release it, or transport it.  For non-transporters the records must identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, as well as the immediate subsequent non-transporter recipients of all foods released. The information must include:

The name of the firm;

  • Its address, phone number, and e-mail address, if available;
  • Type of feed or food including brand name and specific variety; date released;
  • Quantity and type of packaging; and
  • Identity of the immediate subsequent transporter recipients, including the name, address, telephone number, and if available, fax number and e-mail address.

Firms that manufacture, process, or pack food must also include lot or code numbers or other identifiers, if such information exists.

For transporters, records have to include names of the transporter’s immediate previous source and the transporter’s immediate subsequent recipient, origin and destination points, the date shipment was received and the date it was released, number of packages, description of freight, route of movement during the time the food was transported, and transfer point(s) through which the shipment moved.

Persons who transport food in the U.S. have five alternative methods of meeting the requirements of the rule. These are explained at http://www.cfsan.fda.gov/~dms/fsbtac23.html.

Concerning the source of the food or feed ingredients, the recordkeeper must be as specific as possible about the source. For instance, if a feed mill received grain from three separate elevators and segregates the grain into different storage bins, the feed mill should be able to report the source of the grain in each bin. However, if the grain is commingled, the records should indicate all three sources for the grain.

FDA is flexible about what records it will accept. The records can be kept in any paper or electronic format the recordkeeper wants, as long as they provide the required information. Firms do not have to create duplicate records. So records kept for the BSE rule, for instance, could be used for the Bioterrorism rule, if they supply the required information.

The rule says that the records must either be kept at the establishment where the food or feed products are handled, or made available at a reasonably accessible location.

Records relating to recipes, financial data, pricing data, personnel data, research and sales data are excluded from the recordkeeping requirements. A recipe is defined as a formula, including ingredients, quantities, and instructions for manufacturing a food product. So even though recipes are excluded, records relating to only ingredients of a product, but not the quantities or instructions, are required under the recordkeeping rule.

The rule has some exclusions. For instance, it does not apply to farms. Farmers selling grain directly to a feed manufacturer do not have to keep records of that sale. However, the feed manufacturer will have to have a record showing the farmer who supplied the grain. When a feed mill buys grain from a commercial supplier, though, such as a commercial elevator, both the feed manufacturer and the elevator must have records of the transaction.

Ingredient suppliers, such as protein blenders, mineral supplement suppliers, etc., must keep records of suppliers and customers who are not retail customers.

Firms do not have to keep records of sales direct to consumers. For example, a small, local feed mill that receives ingredients from local farmers and makes its own brand of feed to sell to local farmers should have records of who transported the grain to the feed mill, and which farms supplied the grain. But it does not need to keep records about the retail sales.

Other provisions of bioterrorism rule

Registration, prior notice and administrative detention rules have already gone into effect as either final or interim final rules.

  • Registration: The food facilities reg--istration requirement went into effect in October 2003 and initially required all firms that manufacture or process, pack or hold food for human or animal consumption (the rule applies to animal feed and pet food) be registered by December 12, 2003. However, FDA first focused on education. Firms that had not registered by the due date were allowed a grace period to come into compliance before FDA would take action against them.

    (As of December 22, 2004, slightly fewer than 240,000 food firms had registered. FDA is estimating that slightly more than 400,000 firms are required to register.)

    FDA set up a system that allowed firms to register on line at www.fda.gov/furls. It also permits paper registrations to be mailed to: U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, USA, or faxed to 301-210-0247.

    Firms are required to provide the name, address, and phone number for the facility and, if applicable, its parent company. Also, the registrant should provide the name, address, and phone of the owner, operator, or agent in charge; all trade names the facility uses; a statement certifying that the information submitted is accurate and the person submitting the information is the appropriate person to do so; and the applicable food product categories as identified in FDA’s regulation (21 CFR 170.3).

    Animal feeds, though, are not identified under that regulation. FDA encourages feed manufacturers to provide information about their products in the optional information section of the registration form.

  • Prior notice:Also in October 2003, FDA announced its regulation requiring food (including animal feed and pet food) importers notify FDA in advance of the shipment’s arrival. This rule went into effect December 12, 2003.

    Prior Notice must be submitted electronically, either through the Automated Broker Interface/Automated Commercial System (ABI/ACS) of the Bureau of Customs and Border Protection (CBP), or through FDA’s Prior Notice System Interface at http://www.accessfda.gov. Importers must provide much the same information they were already submitting to CBP prior to the Prior Notice rule. That information includes:

    • Identification of the person submitting the information or the person transmitting the information;
    • Entry type and CBP identifier;
    • Identification of the type of food and an estimate of the quantity to be imported;
    • Identification of the manufacturer or, if known, grower;
    • The FDA country of production;
    • The shipper, unless the product is coming in by mail;
    • The identification of the importer, owners and ultimate consignee (except for food being transshipped through the United States);
    • Identification of the carrier; and
    • Planned shipment information.

    FDA must be notified of a shipment no more than 5 days in advance, and no less than 2 hours if the shipment is coming by road, 4 hours if coming by air or rail, and 8 hours if coming by water.

  • Administrative detention:The Bioterrorism Act also gives FDA the authority to take control of an imported food or feed product if FDA “has credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals,” according to a fact sheet FDA issued in May, 2004.

    FDA points out that its authority for administrative detention is different from its right to refuse entry of product. FDA can exercise its authority to refuse entry of an imported product into the United States when it determines that the product was not properly or safely produced, packed, or held. FDA will use its right for administrative detention when it believes the product could be part of a terrorism attempt.

The administrative detention provisions of the act took effect immediately upon enactment of the Bioterrorism Act.