The Bioterrorism Act states that you must maintain records and information of every sale made to the USA and have them available upon request from the FDA. These records need to be maintained for up to two years depending on the type of product that is sold.

GTH Solution

Using the GTH Trading Systems, all records of every sale made to the USA will be maintained electronically in the GTH Databases. These records will be available for the FDA when they are requested and for the required period.

By Regulation, who is obligated to maintain Records?

Domestic Entities that manufacture, process, packs, distribute, receives, stores, transport and imports food products intended for human or animal consumption and the Foreign Entities that manufacture, process, packs, distribute, stores, exports and transports food products destined for the USA for human or animal consumption.

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.

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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:

Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm and the responsible individual; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety (e.g., Brand X Cheddar Cheese, not just cheese; romaine lettuce, not just lettuce); date received; lot number or other identifier if available; quantity and type of packaging (e.g., 12 oz. bottles); and the name, address, telephone number--and, if available, fax number and e-mail address--of the transporter who brought it.

The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.

Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm and the responsible individual; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date released; lot number or other identifier if available; quantity and type of packaging; and the name, address, telephone number--and, if available, fax number and e-mail address--of the transporter who transported the food from you. For transporters, the records for each food transported would have to include:

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. 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.
The type of food, including brand name and specific variety; lot number or other identifier if available, quantity, and type of packaging.

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.

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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 yet. 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.