Maintenance of Records Finalized in FSMA Regulation

The Establishment and Maintenance Rule become final for those companies in the U.S. who manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or animals, and foreign persons who transport food in the U.S.  Here is a simplified version of the FDA guidance to help you identify what you need to know about records needed for food operations.

Of course, this should already be in place, much having been required as part of the Bioterrorism Act of 2002.

What are the record availability requirements?

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, will cause serious adverse health consequences or death to humans or animals, any records or other information accessible to FDA must be made readily available for inspection and photocopying or other means of reproduction. These records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. 
The records may be kept in any format, paper or electronic, provided they contain all the required information.
The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.

For your source of food or ingredients, you need:
The name of the firm; 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;
Quantity and type of packaging (e.g., 12 oz. bottles);
Identify the immediate transporter previous sources, including the name, address, telephone number – and, if available, fax number and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier, if the information exists.

Identify who received the product (the immediate recipients of all foods (not transportation) released, including:
The name of the firm; address; telephone number; fax number and e-mail address, if available;
Type of food, including brand name and specific variety;
Date released;
Quantity and type of packaging;
Identify the immediate transporter subsequent recipients, including the name, address, telephone number – and, if available, fax number and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier, if the information exists.
Information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.

For transporters of foods, records have to include names of the transporter’s immediate previous source and transporter’s immediate subsequent recipient, origin and destination points, date shipment received and date 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

What records are excluded from records access?

Recipes, financial data, pricing data, personnel data, research data, and sales data are excluded from these requirements. A recipe is defined as the formula, including ingredients, quantities, and instructions necessary to manufacture a food product. Therefore, records relating only to the ingredients of a food product, and not the other two components of a recipe, are not excluded.


How will FDA maintain the confidentiality of any protected information in the records it obtains?

Information obtained under the records access provisions may include, but is not limited to, a company’s non-public confidential commercial or trade secret information. Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), and Freedom of Information Act (5 U.S.C. 552) and the Agency’s information disclosure regulations at 21 CFR Parts 20 and 21 govern the Agency’s disclosure of information to the public. FDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information, such as any trade secret or confidential commercial information.  So make sure you important records are marked appropriately with Trade Secret / Commercial Confidential 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 period for which the records must be retained depends on the perishability of the food:

Type of food	Record retention period for non-transporters	Record retention period for transporters or persons keeping records on their behalf
Food having significant risk of spoilage, loss of value, or loss of palatability within 60 days	6 months	6 months
Food having significant risk of spoilage, loss of value, or loss of palatability occurring after a minimum of 60 days, but within 6 months	1 year	1 year
Food having significant risk of spoilage, loss of value, or loss of palatability occurring no sooner than 6 months	2 years	1 year
Animal food, including pet food	1 year	1 year