FDA published an Interim Final Rule to modify their regulations on the establishment, maintenance, and availability of records. Before passage of the Food Safety and Modernization Act (FSMA), section 414(a) of the FD&C Act provided the Secretary of Health and Human Services (and by delegation FDA) with access to records relating to food that was reasonably believed to be adulterated and present a threat of serious adverse health consequences or death to humans or animals. FSMA expanded FDA’s records access authority to records relating to include any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner and foods which FDA considers a reasonable probability that the use of or exposure to the article of food will cause serious adverse health consequences or death to humans or animals.
Although the majority of the rule tracks the FSMA language, one important addition has been made. Records are required to be “provided must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.”
21CFR § 1.361 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 affected in a similar manner, is 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, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information 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.
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 affected in a similar manner, is 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, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information 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.
FDA’s record access authority under section 414 is separate from previously existing records access authority provided in commodity specific regulations, such as the Low-Acid Canned Food regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations (21 CFR part 106). FSMA did not amend these commodity specific record access requirements.
FDA’s records access authority under sections 414(a) and 704(a) applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food when the circumstances in section 414(a)(1) or (2) of the FD&C Act are met.
FDA requests to access and copy records are most likely to occur when FDA becomes aware of reportable food reports, as defined in section 417(a)(2) of the FD&C Act [21 U.S.C. 350f(a)(2)], foodborne outbreaks, epidemiological evidence implicates a food causing illness or death, product recalls, adverse event reports, and consumer complaints.
FDA’s authority under FD&C Act §§ 414(a) and 704(a) applies to records that are required to be kept by regulation under section 414(b), as well as any other records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the food believed to be affected and any other article of food believed to be affected in a similar manner. Examples of records that FDA can access and copy include:
• Manufacturing records
• Raw materials (ingredients and packaging) receipt records
• Product distribution records
• Product inventory records
• Test records
• Recall records
• Reportable food records
• Customer distribution lists
• Complaint and adverse event records
· Recipes, as defined in 21 CFR 1.328 (but a list of the ingredients used to manufacture a food, without quantity information and manufacturing instructions, is not a recipe.)
· Financial data
· Pricing data
· Personnel data
· Research data
· Sales data other than shipment data regarding sales
The refusal to permit access to or copying of records requested under section 414(a) of the FD&C Act is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. In response to such a refusal, FDA may initiate civil or criminal action, as necessary, including:
• Suspension of the food facility’s registration, thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce
• Administrative detention of the food to control its movement
• Seizure of the food
• Issuance of a mandatory recall order for the food
• Injunction against the firm
• Refuse admission of food offered for import into U.S. commerce
FDA has issued two guidance documents:
Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius.
