The Food and Drug Administration (FDA) has issued a final rule expanding its emergency records access authority, as provided by the Food Safety Modernization Act (FSMA). Establishment, Maintenance, and Availability of Records: Amendments to Record Availability Requirements; 79 Fed. Reg. 18799 (April 4, 2014). The final rule adopts, without change, an interim final rule issued in February 2012.
The final rule expands FDA’s records access authority in emergency situations, i.e., when the agency 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. In such situations, FDA may inspect and copy records relating to the suspect article of food that are held by any person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such food.
Under this final rule, FDA’s records access authority is expanded to include records relating to the suspect article of food and “any other article of food that [FDA] reasonably believes is likely to be affected in a similar manner.” Specifically, FDA may inspect and copy records of domestic and foreign person that manufacture, process, pack, transport, distribute, receive, hold, or import food (excluding farms and restaurants) if either:
(a) FDA has a reasonable belief that an article of food, and any other 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
(b) FDA believes there is a reasonable probability that use of or exposure to an article of food, or any other food that FDA reasonably believes to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.
FDA has also issued two final guidance documents explaining how it will exercise this new authority: Guidance for Industry: FDA Records Access Authority Under Section 414 and 704 of the Federal Food, Drug, and Cosmetic Act and Guidance for Industry: What You Need to Know About Establishment, Maintenance, and Availability of Records; Small Entity Compliance Guide.
FDA must invoke this emergency records access authority by providing a special written notice, Form FDA 482c (Notice of Inspection – Request for Records), to the owner, operator, or agent in charge of the facility. FDA’s internal procedures for exercising this authority can be found in § 10-4 of the agency’s Regulatory Procedures Manual.
FDA is most likely to invoke this authority in the following situations:
- Foodborne illness outbreaks;
- Epidemiologic evidence implicating a particular food as a cause of illness;
- Product recalls;
- Reports to FDA’s Reportable Food Registry;
- Adverse event reports (e.g., for dietary supplements);
- Consumer complaints; or
- Other situations in which a specific food presents a threat of serious adverse health consequences.
A determination that another article of food is likely to be affected in a similar manner to the suspect article of food will be made by FDA on a case-by-case basis. FDA offers the following examples of situations in which another article of food may be affected in a similar manner to the suspect article of food:
- Both articles of food prepared and packed on the same processing line;
- Both articles of food processed in shared-use equipment;
- Both articles of food prepared, packed, or held under similar conditions; or
- Both articles of food implicated by epidemiologic evidence as potential sources of foodborne illness.
Under this authority, FDA may inspect and copy: (a) records of immediate previous sources and immediate subsequent recipients of the foods in question (“one up-one down records”); and (b) any records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the foods in question that are needed by FDA to determine whether the food presents a threat of serious adverse health consequences. Examples of the latter include: manufacturing records, raw material receipt records, product inventory records, product distribution records, testing records, recall records, customer distribution lists, complaint and adverse event records, and Reportable Food Registry records.
FDA may not access the following records:
- Financial data;
- Pricing data;
- Personnel data;
- Research data;
- Sales data (other than shipment data regarding sales);
- Recipes;
- Records from farms;
- Records from restaurants; or
- Records relating to food under the exclusive jurisdiction of the U.S. Department of Agriculture.
The final rule is effective immediately upon publication. In fact, it makes no change, since the interim final rule has been in effect since March 1, 2012.
