FDA Finalizes Expanded Records Access Rule and Issues Guidance
On April 4, 2014, the Food and Drug Administration ("FDA") finalized an interim final rule and issued two guidance documents outlining how the agency will implement its expanded authority to access records under the Food Safety Modernization Act ("FSMA"). Before FSMA, FDA’s records access authority was limited to records for food articles that FDA reasonably believed to be adulterated and presented a threat of serious adverse health consequences or death to humans or animals.
Pursuant to FSMA, and the final rule, FDA may now access records for food articles that the agency believes may be affected in a similar manner to a suspect food, even if there is no evidence that the specific food article is adulterated or presents a threat. The rule finalizes without changes an interim final rule amending FDA regulations to reflect FDA’s enhanced authority to review records. It applies to domestic and foreign entities that manufacture, process, pack, transport, distribute, receive, hold, or import articles of food for humans or animals. To help industry understand and comply with the final rule, FDA also released two guidances, including a Small Entity Compliance Guide.
FDA’s expanded records access authority under FSMA is intended to improve the agency’s ability to respond to and contain safety issues in the food supply by allowing FDA to access to food records earlier than previously allowed. Instead of a "reasonable belief" that a food is adulterated or presents a threat of serious adverse health consequences, FDA now needs only a "belief" that there is a "reasonable probability" that exposure to a food will be harmful. This allows FDA to inspect records if it reasonably believes a food is likely to be affected in a similar manner as a suspect food. For example, if FDA reasonably believes that an article of food was processed under the same conditions as a food presenting a known threat, FDA can inspect records related to the production of the other food article, even though that food was not the subject of an adverse event report or recall.
In addition to finalizing the rule, FDA issued two guidance documents to help industry understand and comply with the requirements of the final rule. One of the guidances, FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug & Cosmetic Act ("General Guidance"), contains general information and revises FDA’s November 2005 guidance entitled Guidance for Industry and FDA Staff: Guidance for records access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance. FDA explains that the General Guidance does not address or replace material contained in FDA's staff manuals, the Regulatory Procedures Manual ("RPM"), or the Investigations Operations Manual ("IOM"), which focus on the operational and procedural steps for FDA staff to follow for accessing records under the Food, Drug, and Cosmetic Act ("FDCA").
The General Guidance clarifies that authority to access records does not apply to farms, restaurants, recipes, or financial, pricing, personnel, research or sales data. The authority also does not apply to records for foods within USDA’s exclusive jurisdiction, such as meat, eggs, and poultry products. Records access for commodity-specific regulations were not amended by FSMA.
FDA does not elaborate much on what constitutes a "reasonable belief" or "reasonable probability" of adverse health consequences or death in the General Guidance. Instead, the agency relies primarily on recent, highly publicized food safety hazards as examples of the kinds of events that might prompt it to request access to records. The General Guidance also reassures industry that FDA will maintain the confidentiality of the records it obtains. If a firm refuses to permit access to records, penalties could include seizure of the food, mandatory recall orders, administrative detention of the food, and suspension of facility’s registration for import, export, or introducing the food into inter- or intrastate commerce.
The other Guidance, What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide, is targeted at small firms. The Small Entity Compliance Guide offers a more streamlined format and provides additional details on who is excluded from the requirements of the rule. For example, FDA notes that several kinds of entities, such as fishing vessels not engaged in processing and non-profit food establishments, are excluded from the requirement to establish and maintain records, but they are not excluded from the requirement to provide FDA access to existing records.
Though the guidances do not offer much insight as to how, when, or why FDA will exercise its enhanced records access authority, we can expect that FDA will seek to use this authority during foodborne illness outbreaks, particularly when investigating the source of the contamination or when determining whether an entire supply chain is affected.
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Colleen M. Heisey
Emily K. Strunk
Brigid DeCoursey, an associate in the Washington Office, assisted in the preparation of this Alert.
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