Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”.
The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating to any other article of food that the FDA “reasonably believes is likely to be affected in a similar manner.” Although they are already in effect, the comment period for these rules is May 23, 2012. . These rules were not subject to the normal public review procedure because the FDA found that it was contrary to the public interest to delay them as the FSMA statute called for that access from its inception. The FDA has always indicated that” reasonable belief” determinations are made on a case by case basis because such decisions are fact-specific.
The expanded rule continues to reflect the requirement that 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 only designated by the Secretary of Health and Human services who presents appropriate credentials and a written notice.”
Also issued in February was a “Draft Guidance for Industry: FDA Records Access Directly Under Sections 414 and 704 of the Federal Food, Drug & Cosmetic Ad.”
The guidance makes clear that records request may:
- Apply to either human and animal food;
- Apply to both domestic and foreign persons;
- The scope of records are those that are “needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to human or animals,” and they may access records needed to assist in determining whether there is a reasonable probably that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.
There is also a listing of what FDA believes are examples of the circumstances under which they would access documents for related food articles. They include:
- Salmonella outbreaks with multiple foods implicated;
- Multiple articles of food on an identical processing line;
- Articles of food in shared use equipment;
- Articles of food prepared, packed or held under similar conditions.
They also list examples of the type of records they could/would access:
- Manufacturing records;
- Raw materials (ingredients and packing) receipt records;
- Product distribution records;
- Product inventory records;
- Test records;
- Recall records;
- Reportable food records;
- Customer distribution lists;
- Complaint and adverse event records.
The FDA also lists the types of records the FDA cannot access:
- Records from farms;
- Records from restaurants;
- Financial data;
- Pricing data;
- Personnel data;
- Research data;
- Sales data other than shipment data researching sales.
In the document they also address actions they make take for refusal to provide records, including civil administration actions, suspension of registration, administrative detention, seizure of the food, issuance of a recall and injunction against the firm.
Finally, the FDA also issued a 52-page guidance for Industry, Edition 5, for Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Maintain, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food. This document contains numerous scenarios to provide industry with a better understanding of how the rules play out in practice.