November 29, 2021

Volume XI, Number 333

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November 29, 2021

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Understand FDA’s Authority Over Your Records: Interim Regulation & Guidance Under FSMA

The Food Safety Modernization Act (FSMA), signed into law in January 2011, expanded the Food and Drug Administration’s (FDA) authority to access and copy records under the federal Food, Drug, and Cosmetic Act (FD&C Act). Prior to FSMA, section 414(a) of the FD&C Act provided FDA the authority to access records relating to food that was reasonably believed to be adulterated and present a threat to serious adverse health consequences or death to humans or animals. FSMA has expanded FDA’s reach from records relating to the specific suspect article of food to records relating to any other article of food that the FDA reasonably believes is likely to be affected in a similar manner. FDA can also now access records if the agency believes 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. FDA’s guidance notes that whether FDA “reasonably believes” a food is affected in a similar manner will be made on a case-by-case basis because such decisions are fact-specific. However, the revised guidance documents do not address how the agency intends to implement its “case-by-case” assessment in the context of its expanded authority to request records.

FDA issued an Interim Final Rule[TS1] , effective March 1, 2012, that updated the agency’s regulations to be consistent with FSMA’s expanded authority. At the same time, FDA released new draft guidance[TS2]  for the food industry that provided answers to common questions regarding FDA’s expanded authority and updated its prior guidance [TS3] to the industry regarding establishment and maintenance of records. Given FDA’s expanded access to records, it is a good time for food manufacturers to review their recordkeeping practices.  The newly released guidance documents make clear that:

  • FDA’s records access authority applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food.
  • The agency’s records access authority applies to records relating to both human food and animal feed because the term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
  • FDA may access and copy records if:
    • FDA has a reasonable belief that the 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
    • FDA believes that there is a reasonable probability that use of or exposure to the food, and any other food that the FDA reasonably believes is likely to be affected in a similar manner will cause serious adverse health consequences or death to humans or animals.
  • FDA requests for records are most likely to occur when FDA becomes aware of:
    • Reportable food reports, as defined in the FD&C Act
    • Foodborne outbreaks
    • Epidemiological evidence which implicates food causing illness or death
    • Product recalls
    • Adverse event reports
    • Consumer complaints
    • Situations in which specific foods (or other foods that are reasonably likely to be affected in a similar manner) present a threat of serious adverse health consequences or death to humans or animals
  • FDA's authority to access records under the FD&C Act does not apply to:
    • Records from farms, meaning a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.  The term “farm” includes: 
    • Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership: and
    • Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership
    • Records from restaurants, meaning a facility that prepares and sells food directly to consumers for immediate consumption. Facilities in which food is directly provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens, are restaurants. Pet shelters, kennels, and veterinary facilities in which food is directly provided to animals are restaurants. 
    • Records relating to food that is within the exclusive jurisdiction of the USDA pursuant to the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act
    • Recipes
    • Financial data
    • Pricing data
    • Personnel data
    • Research data
    • Sales data other than shipment data regarding sales 

Requested records must be provided within “24 hours from the time of receipt of the official request, from the officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.” 

Although the interim finale rule is effective as of March 1, 2012, FDA will accept comments on the rule until May 23, 2012. FDA will issue a final rule approximately one year from the close of the comment period (May 2013).

©2021 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume II, Number 128
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About this Author

Leah Hurgten Ziemba, Michael Best Law Firm, Agribusiness and Energy Attorney
Partner, Industry Group Chair

Leah takes a big-picture approach in advising clients as they face challenges on environmental, food safety, and regulatory compliance issues. She draws on experience gained in cases involving the EPA, FDA, and other public agencies.

Leah’s success as a counselor, litigator and negotiator reflects her combination of subject matter expertise, industry knowledge, and creativity. Her work includes:

  • Investigating, assessing, and remediating vapor intrusion issues at sites with historic solvent contamination...

608-283-4420
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