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NGFA urges FDA to change access to facility records

The National Grain and Feed Association has urged the Food and Drug Administration to make several important changes to its draft guidance document that addresses the agency’s expanded powers to access facility records under the Food Safety Modernization Act, the group said today.

The law was passed in 2011 and is in the process of being implemented.

NFGA, which represents grain, feed, processing and grain-related companies, noted that the law expands USDA authority to access records from grain elevators, millers, grain and oilseed processors, and biofuel plants that sell coproducts as feed ingredients, if the agency has a “reasonable belief” that other products — not just a specific lot or product — are adulterated to the extent that they pose a threat of causing serious adverse health consequences or death to humans or animals.

The agency now also may access such records if it believes there is a “reasonable probability” that use or exposure to the product, as well as any other product that it reasonably believes is likely to be affected similarly, will cause serious adverse health consequences or death to humans or animals, NFGA noted.

“FSMA clearly does not provide FDA with unlimited records-access authority,” the NGFA emphasized.

“For example, while access to specific consumer complaints pertaining to the suspect (product) may be appropriate within a certain situation, FDA’s authority clearly is limited to accessing only those consumer complaints ‘needed to assist’ the agency in making a determination” (about a given product or similarly affected products) that are under investigation, and not to other consumer complaints that are unrelated or do not pertain to those specific products for which expanded records access is sought.”

NFGA recommends that:
  • Inspectors should have expanded access to facility records only after being authorized by an FDA official with appropriate seniority and expertise such as the FDA Office of Enforcement and the appropriate FDA Center (e.g., the Center for Food Safety and Applied Nutrition for human food, and the Center for Veterinary Medicine for animal feed and pet food).
  • FDA should have “valid evidence” a product is adulterated and poses a risk of causing serious adverse health consequences or death before expanded records access is authorized for “similarly affected” products.
  • FDA should amend its guidance document to clarify that its expanded records-access authority is limited only to those records needed to “assist” the agency in determining whether a product or similarly affected product is adulterated and poses a risk of serious adverse health consequences or death to humans or animals, or there is a “reasonable probability” that exposure to such products will cause serious adverse health consequences or death to humans or animals.
  • FDA should maintain confidentiality of protected commercial and trade-secret information obtained as a result of its expanded records access authority, and should develop “ironclad” procedures and redundant safeguards to comply with all legal obligations to prevent unauthorized disclosure of a company’s proprietary business information.
  • FDA’s guidance document should be geared to and directed at inspectors.