WASHINGTON, D.C., U.S. – The National Grain and Feed Association (NGFA) said on May 31 that it has urged the U.S. Food and Drug Administration (FDA) to make several important changes to its draft guidance document that addresses the agency’s expanded powers to access facility records under the Food Safety Modernization Act (FSMA).
The 2011 food and feed safety law, which applies to grain elevators, millers, grain and oilseed processors, biofuels plans (that sell co-products as feed ingredients) exporters and many other sectors of the food industry, expanded FDA’s authority to access records to situations in which it has a “reasonable belief” that other products – not just a specific lot or product – are similarly 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.
In its statement to FDA, the NGFA specifically focused on changes it believes need to be made to the agency’s draft guidance that will be used by inspectors and the regulated industry to establish appropriate criteria and parameters to govern expanded records access.
The NGFA’s specific recommendations included the following:
- Expanded access of inspectors to facility records should be invoked only after being authorized by an FDA official with appropriate seniority and expertise. The NGFA supported FDA retaining and incorporating into its guidance document the five-step procedure it currently uses, which includes review by the agency’s 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). The NGFA also recommended that the guidance document include information on how industry members could object to an inappropriate records-access request. “FDA’s authority (to access records under FSMA) is intended for use only in situations that meet the specified statutory legal thresholds, not routine facility inspections,” the NGFA noted. “Therefore, we believe clearly defining the procedures for issuing records-access orders is needed to ensure that the use of such authority is consistent…and uniformly applied” given the more subjective “reasonable belief/reasonable probability” legal standards under FSMA.
- 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. “We believe FDA is obligated to make separate and distinct determinations before requesting to use its emergency records-access authority for foods or feed that it reasonably believes are affected similarly to the initial suspect product,” the NGFA said, noting that individual inspectors should not be able to make independent judgments as to whether the legal threshold has been met without first obtaining review and approval from FDA’s Office of Enforcement, the appropriate FDA center and the chief counsel’s office.
- 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 needs to appropriately maintain confidentiality of protected information obtained as a result of utilizing its expanded records access authority. The NGFA noted that FDA’s draft guidance references that information obtained may include a company’s nonpublic confidential commercial and trade-secret information. “We urge FDA to develop ironclad procedures and redundant safeguards to vigorously comply with all legal obligations and requirements to prevent unauthorized disclosure of a company’s proprietary and/or confidential business information,” the NGFA urged, noting that inappropriate release of such information as manufacturing processes, product formulation, customer distribution lists, complaint records and other documents could cause “irreparable damage” to a company’s business.
- FDA’s guidance document should be geared to and directed at inspectors. In addition, the NGFA strongly recommended thorough training for FDA inspectors and other staff concerning the criteria and parameters contained within the guidance document that define the scope and limits of the agency’s expanded records-access authority.
“We believe our recommendations, if incorporated into FDA’s final guidance, will enhance the understanding of both the regulated industry and inspectors concerning the appropriate application of the agency’s expanded records-access authority,” the NGFA said.