ARLINGTON, VIRGINIA, U.S. — In two sets of comments filed Jan. 27 with the U.S. Food and Drug Administration (FDA), the American Feed Industry Association (AFIA) said it has concerns with foreign supplier verification programs and third-party auditor/certification bodies proposed rules in the Food Safety Modernization Act.
In the first set of comments, which responded to FDA’s Foreign Supplier Verification Programs proposed rule, AFIA stressed that one regulatory solution may not be appropriate for both human food and animal feed.
“FDA has separated the human and animal food preventive controls rules. Although there will be a single Foreign Supplier Verification Program (FSVP) rule for food for humans and animals, FDA should consider different approaches for animal feed where appropriate,” AFIA said.
AFIA also pointed out FDA’s intent to align the FSVP rule with the various provisions of the animal food preventive controls rule, as required by international trade agreements. The organization intends to provide further full and in-depth feedback on certain aspects of the FSVP rule in correlation with their comments currently in development on the animal food preventive control rule. Such areas include the modified requirements for very small importers and very small foreign suppliers, and the section on hazard analysis.
AFIA did express support in their comments for Option 2 for supplier verification for hazards that are controlled or verified by the foreign supplier stating: “Of the two options provided, AFIA recommends Option 2 as it recognizes that the importer should be able to choose the appropriate verification activity based on the risk presented by the imported food.”
“In addition to the lack of consideration of risk-based controls, flexibility and real-world applicability, Option 1 could represent a significant financial burden for some importers,” said Gina Tumbarello, AFIA manager of international trade. “AFIA also suggested FDA consider alternatives to Options 1 and 2, such as requiring an on-site audit or recognized third-party certification at a maximum frequency of three years.”
The second set of comments responded to FDA’s proposed rule on the “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.”
AFIA, although supportive of the development of an accreditation system that will increase the reliability of third-party food safety audits and certifications, expressed concern that the program will not achieve the number of participants needed to make it a viable system due to the onerous notification and reporting requirements proposed by FDA.
“We are particularly concerned about the heavy requirements that would be placed on consultative audits, which are an important tool by which companies find out what they may be doing wrong and improve their food safety practices. Any requirements that discourage use of consultative audits or constrain the free exchange of information between the auditor and the audited facility would be highly counter-productive,” said AFIA.
AFIA’s comments urge FDA to give the term “a serious risk to the public health” a narrow interpretation. AFIA said the preamble of the proposed rule insinuates FDA believes the FDA notification requirements of an accredited auditor/certification body should apply to both Class I and Class II recall situations.
“AFIA believes this broad interpretation of the notification requirement is problematic…If FDA were to require notification of every condition that could result in a Class I or Class II recall, the agency would be flooded with notifications of minor conditions. Such an overbroad notification requirement would also deter many eligible entities from using accredited auditors/certification bodies,” the AFIA said.
AFIA had originally requested all three proposed rules have the same comment deadline, as consistency in the rules is essential for the betterment of the feed industry, and intends on submitting further comments on both proposed rules in their comments on the animal feed preventive control proposed rule, which are due March 31.
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