IDFA submitted two sets of comments this week, asking the Food and Drug Administration to allow more flexibility in its proposed rules on third-party audits and foreign supplier verification under the Food Safety Modernization Act. The proposed rules, released last summer, are designed to ensure the safety of imported food and will work in tandem.
The proposed Foreign Supplier Verification Programs for Importers of Food for Humans and Animals would require importers to have verification programs that would identify hazards that are reasonably likely to occur with each imported food. Importers also would be responsible for providing assurances that these hazards are being adequately controlled.
In the rule, FDA proposed two options: one would require importers to conduct annual onsite audits, regardless of the level of risk involved at the facility; the other would allow the importer to choose a verification procedure, such as auditing, sampling, testing or reviewing safety records, based on the level of risk presented.
IDFA supports the second option, because it encourages importers to consider carefully the appropriate verification activities rather than simply documenting that an audit has been conducted.
“Sometimes an annual audit is not enough and the importer should conduct additional verification activities, such as testing or receiving results of testing for incoming ingredients,” IDFA said. “The opposite is also true: Option 1 could require audits in situation where they are not needed and do not represent a good use of resources.”
IDFA called for FDA to develop industry guidance that would encourage collaboration and information sharing to prevent redundant and counterproductive audits. Extending this guidance to domestic operations would be valuable, IDFA said, because the preventive controls rule under FSMA likely will include supplier verification requirements as well.
Accreditation of Third-Party Auditors
The second proposed rule, the Accreditation of Third-Party Auditors, would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-parties to audit and issue certifications for foreign food facilities and food.
In its comments, IDFA expressed concern that the proposed rule appears to go beyond the intended boundaries of FSMA and could actually impede food safety efforts. IDFA agreed that third-party certifications with extensive reporting requirements are necessary for certain regulatory audits under FSMA, but they should not apply when an FDA-accredited third-party is used by an importer on a consulting or voluntary basis. IDFA called for clarification, saying Congress intended to encourage importers to use FDA-accredited third-parties to facilitate high-quality audits, not to create special “eyes and ears” when the need doesn’t exist.
Under court order, FDA must finalize all FSMA rules by June 30, 2015. IDFA expects that these rules will not be issued until then.
Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at cdetlefsen@idfa.org.