In written comments submitted to the U.S. Food and Drug Administration (FDA) on the Food Safety Modernization Act (FSMA) proposed rules for Accreditation of Third-Party Auditors and Foreign Supplier Verification Programs (FSVP), Produce Marketing Association (PMA) calls on FDA to harmonize requirements across FSMA rules where possible. PMA also stresses the global nature of the produce supply chain which demands that safe practices be harmonized both in the U.S. and around the world.
In comments submitted by Dr. Bob Whitaker, PMA chief science and technology officer, on the Accreditation of Third-party Auditors proposal, he commends FDA for developing requirements that closely parallel internationally recognized guidance, like the International Organization for Standardization and the Global Food Safety Initiative. He also requests FDA to further explore how to balance the need for a transparent system with the need to protect proprietary business information. Whitaker also raised questions to FDA regarding its own capacity, “How will FDA effectively provide oversight of accreditation bodies and manage the deluge of information from audits to protect public health?”
In separate comments from Whitaker on the Foreign Supplier Verification Programs (FSVP) proposal, he emphasizes the need to reduce potentially costly verification redundancy—specifically between the FSVP and Preventive Controls proposed rules. He further points out throughout the proposal where reduction in overlapping audits and verification activities is critical. Whitaker notes the association does not currently support, for FSVP compliance, mandatory use of certification bodies that are accredited by FDA recognized accreditation bodies. He added, “FDA has not established necessary procedures to recognize accreditation bodies, therefore making it unclear if there’d be sufficient certification body audit capacity to accomplish all audits if required.”
The association’s comments were developed from extensive examination of FDA’s detailed proposals with support of member volunteers of PMA’s Produce Safety, Science and Technology Committee and work with allied associations. “All of PMA’s FSMA activities exemplify our strategic plan’s Issues Leadership value area—working to translate and influence issues impacting our industry,” said Whitaker. “And, our work in this area could not be done without the member volunteers of PMA’s Produce Safety, Science and Technology Committee. Thank you for your support and guidance as we continue to engage with FDA as they develop regulations under FSMA.”