Monday, February 03, 2014 by Lee Mannering
Last week, PMA submitted comments to the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) foreign supplier verification program proposed rule, which can be accessed on our FSMA Resource Center. To help our members quickly understand the key points of our comments to FDA, we have developed a six-page executive summary. I’ve highlighted some of these below but I encourage you to read the full summary and our comments.
PMA Chief Science and Technology Officer Dr. Bob Whitaker commented that “we have great expectations that the FSVP rule, by providing a more preventive approach to import produce safety, will significantly reduce the frequency of produce testing at the border, which often causes severe and significant economic losses of perishable commodities.” He addressed these key issues, among others, in our comments:
- Importer Verification Activities of Foreign Suppliers (FDA Proposed Option 2). Here, we noted that, for the importer to perform verification audits before purchasing produce from a foreign supplier, this may greatly restrict the flexibility of marketplace purchases for these highly perishable commodities.
- FDA Proposed English-Only Requirements for FSVP Recordkeeping. Our comments here focus on the industry’s international scope. Since many languages are used to transact business and to verify implementation of produce safety preventive controls, we strongly recommended FDA allow for FSVP recordkeeping in English as well as other languages.
- Mandatory Importer Use of Certifying Bodies (i.e., Auditors) Accredited by FDA-Recognized Accreditation Bodies for FSVP Verification Activities. PMA at this time does not support the mandatory use of certification bodies that are accredited by FDA-recognized accreditation bodies. Since FDA has not established and implemented the processes and procedures necessary to recognize accreditation bodies, it is unclear if there would be sufficient certification-body audit capacity to accomplish all the audits if required.
Our comments also addressed the need for FDA to reduce redundancy of the foreign supplier verification program proposed rule with other FSMA regulations.
To learn more, visit the What’s New tab in our FSMA Resource Center to access the executive summary of our FSVP proposed rule comments, the full comments, and a brief video below from PMA’s Dr. Whitaker on this topic.
Tomorrow I’ll share highlights from our comments on the FSMA third-party accreditation proposed rule, filed last week as well.