The United States Food and Drug Administration (FDA) released three final rules to implement the Food Safety Modernization Act (FSMA): the Produce Safety Rule, Foreign Supplier Verification Program (FSVP) Rule and Accreditation of Third-Party Auditors Rule.
The publication of these final rules by FDA is a major FSMA implementation milestone for this landmark legislation. These final rules will have a significant impact on produce businesses in that they will affect how businesses operate on a daily basis and set definitive regulatory compliance expectations for FDA regulated businesses.
“These final rules published today reflect many, but not all, of the amendments PMA and other leading food trade organizations have recommended in their comments to FDA in the last few years,” said Jim Gorny, PMA vice president of food safety and technology. “We’re pleased that FDA considered the practical needs of the produce industry; however, we still have concerns and questions about some of the specific implementation details regarding these rules.”
“The publication of these FSMA rules is not an endpoint but rather a beginning, which now requires understanding, planning, implementation and verification by businesses,” said Gorny. “To that end, we’re pleased to learn FDA will also soon be issuing important companion guidance documents for these final rules that will provide more detailed information about coverage and compliance requirements.”
Gorny added there will be an opportunity to provide comments on these upcoming draft guidance documents, and PMA will continue to work closely with allied organizations and Congress to assure that FDA FSMA implementation is realistic and well-supported.
PMA staff is in the process of assessing these newly released final rules in detail and will be in dialog with industry members to fully understand the implications of these rules on produce businesses.
Industry members will have an opportunity to interact with FDA and ask questions about the rules and their implementation requirements via two free webinars. Each of the 90-minute webinars are hosted by PMA and United Fresh Produce Association, in partnership with regional produce associations. Registration is now available online.
Produce Rule: Friday, Dec. 11 at 1:30 p.m. EST/ 10:30 a.m. PST
FVSP and Third-Party Accreditation Rules: Monday, Dec. 14 at 12 p.m. EST / 9 a.m. PST