FDA Issues Final Rules to Implement FSMA Produce Safety, FSVP, and Third-Party Auditor Provisions

FDA has issued its long-awaited final rules to implement the produce safety, foreign supplier verification program (FSVP), and accredited third-party certification provisions under the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on November 27, 2015.  The general compliance dates for the Produce Safety rule are in January 2017 for covered activities involving sprouts and in January 2018 for covered activities not involving sprouts.  The general compliance date for the FSVP rule is in May 2017.  FDA must publish the final Model Accreditation Standards guidance and the final user fee rule before the third-party certification program may be implemented.

Below please find links to FDA's rule overviews and the full text of the rules:

• Produce Safety
• FDA overview
• Environmental Impact Statement
• Final Rule (pre-publication)  

• Foreign Supplier Verification Program (FSVP)
• FDA overview
• Final Rule (pre-publication)

• Accredited Third-Party Certification
• FDA overview
• Final Rule (pre-publication)  

FDA also announced two upcoming webinars; a webinar devoted to significant provisions of the product safety final rule will take place on November 17, 2015, while FDA will address significant provisions of the FSVP and Third Party Auditors final rules on November 23, 2015.

Keller and Heckman LLP is reviewing the final rules and their implications for clients and interested parties, and we will provide more detailed summaries as soon as possible.