Summaries of Three FSMA Final Rules - Foreign Supplier Verification Program, Third-Party Accreditation Program, and Produce Safety Standards

We have reviewed and analyzed FDA's recently-issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA), namely those related to the Foreign Supplier Verification Program (FSVP), the Third-Party Accreditation Program, and the Produce Safety Standards.  Below, we provide a brief synopsis of each final rule, as well as links to the full text of the final rules and links to Keller and Heckman's summaries of the requirements and implications of each rule:

•  Foreign Supplier Verification Program (FSVP)
  
  • The FSVP rule generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, e.g., HARPC requirements or produce safety standards.  The final rule is effective January 26, 2016, but companies generally have 18 months from the date of publication to comply, i.e., May 28, 2017. 
  • Text of the final rule:  Final Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 80 Fed. Reg. 74226 (Nov. 27, 2015), available at, http://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf.  
  • Keller and Heckman summary of the requirements and implications of the final rule: http://www.khlaw.com/Files/23697_FSVP.pdf.  
• Third-Party Accreditation Program
  
  • This rule establishes an FDA accreditation system to govern bodies that conduct food safety audits and issue certifications for facilities and food.  Once FDA implements its third-party accreditation program and entities have become accredited in accordance with program guidelines, regulated industry will be able to receive certifications from such entities.  FDA has indicated that it may use certifications:  (1) as a condition of entry for certain foods that FDA has determined may pose a safety risk; and (2) to facilitate participation in the Voluntary Qualified Importer Program (VQIP) that will give importers expedited review and entry of imported food into the U.S.  The final rule is effective January 26, 2016, although ultimate implementation depends on when FDA finalizes its model accreditation standards.
  • Text of the final rule:  Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications, 80 Fed. Reg. 74570 (Nov. 27, 2015), available at: http://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28160.pdf.  
  • Keller and Heckman summary of the requirements and implications of the final rule: http://www.khlaw.com/Files/23698_Third%20Party%20Certification.pdf.  
• Produce Safety Standards
  
  • The produce safety standards apply to farms engaged in the growing, harvesting, packing, or holding of raw agricultural commodities (e.g., fruits, vegetables) for human consumption.  The final rule sets standards related to agricultural water; biological soil amendments; sprouts; domesticated and wild animals; worker training and health and hygiene; and equipment, tools and buildings, among other things.  The final rule is effective January 26, 2016, but companies generally have 2 years from the effective date to comply, i.e., January 26, 2018.  Covered farms have an additional two years to comply with certain agricultural water requirements, and compliance dates for covered activities related to sprouts are sooner (generally, one year from the effective date, i.e., January 26, 2017).   
  • Text of the final rule:  Final Rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 80 Fed. Reg. 74354 (Nov. 27, 2015), available at: http://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf.  
  • Keller and Heckman summary of the requirements and implications of the final rule: http://www.khlaw.com/Files/23699_Produce%20Safety.pdf.  

We will continue to monitor and report on FDA's activities to implement these rules and other FSMA related activities.  Please email fooddrug@khlaw.com and let us know if you have any questions or if you would like to discuss the impact of the final rules or any other FSMA related issues in the meantime.