K&H publishes summaries of FSMA final rules related to produce safety standards, foreign supplier verification program, and third-party certification program.

As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the produce safety standards, the foreign supplier verification program (FSVP), and the third-party certification program under the FDA Food Safety Modernization Act (FSMA).  A brief synopsis and a link to the summary of each rule appears below:

  • Produce Safety:  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).  Click here for our summary of the final produce safety rule.
  • 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, including, but not limited to, 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.  Click here for our summary of the final FSVP rule.
  • Third-Party Certification:  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.  Click here for our summary of the final third-party certification rule.

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.