As part of the U.S. Food and Drug Administration’s (FDA) continued roll-out under the Food Safety Modernization Act (FSMA), the FDA released the text of three new rules:
- Foreign Supplier Verification Programs (FSVP): All U.S. importers of human and animal food must verify that their foreign suppliers are implementing proper safety measures to prevent foodborne illness and contamination. Importers will need to establish and follow new written foreign supplier verification procedures including conducting on-site supplier audits, food testing and review of supplier records. (Advance text of rule)
- Accredited Third-Party Certification: Third-party auditors may be utilized to conduct safety audits and issue certifications for foreign suppliers and their facilities. This rule establishes a voluntary program setting forth the requirements for third-party certification bodies. (Advance text of rule)
- Produce Safety: Farmers (including associated packers and holders) of produce will need to comply with extensive science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The new rules cover agricultural water quality and testing, soil amendments, specific requirements for harvesting sprouts, grazing animals, worker training and hygiene and standards for equipment, tools and buildings. (Advance text of rule)
Official versions of the rules are expected to be published in the November 27, 2015, Federal Register. The compliance deadlines for each rule will be tied to the final rule publication dates:
- Foreign Supplier Verification Programs (FSVP): 18 months after publication of the rule (May 2017)
- Accredited Third-party Certification: TBD
- Produce Safety: Deadlines are determined by business size and type. Larger businesses must comply no later than 26 months after publication of the final rule (January 2018), but compliance with the new sprout requirements must occur within 14 months. Smaller businesses will receive extensions up to two years.
These three new rules round out the first five FSMA regulations. (See our previous alert on the first two rules.) The final two FSMA rules, covering Sanitary Transportation and Intentional Contamination, are expected mid-2016.
We are advising clients on all of the new FSMA requirements and scheduling private educational seminars and Q&A sessions. If you have questions about the new FSMA regulations or other food regulatory questions, please contact Chris Predko (616.752.2190 or cpredko@wnj.com).
