Keller and Heckman has reviewed and analyzed FDA's recently-issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA): the
. Below, Keller and Heckman 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:
The Produce Rule applies 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).
Preventive Controls for Human Food
The final rule achieves three primary goals:
- Promulgating requirements for food facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls (HARPC);
- Modernizing and recodifying existing Current Good Manufacturing Practices (CGMPs); and
- Clarifying the definition of a "farm," which is central to the determination of whether certain entities must register as food facilities (thus generally becoming subject to the HARPC requirements).
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.
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.
These summaries are made available to PMA members by Keller and Heckman LLP. The original paths for this information is:
