Audits or Certification

PSR.33 Is there an audit or certification process required to prove compliance under the FSMA Produce Safety Rule?

FDA is not establishing requirements in the Produce Safety Rule for audits of covered farms. It is the responsibility of the entities subject to the Produce Safety Rule to ensure that they are in compliance with all of the applicable requirements by the applicable compliance date(s).  Farms may opt to have third parties evaluate their operations, such as through a USDA GAPs audit or GFSI certification; however, we are not establishing requirements in the Produce Safety Rule for audits or certification of covered farms (See 80 FR 74353 at 74507 (Comment/Response 384)).

We do intend to pursue the goal of making third-party audits an important part of our compliance strategy by building on current private audit activity and by working with the produce industry and other government and private partners to improve the rigor and reliability of private audits. We believe that strengthening both the quality and credibility of private audits will help improve food safety, especially if conducted on the basis of the standards in this rule, but it can also be the basis for streamlining current audit practices and making them more efficient. We seek public-private collaboration to achieve this goal (see 80 FR 74353 at 74521).

One example of these efforts is the announcement made by FDA and the USDA in June of 2018 regarding the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule. While the requirements of both programs are not identical, the relevant technical components in the FDA Produce Safety Rule are covered in the USDA H-GAP Audit Program. The aligned components include areas such as biological soil amendments; sprouts; domesticated and wild animals; worker training; health and hygiene; and equipment, tools and buildings. The alignment will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. However, the USDA audits are not a substitute for FDA or state regulatory inspections.

While third party audits are not required under the Produce Safety Rule, we do note that private audits may be relevant to some aspects of compliance with the supplier verification requirements in the FSVP and preventive controls regulations, where a farm supplies produce to an importer or receiving facility that seeks to verify that the farm has adequately controlled applicable hazards (see 80 FR 74353 at 74521). Under the final Accredited Third-Party Certification Rule, FDA established a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program. See FSMA Final Rule on Accredited Third-Party Certification