On June 5, 2018, the U.S. Food and Drug Administration (FDA or the Agency) and the U.S. Department of Agriculture (USDA) announced the alignment of USDA’s Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the Agency’s FDA Food Safety Modernization Act (FSMA) Produce Safety Rule (Rule).

Under the aligned program, USDA Secretary Sonny Perdue observed that “[s]pecialty crop farmers who take advantage of a USDA Harmonized GAP audit now will have a much greater likelihood of passing a FSMA inspection as well.”

Despite the differences between USDA H-GAP and FDA’s Produce Safety Rule, the agencies are taking the position that the relevant technical components in FDA’s Rule are covered in USDA’s 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.

However, the agencies are reminding industry that USDA audits are not a substitute for FDA or state regulatory inspections.

Per Agency Commissioner Scott Gottlieb, M.D., FDA and USDA program alignment in this regard “will help FDA and states better prioritize… inspectional activities [and] develop a clearer understanding of the safety and vulnerabilities on produce farms.”

By way of background:

  • FDA’s Produce Safety Rule, which went into effect on January 26, 2016, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.  Large farming operations were required to comply with the Rule in January 2018.  However, the Agency announced in September 2017 that inspections to assess compliance with the Rule for produce other than sprouts would not begin until Spring 2019.  Small and very small farms have additional time to comply.
  • USDA H-GAP is an audit developed as part of the Produce GAP Harmonization Initiative, an industry-driven effort to develop food safety GAP standards and audit checklists for pre-harvest and post-harvest operations. The Initiative is a collaborative effort on the part of growers, shippers, produce buyers, audit organizations, and government agencies, including USDA.  The USDA Harmonized GAP audit, in keeping with the Initiative’s goals, is applicable to all fresh produce commodities, all sizes of on-farm operations, and all regions in the United States.

This recently-announced collaboration is an outgrowth of FDA’s and USDA’s agreement in January 2018 to bolster interagency coordination regarding produce safety, inspections of dual-jurisdiction facilities, and biotechnology activities.

If you have questions regarding an issue raised in this post or related to compliance with produce safety requirements, generally, please contact the author or the attorney at the firm with whom you are regularly in contact.