• On June 5, 2018, FDA and USDA announced a new collaborative effort to streamline produce safety requirements for farmers by aligning 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. This effort follows the signing of a formal agreement in January 2018 that outlined plans to increase interagency coordination regarding produce safety, inspections of dual jurisdiction facilities, and biotechnology activities.
  • As previously mentioned on this blog, FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. The USDA H-GAP Audit Program 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. H-GAP audits focus on best agricultural practices to verify that fruits and vegetables are produced, packed, handled, and stored in the safest manner possible to minimize risks of microbial food safety hazards.
  • While the requirements of both programs are not identical, the relevant technical components in the Produce Safety Rule are covered in the 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.
  • This coordinated effort will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. But USDA audits are not a substitute for FDA or state regulatory inspections. Both FDA and USDA are committed to working together to ensure that the requirements and expectations of the programs are aligned. This effort represents the agencies’ latest initiative to streamline regulatory responsibilities and use government resources more efficiently to protect public health.