As part of the U.S. Food and Drug Administration’s (FDA) and U.S. Department of Agriculture’s (USDA) ongoing efforts to make the oversight of food safety stronger, the two have announced 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.
The new step is part of an ongoing effort to streamline produce safety requirements for farmers. The joint announcement was made by Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D., during a visit by the Secretary to the FDA’s White Oak campus in Silver Spring, Md.
“Government should make things easier for our customers whenever possible and these important improvements help accomplish that goal,” said Secretary Perdue. “Specialty 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. This means one stop at USDA helps producers meet federal regulatory requirements, deliver the safest food in the world and grow the market for American-grown food. This is an important first step. We look forward to continuing to work with FDA, other government agencies and especially our state partners to ensure proper training of auditors and inspectors and to help producers understand changes in the audit.”
Although 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.
“We’re committed to working with USDA to pursue our shared goal of advancing food safety in a way that is efficient and helps farmers meet our regulatory standards. By working together, our two programs can advance these efforts more effectively,” said Commissioner Gottlieb. “Today’s announcement will help FDA and states better prioritize our inspectional activities by using USDA H-GAP audit information to prioritize inspectional resources and ultimately enhance our overall ability to protect public health…”
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The Produce Safety Rule, which went into effect on Jan. 26, 2016, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule is part of the FDA’s ongoing efforts to implement FSMA. Large farming operations were required to comply with the rule in January 2018. However, the FDA had previously announced that inspections to assess compliance with the Produce Safety Rule for produce other than sprouts would not begin until Spring 2019. Small and very small farms have additional time to comply.
The USDA Harmonized 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. The Initiative is a collaborative effort on the part of growers, shippers, produce buyers, audit organizations and government agencies, including USDA. For more information visit: https://www.ams.usda.gov.