Jun 5, 2018
USDA, FDA streamline produce safety requirements for growers

As part of the U.S. Department of Agriculture and the U.S. Food and Drug Administration’s ongoing effort to make the oversight of food safety stronger and more efficient, USDA and FDA today 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.”

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.

“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. Inspections are key to helping to ensure that produce safety standards are being met, but they only provide a snapshot in time. Leveraging the data and work being done by USDA will provide us with more information so that we can develop a clearer understanding of the safety and vulnerabilities on produce farms as well as concentrate our oversight and resources where they are most needed.”

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. 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. For more information visit: www.ams.usda.gov.

The announcement builds on a formal agreement signed earlier this year outlining plans to increase interagency coordination regarding produce safety, inspections of dual-jurisdiction facilities and biotechnology activities. The FDA and USDA are committed to continuing to work collaboratively to ensure that the requirements and expectations of the USDA H-GAP Audit Program remain aligned with the FDA’s Produce Safety Rule.

Farmers who are interested in learning more about this alignment and what they can do to prepare for compliance with the Produce Safety Rule can contact their regional representative of the Produce Safety Network or find more information at FDA.gov.

For more information:

United Fresh commends FDA and USDA

“United Fresh supports and appreciates today’s announcement by USDA and FDA to align the USDA Harmonized GAP audit with the Produce Safety Rule. The alignment provides growers with confidence that the market access audit is consistent with federal produce safety requirements.

“It’s important that federal regulations and private audits don’t require growers to adhere to inconsistent or conflicting requirements,” said Dr. Jennifer McEntire, United Fresh’s Vice President of Food Safety and Technology. “This alignment between FDA and USDA is also evidence of the commitment the agencies have made to work together in support of fresh produce safety.”

The technical requirements of the Harmonized Standard were developed nearly a decade ago by an industry-driven process, facilitated by United Fresh, to reduce audit fatigue. There are several licensees of the Harmonized Standard, each of which combines the freely-downloadable technical standard with their unique audit process and auditor qualifications to encourage and evaluate food safety practices in the growing and post-harvest environments. USDA has been the largest issuer of certificates, using their HGAP, and now HGAP+ audits. The HGAP+ audit adds elements required to achieve technical equivalency with the Global Food Safety Initiative (GFSI), which, if successful, would make HGAP+ the second audit based on the Harmonized Standard to achieve recognition from GFSI. Last summer, GLOBALG.A.P.’s HPSS, also based on the Harmonized Standard, was successfully benchmarked.

“As Secretariat for the Harmonized Standard, United Fresh is pleased that the updates to the technical standards that were made two years ago incorporated aspects of the new FSMA Produce Safety Rule,” said Tom Stenzel, President & CEO. “Recognizing that food safety is of utmost importance to promote consumer health and confidence in fresh fruits and vegetables, our Board of Directors has reaffirmed United Fresh’s commitment to support the Harmonized Standard, and we continue to work closely with USDA and other stakeholders to promote accessibility of the standard. FDA’s recognition of the USDA program is an important step forward,” he said.



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