The U.S. Department of Agriculture and the Food and Drug Administration say they want to make it easier for growers to comply with the Produce Safety rule.
Touted as a way to make produce safety requirements more clear and accessible to growers, the USDA and the FDA 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 Produce Safety Rule.
The joint announcement was made by Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb.
The rule went into effect in January 2016 and puts in place minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables. Large farms were required to comply with the rule in January this year, though FDA had previously announced that inspections related to the produce safety rule (other than sprouts) will not begin until spring 2019.
“The harmonized standard audit is something we started work on ten years ago, as an industry, developing it,” said Tom Stenzel, president and CEO of the United Fresh Produce Association. “The USDA has been doing audits, but you never quite knew if FDA thought they were sufficient or covered the same information (as the Produce Safety Rule) so this is really a good step forward,” Stenzel said June 5.
“For growers are that are using the harmonized audit, it is an audit they are used to and the update may give them a little bit of peace of mind that it incorporates the new rule requirements,” said Betsy Bihn, director of the Geneva, N.Y.-based Produce Safety Alliance. “It makes sense that if you are having an audit, to align it with the rule,”
Among growers, Bihn said there is still confusion about the difference between audits and inspections, and that may take time to resolve.
“I don’t think that confusion is going to go away,” she said.
In addition, growers may not understand that several groups offer harmonized audits.
Last summer, GLOBALG.A.P.’s HPSS, also based on the Harmonized Standard, was successfully benchmarked with the Global Food Safety Initiative. Even within the USDA range of audits, there are multiple versions, including Good Handling Practice/Good Agricultural Practices audit and the harmonized plus audit that is being benchmarked against the Global Food Safety Initiative.
“Where there are multiple versions of something, in the vernacular, you are going to call it a USDA audit,” she said. The USDA may need to spend more effort to explain the differences in their audits to growers, she said.
Administration officials said the harmonized USDA audit will make reap dividends for growers.
“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,” Perdue said in the release.
He said “one-stop at USDA” will help growers meet federal regulatory requirements.
“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,” Perdue said in the release.
The FDA and USDA said that while the requirements of the Produce Safety Rule and the USDA Harmonized Good Agricultural Practices Audit Program 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, according to the release, include topics such as biological soil amendments, sprouts, domesticated and wild animals, worker training, and equipment, tools and buildings.
The audit’s elements will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule.
The release said, however, that the USDA audits are not a substitute for FDA or state regulatory inspections.
The FDA’s Gottlieb said the agency and state will create priorities for inspections by using USDA H-GAP audit information, which he said will conserve resource and protect public health.
Gottlieb said 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 FDA and USDA did not say exactly what, if any, information from individual audits performed by USDA would be shared with the FDA.
Stenzel said the FDA has not said that a USDA audit would replace the need for an FDA inspection for the Produce Safety Rule.
“They did not go that far, but they said an audit should help the grower prepare and meet the needs of the produce safety rule,” he said. “I don’t think they wanted to imply that a USDA audit will get you out of an FDA inspection.”