USDA and FDA align produce safety inspections to meet FSMA requirements
The U.S. Food and Drug Administration and U.S. Department of Agriculture have aligned regulatory programs involving fresh produce with the joint goal of improving produce safety.
According to updates USDA posted this week, the move will streamline requirements for the sector and make sure USDA's Harmonized Good Agricultural Practices Audit Program (H-GAP) — which is voluntary and user-fee funded — will help farmers implement minimum technical requirements under the Food Safety Modernization Act's produce safety rule. Audits applying the combined standard using a newly developed checklist began May 1.
FDA Commissioner Scott Gottlieb told Agriculture Secretary Sonny Perdue in a letter dated June 5 that the two programs aren't the same, but the H-GAP audits are another tool farmers can use to show buyers they're implementing food safety standards under the produce rule. The new policy, Gottlieb wrote, "will further help farmers by enabling them to better assess their food safety practices as they prepare to comply with the FSMA Produce Rule and by providing produce farmers with certifications that they can use to help gain market access."
This move by the two departments should give produce growers, packers and distributors a more solid framework for meeting federal safety standards and avoiding foodborne illness outbreaks. Many in the industry have been looking for regulatory guidance as tougher requirements under FSMA's produce rule are being established, so this may help reduce confusion and uncertainty about what is required.
Perdue said the changes should make things easier for farmers.
"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," he said at a Tuesday announcement event. "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."
The United Fresh Produce Association, which represents members across the produce supply chain, supported and appreciated the announcement because it gives growers confidence that USDA's market access audit is consistent with FSMA's produce safety requirements.
"It’s important that federal regulations and private audits don’t require growers to adhere to inconsistent or conflicting requirements," Jennifer McEntire, United Fresh’s vice-president of food safety and technology, said in a statement. "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."
For producers, USDA said the program alignment will help them better understand how their operations can comply with FDA regulations. However, while the H-GAP audit is meant to bring involved parties together so they know what is needed, it doesn't take the place of inspections by FDA or state inspectors. The FDA is still figuring out how it will handle regulatory investigations under the produce rule, USDA said, but a producer's H-GAP audit status may be considered in that context.
The USDA audit components now aligned with FSMA's technical components include those involving biological soil amendments, domesticated and wild animals, worker training, health and hygiene and equipment, tools and buildings. The alignment could help farmers assess their food safety practices as they get ready to comply with the produce safety rule.
While this partnership's advantages are clear to those in the industry, consumers may not easily understand. They want to know how aligning FDA and USDA produce safety programs will protect them from outbreaks such as the two recent ones linked to leafy greens. It will be up to individual producers, grower organizations and marketing groups to make sure the public is aware of why that's important. If they do that, having such a certificate in hand may help growers stand out in a crowded marketplace.
- U.S. Department of Agriculture Harmonized GAP
- U.S. Food and Drug Administration Letter from Commissioner Gottlieb to Secretary Perdue Recognizing Joint Produce Safety Achievement Under Formal Agreement