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  1. Food Safety Modernization Act (FSMA)

Letter from Commissioner Gottlieb to Secretary Perdue Recognizing Joint Produce Safety Achievement Under Formal Agreement

Back to FSMA Final Rule on Produce Safety

June 5, 2018

Sonny Perdue
U.S. Department of Agriculture
1400 Independence Avenue, SW
Washington, DC 20250 

Dear Secretary Perdue:

On January 30, 2018, we jointly announced a formal agreement between the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) aimed at bolstering coordination and collaboration between our shared goals in the areas of produce safety, dual jurisdiction, and biotechnology. 

Today, I am delighted to formally announce the first achievement under the produce safety efforts of this joint arrangement. Over the past months, USDA’s Specialty Crops Program in the Agricultural Marketing Service (AMS) successfully collaborated with FDA’s Center for Food Safety and Applied Nutrition to align the USDA Harmonized Good Agricultural Practices (H-GAPs) Audit Program with the minimum requirements of the Food Safety Modernization Act Produce Safety Rule (FSMA Produce Rule). For the purposes of this activity, “alignment” means that—while the two programs are not identical—the relevant technical components in the FSMA Produce Rule are (1) covered in the USDA AMS H-GAPs Program; and (2) the market access audit requirements utilized in the USDA AMS H-GAPs Program are aligned with the food safety goals of the FSMA Produce Rule.

I wanted to take this opportunity to acknowledge the efforts of both of our staffs in completing the complex and rigorous process to align the H-GAPs Program with the FSMA Produce Rule’s regulatory requirements. This joint effort will create additional efficiency for produce farmers while promoting the consumer protection goals of the Food Safety Modernization Act.

H-GAPs Program audits are an additional tool that farms can use as a means to demonstrate to buyers that they are implementing effective food safety standards that are aligned with the FSMA Produce Rule. While the USDA H-GAPs audits are not a substitute for FDA or state regulatory inspections, this alignment 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.

While a lot of work has gone into the alignment project, the work does not end today. FDA staff continues to collaborate with USDA as they develop auditor and user manuals for the aligned H-GAPs Program audits. In addition, as science evolves and as we learn more about what is needed to keep produce safe, FDA will continue to work with USDA to ensure that the requirements and expectations of the H-GAPs Program remain aligned with FDA’s FSMA Produce Rule. 

FDA is grateful for our collaboration with USDA, and we are encouraged by the success of our shared efforts to date. In particular, I appreciate your personal commitment and effort to promote food safety throughout the fresh produce industry.


Scott Gottlieb, M.D.
Commissioner of Food and Drugs


Bruce Summers
Agricultural Marketing Service
U.S. Department of Agriculture

Sonia N. Jimenez
Deputy Administrator
Specialty Crops Program
Agricultural Marketing Service
U.S. Department of Agriculture

Greg Ibach
Under Secretary for Marketing and Regulatory Programs
U.S. Department of Agriculture



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