The U.S. Food and Drug Administration (FDA) has been working with partners to develop and make available resources to help stakeholders better understand and meet new requirements under the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule.
The Produce Safety Rule establishes standards for the safe growing, harvesting, packing and holding of fruits and vegetables.
One resource is the Produce Safety Network (PSN). The PSN is made up of produce safety experts located throughout the country to provide stakeholders with localized regulatory and technical assistance to support compliance with the rule.
A network directory can be found on the FDA's website and stakeholders are encouraged to reach out to their local PSN.
The FDA has also been working closely with the National Association of State Departments of Agriculture (NASDA) to help prepare farmers for the new requirements. One area of collaboration has been in the development of the On-Farm Readiness Review (OFRR) program.
The OFRR program is a voluntary opportunity for farmers to get specific feedback from a team of state regulators, FDA regulators, and other educational partners on how prepared they are to meet the requirements of the Produce Safety Rule. More information about the OFRR program and how to sign up can be found on NASDA's website.
Other collaborative efforts include the FDA's work with the U.S. Department of Agriculture (USDA) to align USDA's Harmonized Good Agricultural Practices (H-GAP) audit program with the minimum requirements of the Produce Safety Rule to help farmers better assess their food safety practices. This effort was part of a formal agreement to bolster coordination between the two agencies that was announced in January 2018.
When finalized, the recently-released draft compliance and implementation guide will help stakeholders better understand the FDA's current thinking on how growers can meet the new requirements in the Produce Safety Rule. Companion overviews also highlight key points in each chapter of the draft guidance. Comments on the draft guidance can be submitted to http://regulations.gov using docket number FDA-2018-D-3631.
Stakeholders are encouraged to submit comments by April 22, 2019, to ensure their feedback is considered before work begins on the final version. The agency will also hold four public meetings to provide stakeholders with an opportunity to discuss this draft guidance.
Inspections to ensure compliance with the Produce Safety Rule are set to begin in Spring 2019, and the FDA has released a video, "Virtual Farm Inspection Tour: A General Guide to FDA Farm Inspections" that can help both state regulators and farmers better understand what can be expected during these inspections. As implementation continues for produce safety measures under FSMA, the FDA will remain committed to providing stakeholders with information and resources regarding the Produce Safety Rule.