In a public letter sent to state agricultural personnel, FDA Commissioner Scott Gottlieb, MD, provided updates on issues related to the implementation of the Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA). Among the discussion points were four rulemaking-related updates:
- The Definition of “Farm.” FDA is reconsidering the definition of a “farm” as used in the FSMA regulations in response to stakeholder concerns about whether and when packing houses, terminal markets, and other entities conducting farm-related activities are required to comply with the preventive controls or produce rules. FDA agrees that there is a need for additional clarification, and is working on proposing a draft rule, expected in the next year, that would make changes to general provisions related to the registration of food facilities rule—including edits to the farm definition. In the meantime, as announced in January, FDA intends to exercise enforcement discretion for certain facilities until it completes its rulemaking to address this issue.
- Agricultural Water. In February, FDA joined a summit hosted by the Produce Safety Alliance on the agricultural water standards. Discussion with the hundreds of participants focused on how agricultural water is an important and challenging area that should be addressed by Produce Safety Rule requirements. There were frank conversations about the challenges presented by the current requirements in the Produce Safety Rule, and alternate water testing and management strategies were discussed, the letter states. Feedback from these discussions will help inform further dialogue with stakeholders and other next steps on these important issues. FDA is currently collecting information about on-farm conditions and water systems. During this process, the agency is engaging with stakeholders through on-farm visits and other meetings to learn more about the diverse ways water is used and to ensure that the standards will be as practical and effective as possible for all farming operations.
- Biological Soil Amendments of Animal Origin (BSAAOs). Work continues toward creating a framework for evaluating the safe use of untreated BSAAOs, such as raw manure, on farms. FDA has concluded a major research initiative involving USDA’s Agricultural Research Service and several state universities to develop a multi-year, seasonal and regional dataset involving the persistence of pathogenic E. coli and Salmonella in the growing environment. This dataset will be instrumental in the development of a survival model as a major component of our risk assessment to inform future policy decisions on this issue, the letter states. FDA also is engaged in three more research projects to inform other aspects of the risk assessment activities.
- Produce Guidance. FDA continues to develop the draft guidance for the Produce Safety Rule and anticipate that it will be released for public comment in the near future. To accommodate growing practices that vary by region and commodity, a great deal of flexibility was built into the rule, and there are different approaches that farms can take to meet the requirements. In the draft guidance, FDA will explore some of these approaches by discussing and demonstrating how they might be implemented. FDA also has committed to holding four public meetings around the country, where stakeholders will have the opportunity to publicly discuss the document. Those dates will be announced in the Federal Register.