FSMA: sweeping changes to our nation’s food safety system

Please submit comments to the FDA by December 15th about how the Food Safety Modernization Act (FSMA) impacts your farm or business; FSMA, passed in 2011, represents the most sweeping changes to our nation's food safety system since the 1930s. FSMA may have significant impacts on Vermont's farmers, food producers, and consumers. In response to the thousands of comments FDA received in response to its first proposed rules, the agency has now released a revised set of rules for public comment. Now is your chance to provide feedback on how these new rules will affect your business and/or your access to fresh, local food. You don't have to be a policy expert to comment! Whether you're a farmer, food producer, processor, or consumer, your comments can make a difference.
IMPORTANT: Comments must be submitted by December 15th to be considered!
Click here to learn how to submit your comments online or by mail » In an effort to help our members draft effective comments to FDA, we've put together some guidance and resources on the provisions that will have the greatest impact on NOFA-VT's farmers, processors and consumer members. The following provisions of FDA's revised Produce Safety and Preventive Controls rules have been flagged as areas of concern for organic farmers, small and mid-sized farmers, and anyone engaged in direct-to-consumer marketing. (Scroll to the bottom for a list of additional resources. For a thorough analysis of FDA's new proposed rules, visit NSAC's website.) Manure and Compost. FDA's original rules would have required a 9-month interval from the application of raw manure to harvest, and 45-day interval from the application of finished compost to harvest. These intervals would have been in direct conflict with National Organic Program (NOP) standards for compost and manure applications, and would have effectively taken some fields out of production. In response to numerous comments from the farming community, FDA has eliminated these restrictions until further research can be conducted to determine appropriate risk-based intervals for raw manure and finished compost applications. During the interim period, we recommend that FDA adopt National Organic Program (NOP) standards for manure and compost applications. NOP standards require a 120-day interval for manure that contacts the harvested crop, a 90-day manure interval for no-contact crops, and a 0-day interval for properly aged compost. Read more about proposed rules for manure and compost » Qualified Exemption. Under both the original and new proposed rules, certain farmers qualify for an exemption or modified requirements if they sell a significant portion of their produce directly to consumers. The original rules would have allowed FDA to revoke a farm's exempt/modified status without notice and without a route to regain that status. Under new proposed rules, FDA has specified actions it must take before withdrawing a farm's exemption and a process for reinstatement of the exemption after withdrawal. The new proposed rules represent a significant improvement, but it is essential that FDA hear from those affected by the qualified exemption provisions that these new rules must be maintained and further clarified in order to provide sufficient protections to farmers.  Read more about qualified exemptions and modified requirements » Water Testing. FDA's original proposed rules would have required farmers to test agricultural water every 7 days. The revised rules are an improvement, instead requiring water to be tested 20 times per year. Though they are an improvement, these new water-testing standards are still not based on a science-based risk assessment and will still impose excessively large costs on farmers. We recommend that FDA look to establishGood Agricultural Practices (GAPs) protocol of testing three times per growing season (at or around planting, during peak water use, and at or around harvest) in developing its final water testing requirements.   Read more about proposed rules for agricultural water » Supplier Verification Program. FDA's proposed supplier verification program emerged for the first time in its revised Preventive Control rules. Under the new proposed rules, certain facilities will be required to establish supplier verification programs as part of their food safety plan. Though Congress explicitly prohibited FDA from requiring third party audits as part of its Preventive Controls rules, onsite audits are included as a verification activity under new proposed rules. FDA's new requirements for supplier verification will have especially significant impacts on certain food "aggregators" such as food hubs and farm-to-school programs.  Read more about the proposed supplier verification program » Environmental Monitoring and Product Testing. Requirements for environmental monitoring and product testing also emerged for the first time in the new proposed rules. FDA's new proposed rules impose new requirements for environmental testing (primarily for Salmonella and Listeria) in certain circumstances, and product testing (i.e. of raw ingredients or finished products) in others. The costs of these new requirements are projected to be extremely high and, in combination with other costs imposed by FSMA, could put farmers out of business or impede others from going into farming. According to NSAC, for facilities with fewer than 20 employees, the testing requirement alone is expected to cost $12,276 annually. We recommend that anyone whose business could be affected by these rules comment to FDA on the cost prohibitive nature of these new testing/monitoring requirements.    Read more about proposed rules for environmental monitoring and product testing » Direct-to-Consumer Marketing. Under FDA's proposed rules, some farms selling directly to consumers through farmers markets, farm stands, and CSAs could fall under the definition of a "facility" and thus be subject to both the Preventive Controls rule and the Produce rule, despite clear language from Congress in FSMA to the contrary. FDA has acknowledged the need to clarify that such direct-to-consumer activities don't trigger a "facility" designation, and has said it will issue a separate rule to this effect, but the agency has not yet made this important clarification.  Read more about direct-to-consumer marketing » Share Your Story! Not clear on how FDA's proposed rules will affect you or your business? FDA needs to hear that too. In your comment, explain where you feel FDA needs to provide further clarification or guidance on its proposed rules. Not sure if you qualify as a farm, a facility, or both? Describing your unique operation in your comments to FDA will help the agency to gain a better understanding of the incredible diversity in food and farming business models. FDA has adopted the mantra "Educate before you regulate." We believe that education needs to go both ways! Additional Resources: If you have any questions, don't hesitate to contact me.  Please send me a copy of the comments you submit, as it is also very helpful for us to know what is important to you so we can incorporate those concerns into our comments. Sincerely, Maddie Monty, NOFA-VT Policy Advisor