FDA Facilities Rule Contains Significant Improvements, but Concerns Remain Regarding Impacts on Farmers
Washington, DC, September 11, 2015 – On September 10, 2015, FDA released the much-anticipated final rule detailing preventive control standards for facilities producing food for human consumption. Once officially published in the Federal Register – scheduled for September 17, 2015 – the rule will go into effect in sixty days and compliance clocks will start ticking for facilities covered by this rule. The Produce Safety Rule, another key component of FDA’s new approach to food safety under the Food Safety Modernization Act (FSMA), will be finalized by late October 2015.
This final rule comes after significant public outreach and two rounds of public comment on certain key provisions.
“We commend FDA for its continued engagement with stakeholders throughout this process, and appreciate the agency’s responsiveness to our concerns” said National Sustainable Agriculture Coalition (NSAC) Policy Specialist Sophia Kruszewski. “The final rule reflects many of the issues raised by the sustainable agriculture community, and provides several important modifications to avoid ensnaring farms and local food markets in ill-fitting rules designed for large-scale industrial food facilities.”
In particular, the revised definition of what constitutes a farm – and is therefore exempt from registering with FDA and complying with the new Preventive Controls Rule – hews much more closely to the reality of what farms look like, how they operate, and how they are managed. Similarly, changes to the supporting definitions of “harvesting,” “packing,” and “holding” provide further clarity on the types of activities that farms can do without triggering the “facility” definition. These changes will go a long way toward ensuring that fewer farms are misclassified as subject to this rule, and supporting the continued growth and development of local and regional food systems.
Absent from this final rule, however, is the clarified retail food establishment exemption. In FSMA, Congress clarified that sales through direct-to-consumer sales platforms like roadside stands, farmers markets, and community-supported agriculture (CSAs) operations were included within the exemption for retail food establishments.
This clarification had two goals – the first was to reinforce that CSAs, farmers markets, roadside stands, and other direct-to-consumer operations that sell the majority of their food directly to consumers are not food facilities, do not have to register with FDA as facilities, and are not therefore subject to the Preventive Controls Rule. The second was to clarify that the location of the direct sale could not trigger the facility definition – for example, delivering a CSA box to a location where customers could pick up their boxes would not make that location a facility.
“One of the most concerning aspects of the FSMA rules for farmers has been the confusion surrounding the issue of which farms FDA will consider to be food facilities, and will therefore be subject to food facility registration requirements and the preventive controls rule,” noted Kruszewski. “Belatedly, FDA has initiated a separate rulemaking to address this issue, but failure to incorporate the clarification into the final preventive control rule released today is a missed opportunity, perpetuating the misinformation and confusion surrounding who is covered by these rules and continuing to delay the ability of local food producers to make business decisions based on their understanding of whether and how these new food safety rules apply to their operations. We urge FDA to finalize this important piece of the Preventive Controls regulatory framework without further delay.”
Another major area of concern with the final preventive control rule is expensive audit requirements. When Congress passed FSMA, it was sensitive to the fact that buyers are increasingly requiring audits of farmers and that – while an audit can provide a useful verification tool – it is only one tool to ensure that risks are being minimized across a supply chain. Congress specifically said audits could not be required as part of FDA’s new food safety framework.
“We are severely disappointed to see FDA continue to claim that the rule’s onsite audit requirement does not violate both the letter and the spirit of FSMA,” said Kruszewski. “The statutory text of FSMA could not be clearer: FDA cannot require farms or facilities to undergo, and pay for, third party audits to verify compliance with the rules. Yet, the rule continues to require just that through backdoor channels. The rule does provide various ways that the onsite audit could be avoided, but requiring them to begin with does not adhere to Congressional intent.”
An outsized reliance on third party audits will overshadow the important role of training and education as a way for farmers to demonstrate a culture of food safety and move toward FSMA compliance. NSAC will continue to urge FDA to be transparent in their intentions regarding the role and relative importance of third party audits, and to consider alternative compliance indicators – such as group certification and self-certification – particularly for the most vulnerable entities shouldering disproportionately higher costs of compliance.
The true impact on farmers and small food enterprises of this issue and many others will ultimately be determined as the rule is implemented. FDA noted in the final rule that many of the specifics surrounding how these provisions will be implemented – and enforced – will be determined through the development of guidance documents. NSAC urges FDA to provide as much additional detail to regulators and the regulated industry as possible in these documents and other interpretative materials, particularly regarding activities that may trigger the farm definition, expectations for qualified facilities, how the agency will ensure onsite audits do not become a de facto requirement for farms and food businesses, and the role not just of third party audits, but also how group certification and self-certification schemes fit within compliance activities.
NSAC looks forward to continued participation in the FSMA implementation process to ensure a regulatory framework that supports strong public health goals, while simultaneously supporting thriving family farms, sustainable agricultural operations, and local and regional food systems that increase access to fresh, healthy foods.
We will continue to analyze the rules and their potential impacts, and will continue providing information on the rules through our FSMA website, blog, and press releases on this rule and the upcoming Produce Rule.
The National Sustainable Agriculture Coalition is a grassroots alliance that advocates for federal policy reform supporting the long-term social, economic, and environmental sustainability of agriculture, natural resources, and rural communities.