For Immediate Release

December 19, 2013

Contact: Ferd Hoefner, 202-547-5754 or fhoefner@sustainableagriculture.net

Food and Drug Administration Announces Changes To Be Made to FSMA Rules

Washington, D.C., December 19, 2013 – The Food and Drug Administration announced today that it will be making significant changes to two of its proposed rules to implement the Food Safety Modernization Act.  See the official statement from Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, here.

The National Sustainable Agriculture Coalition and its member organizations mounted a major campaign to help farmers and consumers submit public comment to FDA on its proposed Produce Rule and Preventive Controls Rule.  NSAC’s Policy Director Ferd Hoefner offers these comments on today’s announcement:

“We are encouraged that the Food and Drug Administration is starting in on a new approach.  Thousands of sustainable and organic farmers and local food system entrepreneurs responded with deep concerns to the original proposed rules FDA issued to implement the Food Safety Modernization Act (FSMA).  We commend FDA for listening carefully to those concerns and coming to the proper conclusion that significant changes are needed.  We are cautiously optimistic that the approach they announced today – major changes on targeted issues that will be open for a second round of public comment – will be adequate for the task at hand, namely to lead toward a substantially reworked, clearer, and more practical proposal.  The modernization of food safety rules is a major undertaking and it is more important to get it right than to meet any arbitrary deadlines for completion of the task.

Today’s announcement from the agency specifically flags four issues needing major reform – water quality standards and testing, standards for using raw manure and compost, provisions affecting so-called mixed-use facilities (farms that engage in value-added agriculture), and due process considerations for farms who are eligible for qualified exemptions from FSMA requirements.  We are in full agreement with FDA that these sections of the proposed rules need a new approach and major changes.

These are not, however, the only issues needing major revision.  We therefore very much appreciate that FDA says additional issues may be included in the second comment period revision process.  For example, the on-farm co-management of conservation and food safety practices, including wildlife habitat protections, is a critical issue.  So too is defining farms to include usual and customary farming activities, as well as counting only regulated food and not all farm products in determining eligibility for modified requirements.  Moreover, rules must be written and included in this second public comment period to clarify that direct marketing operations are not subject to food facility registration, a clarification Congress told FDA to make.

It is important for major rulemakings to include careful economic and environmental analysis of the likely outcomes of implementation.  The original economic cost-benefit analysis that accompanied the proposed rules was deeply flawed and needs to be redone.  Farmers need to know that food safety rules are not going to put them out of business.  FDA’s scoping notice for the Environmental Impact Statement to accompany the rule was far too narrow.  That too must be corrected before a legitimate rulemaking can take place.  Congress also directed FDA to put hard numbers on the scope of farming operations that could be considered food processing facilities under the rule, the absence of which is another shortcoming of the rulemaking process that demands further attention.

Also, for a final rule to be truly effective, more discussion is needed on the details of how the federal-state interface will work to ensure effective implementation and prevent unfunded mandates.  We urge FDA to continue its engagement with State Departments of Agriculture as it puts together the comprehensive list of provisions that need to be modified for a second round of public comment.

We look forward to working with FDA as they finish their review of the public comments and as they put together a second set of proposals on key issues for public comment.  We pledge to continue to work with FDA, other farm groups, and with concerned Senators and Representatives to ensure that FSMA implementation leads to a flexible, scale- and supply-chain appropriate framework that supports the growth and success of a more sustainable food and agriculture system.”

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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.