US: NSAC comments on FDA’s revised draft food safety rules

The public comment period on the US Food and Drug Administration’s (FDA) supplemental proposed rules under the Food Safety Modernization Act (FSMA) closes today. The National Sustainable Agriculture Coalition (NSAC) and its member organizations led a national effort to analyze and comment on the revised proposed rules so that they: ensure local food and farms can grow and thrive; encourage farmers to use sustainable farming practices; and provide options that treat family farms fairly without unnecessary, excessive costs.

“The revised rules are a significant improvement from the original proposals,” said NSAC Policy Specialist, Sophia Kruszewski, “However, there are still a number of critical areas where further improvements are necessary to ensure that these regulations simultaneously support food safety goals and thriving sustainable food and farming systems.”

In the reproposed rules, FDA cleared up a concern that farms would be regulated as industrial-scale food facilities just by packing and holding produce from other farms. However, FDA’s definition of ‘farm’ still risks inappropriately classifying farms as facilities because it defines a farm as ‘under one ownership’ and ‘in one general location.’

“This definition presents an unrealistic and incomplete understanding of how most American farms are structured,” said Kruszewski, “and places significant burdens on some of the most innovative farms that are working together to get fresh produce into local markets. The definition of ‘farm’ that FDA ultimately codifies will be with us for a long time; to ensure an appropriate regulatory framework, it is critical that the definition provide an accurate characterization of farms and farm activities.”

Additional concerns include:

The agricultural water standard in the Produce Rule, which continues to rely inappropriately on a standard developed for hazards posed by recreational use, not irrigation, and also requires excessive, expensive water testing;
The need to provide absolute clarity that farmers can, and are encouraged to, use sustainable conservation practices and co-manage for conservation and food safety objectives under the Produce Rule;
The need to provide consistent and clear definitions and processes across all FSMA rules, in particular regarding the process for withdrawing and reinstating a qualified exemption, and how sales are calculated when determining eligibility for certain exemptions, modified requirements, and extended compliance timelines; and
The supplier verification program in the Preventive Controls Rule, which requires onsite audits in certain circumstances – despite Congress’ clear prohibition in FSMA against requiring farms or food businesses to have third parties audit or verify compliance with the rules – and which could pose significant costs on small businesses and duplicative, burdensome requirements on covered farms.

“We thank FDA for this second opportunity to comment on the proposed FSMA rules,” said Kruszewski, “and we sincerely appreciate FDA’s outreach to and engagement with the sustainable agriculture community during this comment period. We hope our comments, along with the comments submitted by farmers and concerned citizens nationwide, provide the agency with the resources and information it needs to build upon the improvements in the supplemental rules, and finalize rules that achieve their food safety goals while supporting the ability of sustainable farms and food systems to grow and thrive.”

NSAC submitted extensive comments with detailed recommendations on the supplemental proposed rules, available on our website.