RAFI-USA Statement on FSMA


Below is our statement to the FDA concerning the Food Safety Modernization Act (FSMA). All public comments must be submitted by this Friday, Nov. 15, 2013. The FDA is seeking comments from the public – that’s you!

To submit a comment and stand up for family farmers, click here.

Re: Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921

The Rural Advancement Foundation International-USA (RAFI) works to cultivate markets, policies and communities that support thriving, socially just, and environmentally sound family farms.

For the reasons detailed below, RAFI respectfully requests that FDA publish a second round of draft rules for public comment before finalizing the Produce Standards Rule and Preventive Controls Rule.

We submit this request while sharing the belief that a strong regulatory system should safeguard consumers, farmers and all who labor in agriculture. However, the proposed Preventive Controls Rule and Produce Standards Rule set forth requirements for farms and facilities that increase compliance costs while discouraging the use of sustainable practices. The result is an unbalanced set of rules that could discourage sustainable practices and growth within local food economies.

The most immediate negative impact of failing to revise these rules would be increased compliance costs. Compliance costs related to the rule are not market neutral, coming down harder on small farms and making it harder for small farms to maintain their operations or grow into mid-scale markets.

According to FDA’s own estimates, the Produce Standards Rule brings new compliance costs and a heavier compliance burden on the small farm. Based on FDA’s estimates of average gross sales for these three farm size categories, the agency estimates that compliance costs will be:

• For a very small farm, six percent of average annual gross sales;
• For a small farm, four percent of average annual gross sales; and
• For a large farm, one percent of average annual gross sales.

Like the Produce Standards Rule, facilities subject to the requirements of the Preventive Controls Rule will see new annual costs of compliance. According to FDA’s own estimates, facilities subject to the entire rule will see annual compliance costs at approximately $13,000 per facility. For qualified facilities subject to modified requirements, the costs of compliance range from $300 to $2,000. For facilities that are exempt from the Hazard Analysis and Risk-based Preventive Controls (HARPC) requirements, the average annual cost to comply is approximately $1,000. Depending on how FDA defines a “very small business,” which remains undecided, anywhere from 65 to 73 percent of compliance costs related to the rule will be borne by businesses with fewer than 20 employees. Again, these are FDA’s own estimates.

The unequal impact on small-scale farms and facilities means the market will disproportionately favor larger-scale and more concentrated food systems. This should force us to ask whether or not large-scale, concentrated food systems are safer, since safety is the goal here. RAFI finds that such systems are not safer. Large-scale, centralized systems accumulate risk, meaning that food contamination, when it happens, will happen on a larger scale. Decentralized and small-scale food systems naturally contain the outbreak of food-born illnesses. Decentralized systems should be regulated to maintain the safety of consumers and famers, but that regulatory system should encourage sustainable practices and not select for large-scale, concentrated systems.

RAFI urges FDA to make the following specific rule changes so that sustainable practices are not discouraged and small-scale farms and facilities are not unfairly treated:

• Rules should not inhibit or discourage the growth of small-scale farms and businesses, particularly diversified and innovative farms and businesses. Achieving this largely depends on two key definitions:
o As mandated by Congress, farmers markets, CSAs, roadside stands, and other direct-to-consumer vendors should be defined as a “retail food establishment,” not facilities subject to additional regulation and compliance costs.
o FDA has presented three options for defining a “very small business.” RAFI urges FDA to define a very small business as one doing less than $1,000,000 in annual sales of food, based on the value of ‘regulated product,’ not ‘all food.
• Rules should not enable FDA to revoke exemptions and modified requirements for farms and facilities that are eligible unless FDA has proof a safety problem. FDA must clearly define the “material conditions” that result in a farm or facility being subject to the full weight of the regulations, and the definition must be written in scientifically measurable terms. FDA must also create a process for the withdrawal of protected status and a process for how the farm or facility can regain that protected status.
• Rules should not inhibit or discourage the use of sustainable practices that are already regulated by the National Organic Program (NOP). Some current rules, such as the 45-day interval requirement for biological soil amendments, exceed existing requirements in NOP. FSMA Requires FDA regulations to not “conflict with or duplicate the requirements of the national organic program established under the Organic Food Production Act of 1990…” (P.L. 111-353, § 105(a)(a)(3)(E)).

Thank you for your consideration of these comments,

Scott Marlow, Executive Director
Rural Advancement Foundation International-USA
274 Pittsboro Elementary School Rd
Pittsboro, NC 27312
smarlow@rafiusa.org