FDA's Proposed Food Safety Rules: Take Action Today!

      Posted On: November 7, 2013

fixFSMAby Jen O’Brien

** Update: The FDA extended the comment deadline to Friday, November 22nd!

The local food movement has gained considerable momentum in the past couple of years, and misguided food safety rules could reverse all of that hard work. Stand up for the farms in your community, by telling the FDA to rewrite their proposed rules.

Signed into law on January 4th, 2011, the Food Safety Modernization Act (FSMA) was the first major food safety reform to take place since 1938. The goal of FSMA was to focus food safety measures on prevention, rather than emergency response, and it did so by giving the Food and Drug Administration (FDA) the power to create new rules governing the production, handling, and import of the US food supply. In addition to focusing on food safety risks from microbial pathogen contamination (such as Salmonella and E. coli), Congress directed that the new food safety regulations be scale-appropriate, conservation-friendly, and accessible to certified organic and value-added producers. While the intentions of FSMA were clear and admirable, the regulations drafted to apply the law have not followed suit.

As a first step in implementing FSMA, the FDA released a draft set of proposed food safety rules on which it is currently seeking comment. In partnership with the National Sustainable Agriculture Coalition (NSAC) and its legal counsel, FMC has reviewed and analyzed the new regulations, and found that they would unfairly burden and discourage diversified, direct-marketing farmers and markets. As they stand now, the rules come down disproportionately hard on local, independent producers who have been the driving force behind the exponential growth of farmers markets across the U.S.

The good news is that the FDA’s rules are still in draft form, and can be shaped by your input. As part of the FSMA implementation process, FDA must consider public comments before finalizing the rules. Supporters of farmers markets and independent farms need to take advantage of this opportunity to tell FDA to make extensive revisions to the proposed FSMA rules. Click here for step-by-step instructions on how to comment. And hurry! Comments are due by November 15, 2013.

So what’s the problem with the rules as they’re currently written? FMC has three major concerns: the FDA’s unclear definition of farms and facilities; the unclear and subjective nature of exemptions for small farms; and the excessive costs that local farmers will incur in order to adhere to new regulations.


Defining Farm vs. Facility

Under the proposed FSMA regulations, all farms are subject to either the Produce Rule, or the Preventive Controls Rule, depending on what type of activities are taking place onsite. A farm that alters product in any way—whether by drying herbs, slicing fruit, shelling fava beans, or including product from a neighbor in your CSA box—may be considered a ‘facility’ and fall under the Preventive Controls Rule. As such, these farms will be subject to many of the same regulations intended for large-scale industrial facilities. Additionally, processing activities considered to be low-risk by many states (pickling, fermenting, acidifying, and baking) are not considered low-risk in FSMA. The additional regulations placed on farmers creating value-added products may be too burdensome, cutting off an important revenue stream that has become integral to the livelihood of many of America’s farmers. Value-added products are big-sellers at farmers markets—we’d hate to see fresh, local salsas and pickles disappear from our favorite markets.

Farmers markets will be directly affected by the new FSMA rules as well. When Congress wrote the FSMA law, it specified that farmers markets, CSAs, and other direct-to-consumer sales platforms were defined as ‘retail food establishments’ and, therefore, were not facilities and did not have to register with FDA. However, in writing the FSMA rules, the FDA has ignored this provision. Under the new rules, all local food initiatives that ‘process, pack, or hold food for consumption in the U.S.’ are considered facilities, and may be subject to the Preventive Control Rules. Imposing further regulations on farmers markets and other low-risk, grassroots food initiatives will limit their ability to serve consumers, with no significant increase in food safety.


Exemptions for Farms Selling Directly to Consumers

While no one is exempt from appropriate food safety efforts, direct farmer-to-consumer supply chains pose lower and different risks to the food supply. Congress recognized this fact when writing FSMA. Through the Tester-Hagan amendment, Congress required that FDA include modified requirements for direct-marketing farmers within FSMA. Unfortunately, the FDA’s attempt to write the rules regulating the modified requirements has failed to protect small farms in a significant way.

Who qualifies for exemptions and modified requirements? Farms that sell less than $25,000 in gross annual sales over the past three years may qualify to be completely exempt from the Produce Rule. Direct-marketing farms are eligible for modified regulations under the Produce Rule if they have less than $500,000 in gross annual sales over the previous three years, and sell their food directly to consumers, restaurants or grocery stores within 275 miles from their farm. If the farm is considered a facility, and must operate under the Preventive Controls Rule, it may also be eligible for the modified requirements if it can be considered a ‘very small business.’ FDA has not decided on a definition of ‘very small business,’ and is proposing that the term refer to facilities with either less than $250,000, less than $500,000, or less than $1 million in total annual sales of food.

While the exemptions sound reasonable on the surface, qualifying for and retaining an exemption is more complicated than it seems. When calculating gross annual sales for the farm, one must include ALL food produced—even meat and dairy not covered by the Produce Rule. If a dairy farmer is selling $10,000 worth of produce a year at a local farmers market, the revenue from dairy sales must be included when reporting gross annual sales to FDA. If those dairy sales place the farm above the $500,000 exemption cut-off, that farmer’s $10,000 worth of local produce will be subject to the same regulations as a large-scale produce operation. This ‘all food’ distinction will discourage dairy, meat, and commodity crop farmers from diversifying their farms, and offering their communities increased access to fruits and vegetables.

There’s another major problem with the exemptions and modified regulations: the proposed rules give FDA unlimited ability to take away exemptions for farmers and facilities and subject them to the full weight of the regulations if they suspect there is a food safety problem on the farm. FDA is not required to have proof of a problem, and there is no way to get exempt status back once FDA revokes it. In order for the exemption to be a feasible plan for protecting independent farms from overwhelming regulations, the FDA must define the material conditions that lead to a withdrawal of a farmer’s protected status in measurable terms. There must also be a clear process for implementing the withdrawal of a farmer’s protected status, and for regaining that status after it’s been lost.


Excessive Compliance costs

The FDA’s own analysis of the cost of implementing the new rules found that very small farms will spend six percent of their annual gross sales on testing, equipment and other compliance measures. The USDA estimates that the average net farm income nationally is 10 percent of total sales. This data indicates that farms with less than $250,000 in annual sales will be spending 60% of their profits complying with the new rules. As a result of these costs, FDA anticipates that some farmers will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs—all of which will contribute to a stagnation in the growth of sustainable farming and local food initiatives.

Specifically, regulations surrounding agricultural water and the use of manure and compost will prove to be very expensive for those attempting to engage in sustainable farm practices. Despite Congress’s provision that the FSMA rules not conflict with or duplicate the requirements for certified organic production, many of the water and manure rules do just that. More information on those rules is available here, on NSAC’s website.


Take Action Today!

Take action today to prevent these new rules from negatively impacting the amazing work of our country’s local, sustainable farmers and markets! The National Sustainable Agriculture Coalition has created comment templates to help you share your concerns with the FDA. It’s important that FDA knows how your farm or market works, so that they can rewrite the rules more effectively. It’s also important to let the FDA know if you’re not sure how your farm or market will be affected—it is their job to ensure that the rules are clearly defined so that they can be effectively implemented.

Visit sustainableagriculture.net/FSMA for more information on the rules, and click here to view FMC’s recent FSMA webinarClick here for detailed instructions on how to submit a comment to FDA. The deadline to comment is November 15th!

Download NSAC’s comment templates here:

And click here to sign a consumer petition!

Additionally, the Michael Fields Agricultural Institute created two short videos explaining how FSMA will impact farmers and consumers. Feel free to share these videos widely!

Thank you for standing up for your community’s farms and food!