The rules proposed by the U.S. Food and Drug Administration (FDA) to implement the Food Safety Modernization Act (FSMA) have caused some concern – and rightly so – among our region’s farmers.

You may recall, FDA began issuing proposed rules to implement FSMA in January 2013. After a comprehensive campaign by New England Farmers Union and its allies to improve the rules for diversified family farmers, FDA released supplemental rules in September 2014.

While those re-proposed rules seemed to align better with the needs of the region’s farmers, there is still work to do regarding proper implementation of this top-to-bottom makeover of the nation’s food safety system. We all agree food safety is crucial. But the rules need to work for the region’s small- and mid-size family farmers.

Addressing concerns about FSMA has been a priority for Farmers Union, and we’ve made significant strides in bringing our issues to FDA. We’ve met with success on several fronts:

  • Swaying FDA to agree to several extensions to the public comment period for the proposed rules. Ultimately, there were tens of thousands of public comments.
  • Leveraging our Congressional delegations to get FDA officials to visit New England to better understand the impact of the rule on our farms and local economies.
  • FDA re-proposing the Produce Safety Rule and Preventive Controls Rules for human and animal food, in addition to one of the imports rules, in response to public comment.

FDA focused on implementation

With final publication expected in August for the Preventive Controls Rules for human and animal food and October for the Produce Safety Rule, FDA is now looking toward implementation. We need to remain concerned about what that will mean for the thousands of farms FDA had earlier recognized as particularly vulnerable to the increased costs imposed by FSMA.

Here is what FDA had to say in its Preliminary Regulatory Impact Analysis: “Small entities with above average costs will be at a competitive disadvantage.” And, “Some small entities might determine that their new expected costs are likely to exceed their revenues.”

When a federal agency tells you their rule may put you out of business, you’d best pay attention. That’s what we are doing at Farmers Union.

FDA is currently seeking funding through Congress to implement FSMA. Our support of that funding is contingent upon FDA addressing the concerns of these “small entities with above average costs.”

Understanding who the players are

Who are these small entities? They are farms like many owned by our members: farms our friends and neighbors run all over New England and beyond. They are farms that sell direct to the consumer through farmers markets, CSAs, farm stands, retailers, restaurants and institutions. They are farms partnering together through co-operatives and food hubs to serve the ever-rising demand for local food.

Increasingly these farms also do value-added production to meet the demand of the market and, while some critics scoff at the “local foods movement,” it’s adding farms and farmers all over the country. It’s increasingly connecting consumers to agriculture.

By some estimates this direct-to-retail sector of agriculture is an $8 billion economic engine, driving consumers to eat more fresh fruits and vegetables, generating increased opportunities for farm-to-school sales, and expanding access to healthy foods for the socially disadvantaged.

These very same farms that provide so much benefit to our local economy are the ones most vulnerable to an improperly implemented FSMA.

Most of these farms have never had to comply with any federal or state regulation relative to the growing of produce. We need FDA to start the education and outreach now to this important sector of agriculture, not to delay the process because of lack of adequate funding nor shift the burden of that funding to other federal or state agencies that have different missions.

FDA’s strategy for putting FSMA into play

FDA has laid out an Operational Strategy for Implementing FSMA. A few key points that are particularly important for our region’s producers are:

  • Technical assistance to facilitate compliance, especially for small and mid-sized operators. This will likely be addressed through the Produce Safety Alliance and our land-grant college and university Cooperative Extension services.
  • Reliable third party audits to verify compliance. We are not sure how this will evolve but we know that Congress, in passing FSMA, has clearly stated that there can be no requirement to for a business “to hire a consultant or third party to identify, implement or certify compliance.” This is a critical issue for small farms with tight margins.

FSMA seeks to change the culture of food safety, and FDA has said it needs to change its own culture. This will require multiple partners, including the farming community, to be engaged with FDA – not only to protect the public but to protect our farms.

We all know this is coming, and engagement early and often with FDA will be critical in assuring that we don’t see a decline in our ranks.

Please take a minute and join New England Farmers Union to be a part of this important work at