Remember FSMA? FDA Releases Revised Food Safety Rules

By: Jen Cheek       Posted On: September 20, 2014

Last year, many of you submitted comments to the Food and Drug Administration (FDA) on the first round of proposed rules governing the Food Safety Modernization Act (FSMA). The 2013 draft of the rules came down disproportionately hard on local, independent producers who have been driving force behind the exponential growth of farmers markets across the U.S. Specifically, FMC was concerned with FSMA’s definition of farm vs. facility, the requirements surrounding exemptions for small farms, and the excessive costs of complying with the proposed rules. More on those concerns can be found on FMC’s Advocacy webpage at this link. 

The good news is that the FDA read your comments and responded to your concerns by revising the rules. Revised regulations for FSMA were relased yesterday, and the FDA is again inviting public comments. FMC will continue to collaborate with the National Sustainable Agriculture Coalition (NSAC) to analyze this round of the proposed rules, and communicate our findings back to you. Thank you for your attention and participation in the long and important process!

Here’s a press release from NSAC:

NSAC Press Release: FDA’s Revised Draft Food Safety Rules for Farms Responsive to NSAC’s Concerns

September 19, 2014, Washington, D.C. – Today, the Food and Drug Administration (FDA) issued revised proposed regulations aimed at ensuring a safe food supply under the Food Safety Modernization Act (FSMA).  FDA is inviting a new round of public comments to respond to its revised language on several key provisions with significant implications for farmers and food businesses.

“FSMA represents a major change to our farm and food system, and it is extremely important for FDA to get these regulations right,” said NSAC Policy Specialist Sophia Kruszewski.

FDA’s original proposed regulations, issued in 2013, included several highly problematic requirements that would have put many sustainable and organic farmers out of business, dampened the growth of local food systems and innovative supply chains, and undermined efforts to conserve critical natural resources.  In response, NSAC  and the sustainable agriculture community undertook an extensive public outreach and education campaign on the proposed rules, resulting in thousands of comments to FDA from concerned farmers, food entrepreneurs, and consumers.

In large part due to that comment campaign last year, FDA announced that it would reexamine several critical areas of the FSMA proposed rules that have major potential impacts for sustainable farming, which are included in the revised language released today.

“We applaud FDA for listening to our concerns regarding the original proposed rules and for recognizing that a second draft was necessary,” Kruszewski said. “These rules must not only ensure a safe food supply, but also that family farms can thrive and that consumers can access foods that are safe, healthy, and sustainably produced, including fresh food from local producers.”

When writing FSMA, Congress intended that the regulations work for small businesses and diverse sectors of American agriculture.  Congress rejected a one-size-fits-all approach, and took several steps to guarantee that the new rules do not put small and mid-sized family farms, sustainable and organic farms, and local food businesses out of business.

To that end, NSAC is reviewing the revised language focused on the following key issues:

  • Will FDA standards allow farmers to continue to use longstanding sustainable practices, like applying compost and manure to their fields for soil fertility, or will they create a preference for chemical fertilizers?
  • Will FDA establish an appropriate and flexible agricultural water standard that works for farmers of all sizes, accounts for different water systems and sources that farmers use, and will not create a preference for chemical water treatment?
  • Has FDA sufficiently clarified the definitions of ‘farm’ and ‘facility’ to ensure that they reflect the modern reality of farming?  Diversified and innovative farms – particularly those pioneering models for increasing access to healthy, local foods – need to be able to continue growing and thriving without being overregulated with rules designed for large industrial food processing facilities.
  • Does the revised process for withdrawing a qualified exemption from the rules ensure basic fairness and due process for farmers and food businesses?  The rules should not unfairly take away a farmer’s right to farm.

NSAC will undertake a thorough review of the revised language, and will provide more insight and reaction in the near future.  We are cautiously optimistic, based on summary information from the agency, that some of our concerns have been addressed.  Kruszewski offered the following initial comments, which will be expanded upon after we are able to read the full re-proposal:

“FDA’s revised definitions of ‘farm’ and activities that happen on farms should be a significant improvement from the original draft.  We commend FDA for clarifying that activities that happen on a farm – like packing and holding produce – are treated the same whether the produce was grown on that farm or a neighboring farm.

“We are pleased that FDA is proposing language to avoid negative impacts to on-farm conservation and wildlife habitat protection, which have been a major problem with previous produce safety standards.

“We are also pleased that FDA is reconsidering the interval for the use of compost, and is proposing to adopt the 0-day interval between the safe application of compost to a field and harvest, consistent with the National Organic Program standards.

“FDA’s responsiveness to our original concerns – evidenced by the decision to undertake a second set of proposals – is encouraging, and NSAC looks forward to continuing to work with FDA as the rulemaking process continues.  It is critical that the final regulations help facilitate sustainable food and agriculture systems, and we look forward to participating in the new public comment period this fall to ensure this is so.”

The new proposed rules will undoubtedly require significant public input to ensure final rules that are fully supportive of sustainable agriculture.  NSAC will continue to work not only with FDA, but also with other farm groups and with concerned Members of Congress to ensure that the final rules are finalized and implemented in a way that supports a flexible, scale- and supply-chain appropriate framework that supports the growth and success of a more sustainable food and agriculture system.

Once published in the Federal Register, farmers, organizations, and the public will have the opportunity to weigh in on the rules for 75 days.  NSAC will issue regular updates via our FSMA Action Center and email listas we analyze the rules’ impact on sustainable farm and food systems.