By Roland McReynolds, CFSA Executive Director

A huge portion—maybe a majority—of the businesses serving local and regional food markets will face a new, higher level of food safety bureaucracy and paperwork beginning in September 2017, thanks to the Food Safety Modernization Act (FSMA).FSMA

On September 10, 2015 the U.S. Food and Drug Administration (FDA) issued final rules establishing new ‘preventive controls’ standards for food processing facilities and animal feed manufacturers under FSMA.  Beginning September 17, the timelines for compliance with the Preventive Controls Rules (PCR) started counting down: businesses with 500 or more employees must come into compliance within one year, those with less than 500 employees but over $1 million in sales will have two years, and those with less than $1 million in sales with have three years.  Five other FSMA regulations are due for publication over the next several months.  Together, these rules create new obstacles for farmers and food businesses to sell fruits, vegetables and value-added foods in local and organic product markets.  The PCR for human food is the most complex and far-reaching of them all.

Sustainable agriculture has fought through two rounds of public input to make the rules practical and appropriate to the scale and nature of local and regional food and farming businesses, and the final rules show that those determined efforts made an impact. But substantial threats remain—most importantly, the requirement for food facilities to prove that their suppliers comply with FSMA; in direct contradiction of the FSMA statute, the PCR in effect requires farms and food makers to pay for third party audits.  This requirement—known as supply chain verification—alone may bring the expansion of local food into mainstream distribution channels to a screeching halt.


New definitions of what counts as a farm and the types of things that farms can to do to prepare their crops for market post-harvest look like improvements from previous drafts of the regulations.  With these changes, the new PCRs allow farmer cooperatives to continue to operate as extensions of farms, instead being treated the same as giant-scale food manufacturing plants.

For other forms of food hubs and value-added processing facilities, the impacts remain to be seen.  There are many gray areas and ambiguities in the rules.

Supporters of sustainable agriculture will need to continue to fight to ensure common sense application of these new rules.

CFSA is a member of the National Sustainable Agriculture Coalition (NSAC), which issued a press statement highlighting areas of the rule where improvements have been made, and where additional clarity is needed to ensure the rules do not unfairly require farms to undergo third party audits.  NSAC also urged FDA to quickly finalize a related rule clarifying how farms and food businesses serving direct-to-consumer markets will be covered under the PCRs.  You can read the press statement here.

Combined, the PCRs for human food and for animal feed total over 1,500 pages.  CFSA staff and our allies are undertaking a thorough review of the rules over the coming weeks, and will publish more analysis on specific provisions on an ongoing basis. In addition to the supply chain verification requirement and farm definition, we will be looking closely at several key issues:

  • Definitions related to farming operations and activities that may trigger the facility definition;
  • Classification of various value-added activities, and the corresponding exemption for those activities classified as low-risk;
  • Requirements for so-called ‘exempt’ facilities – including the process for withdrawing and reinstating an exemption;
  • Requirements for facilities to conduct environmental monitoring and product testing; and
  • Compliance timelines for facilities that must register with FDA and comply with the rule.

NSAC will also be updating its “Am I Affected?” flow chart to help farms and food businesses assess whether the PCRs apply to their operations.

One of several flowcharts developed by NSAC to help farmers determine if FSMA applies to them.

One of several flowcharts developed by NSAC to help farmers determine if FSMA applies to them.

You can access the pre-publication version of the final rule here (PDF), as well as via FDA’s website, which includes additional supporting materials.

The next important FSMA milestone is publication of the final Produce Rule, due by late October 2015, which will establish minimum requirements for the ‘safe’ production of fruits and vegetables on farms.  More about FSMA implementation and background information on the proposed PCRs is on our website.

In every round of the struggle over FSMA, sustainable ag has influenced the process effectively, and won concessions to common sense.  As the final rules are put into practice, we will still need to steer the implementation in favor of practical, reasonable requirements that will allow local, organic food to continue to grow and thrive.  Please stay connected with CFSA to learn more about what still can, and must, be done to protect sustainable agriculture.