New Food Safety Regulations: Food Safety Modernization Act (FSMA)

Your Comments Due Dec. 15

If you are a farmer, a food business, a farmers' market manager, a CSA coordinator, or pretty much anyone involved with food, FDA needs to hear from you!

The U.S. Food and Drug Administration is taking public comment on revised draft regulations that will affect farms and food businesses

Comments are due December 15, but we strongly recommend submitting yours before then (last fall, the federal comments website crashed on the due date).

The OSU Small Farms Program, working with others who support small-scale, organic and sustainable, local farms and food businesses, analyzed the reproposal.

Here's What We Think: Download and Read Our Comments

How Will FSMA Affect You?

The National Sustainable Agriculture Coalition has created a useful flowchart to help farms and food businesses figure out which rules apply to them and how.  

What is FSMA?

The Food Safety Modernization Act (FSMA), signed into law in 2011, is the first significant overhaul of food safety regulations since the 1930s. The intent of the law, which will be implemented by the U.S. Food and Drug Administration (FDA), is to prevent food borne illness.

FDA is currently in "rulemaking," writing the rules it will use to implement the law. During the first public comment period in 2013, tens of thousands of farmers and others expressed many concerns about two key rules: the produce rule (farms) and the preventive controls rule (facilities that manufacture, process, pack, and hold food). 

FDA agreed to revise specific parts of the rules to offer alternatives for provisions that raised the most concern. 

Revised Rules: Some Progress, Concerns Remain 

The revised rules, issued this September, show that FDA listened on many points.

“The extensive input we have received from public comments," the Agency wrote, "has led to significant changes in our current thinking on certain key provisions of these proposed rules.”

For example, the Produce Rule no longer conflicts with the National Organic Program regarding the use of composted manure as fertilizer. That's big.

But many challenges remain. For example:

  • FDA redefined “farm” and "farm activities" so that farms that pack or hold produce from other farms are no longer “facilities” subject to the Preventive Controls rule. Yet if these same activities are done by the same farmers to the same produce in an off-farm location, they are no longer "farm activities" and are subject to the PC rule. That's a problem.
  • Also, Congress explicitly said, in FSMA, that farm stands, farmers' markets, and CSAs are not covered by the Preventive Controls Rule, but FDA still hasn't included that in the Rule.  
  • The Produce Rule now says that farmers are not authorized or required by the produce rule to “take” endangered species, exclude wildlife from outdoor growing areas, or destroy wildlife habitat, BUT conservation practices like pollinator habitat are still not explicitly protected; 
  • The new agricultural water testing requirements are much more risk-based and flexible, but the sheer number of required tests is still high given that the scientific justification is still unclear;
  • The process for withdrawing or reinstating a farm’s qualified exemption has been clarified but some important details are still missing.


The National Sustainable Agriculture Coalition has published its analysis along with instructions for how to submit comments

To learn about FSMA and the draft rules, read our short guide, in the "More About the Draft Rules" box (right side of this page).

How We Commented on the Proposed Rules: Round 1

The OSU Small Farms Program submitted comments on both rules. We developed our comments in consultation with small farms and food businesses and other local food system stakeholders around Oregon. 

How Others Commented

The National Sustainable Agriculture Coalition provided important leadership to assure that the provisions in FSMA that protect sustainable and organic agriculture as well as local food systems were upheld. Read their comments here

The Oregon Department of Agriculture also commented, including several issues important to Oregon's thriving small farms and local food systems. Read their comments here

Steve Gilman, Northeast Organic Farming Association, provides valuable political background and analysis of FSMA in this May 2013 article (click on "read more").

Stay Tuned

The OSU Small Farms Program will provide information and analysis on the revised rules, so check back here and watch our Facebook page.