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

What's Happening with FSMA? 

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

In December, FDA wrapped up the second of two comment periods on draft rules it has written to implement the law. There are seven FSMA rules covering everything from human food to pet food to imports to transportation.

The OSU Small Farms Program, working with others who support small-scale, organic and sustainable, local farms and food businesses, have focused on two rules: the Produce Rule and the Preventive Controls Rule (more details below).

FDA will analyze public comments and issue final versions of those two rules this fall. 

What Are the Issues?

OSU Small Farms submitted comments on the original draft rules and the Sept. 2014 revisions. Read what we told FDA:

We relied heavily on analysis done by the Food Safety Integrity Committee of the National Sustainable Agriculture Coalition (NSAC). Read what they told FDA: 

Will FSMA Affect You?

This useful flowchart, developed by NSAC, helps farms and food businesses figure out which rules apply to them and how.  

More About the FSMA Reproposal

During the first public comment period in 2013, tens of thousands of farmers and others expressed many concerns about 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. 

The revised rules showed 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.

Stay Tuned

The OSU Small Farms Program will continue to provide information here about FSMA next steps, including the final rules, implementation information and compliance dates, training opportunities, and whatever else small farms in Oregon need to know. Check back here and watch our Facebook page.