Food Safety Modernization Act (FSMA) and FDA Regulations

After FSMA Cartoon

The Food and Drug Administration (FDA) is implementing the Food Safety Modernization Act (FSMA) which was passed by Congress in 2010. They are issuing six rules, two of which are of great concern to U.S. farmers: the Produce Rule and the Preventive Controls Rule. Comments on these two rules are due by November 15.

FDA Materials

To read just the Produce Rule itself (17 pages): download the PDF
To read the entire preamble and the Produce Rule (144 pages): download the PDF
To read just the Preventive Controls Rule itself (29 pages): download the PDF
To read the entire preamble and the Preventive controls Rule (179 pages): download the PDF

Information on all of the FSMA rules can be found on the FDA website.

You can learn about some of the issues farmers are concerned about with the rules by reading the discussions of problematic proposals on the National Sustainable Agriculture Coalition’s website.

Produce Safety Alliance-FDA Question and Answer recordings on FSMA

How to Comment: Download the Instructions

Comment on the Produce Rule
Comment on the Preventive Controls Rule

CAFF Commentary on Key Issues

Direct Marketing in the Preventive Controls Rule
Food Safety Advantages of Short Supply Chains (Direct Marketing)
Discussion of FDA Produce Rule – Water
Discussion of FDA Produce Rule – Exemptions (Tester-Hagan)
How to deal with an FDA visit
Domesticated and Wild Animals in the Produce Rule (Wild Farm Alliance)
Biological Soil Amendments in the Produce Rule (Wild Farm Alliance)

Daniel Cohen’s Analysis

FDA’s Proposed Produce Rule is ‘Food Safety Theater’, Daniel Cohen, September 10, 2013
FDA Barely Considers Biological, Chemical and Radiological in Proposed Produce Rule, Daniel Cohen, September 26, 2013
FDA’s Proposed Produce Rules Consistently Ignore Microbial Ecology, Daniel Cohen, October 23, 2013
FDA Comment, Daniel Cohen


CAFF will be holding informational workshops for farmers, to discuss how to comment to the FDA and answer questions.

- November 4 at 1 PM at the Glenn County Farm Bureau Office, 831 5th Street, Orland, CA 95963 (RSVP to or (530) 894-7738)

- November 8 at 6:30 PM at the San Luis Obispo Grange, 2880 Broad St., San Luis Obispo (RSVP to or by calling (805) 438-4609)

- November 11 at 5:00 PM at the Watershed Resource Center at Hendry’s Beach in Santa Barbara (RSVP to or by calling (805) 816-8188)

National Sustainable Agriculture Coalition Commentary on Key Issues

You can learn about some of the issues farmers are concerned with concerning the rules by reading the discussions of problematic proposals on NSAC’s website.

Top ten problems with the FDA’s proposed food safety regulations for farmers and local food businesses

Food Safety Modernization Act: Sample farmer commenting template

Produce Rule issues include:


Preventive Controls Rule issues include:


Other organizations with information about FSMA:

Organic Trade Association:
Farm and Ranch Freedom Alliance:
United Fresh:
Cornucopia: Cornucopia white paper on FSMA
Food safety regulations threaten local and regional food systems, and why dirt on your vegetables is one way to prevent that threat from materializing, Steve Warshawer, New Mexico farmer
North Carolina Comments on “Farm” vs. “Facility”
NASDA talking points on FDA rules


Farmers ask FDA about aspects of food-safety rules, Christine Souza, April 17, 2013
Will the FDA’s new food safety rules hurt small farmers?,  Twilight Greenaway, October 1, 2013
Don’t let the FSMA burden family farmers, Dave Runsten and Brian Snyder, October 3, 2013
NSAC’s press release about FSMA, Ariane Lotti, October 3, 2013
FDA’s Culture of Fear Threatens Food Safety, Brian Snyder, October 14, 2013

Other Resources

Domestic Facility Risk Categorization (FY 2012):  This website defines what a facility is for FDA regulatory purposes.  Facilities are subject to a different set of rules than non-facilities. Farms themselves are not facilities, but a farm could contain a facility.

Sprouts Safety Alliance (FDA): This website describes the FDA collaboration for food safety in sprouts.


Updated 10-24-13