The Food and Drug Administration created waves in all sectors of agriculture, but especially among small-scale farmers, in January 2013 with its rules proposal for the Food Safety and Modernization Act. The agency asked for comments on the rules, which are officially known as “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.” The FDA took those comments back to the drawing board, and it has revised rules for us to look at. These rules will severely impact farmers, thereby also impacting farmers’ customers. Everyone needs to pay attention to the regulations being instituted here!

Up until this point in American food-growing history, farmers haven’t been told how to grow and handle produce, rather they’ve been trusted to employ common-sense food-safety systems in their operations. Farmers could, of course, opt for USDA Good Agricultural Practices certification (or a more stringent food-safety certification), which verifies produce is being grown and handled in a food-safe manner. GAP certification is largely practiced by those selling to wholesale accounts, rather than by small-scale farmers only doing direct marketing, like those you most often find at farmers markets and roadside stands.

The folks at USDA decided that uniform food-safety practices shouldn’t be optional; that every farmer who sells food should have to follow FDA-enforced guidelines. (Please note that these rules do not apply to people growing food only for home consumption.) From the FDA:

“Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in our approach to food safety. … The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.”

And so FSMA was born.

Round 2
Because of the outpouring of comments and suggestions from farmers and producers concerned about how the original proposed FSMA rules will affect their businesses, the FDA revised a few of the rules and are again asking for comments. Comments submitted need to focus on the rules in the four sections that have changed:

• Produce Safety
• Preventive Controls for Human Food
• Preventive Controls for Animal Food
• Foreign Supplier Verification Programs 

Comments on FSMA in general or on the rules that have not changed are not being accepted.

What’s New
While I did submit comments on the original FDA FSMA proposal a year ago, I can’t say I remember every detail of the proposal, so I’m relying on the folks who dedicate themselves to this sort of thing, namely the National Sustainable Agriculture Coalition, who I go to often for research. Of the four FSMA sections above, two directly affect the majority of small-scale, direct-marketing farmers—Produce Safety and Preventive Controls for Human Food—and there are changes in those sections that you should know about. A few notable sections that had small-scale farmers up in arms last year that have been amended include:

• testing and quality standards for water that comes in contact with produce
• manure and compost use on crop and garden land
• dealing with wild and domestic animals
• the definition of “farm” versus “packing facility”
• processed-food testing, such as farm produce canned in a commercial kitchen
• environmental monitoring for packaged foods (This rule was not introduced in the first round of FSMA regulations, so this one especially needs our comments.)
• modified requirements for farms that qualify as “very small” businesses (those having annual produce sales of$25,000 to $250,000)

Whether you are a farmer or simply a local-foods consumer, please read NSAC’s FSMA website for the big picture. Another great, concise summary of FSMA changes worth reading is by University of Vermont Extension’s Vern Grubinger. The whole, confusing FDA FSMA website can be combed through, too, if you just like this kind of stuff.

Take Your Stand
FDA estimates it will cost very small farms more than $4,000 per year to implement the FSMA changes; small farms nearly $13,000; and large farms more than $30,000. This is not chump change. If this number is a shock to your small-scale farm’s bottom line, the FDA needs to know.

The FDA took into account the comments submitted last year, so there’s hope the comments submitted this year will also have an impact. You have until Dec. 15 to help shape FSMA rules!

The smart folks at NSAC also put together some guidelines on how to clearly state your concerns or support for FSMA rules. The regulations being imparted on farmers are easy to get fired up about, but keep in mind your comments will be taken more seriously if they’re fact-based rather than emotional. You can yell, curse and cry while you’re writing your comments, but edit out those parts before you click “Submit Comment.”

Comments are available for public view, so don’t write anything you wouldn’t want your mother to read. And she should read it, because she should be commenting, too! That also means you should not share any personal information in the text of your comments.

Comment Online
Once you figure out what you want to say, submitting it is easy:

1. Go here to comment on the Produce Safety rules, and here to comment on the Preventive Controls for Human Food rules.
2. Write your comments, and attach any supporting documents.
3. Enter your name if you’d like—it’s not necessary. Additional contact information is optional, too.
4. Select the category that best describes your identity in this context. Try to not become angry like I did when you see “farmer” is not on the list.
5. Click “Continue,” and review your submission on the next page.
6. Click “Submit Comment,” and wait patiently for FDA to tell us how bad FSMA is going to be.

Comment by Mail
You can make your voice heard the old-fashioned way, if the Internet isn’t your thing. Include your comments, your name, and the docket numbers for the FSMA regulations (Produce Safety: FDA-2011-N-0921; Preventive Controls for Human Food: FDA-2011-N-0920). Mail all of this to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Help Inform the Public
Also consider volunteering with an organization that is educating farmers and consumers and working with the FDA to make FSMA as farmer-friendly as possible. These organizations include the National Sustainable Agriculture Coalition and your state agricultural groups. Heck, just tell your friends about these new regulations that are about to change the way you farm and the way they eat, and help them submit comments. These new regulations will affect everyone in the food system! (Have I said that enough times for you to believe me?)

The FDA will release the final FSMA regulations in October 2015.

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