Time to Speak Up about Food Safety Rules

It is time for all producers of food to put the Food Safety Modernization Act front and center. 

You have until November 15 to tell the U.S. Food and Drug Administration what you think about how they have proposed to implement the most significant overhaul of food safety legislation since the 1930s.

Two rules need your attention: the produce rule and the preventive controls rule.

Who should comment?

All of us! Not just the farmers and food processors directly affected by the rule but restaurants, retailers, food service buyers, distributors, and eaters – pretty much anyone who wants to keep fresh, local food available in our communities.

What’s FSMA again?

The Food Safety Modernization Act, passed by Congress in 2011, gives the FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. FSMA authorizes FDA to write, implement, and enforce new regulations for farmers who grow fresh produce and for certain facilities that process fresh produce for people to eat.

Food safety is everyone’s responsibility and must be assured by all farms and food businesses, regardless of size. “Small” doesn't automatically mean “safe.” Yet food safety practices can and should be risk appropriate and recognize that food safety can be adequately assured in short, local and regional supply chains through clear trace ability from farm to fork. Food safety practices should co-exist – not conflict – with sustainable and organic farming practices and on-farm conservation. The Food Safety Modernization Act recognized all of this, to some degree, through the Tester Amendment.

However, the rules that FDA has proposed for farms and facilities neglect these important   principles. As written, the rules will create unnecessary economic hardship and unfairly burden the farms and small processors that are the heart of our vibrant local and regional food systems.

“I’ll be exempt. Why should I comment?”

Short answer: The rules will affect you, too, directly or indirectly.

Longer answer: In theory, many small farms that sell mostly into local marketing channels should qualify for an exemption (and the very smallest farms aren't covered by FSMA at all). That’s because, as noted earlier, the Act required the rules to be risk-appropriate.

Exempt farms aren't entirely off the hook: they still have to comply with FSMA trace ability requirements. Exempt food facilities still have to prove they comply with state or local requirements – as noted above, we are concerned about the effect of this requirement on farms processing and selling food under Farm Direct.  But even farms that think they qualify for an exemption should weigh in on the draft rules. Why? Two reasons.

First, the way the rules are written makes it unclear whether FDA will actually honor the exemptions. The income thresholds and the process by which farms can lose exemptions are two key pieces of the proposed rules that FDA must fix and clarify.

Second, depending on your target markets, some wholesale buyers may decide they want a level playing field for all their suppliers and will require exempt farms to comply with the FSMA rules and standards anyway. Exempt farms should therefore care about what the final FSMA rules look like.

What now?

Step 1: Educate yourself on the issues. Some good places to start:

• FDA FSMA fact sheets (scroll down to “About Proposed Rules”)

• National Sustainable Agriculture Coalition FSMA issue briefs

On the Small Farm Program FSMA webpage, you can download and read:

• Small Farm Program Comments on the Produce Rule

• Small Farm Program Draft Comments on the Preventive Controls Rule

• Past OSFN articles about FSMA

• Oregon Department of Agriculture Draft Comments on the Produce Rule

Visit the Oregon Small Farm Program Facebook page to read commentaries we've posted about the draft rules.

Step 2: Think about how you will be affected by the proposed rules. How will they change how you farm, process, sell, buy, and eat fresh produce? Are you concerned about those changes? Why? And – this is important – how should FDA rewrite its rules to address your concerns? FDA needs us to propose alternatives.

Step 3: Write it down in a letter to FDA, and submit it online, at regulations.gov. If you comment on both rules – the produce rule and the preventive controls rule – write two separate letters, as you must submit comments on them separately.  Make sure your letter includes the correct docket numbers:

• Produce rule: FDA-2011-N-0921

• Preventive Controls Rule: FDA-2011-N-0920 Step by step instructions for submitting comments through regulations.gov are posted here: http://sustainableagriculture.net/fsma/speak-out-today/.

(by Lauren Gwin, Small Farms Program, Oregon State University)