FDA

Commenters Blast Proposed FDA Food Safety Rules

The comment period for two controversial proposed FDA food safety regulations, part of the Food Safety Modernization Act, closed yesterday. What did commenters have to say?

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Earlier this week Keep Food Legal, the nonprofit I lead, submitted formal comments to the FDA in opposition to two proposed food safety rules the agency is currently considering. The comment period closed yesterday.

The proposed rules, mandated thanks to passage of the Food Safety Modernization Act ("FSMA") in 2011, would increase the regulatory burden faced by fruit and vegetable farmers and other food handlers, packers, and sellers and require many to adopt procedural standards the FDA claims would prevent a small percentage of foodborne illness (between 3.7% and 5.7%, according to Keep Food Legal's research).

Keep Food Legal also joined with the Farm and Ranch Freedom Alliance and others to submit joint comments authored by FARFA pertaining to an existing amendment to the FSMA, commonly referred to as the Tester Amendment, which requires the FDA to exempt small farmers from many FSMA requirements.

As of noon yesterday, the FDA had received about 12,000 comments on the proposed produce rule and more than 5,000 on the procedural standards rule.

In our independent comments, we urged the FDA to reject the proposed rules for three reasons—1) the proposed rules would hurt small farmers, other small food entrepreneurs, and their customers; 2) the proposed rules, despite their great cost, are unlikely to make food any safer; and 3) the proposed rules violate the U.S. Constitution.

Rather than rehash Keep Food Legal's comments here, I urge you to read them at our website—and to check out my previous columns (like this one and this one) and my 2012 law journal article on the FSMA and food safety.

Instead, I'd like to highlight a few of those comments I've read that were made by others around the country.

In doing so, I won't pretend to have read (nor to have any intent to read) the thousands of comments submitted to the FDA as part of the rulemakings. But in reading several dozen comments, I've noticed some common themes coursing through the comments.

First, small farmers appear to be united in their opposition to the proposed rules.

Tellingly, I did not come across a single commenter who both identified herself or himself as a small farmer and who also supported the proposed rules.

Small farmer Kyle Young's comments typified those of small farmers opposing the proposed rules. Young referred to himself as "a small farmer utilizing farming techniques that have been safely providing food for humans for the past 10,000 years[.]"

Western Pennsylvania farmers Donald and Rebecca Kretschmann, who grow fruits and vegetables on fifteen acres and sell their produce via a burgeoning CSA program, also commented in opposition to the proposed rules.

"The FSMA has the real potential to make it impossible for small produce growers to make a living by requiring costly and we feel unnecessary alterations to the way produce is handled," wrote the Kretschmanns.

And small farmer Erica Gruebler commented that she is "deeply concerned about the impact that FDA's proposed rules under FSMA would have on my farm and business as well as my family."

Second, some groups representing farmers also appear to oppose the proposed rules.

The Rhode Island Farm Bureau, in its comments, urged the FDA not to adopt the rules, which it says will "drive a lot of farmers out of business."

The Wisconsin Farmers Union argued that the proposed "rules could potentially have devastating effects on small and medium sized produce farmers."

Third, members of the public health community should be commended for criticizing the proposed rules.

The comments of Sam Dickman, a third-year medical student at Harvard University, typified some of the public-health community's welcome opposition to the proposed rules.

"I am very concerned about the ways that the FSMA rules as currently outlined will threaten the viability of small to midsize family farms and new farmers," writes Dickman.

Dayna Green-Burgeson, a farmer and registered dietician, commented about her concerns over "the impact that FDA's proposed FSMA rules will have both on my ability to farm and on my patient's access to locally grown, healthy and tasty fruits and vegetables at a reasonable price."

Jane Pearson, a Washington State physician, noted in her comments that she's "concerned that these additional rules will make it more difficult for [local farmers] to continue supplying our community with healthy food and the support they give to creating healthier environments for us locally."

And Joseph Kohn, a doctor and farmer, commented that he's "deeply concerned about the impact that FDA's proposed rules under FSMA would have on my food business and the farms that I buy food from."

Finally, I'd be remiss if I didn't note that opposition to the proposed rules is not universal.

Some commenters view the proposed rules quite differently than I do. Take, for example, a group called the Center for Progressive Reform.

"Not only will it substantially prevent many of the wide-ranging harms associated with contaminated produce," writes the CPR, commenting in support of the proposed produce rule, "but it will do so at a reasonable cost[.]"

I suppose that's true, if by "substantially prevent[ing]" harms at a "reasonable cost" the CPR means spending hundreds millions of dollars in order to decrease foodborne illness by somewhere between zero and two percentage points.

So will the FDA adopt these costly rules and crush small farmers? Only time will tell.