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Pushback Begins Against FSMA On-the-Farm Rules

UPDATE:   The U.S. Food and Drug Administration (FDA) has extended today’s deadline for comments for both the produce rule and the preventive controls rule for one week to make up for time lost due to the website issues described below.   FDA also announced that comments for the Environmental Impact Statement on the produce rule  is extended to March 15, 2014.

More time was added to cover for another of the federal government’s malfunctioning computer systems, but today is the original deadline for commenting on the produce and preventive controls rules.

Glitches and all, the federal government’s electronic system for collecting opinions on draft regulations has received more than 11,500 comments on the produce rule and more than 5,240 on preventive controls for processing foods.

Each regulation would implement part of the historic Food Safety Modernization Act, which was signed into law on Jan. 4, 2011. The 1,600 pages of regulations mean that rural America is going to be coming under more attention than ever from the U.S. Food and Drug Administration (FDA), the federal agency charged with enforcement of the new food-safety law.

There have been complaints, some in writing, about too much down time for the comment system. Access to the Regulations.gov site has been spotty since early November. While comments go to FDA, the site for regulatory comments is actually run by the U.S. Environmental Protection Agency (EPA).

Nevertheless, once the comment period ends, pushback against this new FDA role on the farm will begin in earnest. Take dry bulb onions, for example. The worlds of dry bulb onions and E. coli have not crossed in 100 growing seasons in the area of eastern Oregon and western Idaho responsible for one-fourth of the U.S. onion production.

Yet the produce rule regulates the irrigation water used in growing any produce that may be consumed raw, including dry bulb onions. Oregon State University researchers have found no evidence of E. coli being present on onions, regardless of the source of water or whether a drip or furrow irrigation system is used.

Republican Congressman Greg Walden, who represents the onion growers in Oregon, plans to use the OSU research to “push back” against the rules. He wants language inserted into the Farm Bill that would require FDA to do more scientific review and economic analysis before the FSMA on the farm can take effect.

That is known as Section 12321 in the House version of the Farm Bill. The issue is now in the hands of a House-Senate Conference Committee, which consists of the agriculture committee leaders from each body.

A string of top House Democrats, who were among the original supporters of the FSMA, have come out against Section 12321 in a letter to the conferees. Signers included: U.S. Reps. Rosa DeLauro, CT; Henry Waxman, CA; John Dingell, MI: Frank Pallone, NJ; Diana DeGette, CO: Louise Slaughter, NY, and Nita Lowey, NY.

“This section (12321) apparently is intended to address concerns raised with regard to proposed rules to enhance produce safety,” the Democrats wrote. “However, those concerns should be addressed, and are already being addressed, through the notice and comment rulemaking process, not through legislation that holds hostage the entire Food Safety Modernization Act.”

Indeed, the Republican House language drafted last June does not appear to be a part of the real “push back” strategy that has been coming together more recently. It has taken form since late September, when the National Association of State Departments of Agriculture (NASDA) unanimously agreed Congress should give FDA more time to work the rulemaking process.

Since then, there’s been a coalescing around an approach led by the National Sustainable Agriculture Coalition (NSAC).

“The proposed rule is fundamentally flawed, and the problems are so numerous that a decent revised proposal will be a substantially new proposal,” Ferd Hoefner, the NSAC policy director, told Food Safety News. “We have great hope that FDA will be making the needed changes, but, at that point, it needs to be a new proposed rule open to a second round of public comment.”

Among the stakeholder groups that Hoefner says are “in accord on this important point” are the state agriculture directors, the United Fresh Produce Association, NSAC and others.

While it will take some time for anyone to read all the comments that were turned in, NSAC has identified problem areas that are coming in for criticism in the comments on the new rules. Among the problem areas cited are:

  • Added regulatory costs that could cut profits in half for existing farmers and prevent farm start-ups.
  • Too much power invested in FDA, including the ability to revoke state exemptions.
  • Reduced access to fresh local food with elements that would discourage actions such as a fruit grower making jam.
  • Farms will have a harder time diversifying because more revenue would bring more regulation.
  • Excessive and costly water testing, including a requirement that farmers test water from streams or lakes every seven days.
© Food Safety News
  • Simone


    • Gracie Too

      What’s the status now?

  • Scott Horsfall

    The update posted at the top of this article is incorrect – the comment period extended to March 15th is for the environmental impact report being done on the rules, not the rules themselves. However, FDA has just posted an extension to the comment period for the produce and preventive practices rules, but only until November 22nd. Clear?

  • farmber

    The (now extended) comment period has revealed major flaws in FDA’s produce and facilities rules, not the least of which are multi provisions defining farms as facilities.

    One could only hope that in receiving an earful, FDA has learned a few thing about farming — but don’t count on it. Office-dwelling FDA officials — and inspectors — are strangers in a strange land when it comes to comprehending farming operations. And Congress will have a lot to say about how their intent has been badly mis-interpreted in these first proposed rules.

    To get this right the only wise course of action at this point is for FDA to voluntarily withdraw their produce and preventative control rules and take the whole process back to the drawing board for a complete review and rewrite. After a lengthy review of the comments and time spent consulting stakeholders (and especially farming organization) FDA should then issue a brand new corrected set of proposed rules (along with a revamped Environmental Impact Statement) and again present their proposals to the public for an extended comment period.

    Pushback? More likely a major Push Forward toward sane and truly effective food safety rules that don’t kill off the very farms we need in a localized food system …