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Many in Congress Want to Give FDA a ‘Do-Over’ on Draft Rules

Among nearly 20,000 written comments to the U.S. Food and Drug Administration (FDA) on draft rules regarding produce and preventive controls are letters from lawmakers on Capitol Hill. The National Sustainable Agriculture Coalition (NSAC), which is trying to nudge FDA into doing a second draft of the rules, made sure the media would notice several of the recently filed letters with return postmarks from the Hill.

A House-Senate bipartisan letter signed by U.S. Sens. Jeanne Shaheen, D-NH, and Roy Blunt, R-MO, and U.S. Reps. Joe Courtney, D-CT, and Chris Gibson, R-NY, calls on FDA to draft and release a second set of rules for another round of public comments before any regulations become final.

The produce and preventive controls rules were written to help FDA implement the landmark Food Safety Modernization Act (FSMA) of 2010.

About 75 lawmakers from both parties and both chambers signed the Nov. 22 letter calling for a “do-over” by FDA. They say to do otherwise would lead to “unintended consequences” that would be “severely detrimental” to American agriculture at the national, regional and local levels.

Also making a bipartisan pitch to FDA is a Nov. 22 letter from the House Organic Caucus, signed by U.S. Reps. Peter DeFazio, D-OR, Sam Farr, D-CA, Richard Hanna, R-NY, Ron Kind, D-WI, and 19 of their colleagues. Their letter addresses concerns that organic produce growers have about conflicts between their long-standing practices and regulations drafted for manure and compost. The lawmakers want the regulations brought into line with those of the National Organic Program.

Also getting some notice is a Nov. 13 letter from U.S. Sens. Jon Tester, D-MT, and Kay Hagan, D-NC, which raises similar concerns from the perspective of those operating small farms and facilities “with short supply chains.”

The campaign to persuade FDA into doing a second draft of the rules was launched in September by the influential National Association of State Departments of Agriculture and quickly embraced by the well-funded United Fresh Produce Association, along with small and organic producers like those represented by NSAC.

State agriculture directors are also weighing in with their concerns. For example, Pennsylvania’s Secretary of Agriculture, George Greig, said the FDA regulations as currently drafted will have a negative impact on his state’s produce and food processing industries.

“The Food Safety Modernization Act is the most sweeping food policy reform in 70 years, and we need to get it right,” Greig said. “While we need reforms to keep consumers safe, parts of these proposed rules don’t make sense for agriculture. They don’t reflect the realities of food production and could force small growers out of business.”

Greig submitted comments, developed with the state’s agriculture industry, to FDA in two documents covering the act’s proposed produce and preventative control rules and calling for:

  • Training and education to effectively implement the final rules;
  • Standards that do not put domestic producers and processors at a competitive disadvantage with imported food and produce;
  • Clarification for water quality standards for agricultural use; and
  • Recognition of the Pasteurized Milk Ordinance, which establishes a set of scientific standards for the high quality and safe production of milk for pasteurization in all 50 states, as meeting preventive control requirements without adding an additional set of regulations.
© Food Safety News
  • pawpaw

    Thanks for compiling this. Note that the pic posted in your article, potatoes are the type of veggie not included in the produce rule because they are “rarely consumed raw”. And the onion growers in Idaho complained about proposed fresh produce rules on onions, saying they’re a very low risk ‘fresh produce’, hence should not be lumped in with many other veggies and fruits eaten fresh. (Onions and garlic are antibacterial for a number of human pathogens.) But at the same time, lumping the management of many fruits and veggies together, or at least that option, helps many diversified farms. Instead of being required to follow separate and differing regs for multiple crops grown in small quantities, all at same time and often adjacent rows in same field.

    Glad congressional representatives heard their constituents and weighed in on this, specifically in areas where proposed FDA (FSMA) and current USDA regs may end up at odds with each other.


    It appears that for the first time, subsidies would NOT be tied to best agricultural practices. It has always been the case in the past.
    Many years ago, real scientists had more impact on the rulings of the FDA, because grants for research did not come from the very companies that stand to profit from the sale of all the “icides” (insecticides, herbicides, fungicides etc.). Nowadays, these “labs” where the goodness or effectiveness of a product is decided are owned by Bayer, Montsanto, Archer Danields etc.
    Also problematic is that they get a “Conditional Use Permit”, which allows them to do business and sell their product AS IF IT HAD BEEN VETTED PROPERLY. The patent runs 10 years, during which these companies can make a hefty profit. The onus is on US, beekeepers, farmers and others observers to litigate and get the product removed from the shelves. We don’t have the money! After 10 years, these companies have made the profit they were after and have had many new other “icides” similarly approved. Since we do not have the credentials of scientists, we can be easily rebuked in a court of law by their savvy lawyers.
    We need to change the FDA so that again it can offer real analysis of a product: The FDA has to be funded properly to actually inspect these products BEFORE they get on the market, not rubber stamped as is too often the case.
    Look around you: Something terrible is happening to our environment and our health: We have a much greater percentage of people with allergies, obesity, cancers. All of these sicknesses are the product of stress on the system. Our bees are the “canary in the mine”, and they are dying at such a rate that we cannot replace them. They and us are sick and getting sicker.
    Centuries ago, if one new product was added to our environment, critters could run away to better pastures, or adapt. What can your system do when 12 000 new “icides” are approved in ONE year? The organisms can’t cope, and that is what we are seeing. We need to wake up, smell the coffee, see the writing on the wall and remove these chemicals from our environment.

  • Dr. Rob Stuart

    It is very interesting that we have one federal organization (Food and Drug Administration) that certifies feed and food additives to be safe and effective. We also have another federal organization (USDA-Organic Certification Program) that exists to be sure that the industry can not use all of the products that FDA has determined to be safe and effective. Isn’t our country great?