FSMA: Comment on FDA’s Proposed Food Safety Regulations by November 15 Deadline Action Alert

DEADLINE for Comments Extended to November 22, 2013!

Comment before midnight Friday, Nov. 22 (11:59 p.m. Eastern).

Food safety regulations proposed by the U.S. Food and Drug Administration (FDA) pose significant problems for sustainable farmers, food producers, and food hubs across the country.

FDA Food Safety Modernization Act (FSMA)bit.ly/FSMA-flyer

Action Alert – Quick Links

  • Comment on Produce Rule
  • Comment on HARPC Rule
  • Analysis of Proposed Regulations
  • Print 2-sided Flyer to share

  • How to Submit Comments
  • How to Contact Congress
  • See Sample and More Info
  • Action Alert to Preserve Tester-Hagan Exemption
  • Under the proposed regulations, many farmers will be forced to comply with high-cost, industrial-scale regulations, and they will be unable to use traditional, sustainable growing practices. Food hubs and local food businesses will be forced to deal with costly and burdensome paperwork. Ultimately, consumers will face increased food prices and reduced availability of locally and sustainably produced foods.

    Below is information on how YOU can help, with sample comments to FDA and more! To learn more about the proposed regulations, scroll to the end of this alert for an overview or visit www.farmandranchfreedom.org/fda-proposed-food-safety-regulations-2013 for a detailed analysis. Print the 2-page FSMA flyer to share with others.

    It is very important to personalize your comments! We’ve included some questions in italics below, to help you think about some of the comments you can make about the specific impact on you.

    Please send a copy of your comments to both your U.S. Senators and your U.S. Representative.
    See Action Alert : Call to Support Benishek Amendment in Farm Bill (bit.ly/ftcaa-fb1).

    Spread the Word – Submit Your Comments for Both Proposed Rules


    Deadline Extended to Friday, November 22th before midnight (11:59 p.m. Eastern)

    Near the end of this alert is a sample letter on FDA’s proposed rules. Comments must be received by the agency by Friday, November 22, 2013 (extended from Nov. 15).

    Please comment on BOTH proposed rules—you may comment online or by postal mail:

    To Submit Comments to FDA Online:

      1. Enter your comment in the “Comment” box or type “see attached”. [See tips to the right here.] If you are attaching comments as a separate file, click on “Choose files” to select and upload your document.
      2. Enter your “First Name” and “Last Name”.
      3. If you want to give your “Zip/Postal Code” and/or “Email Address”, click the box for “I want to provide my contact information” and enter your information. Otherwise, leave box unchecked
      4. Click the box to deselect “I am submitting on behalf of a third party” to remove the fields for “Submitter’s Representative” and “Organization Name”.
      5. For “Category,” select “Individual Consumer” or “Private Industry”.
      6. Click “Continue” to see “Your Preview” and verify the information you entered. You may click “Edit” if you need to make changes; otherwise, click the box “I read and understand the statement above” and click “Submit Comment”.
      To Enter Your Comment Online:
      We recommend that you write your comment ahead of time and save it on your computer, because there is a time limit when using the Federal Register System and you may get timed out if you write your comment from scratch.

      • If your comment is less than one page, you can copy and paste it into the comment box.
      • If it is longer, you can instead write “see attached” and UPLOAD a separate document, such as a Word or PDF file, with your comments.

    If you mail your comments, be sure to include the docket number(s):
    FDA-2011-N-0921 for the proposed On-Farm Produce Rule
    FDA-2011-N-0920 for the proposed Preventive Controls /HARPC Rule

    Address for Mailing Comments:
    Division of Dockets Management (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane, Room 1061
    Rockville, MD 20852
    Direct links for posting comments:
    • On-Farm Produce Rule —

    • Preventive Controls / HARPC Rule —

    It is vital that your elected officials know how you feel about your food! Tell your U.S. Representative and U.S. Senators about your concerns for farmers and local food producers.

    • Find out who represents you by going to www.house.gov
    and www.senate.gov or by calling the Capitol Switchboard at 202-224-3121.

    • Call and ask to speak to the staffer who handles agricultural issues. Explain that you’re a constituent and that high-quality food is very important to you. Ask your Congressman to contact FDA directly on behalf of you and other constituents.

    • Get the staffer’s email address and follow up by sending them a copy of your comments to FDA.

    See Action Alert : Call to Support Benishek Amendment in Farm Bill (bit.ly/ftcaa-fb1).

    The italicized portions at the beginning are intended to help you personalize your comments. You don’t have to write a lot – even a couple of sentences can really increase the impact your comments will have!

    Use the sample below as a starter for your own comments. You may also download a Word version for editing; click on this link, bit.ly/FSMA-sample-letter-doc

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

        Re: Preventive Controls Rule: FDA-2011-N-0920 and RIN 0910-AG36
        Produce Standards Rule: FDA-2011-N-0921, and RIN 0910-AG35

    I am a ______ [farmer, food producer, consumer, parent…]. I am deeply concerned about the impact that FDA’s proposed rules under FSMA would have on [my farm, my food business, the farms that I buy food from…].

    For consumers, do you make an effort to buy from farms that use sustainable practices? Why do you care about these rules? Just a sentence or two is sufficient to explain.

    If you are a farmer, explain your farm practices that would be impacted by the rule. Do you use manure, vermicompost, or compost teas? Do you use surface water or multiple different water sources? Do you do rotational grazing of your livestock with your crops, or use draft horses?

    Do you have a CSA that involves more than one farm and would thus be required to do a HARPC plan? Do you do low-risk activities, such as bottling honey, grinding grains, or making jam? Do you have staff who could handle the HARPC paperwork or would you need to hire new people?

    For food processors or food hubs, could you absorb the cost of writing a HARPC plan? Do you rely on supplies from farms that would be exempt under the Tester-Hagan provision?

    I urge the FDA to address the following issues in the proposed FSMA rules:

    TESTER-HAGAN “QUALIFIED EXEMPTION” in both the Produce Rule and the Preventive Controls Rule:

      1. The gross sales test to qualify for the Tester-Hagan provision should be based on sales of food that is subject to FSMA, whether the produce standards or the preventive controls rule. Sales of food that would not be regulated under FSMA should not be included.
      2. The FDA should not rush the process of revoking a producer’s Tester-Hagan exemption. The agency has other mechanisms it can use if there is an immediate threat of foodborne illness.

        a) The FDA should be held to specific evidentiary standards before it can revoke a farmer’s or food facility’s Tester-Hagan exemption.
        b) A farm or facility that is exempt under Tester-Hagan should be given at least 90 days to submit evidence and defend its exemption if FDA seeks to revoke it.
        c) If the exemption is revoked, the farm or facility should have at least two years to come into compliance with the FSMA rules.


      1. The FDA’s approach to traditional farming methods, such as diversified livestock-crop farms, the use of working animals, and the use of biological soil amendments, is fundamentally flawed. The agency should not restrict these sustainable methods of farming without data showing an actual, verified increased rate of foodborne illness; the simple fact that these methods include diverse microbiological communities is not a sound scientific basis for restricting them.
      2. The waiting period between applying manure and harvesting the crop should be no more than 4 months, and there should be no waiting period between applying compost and harvesting the crop. The excellent track record for safety on organic farms shows that this standard is sufficient.
      3. Compost teas and other biological inoculants, including normal additives such as molasses, should be treated the same as compost.
      4. Water testing should not be required more often than once a month, and farmers should be able to test less frequently after establishing the safety of their water source through consecutive negative tests. In addition, farmers should be given the option to test for pathogens, rather than having to treat or stop using the water that tested positive for generic e. coli.
      5. The provisions on wildlife and domestic livestock need to be clarified to protect farmers who use biologically diverse farming from field inspectors using their discretion to require measures such as fencing or destruction of habitat.


      1. “Very small facilities” should be defined as being under $1 million in total annual sales, adjusted for inflation. Imposing HARPC requirements on businesses smaller than that is unnecessary and overly burdensome.
      2. Any requirement for “supplier verification” should not prevent a facility from purchasing foods or ingredients from farms and facilities that are exempt from the regulations under the Tester-Hagan provision or other exemptions.
      3. Low-risk activities conducted by a farm using its own products, such as making jams, grinding grains, or dehydrating vegetables, should not be subject to these regulations.
      4. Low-risk activities, when conducted off-farm or by multiple farms working together, should not be subject to the same requirements as high-risk processing activities. The requirements should address both the scale of the operations and the level of risk of the activity.

    Full Name

    For more information and to stay informed on additional actions to take, visit


    Congress included a very important provision in the Food Safety Modernization Act (FSMA) to exempt small-scale, direct-marketing producers. Specifically, under the Tester-Hagan amendment, farmers and food producers who sell less than $500,000 annually, and who sell more than half of their products directly to consumers or local restaurants and retailers, are exempt from the new regulations.

    But FDA’s proposed regulations don’t fulfill the intent of the provision. First, FDA wants to judge farmers’ sales based on all their sales, not just the food that is subject to FDA regulation. This means that many diversified farmers will be unable to qualify for the exemption, even if they are raising only small amounts of food that is covered by the law.

    Second, FDA wants to be able to revoke farmers’ and producers’ exemptions without respecting basic principles of fairness and due process. As proposed, the regulations:
    • Leave too much discretion in the hands of individual FDA officials;
    • Do not give small farmers and local food producers enough opportunity to respond to a decision to end their exemption; and
    • Do not give small farmers and local food producers enough time to comply with the rules if their exemption is revoked.

    In essence, this means that any farmer or producer targeted by FDA for revocation of its exemption will almost certainly go out of business. The number of producers targeted this way by FDA is likely to be small, but it will be devastating for those affected. And the uncertainty of not knowing who might be the agency’s next target will have a chilling effect on many small producers.

    Submit Your Comments NowTalking Points for Exemption


    For farmers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the proposed produce safety regulations cover every aspect of growing and harvesting crops. Overall, the agency has taken a “guilty until proven innocent” approach to many traditional farming practices, forcing farmers to present scientific evidence in order to continue using farming methods that have been used for decades or even centuries.


    Biological soil amendments are vital for farmers seeking to grow produce without synthetic chemicals, and they have an excellent track record for safety. But under the proposed regulations, a farmer would have to wait 6 weeks in between applying compost and harvesting the crop, making it much more difficult to use compost in many cases. A farmer using manure would be required to wait 9 months before harvest, effectively making it unusable for many farmers around the country.

    FDA goes further and treats all of the following as if they were manure:
    • Compost made without specific heating periods (“static compost”);
    • Vermicompost or worm castings;
    • Compost teas with any additives, even simple molasses or kelp meal;
    • Any compost that does not meet the precise methods and testing requirements specified in the rule.

    Applying any of these proven, valuable soil amendments would require the farmer to wait 9 months until harvest, essentially making them unusable. The practical effect of the proposed rule is to allow synthetic chemicals to be easily used, while making the use of many natural soil amendments difficult or even impossible for many farmers.

    In contrast, the certified organic regulations have no waiting period in between applying compost and harvest, and only a 4-month waiting period between applying manure and harvest. Farmers have operated safely under the certified organic standards for over two decades, yet FDA’s proposed regulations would make it all but impossible for these farmers to continue farming as they have been.


    FDA’s proposed regulations also require farmers to take steps to prevent contamination by domestic livestock or wildlife, but they leave out the specifics of what is required to the discretion of the field inspectors. It would be difficult to comply with a strict interpretation of the proposed requirements without taking measures such as fencing animals out and destroying wildlife habitat—essentially a “scorched earth” approach.

    The combination of the animal and soil amendment requirements poses significant problems for diversified farms that raise both vegetables and animals. Diversified farms are efficient, both biologically and economically, yet they would be hard-pressed to comply with the proposed rules. At the least, it would be very expensive; in many cases, the farmers simply could not comply without changing their entire approach to farming.


    FDA’s proposed rule would require farmers to test their irrigation water every single week if they use a surface water source, such as a river or stock pond. If the water exceeds FDA’s standard for generic e. coli, the farmer would either have to treat it with chemicals or stop using it immediately. Yet generic e. coli is not a pathogen or disease causing organism. In other words, farmers will be forced to spend thousands of dollars testing for something that wouldn’t make a person sick, and then forced to either dump chemicals in the water or somehow find another water source based on these generic tests.

    Submit Your Comments NowTalking Points on Produce


    FDA’s second rule, on Preventive Controls, deals with anyone who is handling or processing food. For producers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the Preventive Controls rule requires that any business that packs, holds, processes, or manufactures food creates a Hazard Analysis and Risk-based Preventive Control (HARPC) plan.

    This encompasses a large number of low-risk activities that farms, food hubs, and cooperative produce distributors normally conduct. All of the following would be subject to the new requirements:
    • A farm that dehydrates fruits, makes pickles, or mills grains;
    • Two farms running a joint CSA and handling each other’s produce;
    • A farm that stores food from any other farm or producer (even if they do no processing);
    • All sorts of “food hubs” that distribute food from multiple local producers.

    A producer subject to this rule must develop a HARPC plan. Developing such plans can cost thousands of dollars—up to $20,000—for a small operation in the first year. The rule then requires annual “verification” that the plan is working, with records of this verification process and its findings, at continued significant expense.

    The scope and complexity of the paperwork that will be required is daunting for both on-farm and off-farm processors. In the early 1990s, similar HACCP requirements led to many small- and mid-scale slaughterhouses having to shut their doors. The FDA’s proposed rule has the potential to put an end to many of the exciting innovations taking place right now with local food hubs, community processing facilities, and the other infrastructure so vital to re-establishing local food systems.

    In addition, while not spelled out in the proposed rule, the references to “source verification” could easily lead to a requirement that all the producer’s sources be similarly regulated. In other words, a food hub or other regulated facility might not be able to purchase food or ingredients from farms and facilities that are exempt from some federal regulations—such as those protected by the Tester-Hagan exemption. The proposed regulation does not explicitly require this, but it does lay the foundation for such a step.

    Submit Your Comments NowTalking Points on HARPC

    • Preventive Controls / HARPC Rule: bit.ly/fsma-harpc-rule