How the FDA Can Use S 510 to Close Down Raw Milk Dairies


FDA Currently Spends $1,000,000 a month to Get a State to Shut Down Artisan Farms Like this Sustainable Dairy

by Harry Hamil, Guest Blogger, Black Mountain Farmers Market

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

— 10th Amendment to the U.S. Constitution

Right now, the United States has a three tiered approach to food safety–local, state and national. However, slowly but surely, the FDA is expanding its power. More and more, states are being told what to do by the FDA and given financial incentives for carrying out its directives.

The FDA Food Safety Modernization Act (S 510) further nationalizes food safety regulation.

Currently, regulation of  raw milk clearly respects a diversity of state policies. That will surely change if S 510 passes.

The FDA permits only Grade A milk (i.e, pasteurized milk) to be shipped interstate; whereas, regulation of raw milk (i.e., Grade B) is left up to the individual states and that regulation varies widely.  Only available for pet use in NC, raw milk is available through regulated and state inspected dairies in SC.  The FDA and some states are pushing hard to abolish raw milk sales.  As a result, Farm-to-Consumer Legal Defense Fund and a group of individual plaintiffs are currently suing Kathleen Sebelius, Secretary of HHS over the extent of the FDA’s authority in this area.  For more info, see: FDA Interstate Raw Milk Shipment Ban.

In the meantime, along came Sec. 103 Hazard Analysis and Risk-based Preventive Controls (HARPC) in the proposed FDA Food Safety Modernization Act (S 510).  If S 510 passes, it will require these HARPC plans of all “food facilities” not exempted by the Tester-Hagan amendment.  Grade B dairies, which include raw milk and most cheesemakers, are food facilities so they will have to develop and implement HARPC plans in addition to fulfilling the existing requirements of their home state.

Here is how the FDA can easily use the new HARPC plan requirement to wipe out fresh raw milk and raw milk cheese:

1.  Section 415 of the Federal Food, Drug and Cosmetic Act (21USC350d) requires all dairies, whether in interstate commerce or not, to register as a “food facility” (21CFR1.225).  This registration is a requirement of the National Preparedness for Bioterrorism and Other Public Health Emergencies (aka 2002 Bioterrorism Act).

2.  The current version of Sec. 103 of the FDA Food Safety Modernization Act (S 510) requires all such registered food facilities to have Hazard Analysis & Risk-based Preventive Control (HARPC) plans.  HARPC plans are a legislated version of the Hazard Analysis Critical Control Point (HACCP) plans which grew out of the space program.

3.  Thus, all dairies would be required to have a HARPC plan(s) in addition to meeting its existing Grade A or Grade B requirements.  Pascal Destandau of Pug’s Leap Farm near Healdsburg, CA realized this would make the current requirements of the Pasteurized Milk Ordinance (PMO) and Grade B regulations redundant and, almost certainly, lead to their elimination.  This would mean that all dairy regulation would follow the pattern of meat and be via HARPC plans.

4.  Appendix K of the current Pasteurized Milk Ordinance (PMO) offers a voluntary National Conference on Interstate Milk Shipments (NCIMS) HACCP Program alternative to the traditional inspection system.  This option started in 2002 PMO based upon a pilot program begun by NCIMS in 1999.  As a result, it seems clear that it will be the model for the new HARPC plan requirement.

5.  All dairies would be required to have a separate HARPC plan approved by the FDA for each individual process before the dairy can sell products created via that process.

6.  Just as it with yogurt and cheese, the FDA would be able to view raw milk production as a distinct process.

7.  The hazard analysis for raw or pasteurized milk processing would be the same.

8.  Thus, the FDA could simply turn down the raw milk portion of the HARPC plan because it doesn’t “identify and implement preventive controls, including at critical control points, if any, to provide assurances that [the] hazards identified in the hazard analysis conducted under subsection (b) will be significantly minimized or prevented.” [See new Section 418(c) Preventive Controls]

9.  As shown by the Federal Court ruling in Montana Quality Meats’ lawsuit against the FSIS under similar circumstances, the FDA would be able to turn down a dairy’s proposed HARPC plans without any limitation on the number of times it did so, thereby, denying the dairy recourse to the courts.  This is because there will be no way for the dairy to exhaust its administrative remedies.

What You Can Do to Protect Raw Milk Producers

If you favor raw milk or just the freedom of people to obtain raw milk from state regulated dairies, I urge you to call both of your Senators today, every Republican Senator and both Independent Senators (Lieberman of CT and Sanders of VT) and tell them the following:

1.  Your name and whether or not you are a constituent.  If you are not a constituent, please say where you live.

2.  You are a local, healthy food supporter who is concerned about S 510.

3.  If you are a North Carolinian calling Hagan or Burr, please thank them for their work and add, “…and I must ask her/him to do more.”

4.  You ask the Senator to vote:

“No” on cloture,
“Yes” on the Coburn substitute,
“Yes” on the Managers’ substitute bill, if Coburn fails
“No” on the overall bill.

If you get a busy signal, please call a local office.  If you get a voice mail, leave a message covering all of the points quickly.

Please call now or as soon as you can even if it is during the holiday or weekend.  I have attached detailed contact info for NC & SC and Washington Office info on the rest.

I recognize that my suggestions are involved and the votes may be a bit confusing.  I’ll be happy to answer any questions anyone has about this.

The FDA Food Safety Modernization Act (S 510) is a fundamentally flawed approach to food safety.  The Tester-Hagan amendment helps, but nothing can fix S 510 because it is wrongheaded.  For more info and talking points, write to

S 510 will have a cataclysmic effect on all of agriculture not just local, healthy food.  Please help defeat S 510.  Doing so is a gift to our children and grandchildren.

Harry Hamil (with his wife Elaine) is the owner of Black Mountain Farmers Market, a year round store for local food in Black Mountain, North Carolina. They coordinated the local Black Mountain Saturday morning tailgate farmers’ market from 1995 through 2009, and decided in 2003 to create a store as a sort-of full time tailgate market. He is so concerned about the pending Food Safety Modernization Act, he has worked full time for 16 months to sound the alarm about the real impact of S510.


  1. Oh, this is all very disturbing. To live without our farmers or our fresh raw milk would not be a happy life.

  2. I am really concerned about this! The only milk my 7 year old will even drink is raw milk. I am still trying to understand this issue completely but obviously it is urgent. When is this going to be voted on? Thanks!

  3. Kimberly Hartke says:

    Elizabeth, this Monday is the day it will be voted on. Please contact your Senator first thing Monday morning or by email this weekend. Google the name of your Senators and their contact forms should come up.

  4. It is so crucial to stop this bill. Mr Hamil is right. If S510 becomes law, the FDA will be able to fulfill what seems to be its number one priority – banning raw milk and all raw dairy.

    Since the only solution the FDA seem to have for Food Safety is to destroy all the life in the food, whether by pasteurizing, or chemicals, or radiation, there is a real danger that all live food will be banned, as the FDA will have the power to do this. Mr Hamil’s article shows one way, and there are others, as the FDA is given almost unlimited power over crops by this freedom killing bill.

    This is time where each of us can make a difference. Every letter, email, and phone call helps, and if enough of us contact congress, S510 will be stopped.

  5. Kimberly Hartke says:

    Stan, thanks for your insights. All living food will be considered bacteria laden by our germ phobic public health officials. Those of us who have embraced the fact that our bodies are teaming with internal colonies of health promoting, “pro-biotic” (which if you think about it, means pro-life) organisms, need to realize that our food safety protectors think the only safe food is dead food.

    Here is a link where you can easily send a letter of protest about S 510:

  6. Wilma J OConnor says:

    I am a local food supporter who is concerned about S 510. I am asking you to
    oppose S.510 “Food Safety Modernization Act,” on every vote including cloture
    S.510 will open the flood gates for tyrannical fedral bureaucrats to crash the food industry’s small businesses.
    Please vote:
    “No” on cloture,
    “yes” on the Coburn substitute,
    “Yes” on the Managers’ substitute bill, if Coburn fails,
    “No” on the overall bill.

    Thank You Very Much!
    Wilma J OConnor

  7. I am a raw milk cheese producer and I myself do not have a problem with the requirement of every food processor implementing a HACCP Plan (Hazard Analysis Critical Control Plan).
    In fact, I believe it was in 2001 I gave a seminar at the annual American Cheese Society Conference on how to simplify HACCP for farmstead dairies… a properly implemented HACCP plan is nothing to be feared and is actually very free-ing for the producer since it indentifies AHEAD of time where the most likely hazards may exist and how to avoid them, the paper work really isnt hard at all (once simplified). It also greatly reduces anxiety since knowledge is power, a farmer doesnt needlessly worry about some “spook” organism that the media is promoting and whipping into a frenzy at the prompting of some overzealous health authority (or milk marketing board!),
    Now, that being said….I firmly believe that HACCP should be VOLUNTARY. allow the market place to determine it’s implementation. I know that when I wholesaled my cheese my buyers LOVED the fact that I had a HACCP plan and it did help with promoting sales. My direct sale customers dont quite understand what a HACCP plan is, but knowing that we have a “formal” food safety plan of sorts in place goes a LONG way in reassuring them that we are responsible producers.
    We should be proactive in promoting HACCP SIMPLIFIED for ALL milk producers, not just raw milk producers.
    The only drudgery about HACCP is in the actual writing of the plan, organizing the day to day information and putting it in writing. Once written, it is simply charting (very simple) what a responsible producer is already doing.
    If our food authorities REALLY cared about food safety then HACCP (simplified) shouldve been promoted at the farm level for the past 10 years with ongoing short courses being offered to the local farmers promoting preventative food safety which also shows the farmer/producer that implementing a HACCP plan is also a huge money saver because of increased product quality and much less waste.
    In no way should HACCP be forced upon anyone, you need a willing producer that is going to take the time to understand the concepts in order to properly implement the plan.
    “Implementing” a HACCP plan is not a big deal, that is why I co-wrote the simplified version to begin with, I wanted to show everyone that if Mary Falk could do it, then ANYONE can, and I wanted to show how free-ing it could actually be, a bonifide CYA shield that prevents “big brother ” from fabricating B.S. about your product,
    The simplified format of HACCP for farmstead has been available for 10 years, but the reason it has not been promoted is because it SHOWS that raw milk cheese can be easily made safely. No joke! I am serious!
    The Wi Milk Marketing Board (which funds the WI Center For Dairy Research) actually funded the writing of this plan, but when the end result was delivered it was NOT allowed on the WI Center For Dairy Research’s own website (and they co -wrote it!) because the powers that be decided it SHOWED that raw milk cheese production could be easily accomplished SAFELY. It took over SIX YEARS before the Wi Dairy “Artisan ” Network” website even published a remote link to Alfa Delaval’s website (which had the guts to publish it for small producers).
    All the info is “out there” for small producers to facillitate safe raw milk production, what we REALLY need to be focusing on is the fact that NONE of this information is carried to the public via the media.
    20 years ago we used to have HUNDREDS of independently owned radio, and t.v stations and newspapers, now there are less than half a dozen nationwide!!! THIS is the REAL problem, without valid news dispersal the public is simply dumb to all of the sheanigans, and dont think that is unintentional!

  8. Kimberly Hartke says:

    Hi Mary, so nice of you to add your experience to this post! For those of you who don’t know Mary, Bill Anderson recently wrote about her lovely farm for Hartke is Online!

    Here’s the link:

  9. Kevin Gordon says:

    I would like to comment mainly in response to Mary’s comment on HACCP plans.

    I should qualify that I am not a raw milk cheesemaker, dairy farmer, or really anything related to farming. However, as an engineer, I have had to extensively use a paperwork process very similar to HACCP/HARPC called DFMEA, which stands for Design Failure Modes and Effects Analysis…it was developed by the automotive industry as a standardized process to help improve product quality, reliability, and safety. This very time-consuming paperwork alone does not make the products I design safe, even though it MAY help identify some failure modes that are not readily obvious to the well-trained, experienced engineer…of course, it means NOTHING if you don’t actually apply what you learn from it. Good managers (unlike the FDA) that I’ve worked with don’t just go around asking if we’ve checked all the boxes (DFMEA being one of them) to make sure that our designs are safe, they make sure that we have the appropriate support and training to do our jobs, and they periodically ‘inspect’ our actual work (not paperwork), and provide help and support as needed (i.e. they don’t shut down the project and fire us). The point here is that if you provide good engineers (and farmers) with resources, information, and support, they will produce a safe, quality product. I think that is partly what Mary is trying to say as well, but I guess I just wanted to de-emphasize the ‘paperwork’ component, since it is not what makes the product safe.

    Now as a raw milk consumer, my bigger concern with all of this is that the FDA has already shown (and publicly stated in very direct ways) that it is intent on ending raw dairy production/sales in the US as we know it…to the degree that it is spending a lot of effort (and tax dollars) to shut down small dairies like Morningland and Estrella, while ignoring more egregious and obvious risks like Wright County eggs. Do we really want this organization to have even more power?


  10. The Senate is scheduled to vote on S510 today. Now we each have a chance to fight for our right to real food. Please call and email your senators now. Every call and email makes a difference!

  11. I wonder if this bill affects those small farms and dairy where we buy into the herd
    and buy our products outside of stores? If they can continue operating outside of the realms of “interstate transport” and “retail”, (since they are “our” cows) I would imagine more of these farms would arise, and also flourish, because they are not trying to compete with the others, they are an alternative to industrial government food.

  12. These farms are being targeted for “presence of” listeria without checking for whether or not the strain is pathogenic, and what concentration is present if it is even in the product. If you keep swabbing, you can find listeria at any dairy operation. Cooking and eating is not a sterile procedure. Educate me about the risks I’m taking, and let me make up my own mind. I’m educated about burger chains – I don’t go there. I know my raw milk producer!

  13. Kimberly…have you heard the news that S510 IS STALLED??? Possibly for good? Go to my post to read about it at! I feel a dance in my step and a smile on my face coming on!

  14. Kimberly Hartke says:

    Yes, thanks Nancy, I will check out your blog!

    Perhaps there is hope for freedom for farmers, after all!

  15. -not for publication.
    E. coli strains of coliforms produce vitamins? (Wightman., p.33) Is this true?
    Who were the discoverers of this? Google scholar is hard to navigate on this subject.

    Wightman, T., ( 2009) Raw Milk Production. Farm to consumer Legal Defence Fund.
    I would appreciate help with this and would like to encourage you on your publication.

  16. “She’s Mother Theresa meets MacGyver” says Doug Broeska President of the CliniCard while visiting Sassoon Hospital in Pune, India. “She should probably at least be nominated for the Nobel Prize in Medicine.”

    That’s an impressive statement but also accurate when it comes to Dr. Aarti Kinikar, Head of Pediatrics at Sassoon Hospital in Pune, India (Pune is a city of nearly 10 million, just south of Mumbai, and Sassoon General Hospital is the biggest public hospital in the region). During the H1N1 Flu outbreak last year (2009-2010), Dr Kinikar was faced with a medical emergency seemingly out of all proportion to anyone’s ability to deal with it. Bodies were literally piling up outside of the hospital morgue and she feared that most of the young children and babies that were coming to Sassoon with severe breathing problems would be added to the growing pile. The hospital had only 4 working ventilators and was facing a steady flow of children to the pediatric ward that quickly swelled to a deluge of over 1200, all of whom were in severe respiratory crisis.

    As the numbers of very sick children grew so did Dr. Kinikar’s resolve. There had to be way to create the bit of air flow needed to keep a child’s lungs breathing. “The best medication is sometimes oxygen, and even though the children had made it to the hospital, without it they might die right in front of you…that’s a helpless feeling for a doctor” said Kinikar. Motivated by equal parts of desperation and inspiration, Dr. Kinikar rigged a simple breathing tube device only with materials on hand. The PNC pressure device called a “nasal bubble CPAP device” (Continuous Positive Airway Pressure) miraculously worked for 85% of the children who were treated. Although bubble CPAP has been around for decades, the device she rigged was much less elaborate than the expensive tubing and valve configurations that are commercially available by the same name. “I was taking a risk,” Kinikar said. “I didn’t know whether people would back me using a technique which didn’t seem to have much scientific push.” As a result of her willingness to step outside of convention, an estimated 500 childrens’ lives were saved at Sassoon Hospital because her fast thinking in a time of extreme crisis. A few dollars worth of plastic tubing had taken the place of much more expensive devices which weren’t available to the hospital at the height of the emergency anyway.

    Just as importantly, she has now shown the rest of the world how to rig this simple device which will undoubtedly be used in future medical emergencies everywhere a pandemic occurs.
    Although soft spoken & diminutive in stature, her calm voice, measured words and resolve behind the eyes lets you know that she is certain of what must be done for her hospital. “The immediate crisis is past but we know that the next one may be right around the corner” says Kinikar. “We don’t want money” she says somewhat surprisingly, but goes on to explain. “We need equipment and supplies. Money just gets misdirected and anything we order though the local government takes a very long time to get here. If donations can come in the form of medical equipment like ventilators, we can cut through the red tape and start using them right away.” The recent flu outbreak underscored the need. “The little nasal bubble CPAP device,” now dubbed “Bubbles of Hope” by Dr. Kinikar, “helped pull us out of a crisis and saved many lives, but we need so much more on an ongoing basis for the next public health emergency.”

    The owners of CCSVI Clinic and The CliniCard have jointly donated working capital and a pledge to purchase medical equipment on an ongoing basis for Sassoon Hospital. We hope the bit of personal money we have put up will attract some attention and challenge others to do the same.” says Broeska. “I don’t think there is a case in medical history where such a small amount of equipment could be proven to have gone so far. Anyone who wants to donate can do it through us. We’ll show you what your money bought and every penny will go to the purchase of medical supplies and equipment for Sassoon Hospital. Of course if you want to buy medical equipment directly for Dr. Kinikar, I’ve got their grocery list”. Please contact us at CCSVI Clinic on this site to donate.

    Dr. Aarti Kinikar’s Philosphy:

    Dr. Kinikar teaches her students to think things through.

    “You must use your creativity and if you have the basic scientific knowledge, you will be able to do a lot of things with the medical supplies on hand in a hospital.”

    Many areas of the world like the US and Europe are fortunate to be able to offer their patients the latest, most expensive medical technology. A recent study confirmed that US hospitals have more ventilators per capita than any other country. But in a severe pandemic or other extreme crisis, the number of patients could easily overwhelm the supply of medical equipment at any hospital. Rationing supplies and treatment along with prioritizing patients might look necessary but Kinikar’s experience points to another possible solution: “Just keep on thinking.” she tells her students.

    In 2010, the B J Medical College Research Society awarded Dr. Kinikar the Suchintan trophy for her unique invention and the way she dealt with the crisis at Sassoon.


  1. […] How The FDA Can Use S.510 to Close Down Raw Milk Dairies […]

  2. […] Harry Hamil is a 63 year old farmer, and the purveyor of fresh and local products in his North Carolina retail store, the Black Mountain Farmers Market.  Harry, for the past 18 months has worked full time as a volunteer activist, working tirelessly to sound the alarm about the pending food safety modernization act in Congress. See his recent blog post on the negative implications for the raw milk industry. […]

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