FDA Bootstrapping Its Power under FSMA

Recently the New York Department of Agriculture and Markets (NYDAM) sent what it called a “Milk Control Facility FSMA Survey” to a number of licensed dairy producers in the state, including raw cheesemakers. The survey was mainly concerned with whether the producers were complying with various requirements related to the FDA Food Safety Modernization Act (FSMA) but there was one requirement the survey asked about that was never brought up at all when Congress was deliberating over FSMA–current Good Manufacturing Practices (cGMPs), which FDA could try to use for regulating all commerce other than most meat and poultry that are under the jurisdiction of the United States Department of Agriculture (USDA). This could include all intrastate commerce; under FDA’s interpretation of the law, any local producer– whether a raw milk dairy with a couple of cows or a private homemaking cottage foods operation–would be subject to the cGMP requirement and FDA jurisdiction.

The agency is claiming that authority given it by the Public Health Service Act (PHSA) to regulate communicable diseases gives it the power to impose cGMP requirements. The PHSA provides that “[t]he Surgeon General, with the approval of the Secretary [of Health and Human Services], is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For the purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.”1

A common sense reading of this power would be that FDA could get involved if there was a foodborne illness outbreak confined to one state or if a producer solely in intrastate commerce was found to be manufacturing food under unsanitary conditions but, according to the agency, its power to regulate communicable disease gives it the authority to impose cGMP requirements on all food manufacturers (other than those in the meat and poultry business) for the following: “plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; processes and controls; warehousing and distribution; and natural or avoidable defect levels.”2

The cGMPs are part of a one-size-fits-all regulatory scheme; unlike some of the more onerous FSMA provisions such as the national produce safety standards and the food safety standards (HAPRPC – Hazard Analysis Risk-Based Preventive Controls) in which many smaller producers are exempt from those mandates, there are no exemptions from the cGMP requirements.

FDA has long held that cGMPs apply to food manufacturers in intrastate commerce but the agency’s position fell on deaf ears until after the passage of FSMA. The cGMPs used to have their own section in the Code of Federal Regulations (21 CFR part 110) but, when FDA issued regulations governing the HARPC requirement (21 CFR part 117), it moved the cGMP regulations over to that section as well. FDA wants to make it seem like cGMPs are part of FSMA even though they were never brought up when Congress was considering the food safety legislation in 2009 and 2010.

At this time FDA doesn’t have nearly the resources to enforce the cGMP requirements across the board but that doesn’t have to happen for the agency to create a chilling effect among local food producers; an occasional inspection of or enforcement action against a raw milk producer or cottage food operation will do the trick. The cGMPs potentially threaten to roll back some of the progress made in recent years through legislative and policy changes in the areas of consumer access to raw dairy and cottage foods.

There are ways to protect against the cGMP threat to intrastate business. One way would be for state legislatures to more closely monitor FDA cooperative agreements between state departments of health and agriculture to make sure the state agencies don’t impose these requirements on food producers operating only in intrastate commerce; with FSMA, states will be counted on to carry out much of its enforcement. Another way would be to amend the Federal Food, Drug and Cosmetic Act to make it clear that the cGMP requirements only apply to firms operating in interstate commerce. As it is FSMA is possibly the most draconian piece of food legislation ever passed; FDA needs to be stopped from expanding its power beyond what Congress ever intended.

1 United States Code of Laws, 42 USC 264(a). Accessed 2/28/2018 at https://www.law.cornell.edu/uscode/text/42/264

2 Federal Register, 78 FR 3651. Section II.B.1 accessed 2/28/2018 at

Should British Columbia Model Raw Milk Regulations on California?

Mark McAffee, a California raw milk entrepreneur and the CEO of the Raw Milk Institute, toured British Columbia last month for speaking engagements and on-farm training sessions in raw milk safety. During his trip, McAffee implied that British Columbia could cut the expensive legal disputes stemming from the distribution of raw milk by taking a cue from California and adjusting its raw milk regulations.

“In California, raw milk is 100% legal, but it is highly regulated with a different set of standards from pasteurized milk,” explains McAffee. In British Columbia, the government could declassify raw milk as a health hazard by grouping it in with other foods that carry no more risk but are less regulated, like oysters.

Listen to McAffee’s full interview with the Green Man Podcast: BC Takes a Lesson in Raw Milk Production From California.

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

Is the FDA Falling Behind Other Countries in Raw Milk Run?

In July 2014, the United Kingdom’s Food Standards Agency released a report on raw milk that took into account the opinions of over 100 raw milk consumers. Their findings concluded that both consumers and producers “…hold a strong view…that there should be wider accessibility to raw drinking milk but this should still be managed and controlled.”

In exploring how they could take a more lenient approach to raw milk consumption in the United Kingdom, the FSA said it was open to allowing the sales of raw milk through vending machines – which would increase sales within a controlled environment.

David Gumpert, author of The Complete Patient blog, points out that this new report, in addition to New Zealand’s recent consideration of more lenient raw milk regulations, means that the FDA could quickly be becoming internationally isolated on the issue of raw milk.

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

Small Dairies in South Dakota Decide to Stop Selling Raw Milk Due to New Regulations

On December 11, 2013, the South Dakota Department of Agriculture implemented new, stricter regulations on raw milk that has already forced at least one small dairy to stop selling the food.

After the new regulations were announced but before they went into effect, the owner of Black Hills Milk in Belle Fourche made her own announcement: the dairy would stop selling raw milk because the new regulations, including one that sets the maximum coliform level at 10 parts per milliliter, would make it too difficult to continue.

Dawn Habeck, co-owner of Black Hills Milk, explained: “The coliform level increases every minute after the milk comes from the cow’s udder. [It] only drops after it’s pasteurized. So the rule basically makes it impossible to sell raw milk.”

Gena Parkhurst, Secretary of the Black Hills chapter of Dakota Rural Action, argues that coliform is a naturally occurring bacteria in raw milk that can be beneficial for human health, and points out that maximum levels of coliform vary widely between states.

“The [new] rules are burdensome, confusing and basically anti-business,” Parkhurst says. “We’re supposed to be the most business-friendly state, so why is the department being so hard on raw milk producers?”

Katie Konda, a policy analyst for the South Dakota Department of Agriculture, says that the new coliform level is not unattainable and raw milk producers in nine other states meet the same requirements.

Read more about the dairies’ struggle to adjust to the new regulations here.

The Campaign for Real Milk is a project of the nutrition education non-profit, The Weston A. Price Foundation. Donate to help fund research into the benefits of nutrient dense foods.  http://www.westonaprice.org/lab

Wisconsin Senate Committee Passes Raw Milk Legislation

On November 12, 2013, the Wisconsin Senate Committee on Financial Institutions and Rural Issues passed Senate Bill 236, which would allow the sale of raw milk directly to consumers on the farm.

The Bill makes several requirements of the farms, including:

  • Farms selling raw milk must register with the Wisconsin Department of Agriculture, Trade and Consumer Protection.
  • Farms must keep records of the names, addresses and telephone numbers of raw milk customers.
  • Farmers must take daily milk samples that must be available to health officials.
  • Raw milk must be free of pathogens, as determined by monthly tests, and meet bacterial and somatic cell counts.

Unfortunately, people on both sides of the issue have complaints about the bill. Some raw milk advocates believe the requirements could make it too expensive for small farms to sell raw milk. Some raw milk opponents believe the bill is too relaxed and are unlikely to support farm inspections once every two years when once every six months is standard for other dairy businesses.

Current Wisconsin law prohibits the sale of raw milk, so the passage of this bill is a small yet significant step. Wisconsin is the heart of America’s Dairyland, and “…has been at the center of the national raw milk debate for several years, [so] the current legislation will be watched closely by both sides of the issue in other states.” The bill passed the committee by 3-2 and now goes to the full Senate for vote.




The Campaign for Real Milk is a project of the nutrition education non-profit, The Weston A. Price Foundation. Donate to help fund research into the benefits of nutrient dense foods.  http://www.westonaprice.org/lab

Farmers Experiment with Milk Treated with UV Light Instead of Pasteurization

Several farmers in the United States and other countries are experimenting with treating milk with ultraviolet light instead of pasteurization, for feeding calves on the farm. Pasteurization does not guarantee the destruction of all pathogens, but it does kill beneficial nutrients such as proteins and vitamins. Exposure to UV light does not destroy pathogens but it does prevent them from reproducing, and the technology has been successfully used to purify water.

One dairy farmer in New York has been feeding his calves UV-treated milk. He “wrestles a 3-week-old calf onto a scale. The calf totters about; the scale reads 52 kilograms, a healthy weight. [The farmer] makes a note.”

Another dairy farmer in Minnesota installed a UV milk purifier on his farm a year and a half ago. “We were having a lot of problems with clostridia when we were feeding milk replacer,” he said. “That was all but eliminated after we switched over to feeding UV purified milk.”

Michael Schmidt, the author of The Bovine blog who conducted his own two-calf study comparing the effects of feeding calves raw milk vs. store-bought pasteurized milk, writes of the UV milk experiments: “If it works for calves, why wouldn’t it work for people? Though probably the bar of surety is set higher when we’re dealing with food for humans.”

Draw your own conclusions by reading more about the experiment here:


The Campaign for Real Milk is a project of the nutrition education non-profit, The Weston A. Price Foundation. Donate to help fund research into the benefits of nutrient dense foods.  http://www.westonaprice.org/lab