FSMA Food Safety Regs Going Local

Starting September 17, 2018, all “very small business“ (roughly defined as business with less than $1 million in annual sales1) manufacturing, processing2 or holding food must be in compliance with applicable federal regulations issued pursuant to the FDA Food Safety Modernization Act (FSMA) that govern “Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food.”3 These regulations break down into two different requirements: first, that the food business be in compliance with current good manufacturing practices (CGMPs) and, second, that it develop and implement a food safety plan that effectively performs a hazard analysis and designs risk-based preventive controls for human food (HARPC, Hazard Analysis and Risk-based Preventive Controls).4

The way FDA is interpreting these regulations, many local food producers will be under FDA‘s jurisdiction and subject to inspection by the agency, possibly even including a home kitchen producing cottage foods. The biggest potential problem for local food producers is not going to be the HARPC requirements but rather the CGMP mandate.

HARPC–Who Is Exempt?
HARPC does not apply to any business manufacturing, processing, packing or holding food that is not required to register with FDA as a “food facility.” There are a number of exemptions from the registration requirements; the exemption most applicable to local food producers would be the one for “farms” and “retail food establishments.“5

“Farm” is defined, in part, as “an operation under one management in one general physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood) or any combination of these activities.6 The term “farm“ also includes “packaging and labeling raw agricultural commodities when these activities do not involve additional manufacturing/processing. Farmers growing/raising and selling raw milk, eggs, raw honey7, whole fruits and vegetables8, meat from amenable species (cattle, hogs, sheep, goats and poultry)9 or any combination of the above foods would qualify as a farm and be exempt from the registration requirement. The farmer/producer selling any processed fruits and vegetables (with one exception)10, any products processed from raw milk, maple syrup11 or any meats from non-amenable species (e.g., rabbit, bison, deer, elk)12 would result in the loss of the “farm“ exemption from registration.

If the farm business doesn’t qualify as a “farm“, it can still be exempt from the registration requirement if it qualifies as a retail food establishment. A business qualifies as a retail food establishment if over half of the “annual monetary value of its sales of food products are direct to consumers.13 This would include sales of all food products sold by the farmer/artisan not just food products that the business produced.

For those not aware of the “farm” or “retail food establishment” exemption who have registered with FDA, it is recommended—if your business qualifies as a farm or retail food establishment—that you contact FDA and request that it cancel your registration. If FDA independently verifies that your business is not required to register, it will cancel your registration.14

Those registering with FDA as a food facility with less than $1 million in annual sales are eligible for a “qualified facility” exemption from the HARPC requirement.15 To obtain the exemption, eligible facilities must submit form FDA 3942a to the agency by December 17, 2018 (those facilities starting up their business after September 17, 2018, must submit the same form before beginning operations).16 According to FDA’s Outreach Info Center, form 3942a will be available September 19; currently, only a draft version of the form is in circulation.

On the form, those seeking the exemption must attest that they are a qualified facility17 (e.g., a “very small business“) and either that they “have identified the potential hazards associated with the food being produced, are implementing preventative controls to address the hazards, and are monitoring the performance of the preventative controls to ensure that such controls are effective“18 or that they are in compliance with state or other applicable non-federal laws and include evidence of regulatory oversight19 (e.g., licenses, permits). Beginning in 2020, those seeking the exemption must submit form 3942a every two years.20 Under certain circumstances, FDA can revoke the qualified facility exemption.21

CGMPs
The CGMP requirements are where FDA will directly regulate local food producers. FDA has been low-key about to whom it will apply the CGMP requirements22, but a read of the regulations indicates that FDA can apply them to local food. Unlike the HARPC requirement, small farms and local artisan producers will have no exemption from the CGMP mandate based on their revenues. Among those exempt from the CGMP are: producers exclusively under USDA jurisdiction (e.g., producing and selling only beef, pork, lamb, goat and poultry products); and farms meeting the “farm” definition discussed above. It appears all, or nearly all, other local food producers will be subject to the CGMPs. According to FDA, the CGMP requirements apply even to businesses operating only in intrastate commerce.23

CGMPs are a one-size-fits-all regulatory scheme–easily subject to varying interpretation by inspectors–that contain requirements for personnel24, plants and grounds25, sanitary operations26, sanitary facilities and controls27, equipment and utensils28, processes and controls29, warehousing and distribution30, holding and distributing distribution of human food by-products for use as animal food31, and the defect action levels32. These are requirements that state legislatures should be determining but FDA wants to regulate as much food and as many food producers as possible. Value-added products are where the money is; FDA wants to have jurisdiction over all of these products, no matter how small the food producer is.

The FDA Bootstrap
As far as is known, Congress never brought up CGMPs when the Food Safety Modernization Act was under consideration but FDA took advantage of the broad power the Act gave it to issue regulations and bootstrapped the CGMP requirements into FSMA. FDA had long contended that FDA could regulate intrastate food commerce under powers granted it by the Public Health Service Act (PHSA) to regulate communicable disease; it wasn’t until FSMA became law that the agency had the traction to do so (the CGMPs had their own Part in the Code of Federal Regulations, 21 CFR 110; FDA used FSMA to insert the CGMPs into Part 117 and 21 CFR 110 will be repealed on September 17, 2018).

The PHSA provides that:

    “The Surgeon General, with the approval of the Secretary [of Health and Human Services] is authorized to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the states or possessions, or from one state or position 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, distraction 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.”33

That this power authorizes FDA to inspect home kitchens making cottage foods is definitely a reach. There is nothing in the PHSA or in its legislative history indicating FDA has the authority to inspect an intrastate food business when there is no credible evidence that the business is producing food under unsanitary conditions or is responsible for a foodborne illness outbreak. FDA has claimed that “due to the nationwide interrelated structure of the food industry, communicable disease may, without proper intrastate food controls, easily spread interstate.“34 That statement describes the industrial food system, not the local food system. FDA should recognize the difference between the two and leave the latter alone.

In addition to being beyond its power, enforcing the CGMPs against local food is a waste of resources if FSMA is about improving food safety. Instead of spending whatever money FDA intended to budget towards inspections of intrastate food producers, why doesn’t FDA put its resources towards areas of the food sector where there are actually food safety problems, like imported food?

There are built-in incentives for small farmers and local artisans to produce safe food; those producers are feeding the same food to their families, one product recall can put them out of business, one case of foodborne illness can put them out of business. Legislatures in nearly all states have recognized this with the passage of cottage food bills that allow the direct-from-producer-to-consumer sale of a variety of foods with little or no regulation. Four states have passed food freedom bills and other legislation that allow the unregulated sale from producer to consumer of nearly all foods other than meat. There have been few, if any, cases of foodborne illness attributed to producers operating under cottage food or food freedom laws.

Will FDA actually inspect private home kitchens to make sure that the kitchens are in compliance with applicable CGMP requirements? If there were inspections, they would likely be conducted by state agencies pursuant to a cooperative agreement with FDA. So, state legislators who voted on behalf of their constituents who want to deregulate local food transactions between consumers and producers are now being told by FDA that the same state agencies that the legislators didn’t want inspecting local food producers will now be inspecting them; this even though there is little or no evidence that Congress wanted FDA to inspect these same producers for compliance with CGMPs.

FDA might not have the resources to carry out widespread inspections of local food producers, but the threat is that FDA can create a chilling effect on local food production with a small number of inspections of small farms and cottage food operations; convincing some local food producers to get out of business while deterring others from starting up operations.

There are ways to fight against FDA’s attempt to regulate all local food production. For starters, having Congress deny FDA funding to conduct inspections of those in the food business who are not required to register with the agency as a food facility. State legislatures could also require that any FSMA cooperative agreements between state agencies and FDA exclude in the agreement inspections of businesses not required to register as food facilities. Congress could also amend FSMA to clarify that those not required to register as a food facility be exempt from the CGMP requirements. Those processing, manufacturing, packing or holding food for animal consumption not required to register with FDA don’t have to comply with the CGMP mandate35; FDA can apply the same standards to human food.

An immediate move FDA can make is to include additional kinds of manufacturing/processing under the definition of “farm”, enabling farmers to produce more value-added products while still remaining under the “farm” exemption. The agency is currently in the process of amending that definition.36

The more local food producers there are the safer food will be in this country; applying the CGMPs to small farmers and local artisan producers is a big step in the wrong direction.

Those with questions about food facility registration or exemptions from the HARPC and CGMP requirements can email Pete Kennedy at pete@realmilk.com.

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FOOTNOTES

[1] The exact definition of “very small business” in 21 CFR 117.3 reads:

    Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). [bolded emphasis added]

[2] The definition of manufacturing/processing is extremely broad; 21 CFR 1.227 and 21 CFR 117.3 state the same definition:

    Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding. [bolded emphasis added]

[3] 21 CFR Part 117
[4] The deadline for compliance with the CGMP and HARPC requirements is September 17, 2018, for those very small businesses that manufacture, process, pack and/or hold animal food. “Very small business”, in the case of animal food, is roughly defined as those businesses with under $2.5 million in annual sales. See 21 CFR 507.3 and 21 CFR 507.5
[5] 21 USC 350d(c)(1), 21 CFR 1.226(b) and (c)
[6] 21 CFR 1.227
[7] FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry, August 2018, pp. 10-11. Last viewed 8/30/18 at https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf
[8] Farms growing and selling vegetables could be subject to FSMA’s produce safety standards depending on their income levels and whether the vegetables are usually cooked before being consumed. See 21 CFR 112.1-112.5
[9] Meat from amenable species is not considered a raw agricultural commodity but, since it is under USDA’s jurisdiction, a farmer selling meat from amenable species the farmer raised would not cause the loss of “farm” status.
[10] “Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing….” — from definition of “farm”, 21 CFR 1.227
[11] FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry, August 2018, p. 9. Last viewed 8/30/18 at https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf
[12] Ibid., p. 21
[13] 21 CFR 1.227
[14] 21 CFR 1.241(c)
[15] 21 CFR 117.3 contains definitions and 21 CFR 117.5 gives greater detail about exemptions.

    Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:

      (1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
      (2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation. Qualified facility exemption means an exemption applicable to a qualified facility under § 117.5(a).

    [21 CFR 117.3, bolded emphasis added]

[16] 21 CFR 117.201(c)(2)(i)(A)(b)
[17] Applicants for the exemption must have financial records from 2016-2018 to show that they are a “very small business” as defined in 21 CFR 117.3
[18] 21 CFR 117.201(a)(2)(i)
[19] 21 CFR 117.201(a)(2)(ii)
[20] 21 CFR 117.201(c)(2)(i)(C)(ii)
[21] 21 CFR 117.251
[22] FDA states on its website, “It is important to note that applicability of the CGMPs is not dependent on whether a facility is required to register.” See “FSMA Final Rule for Preventive Controls for Human Food” webpage. Last viewed 8/30/18 at https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
[23] 78 FR 3646, 3651
[24] 21 CFR 117.10 – employee cleanliness and disease control
[25] 21 CFR 117.20 – plant construction, condition of the grounds
[26] 21 CFR 117.35 – general maintenance, cleaning food and non-food contact surfaces, storage of equipment and utensils
[27] 21 CFR 117.37 – water supply, plumbing, sewage disposal, toilet facilities, handwashing facilities, garbage disposal
[28] 21 CFR 117.40 – equipment design requirements
[29] 21 CFR 117.80 – operational requirements for food manufacturing, and food and ingredient storage
[30] 21 CFR 117.93 – sanitary requirements for storage and transportation of food
[31] 21 CFR 117.95 – includes requirements on containers, equipment, and labeling food by-products
[32] 21 CFR 117.110 – Defect action levels. Per 21 CFR 117.3, Defect action level means a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product ‘adulterated’ and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.” [bolded emphasis added]
[33] 42 USC 264(a)
[34] 78 FR 3646, 3651 citing 44 FR 23238 at 33239
[35] 21 CFR 507.5(a)
[36] Letter from FDA Commissioner Gottlieb, July 31, 2018. Last viewed 8/30/18 at
https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM615393.pdf


Photo source at top of article: Sandrine Perez. Photo source at bottom: FSMA webpage on FDA website

A Tale of Two Food Systems


The International Association of Food Protection (IAFP) held its annual meeting July 8-11 at the Salt Palace Convention Center in Salt Lake City, Utah. The event is the world’s largest food safety conference. The IAFP meeting is where food safety professionals meet to discuss pathogens in food and ways to prevent and respond to the problems those pathogens cause. The meeting is an incubator for the one-size-fits-all food safety laws that make it more difficult for small farmers and artisan food producers to make a living. Most of the crowd at the meeting does not distinguish between the industrial food system and the local food system; the regulations the conference sets in motion are geared for industrial food production and distribution and should apply to all food production and distribution in the eyes of the majority of attendees.

Food safety is a growth industry. Globalization and deteriorating quality in the industrial food system are drivers. Over 3,500 attended this year’s meeting; FDA and USDA both sent dozens of personnel to Salt Lake City. State regulatory agencies, academia (students and faculty) and big business were all well represented at this year’s meeting. Cargill, Merck Animal Health, Smithfield, Kroger, the Grocery Manufacturers Association and Walmart were all sponsors of the event.

Food safety is about the prevention of or response to cases of acute illness; there was little mention at the meeting about nutritious or nutrient-dense food and its role in the prevention of chronic disease.

A point those at the meeting frequently discussed was the complexity of long supply chains starting with the manufacturers of ingredients used by the food producer and continuing through various phases of distribution leading to the purchase of the food by the final consumer. The talk was about difficulties in traceability and ensuring safe food along the supply chain. An antidote to this problem would be to facilitate the local production and distribution of food with its short, direct supply chain, and high level of traceability but that was a solution that was seldom, if at all, brought up at the meeting.

Presentations at the meeting included talks on recent outbreaks, developments in testing for pathogens, and various food safety processes such as HACCP. At the same time the presentations are taking place, there is a trade show where vendors showcase, among other things, the latest products for testing and sanitation measures. Also present in the same location as the trade show are posters (written summaries) of studies related to food safety that are displayed for viewing by meeting attendees. Individuals who worked on the studies are present to answer questions.

Some takeaways from the meeting:

  • The FDA’s longtime plan to extend the aging requirement for raw cheese from 60 days to 90 days is alive and well. Part of the evidence for the latest push on this 90-day requirement is an FDA study on how raw gouda cheese inoculated with listeria still contained listeria after 90 days. The FDA scientists who spoke on the study at the meeting acknowledged that the raw milk used in the experiment was intended for pasteurization not direct consumption–a continuation of the agency’s refusal to recognize that raw milk for the pasteurizer and raw milk for the consumer are two different products. Two food safety professionals contacted at the meetings said privately that listeria was a bigger health threat in pasteurized cheese than it was in raw cheese. Regardless, those at the meeting overwhelmingly favor the “kill step” of pasteurization for all dairy products and for other foods.
  • A high-ranking USDA official disclosed that the Office of Investigation, Enforcement and Audit (OIEA), a division of USDA’s Food Safety Inspection Service (FSIS), has undertaken an initiative to increase inspections of small and very small plants (e.g., slaughterhouses and processing facilities); there is evidence that this initiative includes inspecting small food buyers clubs selling meat to their members. The question is why? As of 2016 there were only 150 OIEA inspectors in the whole country. Few, if any, food safety problems have been attributed to small plants and very small plants much less to small private food buyers clubs. Wouldn’t it be a more productive use of resources to have the OIEA personnel increase oversight for imported meat and large USDA facilities slaughtering 300-400 cattle an hour–where there are many more food safety problems?
  • A high-ranking FDA official spoke about the proposed merger of food regulation between USDA and FDA with the former taking over all food regulation The official said it could be a long process but did not dismiss the merger. The merger would likely be an improvement over the current situation; FDA policies on positive bacteria test results are more strict than either the USDA or European Union countries and lead to more cases of quality, safe food winding up in a landfill.
  • One of the featured speakers at the meeting supported the universal adoption of the FDA Food Code, a burdensome regulatory scheme whose cost of compliance is difficult to afford for many small farmers and local artisans producing nutrient-dense food. The late Sue Wallis, the legislator who initially introduced the Wyoming Food Freedom Act, indicated that the main reason she introduced the legislation was to get local food producers selling direct-to-consumers as far away from the requirements of the Food Code as possible. Since 2015 four states–Wyoming, North Dakota, Utah and Maine–have passed food freedom legislation allowing for the unregulated sale of food direct to consumers. As far as is known not a single foodborne illness outbreak has been attributed to a producer operating under these laws in any of the four states.
  • Bill Marler, regarded by many as the leading foodborne illness personal injury lawyer in the country, acknowledged that in his 25 years of experience he could not recall having a single client sickened by food purchased at a farmers market.
  • There was lots of discussion at the meeting about the recent outbreak attributed to the consumption of romaine lettuce where 5 people died and over 200 others became ill. It turns out that the plant which processed the lettuce was subject to the requirements of the Food Safety Modernization Act (FSMA). Excessive regulation from FSMA doesn’t necessarily mean greater food safety but can mean a decline in food safety with small and midsize producers going out of business due to being unable to afford the cost of compliance.
  • Out of 50 states, 46 have signed cooperative agreements with FDA, receiving federal grant money in return for carrying out inspections to enforce FSMA’s federal produce safety. An attendee at the conference from a state public health department related how her department ran out of the federal money in carrying out a cooperative agreement with FDA and had to tap into a state general fund to get more money to finish carrying out the agreement. This is not uncommon. State agencies signing cooperative agreements with FDA should have a clause in the agreement that they do not have to carry out any further duties under it if the federal money runs out.
  • Most of the presentations and posters at the meeting had to do with industrial food but there were at least a couple exceptions that were favorable to local food. A USDA scientist did a presentation on pastured poultry reporting among other things that poultry fed a soy-free diet had substantially less campylobacter in their systems. There was a poster on the quality of raw milk for retail sale in Maine reporting on the low incidence of illness attributed to raw milk consumption in that state.
  • The atmosphere at the meeting was friendly, a good one for engaging attendees on why locally-produced food should not be regulated the same as industrial food. Most of those attending are trained that there is only one food system. One individual who worked on a poster supporting more regulation of cottage food producers was asked if she was aware of any cases of foodborne illness attributed to the consumption of cottage foods. She said no but then added that it was because cottage foods weren’t traceable. In general there are hardly any foods that are more traceable than cottage foods.

Most cases of foodborne illness are caused by industrial food; this is true even when factoring in the market share industrial food has compared to local food. Unregulated local food producers have plenty of incentive to produce safe food: their families consume the same food they are selling, one recall can put them out of business, and one case of foodborne illness can put them out of business. Food safety regulators like dealing with short supply chains and a high degree of traceability; local food producers–regulated or not–satisfy both of these parameters

When you also factor in the amount of chronic illness the local food and industrial food systems are responsible for, there is no question the local food system is responsible for fewer cases of chronic illness even when the market share of the two systems is accounted for. Take a survey on the demand those who obtain a majority of their food from the local system make for services on the medical system versus those who obtain a majority of their food from the industrial system. Policymakers should take both acute and chronic illness into consideration when crafting food regulations and legislation. The more local food producers there are the less demand there will be on the medical system for services; food freedom laws lead to more local producers.

The IAFP meeting is a place where ideas for food safety legislation are first introduced. It can also be the place where the effort begins to convince regulators that there are two food systems and that one-size-fits-all food safety regulation doesn’t work.

Food safety professionals have done a great job improving safety in areas of the industrial food system; often when dealing with multiple producers/distributors and multiple countries in an investigation–thankless work. Laws and policies contributing to an increase in local food production would make their jobs easier.

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.

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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
https://www.federalregister.gov/documents/2013/01/16/2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human

FDA Antibiotic Test Requirement Threatens to Cut Raw Milk Supply in Pennsylvania


Controversial antibiotic test requirements imposed by the U.S. Food and Drug Administration (FDA) will be going into effect next month in Pennsylvania. According to the Pennsylvania Department of Agriculture (PDA), Pennsylvania will be the last state to implement the testing requirements; FDA initially issued them in 2011.1 The requirements will especially impact raw milk farmers who sell part of their production to dairy cooperatives for pasteurization as well as selling raw milk direct to the consumer or through retail stores. The main reason that the FDA testing mandate has received much more attention than in any other state is that there are more producers in Pennsylvania than any other state whose raw milk goes for both pasteurization and for direct consumption. Thanks to laws in neighboring states that either restrict or prohibit raw milk sales or distribution to consumers in both the northeastern and mid-Atlantic regions rely on Pennsylvania raw milk producers for their sustenance.

The antibiotic testing requirements are that farmers producing either raw milk for pasteurization or raw milk to be manufactured into other dairy products (such as raw or pasteurized cheese) must test every batch of raw milk produced for antibiotic residue even if the producer’s dairy operation is certified organic. Producers who only produce raw milk for human consumption are not subject to the FDA testing requirement. Producers subject to the testing mandate will either have to do their own testing on equipment that could cost thousands of dollars to purchase, pay thousands each year for testing by a state-approved lab or, in the case of producers selling to a co-op, wait to get test results (milk haulers transporting milk for co-ops collect samples for testing of each batch of raw milk they pick up from a farm belonging to the co-op). Producers cannot commingle any milk from a subsequent batch until they get test results back from the co-op; further complicating matters is the fact that co-ops typically do not report test results to member farmers at all, much less on a timely basis. PDA has gotten reports of producers working with co-ops to create a process for timely reporting of test results but it remains to be seen how these efforts pan out.

Dairy Farmers of America, a co-op with a history of strong opposition to legalizing raw milk sales for human consumption, controls a substantial percentage of raw milk produced for pasteurization in Pennsylvania, possibly over one-half of the total. Trickling Springs Creamery, a well-known Pennsylvania co-op, has already notified its members that one hundred percent of their production must go to the co-op; members will not be able to retain any raw milk for retail sales or for manufacturing into any other dairy product. If a farmer selling raw milk to a co-op for pasteurization is found to violate the antibiotic testing requirements, FDA can not only stop the farmer’s shipments to the co-op, it can shut down the co-op from making any shipments in interstate commerce.

To its credit, PDA (with FDA’s approval) has established a variance process, where those dairies it grants a variance will be exempt from the antibiotic testing requirements.2 Forty farmers have applied for the variance so far; out of the sixteen applications PDA has reviewed, it has approved seven for a variance. Those eligible for the variance include those farmers that pasteurize and bottle all the raw milk they produce and those manufacturing other dairy products only from raw milk produced on their farm. Producers selling any of their raw milk production to a co-op are not eligible for a variance per order of FDA; the nine applications PDA rejected were all from those selling part of their production to a co-op.

A PDA official estimated that as many as one-half of the 68 Pennsylvania dairies permitted to produce and sell raw milk for human consumption are Grade A dairies that sell some of their milk production to a co-op. If these dairies aren’t able to make a workable arrangement with their co-ops on reporting test results, the cost of antibiotic testing could drive many to drop their permits and get out of the raw milk business when antibiotic residues in the milk was never a problem for any of them to begin with. The FDA testing requirement, in their cases, has nothing to do with protecting the public health.

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[1] Public Health Service/FDA, Appendix N Drug Residue Testing and Farm Surveillance, “Grade A” Pasteurized Milk Ordinance 2015 Revision; pp. 374-379. Note: the PMO is a document governing the production distribution, and transportation of raw milk intended for pasteurization; Pennsylvania and nearly all other states have adopted the PMO and the other states must have standards at least as strict. Accessed 12/20/2017 at https://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/milk/ucm513508.pdf
[2] PDA Commissioner Russell Redding, Letter to Pennsylvania Milk Permitholder, 4 October 2017. Subject: Update on Implementation of Drug Residue Testing Requirements of FDA’s Appendix N of the Pasteurized Milk Ordinance”

FDA Files Lawsuit to Seize Healthy Food

On October 19, 2017, the United States Food and Drug Administration (FDA) filed a complaint with a federal district court in Kansas to seize and condemn around $70,000 of raw camel milk, pasteurized camel milk, raw camel milk colostrum, and raw camel milk kefir.[1] The camel milk products are currently being held at a frozen food warehouse, My Magic Kitchen, located in Kansas City. The Kansas Department of has placed all the products under embargo, prohibiting their movement from the warehouse.

All labels on the frozen products FDA wants to seize bear the name Desert Farms; the Santa Monica, California based company is the largest raw milk distributor in the U.S. According to the complaint, Hump-Back Dairys of Miller, Missouri produced nearly all of the product being held at the warehouse; the dairy is, by far, the largest camel milk producer in the country.

There has been a thirty-year ban on raw dairy products (other than aged raw cheese) in interstate commerce; FDA interprets the ban to extend to raw milk camel products. In December 2016 Samuel Hostetler, the owner of Hump-Back Dairys, received a warning letter from FDA.[2] The letter to Hostetler warned that he was violating the interstate ban by shipping both raw camel milk and raw camel milk products in interstate commerce; Hostetler responded to the warning letter by informing the agency that he would be complying with the federal regulation establishing the ban.

Walid Abdul-Wahab, the president of Desert Farms, also received a warning letter from FDA in September 2016 but the letter did not mention the interstate raw dairy ban; instead the letter accused Desert Farms of violating the law by shipping “new drugs” that were not approved by FDA in interstate commerce.[3] The letter noted that Desert Farms was making health claims on its website and facebook page about how camel milk was being successfully used to treat various diseases, especially autism. The letter warned that the camel milk products were drugs because “they are intended for use in the care, mitigation and treatment of disease”. As such they were “new drugs” that needed approval from FDA before they could be marketed. The FDA approval for new drugs processing can cost in the hundreds of millions of dollars.

The FDA suit filed for the seizure and destruction of the camel milk products alleges that Desert Farms’ social media pages (Facebook, Twitter, YouTube and Instagram) linked to the company’s website contain claims that “demonstrate that the camel milk products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, including autism, diabetes, multiple sclerosis, Crohn’s disease, viral infections such as hepatitis, the genetic disorder Machado-Joseph, depression, gastrointestinal disease, heart problems, attention deficit disorder, autoimmune diseases, Hashimoto’s disease and cancer.”[4]

What neither the warning letters nor FDA’s complaint for seizure allege is that the camel milk products are adulterated or a threat to human health. As far as is known there has never been a case of foodborne illness in this country attributed to consumption of camel milk. Destruction of the camel milk products at the warehouse would be an absolute waste of healthy food.

It is estimated there are over 10,000 families with autistic children in the U.S. that purchase raw camel milk; many of these families pay $18 a pint or more for the product. There is a reason for that; parents of autistic children have found that raw camel milk and camel milk products can alleviate the symptoms of the condition known as autism spectrum disorder. The science backs them up [5]; pasteurized camel milk can be effective in alleviating the symptoms of autism as well though not to the same degree.

Earlier this year FDA released an article on its Consumer Updates page titled, “Autism: Beware of Potentially Dangerous Therapies and Products.”[6] In the article FDA warns about taking camel milk as a treatment for autism and autism-related symptoms. When FDA warns about taking a product for a disease, it is often because the product is a threat to the profits of the pharmaceutical industry.

FDA is seeking a court order to destroy over 4,300 8- and 16-ounce bottles of camel milk products; product that can help autistic children cope with their condition. The judge hearing the case has the discretion to release the product to Desert Farms.[7] If Walid Abdul-Wahab shows the court that any health claims are no longer on the Desert Farms website and social media and that he is willing to pasteurize the camel milk (with the interstate ban, he would have no choice if he wants the product released) and label the milk containers accordingly the judge could release the product to Desert Farms. Healthy food like this should not wind up in a landfill.

A court date for a hearing on the seizure petition has not been set yet.

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[1] United States of America v. Camel milk products, et al, Kansas Civil Action No. 17-2609 (2017). Access docket files via Pacer.gov for Case #: 2:17-cv-02609-CM-KGS. Retrieved 11/18/2017 from Justia.com at https://dockets.justia.com/docket/kansas/ksdce/2:2017cv02609/118800

[2] FDA warning letter to Samuel P. Hostetler (DBA) Hump-Back Dairys, dated 12/19/16. Retrieved 11/18/2017 at https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534108.htm

[3] FDA warning letter to Desert Farms, dated 9/15/16. Retrieved 11/19/2017 at https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm524663.htm

[4] United States of America v. Camel milk products, et al

[5] “Casualties of the Raw Milk Ban”, January 17, 2017, Farm-to-Consumer Legal Defense Fund website. Retrieved 11/18/2017 at https://www.farmtoconsumer.org/blog/2017/01/17/casualties-raw-milk-ban/

[6] FDA, “Autism: Beware of Potentially Dangerous Therapies and Products”, www.fda.gov updated April 12, 2017; originally published April 25, 2014 (see https://www.actcommunity.ca/resource/3565/). Retrieved 11/18/2017 at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm394757.htm

[7] United States Code, 21 USC 334(d). Accessible at https://www.law.cornell.edu/uscode/text/21/334

FDA Boxed in on Interstate Ban

For some time now, enforcement on the interstate ban of raw milk and raw milk products by the United States Food and Drug Administration (FDA) has looked to be an exercise in futility (only raw cheese aged 60 days or more is legal in interstate commerce). Thousands of otherwise law-abiding citizens violate the ban in this country on a regular basis. FDA has stated that it will not enforce the ban against individuals transporting raw milk across state lines for their own consumption; to the FDA, it is dangerous when someone is transporting raw milk for consumption by a group of people but is somehow safe when it is only for an individual.

FDA’s last enforcement action against a raw milk producer, concluded over five years ago, has not deterred demand; more consumers want raw dairy products than ever. FDA has never publicly acknowledged that the ban has been a failure but once again it has the opportunity to do so and respect consumer freedom of choice. There are currently two petitions before FDA on the regulation (21 CFR 1240.61) establishing the interstate ban—one filed by Organic Pastures Dairy Company (OPDC) and the Farm-to-Consumer Legal Defense Fund (FTCLDF) and the other filed by the Real Food Consumer Coalition (RFCC). Repeal of the interstate ban is long overdue; granting of the two petitions would be a significant step toward making that a reality. No matter what FDA decides, it is going to have to answer once again why it has not repealed a law that does not work.

On June 22, 2016, FDA received a petition from OPDC and FTCLDF requesting that FDA lift the interstate ban on raw butter. FDA’s only response to date has been a December 13, 2016 letter stating it needed more time to reach a decision on the petition. Federal law requires that FDA respond to a citizen petition within six months of its filing; unfortunately, the courts regard a statement from the agency that it needs more time as a satisfactory response.

More than anything the raw butter petition is a request to FDA that the agency obey the law; in establishing the raw butter ban, FDA violated and continues to violate the Federal Food, Drug, and Cosmetic Act (FFDCA). The FFDCA contains a statute governing standards of identity for foods. Standards of identity are requirements prescribing what a food product must contain to be marketed under a certain name in interstate commerce. For instance, the standard of identity for milk in final packaged form requires that it be pasteurized or ultra-pasteurized and that it contain not less than 8.25% non-fat milk solids and not less than 3.25% milkfat.1 FDA’s long held position is that the pasteurization requirement can be part of the standard of identity. Standards of identity are intended to promote honesty and fair dealing for the benefit of consumers.

Congress has given FDA power to issue regulations establishing standards of identity for most foods, but there are exceptions and one of those is butter. The FFDCA specifically prohibits FDA from establishing a standard of identity for butter; Congress has passed a law defining butter that serves as a standard of identity for the product. That definition does not require butter to be pasteurized. The petition asks FDA to abide by the statutory standard of identity and to stop breaking the law in the name of the law.2

FDA justifies the ban on the grounds that it has the power to regulate communicable disease, a claim the federal government’s own statistics show has no foundation. If raw butter can be banned under this power, just about any other food could be, as well. The citizen petition notes that since the Centers for Disease Control (CDC) created the Foodborne Outbreak Online Database in 1998, not even one foodborne illness outbreak has been attributed to the consumption of commercially produced raw butter.3 There is one 2007 outbreak in Utah where homemade butter was listed as a possible cause for an outbreak as were raw milk and homemade soft raw cheese; given butter’s food safety history, it is likely that the milk or cheese was the cause.

The irony is that possibly more than any other raw dairy product, consumers purchase raw butter for its health benefits. FDA can do better than violate the law by banning a product that doesn’t make people sick.

The RFCC petition, sent to FDA on April 26, 2017, requests that:

“FDA exercise its enforcement discretion to avoid taking, and to cease taking, enforcement action against those who distribute unpasteurized milk and milk products in interstate commerce when the milk products bear labels that include in conspicuous bold face type prominently displayed on the statement of identity for the product: (1) a warning regarding the health risks of unpasteurized milk and milk products; and, when applicable, (2) instructions for safe handling, including self-pasteurization.”4

There is a precedent for the warning label requirement; another regulation, 21 CFR 101.17(g) requires that there be a warning label with a specific statement for juice that has not been pasteurized. The warning label and safe handling statements are intended to provide information and education to the consumer to address FDA’s concern that the agency needs to protect people from themselves.

The petition notes that the request it is making is in line with presidential executive orders issued earlier this year to reduce the regulatory burden on a Regulatory Reform Task Force that is required “at a minimum” to identify regulations that “eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency. . .”5 The quote is a good description of the interstate raw milk ban.

The RFCC consists of members of some of the bigger food buyers clubs around the country obtaining raw milk, including many mothers who will do whatever it takes to access the foods they believe best for their children’s health, even if that means violating ill-conceived regulations banning foods they have a legal right to consume.

The two petitions are pushing FDA to reevaluate the ban and do the right thing by repealing it. It is time for the FDA to honor freedom of choice and get rid of a regulation a federal judge once described as being in a state of “desuetude,”6 a word meaning “not being used.” A law not worth enforcing is not worth having on the books.

FTCLDF Code of Regulations states that a goal of the organization is “overturning the federal regulation banning the interstate shipment of raw milk (and raw milk products) for human consumption.” That day is getting closer. Thanks to  your support, FTCLDF and other raw milk advocates are winning this battle. Help us continue our push towards ending the ban by attending our fundraiser or by making a donation.

Footnotes:
1 Farm-to-Consumer Legal Defense Fund. Raw Butter Is a Communicable Disease. June 23, 2016. Posted online at https://www.farmtoconsumer.org/blog/2016/06/23/raw-butter-communicable-disease/
2 Mark McAfee and Farm-to-Consumer Legal Defense Fund. Citizen Petition to Lift Interstate Ban on Raw Butter. p. 5 Posted online at
https://www.farmtoconsumer.org/wp-content/uploads/2016/06/1-CitPetFDA-Butter-062216-1.pdf
3 Centers for Disease Control and Prevention. Foodborne Outbreak Online Database. Posted online at https://wwwn.cdc.gov/foodborneoutbreaks/
4 Emord & Associates. Citizen Petition to Exempt from 21 C.F.R. § 1240.61(a) Certain Unpasteurized Milk and Milk Products if Properly Labeled. Posted online at http://hartkepr.com/wp-content/uploads/2017/05/2017-4-26-RFCC-Petition-GoFundMe.pdf
5 Ibid.
6 Judge Mark Bennett. Memorandum Opinion and Order Regarding Plaintiffs’ Motion to Amend Judgment. May 1, 2012. [PDF]

Raw Milk Dairy Under Investigation

CDC accuses Millers Organic Farm of causing raw milk illness

CDC accuses Millers Organic Farm of causing raw milk illness

A Pennsylvania Raw Milk Dairy Under Investigation by government agencies?

The raw milk dairy under investigation is Miller’s Organic Farm in Pennsylvania, which we wrote about several weeks ago when the CDC accused them of causing illness in 2 people.

David Gumpert has been uncovering additional facts in the case agains this raw milk dairy and reporting about it on his blog.

In his most recent article, he states

“If owner Amos Miller fails to allow inspection of his facilities by the deadline, the U.S. Justice Department “will be forced to initiate enforcement proceedings,” it said in a recent letter to the Pennsylvania farmer. While the Justice Department didn’t say exactly what it plans, presumably it will seek either an injunction of some kind, or a similar action, which would ostensibly restrict sales of Miller’s food and impose severe fines or raids for violation of a court order.”

“Regardless of which agency takes the legal lead, the government’s intent is to challenge Miller’s on the basis of safety rather than the legitimacy of private food distribution. Government lawyers know that it will be much easier to convince a judge to enforce an injunction or similar legal device based on fear-mongering than on the legal aspects of private membership associations.”

Since Miller’s Organic Farm operates as a private membership association so that others can enjoy the raw milk and other raw dairy products, this is an important case to watch. When the FDA, USDA or state level agencies target one farm for “enforcement,” they are effectively targeting all who want access to nutrient dense and healing foods. Including and most especially fresh raw milk from grassfed cows.

An email address is set up to collect testimonials about products from Miller’s Organic Farm and all letters of support. Send emails to WriteToMillers@gmail.com

For a virtual tour of the farm and the family who operates it, see the recent post on Nourishing Liberty about Miller’s Organic Farm

We will continue to update this situation as it changes.

To learn more about raw milk and other nutrient dense foods, visit westonaprice.org

Is the FDA Quietly Beginning a Campaign Against Raw Milk Cheese?

Maybe it is because it is considered “artisanal” or maybe because it is camouflaged in grocers’ coolers among other cheeses but, for whatever reason, unpasteurized cheeses have never produced quite the same uproar as has raw milk. That might change in the future – David Gumpert is watching the FDA and, on his blog The Complete Patient, he suggests that the FDA is quietly gathering information to begin a campaign against raw milk cheese.

Gumpert noticed that the FDA recently posted a notice on its website that it is seeking input to help it “minimize the impact of harmful bacteria in cheeses made from unpasteurized milk” and is particularly interested in “learning more about the standards and practices in use by…the growing artisanal cheese manufacturing community.”

While this might seem to be an innocent start of an ongoing dialogue between the FDA and the cheese community, Gumpert points out that the FDA does not currently have any evidence of illnesses caused by raw milk cheeses. Gumpert suspects that the FDA appears to be looking for data that will allow it to ultimately try to ban raw milk cheeses.

Read more here.

Support the Campaign for Real Milk, join the Weston A. Price Foundation, today!

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.

Popular Wisconsin Raw Cheese Producer Stops Production

In August, Wisconsin-based Rush Creek Reserve announced it would stop making its popular raw milk cheese, due to uncertainty over pending FDA regulations related to raw cheese.

“Food safety officials have been unpredictable, at best, in their recent treatment of soft, raw-milk cheeses, and until our industry is given clear and consistent guidance, we are forced to stop making these cheeses,” said co-owner Andy Hatch.

He added that he hoped the halt in production would be temporary, but loyal customers have already taken to Twitter to express their outrage: @cheesegeek wrote, “The premature death of Rush Creek Reserve is the canary in the coal mine for all American raw milk cheeses.”

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.