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.

—————–
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.

Utah Raw Milk and Homemade Food Bills Now Law


On March 21 Governor Gary Herbert signed the Home Consumption and Homemade Food Act (House Bill 181 – HB 181) into law, making Utah the fourth state after Wyoming, North Dakota and Maine to adopt food freedom legislation. Utah, with a population over 3 million, is the most populous state to pass a food freedom bill so far. The population of the capital, Salt Lake City, is a little under 200,000; the Salt Lake metro area population is over one million.

Two days prior, on March 19, Herbert signed Senate Bill 108 (SB 108), legislation increasing opportunities for the permitted sales of raw milk as well as expanding consumer access to the product. It’s been some week for supporters of local food in the state. The mother-daughter team of farmers Symbria and Sara Patterson were the driving force behind both bills. Both pieces of legislation go into effect immediately.

HB 181 allows the unregulated sale of all foods within Utah except raw dairy and meat products direct from the producer to an “informed final consumer.” There are two exceptions to the prohibition on the unregulated sale of meat products. Producers can sell poultry and poultry products under the bill as long as they slaughter less than 1,000 birds a year. Producers of domesticated rabbit meat are also able to sell direct to consumers without regulation “pending approval from the United States Department of Agriculture that the state’s role in meat inspection is preserved”–approval that shouldn’t be more than a formality.

Sales under the bill can be made at a farm, ranch, “direct-to-sale farmers market”, home, office or any location agreed upon between the producer and consumer. The only requirement for producers is that they inform consumers that the food sold has “not been certified, licensed, regulated or inspected by state or local authorities.” If producers are selling at a farmers market, they must display signage indicating this information; producers selling without regulation at the farmers market must be separated from other vendors at the market.

SB 108 allows producers with a permit to deliver and sell raw milk “from a mobile unit where the raw milk is maintained through mechanical refrigeration at 41 degrees Fahrenheit or a lower temperature.” Under prior law licensed dairies could only sell raw milk on the farm or at a retail store if the dairy had a majority ownership interest in the store–only two of the state’s ten permitted dairies meet this requirement.

SB 108 also allows unpermitted dairies to sell up to 120 gallons of raw milk per month direct to the consumer on the farm. Producers selling under this exemption must comply with labeling, recordkeeping, animal health and milk testing requirements; producers must also notify the Utah Department of Agriculture and Food (UDAF) “of their intent to sell raw milk.”

Symbria and Sara Patterson have taken time off from the farm each of the last four legislative sessions to lobby for legislation they have developed promoting unregulated producer-to-consumer direct trade. The Pattersons are respectful but persistent. In 2015 they were successful in getting micro-dairy herdshare legislation passed despite opposition from Utah Farm Bureau, the state dairy industry, and UDAF. In 2016 and 2017 they worked on food freedom legislation that did not make it out of committee–showing the tremendous progress they have made in a short period of time. As the session went on, opposition to HB 181 and SB 108 steadily decreased; HB 181 passed unanimously in the Senate and SB 108 did the same in the House.

The Pattersons have put together a formidable team to work on local food legislation consisting of Representative Marc Roberts, lobbyist Royce Van Tassell and farmer/analyst Paula Milby. Roberts has been the champion of food freedom in the Utah legislature the past four years, patiently staying the course when the opposition to the bills he introduced looked to be overwhelming. He, the Pattersons, Van Tassell and Milby showed a knack this past session for crafting legislation that would minimize opposition while not compromising what they were trying to accomplish. Connor Boyack, the president of the non-profit Libertas Institute, has helped significantly since 2015.

The Pattesons received earlier funding to help their legislative work from the Farm-to-Consumer Legal Defense Fund and State Policy Network but thanks to their formation of the non-profit Red Acre Center (RAC), they are now able to pay for lobbying and other expenses related to legislative efforts through donations to RAC–among expenses is paying for a farm manager when the Pattersons are away lobbying in the capital, Salt Lake City. Their Red Acre Farm in Cedar City operates a thriving vegetable CSA and sells meat and poultry products as well. The RAC is an education and advocacy nonprofit center that holds an annual conference in January; it has quickly become part of the conversation about who the influential organizations are in Utah food and agricultural policy. The Pattersons are building Red Acre Center for the long haul to be part of the political and educational landscape of food and agriculture in the state.

An interesting dynamic in SB 108 was that the bill likely would not have passed without the support of the Utah business empire, Redmond Inc. Redmond is primarily known for its manufacture of salt but it also has a raw milk operation, Redmond Heritage Dairy, that sells raw milk in several stores Redmond owns throughout Utah. Redmond wanted SB 108 to pass so it could deliver around the state. The company was the driver behind 2007 legislation that banned herdshares while allowing the sale of raw milk retail stores by a permitted producer that held a majority ownership interest in the store selling the raw milk. The Pattersons partially rectified the ban on herdshares with the 2015 legislation legalizing micro-dairy herdshare programs; they worked with officials from Redmond on the passage of SB 108.

RAC has joined Redmond, Utah Farm Bureau, the conventional dairy industry and UDAF as a player in Utah food and agriculture legislation. For Red Acre Center it shows the success that can result when you have a few dedicated individuals that don’t take “no” for an answer.

Victory in North Dakota: Food Freedom Act Intact


One of the more brazen power grabs involving local food in recent years came to end March 21 when the North Dakota Department of Health (NDDoH) withdrew proposed rules that would have substantially watered down the North Dakota Food Freedom Act (FFA), groundbreaking legislation that passed in 2017.

The FFA allows producers to sell any food (referred to as cottage foods in the legislation) without regulation except meat, dairy and foods with either meat or raw dairy as an ingredient. The FFA gave NDDoH no rulemaking power but that didn’t stop the department from trying to weaken the legislation. NDDoH convened a workgroup after the bill passed last year to draft regulations governing the FFA; the composition of the workgroup was stacked against its members that had supported the legislation.

Last month NDDoH published proposed rules that were an attempt to substitute its judgment for the legislature’s and reduce the number of cottage foods that could be sold without regulation from what the FFA allowed.

The proposed rules prohibited the sale of canned foods such as sauerkraut or pickles if their pH and/or water activity was above a certain level; nothing in the FFA contained this requirement. The rules required that producers sell only whole frozen poultry; nothing in the FFA has this limitation. Moreover, North Dakota has adopted the federal regulation governing the production and sale of poultry which allows the sale of fresh poultry, poultry parts and value-added products such as chicken pot pie and chicken broth.

The proposed regulations would also have prohibited the production and sale of certain dry goods, dehydrated and beverages such as kombucha that are all allowed under the FFA.

Opposition to NDDH was widespread. North Dakota Farm Bureau which had supported the FFA worked to get the department to withdraw the proposed rules. The national nonprofit Institute for Justice also made an impact, pointing out in a letter to NDDH Commissioner Mylynn Tufte by one of its attorneys that under the FFA a state agency could not regulate the preparation or sale of cottage food products.

Dairy farmer LeAnn Harner who heads the advocacy group North Dakota Food Freedom helped coordinate opposition to the rules, Harner, who was instrumental in the passage of the FFA, worked with legislators to move NDDoH to honor the legislative intent that there be no regulation of cottage foods.

The key legislators in getting NDDoH to withdraw the rules were Representative Luke Simons (the sponsor of the FFA) and Representative Aaron McWilliams. In a statement posted on the North Dakota Food Freedom Facebook page, Rep. McWilliams said that he and Rep. Simons had met with Commissioner Tufte along with a representative from the governor’s office and explained to them the legislative intent behind the FFA. McWilliams said, “We discussed what the role of the health department would be with cottage food producers, mainly education.”

On March 20 NDDoH issued a news release stating it was “closing the public comment period and cancelled three hearings inviting comment on proposed cottage food laws [scheduled for March 22nd and 23rd]”–meaning it was withdrawing the proposed rules.

The FFA is staying intact. The department’s bureaucratic power grab came up short.

Governor Burgum with supporters of the North Dakota Food Freedom Act

Michigan MDARD’s Farewell Present to Mark Baker

This past June heritage breed hog farmer Mark Baker announced that he was getting out of commercial farming and would be moving to a smaller farm where he and his family would continue to grow their own food. After a four-year battle with the state of Michigan over his challenge to an Invasive Species Order (ISO) on feral hogs, Baker had grown tired of dealing with state agencies and an unfavorable regulatory climate and was ready to move on to homesteading. Little did he know that the Michigan Department of Agriculture and Rural Development (MDARD) was going to give him a final reminder of why he wanted out of commercial farming.

Baker operates a custom slaughterhouse on his farm in Missaukee County, mainly slaughtering and processing chickens for some 200 families in his community. He also has a permit from MDARD enabling him to sell chicken and pork raised on his farm and each year pays a renewal fee for the permit. His plan was to keep the permit and continue sales of pork and chicken until he sold the farm.

In July Baker received a letter from MDARD stating that he was being denied a permit to conduct his custom slaughter business because he hadn’t paid his renewal fee. When Baker’s wife Jill produced the canceled check showing he had paid, the department changed its story, now claiming it was denying the permit because Baker refused to let MDARD officials conduct an inspection of his farm during a December 2015 raid of his farm, Baker’s Green Acres (BGA). MDARD had obtained a warrant to search the farm; someone contacted the department to notify it that there was a picture in a magazine story of a chef holding a ham that the story said was produced by BGA. MDARD wanted to search Baker’s premises to make sure the meat he was selling was slaughtered and processed at a USDA facility.

Baker responded to this latest accusation by explaining that he hadn’t refused an inspection but had only asked the inspectors to wait until some friends of his arrived at the farm to observe the proceedings. The inspectors decided to leave rather than wait.

On August 5 MDARD relented and renewed Baker’s permit; before the renewal, an official from the department called a farmer who relied heavily on Baker’s establishment for her meat sales and told her that she couldn’t use the facility at BGA because it wasn’t permitted.

The harassment from MDARD over the permit convinced Baker to move his timetable up on his sales of chicken and pork; on August 27 Baker decided to surrender his permit saying that MDARD’s jurisdiction over his business was like a forced partnership that he no longer wanted to have. It’s the kind of partnership where the farmer supplies the labor and innovation and MDARD supplies the red tape.

Baker said that regulation by MDARD is not about food safety but control; a belief many others hold. He pointed out that bureaucrats should not be able to use their influence to pick winners and losers. He said that he was no longer going to put his family through MDARD’s harassment.

The MDARD permit denial of BGA was retribution for Baker’s successful challenge to the ISO on feral swine issued by the Michigan Department of Natural Resources (DNR) in December 2010. The ISO, which had the strong backing of the Michigan Pork Producers Association prohibited the possession of a number of breeds of swine. When asked to clarify what the ISO meant, DNR issued a declaratory ruling establishing that whether a pig violated the ISO was not going to be determined by whether the pig was living in the wild or outside containment but rather on its physical characteristics. According to the declaratory ruling, a pig could be prohibited if it has either “curly or straight tail structure” or “either erect or folded/floppy ear structure.”

Baker, who was raising heritage breed mangalitsa pigs, filed a lawsuit challenging the constitutionality of the ISO in April 2012. DNR, through the state attorney general, responded to the lawsuit by filing a countersuit of its own, seeking to have Baker’s pigs condemned and destroyed for violating the ISO. Later, after Baker became publicly critical of Michigan Attorney General Bill Schuette for his handling of the case, DNR amended its complaint and sought a court order fining Baker $700,000–$10,000 for each pig Baker owned that it claimed was illegal.

Just weeks before the case was to go to trail, DNR changed its position on Baker’s pigs, now saying they were legal; this shift by the agency resulted in the dismissal of both Baker’s lawsuit and DNR’s countersuit in February 2014. DNR officials did not want the case to go to trial because they knew Baker would expose the declaratory ruling for the sham that it was. DNR subsequently withdrew the declaratory ruling but the ISO is still on the books to this day. As Baker has said many times, there is no evidence that there is a feral swine problem in Michigan.

Even though the focus has been more on DNR and the Michigan Pork Producers Association, MDARD was right in the middle of the creation of the ISO. Nancy Frank, state veterinarian in MDARD’s Division of Animal Industry, had a major role in the creation of the order. MDARD was also responsible for significant losses in Baker’s business because he stood up to the state. Shortly after Baker filed his lawsuit, MDARD employees started contacting restaurants purchasing pork and other products from Baker intimidating them into dropping their business with the farmer; Baker lost almost all of his restaurant accounts. MDARD also worked with the U.S. Department of Agriculture to inform slaughterhouses not to process feral swine, effectively limiting Baker’s access to those facilities.

Food produced at Baker’s Green Acres has never been accused of making anyone sick.

Baker and his family have paid the price for his successful challenge to government and industry’s attempt to create the conditions for cutting out the market share for heritage breed hog farmers. MDARD’s latest harassment was one final message to the farmer that it’s time to move on.

Making a Difference in Tennessee


The story of Michele Reneau serves as an example of how a consumer can make an impact in advancing freedom of food choice. Reneau, who along with Nate and Anju Wilson manages a Chattanooga food buyers club, was the one most responsible for turning a potential enforcement action by the Tennessee Department of Agriculture (TDA) into a legislative breakthrough and a new law benefiting food buyers clubs throughout the state.

Reneau, a Weston Price chapter leader and Farm-to-Consumer Legal Defense Fund (FTCLDF) member, has the right temperament and personality to take on government regulators. She doesn’t accept their general assertions of authority, contesting the regulators point by point—asking for specific citations in the law to back up their claims. She gives up ground to regulators grudgingly and is a strong believer that there is a legal distinction between the private and the public distribution of food.

Reneau, along with the Wilsons, manages the Weekly Fig, a private membership association. Among other foods, Weekly Fig distributes meats, eggs, raw dairy and baked goods to its members. On May 4, 2016, an official from TDA attempted to inspect the Weekly Fig’s facility for the storage and distribution of food. TDA had discovered Weekly Fig through the inspection of a neighboring licensed facility in the same complex. Reneau refused to let TDA conduct the inspection of the buyers club facility claiming TDA did not have jurisdiction over her operation. On June 6 counsel for TDA sent Reneau and the Wilsons a warning letter identifying violations the Weekly Fig had allegedly committed, including operating an unlicensed establishment, offering for sale raw juice, and offering for sale raw milk and raw milk products.

An informal hearing was held on the matter June 30 between a representative for Weekly Fig and TDA officials; subsequently, the department sent Weekly Fig correspondence upholding the written warnings against their unlicensed operation of a “food establishment” and their sale of raw milk, putting Reneau and the Wilsons on notice that “future violations of the same or similar sort—i.e. unlicensed operation as a food establishment or sale of raw milk—will be considered grounds for the Department to seek actions for injunction and/or criminal charges.”

With there not being favorable case law on a legal distinction between public and private distribution of food, Reneau took the legislative route to fight back against the threat from TDA. On February 8, 2017, Tennessee State Senator Frank Niceley and State Representative Kevin Brooks introduced, respectively, Senate Bill 651 and House Bill 702, legislation providing that no permit is required to operate “a farm to consumer distribution point” (e.g., food buyers club). The bills were amended to add that the facility must register with the state department of revenue for purposes of paying sales tax 1 and must agree to only allow deliveries of meats produced by farmers who comply with the Tennessee Meat and Poultry Inspection Act; these are both existing requirements the facility is expected to comply with anyway. On May 11, 2017, SB 651 was signed into law. Reneau testified at the Senate committee hearing on the bill and, according to Senator Niceley, did a great job. FTCLDF worked on the development of the bill.

SB 651 is a big help for farmers; consumers like their convenience and will go more often to a centrally located buyers club site to spend their food dollar than they would going to a farm. Unless there was an exemption from the permit requirement, many food buyers clubs would not bother having a fixed central location for the distribution of food.

It would be great to end by saying the government is leaving Weekly Fig alone with the new law in place but that hasn’t been the case. Even though state regulatory agencies have stopped bothering the food buyers club 2, for the past several months USDA’s Food Safety Inspection Service (FSIS) has been requesting that FSIS personnel be allowed to conduct an inspection of the Weekly Fig facility. FSIS has broad jurisdiction to inspect firms handling meat products but almost never uses it to inspect a facility like the Weekly Fig’s. The agency is asking for customer records detailing meat purchases and sales. The Weekly Fig’s charter prohibits the sharing of member information with anyone.

Reneau doesn’t know who made the complaint to FSIS but it doesn’t look like a coincidence the complaint was made shortly before SB 651 became law. Reneau, as she did with TDA, is contesting FSIS jurisdiction to inspect the facility by requesting that the agency give her specific citations in the law giving it the authority to inspect Weekly Fig; she is not giving FSIS an inch until it does so. To this point the agency has yet to attempt an inspection.

What Reneau and the Wilsons have done is to realize the potential consumers have to make changes in the laws governing local food. They have shown it doesn’t take many to make a difference.

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1 Food sold for human consumption is taxable in Tennessee.

2 TDA has stopped pursuing any action against the Weekly Fig over the allegation that it was selling raw milk. The Weekly Fig does not sell raw milk and raw milk products, rather it distributes them to its members pursuant to a herdshare agreement; herdshare contracts are legal in Tennessee.

Food Freedom Movement Spreading State to State

In March 2015, Wyoming passed its Food Freedom Act, a groundbreaking law that deregulates many homegrown farm foods sold direct-to-consumer. Wyoming State Representative Tyler Lindholm, who co-sponsored the bill, predicted that farmers in the state would immediately feel positive impacts from the changes in regulation.

So how has it been going?

Lindholm says, “Wyoming’s first season under the Wyoming Food Freedom Act was one of bounty without a doubt…the results have been exactly what we all knew already. The free market will thrive if given the chance…I’ve talked with several Farmers Markets and their managers and have found the numbers being reported as doubling the number of consumers and produces in a multitude of products.”

Wyoming’s success is apparently inspiring other states, including Utah, to consider their own food freedom bills.

Read more via Reason.com.

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

Through the Eyes of a Food Freedom Fighter in Maine

This year, Maine is considering several “food freedom” bills (including a bill just passed by the House of Representatives that would loosen restrictions on raw milk sales), earning national attention from those who believe it is a human right to acquire fresh wholesome foods without interference from government regulators.

Maine Representative Craig Hickman is proposing an amendment to the Maine constitution that would legitimize and protect private food sales between producers and consumers. “Right to Food” reads: Every Individual has a natural and unalienable right to food and to acquire food for that individual’s own nourishment and sustenance by hunting, gathering, foraging, farming, fishing, or gardening or by barter, trade or purchase from sources of that individual’s own choosing, and every individual is fully responsible for the exercise of this right, which may not be infringed.

Joel Salatin, who recently testified before a Maine legislative committee in support of this amendment, shared a fascinating behind-the-scenes look at this hearing and the tension between the two opposing sides. He describes how 30 people showed up to testify in support of the amendment, while 2 testified against it. Predictably, the two that testified against were from the Maine Farm Bureau Federation and the Maine Department of Agriculture, and their remarks illustrated how “the orthodoxy of the industrial food system has no clue what our food freedom tribe thinks and can’t imagine why we can’t be satisfied with pasteurized milk, Hot Pockets, or microwaveable frozen dinners. They see this as choice; we see it as poison.”

Read more via his Facebook post here, Joel Salatin on Maine “Food Orthodoxy vs. Heresy”.

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

Wyoming House of Representatives to Vote on Food Freedom Bill

The Wyoming House of Representatives is preparing to deliver a final vote on House Bill 56, the “Wyoming Food Freedom Act,” which would legalize the sales of homegrown foods from farms directly to consumers without interference from the state.

Wyoming House Bill 56 would apply to all homemade and homegrown foods, including raw milk, eggs, jam and other commonly purchased farm goods. Essentially, this bill would, “…exempt so-called single transactions of food between the producer and any ‘informed end consumer’ from inspections, licensing and certifications by the state” (see Wyoming House Ready to Vote on Food Freedom on Food Safety News).

One of the bill’s sponsors, Representative Tyler Lindholm, points out that people all across Wyoming are already purchasing such foods from neighboring farmers and ranchers; this bill simply legalizes sales that are already happening – sales that shouldn’t be regulated by the state in the first place.

The Wyoming House Agriculture, State and Public Lands & Water Resources Committee already approved Bill 56 by an 8-1 vote in January 2015.

Realmilk.com is a consumer education project of the Weston A. Price Foundation, a nutrition education nonprofit based in Washington, D.C. Visit their website, westonaprice.org.

 

Why Does the USDA Need Submachine Guns?

Many people are asking “Why would the USDA need Submachine Guns?”

In May 2014, the US Department of Agriculture filed a request for weapons including submachine guns and semi-automatic or 2 shot burst trigger guns. This request has many, including the Farm to Consumer Legal Defense Fund, questioning what need the USDA could possibly have for such heavy arms.

According to a USDA spokesperson, the weapons are necessary for self-defense during undercover operations and surveillance. As Modern Farmer points out, this sounds like a legitimate reason when, in actuality, most of their enforcement operations relate to white-collar fraud of government programs like Supplemental Nutrition Assistance Program (SNAP).

Nor would such heavy arms be necessary in on-ground investigations into small farms and producers – for example, investigations and raids surrounding whether small farms are selling raw milk.

“Do we really want to have our federal regulatory agencies bring submachine guns onto these family farms with children?” asks Liz Reitzig, co-founder of the Farm Food Freedom Coalition.

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.