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

Milk a Terrorism Threat?

As part of the Food Safety Modernization Act, the Food and Drug Administration (FDA) has proposed an “intentional adulteration rule” which requires that domestic and foreign food facilities address risks of contamination that could occur by intentional acts of terrorism.

The National Milk Producers Federation (NMPF) has asked the FDA that dairy farms be exempted from the intentional adulteration rule, arguing that because pasteurized milk goes through so many processing steps it would be a poor choice for intentional adulteration.

“In considering whether activities that occur on dairy farms represent a high risk for intentional adulteration, FDA concluded fluid milk storage and loading in a dairy farm operation pose a significant vulnerability,” wrote Beth Briczinski, the Vice President of Dairy Foods and Nutrition at the NMPF. “However, for a number of reasons, we disagree with the premise that on-farm milk destined for pasteurization is a high-risk food and, therefore, we maintain that activities on dairy farms should not be addressed through this rule.”

“Raw milk that is produced for direct human consumption and not destined for pasteurization should not be exempted,” NMPF noted.

NMPF also submitted comments to the FDA in conjunction with the International Dairy Foods Association (IDFA) arguing that food defense and food safety should be regulated differently. The deadline for the FDA to issue its final ruling in response to these comments is May 31, 2016.

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