2024 Annual IAFP Meeting in Long Beach, California

The International Association for Food Protection (IAFP) held its annual meeting from July 14-17. The IAFP meeting is the largest food safety conference in the world; this year, over 3,000 people from industry, government and academia attended. The meeting is the conference for the industrial food system; this year, as in the past, Merck Animal Health and Cargill were major sponsors. Labor shortages and broken down supply chains over the past few years have made the food safety regulators’ jobs more thankless than ever. The regulators might have to deal with a foodborne illness outbreak that contains ingredients sourced from multiple countries where the traceability is difficult. The FDA Food Safety Modernization Act (FSMA), which went into effect in 2011, was supposed to reduce the number of foodborne illnesses in the U.S. A high ranking FDA official provides a regulatory update at the meeting each year; until the 2023 conference, that official acknowledged that the number of foodborne illnesses has remained flat. The past two years, the official giving the regulatory update hasn’t covered the matter; with the noticeable deterioration in quality in the conventional food supply, the likelihood is that foodborne illness has not declined.

A solution to the food safety problem would be to decentralized food production and deregulate both food production and distribution at the state and local level—a move attendees at the conference do not consider; their job is to figure out and implement improvements to food safety under the existing industrial paradigm. Nevertheless, the IAFP meeting is an important event to follow; it can serve as an incubator for laws and policies that have an effect on the local food system.

The following is a review of some topics covered at this year’s meeting.

Bird Flu—Highly Pathogenic Avian Influenza (HPAI)

With reports on the bird flu “pandemic” being blared in the media daily, a panel consisting of federal government regulators (FDA, USDA, CDC) and individuals from academia and industry convened to discuss what to do about the outbreak of HPAI that had first spread to dairy cattle towards the end of March.¹ The panelists lamented how the public was not listening to their warnings not to consume raw milk; in May, one polling firm estimated that demand for raw milk had risen as high as 65% since the onset of the “pandemic”. The panel members spoke about how social media such as TikTok and Instagram are influencing the public to purchase raw milk. One panel member thought the public was buying raw milk out of fear. Another panelist was closer to the truth when he acknowledged that mistrust of government, academia and industry has led to an increase in the consumption of raw milk. Accurate science was what the panel thought could stop or slow down the increase in raw milk consumption.

Another reason brought up in the discussion about why the consumption of raw milk was going up was a fear of industrial food and not knowing where your food was coming from. One panelist thought the consumer would support locally produced pasteurized milk. A panel member resolved to gather more information on why consumers think raw milk is the right thing. The panel agreed that HPAI was going to be around for a while and that it would be important to harmonize messaging with partners whether they be in the federal government, state government, or in industry.

Reports are that labs are using the notoriously inaccurate PCR test to test for HPAI; numerous labs during COVID were running the test at 40 cycles or more where the chances of a false positive test result were high. Two employees for a lab exhibiting at the IAFP conference tradeshow guessed that their lab was running the PCR test at 45 cycles to test for HPAI. Interestingly, an official with the Massachusetts Department of Agriculture and Natural Resources stated, “PCR tests are only viable up to 30 cycles, so these labs would likely run no more than 30 cycles.”² Massachusetts has been the only state so far to require raw milk dairies to test for bird flu; so far, all milk samples tested have been negative for HPAI.

Cronobacter

Another talk impacting raw milk at IAFP was a panel discussion on cronobacter³, a pathogen found mainly in powdered infant formula. A speaker at a past IAFP conference disclosed that there is a 20% mortality rate for infants infected with the pathogen. A panelist at the 2024 conference stated that cronobacter can survive in the powdered formula up to five years. Another panelist said that cronobacter has characteristics of both salmonella and listeria. Takeaways from the panel discussion were that cronobacter is ubiquitous in the environment and that there’s still lots to be learned about the pathogen.

In 2022 an Abbott Laboratory plant in Michigan shut down after infant formula produced in it was linked to deaths and illnesses caused by cronobacter. Shortly after the shutdown, traffic to a page on raw milk infant formula on the Weston A. Price Foundation’s website went up 1,000% as demand for raw milk surged. Much of the panel discussion centered on how difficult and complex the cleaning process is in a plant producing powdered infant formula; profit margins are high so firms in the business have the incentive to stay in even though the risks are considerable compared to most foods. It would not be surprising if future problems with cronobacter occur in infant formula plants, directly leading to further jumps in the demand for raw milk.

Food Fraud

One of the more eye-opening sessions at IAFP was a panel discussion on food fraud⁴—something that affects 10% of the commercial food supply according to a speaker at the session. Food fraud is especially present with honey, oils, spices, fish, and juices. Food fraud is the intentional adulteration and mislabeling (misbranding) of products; one trick of the trade is altering expiration dates on the label, and another is putting a low quality product in the packaging and labeling used by a competitor and passing that product off as the competitor’s. Undeclared allergens on food labels are also a problem.

Protecting against food fraud is a complex and arduous process for a business. Different sectors within a firm work on it from product development to quality assurance to procurement. Tracking supply chains, vulnerability (to fraud) assessments, verifying authenticity (e.g., GMO-free, organic, country of origin), lab testing ingredients or finished food products, and being in compliance with legal requirements are all part of the process. The world of food fraud is great incentive for buying directly from a farmer you know and trust.

Cell Cultured Meat (CCM)

Investors have spent billions on cell cultured meat but so far there is very little product on the market. Pre-market approval from FDA is necessary to sell cell cultured meat; that agency has joint jurisdiction with USDA in regulating that product. In IAFP session on cell cultured meat (CCM)⁵, a speaker said that FDA had only granted approval for two cell cultured poultry products, and no approval for any beef or pork products yet. Another speaker remarked that price and perfection for cell cultured meat are not there. The legal framework to navigate to get approval is difficult. A typical CCM product will have anywhere from 60 to 100 inputs (ingredients); FDA evaluates each to determine whether it is a food additive recognized in the law or, in most cases, whether it is GRAS (generally recognized as safe). One speaker remarked that the infrastructure for the CCM industry is lacking; there is no large-scale commercialization of the product. Another said that pathogens such as Campylobacter, Salmonella, and E. coli in CCM are a problem. There was a comment that, with the expense of manufacturing CCM, there was little product available. One of the speakers disclosed that the U.S. is a test market for CCM and that much of the investment in the product was European. The upshot of the session was that CCM is not having success getting established in the market; the speakers at the session spent little or no time addressing the complete lack of demand for CCM.

Attending the IAFP conference is an affirmation of how important it is to build out a parallel food system; the pace which favorable laws and infrastructure for a prosperous local food system is rounding into place needs to increase.

Footnotes:
1. Anderson N, Detlefsen C, Nichols M, Martin N, Suarez D, & Sinatra J. (2024, July 16). LB – Late Breaking Session – Responding to an Outbreak of Highly Pathogenic Avian Influenza (HPAI). [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/10155

2. Cahill M. (2024, August 28). Government email. MA Dept. of Agricultural Resources Div. of Animal Health.

3. Clifford D, Farber J, Gollinger M, Hanlin J, van der Sanden J, & Warren B. (2024, July 15). RT11 – Cronobacter spp. Control: Bridging Knowledge Gaps and Taking Action. [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9571

4. Burke J, de Leonardis D, Jorgens A, & Winkel, C. (2024, July 15). RT10 – Think Like a Criminal – The Dark World of Food Fraud. [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9766

5. Anandappa A, Overbuy K, Pantano A, Rainer N, & Yang L. (2024, July 17). S64 – Cultivating Meaty Cells – A Perspective Focus on Food Safety, Regulatory, and Experiences. [Conference symposium]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9808

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Reneau’s is limiting government power, not surprising for someone who endured a combined three-year investigation of the Tennessee Department of Agriculture (TDA) and USDA’s Food Safety Inspection Service (FSIS), all in connection with providing nutrient-dense food to her community through a food buyers club. Reneau was able to turn this adversity into a major legislative success.

In 2016 Reneau along with Nate and Ajnu Wilson started the Weekly Fig, a private membership association that distributed raw milk, meat and other nutrient-dense foods from local farmers to members of the food buyers club. A passage in Weekly Fig’s Articles of Association stated, “We proclaim the freedom to choose and decide for ourselves, the types of products, services and methods that we think best for healthy eating and preventing illness and disease of our minds and bodies, and for achieving and maintaining optimal wellness. We proclaim and reserve the right to healthy food options that include, but are not limited to, cutting-edge discoveries and farming practices used by any types of healers or therapists or practitioners the world over, whether traditional or non-traditional, conventional or non-conventional.” 

Weekly Fig rented out space to handle the storage and distribution of farm-produced food to its members; a short time after it had been in operation, a health department inspector barged in on the facility and conducted an unauthorized, warrantless inspection. The health department subsequently issued the Weekly Fig citations for not having the proper licenses for what they were doing. Soon after, TDA became involved sending its own inspector over to the facility. Reneau refused to let the inspector in, claiming TDA did not have jurisdiction over a private buyers club distributing food only to its members. TDA followed up by sending a warning letter to Weekly Fig stating, among other violations, that it was illegally operating a food establishment without a license and offering raw milk for sale. When TDA and the buyers club couldn’t come to a resolution on the matter, the department sent further correspondence to Weekly Fig 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.”

TDA did not take an enforcement action against Weekly Fig, but the threat of one remained over its head; so, when the 2017 Tennessee legislative session rolled around, Reneau contacted State Senator Frank Niceley to see if he could help the food buyers club with legislation.  Niceley introduced Senate Bill 651 (SB 651) which established that there was no regulation or licensing requirement for a “farm to consumer distribution point.“ Reneau testified at a Senate committee hearing for the bill; on May 11, 2017, SB651 was signed into law. A law distinguishing between the public and private distribution of food was now on the books—a major victory for food buyers clubs and farmers in Tennessee.

Unfortunately, Reneau’s problems did not end, even though there was no longer a conflict with TDA. Shortly before SB 651 became law, the Weekly Fig received a visit from two FSIS officials seeking to inspect the facility and the freezers in it. Reneau refused to let them in, telling them this was a private membership association and that, unless they had a warrant, they could not conduct an inspection of the facility.

FSIS Inspectors attempted a second inspection, and Reneau refused them again. When the inspectors provided her with copies of the laws they claimed gave them authority to inspect, she told them those laws apply to the general public, not a private membership association. In battling FSIS, Reneau showed the same courage and tenacity she did in her dispute with TDA—not accepting the government’s general assertions of authority and contesting the regulators point by point, asking for specific citations in the law to back up their claims. She grudgingly gave up ground to regulators, standing on her belief that there is a legal distinction between the public and private distribution of food.

Reneau said, “My whole life I have typically been a law-abider. I very much have a great respect for authority. It became very clear to me though, in my journey over the last 10 years with health and food and medical, that I need to be cautious about any authority exerted from those places because they had already proven themselves wrong in many cases.”

FSIS sent warning letters to Reneau and Weekly Fig after the attempted inspections and subsequently filed a court action to inspect the facility and look at the buyers club’s records. During the standoff, Reneau decided to shut down the Weekly Fig when it lost its lease and a suitable replacement within its budget could not be found; being pregnant with her fifth child made the decision easier to discontinue with the day-to-day operations. Nevertheless, FSIS pressed on with the case seeking records from the Weekly Fig.

In April 2019, Reneau had a court hearing, attending it while 37 weeks pregnant; the judge ordered that she appear for a deposition and bring buyers club records. The deposition took place in July 2019; Reneau brought her two-month-old baby with her—nursing the baby throughout the questioning from DOJ and USDA attorneys. She was worried about protecting the privacy of her club members and farmers; as it turned out, the deposition was more about getting the matter off FSIS’s desk—after two years, the federal investigation of Weekly Fig was over.

Through her experience with the Weekly Fig, Reneau has seen a side of government that most have not. She says, “I would just like to see less of the government making decisions on behalf of people as it affects their private lives. We should be able to make decisions for ourselves as long as it is not impacting other people … I just feel like the government has taken too much of a role in private life and that is where I would like to see things shift.”

Michele Reneau is active in defending faith, family and freedom, and constitutional rights—including the fundamental rights of parents to direct the upbringing, health and education of their children according to their values and beliefs. Acting on the courage of her convictions, she is someone who walks the talk.

The post How One Weston Price Chapter Leader Made an Impact appeared first on Real Milk.

Raw dairy products are the only foods for human consumption banned in interstate commerce. A question for the court of appeals to consider is: does FDA have the power to prohibit raw butter from crossing state lines when the record before the court does not list a single foodborne illness outbreak definitively attributed to the consumption of commercially produced raw butter?

FDA is claiming it can ban raw butter in interstate commerce under its authority to regulate communicable disease [1], a power granted the agency by the Public Health Services Act (PHSA). Thirty years ago FDA issued a regulation banning all raw dairy products in interstate commerce other than cheese aged 60 days [2].

Does FDA have the power to issue a blanket ban on a food? Or is its authority limited to instances when a specific batch or a lot is suspected of being adulterated and/or making people sick?

The Department of Health and Human Services (HHS) has been getting lots of mileage out of its authority to regulate communicable disease. In 2020 the Centers for Disease Control (CDC) used that power to justify an order staying any eviction of residential tenants by landlords during the COVID crisis. In striking down the order, the Supreme Court found that “regulations under this authority have generally been limited to quarantining infected individuals and prohibiting the import or sale of animals known to transmit disease” [3].

Another question for the court is: can FDA require that butter be pasteurized under its power to regulate communicable disease, when the Federal Food, Drug and Cosmetic Act (FDCA) seemingly prohibits the agency from doing just that?

There is a conflicting statute in the FDCA defining butter that does not require it to be pasteurized [4]. A separate statute in the FDCA specifically mandates that “[n]o definition and standard of identity and no standard of quality shall be established for … butter” [5]. Standards of identity are requirements for prescribing what a food product must contain to be marketed under a certain name in interstate commerce; they are intended to promote honesty and fair dealing for the benefit of consumers.

The U.S. Supreme Court has held that a standard of identity exists, for purposes of the FDCA, whenever the government, “by regulation, fix[es] the ingredients of any food,” such that “a commodity cannot be introduced into interstate commerce which purports to be … [that] food … unless [the commodity] is composed of the required ingredients” [6]. The regulation governing the interstate raw dairy ban provides, in part, “No person shall cause to be delivered into interstate commerce or shall sell, or otherwise distribute…any milk or milk product [e.g., butter]…unless…made from dairy ingredients… that have all been pasteurized…” [7].

The demand for raw dairy in the U.S. is booming. There are around a dozen states that currently allow the distribution or sale of raw butter. A court decision in favor of McAfee and FTCLDF will increase that number rapidly in a short period of time as well as reduce the power of an agency that is a major threat to bodily autonomy and freedom of choice and that has long placed the profits of the pharmaceutical and biotech industries ahead of the public health.

The oral argument before the court of appeals will be livestreamed.

• For the archive of Oral Argument Recordings, find links at

https://www.cadc.uscourts.gov/recordings/recordings.nsf

A recording of all Oral Arguments for April 8, 2022, will also be posted on YouTube at https://www.youtube.com/watch?v=jyWi9futNwg

Livestream link – https://www.cadc.uscourts.gov/internet/home.nsf/Content/VL%20-%20Calendars%20-%20Live%20Audio%20Streams%20of%20Oral%20Arguments

For more background on the Raw Butter case and related documents, go to the Farm-to-Consumer Legal Defense Fund website at https://www.farmtoconsumer.org/campaign-for-raw-food/

FOOTNOTES
1. See 42 USC 264(a)
2. 21 CFR 1240.61
3. Ala. Ass’n of Realtors v. HHS 141 S. Ct. 2485, 2487-2488.
4. 21 USC 321a
5. Subbaraman, M. Principal Brief of Appellants Mark McAfee & Farm-to-Consumer Legal Defense Fund. USCA Case 21-5170 (Document #1929731, filed 01/07/2022), p. 24 citing 21 USC 341. https://www.farmtoconsumer.org/wp-content/uploads/2022/01/Raw.Butter.1.07.22.ECF-Stamped-Opening-Merits-Brief.pdf
6. Subbaraman, p. 24 citing 62 Cases of Jam v. United States 340 U.S. 589, 593 (1951) (internal quotation marks omitted)
7. 21 CFR 1240.61(a)

Photo Credit: congerdesign on pixabay.com

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By Pete Kennedy, Esq.

FDA has compiled statistics for the first half of 2019 on the number of inspections it and state regulatory agencies under contract to FDA have conducted pursuant to the Food Safety Modernization Act (FSMA).¹ What stands out in the numbers is that by far, the most inspections FDA has conducted has been for compliance with Current Good Manufacturing Practices (GMPs).²

The GMPs are a one-size-fits-all regulatory scheme that includes requirements for plant construction and design, equipment, sanitation, and warehousing and distribution; GMPs are broadly worded and subject to varying interpretations by inspectors. According to an FDA official who spoke at the recent annual meeting of the International Association for Foods Protection (IAFP), some of those inspections for GMP compliance were for firms under the Tester-Hagan exemption that removes the requirement of having a food safety plan (known as HARPC or Hazard Analysis and Risk-based Preventive Controls). The average inspection for the GMP requirements is 3 to 4 days; if the firm has a compliance history with FDA, that inspection could be as long as 7 to 9 days.³ Arguably, FDA has no legal authority under FSMA to conduct GMP inspections of most or all of the Tester-Hagen exempt firms.

Among other requirements, FSMA requires facilities engaged in processing, manufacturing, packing, or holding food to have a written food safety plan showing that the facility

• has identified the potential hazards associated with the food being produced, packed, or held;
• has implemented preventive controls to address the hazards; and
• is monitoring the performance of the preventive controls to ensure that such controls are effective.

This requirement for HARPC is found in 21 CFR 117 Part C.

HARPC for human food has several exemptions from its mandates, one of which is a “qualified exemption for those firms grossing less than one million dollars per year ⁴, an exemption known as Tester-Hagen. In addition, to be eligible for the exemption, the facility must make more than half its sales either directly to consumers or to a restaurant or retail food establishment located either in the same state or within 275 miles of the facility.⁵

To obtain the exemption, facilities must submit a form to FDA that includes one of the following attestations:

• that the facility has a modified food safety plan addressing most of the HARPC requirements [FDA could mandate that the food safety plan include GMPs]; or
• that the facility is “in compliance with state local, county, tribal or other applicable non-Federal food safety law…including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency such as a state department of agriculture, or other evidence of oversight.”⁶

A reading of the federal statute on HARPC, 21 USC 350g, shows how FDA could be exceeding its authority by inspecting those under the Tester-Hagen exemption for the GMP requirements; 21 USC 350g(L)(2)(A) provides that a qualified facility “(A) shall not be subject to the requirements under Subsection (a) through (i) and Subsection (n) in an applicable calendar year….” Subsection (c) covers preventive controls, which is defined in Subsection (o) as:

• “…those risk-based, reasonably appropriate procedures and practices, and processes that a person knowledgable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include: …(F) Current Good Manufacturing Practices under part 110 of title 21, Code of Federal Regulations (or any successor regulations).”⁷

  NOTE: The Current Good Manufacturing Practices (CGMP) have since been moved to the HARPC section (part 117).

Most, if not nearly all, facilities exempt by Tester-Hagen would obtain the exemption by attesting that their business is subject to some kind of state regulation. Why spend that time and resources drawing up a modified HARPC plan when you can get the exemption by sending FDA a copy of a state license or other proof of state oversight?

The only food business that would not be subject to state regulation would be those selling only direct to consumers; those firms would not have to register as food facilities and, therefore, would not have to be subject to any of the FSMA requirements for HARPC if over half of their gross revenues are from direct-to-consumer sales in which case they would be exempt as a “retail food establishment” under federal regulation.⁸

FDA hasn’t divulged how many facilities with a qualified exemption it has inspected but it looks like it has exceeded its authority if it has inspected any facility that obtained its exemption through an attestation that it was subject to non-federal regulation. To go from being allowed to include GMPs as a part of preventive controls regulations to issuing GMP rules under FSMA that are separate from preventive controls is a big reach. There was never any deliberation by Congress contemplating separate regulation of requirements for CGMPs as part of FSMA.

A food law attorney speaking at the IAFP conference observed that FDA is paying close attention to GMP compliance and has no tolerance for GMP violations. Given the length of GMP inspections, how FDA is interpreting the GMPs more strictly, and the number of enforcement tools the agency has which use to cripple a small business without the economies of scale to comply, it’s recommended that small farmers and local artisans have, if at all possible, over half of their sales as direct-to-consumer to be exempt from the food facility registration requirement. This includes firms currently registered; there is a procedure to cancel registration.⁹

The time to move is now; it looks like FDA’s interpretation of the FSMA requirements will only be getting more strict. The likelihood is that neither Congress or the court will exercise oversight to limit FDA’s inspection authority to what FSMA provides.

————–

1. Bass, Glenn. US Food and Drug Administration. “FDA’s Perspective and Experience on FDA Enforcement and Inspection.” Symposia S1: Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection, 22 July 2019. Speech, Kentucky International Convention Center, Louisville, KY.

2. Ibid. Out of nearly 9,000 FSMA inspections conducted, over 7,500 included assessing GMP compliance as well as HARPC (of which 7,000 were inspections for limited provisions of HARPC). Of the remaining, the FSMA inspections fell into the following categories: Sanitary Transport, Foreign Supplier Verification Program, Produce Safety Standards, HARPC for Animal Food, and GMPs for Animal Food.

3. Ibid.

4. 21 CFR 117.5

5. 21 CFR 117.3, see definition of “qualified end-user”

6. 21 CFR 117.201

7. 21 USC 350g(L)(2)(A)

8. 21 USC 350d, 21 CFR 1.226, 21 CFR 1.227

9. 21 CFR 1.241(c)

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The Weston A. Price Foundation (WAPF) and the Communities Alliance for Responsible Eco-agriculture (CARE) are providing funding for Turner’s legal expenses. WAPF is the leading advocacy group in the U.S. for raw milk and raw milk products, including butter. CARE is a Pennsylvania-based food buyers club that has long been a strong supporter of freedom of food choice, especially raw dairy products.

Turner is no stranger to FDA, having dealt with the agency on various matters since the 1960s. His law practice consists of representing businesses, individuals, and consumer groups on regulatory issues concerning food, drug, health product safety and environmental matters.

In 1970 he was largely responsible for getting Cyclamate, an artificial sweetener, pulled off the market. For nearly ten years he fought against FDA and the G.D. Searle Corporation in an effort to take the artificial sweetener, aspartame, off the market. There have been more complaints filed with FDA about aspartame than any other food product.

Federal law requires FDA to file a response to a citizen petition within six months after receiving a copy. In December 2016 FDA sent FTCLDF and McAfee a letter stating it needed more time to review the petition; in the two years since, the agency has sent nothing to the two petitioners. If Turner can’t convince FDA to issue a substantive response to the petition, he will likely file a writ of mandamus motion in a federal district court to have the court compel FDA to respond. If FDA rejects the petition, petitioners can appeal the agency’s decision to a federal appellate court.

There has been a federal ban on raw milk and raw milk products for human consumption (other than raw cheese aged sixty days) in interstate commerce since 1987 when FDA issued a regulation (21 CFR 1240.61) establishing the ban in response to a court order. Three arguments Turner can make to lift the ban are: that FDA exceeded its authority in banning raw butter since the case resulting in the court order, Public Citizen v. Heckler, only concerned fluid milk products (milk, cream, yogurt) not manufactured milk products (butter, cheese); that federal statute (21 CFR 341) prohibits FDA from issuing a federal ‘standard of identity’ regulation for butter [standards of identity are requirements prescribing what a food product must contain to be marketed–pasteurization is one such requirement]; and that there isn’t a single foodborne illness outbreak attributed to the consumption of commercially produced raw butter [OPDC has sold over 2 million pounds of raw butter since 2001 without incident]. FDA is basically claiming that its power to regulate communicable disease allows it to ban a food that makes few, if any, sick.

The butter petition is a great opportunity to weaken the interstate raw dairy ban — a significant step towards the day when the transport of all raw dairy products across state lines will be legal. Jim Turner has the experience and ability to make that happen.

———
Image from video: Jim Turner Recalls Rumsfeld Meeting over Nutrasweet Toxicity, published on YouTube October 7, 2011

The post FTCLDF Hires Jim Turner to Litigate Raw Butter Petition appeared first on Real Milk.

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.

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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

The post FSMA Food Safety Regs Going Local appeared first on Real Milk.

By Pete Kennedy, Esq.

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.

The post A Tale of Two Food Systems appeared first on Real Milk.

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

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

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

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

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

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

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

² Federal Register, 78 FR 3651. Section II.B.1 accessed 2/28/2018 at
https://www.federalregister.gov/documents/2013/01/16/2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human

The post FDA Bootstrapping Its Power under FSMA appeared first on Real Milk.

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.

———–
[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”

The post FDA Antibiotic Test Requirement Threatens to Cut Raw Milk Supply in Pennsylvania appeared first on Real Milk.

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.

—————-
[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

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