McDonald’s E. coli Outbreak

As of November 13, 2024, 104 people infected with the outbreak strain of E. coli O157:H7 have been reported from 14 states: Colorado 30, Montana 19, Wyoming 6, Kansas 3, North Carolina 1, Iowa 1, Missouri 8, Michigan 1, Nebraska 12, New Mexico 10, Oregon 1, Utah 8, Washington 1 and Wisconsin 1. Of 98 people with information available, 34 have been hospitalized, and 4 people developed HUS, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. This person is not one of those who developed HUS. Of the 81 people interviewed, 80 (99%) report eating at McDonald’s. Seventy-five people were able to remember specific menu items they ate at McDonald’s. 63 of 75 people (84%) reported a menu item containing Taylor Farm’s fresh slivered onions. 

Past Recent Onion Outbreaks:

• 80 illnesses in 23 states linked to Gills Onions
• 1040 illness in 41 states linked to ProSource and Keeler Family Parms Onions
• 1127 illness in 48 states linked to Thomson Onions
• 19 illnesses in 7 states linked to Taylor Farms Onion and Celery Mix

You just cannot make this shit up. Will Kennedy and McAfee team up to start the MASA movement?

Here is a bit of history of just McAfee and raw milk.

On October 18, 2023, an investigation of an outbreak associated with Raw Farm, LLC products was initiated. At least eight Salmonella cases who had reported consuming raw milk from Raw Farm, LLC of Fresno County, California, were discovered and reported to the California Department of Public Health (CDPH). As of October 15, 2024, 171 cases (159 confirmed and 12 probable) have been reported from five states: CA (167), NM (1), TX (1), WA (1), and PA (1). In California the following counties reported cases: Los Angeles (27), San Diego (25), Orange (19), Placer (7),Riverside (7), Sacramento (7), Alameda (6), Ventura (6), Contra Costa (5), Kern (5), San Bernardino (5), Santa Clara (5), Solano (5), Santa Barbara (4), Stanislaus (4), Long Beach (4), Fresno (3), Kings (2), Madera (2), Nevada (2), San Joaquin (2), and Yolo (2). Illness onsets ranged from September 21 to March 12, 2024. Symptoms included fever, bloody or watery diarrhea, nausea, vomiting, and headache. The age range of cases was <1 to 87 years (median 7). Sixty-five percent of cases were male. Twenty cases (14%) were known to require hospitalization; no deaths were reported. Four cases were discovered to have co-infections with S. Typhimurium and Campylobacter and/or STEC. Most illnesses were among children. 

Since September 2006, Raw Farm, LLC, formerly known as Organic Pastures Dairy Company (“OPDC”), has issued multiple recalls of unpasteurized milk products, and been linked to multiple outbreaks as outlined below.  The following table shows Raw Farm’s previous history with contaminated products: 

Date	Product	Contaminant	Recall/Illnesses
September 2006	Raw Milk	E. Coli O157:H7	Six ill, two severely ill with Hemolytic Uremic Syndrome
September 2007	Raw Cream	Listeria monocytogenes	Recall Issued
December 2007	Raw Milk	Campylobacter	Eight Illnesses
September 2008	Raw Cream	Campylobacter	Recall Issued
November 2011	Raw Milk	E. Coli O157:H7	Five ill, three severely ill with Hemolytic Uremic Syndrome
May 2012	Raw Milk/Cream	Campylobacter	Ten Illnesses
October 2015	Raw Milk	Campylobacter	Recall Issued
January 2016	Raw Milk	E. Coli	Nine ill, two severely ill with Hemolytic Uremic Syndrome
May 2023	Raw Milk	Campylobacter	Recall Issued
August 2023	Unpasteurized Cheese	Salmonella	Recall Issued

And, did I mention the DOJ Consent Decree?

U.S. District Judge  Jennifer L. Thurston for Eastern California has signed a Consent Decree agreed upon by attorneys for the United States and Organic Pastures and Mark McAfee.

It continues the 15-year-old jurisdiction of the Eastern District Court over the civil matter involving the concern over RAW FARM LLC, Organic Pasture’s new legal name.

Last March, the U.S. Department of Justice raised possible civil contempt allegations against RAW FARM, Mark McAfee, and Arron McAfee. An evidentiary hearing on that issue was set for Aug. 9, 2023, but has now been canceled by the Consent Decree.

It means that the Court’s jurisdiction continues over the Defendants, and an April 2010 Order remains in effect for all the directors, officers, agents, representatives, attorneys, and others involved.

The RAW FARM defendants, after 60 months, can petition the Food and Drug Administration (FDA) for “relief  from this Decree.”  In the meantime, they must “abide by the decisions of the FDA.”

FDA gets the power of inspections without prior notice. The Decree spells out specific requirements for audits and labeling that must be followed. It includes hiring an independent “labeling expert.”

The Department of Justice reopened the 2008 litigation last March, claiming Organic Pastures, known now as RAW FARM LLC, was violating the April 2010 Permanent Injunction, which imposed restrictions from distributing in interstate commerce unapproved drugs, misbranded food, and raw milk and raw milk products for human consumption.

The production and sale of raw milk by Organic Pastures within California, where it is legal, was not impacted by the April 2010 order. It’s estimated that OP has 60,000 retail customers of raw milk in the Golden State.

In re-opening the case, DOJ said a raw cheese claiming it can cure, mitigate, treat, or prevent human disease, including heart disease, osteoporosis, and viral infections, violates the April 2010 order.  

The Court previously agreed with the DOJ that RAW FARM and the McAfee parties violated the Permanent Injunction Order issued on April 20, 2010.  Before any new testimony was taken, the Defendants agreed to the Consent Decree.

The government also takes issue with RAW FARM’s claim that its raw milk labeled as “pet food” is safe for human consumption.

“Organic Pastures and its principals, Mark and Aaron McAfee, have thus continued their pattern of distributing their products in interstate commerce with unproven claims about the ‘wonders’ of raw milk and its associated products,” said the DOJ petititon.

In that March 2023 petition, the government wanted to hold  RAW FARM/Organic Pastures and McAfee in contempt with contempt sanctions.

While the 2008 civil case was pending, Organic Pastures 15 years ago also faced similar charges in a criminal action involving similar conduct. The criminal matter concluded in settlement by plea agreement on Dec. 22, 2008, and was approved by Magistrate Judge Sandra M. Snyder on Jan. 9, 2009. 

 Pursuant to the plea agreement, Organic Pastures pleaded guilty to two counts of misdemeanor introduction and delivery for introduction into interstate commerce of misbranded food. McAfee entered into a deferred prosecution agreement whereby he agreed to the filing of a two-count information charging him and Organic Pastures with the same violations. 

In these agreements, both defendants admitted that: (1) on two separate occasions “one or more of defendant Organic Pastures’ agents or employees, with the knowledge and consent of Organic Pastures, caused [a] box of raw milk and dairy products, labeled as or otherwise represented to be ‘pet food,’ to be sent by defendant Organic Pastures” into interstate commerce, “knowing that the intended use of such foods and/or dietary supplements was for human consumption;” and (2) Organic Pastures’ raw milk and raw milk products “were foods and/or dietary supplements, and were misbranded when so introduced into or delivered for introduction into interstate commerce, in that they were falsely and misleadingly labeled as, or otherwise represented.

In the April 2010 order, Organic Pastures and McAfee acknowledged violating federal food safety law by introducing and/or distributing raw milk into interstate commerce in 2007. They also conceded that they violated the “unapproved raw drugs” provision of the FDA. 

Some more history of raw milk laws in the United States:

Winston Churchill once said, “There is no finer investment for any community than putting milk into babies.” Perhaps he was right, but at the turn of the 20th century, the process of pasteurizing milk was still in its infancy, and the safety of milk was a preeminent public health challenge. As people in the United States moved from the countryside into cities, their milk supply became increasingly unhealthy. Milk from cows in the country was transported further and stored at higher temperatures than in the past. Milk produced closer to cities came from cows kept under crowded and unsanitary conditions, and as a result, many city residents, especially children, were increasingly getting sick and dying after consuming contaminated milk. (1)

Public health reformers and activists of the late 19th century put milk at the top of their agenda, and the safety of the milk supply increasingly became a matter of regular public concern, discussed in newspapers, medical journals, public health circles, and the legal system. In a 1914 decision, the Illinois Supreme Court described the importance of the question, saying, “There is no article of food in more general use than milk; none whose impurity or unwholesomeness may more quickly, more widely, and more seriously affect the health of those who use it” Koy v. City of Chicago , 104 N.E. 1104 (1914). 

Urban areas were first to act, but by 1920, milk regulations had reached every part of the country, with regulations beginning to appear in state statutes. The U.S. Public Health Service considered milk health to be such a high priority that it drafted the Model Milk Health Ordinance and promoted it actively for adoption at the local level (U.S. Public Health Service, 1939). (1) 

Milk producers and sellers attacked the first regulations as unconstitutional and unwarranted governmental limitations on their rights to produce and sell their products as they wished. In response, local and state authorities relied on their intrinsic legal police power duty and authority to protect the public’s welfare. Presented with growing evidence of the potential danger created by the sale of raw milk, most courts found these regulations to be valid, as a legitimate exercise of the government’s police power. 

In the representative case of Pfeffer v. Milwaukee, 171 Wis. 514 (1920), milk dealers claimed that a Milwaukee ordinance requiring that all milk sold within the city be pasteurized would hurt their business, and that the ordinance was an invalid exercise of the police power because it did not promote the public health. The Wisconsin Supreme Court, however, disagreed. “Public health demands that milk and all milk products should be pure and wholesome. It is also common knowledge that milk containing deleterious organisms is an unsuitable article of food. Milk is known to be a product easily infected with germ life and to require special attention and treatment in its production and distribution for consumption as an article of food. Scientific knowledge concerning these facts and the best method of pasteurizing milk for human use in course of production and distribution as a pure and wholesome food is so generally understood and known that courts take judicial notice of these facts.”

The regulation of raw milk sales in the first half of the 20th century proved to be a major public health success in this country. In 1938, milk-borne outbreaks constituted approximately 25% of all disease-outbreaks from contaminated food and water. As of 2005, that figure was down to about 1%.

Outbreaks of illness linked to the consumption of contaminated milk did continue, however. The ban on the sale of raw milk was not universal because at the time no federal law or regulation prohibited the sale of raw milk on a national level. The regulatory scheme controlling the sale of raw milk on a state and local level was spotty; some states banned the sale of milk that was not pasteurized, some states did not. In states that did not ban the sale of raw milk, some cities and counties did. The ability to sell and purchase raw milk was thus determined more by the social and political nature of the individual jurisdiction than by scientific knowledge. The impact of regulations was clear: forty (87%) of the forty-six raw milk outbreaks reported by the CDC during the period from 1973 through 1992 occurred in states in which the intrastate sale of raw milk was legal. (2)

Efforts to comprehensively ban the sale of raw milk continued. In 1973, the Food and Drug Administration (FDA) proposed and adopted a regulation requiring that all milk moving in interstate commerce be pasteurized; but “certified” raw milk became exempt from the regulation after FDA received an objection from a producer of certified raw milk. Between 1974 and 1982, FDA accumulated evidence of the association of certified raw milk with human disease, and in 1982, began drafting a proposed regulation to ban all interstate sales of raw milk and raw milk products. In an attached memorandum supporting the regulation, FDA concluded that consumption of raw milk “presents a significant public health problem” and that pasteurization was the only feasible way to assure the safety of milk. The proposed regulation, however, was again not adopted. (3)

Public Citizen v. Heckler, 602 F. Supp. 611 (1985) was filed on September 19, 1984. Public Citizen, a public service organization, the American Public Health Association, and others brought the suit to compel the Secretary of Health and Human Services (HHS) to ban all domestic sales of raw milk and raw milk products. Claiming that federal officials had long known of serious risks to human health from consumption of raw milk, plaintiffs contended that the Secretary had unreasonably delayed her decision, in violation of the Administrative Procedure Act. The Court’s opinion was explicitly direct, and its ruling simple. “The facts here speak for themselves and need little elaboration. Officials at the highest levels of the Department of Health and Human Services have concluded that certified raw milk poses a serious threat to the public health. Leading health organizations are unanimous in proposing that sales of any raw milk should be banned. … The Department’s justification for its continued delay is lame at best and irresponsible at worst. ‘When the public health may be at stake, the agency must move expeditiously to consider and resolve the issues before it.’ Public Citizen Health Research Group v. Commissioner of Food and Drugs, 740 F.2d at 34. The Department has wholly failed to meet that mandate here.” The court then ordered that the Department publish a proposed regulation within 60 days of its order.

On August 10, 1987, the FDA published in 21 CFR Part 1240.61, a final regulation mandating the pasteurization of all milk and milk products in final package form for direct human consumption. This regulation banned the shipping of raw milk in interstate commerce, and became effective September 9, 1987. In the Federal Register notification for the final rule to 21 CFR Part 1240.61, the FDA made a number of findings, including the following: “Raw milk, no matter how carefully produced, may be unsafe.” (3)

Today, it is a violation of federal law to sell raw milk packaged for consumer use across state lines (interstate commerce), but each state regulates the sale of raw milk within the state (intrastate), and some states allow it to be sold. Nationally, the distinctions between applicable laws in individual states are bewildering. In 2006, 25 states had laws making the sale of raw milk for human consumption illegal. In the remaining states, dairy operations may sell raw milk to local retail food stores or to consumers directly from the farm, or at agricultural fairs or other community events, depending on the state law. Restrictions vary from specific labeling requirements, to requirements that milk only be bought with personal bottles, to purchase of raw milk through cow shares exclusively, to permitting a sale only with a written prescription from a doctor, to sales of raw goat milk only, and to sales of a limited daily quantity only if made without advertising. Even in states that prohibit intrastate sales of raw milk, some people have tried to circumvent the law by “cow sharing” or “cow leasing.” 

Because raw milk sales have not been outlawed altogether, outbreaks associated with raw milk continue to occur. There have been numerous documented outbreaks of E. coli, Salmonella, and Campylobacter infections directly linked to the consumption of unpasteurized milk in the past 20 years. During 1998–2005, a total of 45 outbreaks of foodborne illness were reported to CDC in which unpasteurized milk (or cheese suspected to have been made from unpasteurized milk) was implicated. These outbreaks accounted for 1,007 illnesses, 104 hospitalizations, and two deaths (CDC, unpublished data, 2007). (4) Because not all cases of foodborne illness are recognized and reported, the actual number of illnesses associated with unpasteurized milk likely is greater. In December 2005, following an outbreak that sickened at least nineteen people in Washington State, the FDA again publicly warned consumers to avoid drinking raw milk. (5) 

Government regulation of the food industry is commonly accepted as a means both to protect public health and to maintain public confidence in the food supply. Despite its great success in reducing raw milk outbreaks during the past hundred years, government regulation and enforcement has not yet succeeded in wholly eradicating the sale of raw milk. The sale of raw milk continues to be legal, in some form or another, in almost half of our states, and the attendant risk of raw milk-related outbreaks therefore also continues to be present. 

References:

(1)R. Wright, P. Huck, “Counting Cases About Milk, Our “Most Nearly perfect Food,” 36 Law & Soc’y Rev 51 (2002). 

(2) M L Headrick, et al,” The epidemiology of raw milk-associated foodborne disease outbreaks reported in the United States, 1973 through 1992”, Am J Public Health. 1998 August; 88(8): 1219–1221. 

(3) “Sale/Consumption of Raw Milk-Position Statement,” U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, March 19, 2003.

(4) “Salmonella Typhimurium Infection Associated with Raw Milk and Cheese Consumption — Pennsylvania, 2007”, MMWR, (CDC), November 9, 2007 / 56(44);1161-1164.

(5) “FDA Warns Consumers to Avoid Drinking Raw Milk”, FDA NEWS, December 16, 2005.