The Science and Politics of Raw Milk Odom Fanning Slogans vied with science at an informal FDA hearing on raw vs. pasteurized milk held in Washington, D.C., on October 11th and 12th, 1984. The hearing’s purpose was to help the Secretary of Health and Human Services (HHS) decide whether new rule-making is needed. Pasteurization is accomplished by heating milk for specified time/temperature combinations, most commonly 161º (71.6ºC) for 15 seconds. This kills microorganisms that can transmit disease to humans through milk, and also kills almost all spoilage bacteria. The process does not sterilize milk, but does make it safe to drink and extends shelf life. Unpasteurized (raw) milk may be certified or uncertified. Certified raw milk (CRM) is the trademark designation of milk produced according to standards set by the American Association of Medical Milk Commissions, an industry organization. CRM is produced by three large dairies and can be sold through retail food stores in 24 states. In 6 other states, sale is limited to direct farm sales, while in 20 it is prohibited. Uncertified raw milk is typically produced in small quantities by individual dairy farmers and sold on the farm or by home delivery. Even though a final regulation mandating pasteurization was proposed by the FDA 11 years ago, it was never issued. Last April, Public Citizen’s Health Research Group (HRG), an organization founded by Ralph Nader, petitioned HHS to ban all raw milk sales in the United States. Then in September, joined by the American Public Health Association, HRG filed suit in U.S. District Court for the District of Columbia to force the agency to respond. The hearing was held before FDA Commissioner Frank E. Young, M.D., Ph.D., Walton B. Read, M.D., of the FDA Bureau of Foods, and HHS attorney Fred Degman. Witnesses were not allowed to question the panel or one another-but were interrogated by the panel after giving testimony on two pre-announced questions: Is the consumption of raw milk, including certified raw milk (CRM) and raw milk products, of public health concern?

Would requiring pasteurization of raw milk, including CRM and such products, be the most reasonable regulatory option? The Commissioner also asked witnesses whether labeling CRM as to its risks would provide adequate protection for the public. Should he make a finding of fact that consumption of raw milk is of public health concern, he would then make a recommendation to the HHS Secretary-presumably for either compulsory pasteurization or mandatory labeling of milk in interstate commerce. Before a proposed regulation could be published, it would have to be approved by the Office of Management and Budget-and presumably the President. A final regulation is unlikely to be developed and take effect within the next year. The political strength of raw milk advocates can be judged by the string of witnesses produced for the FDA hearing by Alta-Dena Certified Dairy, of City of Industry, California. According to a press kit distributed by the company, it is the largest producer-dairy in the world. It spans 600 acres and has 8,000 milking cows, 7,000 stock cows, 800 employees, and annual sales of $100 million. Twenty percent of its production is sold as raw milk or raw milk products. About 90% of all raw milk sold in California comes from Alta-Dena, which also funds the Los Angeles County Milk Commission, a certifying body. Press reports assign to Alta-Dena a high political profile in California, where between 100,000 and 200,000 residents are said to drink certified raw milk or feed it to their children daily. The dairy and its supporters once marshalled 17,000 letters to the governor, against only a handful opposing its position. One witness at the hearing was Harold Stueve, Alta-Dena’s founder and co-owner. More than 60 members of the Stueve family are said to work for the company. Another witness was Rep. William E. Dannemeyer (R-Calif.), who was an attorney for Alta-Dena from the early 1960s until he entered Congress in 1978. Last Spring Dannemeyer got 36 of the other 44 Congressional representatives from California to join him in signing a letter to HHS urging FDA to back off from regulating certified raw milk. (Some have since withdrawn their support.) “This ostensibly is a battle over public health,” he testified at the hearing. “Disabuse yourself. It’s a battle over the politics of public health. We are in this controversy because the medical profession for decades has produced doctors who are taught that all milk should be pasteurized. They don’t get into the whys. It is only natural that people who achieve positions of responsibility then base their actions on what they were taught. These are dedicated people who believe that milk should be pasteurized.” Dannemeyer traced the history of opposition to Alta-Dena and CRM from 1966 and said that the public has lost respect for public health authorities in California in regard to this issue. He claimed that health department records show that 3.6 million human cases of salmonellosis were reported between 1971 and 1982 in California, and that almost half of them were attributed to food service establishments, most of the remainder to meat and poultry, and only 103 to certified raw milk. He asked, “If it is the intention of public health authorities to eliminate Salmonellas from humans in the United States, how is it they ignore all except CRM?” Another witness for Alta-Dena was Joseph L. Fleiss, Ph.D., head of the Division of Biostatistics at Columbia University’s School of Public Health. He described an “odds ratio” scheme for controlled retrospective studies, with relative risks from 1 to 15. A value of 1 means “no associated risk.” A value of 5 means “important public health risks,” while 6 to 15 mean “probable cause and effect.” Asked to rate certified raw milk on that scale, Dr. Fleiss responded: “My experience is that, if all things were known, it would not come down to 1, it would come down to 5.” Another Alta-Dena witness was John M. Douglass, M.D., an internist from Los Angeles. “Isn’t it better to maintain control in the marketing of certified raw milk than to lose control?” he asked. “We might want to label it with some of the pros and some of the cons. That gives people freedom of choice. The label should be informative. Some people tolerate raw milk better than others. It may contain deleterious antigens.” Also testifying was William Campbell Douglass, M.D. (no relation to John Douglass), president of the Douglass Center for Nutrition and Preventive Medicine and author of The Milk of Human Kindness-Is Not Pasteurized. “For rapid, healthy growth in young children, there is no substitute for raw, certified milk,” he asserted. “Pasteurized milk is dead milk, which will rot on standing. One of nature’s most perfect foods has been murdered. At the turn of the century, 5,000 babies died annually from drinking raw milk, but instead of requiring dairymen to clean up their act they required pasteurization. Today, milk producers are clinging to outdated methods such as heat treatment to cover up sloppy production methods.” [Editor’s note: Pasteurization is not the only public health measure opposed by Dr. Douglass. A recent article by him in the National Health Federation’s monthly magazine states that chlorinated-fluoridated water causes cancer, chronic fatigue, atherosclerosis, allergy, heart attacks and strokes. Clinton Ray Miller, NHF’s Washington lobbyist, also testified.] Paul M. Fleiss, M.D. (a cousin of Joseph L. Fleiss), a pediatrician from Hollywood, California, admitted that he had been “repelled” to discover that in Hollywood there was a large group of consumers of raw milk. For a number of years, he said, he tried to dissuade mothers from feeding their infants and children a product with such a bad reputation. Finally, he investigated for himself, read the literature, visited dairies, “became a convert,” and now heads the Los Angeles County Milk Commission. “I have a very busy pediatrics practice, and many mothers tell me that their children do better on raw milk,” he said. “Some dairies are heating milk far beyond the heating required for pasteurization-they’re sterilizing it. This destroys some important nutrients. And you can taste the difference.” He also claimed that immunoglobulins and enzymes such as lactases and lipases are destroyed by sterilization. “Raw milk contains lipase, free fatty acids, which when absorbed help the body utilize fat better,” he explained. “This is why some allergies might be due to pasteurized milk.” Another witness at the hearing was Mrs. Sandy Gooch, author of the book, If You Love Me, Don’t Feed Me Junk. She identified herself as the proprietor of a California health food store which in June sold 5,319 gallons of raw milk, and as vice president of the Natural Foods Network [NF 1:16], which she said has three million customers nationwide. She asserted that she knew of no report of illness ever attributed to raw milk consumption. Other supporters of raw milk marketing said repeatedly that mandatory pasteurization would threaten consumers’ “freedom of choice.” One contended that everybody knows that cigarettes cause cancer, but government has not banned them, and everybody knows that passive restraints in automobiles save lives, but government has not mandated them. Another said, “We tried prohibition (of liquor) once, and it didn’t work. Is raw milk next?” The witnesses against raw milk were equally outspoken. One was public health veterinarian Morris E. Potter who, with three others from the U.S. Centers for Disease Control (CDC), published a state-of-the-art report on the hazards of unpasteurized milk in the October 19th Journal of the American Medical Association. The report lists seven supposed benefits claimed by raw milk advocates, including higher nutritive value, reduced incidence of tooth decay, enhanced resistance to disease, and enhanced fertility. Citing 65 references, however, Potter et al. conclude that no significant nutritional difference has been found between raw and pasteurized milk in numerous studies in both animals and humans. The report explains that pasteurization affects six milk constituents with known nutritional benefits

. Three vitamins for which milk is a minor source (thiamine, B12, and C) are reduced about 10%. About 6% of the calcium in milk is rendered insoluble, about 1% of milk protein is coagulated, and some fat globules are dispersed; but these changes have no effect on the bioavailability of these three nutrients. On the public health issues, the CDC group states that, “Abundant evidence has shown that raw milk serves as the source of bacteria that cause outbreaks of disease in humans: in recent years, most frequently salmonellosis and campylobacteriosis. In the investigations of such outbreaks, the epidemiologic evidence, combined with knowledge about the occurrence of specific pathogens in cattle and the isolation of some of these pathogens from raw milk, leaves no doubt that raw milk is a vehicle for disease in humans.” The main symptoms of these infections are cramps, diarrhea and fever, but Salmonella dublin presents a special problem. This relatively rare organism is known to be host-adapted to cattle and is more likely to be identified as being derived from raw milk than are the more commonly isolated types of Salmonellae. The authors note that, “Numerous studies in multiple locations have confirmed the role of raw milk in the transmission of S. dublin to humans…S. Dublin infections are of particular concern because the associated illness tends to be severe” —and is not limited to the digestive tract. At the FDA hearing, Dr. Potter added that, “From 1980 to 1983, 53% of the foodborne outbreaks of Campylobacter reported to CDC were associated with drinking unpasteurized milk. The reported rate of isolates identified is 20 times greater in states that permit the sale of unpasteurized milk.” According to CDC, outbreaks of campylobacteriosis associated with raw milk consumption have been reported recently in Arizona, California, Colorado, Georgia, Kansas, Maine, Oregon and Pennsylvania. Michael Osterholm, M.D., Minnesota Department of Health epidemiologist, described the investigation of a current mysterious disease outbreak in that state. After months of investigation, in which 94 families have been contacted, the investigators know only this: The causative agent has not been identified, but the method of transmission is undisputed. Unpasteurized milk produced by one dairy had been drunk by all 122 victims during the three weeks before onset. Some have been sick for months. For those under age 18, the median is 76 days’ duration. Children have recovered more quickly than adults, but only 11 (9%) have fully recovered. The producing dairy has voluntarily stopped selling raw milk products. “All cases of which we are aware are associated with raw milk consumption, and there have been no new cases since the implicated milk product was withdrawn,” said Dr. Osterholm. “This is no S. campylobacter. It is not a virus or a fungus. It stumps the best experts.” Raw milk’s growing popularity as a “supposed health food” is of concern to the American Academy of Pediatrics, said another witness, John Bolton, M.D., a San Francisco pediatrician. The Academy “has reviewed both the nutritional properties and the safety records of raw milk and has found that the risks outweigh the benefits,” he declared. “There are no benefits of raw milk that would outweigh the extreme risk of infection that sometimes follows feeding raw milk products to infants, children with malignancies, and children with problems involving the immune system.” He said that, since 1977, 192 isolates of Salmonella have been made in certified raw milk in California. This milk is also transported across state lines by distributors. According to Dr. Bolton, “The most recent finding on September 28, 1984, involved 4,000 gallons of certified raw milk distributed to consumers and retail outlets.” Press reports prior to the hearing indicate that California health officials had recalled Alta-Dena’s raw milk products 17 times since 1977 because state tests found S. dublin in samples. The incident referred to by Dr. Bolton occurred just hours before Gov. George Deukmejian vetoed a controversial bill that would have freed the dairy from control by state regulatory agencies. The bill would have allowed the sale of CRM shown by state labs to harbor salmonellae. Another recall involving Alta-Dena and two other California dairies has occurred since the FDA hearing. Dr. Bolton exhibited a chart which analyzed the 123 cases of S. dublin reported in California in 1983. It showed 51 patients who used raw milk, including 44 who used it from Alta-Dena. Only 10 of the 51 had been exposed to such other possible sources of S. dublin infection as raw eggs or raw or rare meat. The list of pre-existing diseases in these patients “reads like the index to a pathology textbook: cancer, leukemia, lymphoma, cirrhosis, lupus, AIDS, etc.,” he said. “This points out one of the most tragic aspects of this problem. Seriously ill patients purchase a so-called ‘health food’ only to be exposed to S. dublin. Raw milk is even advertised as a basic food for invalids.” In response to certified raw milk producers’ claim that the product is made safe by the practice of spraying the udders of the cattle with an antiseptic solution and then using two clean towels to wipe off, Dr. Bolton stated categorically that, “Potentially harmful bacteria still reside on the udders and inside some of the cattle as well.” Advocates of raw milk consumption point to other foods such as poultry which are frequently contaminated with Salmonellae. “What they fail to point out,” said Dr. Bolton, “is that these foods are intended to be cooked before consumption. Heat destroys Salmonellae. Pasteurization, heat treatment of milk, is the only way to assure safe milk supplies.” Referring to the statistical analysis of Salmonella illnesses cited by Congressman Dannemeyer, Dr. Bolton called it “creative.” Literature distributed by Alta-Dena shows that the figure of “3.6 million cases between 1971 and 1982” was derived by multiplying the number of all types of Salmonella infections reported annually (3,000) by 12 years and again by 100, “since some say that only 1 out of 100 Salmonella cases are ever detected/reported.” However, the number of S. dublin cases connected with raw milk consumption was given as the actual number reported (103), not the 10,300 which would result from multiplying this figure by 100. According to state health officials, the fact that the number of S. dublin cases in California is not larger “relates to the fact that the population that drinks CRM is very small and that contamination of CRM appears to be intermittent.” In its March 30, 1984 morbidity report, the Infectious Disease Section of the California Department of Health Services estimates that S. dublin infections are 158 times more likely in CRM users than in non-CRM users. Others testifying in favor of a federal rule regarding raw milk included representatives of the Association of Food and Drug Officials; International Association of Milk, Food, and Environmental Sanitarians; National Conference on Interstate Milk Shipments; and National Milk Producers Federation. The FDA hearing was but a skirmish in what The Los Angeles Times [Aug. 31] called “a holy war over milk” in California. “Each time the state laboratories have found salmonella in Alta-Dena’s milk,” the writer noted, “another recall notice has been issued, warnings have appeared in newspaper articles and the raw milk has been pulled off supermarket shelves. In this war of attrition, the state seems to be slowly winning.” Although Alta-Dena’s total sales have increased steadily in recent years, raw milk sales have declined from almost 20,000 gallons a day in 1977 to about half of that amount today. Yet, the article points out, “after all the recalls and all the press releases, an estimated 200,000 people a day still drink raw milk in California.” __________________________ Mr. Fanning was a freelance science writer who produced the nationally syndicated consum

er action column, “Help-Mate,” and was Nutrition Forum’s Washington correspondent. He was also editor and publisher of Con$umer New$weekly.