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Udder Nonsense? The Emerging Issue of Raw Milk Sales in Florida, Part I: Regulation

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A growing number of consumers are devotees of unpasteurized “raw” cow, goat, and sheep milk. Pasteurization is “the application of heat to destroy human pathogens in foods.”2 While pasteurization has proven to substantially reduce milk’s disease pathogen load, raw milk advocates claim pasteurization reduces milk’s inherently beneficial qualities, such as available nutrients, active enzymes, helpful bacteria, calcium absorption, and taste.3 Despite the potential risks to human health, consumers continue to demand and producers continue to market raw milk to the general public.4 The resulting raw versus pasteurized milk dynamics has resulted in an hodge-podge of federal and state regulatory schemes over the broad milk spectrum from strict prohibition to liberal marketing. The inherent danger of raw milk consumption, coupled with varying legal permissiveness, can trigger liability under a number of legal theories. This article outlines the regulation of raw milk by the federal government and the states, paying particular attention to Florida. A second article will examine the legal ramifications of marketing raw milk to the end consumer.

While milk is a rich source of nutrition,
it also provides an ideal environment for a number of dangerous bacteria and viruses:5 anthrax, campylobacter,6 E. coli,7 listeria,8 rabies,9 salmonella,10 staphylococcus, tuberculosis, typhoid fever, and yersiniosis.11 These illnesses have serious health consequences. Pasteurization does not provide fail-safe protection, but does provide an added layer of liability protection by its reduction of pathogens that can injure consumers.12 Milk contamination primarily occurs via the mammary gland and from the outside environment, like fecal matter on milking equipment or udders. Outside contamination has numerous sources, including sick farm labor, generally unsanitary conditions,
and improper refrigeration or improper handling.13 According to the Centers for Disease Control and Prevention, from 1973 to 1992, there were 1,733 documented raw milk-related illnesses in the United States.14 A 2004 National Association of State Departments of Agriculture survey found 29 states that have recorded raw milk-related illness outbreaks.15 From 1998 to May 2005, states reported at least 45 such outbreaks to the FDA.16 Some of these outbreaks involved severe symptoms and hospitalization.17

Despite the health risks, raw milk enthusiasts continue to seek the product, arguing that heat exposure from pasteurization harms the flavor and nutritional composition of milk.18 Milk’s principal sugar (lactose) reacts with amino acids to change the flavor of milk when heated,19 known as the Maillard reaction.20 Nutritional quality is also easily influenced by environmental factors, such as heat. Depending on the pasteurization method, vitamin loss can be up to 50 percent for vitamins B1, B6, B12 and 100 percent for vitamins B9 and C within three months.21 UHT sterilization, an extreme pasteurization method designed for long-term nonrefrigerated storage, can result in severe vitamin loss.22 However, proponents of pasteurization argue that these issues are negligible. They point out that although some pasteurization methods result in large vitamin losses, average losses of less heat-resistant vitamins via pasteurization include less than 10 percent of vitamins B1, B12, and folic acid; 0-8 percent of B6 and 10-25 percent of vitamin C.23 These losses are considered nutritionally insignificant.24

Whether for perceived taste or health benefits, raw milk advocates are willing to pay very high prices for the milk, and several dairy farms have been cashing in.25 As they do so, these farmers must be aware of the complex set of federal and state regulations regarding raw milk sales.

Laws regulating the sale of milk are clearly divided along state commerce lines. Any milk passing into interstate commerce is regulated by the FDA, allowing states to regulate milk sales wholly within intrastate commerce. In 1927, the United States established federal standards for safe milk production and interstate transport.26 The FDA adopted rules on proper milk production and handling, known initially as the “Milk Ordinance” and later as the “Pasteurized Milk Ordinance (PMO).”27 Beginning in 1974, the FDA required pasteurization of all milk but “certified” raw milk in interstate commerce28 but, by 1987, the FDA prohibited the sale of any raw fluid milk to the final consumer.29

States regulate milk in intrastate commerce via their police powers to protect public health.30 Today, 22 states and the District of Columbia essentially ban raw milk sales (by adopting some form of the FDA’s model PMO).31 Florida addresses raw milk sales in F.S. §502.091, which states “Only Grade A [applying PMO standards] pasteurized milk and milk products shall be sold to the final consumer….”32 Some states allow the sale of raw milk for human consumption, but severely restrict sales by quantity, by type, or by requiring physician approval or warning labels.33 Dairy animal leasing and animal share programs exploit a loophole in some states’ milk prohibitions. For example, animal shares involve the purchase of an ownership interest in the dairy animal, also essentially resulting in a transfer of milk for money.34 Few states have specifically addressed this. Florida, Maryland, North Carolina, Virginia, and Wisconsin have closed this loophole, but Colorado specifically allows the practice.35 Florida closed the loophole by defining the term “sold” to include any “transfer of milk. .. that involves any direct or indirect form of compensation in exchange for the right to acquire such milk.”36 Most states, including Florida,37 have no prohibitions against selling raw milk as pet food. This is another loophole which raw milk marketers have exploited.38

The existing sieve structure of federal and state milk regulation provides incomplete protection of both the raw milk consumer and producer or vendor. Populations of at-risk consumers39 ( i.e. , consumers with deficient immune systems, pregnant women, children, and the elderly), consolidation of industry and mass distribution of food from few central food processing centers,40 and people’s increased reliance on take-out food41 contributes to the risk of mass foodborne disease outbreaks. While no safety protocol is absolute, many states view pasteurization as a cheap, effective, and proven additional bulwark against disease, with arguably negligible negative impact on the quality of milk. Given the potential health risks, raw milk producers and vendors must exercise extreme caution to avoid running afoul of state and federal law.

1 This article is a modified version of D.C. Adams, et al., Déjà Moo: Is the Return to Public Sale of Raw Milk Udder Nonsense? 13(3)Drake J. Agr. L., and is published with permission.

2 International Dairy Foods Association, Pasteurization: Definition and Methods, available at www.idfa.org/facts/milk/pasteur.cfm; see also James H. Steele, History, Trends, and Extent of Pasteurization, 217(2) J. Am. Vet. Med. Assn. 175, 175-177 (July 2000). Today, there are two widely used pasteurization methods: low temperature/long time treatment (LTLT) and high temperature/short time treatment (HTST). LTLT heats milk for 30 minutes at 145 degrees Fahrenheit, while HTST heats milk at a temperature of 161.5 degrees Fahrenheit for a minimum of 15 seconds. See Jeremy Stranks, The A-Z of Food Safety 218 (Thorogood 2007).

3 “Raw milk advocates claim that unprocessed milk is healthier because pasteurization destroys nutrients and enzymes necessary to absorb calcium. It also kills beneficial bacteria and is associated with allergies, arthritis, and other diseases….” Linda Bren, Got Milk? Make Sure It’s Pasteurized, 38(5) FDA Consumer Magazine 29, 29-31 (Sep/Oct 2004).

4 Forty of the 46 disease outbreaks from raw milk that were reported by the U.S. Centers for Disease Control from 1973-1992 were in states where raw milk sales were legal. M.L. Headrick, et al., The Epidemiology of Raw Milk-associated Foodborne Disease Outbreaks Reported in the United States, 1973 through 1992, 88(8) Am. J. Public Health 1219, 1219-1221 (Aug 1998).

5 Endel Karmas & Robert S. Harris, Nutritional Evaluation of Food Processing 205 – 207, 609 (Van Nostrand Reinhold, 3d ed. 1988); see also P. Walstra et al., Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology 37, 37-38 (1999); Lore A. Rogers, The Bacteria of Pasteurized and Unpasteurized Milk Under Laboratory Conditions 17, 17-23 (USDA Bureau of Animal Industry 1905).

6 Cindy R. Friedman, et al., Risk Factors for Sporadic Campylobacter Infection in the United States: A Case-Control Study, Clinical Infections Disease 38 (Supp. 3), S285-S296 (Apr. 2004); see also Sean F. Altekuse, et al., Campylobacter jejuni — An Emerging Foodborne Pathogen, 5(1) Emerging Infectious Diseases 28, 28-35 (Jan.-Feb. 1999).

7 Centers for Disease Control, PulseNet Pathogens-Escherichia Coli 0157:H7 (Aug. 2005), available at www.cdc.gov/pulsenet/pathogens_pages/escherichiacoli_O157H7.htm.

8 Bren, Got Milk? Make Sure It’s Pasteurized, 38(5) FDA Consumer Magazine at note 1 (Sep./Oct. 2004); see also Anita Rampling, Raw Milk Cheeses and Salmonella, 312 Brit. Med. J. 67-68 (Jan 1996).

9 M. McGuill, et al., Mass Treatment of Humans Who Drank Unpasteurized Milk from Rabid Cows-Massachusetts, 1996-1998, 48(11) Morbidity & Mortality Weekly Rep’t 228, 228-229 (Mar. 1999); Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 162 (1999).

10 Ron Schmid, The Untold Story of Milk: Green Pastures, Contented Cows and Raw Dairy Foods 253 (New Trends Publishing 2003). See also P.D. Frenzen, et al., Salmonella Cost Estimate Updated Using FoodNet Data, 22(2) Food Review 9, 9-10 (1999).

11 Center for Disease Control, Epidemiologic Notes and Reports Multi-State Outbreak of Yersiniosis, 31(37) Morbidity & Mortality Weekly Rep’t 505, 505-506 (Sept. 1982).

12 E. Melanie DuPuis, Nature’s Perfect Food: How Milk Became America’s Drink 386 (New York University Press 2002); see also Irene R. Grant, Mycobacterium Avium ssp. Paratuberculosis: Its Incidence, Heat Resist and Detection in Milk and Dairy Products, 54 Int’l J. of Dairy Tech. (No. 1) 1, 2 – 11 (Feb. 2001); see also Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 163-64; see also Karmas & Harris, Nutritional Evaluation of Food Processing at 609 (1988).

13 See Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 163-67 (1999); see, e.g., M.W. Griffiths, et al., Effect of Low-temperature Storage on the Bacteriological Quality of Raw Milk, 4 Food Microbiology 285, 285-291 (1987); see also Thomas A. McMeekin and Thomas Ross, Shelf Life Prediction: Status and Future Possibilities, 33 Int’l J. Food Microbio. 65, 65-83 (1996).

14 Headrick, The Epidemiology of Raw Milk-associated Foodborne Disease Outbreaks Reported in the United States, 1973 through 1992, 88(8) Am. J. Public Health 1219 (Aug 1998). In 1938, milk-related diseases constituted about one-quarter of the US disease outbreaks from consumer food or water supplies. Today they account for less than one percent. See Center for Food Safety and Nutrition [hereinafter CFSAN PMO], Food and Drug Administration, Grade A Milk Ordinance 2 (Mar. 2, 2004), available at www.cfsan.fda.gov/~ear/pmo03.html#foreword.

15 National Association of State Departments of Agriculture, Raw Milk Survey (Nov. 2004), www.nasda.org/file.aspx?id=11160.

16 U.S. Food and Drug Administration, FDA and CDC Remind Consumers of the Dangers of Drinking Raw Milk (Mar. 1, 2007), available at www.fda.gov/bbs/topics/NEWS/2007/NEW01576.html.
17 See, e.g., Centers for Disease Control, Outbreak of Campylobacter jejuni Infections Associated with Drinking Unpasteurized Milk Procured Through a Cow-Leasing Program-Wisconsin, 2001, 51(25) Morbidity & Mortality Weekly Rep’t 548 (June 2002) (In 2001, 75 cases of severe gastro-intestinal illnesses from C. jejuni were linked to people drinking unpasteurized milk); see also Centers for Disease Control, Multistate Outbreak of Salmonella Serotype Typhimurium Infections Associated with Drinking Unpasteurized Milk — Illinois, Indiana, Ohio, and Tennessee, 52(26) Morbidity & Mortality Weekly Rep’t 613 (July 2003) (In 2002, several Ohio children were hospitalized with salmonella food poisoning after visiting a small dairy).

18 See, e.g., Advocates for Unpasteurized Milk Hoping to Change State Law, The Associated Press (Dec. 28, 2004); see also Eric Schwartzberg, Got Real Milk?: Raw Milk — The Underground Network for “Moo-shine,” The Oxford Press (Apr. 19, 2007); Milk Does a Body Good, But What If It’s Raw?, The Times Union (Albany) E3 (Aug. 9, 2007); James L. Smith, Consumers’ Enthusiasm Growing for Farmer’s Raw Milk, Flint J. A08 (Mar. 12, 2006); Weekly Farm: Unpasteurized Milk Has Fans Despite Health Officials’ Warnings, The Associated Press (Apr. 3, 2004).

19 Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technologyat 208.

20 Small amounts of ketones and aldehydes impact flavor and melanodines cause milk to color brown. Loss of nutrition is mainly lysine unavailability, caused by the Maillard reaction. Id. at 191-92; see also id. at 198-200 (Storage temperature and pH impacts the Maillard reaction).

21 Id. at 403, Table 14.3.

22 Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 209, 393 (UHT is Ultra High Temperature).

23 Karmas & Harris, Nutritional Evaluation of Food Processing at 212 (Table 8.6) (1988).

24 Id. Furthermore, some vitamins are not found in sufficient quantities in unfortified raw milk. For example, Vitamin D, a contributing factor for calcium absorption, does not exist in significant levels of raw milk and is routinely added to pasteurized milk. See Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 77, 79 (raw milk has. 0008 mg/L of vitamin D); see also Bren, Got Milk? Make Sure It’s Pasteurized, 38(5) FDA Consumer Magazine 29 (Sep/Oct 2004). Specially treated fortified vitamins and minerals, including A, B1, B12, C, and D, can be more resistant to degradation and heat than natural vitamins and minerals. See Karmas & Harris, Nutritional Evaluation of Food Processing at 609-613 (1988). Raw milk supporters also argue that pasteurized milk suffers from partially broken down proteins and enzymes. Pasteurization breaks down between 10 percent and 80 percent of whey protein in milk, and some enzymes are eliminated altogether. See Karmas & Harris, Nutritional Evaluation of Food Processing at at 208, 210, 387 (1988). Pasteurization also breaks down milk’s natural bacteria inhibitors, like immunoglobulin antibodies that attack specific antigens and bacteria “specific for the species and strains of bacteria encountered by the cow.” See Walstra, Dairy Technology: Principles of Milk Properties and Processes, 90 Food Science and Technology at 155. However, most “natural” milk enzymes have no apparent “biological function in milk,” even despite some enzymes’ high concentrations. See id. at 91, 155-56. Furthermore, the concentration of immunoglobulins and other inhibitors in milk is generally very low. See id.

25 See, e.g., Farmer Challenges State Law, Fights Restrictions on Raw Milk, The Associated Press (Mar. 5, 2004) (Noting that raw milk can be sold for triple the price of pasteurized milk).

26 Milk Importation Act, Pub. L. No. 69-625, 44 Stat. 1101 (Feb. 15, 1927).

27 See CFSAN PMO.

28 38 Fed. Reg. 27924 (Oct. 10, 1973); see also Center for Food Safety and Applied Nutrition [hereinafter CFSAN Statement], US Food and Drug Administration, Sale/Consumption of Raw Milk — Position Statement (M-I-03-4) (Mar. 19, 2003), available at http://vm.cfsan.fda.gov/~ear/mi-03-4.html (Limited exceptions allow the sale and transportation of raw milk for further processing. None of the exceptions allow raw milk to reach the final consumer after it enters interstate commerce. See 21 U.S.C. §143.); Jan K. Shearer, Kermit C. Bachman, and J. Boosinger, The Production of Quality Milk, Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of Florida (Sep. 1992), available at http://edis.ifas.ufl.edu/DS112; see also 21 C.F.R. §1240.61 (2006) (exception for aged raw milk cheeses).

29 21 C.F.R. 1240.61 (1987). In 1973-74, after a complaint from a certified raw milk producer, the FDA stayed this rule for “certified” raw milk, and, from 1973 to 1982, the FDA held hearings and collected evidence on the human health implications of raw milk. In 1982, the FDA drafted but did not adopt a new rule requiring pasteurization of all milk and milk products meant for human consumption. After a court battle with the government watchdog group Public Citizen, the FDA adopted its current regulatory stance. See Public Citizen Health Research Group v. Commissioner of Food and Drugs, 740 F.2d 34 (D.C. Cir. 1984); Public Citizen v. Heckler (I), 602 F. Supp. 611 (1985); Public Citizen v. Heckler (II), 653 F. Supp. 1229 (D.D.C. 1986).

30 See, e.g., Powell v. Pennsylvania, 127 U.S. 678 (1888); see also Schlenker v. Bd. of Health of Auglaize County Gen. Health Dist., 167 N.E.2d 920, 920-922 (Ohio 1960); see also Allegheny County v. Brumner, 28 Pa. D. & C.2d 32, 33-35 (Pa. Ct. Com. Pl. 1961); See also Shelton v. Shelton, 150 A. 811, 813 (Conn. 1930); see also Brielman v. Comm’r of Pub. Health, 17 N.E.2d 187, 188-189 (Mass. 1938); see also Phoenix v. Breunger, 72 P.2d 580, 582 (Ariz., 1937); see also Udey v. Kastner, 644 F. Supp. 1441, 1446 (E.D. Tex. 1986); see also Aerated Products Co. of Penn. v. Dep’t of Health, N.J., 59 F. Supp. 652, 657 (D.C.N.J. 1945).

31 Agricultural Law Update 23(3) no. 268, (Mar. 2006) at 2. (In Alabama, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Indiana, Iowa, Kentucky, Louisiana, Maryland, Michigan, Montana, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Virginia, West Virginia, and Wyoming, raw milk sales for human consumption is essentially illegal.).

32 See Fla. Stat. Ann. §502.091 (2006); Fla. Admin. Code. Ann. r. 5D-1.001 (2006).

33 See D.C. Adams, et al., Déjà Moo: Is the Return to Public Sale of Raw Milk Udder Nonsense? 13(2) Drake J. Agr. L. at notes 74-85; see also, e.g., 2 Okl. Stat. §§7-406 (2007), 7-408 (2007), 7-417 (2007), & 7-414(A-B) (2007) (Specifically allowing “incidental sales of raw milk directly to consumers at the farm where the milk is produced” and defining “incidental sales” of goat milk as less than 100 gallons per month on average); and 17 Ca. Code Reg. §11380 (2008) (Requiring the label: “WARNING Raw (unpasteurized) milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity.”).

34 See, e.g., The Campaign for Real Milk, Share Agreements: Cow Shares, Herd Shares, Farm Shares, www.realmilk.com/cowfarmshare.html (defining cow share: “consumers pay a farmer a fee for boarding the cow, (or share of a cow), caring for the cow and milking the cow”).

35 See Fla. Admin. Code. 5D-1.001(1)(a) & (2)(j) (2008); see also Adams, et al., note 33.

36 Fla. Admin. Code. Ann. r. 5D-1.001(2)(j) (2008).

37 Nathan Crabbe, State Finds Claims of Raw Milk’s Benefits Hard to Swallow, The Gaiinesville Sun, Dec. 3, 2005, at 1A, 6A.

38 See, e.g., Suzette Nielson, A Gray Market for Raw Milk?, Indyweek.com (Sept. 26, 2007), available at www.indyweek.com/gyrobase/Content?oid=oid%3A160975; see also Elizabeth Lee, Hearing to Cover Raw Milk, The Atlanta Journal-Constitution (Oct. 5, 2007); Ida. Code §37-404 (2008).

39 William T. Jarvis, National Council Against Health Fraud, Raw Milk Can Be Deadly (1997), available at www.ncahf.org/articles/o-r/rawmilk.html.

40 S.F. Altekruse, M.L. Cohen, and D.L. Swerdlow, Emerging Foodborne Diseases, 3(3) Emerging Infectious Diseases 285, 285-293 (July-Sept. 1997), available at www.cdc.gov/Ncidod/eid/vol3no3/cohen.htm.

41 Id. (nearly 80 percent of U.S. food borne outbreaks occurred outside the home in the 1990s).

Damian C. Adams, J.D., Ph.D., is an assistant professor in the Agricultural Economics Department at Oklahoma State University, Stillwater. Michael T. Olexa is professor and director of the Agricultural Law Center at the University of Florida. Tracey L. Owens is staff attorney in the 10th Judicial Circuit Court, Bartow. Joshua A. Cossey is an attorney with the Law Offices of R.W. Bauer, P.A.
This column is submitted on behalf of the General Practice, Solo and Small Firm Section, Ana M. Veliz, chair, and Craig Ferrante, editor.

Solo and Small Firm