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Raw Milk-Associated Public Health Risks

Raw Milk-Associated Public Health Risks. January 24, 2007 Dairy and Egg Safety Division Office of Plant and Dairy Foods Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration. No, It’s Not New…

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Raw Milk-Associated Public Health Risks

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  1. Raw Milk-Associated Public Health Risks January 24, 2007 Dairy and Egg Safety Division Office of Plant and Dairy Foods Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration

  2. No, It’s Not New… There have been and continue to be Public Health Risks of Consuming Raw Milk and Raw Milk Products RAW MILK

  3. Outbreaks • 2004 National Association of State Departments of Agriculture (NASDA) Survey indicated 29 States have recorded milkborne outbreaks traceable to raw milk consumption. • In 2005-2006 more than 10 outbreaks caused by the consumption of raw milk or raw milk cheese were reported to FDA.

  4. Raw Milk Safety Concerns –Information Available • “On the Safety of Raw Milk (with a Word about Pasteurization)” presented to the 2005 National Conference on Interstate Milk Shipments (NCIMS) by Div. of Dairy and Egg Safety/CFSAN/FDA. • Includes Myths and Claims with Science Responses http://www.cfsan.fda.gov/~ear/milksafe.html

  5. Raw Milk Safety Concerns – Information Available • FDA has been providing information and assistance to states dealing with raw milk issues, including to legislative committees. • DDES Director, John Sheehan, J.D., B.S. Dy Sci., provided FDA written Testimony on Raw Milk to Ohio House of Representatives Agriculture Committee, May 24, 2006. • http://www.ohioagriculture.gov/dairy/documents/FDATestimonyRawMilk.pdf

  6. Raw Milk Cheese Food Safety Risk

  7. Long History of Risk • FDA and other Federal and State agencies have acknowledged a long history of the risks associated with the consumption of raw milk. • Raw milk (no bactericidal/bacteriostatic treatment, apart from cooling) is a vehicle for transmission of pathogens, such as: • Listeria monocytogenes • Brucella spp. • E. coli • Campylobacter spp. • Mycobacterium bovis • Coxiella burnetti • Salmonella spp.

  8. National Policy and Position Statements • U.S. Food and Drug Administration (FDA) • Centers for Disease Control and Prevention (CDC) • National Conference on Interstate Milk Shipments (NCIMS) • National Association of State Departments of Agriculture (NASDA) • Association of Food & Drug Officials (AFDO)

  9. FDA Sale/Consumption of Raw Milk-Position Statement (M-I-03-4) • “strongly advises against the consumption of raw milk” • "Raw milk, no matter how carefully produced, may be unsafe." • In the court case Public Citizen v. Heckler, 653f. Supp. 1229 (D.D.C. 1986), the federal district court concluded that the record presents "overwhelming evidence of the risks associated with the consumption of raw milk, both certified and otherwise". • The court stated that the evidence FDA has accumulated concerning raw milk "Conclusively shows that raw and certified raw milk are unsafe" and "There is no longer any question of fact as to whether raw milk is unsafe". • http://www.cfsan.fda.gov/~ear/mi-03-4.html

  10. CDC • Memo from CDC to FDA: CDC “strongly endorses regulatory efforts to restrict the sale of raw milk and soft fresh cheeses made from unpasteurized milk to consumers. We also support health education efforts to inform consumers of the health risks of these products.” “CDC continues to receive reports of foodborne illness outbreaks due to unpasteurized milk and soft fresh cheeses, such as queso fresco, often made from unpasteurized milk.”

  11. 2005 NCIMS Resolution 10 • “Therefore, Be It Resolved: That the NCIMS, due to the serious public health concerns, discourages the consumption of raw milk and encourages states to pass laws or adopt administrative rules that prohibit the sale of raw milk directly to the household consumer and to the unlawful manufacturers of unlawful dairy products;” • “Be It Further Resolved: That the NCIMS continues to support the motto of the conference, which is “To assure the safest possible milk supply for all the people”.”

  12. NASDA Policy Statement • National Association of State Departments of Agriculture (NASDA) issued policy statement September 18, 2006. • “…only pasteurized milk, milk products and properly aged cheeses should be sold for human consumption.” • Defines ‘Sale’ http://www2.nasda.org/NR/exeres/480DACB7-AC68-4980-AB3C-3F50BCEC252F.htm

  13. NASDA Policy Statement “ Milk Quality: Pasteurization - Inasmuch as apparently healthy cows and goats can shed in their milk organisms which are pathogenic to human beings and may cause diseases such as brucellosis, Campylobacter enteritis, salmonellosis, and tuberculosis; and inasmuch as milk handlers may introduce pathogenic agents during the handling of unpasteurized milk (including certified raw milk), only pasteurized milk, milk products and properly aged cheeses should be sold for human consumption. 

  14. NASDA Policy Statement cont’d Sale includes distribution by use of animal or herd sharing, bartering, exchange or agistment.  In those states where the sale of unpasteurized milk is authorized, those products should be labeled, "Not Pasteurized and May Contain Organisms that cause Human Disease."

  15. AFDO Position Statement • Association of Food & Drug Officials (AFDO) December, 2006 • Supports Mandatory Pasteurization • http://www.afdo.org/afdo/position/PosStmt-2006-RawMilk.cfm

  16. From AFDO Position Statement • “By building consensus with program managers at the state and local levels, AFDO is able to establish united positions on national food safety matters that affect all of us.” • “AFDO supports mandatory pasteurization for all milk and milk products intended for direct human consumption except where alternative procedures to pasteurization are provided (i.e. curing of certain cheese varieties) to ensure the safety of finished products.”

  17. From AFDO Position Statement cont’d • “Foodborne illnesses related to the consumption of fresh, soft, raw milk cheeses such as queso fresco and queso cotija point out the hazards of consuming raw milk products. • These products are popular among people from societies where milk pasteurization is not as common as in the United States, and the product is distributed mainly through unregulated practices. • While mandatory pasteurization requirements will not stop black market distribution, they will curtail mass distribution and facilitate raising the awareness of potential consumers.”

  18. Pasteurization • Pasteurization destroys pathogenic bacteria Such as Listeria monocytogenes

  19. Why Pasteurize? • Pasteurization was first implemented to destroy Mycobacterium bovis, which causes systemic tuberculosis in humans. • Pasteurization temperatures were later increased to destroy Coxiella burnetii, which causes Q-fever. • Pasteurization can destroy emerging pathogens, such as E. coli O157:H7 and Salmonella typhimurium DT-104, which cause serious illness and are difficult to treat due to resistance to many common antibiotics (Cornell Univ.).

  20. Pasteurization Regulations • In 1987, FDA implemented a ban on the interstate sale of raw milk. (21 CFR 1240.61) • However, each state regulates the sale of raw milk within its jurisdiction (intrastate commerce). • Some states permit the sale of raw milk to local retail food stores or directly to consumers from the farm or at community events.

  21. CFR Pasteurization Regulation • The federal regulation describing mandatory pasteurization requirement is 21 CFR 1240.61. • In promulgating this regulation, FDA made a number of findings relative to raw milk, including the following: "Raw milk, no matter how carefully produced, may be unsafe." (52 FR 29514, Aug. 10, 1987)

  22. Methods of Raw Milk Sales • Cow Shares • Herd Shares • Cow Boarding • Co-Ops • Pet Food Sales

  23. Cow Sharing • Cow sharing or cow leasing has occurred in states where intrastate sale of raw milk is prohibited. • Consumers buy a percentage of a cow’s milk production for a fee and then receive a certain amount of raw milk per week.

  24. Survey of Raw Milk Sales 2005 • March, 2005, John A. Beers, Program Supervisor, Virginia Department of Agriculture and Consumer Services, Division of Animal and Food Industry Services surveyed 50 U.S. states and Puerto Rico to determine the extent of regulatory requirements on the sale of raw milk and cheese products.

  25. Cow Sharing • 4 states* allow animal shares with licensing or permitting and inspection: • Arizona, Idaho, New York and Washington • 7 states and Puerto Rico ban animal shares as a means to obtain raw milk: • Florida, Iowa, Montana, Nevada, North Carolina, West Virginia and Wisconsin • The remaining 39* states do not have specific laws or regulations pertaining to animal shares as a means to obtain raw milk. *Adjustment made to survey per Illinois

  26. Legal Actions • Wisconsin has prosecuted several cases of "cow share" schemes under their State law.  • Indiana currently has Cease and Desist Orders on Sales of Raw Milk and Cow Sharing.

  27. FDA Warning Letters • Organic Pastures Dairy Company, Fresno, California, February, 24, 2005 • Distribution of unpasteurized milk, buttermilk, butter, cream and colostrums in interstate commerce, in finished form for human consumption • Violation PHS Act, Title 42, U. S. Code, Sections 264(2) and 271(a) and 21 CFR 1240.61

  28. FDA Warning Letters • White Egret Farm, Austin, Texas, December 15, 2005 • Distribution of unpasteurized goat milk in interstate commerce, in finished form for human consumption • Violation of PHS Act, 42 U.S.C. 264(2) and 272(a) and 21 CFR 1240.61

  29. FDA Warning Letters • Dee Creek Farm, Woodland, Washington, May 2, 2006 • Dairy Farm caused to be delivered into interstate commerce unpasteurized milk, in finished form for human consumption • Violation of PHS Act, 42 U.S.C. 264(2) and 272(a) and 21 CFR 1240.61

  30. Raw Milk Confiscated • Double O Farms, Verona, Kentucky • Cow Share business - routine deliveries distributing milk to shareholders of farm’s cows at various drop off points in Cincinnati area. Sell shares of cows to people for $75 a share. • Ohio Department of Agriculture, Kentucky Public Health Department, and USFDA confiscated milk from truck and shareholders bottles in Cincinnati parking lot on March 6, 2006.

  31. Suitcase Cheese and Border Action • U.S. Customs and Border Protection and Agriculture Specialists seized 130 pounds of cheese from three- time violator at the Laredo, Texas Port of Entry, December 12, 2006. • In lieu of violator’s inability to pay a $5000 fine, his truck and travel trailer were seized.

  32. FDA Science Poster • “Raw Milk-Associated Illnesses Reported to FDA from 2000-2005” M. Ross, C. Leonard, J. Sanders, K. Klontz, J. Sheehan, R. Childers, D. Street • CFSAN presented poster at • The FDA Science Forum, Washington D.C. April, 2006 • The National Association of City and County Officials Conference, San Antonio, TX, July, 2006. • CFSAN will be presenting poster to the 2007 U.S. Public Health Service Commissioned Officer’s Association Meeting in Cincinnati, OH in June.

  33. FDA Raw Milk Associated Illnesses Science Poster • CFSAN/FDA reviewed raw milk-associated events reported to FDA from 2000-2005 • Provides examples of raw milk-associated events.

  34. Sources for Raw Milk Science Poster • Electronic search of CFSAN’s Food Emergency Response (FER) outbreak folders. • Descriptive information, such as demographic, epidemiological and clinical information

  35. 19 Events of Illnesses 2000-2005 • This review highlighted 19 raw milk-associated events of illness in 5 years that affected 473 persons, many of them children and pregnant women. • 18 events were related to the consumption of bovine-derived raw milk or raw milk products, and 1 event was related to the consumption of caprine-derived raw milk.

  36. Events 2000-2005 • Events involved 473 ill persons in 16 states. Many were children and pregnant women, and many of the cases were persons of Hispanic origin. • Listeria monocytogenes and Salmonella spp. each accounted for 5 of the 19 (26%) events. • Salmonella spp. accounted for 193 (41%) illnesses (Table 1). • There were 7 deaths including 3 infant fatalities.

  37. Table 1: Morbidity, Mortality and Etiology of Raw Milk-Associated Events.

  38. Raw Milk Cheese Events 2000-2005 • 55% of persons affected consumed raw milk as opposed to raw milk cheeses. • There were 11 events that solely mentioned raw milk cheeses (Table 2). Of those, 10 were specifically related to the consumption of Mexican-style soft cheeses, such as queso fresco. • Queso fresco, a Mexican-style cheese made from raw milk, was more frequently purchased from street vendors than from retail stores.

  39. Table 2. Pathogens and Accompanying Vehicles Implicated in Raw Milk-Associated Events. . *Bovine-derived product unless specified

  40. Pathogens • Five bacterial organisms were implicated in these events, several of which have the potential to cause severe illness and death. Among these organisms, E. coli O157:H7 and multidrug-resistant Salmonella species have recently emerged as causes of human illness.

  41. Raw Milk Risk • A search of CFSAN FER from 2000-2005 produced 44 illnesses associated with pasteurized milk products as compared with 473 from raw milk. • Raw milk is a potentially high-risk food for all persons, particularly for pregnant women and young, elderly or infirmed persons.

  42. Consumption of raw milk has been found to account for less than 1% of total milk sold in the states that permit the sale of raw milk (Headrick). Although consumption is relatively low, raw milk continues to cause outbreaks of illness. Raw Milk Risk

  43. Consumer Outreach • Consumer outreach is an important consideration in deterring the consumption of cheeses made from raw milk.

  44. Four Examples of Raw Milk-Associated Events • Rabies Scare • Cow Share • Suitcase Ware • Caprine Case

  45. Rabies Scare • Possible exposure to rabies virus in raw milk, Oklahoma, 2005. • 1 cow on the dairy farm was confirmed to have rabies. • Dairy announced that milk from the infected cow was bottled and sold to the public from December 4-19. • Milk from infected cow was commingled with that of up to 70 other cows;10,000 consumers potentially exposed. • Following the issuance of a State public health alert, > 500 people called the State hot line and local county health department for more information.

  46. Rabies Scare Public Health Effects • Special clinics staffed by health department employees provided rabies post-exposure prophylaxis to consumers deemed to be at greatest risk (those with immuno-compromising conditions or oral lesions). • 62 consumers received post-exposure rabies prophylaxis. • Estimated cost of rabies prophylaxis: $186,000 ($3,000/ person x 62 persons). • No cases of human rabies reported. • Pasteurization of milk would have made any rabies virus present in milk ineffective.

  47. Cow Share • Outbreak of E. coli O157:H7 infections linked to raw milk produced by a cow share program, Washington and Oregon, December, 2005 • Woodland, WA: Unlicensed dairy with 5 cows produced milk for 45 families. • 18 cases (9 cases between ages of 5 and 13) of E. coli O157:H7 infection, 5 patients hospitalized (no deaths), 2 children with Hemolytic Uremic Syndrome (HUS)

  48. Cow Share Public Health Effects • DNA "fingerprints" (PFGE) of E. coli O157:H7 recovered from samples of raw milk obtained from cow-share customers, from farm environment, and from swabs of cattle all matched. • Milk sales from farm stopped by the State after owners ignored demand by State agriculture department officials in August 2005 to obtain a $55 state license to supply raw milk. • February 2006: WA State Senate passed measure that explicitly included "cow share" programs among classes of dairies requiring licensure by state. Felony for repeat offenders who ignore the law.

  49. FDA Warning Letter to WA Dairy • As previously referenced, FDA issued Warning Letter to Dee Creek Farm, Woodland Washington. • This establishes FDA’s position that Cow Sharing is another form of introduction of raw milk into interstate commerce.

  50. Suitcase Ware • Mycobacterium bovis cases linked to raw Mexican cheese, New York City, 2001-2004 • 35 cases (22 adults, 13 children) were reported. • All 5 patients aged<5 years had extrapulmonary disease (lymphatic and peritoneal), were born in U.S. to Mexican-born parents, had not traveled outside U.S., and had no epidemiologic link to other TB cases. • 15-month-old boy with peritonitis died. • 19 (83%) of 23 patients interviewed reported eating cheeses produced in Mexico.

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