March 19, 2003
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Sale/Consumption of Raw Milk-Position Statement
Attached is the FDA/CFSAN/Office of Compliance's position statement regarding the public health hazards involved with the sale/consumption of raw milk. This document provides an excellent background, epidemiological reasoning, and milkborne disease information and may be useful in defending or discussing
any raw milk sale/consumption issues that may develop in the future.
If you wish to obtain a copy of the documents cited under the attachment of the letter, please feel free to contact Milk Safety Branch at (301) 436-2175 or fax at (301) 466-2715 or e-mail at Robert.Hennes@cfsan.fda.gov.
Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. This memorandum will also be available on the FDA Web site at http://www.cfsan.fda.gov (Updated Web Address) at a later date and should be widely distributed to representatives of the dairy industry and other interested parties.
CAPT Richard D. Eubanks, RS, MPH
Senior Milk Sanitation Officer
CAPT Robert F. Hennes, RS, MPH
Chief, Milk Safety Branch
March 18, 2003
This is in reply to your e-mail message of March 11, 2003, in which you requested a statement on the Food and Administration's (FDA) position on the public health concerns surrounding the sale/consumption of raw milk.
Please be advised that FDA and other federal and state health agencies have documented a long history of the risks to human health associated with the consumption of raw milk. Clinical and epidemiological studies from FDA, state health agencies, and others have established a direct causal link between gastrointestinal disease and the consumption of raw milk. The microbial flora of raw milk may include human pathogens present on the cow's udder and teats. Further, the intrinsic properties of milk, including its pH and nutrient content, make it an excellent media for the survival and growth of bacteria.
On August 10, 1987, 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 addresses milk shipped in interstate commerce and became effective September 9, 1987.
In this Federal Register notification for the final rule to 21 CFR Part 1240.61, FDA made a number of findings including the following:
"Raw milk, no matter how carefully produced, may be unsafe."
"It has not been shown to be feasible to perform routine bacteriological tests on the raw milk itself to determine the presence or absence of all pathogens and thereby ensure that it is free of infectious organisms."
"Opportunities for the introduction and persistence of Salmonella on dairy premises are numerous and varied, and technology does not exist to eliminate Salmonella infection from dairy herds or to preclude re-introduction of Salmonella organisms. Moreover recent studies show that cattle can carry and shed S. dublin organisms for many years and demonstrated that S. dublin cannot be routinely detected in cows that are mammary gland shedders."
During this rulemaking process, the American Academy of Pediatrics and numerous others submitted comments in support of the proposed regulation.
In deciding upon mandatory pasteurization, FDA determined that pasteurization was the only means to assure the destruction of pathogenic microorganisms that might be present. This decision was science-based involving epidemiological evidence. FDA and the Centers for Disease Control and Prevention (CDC) in Atlanta have documented illnesses associated with the consumption of raw milk, including "certified raw milk" and have stated that the risks of consuming raw milk far outweigh any benefits.
In light of research showing no meaningful difference in the nutritional value of pasteurized and unpasteurized milk, FDA and CDC have also concluded that the health risks associated with the consumption of raw milk far outweigh any benefits derived from its consumption.
There are numerous documented outbreaks of milkborne disease involving Salmonella and Campylobacter infections directly linked to the consumption of unpasteurized milk in the past 20 years. Since the early 1980's, cases of raw milk-associated campylobacteriosis have been reported in the states of Arizona, California, Colorado, Georgia, Kansas, Maine, Montana, New Mexico, Oregon, and Pennsylvania. An outbreak of Salmonellosis, involving 50 cases was confirmed in Ohio in 2002. Recent cases of E. coli O157:H7, Listeria monocytogenes and Yersinia enterocolitica infections have also been attributed to raw milk consumption.
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".
State health and agricultural agencies routinely use the U.S. Public Health Service/FDA Pasteurized Milk Ordinance (PMO) as the basis for the regulation of Grade "A" milk production and processing. The PMO has been sanctioned by the National Conference on Interstate Milk Shipments (NCIMS) and provides a national standard of uniform measures that is applied to Grade "A" dairy farms and milk processing facilities to assure safe milk and milk products. Section 9 of the PMO specifies that only Grade "A" pasteurized milk be sold to the consumer.
In summary, since raw milk may contain human pathogens, the consumption of raw milk products increases the risk of gastrointestinal illness due to the likelihood that it may contain infective doses of human pathogens. The only method proven to be reliable in reducing the level of human pathogens in milk and milk products is by those milk products being produced and processed under sanitary conditions and subsequently being properly pasteurized. The U.S. Food and Drug Administration; therefore, strongly advises against the consumption of raw milk.
References related to this subject may be found in the following documents:
- American Journal of Public Health, -- November 21, 1997
- Journal of the American Medical Association -- October 1984, May 1999, March 3, 1989
- Journal of Public Health Policy, Inc. -- September 1981
- Morbidity and Mortality Weekly -- June 28, 2002
- Journal of Food Protection -- Volume 61, Number 10, 1998
- United States Department of Agriculture (USDA) -- Fact Sheet -- July 1995
We trust this information responds to your request. If you would like additional information or have any questions, please feel free to call Mr. Robert Hennes, Chief, Milk Safety Team at (301) 436-2175. If we can be of any further assistance, please feel free to contact us.
Joseph R. Baca, Director
Office of Compliance
Center for Food Safety and Applied Nutrition
AFDO Food Committee-Position Paper Regarding Raw Milk and Raw Milk Products-10/14/2002
VMA Positions on Pasteurization of Milk and Milk Products
Public Health Veterinarian Coalition Committee-American Association of Public Health Veterinarians-Veterinary Public Health Policy Statements-2000 (Position Statement on Raw (Unpasteurized) Milk/Products)
Raw Milk and Milk Products for Human Consumption-Helen M. Piotter, Indiana State Board of Animal Health, November 2002