Raw Milk-Associated Raw Milk-Associated Public Health RisksPublic Health Risks

January 24, 2007January 24, 2007

Dairy and Egg Safety DivisionDairy and Egg Safety Division

Office of Plant and Dairy FoodsOffice of Plant and Dairy Foods

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

U.S. Food and Drug AdministrationU.S. Food and Drug Administration

RAW MILK

No, It’s Not No, It’s Not

New… New…

There have been There have been and continue to and continue to be Public Health be Public Health Risks of Risks of Consuming Raw Consuming Raw Milk and Raw Milk and Raw Milk ProductsMilk Products

Outbreaks Outbreaks

2004 National Association of State 2004 National Association of State Departments of Agriculture (NASDA) Departments of Agriculture (NASDA) Survey indicated 29 States have recorded Survey indicated 29 States have recorded milkborne outbreaks traceable to raw milk milkborne outbreaks traceable to raw milk consumption.consumption.

In 2005-2006 more than 10 outbreaks In 2005-2006 more than 10 outbreaks caused by the consumption of raw milk or caused by the consumption of raw milk or raw milk cheese were reported to FDA.raw milk cheese were reported to FDA.

Raw Milk Safety Concerns –Raw Milk Safety Concerns –Information AvailableInformation Available

““On the Safety of Raw Milk (with a Word On the Safety of Raw Milk (with a Word about Pasteurization)” presented to the about Pasteurization)” presented to the 2005 National Conference on Interstate 2005 National Conference on Interstate Milk Shipments (NCIMS) by Div. of Dairy Milk Shipments (NCIMS) by Div. of Dairy and Egg Safety/CFSAN/FDA.and Egg Safety/CFSAN/FDA.

Includes Myths and Claims with Science Includes Myths and Claims with Science ResponsesResponses

http://www.cfsan.fda.gov/~ear/milksafe.htmlhttp://www.cfsan.fda.gov/~ear/milksafe.html

Raw Milk Safety Concerns – Raw Milk Safety Concerns – Information AvailableInformation Available

FDA has been providing information and FDA has been providing information and assistance to states dealing with raw assistance to states dealing with raw milk issues, including to legislative milk issues, including to legislative committees.committees.

DDES Director, John Sheehan, J.D., B.S. DDES Director, John Sheehan, J.D., B.S. Dy Sci., provided FDA written Testimony Dy Sci., provided FDA written Testimony on Raw Milk to Ohio House of on Raw Milk to Ohio House of Representatives Agriculture Committee, Representatives Agriculture Committee, May 24, 2006. May 24, 2006.

http://www.ohioagriculture.gov/dairy/documhttp://www.ohioagriculture.gov/dairy/documents/FDATestimonyRawMilk.pdfents/FDATestimonyRawMilk.pdf

Raw Milk CheeseRaw Milk Cheese

Food Safety Risk

Long History of RiskLong History of Risk FDA and other Federal and State agencies FDA and other Federal and State agencies

have acknowledged a long history of the have acknowledged a long history of the risks associated with the consumption of raw risks associated with the consumption of raw milk. milk.

Raw milk (no bactericidal/bacteriostatic Raw milk (no bactericidal/bacteriostatic treatment, apart from cooling) is a vehicle for treatment, apart from cooling) is a vehicle for transmission of pathogens, such as:transmission of pathogens, such as:• Listeria monocytogenesListeria monocytogenes • BrucellaBrucella spp. spp. • E. coliE. coli• Campylobacter Campylobacter spp.spp.• Mycobacterium bovisMycobacterium bovis • Coxiella burnettiCoxiella burnetti• Salmonella Salmonella spp.spp.

National Policy and Position National Policy and Position Statements Statements

U.S. Food and Drug Administration U.S. Food and Drug Administration (FDA)(FDA)

Centers for Disease Control and Centers for Disease Control and Prevention (CDC)Prevention (CDC)

National Conference on Interstate Milk National Conference on Interstate Milk Shipments (NCIMS)Shipments (NCIMS)

National Association of State National Association of State Departments of Agriculture (NASDA)Departments of Agriculture (NASDA)

Association of Food & Drug Officials Association of Food & Drug Officials (AFDO)(AFDO)

FDA Sale/Consumption of Raw Milk-Position FDA Sale/Consumption of Raw Milk-Position Statement (M-I-03-4)Statement (M-I-03-4)

““strongly advises against the consumption of strongly advises against the consumption of raw milk”raw milk”

"Raw milk, no matter how carefully produced, "Raw milk, no matter how carefully produced, may be unsafe." may be unsafe."

In the court case In the court case Public Citizen v. HecklerPublic Citizen v. Heckler, 653f. , 653f. Supp. 1229 (D.D.C. 1986), the federal district Supp. 1229 (D.D.C. 1986), the federal district court concluded that the record presents court concluded that the record presents "overwhelming evidence of the risks associated "overwhelming evidence of the risks associated with the consumption of raw milk, both certified with the consumption of raw milk, both certified and otherwise". and otherwise".

The court stated that the evidence FDA has The court stated that the evidence FDA has accumulated concerning raw milk "Conclusively accumulated concerning raw milk "Conclusively shows that raw and certified raw milk are shows that raw and certified raw milk are unsafe" and "There is no longer any question of unsafe" and "There is no longer any question of fact as to whether raw milk is unsafe". fact as to whether raw milk is unsafe".

http://www.cfsan.fda.gov/~ear/mi-03-4.htmlhttp://www.cfsan.fda.gov/~ear/mi-03-4.html

CDCCDC Memo from CDC to FDA: Memo from CDC to FDA:

CDC “strongly endorses regulatory efforts CDC “strongly endorses regulatory efforts to restrict the sale of raw milk and soft to restrict the sale of raw milk and soft fresh cheeses made from unpasteurized fresh cheeses made from unpasteurized milk to consumers. We also support health milk to consumers. We also support health education efforts to inform consumers of education efforts to inform consumers of the health risks of these products.”the health risks of these products.”

“ “CDC continues to receive reports of CDC continues to receive reports of foodborne illness outbreaks due to foodborne illness outbreaks due to unpasteurized milk and soft fresh cheeses, unpasteurized milk and soft fresh cheeses, such as queso fresco, often made from such as queso fresco, often made from unpasteurized milk.”unpasteurized milk.”

2005 NCIMS Resolution 102005 NCIMS Resolution 10 ““Therefore, Be It Resolved:Therefore, Be It Resolved: That the NCIMS, due to the serious public That the NCIMS, due to the serious public

health concerns, discourages the consumption health concerns, discourages the consumption of raw milk and encourages states to pass laws of raw milk and encourages states to pass laws or adopt administrative rules that prohibit the or adopt administrative rules that prohibit the sale of raw milk directly to the household sale of raw milk directly to the household consumer and to the unlawful manufacturers of consumer and to the unlawful manufacturers of unlawful dairy products;” unlawful dairy products;”

““Be It Further Resolved:Be It Further Resolved: That the NCIMS continues to support the motto That the NCIMS continues to support the motto

of the conference, which is “To assure the of the conference, which is “To assure the safest possible milk supply for all the people”.”safest possible milk supply for all the people”.”

NASDA Policy StatementNASDA Policy Statement National Association of State Departments of National Association of State Departments of

Agriculture (NASDA) issued policy statement Agriculture (NASDA) issued policy statement September 18, 2006.September 18, 2006.

• “…“…only pasteurized milk, milk products and properly aged only pasteurized milk, milk products and properly aged cheeses should be sold for human consumption.”cheeses should be sold for human consumption.”

• Defines ‘Sale’ Defines ‘Sale’

http://www2.nasda.org/NR/exeres/480DACB7-AC68-4980-AB3C-3F50Bhttp://www2.nasda.org/NR/exeres/480DACB7-AC68-4980-AB3C-3F50BCEC252F.htmCEC252F.htm

NASDA Policy Statement NASDA Policy Statement

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

NASDA Policy Statement cont’dNASDA Policy Statement cont’d

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

AFDO Position StatementAFDO Position Statement

Association of Food & Drug Officials Association of Food & Drug Officials (AFDO) December, 2006(AFDO) December, 2006

Supports Mandatory PasteurizationSupports Mandatory Pasteurization

http://www.afdo.org/afdo/position/Poshttp://www.afdo.org/afdo/position/PosStmt-2006-RawMilk.cfmStmt-2006-RawMilk.cfm

From AFDO Position StatementFrom AFDO Position Statement

““By building consensus with program By building consensus with program managers at the state and local levels, AFDO managers at the state and local levels, AFDO is able to establish united positions on is able to establish united positions on national food safety matters that affect all of national food safety matters that affect all of us.”us.”

““AFDO supports mandatory pasteurization for AFDO supports mandatory pasteurization for all milk and milk products intended for direct all milk and milk products intended for direct human consumption except where alternative human consumption except where alternative procedures to pasteurization are provided procedures to pasteurization are provided (i.e. curing of certain cheese varieties) to (i.e. curing of certain cheese varieties) to ensure the safety of finished products.”ensure the safety of finished products.”

  

From AFDO Position Statement cont’dFrom AFDO Position Statement cont’d ““Foodborne illnesses related to the Foodborne illnesses related to the

consumption of fresh, soft, raw milk cheeses consumption of fresh, soft, raw milk cheeses such as queso fresco and queso cotija point such as queso fresco and queso cotija point out the hazards of consuming raw milk out the hazards of consuming raw milk products. products.

These products are popular among people These products are popular among people from societies where milk pasteurization is from societies where milk pasteurization is not as common as in the United States, and not as common as in the United States, and the product is distributed mainly through the product is distributed mainly through unregulated practices.unregulated practices.

While mandatory pasteurization requirements While mandatory pasteurization requirements will not stop black market distribution, they will not stop black market distribution, they will curtail mass distribution and facilitate will curtail mass distribution and facilitate raising the awareness of potential raising the awareness of potential consumers.”consumers.”

PasteurizationPasteurization

Pasteurization Pasteurization destroys destroys pathogenic pathogenic bacteriabacteria

Such as Listeria monocytogenes

Why Pasteurize?Why Pasteurize? Pasteurization was first implemented to Pasteurization was first implemented to

destroy destroy Mycobacterium bovis, Mycobacterium bovis, which causes which causes systemic tuberculosis in humans. systemic tuberculosis in humans.

Pasteurization temperatures were later Pasteurization temperatures were later increased to destroy increased to destroy Coxiella burnetiiCoxiella burnetii, which , which causes Q-fever.causes Q-fever.

Pasteurization can destroy emerging Pasteurization can destroy emerging pathogens, such as pathogens, such as E. coliE. coli O157:H7 and O157:H7 and Salmonella typhimurium Salmonella typhimurium DT-104, which DT-104, which cause serious illness and are difficult to treat cause serious illness and are difficult to treat due to resistance to many common due to resistance to many common antibiotics (Cornell Univ.).antibiotics (Cornell Univ.).

Pasteurization RegulationsPasteurization Regulations In 1987, FDA implemented a ban on the In 1987, FDA implemented a ban on the

interstate sale of raw milk. interstate sale of raw milk. (21 CFR 1240.61)(21 CFR 1240.61)

However, each state regulates the sale of However, each state regulates the sale of raw milk within its jurisdiction (intrastate raw milk within its jurisdiction (intrastate commerce).commerce).

Some states permit the sale of raw milk to Some states permit the sale of raw milk to local retail food stores or directly to local retail food stores or directly to consumers from the farm or at community consumers from the farm or at community events.events.

CFR Pasteurization RegulationCFR Pasteurization Regulation

The federal regulation describing The federal regulation describing mandatory pasteurization mandatory pasteurization requirement is 21 CFR 1240.61. requirement is 21 CFR 1240.61.

In promulgating this regulation, FDA In promulgating this regulation, FDA made a number of findings relative made a number of findings relative to raw milk, including the following: to raw milk, including the following: "Raw milk, no matter how carefully "Raw milk, no matter how carefully produced, may be unsafe." (52 FR produced, may be unsafe." (52 FR 29514, Aug. 10, 1987)29514, Aug. 10, 1987)

Methods of Raw Milk SalesMethods of Raw Milk Sales

Cow SharesCow Shares Herd SharesHerd Shares Cow Boarding Cow Boarding Co-OpsCo-Ops Pet Food SalesPet Food Sales

Cow SharingCow Sharing Cow sharing or cow Cow sharing or cow

leasing has leasing has occurred in states occurred in states where intrastate where intrastate sale of raw milk is sale of raw milk is prohibited.prohibited.

Consumers buy a Consumers buy a percentage of a percentage of a cow’s milk cow’s milk production for a production for a fee and then fee and then receive a certain receive a certain amount of raw milk amount of raw milk per week.per week.

Survey of Raw Milk Sales 2005Survey of Raw Milk Sales 2005

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

Cow Sharing Cow Sharing 4 states* allow animal shares with licensing or 4 states* allow animal shares with licensing or

permitting and inspection:permitting and inspection:

• Arizona, Idaho, New York and WashingtonArizona, Idaho, New York and Washington

7 states and Puerto Rico ban animal shares as a 7 states and Puerto Rico ban animal shares as a means to obtain raw milk:means to obtain raw milk:

• Florida, Iowa, Montana, Nevada, North Carolina, Florida, Iowa, Montana, Nevada, North Carolina, West Virginia and WisconsinWest Virginia and Wisconsin

The remaining 39* states do not have specific The remaining 39* states do not have specific laws or regulations pertaining to animal shares as laws or regulations pertaining to animal shares as a means to obtain raw milk. a means to obtain raw milk.

*Adjustment made to survey per Illinois *Adjustment made to survey per Illinois

Legal Actions Legal Actions

Wisconsin has prosecuted several Wisconsin has prosecuted several cases of "cow share" schemes under cases of "cow share" schemes under their State law.  their State law. 

Indiana currently has Cease and Indiana currently has Cease and Desist Orders on Sales of Raw Milk Desist Orders on Sales of Raw Milk and Cow Sharing.and Cow Sharing.

FDA Warning Letters FDA Warning Letters

Organic Pastures Dairy Company, Fresno, Organic Pastures Dairy Company, Fresno, California, February, 24, 2005California, February, 24, 2005

Distribution of unpasteurized milk, Distribution of unpasteurized milk, buttermilk, butter, cream and colostrums buttermilk, butter, cream and colostrums in interstate commerce, in finished form in interstate commerce, in finished form for human consumptionfor human consumption

Violation PHS Act, Title 42, U. S. Code, Violation PHS Act, Title 42, U. S. Code, Sections 264(2) and 271(a) and 21 CFR Sections 264(2) and 271(a) and 21 CFR 1240.611240.61

FDA Warning Letters FDA Warning Letters

White Egret Farm, Austin, Texas, White Egret Farm, Austin, Texas, December 15, 2005December 15, 2005

Distribution of unpasteurized goat Distribution of unpasteurized goat milk in interstate commerce, in milk in interstate commerce, in finished form for human consumptionfinished form for human consumption

Violation of PHS Act, 42 U.S.C. 264(2) Violation of PHS Act, 42 U.S.C. 264(2) and 272(a) and 21 CFR 1240.61and 272(a) and 21 CFR 1240.61

FDA Warning Letters FDA Warning Letters

Dee Creek Farm, Woodland, Dee Creek Farm, Woodland, Washington, May 2, 2006Washington, May 2, 2006

Dairy Farm caused to be delivered Dairy Farm caused to be delivered into interstate commerce into interstate commerce unpasteurized milk, in finished form unpasteurized milk, in finished form for human consumptionfor human consumption

Violation of PHS Act, 42 U.S.C. 264(2) Violation of PHS Act, 42 U.S.C. 264(2) and 272(a) and 21 CFR 1240.61and 272(a) and 21 CFR 1240.61

Raw Milk ConfiscatedRaw Milk Confiscated

Double O Farms, Verona, KentuckyDouble O Farms, Verona, Kentucky Cow Share business - routine deliveries Cow Share business - routine deliveries

distributing milk to shareholders of farm’s distributing milk to shareholders of farm’s cows at various drop off points in cows at various drop off points in Cincinnati area. Sell shares of cows to Cincinnati area. Sell shares of cows to people for $75 a share.people for $75 a share.

Ohio Department of Agriculture, Kentucky Ohio Department of Agriculture, Kentucky Public Health Department, and USFDA Public Health Department, and USFDA confiscated milk from truck and confiscated milk from truck and shareholders bottles in Cincinnati parking shareholders bottles in Cincinnati parking lot on March 6, 2006.lot on March 6, 2006.

Suitcase Cheese and Border ActionSuitcase Cheese and Border Action

U.S. Customs and Border Protection U.S. Customs and Border Protection and Agriculture Specialists seized and Agriculture Specialists seized 130 pounds of cheese from three- 130 pounds of cheese from three- time violator at the Laredo, Texas time violator at the Laredo, Texas Port of Entry, December 12, 2006.Port of Entry, December 12, 2006.

In lieu of violator’s inability to pay a In lieu of violator’s inability to pay a $5000 fine, his truck and travel $5000 fine, his truck and travel trailer were seized.trailer were seized.

FDA Science PosterFDA Science Poster

““Raw Milk-Associated Illnesses Reported to FDA Raw Milk-Associated Illnesses Reported to FDA from 2000-2005” M. Ross, C. Leonard, J. Sanders, from 2000-2005” M. Ross, C. Leonard, J. Sanders, K. Klontz, J. Sheehan, R. Childers, D. Street K. Klontz, J. Sheehan, R. Childers, D. Street

CFSAN presented poster at CFSAN presented poster at • The FDA Science Forum, Washington D.C. April, The FDA Science Forum, Washington D.C. April,

2006 2006 • The National Association of City and County The National Association of City and County

Officials Conference, San Antonio, TX, July, Officials Conference, San Antonio, TX, July, 2006.2006.

CFSAN will be presenting poster to the 2007 U.S. CFSAN will be presenting poster to the 2007 U.S. Public Health Service Commissioned Officer’s Public Health Service Commissioned Officer’s Association Meeting in Cincinnati, OH in June.Association Meeting in Cincinnati, OH in June.

FDA Raw Milk Associated Illnesses FDA Raw Milk Associated Illnesses Science Poster Science Poster

CFSAN/FDA reviewed raw milk-CFSAN/FDA reviewed raw milk-associated events reported to FDA associated events reported to FDA from 2000-2005from 2000-2005

Provides examples of raw milk-Provides examples of raw milk-associated events.associated events.

Sources for Raw Milk Science PosterSources for Raw Milk Science Poster

Electronic search of CFSAN’s Food Electronic search of CFSAN’s Food Emergency Response (FER) outbreak Emergency Response (FER) outbreak folders. folders.

Descriptive information, such as Descriptive information, such as demographic, epidemiological and demographic, epidemiological and clinical informationclinical information

19 Events of Illnesses 2000-200519 Events of Illnesses 2000-2005 This review highlighted This review highlighted

19 raw milk-associated 19 raw milk-associated events of illness in 5 events of illness in 5 years that affected 473 years that affected 473 persons, many of them persons, many of them children and pregnant children and pregnant women. women.

18 events were related 18 events were related to the consumption of to the consumption of bovine-derived raw milk bovine-derived raw milk or raw milk products, or raw milk products, and 1 event was related and 1 event was related to the consumption of to the consumption of caprine-derived raw caprine-derived raw milk.milk.

Events 2000-2005Events 2000-2005 Events involved 473 ill persons in 16 Events involved 473 ill persons in 16

states. Many were children and states. Many were children and pregnant women, and many of the pregnant women, and many of the cases were persons of Hispanic cases were persons of Hispanic origin. origin.

Listeria monocytogenesListeria monocytogenes and and SalmonellaSalmonella spp. each accounted for 5 spp. each accounted for 5 of the 19 (26%) events.of the 19 (26%) events.

SalmonellaSalmonella spp. accounted for 193 spp. accounted for 193 (41%) illnesses (Table 1).(41%) illnesses (Table 1).

There were 7 deaths including 3 There were 7 deaths including 3 infant fatalities.infant fatalities.

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

PathogenPathogen# Events# Events

# Persons # Persons AffectedAffected

# # HospitalizedHospitalized

# # DeathsDeaths

State(s) State(s) InvolvedInvolved

Salmonella Salmonella (including (including Multidrug-resistantMultidrug-resistant S. newport S. newport andand S. S. typhimurium,)typhimurium,)

55 193193 2121CA, IL, IN, CA, IL, IN, OH, TN, CTOH, TN, CT

CampylobacterCampylobacter44 123123

IL, WI, CT, IL, WI, CT, COCO

Rabies virusRabies virus 11 6262 OKOK

Mycobacterium bovisMycobacterium bovis 22 4040 22 NY, MDNY, MD

Listeria Listeria monocytogenesmonocytogenes

55 36361212 55 TX, NY, TX, NY,

NH, NCNH, NC

Escherichia coliEscherichia coli O157:H7O157:H7

22 191977

OR, WAOR, WA

TotalTotal 1919 473473 4040 77 1616

Raw Milk Cheese Events Raw Milk Cheese Events 2000-20052000-2005

55% of persons affected consumed raw 55% of persons affected consumed raw milk as opposed to raw milk cheeses.milk as opposed to raw milk cheeses.

There were 11 events that solely There were 11 events that solely mentioned raw milk cheeses (Table 2). Of mentioned raw milk cheeses (Table 2). Of those, 10 were specifically related to the those, 10 were specifically related to the consumption of Mexican-style soft cheeses, consumption of Mexican-style soft cheeses, such as queso fresco. such as queso fresco.

Queso fresco, a Mexican-style cheese made Queso fresco, a Mexican-style cheese made from raw milk, was more frequently from raw milk, was more frequently purchased from street vendors than from purchased from street vendors than from retail stores. retail stores.

Table 2Table 2. Pathogens and Accompanying Vehicles . Pathogens and Accompanying Vehicles Implicated in Raw Milk-Associated Events.Implicated in Raw Milk-Associated Events.

.Pathogen (#events)Pathogen (#events) Vehicle*Vehicle*

Campylobacter Campylobacter spp. (1)spp. (1) raw milk raw milk

Campylobacter spp.Campylobacter spp. (1) (1) raw milk and raw milk cheeseraw milk and raw milk cheese

Campylobacter jejuni (Campylobacter jejuni (2)2) raw milk raw milk

E. coliE. coli O157:H7 (1) O157:H7 (1) raw milkraw milk

E. coliE. coli O157:H7 (1) O157:H7 (1) raw caprine-derived milkraw caprine-derived milk

Rabies virus (1)Rabies virus (1) raw milkraw milk

Salmonella typhimuriumSalmonella typhimurium (1) (1) raw milkraw milk

Listeria monocytogenesListeria monocytogenes (5) (5) raw milk cheeseraw milk cheese

Multi-drug resistant Salmonella newport Multi-drug resistant Salmonella newport ((1)1)

raw milk cheeseraw milk cheese

Mycobacterium bovis Mycobacterium bovis (2)(2) raw milk cheeseraw milk cheese

Salmonella typhimuriumSalmonella typhimurium (3) (3) raw milk cheeseraw milk cheese*Bovine-derived product unless specified

Pathogens Pathogens

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

Raw Milk Risk Raw Milk Risk A search of CFSAN A search of CFSAN

FER from 2000-2005 FER from 2000-2005 produced 44 illnesses produced 44 illnesses associated with associated with pasteurized milk pasteurized milk products as compared products as compared with 473 from raw milk. with 473 from raw milk.

Raw milk is a potentially Raw milk is a potentially high-risk food for all high-risk food for all persons, particularly for persons, particularly for pregnant women and pregnant women and young, elderly or young, elderly or infirmed persons.infirmed persons.

Raw Milk RiskRaw Milk Risk

Consumption of raw Consumption of raw milk has been found milk has been found to account for less to account for less than 1% of total milk than 1% of total milk sold in the states sold in the states that permit the sale that permit the sale of raw milk of raw milk (Headrick).(Headrick).

Although Although consumption is consumption is relatively low, raw relatively low, raw milk continues to milk continues to cause outbreaks of cause outbreaks of illness.illness.

Consumer OutreachConsumer Outreach

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

Four Examples of Raw Milk-Four Examples of Raw Milk-Associated EventsAssociated Events

Rabies ScareRabies Scare

Cow ShareCow Share

Suitcase WareSuitcase Ware

Caprine CaseCaprine Case

Rabies ScareRabies Scare Possible exposure to rabies virus in raw milk, Possible exposure to rabies virus in raw milk,

Oklahoma, 2005.Oklahoma, 2005. 1 cow on the dairy farm was confirmed to have 1 cow on the dairy farm was confirmed to have

rabies.rabies. Dairy announced that milk from the infected Dairy announced that milk from the infected

cow was bottled and sold to the public from cow was bottled and sold to the public from December 4-19.December 4-19.

Milk from infected cow was commingled with Milk from infected cow was commingled with that of up to 70 other cows;10,000 consumers that of up to 70 other cows;10,000 consumers potentially exposed. potentially exposed.

Following the issuance of a State public health Following the issuance of a State public health alert, > 500 people called the State hot line and alert, > 500 people called the State hot line and local county health department for more local county health department for more information.information.

Rabies Scare Public Health EffectsRabies Scare Public Health Effects

Special clinics staffed by health department Special clinics staffed by health department employees provided rabies post-exposure employees provided rabies post-exposure prophylaxis to consumers deemed to be at prophylaxis to consumers deemed to be at greatest risk (those with immuno-greatest risk (those with immuno-compromising conditions or oral lesions).compromising conditions or oral lesions).

62 consumers received post-exposure 62 consumers received post-exposure rabies prophylaxis.rabies prophylaxis.

Estimated cost of rabies prophylaxis: Estimated cost of rabies prophylaxis: $186,000 ($3,000/ person x 62 persons).$186,000 ($3,000/ person x 62 persons).

No cases of human rabies reported.No cases of human rabies reported. Pasteurization of milk would have made any Pasteurization of milk would have made any

rabies virus present in milk ineffective.rabies virus present in milk ineffective.

Cow ShareCow Share

Outbreak of Outbreak of E. coliE. coli O157:H7 infections linked O157:H7 infections linked to raw milk produced by a cow share to raw milk produced by a cow share program, Washington and Oregon, program, Washington and Oregon, December, 2005December, 2005

Woodland, WA: Unlicensed dairy with 5 cows Woodland, WA: Unlicensed dairy with 5 cows produced milk for 45 families. produced milk for 45 families.

18 cases (9 cases between ages of 5 and 13) 18 cases (9 cases between ages of 5 and 13) of of E. coliE. coli O157:H7 infection, 5 patients O157:H7 infection, 5 patients hospitalized (no deaths), 2 children with hospitalized (no deaths), 2 children with Hemolytic Uremic Syndrome (HUS)Hemolytic Uremic Syndrome (HUS)

Cow Share Public Health EffectsCow Share Public Health Effects DNA "fingerprints" (PFGE) of DNA "fingerprints" (PFGE) of E. coliE. coli O157:H7 O157:H7

recovered from samples of raw milk obtained from recovered from samples of raw milk obtained from cow-share customers, from farm environment, cow-share customers, from farm environment, and from swabs of cattle all matched.and from swabs of cattle all matched.

Milk sales from farm stopped by the State after Milk sales from farm stopped by the State after owners ignored demand by State agriculture owners ignored demand by State agriculture department officials in August 2005 to obtain a department officials in August 2005 to obtain a $55 state license to supply raw milk.$55 state license to supply raw milk.

February 2006: WA State Senate passed February 2006: WA State Senate passed measure that explicitly included "cow share" measure that explicitly included "cow share" programs among classes of dairies requiring programs among classes of dairies requiring licensure by state. Felony for repeat offenders licensure by state. Felony for repeat offenders who ignore the law.who ignore the law.

FDA Warning Letter to WA Dairy FDA Warning Letter to WA Dairy

As previously referenced, FDA issued As previously referenced, FDA issued Warning Letter to Dee Creek Farm, Warning Letter to Dee Creek Farm, Woodland Washington.Woodland Washington.

This establishes FDA’s position that This establishes FDA’s position that Cow Sharing is another form of Cow Sharing is another form of introduction of raw milk into introduction of raw milk into interstate commerce.interstate commerce.

Suitcase WareSuitcase Ware Mycobacterium bovis Mycobacterium bovis cases linked to raw Mexican cases linked to raw Mexican

cheese, New York City, 2001-2004cheese, New York City, 2001-2004 35 cases (22 adults, 13 children) were reported. 35 cases (22 adults, 13 children) were reported. All 5 patients aged<5 years had extrapulmonary All 5 patients aged<5 years had extrapulmonary

disease (lymphatic and peritoneal), were born in disease (lymphatic and peritoneal), were born in U.S. to Mexican-born parents, had not traveled U.S. to Mexican-born parents, had not traveled outside U.S., and had no epidemiologic link to other outside U.S., and had no epidemiologic link to other TB cases. TB cases.

15-month-old boy with peritonitis died. 15-month-old boy with peritonitis died. 19 (83%) of 23 patients interviewed reported eating 19 (83%) of 23 patients interviewed reported eating

cheeses produced in Mexico.cheeses produced in Mexico.

Suitcase Cheese Sampled at Suitcase Cheese Sampled at BorderBorder

Kinde et al. reported (J. Food Protection Kinde et al. reported (J. Food Protection January 2007) about January 2007) about SalmonellaSalmonella outbreak outbreak in San Diego County, CA, 2004in San Diego County, CA, 2004

In response to the outbreak, Multi-agency In response to the outbreak, Multi-agency project was initiated and samples of project was initiated and samples of cheese collected during four 1-day cheese collected during four 1-day operations at the San Ysidro port of entry, operations at the San Ysidro port of entry, along U.S. – Mexico borderalong U.S. – Mexico border

Persons crossing border as pedestrians or Persons crossing border as pedestrians or in vehicles had minimum of 2.27 kg of in vehicles had minimum of 2.27 kg of cheesecheese

Suitcase Cheese Samples TestedSuitcase Cheese Samples Tested

240 Cheese samples were submitted 240 Cheese samples were submitted to CA Animal Health and Food Safety to CA Animal Health and Food Safety Laboratory System-San BernardinoLaboratory System-San Bernardino

94% (190 of 203) tested positive for 94% (190 of 203) tested positive for alkaline phosphatasealkaline phosphatase

Salmonella Salmonella detected from 13% (27 of detected from 13% (27 of 204)204)

Suitcase Cheese - PathogensSuitcase Cheese - Pathogens ListeriaListeria spp. detected from 4% (8 of spp. detected from 4% (8 of

204) and one half were 204) and one half were L. L. monocytogenesmonocytogenes

Mycobacterium Mycobacterium detected in 10 samplesdetected in 10 samples M. bovis M. bovis was detected from one panela-was detected from one panela-

style cheese samplestyle cheese sample

Kinde, H. et al. Recovery of Salmonella, Listeria Kinde, H. et al. Recovery of Salmonella, Listeria monocytogenes, and Mycobacterium bovis from monocytogenes, and Mycobacterium bovis from cheese entering the United States through a cheese entering the United States through a noncommercial land port entry. J. Food noncommercial land port entry. J. Food Protection. January, 2007. 70:47-52Protection. January, 2007. 70:47-52

Suitcase WareSuitcase Ware

Cheeses obtained from more than Cheeses obtained from more than one source: courier agency delivering one source: courier agency delivering Mexican products; visitor carrying Mexican products; visitor carrying food in luggage; Mexican-specialty food in luggage; Mexican-specialty grocery; or door-to-door vendor in grocery; or door-to-door vendor in NYC.NYC.

Similar cases occurred in MD with 5 Similar cases occurred in MD with 5 pediatric cases, 1 death, due to pediatric cases, 1 death, due to consumption of Mexican-style cheese consumption of Mexican-style cheese or cream products.or cream products.

Caprine CaseCaprine Case 2005-Texas, report of an infant with 2005-Texas, report of an infant with

E. coliE. coli O157:H7 infection and kidney O157:H7 infection and kidney failure from HUS.failure from HUS.

Infant was put on the list for kidney Infant was put on the list for kidney transplant and was on dialysis for 2 transplant and was on dialysis for 2 weeks.weeks.

Infant exhibited allergic reactions to Infant exhibited allergic reactions to several infant formulas, so parents several infant formulas, so parents fed the baby raw goat’s milk.fed the baby raw goat’s milk.

Recent Outbreaks - California Recent Outbreaks - California

Reported by State of California Reported by State of California Health and Human Services Health and Human Services Agency, Department of Health Agency, Department of Health Services, Infectious Diseases Services, Infectious Diseases Branch, Division of Communicable Branch, Division of Communicable Disease ControlDisease Control

Recent Outbreaks – California Recent Outbreaks – California

September, 2006September, 2006 6 Children had E. coli 0157:H7 6 Children had E. coli 0157:H7

infections and/or Hemolytic Uremic infections and/or Hemolytic Uremic Syndrome (HUS) Syndrome (HUS)

5 consumed raw dairy products from 5 consumed raw dairy products from one dairy, and 1 could have.one dairy, and 1 could have.

HUS can cause kidney failure and deathHUS can cause kidney failure and death

Recent Outbreaks - WashingtonRecent Outbreaks - Washington

Washington Washington • Onset 9/20 and 9/21/06Onset 9/20 and 9/21/06• 2 Patients2 Patients• 1 Hospitalized1 Hospitalized• 2 children were ill. The two cases were 2 children were ill. The two cases were

two unrelated children, one 8 yr old two unrelated children, one 8 yr old male from King County was hospitalized. male from King County was hospitalized. The other case was a 5 year old female The other case was a 5 year old female from Snohomish County. She was not from Snohomish County. She was not hospitalized; she had exposure to a hospitalized; she had exposure to a grandmother who had been ill with grandmother who had been ill with diarrhea. diarrhea. 

In Summary – In Summary – FDA Testimony on Raw Milk FDA Testimony on Raw Milk

““Raw milk is inherently dangerous and should Raw milk is inherently dangerous and should not be consumed. Raw milk continues to be a not be consumed. Raw milk continues to be a source of foodborne illness within the United source of foodborne illness within the United States. States.

Pasteurization destroys pathogens which might Pasteurization destroys pathogens which might be expected to be present in milk and most other be expected to be present in milk and most other vegetative microbes besides. Pasteurization vegetative microbes besides. Pasteurization does not appreciably alter the nutritive value of does not appreciably alter the nutritive value of milk. milk.

Claims to the contrary by raw milk advocates are Claims to the contrary by raw milk advocates are without scientific support.”without scientific support.”

In Summary – FDA TestimonyIn Summary – FDA Testimony

““FDA encourages everyone charged FDA encourages everyone charged with protecting the public health to with protecting the public health to prevent the sale of raw milk to prevent the sale of raw milk to consumers and the operation of so-consumers and the operation of so-called “cow-sharing” schemes. called “cow-sharing” schemes.

To do otherwise would be to take a To do otherwise would be to take a backwards step with public health backwards step with public health protection.”protection.”

Additional ReferencesAdditional References Outbreak of Outbreak of Campylobacter jejuniCampylobacter jejuni Infections Associated Infections Associated

with Drinking Unpasteurized Milk Procured through a Cow-with Drinking Unpasteurized Milk Procured through a Cow-Leasing Program, Wisconsin, 2001. MMWR June 28, Leasing Program, Wisconsin, 2001. MMWR June 28, 2002;51(25); 548-549.2002;51(25); 548-549.

Why Pasteurize? The Dangers of Consuming Raw Milk. Why Pasteurize? The Dangers of Consuming Raw Milk. Cornell University, College of Agriculture and Life Cornell University, College of Agriculture and Life Sciences, Department of Food Science. Dairy Science Sciences, Department of Food Science. Dairy Science Facts. 1998.Facts. 1998.

Code of Federal Regulations: Requirements Affecting Raw Code of Federal Regulations: Requirements Affecting Raw Milk for Human Consumption in Interstate Commerce, 21 Milk for Human Consumption in Interstate Commerce, 21 CFR Part 1240 (1987). Federal Register/Vol. 52. No. CFR Part 1240 (1987). Federal Register/Vol. 52. No. 153/August 10, 1987/Rules and Regulations.153/August 10, 1987/Rules and Regulations.

Headrick M, Korangy S, Bean N, Angulo F, Altekruse S, Headrick M, Korangy S, Bean N, Angulo F, Altekruse S, Potter M, Klontz K. The Epidemiology of Raw Milk-Potter M, Klontz K. The Epidemiology of Raw Milk-Associated Foodborne Disease Outbreaks Reported in the Associated Foodborne Disease Outbreaks Reported in the United States, 1973-1992. Am J Pub Health 1998;88 United States, 1973-1992. Am J Pub Health 1998;88 (8):1219-1221.(8):1219-1221.

Special ThanksSpecial Thanks

San Diego, Department of Environmental San Diego, Department of Environmental Health, CA:Health, CA:

Elizabeth Pozzebon, ChiefElizabeth Pozzebon, Chief

Mark Janowski, MD and Joy Van Meter, PHNMark Janowski, MD and Joy Van Meter, PHN Division of Community EpidemiologyDivision of Community Epidemiology

Corina Santana-AlleeCorina Santana-Allee Supervising Environmental Health SpecialistSupervising Environmental Health Specialist

Special ThanksSpecial Thanks

Linda Gaul, PhD, MPHLinda Gaul, PhD, MPH EpidemiologistEpidemiologist Infectious Disease Surveillance and Infectious Disease Surveillance and

Epidemiology BranchEpidemiology Branch Department of State Health Services, Department of State Health Services,

TexasTexas

Jessica Gullion, PhD Jessica Gullion, PhD Chief EpidemiologistChief Epidemiologist Denton County Health Department, TXDenton County Health Department, TX

Questions?Questions?