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Hepatitis A up in Macomb, Oakland, and Wayne Counties in Michigan

Public health officials and the Michigan Department of Health and Human Services (MDHHS) are continuing to see an elevated number of hepatitis A cases in the city of Detroit, and counties of Macomb, Oakland, and Wayne.

“Together with our local health partners, we are increasing outreach to vulnerable populations to raise awareness and promote vaccination of hepatitis A,” said Dr. Eden Wells, chief medical executive of MDHHS. “Those who live, work, or play in the city of Detroit, as well as Macomb, Oakland, and Wayne counties are urged to get vaccinated for hepatitis A and talk to their healthcare provider about their risks.”

From August 1, 2016 to March 21, 2017, 107 cases of lab-confirmed hepatitis A have been reported to public health authorities in these jurisdictions. This represents an eightfold increase during the same time last year. Ages of the cases range from 22 to 86 years, with an average age of 45 years. The majority of the cases have been male. Eighty-five percent of the cases have been hospitalized with two deaths reported.  Approximately one-third of the cases have a history of substance abuse, and 16 percent of all cases are co-infected with hepatitis C. No common sources of infection have been identified.

Hepatitis A is a vaccine-preventable disease. While the hepatitis A vaccine is recommended as part of the routine childhood vaccination schedule, most adults have not been vaccinated and may be susceptible to the hepatitis A virus.

Hepatitis A vaccination is recommended for:

  • All children at age 1 year
  • Close personal contacts (e.g., household, sexual) of hepatitis A patients
  • Users of injection and non-injection illegal drugs
  • Men who have sex with men
  • People with chronic (lifelong) liver diseases, such as hepatitis B or hepatitis C. Persons with chronic liver disease have an elevated risk of death from liver failure
  • People who are treated with clotting-factor concentrates
  • Travelers to countries that have high rates of hepatitis A
  • Family members or caregivers of a recent adoptee from countries where hepatitis A is common

Individuals with hepatitis A are infectious for 2 weeks prior to symptom onset. Symptoms of hepatitis A include jaundice (yellowing of the skin), fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, and light-colored stools. Symptoms usually appear over a number of days and last less than 2 months; however, some people can be ill for as long as 6 months. Hepatitis A can sometimes cause liver failure and death.

Risk factors for a hepatitis A infection include living with someone who has hepatitis A, having sexual contact with someone who has hepatitis A, or sharing injection or non-injection illegal drugs with someone who has hepatitis A. The hepatitis A virus can also be transmitted through contaminated food or water.

MDHHS encourages residents in the city of Detroit and Macomb, Oakland, and Wayne counties to check their hepatitis A vaccination status and talk to their healthcare provider about their risks for hepatitis A.

Pennsylvania Department of Health Warns Visitors to Heaven on Earth Farm of Cryptosporidium Outbreak

Residents who have come into contact with animals should take precautions

Pennsylvania Secretary of Health Dr. Karen Murphy today warned visitors to the Heaven on Earth Farm in Easton, Northampton County, of an outbreak of Cryptosporidium, an intestinal parasite that can cause severe diarrhea, related to infected manure at the farm.

Cryptosporidium is a parasite that can be found in water, food and soil, as well as on contaminated surfaces or dirty hands,” Secretary Murphy said. “Anyone sickened after visiting or working on the farm since February 14 is advised to contact the Department of Health at 1-877-PA-HEALTH and to talk to their personal physician. Even residents who may have come into contact with a visitor to the farm should take precautions to prevent the spread of this parasite, mainly through hand-washing and cleaning surfaces.”

The farm received young goats and calves that required frequent bottle feedings, and solicited assistance from the public via Facebook. It is possible that hundreds of people were exposed to infected manure while helping to care for the animals.

The most common symptom of cryptosporidiosis, a parasitic infection caused by Cryptosporidium species, is watery diarrhea, which usually begins two to 10 days after becoming infected with the parasite. Symptoms can last on and off for weeks. People with weakened immune systems are more likely to experience symptoms of the disease, which can be severe and can lead to life-threatening illnesses.

To prevent illness, people should thoroughly wash their hands with soap and hot water before preparing or eating food, after using the toilet, after changing diapers or cleaning up a child who has used the toilet, before and after caring for someone who is ill with diarrhea, and after handling animals, particularly young livestock, or cleaning up animal manure.

Persons with symptoms of cryptosporidiosis should be excluded from high-risk settings. These include food service handlers, daycare workers or attendees, and healthcare workers.

Washington Announces Another E. coli HUS Case Linked to I.M. Healthy Soy Nut Butter

A second child in Washington became seriously ill after eating a soy nut butter product included as part of a nationwide illness outbreak and food recall. The Washington State Department of Health is urging people in Washington to double-check their cupboards for I.M. Healthy SoyNut Butter and other products recalled after people who ate them became ill.

The Centers for Disease Control and Prevention (CDC), the federal Food and Drug Administration (FDA) and state health departments including Washington are investigating an ongoing outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 reported from several states. CDC recommends that consumers do not eat, and childcare centers, schools, and other institutions do not serve, any variety or size of I.M. Healthy SoyNut Butter, I.M. Healthy Granola, or Dixie Diner’s Club Carb Not Beanit Butter, regardless of the date of purchase or the date listed on the container.

Health officials say that even if a portion of the products were eaten or served and no one became sick, the remaining product should be sealed in a bag and thrown in the trash so that children, pets, or other animals can’t eat it.

The symptoms of STEC infections vary but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Most people get better within 5–7 days, but some infections are severe or even life-threatening. Hemolytic uremic syndrome (HUS), a type of kidney failure, is a potentially life-threatening complication of E. coli O157 infection. Very young children and the elderly are more likely to develop severe illness and HUS than others, but even healthy older children and young adults can become seriously ill. The majority of the illnesses confirmed so far are in people younger than 18 years old, at least eight have been hospitalized.

Contact your healthcare provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

Raw Milk Cheese Risks

An Article I wrote in 2001

Bill Neuman wrote yet another article on cheese – “Raw Milk Cheesemakers Fret Over Possible New Rules” – after Food Safety News reported it and in follow-up to my five part series on raw milk and the “60 day rule” – Part 1Part 2Part 3Part 4 and Part 5, and the continuing outbreaks, illnesses and recalls linked to raw (unpasteurized) and pasteurized dairy products in the United States.  He did note in his article from the FDA Inspection Report – Observation 2  that Bravo packaged cheese for shipment BEFORE the 60 days had run.

Mr. Neuman last year also penned – “As Cheesemaking Blooms, So Can Listeria” and “Small Cheesemaker Defies F.D.A. Over Recall” – following a Listeria recall linked to Estrella Family Creamery (See Inspection) and an E. coli O157:H7 outbreak linked to Sally Jackson Cheese (See Inspection) – both producers from the state of Washington. Here is my full series on the 60 Day Rule:

The Raw Milk Beat Goes On: 

A Look at the Literature and the 60-Day Raw Milk Cheese Aging Rule

Introduction

Some say raw milk cheeses are being beat-up by US regulators this year. Indeed, if there was a Food Safety Zodiac, 2010 would be the Year of the Cheese (shell eggs a close second). Whatever the underlying explanation, the number of cheese-related illnesses and recalls in 2010 appears unprecedented. While covering these events, my blog has been inundated with comments expressing outrage at FDA and state regulators for raw milk cheese “crackdowns.” The comments range from fringe screams about food Nazis and fascists to thoughtful and informative discussions about the microbiology of raw milk cheeses and implications for food safety and quality.

Tami Parr of the Pacific Northwest Cheese Association portended regulatory changes that may affect the fate of raw milk cheeses on her blog earlier last month. Interestingly, she links to a 1997 memo that recommended FDA re-examine its 60-day aging process for hard cheeses made from raw milk. No changes were made to the rule at that time, but clearly the issue of aged raw milk cheeses and food safety is not new, as shown in the timeline below.

To look at the issue closer, this paper provides an overview of the historical context and timeline of raw milk cheese regulations in the US, and examines the state-of-the-science surrounding the 60-day aging rule established by FDA.  I have broken it into 5 parts for ease of reading.  At the end of part 5, I will provide the entire paper in PDF.

I welcome comments, suggestions, and additional literature from readers to add to the analysis.

Historical Perspective

Timeline of Key Studies and Regulatory Changes for Cheeses Made from Raw Milk

1941-1944: Typhoid fever epidemics are linked to cheddar cheese made from raw milk in Canada; outbreak-related Salmonella typhi strains are recovered from 30-day-old cheese, but not from 48- or 63-day-old cheese resulting in Alberta, Canada halting the sale of raw milk cheese unless ripened for at least 90 days (Marth 1969).

1946: Brucella abortus is found to survive in cheddar cheese made from raw milk for up to 6 months depending on initial inoculation level, but the authors of the study conclude that cheddar cheese is not a proven carrier of undulant fever (the human disease caused by B. abortus). D’Amico (2008a) suggests that this study, combined with the earlier data on typhoid fever illnesses not attributed to cheese cured for more than 63 days, is the likely origin of the 60-day curing period in the US. However, subsequent reports in the 1940s show extended survival of Mycobacterium tuberculosis (>100 days), Salmonella typhi (3-10 months), and hemolytic Streptococcus (>160 days) in cheddar cheese (D’Amico 2008a).

1950: FDA promulgates regulations (21 CFR Section 133) requiring that cheesemakers use pasteurized milk, or cure the cheese for no less than 60 days at a temperature greater than 35°F. According to D’Amico (2008a), there are over 30 natural cheeses that can be made legally from raw milk in the US under this rule.

1960s: Additional challenge studies show survival of pathogens including Salmonella enterica subtype Typhimurium beyond the 60 day curing period; Salmonella typhi is found to survive in stirred curd granular cheddar cheese for 150-180 days when held at refrigeration temperatures (D’Amico 2008a).

1987: Numerous foodborne illnesses are linked to commercial fluid raw milk including 22 deaths from Salmonella Dublin infections from 1971-1975 (Werner 1979). This prompts a Citizen’s Petition and federal judge’s ruling that orders the FDA to ban fluid raw milk and milk products from interstate commerce (21 CFR Section 1240.61). The regulations allowing cheesemakers to sell cheese made with raw milk if cured for 60 days at a temperature greater than 35°F remain in place (21 CFR Section 133).

1973-1992: CDC reviews reported outbreaks and illnesses from raw milk (Headrick 1998) and cheeses made from raw milk (Altekreuse 1998). During this time, there were 32 reported cheese-associated outbreaks and 58 deaths, but the authors conclude that “If current Food and Drug Administration sanitary requirements for cheesemaking had been met, these outbreaks would have been preventable.” They go on to say: “Curing cheeses kill
s most bacteria present in cheeses; however, evidence from sources other than the CDC Foodborne Disease Outbreak Surveillance System suggests that curing alone may not be a sufficient pathogen control step to eliminate Salmonella, Listeria, and E. coli O157:H7 from cheese.”

1996: Researchers at South Dakota State University publish a study showing that 60-day aging is largely ineffectual in reducing levels of E. coli O157:H7 in cheddar cheese. FDA then asks the National Advisory Committee for Microbiological Criteria for Food (NACMCF) to re-examine the literature on the efficacy of 60-day aging. In a memo to FDA, the committee states: “the sixty-day aging process for hard cheese is questionable as an effective measure in support of the public’s health.”

2002: Health officials from Alberta, Canada report an outbreak of E. coli O157:H7 hemorrhagic colitis associated with Gouda cheese made from raw milk (Honish 2005). In their paper, the authors suggest that Canada re-evaluate the federal regulations for aging of hard cheeses made from raw milk.

2004: In an interview with Food Safety Magazine, FDA officials state that they are developing a “risk profile for raw milk cheeses, which will aid in the Agency’s assessment of the requirements for processing these cheeses,” based, in part, on the report by the NACMCF and other recent research suggesting that 60-day aging may be insufficient to protect the public’s health (Sheehan 2004).

2006: Schlesser and colleagues report results from a study of E. coli O157:H7 survival in cheddar cheese made from raw milk, and confirm previous reports questioning the efficacy of 60-day aging to eliminate E. coli O157:H7 during cheese ripening.

2008: D’Amico and colleages determine that the 60-day aging requirement does not ensure safety of surface-mold-ripened soft cheeses manufactured from raw or pasteurized milk when Listeria monocytogenes is introduced as a postprocessing contaminant. The authors conclude that “the safety of cheeses of this type must be achieved through control strategies other than aging, and thus revision of current federal regulations is warranted.”

2010: According to press quotes, FDA officials are conducting a nationwide survey of cheese safety with a focus on Listeria monocytogenes contamination. Notably, this survey encompasses both raw and pasteurized cheese products from large and small cheesemakers.

In November, the CDC reports 38 illnesses from Gouda cheese made from raw milk and aged for 60 days in accordance with regulations (CDC, 2010).

A study in the December 1, 2010 issue of the Journal of Food Protection documents survival of E. coli O157:H7 in aged Gouda and stirred-curd cheddar cheese (D’Amico 2010). The authors conclude that “the 60-day aging requirement is based on decades-old research indicating that Brucella abortus is eliminated in cheddar cheese alone is insufficient to completely eliminate levels of viable E. coli O157:H7 in Gouda or stirred-curd cheddar cheese manufactured from raw milk contaminated with low levels of this pathogen.”

Definitions

Before embarking on a discussion of the 60-day curing criteria for cheeses made from raw milk, it is important to understand the definition of cheese styles and differences in regulation.  Cheese was originally developed by human societies as a method to preserve milk.  In the US, cheeses are usually made from cow’s, goat’s, sheep’s, or buffalo’s milk.  Among 72 different cheese and cheese product types defined in 21 C.F.R. Part 133, the FDA allows only a limited number of cheese types to be made with raw milk so long as the cheese is cured at a temperature of not less than 35°F for not less than 60 days. The Raw Milk Cheesemakers’ Association adds an additional criteria for low-temperature (thermised) heat treatment of raw milk cheese:  ”Cheese produced from milk that, prior to setting the curd, has not been heated above the temperature of the milk (104°F, 40°C) at the time of milking and that the cheese produced from that milk shall be aged for 60 days or longer at a temperature of not less than 35°F (2°C) in accordance with US FDA regulations.”  Table 1 summarizes cheeses and cheese types subject to the 60-day aging rule.

Cheese and Cheese Products in the US (adapted from The American Cheese Society) Application of the 60-Day Aging Rule

Fresh cheeses: 60-day aging rule not allowed. Italian style mascarpone and ricotta, chevre, feta, cream cheese, quark and cottage cheese, queso freso and other Mexican-style fresh cheeses.

Soft-ripened cheeses: 60-day rule allowed. Brie and camembert styles, triple crèmes.

Semi-soft cheeses: 60-day aging rule allowed. Blue cheeses, colby, fontina styles, havarti and Monterey Jack, washed rind cheeses.

Firm/hard cheeses: 60-day aging rule allowed. Gouda styles, most cheddars, dry jack, Swiss (Emmenthaler) styles, Gruyere styles, many “tomme” styles and Parmesan styles.

Blue cheeses: 60-day aging rule allowed. French (roquefort), Italian (gorgonzola) and Danish blue styles.

Pasta Filata cheeses: 60-day aging rule not allowed. Italian style Mozzarella, Provolone, and Scamorza.

Natural or washed rind cheeses: 60-day aging rule allowed. French Tomme de Savoie and Mimolette, as well as the English Stilton (also a blue), and Lancashire cheeses (natural); Epoisses, Livarot and Taleggio (washed).

Processed cheeses: 60-day aging rule not applicable. American Cheese, processed cheese spreads, and “cheese flavored” spreads.

Regulation of Raw Milk Cheeses in Other Countries

Canada regulates cheeses made from raw milk similar to the US, except for Quebec where raw milk cheeses can be manufactured without 60-day aging if strict rules for milk quality and veterinary inspections of cattle herds are followed.  In 1996, following an outbreak of E. coli O157:H7 linked to cured Gouda cheese, Health Canada proposed a ban on all raw milk cheeses, but the initiative was defeated by industry and consumer groups (Honish 2005).

The European Union has no aging rule, but their requirements for hygiene during milking, storing, and collection of milk for cheesemaking are likely much stricter than in the US.  Additionally, requirements for both animal health and worker/personnel health help ensure safe raw milk cheese production.  Cheeses made from raw milk in Europe must be labeled “Made with Raw Milk.”

The regulation of raw milk cheeses in Australia and New Zealand has been an area of intense controversy in recent years.  Australia bans all domestic raw milk cheeses, but allows importation of certain cheeses–Roquefort, Gruyere, Sbrinz, Emmental–from Europe and Switzerland provided they are aged 90 days and meeting European safety standards (Standard 4.2.4A).  Domestic cheeses must be “thermised” by using a low temperature heat treatment followed by aging for 90-days.

Epidemiology

The epidemiology of cheese-related outbreaks has changed in the US since the 60-day aging rule was established in 1950.  The studies conducted in the 1940s that presumably  provided the basis for the rule were based on diseases such as Typhoid fever, an infection transmitted by human carriers.  Today, most of the cheese-linked illnesses are due to zoonotic enteric pathogens carried by ruminants including Campylobacter, E. coli O157:H7, Listeria monocytogenes, and Salmonella.  L. monocytogenes is also a ubiquitous inhabitant of the dai
ry environment.

Dairy-related Outbreaks Attributed to Raw Milk Cheese  

Internationally, dairy-related outbreaks are relatively uncommon in developed countries, but an estimated 11.8 percent are attributed to cheeses made from raw milk (FSANZ 2006).  Foodborne disease outbreaks have been reported in all countries that allow raw milk cheese including France where raw milk cheeses are popular (Desenclos 1996; Desenclos 1996; DeValk 2000; Dominguez 2009; Haeghebaert 2003; Ostyn 2010).  The most recent published review in the US examined reported cheese-related outbreaks and illnesses from 1973 – 1992 (Altekruse 1998).  Fresh Mexican-style cheeses (for example, queso fresco) were the most frequently implicated vehicle and caused 56 of the 58 deaths described in the review; the other 2 deaths were linked to improper pasteurization of Mozzarella cheese.

Bacterial Pathogens That Can Survive in Cheeses Aged for 60 Days

Brucella spa.: incubation 1-2 months or longer; duration, may relapse for years; signs and symptoms, fever, headache, joint pain, depression, weight loss. Can cause abortions in dairy animals.

Campylobacter: incubation, 2-5 days; duration, 2-7 days, some patients develop paralytic syndrome as a long-term complication; symptoms, diarrhea (sometimes bloody), cramps, fever, nausea, vomiting, muscle aches. Found in healthy dairy animals.

E. coli O157 and other pathogenic E. coli: incubation, 2-8 days; duration, 5-8 days, some patients develop kidney disease or other long-term complications; symptoms, diarrhea (often bloody), cramps, sometimes low-grade fever. Found in healthy dairy animals.

Listeria monocytogenes: incubation, 3-70 days (average 3 weeks); duration, variable depending on susceptibility, death rate in patients with meningitis as high as 80 percent, septicemia as high as 50 percent; symptoms, septicemia, meningitis, intra-uterine infections in pregnant women with spontaneous abortions and stillbirths. Found in healthy dairy animals and the dairy processing environment

Mycobacterium bovis: incubation, 4-12 weeks to positive tuberculin test, 1-2 years for systemic infection; duration, years, may persist lifetime as latent infection; symptoms,pulmonary and extra-pulmonary disease. Systemic illness in cattle, transmitted through milk and aerosols.

Salmonella enteric: incubation, 6 – 48 hours; duration, 2-8 days, some patients develop long-term complications including arthritic disease;  symptoms, diarrhea, nausea, vomiting, cramps fever. Some strains cause illness in dairy animals.

Salmonella typhi: incubation, 8-14 days; duration, variable, case fatality of 10-20 percent without antibiotic treatment; symptoms, fever, cramps, diarrhea, anorexia. Human carriers.

Staphylococcus enterotoxin: incubation, 2-4 hours; duration,1-3 days; symptoms, vomiting, nausea, cramping. Animal and human carriers; toxin produced following growth in a food.

The problem with fresh, soft cheeses is ongoing and most often associated with use of inadequately pasteurized milk and cross-contamination in the processing environment (CDC 2000; CDC 2001; CDC 2008; CDC 2009; Cody 1999; MacDonald 2005; Villar 1999).  Listeria monocytogenes and Salmonella are pathogens most often found in fresh Mexican-style soft cheeses as reviewed previously (Marler, 2009).  Over the last decade, there have been only two deaths from cheese made with raw milk; both occurred in 2003, and were due to consumption of contaminated fresh (un-aged) queso fresco Mexican-style cheese (CDC OutbreakNet).

In contrast, outbreaks and illnesses linked to 60-day aged cheese are relatively rare despite microbiological evidence of pathogen survival in these cheeses (Altekruse 1998; D’Amico 2008b; D’Amico 2010; Donnelly 1990; Jaros 2008; Reitsma 12996; Schlesser 2006).  Researchers from the University of Vermont have speculated that the relative paucity of outbreaks and illnesses associated with 60-day aged cheese may be due to 1) a low contamination level in milk used for cheesemaking or 2) alterations in virulence of pathogens within the cheese matrix (D’Amico 2010).

However, there are notable exceptions including E. coli O157:H7 outbreaks linked to cured Gouda cheese in Canada in 2002 (Honish 2005) and the US in 2010 (CDC 2010).  In the latter, at least 38 cases have been linked to consumption of Gouda cheese made with raw milk and presumably aged for 60 days in accordance with FDA regulations.  The CDC summarized findings from the ongoing investigation in a November 24, 2010 report.

Microbiology

Johnson (2001) reviewed the microbiology of cheese products and noted the complexity of the subject because of the great diversity in cheese manufacturing and ripening protocols, as well as composition of the different cheese types.  The 60-day aging rule is based on the theory that pathogens, if present, will die off to levels below the infectious dose during the aging process. However, the effectiveness of this system depends on the initial microbiological quality of the milk and other ingredients used, and the hygienic practices used during cheese processing (Donnelly 1990). No amount of curing or aging or even pasteurization will compensate for poor quality milk or lack of hygiene during manufacturing and storage.

The intrinsic properties of the cheesemaking process that affect pathogen survival and growth include:

•pH

•moisture

•salt content

•acidity

•temperature

•humidity

•redox potential

•cheese microbial flora including starter culture (microbial community)

Individually and in combination, these factors can have significant impacts on whether a foodborne pathogen survives or grows in cheese during curing. The effectiveness of these natural processes is ultimately dependent on the initial contamination level of the cheese. A high inoculum of a pathogen, especially one with a low infectious dose, will overwhelm these control systems. The soft and semi-soft surface-mold-ripened cheeses are at the greatest risk of contamination due to their higher pH and moisture content (D’Amico 2008a).

The presence of pathogens in milk used for production of raw milk cheeses represents a risk for consumers.  Oliver (2009) reviewed the literature on pathogen prevalence in US bulk tank milk and found these levels.

•Campylobacter: 2 – 9.2 percent

•E. coli O157:H7: 0 – 0.75 percent

•Listeria monocytogenes: 2.8 – 7.0 percent

•Salmonella spp: 0 – 11 percent

•Shiga-toxin E. coli: 2.4 – 3.96 percent

•Yersinia enterocolitica: 1.2 – 6.1 percent

D’Amico (2008b and 2010) surveyed milk used to produce small-scale farmstead cheese in Vermont and found an overall low level of contamination, but documented variations from farm-to-farm indicating that some operations practice strict hygienic controls while other need improvement in their food safety practices.

Experimental studies of the behavior of pathogens in aged cheese show mixed results (Bachmann 1995; Back 1993; D’Amico 2008a; D’Amico 2008b; D’Amico 2010; Govaris 2002; Marth 1969; Reitsma 1996; Schlesser 2006).  The studies are difficult to compare because of different experimental methods, and variations in how the cheese was manufactured for the experiments.  For example, Reitsma (1996) found viable E. coli O157:H7 in cheddar cheese at 158 days, but used pasteurized milk in their comparisons.  Schlesser (2006) inoculated cheddar cheese with a 5-strain E. coli O157:H7 cocktail and demonstrated an inadequate reduction at 60 days (1 log) and 120 days (2 logs); in contrast, heat treating the milk resulted in a 5-log reduction.  D’Amico (2010) examined the behavior of E. coli O157:H7 in aged Gouda and stirred-cured cheddar cheeses manufactured from raw milk and was able to recover viable cells for more than 270 days in both cheese types using selective enrichment.

Listeria monocytogenes can be a pervasive problem in the dairy processing environment.  There is evidence that L. monocytogenes can survive aging in both pasteurized and surface-mold-ripened cheeses if the pathogen is introduced post-processing (D’Amico 2008b). These findings underscore the importance of hygienic practices at cheesemaking facilities regardless of pasteurization status. D’Amico (2008a) provides a more comprehensive review of experimental studies using different pathogens and cheese types.

Producing Cheese Safely

Unlike fluid raw milk producers who have been the subject of intense conflict with regulators for many years, artisanal and specialty cheesemakers that use raw milk have maintained a relatively good relationship with state and FDA regulators in the US. According to their website, the American Cheese Society (ACS) shares resources to help producers adequately prepare for audits and inspections and work collaboratively with state regulators and the FDA.  The recent increase in FDA inspections and Listeria testing of soft cheeses and cheesemaking facilities has no doubt caused tensions between cheesemakers and regulators. The New York Times reports that FDA inspectors visited 102 facilities beginning in April 2010, including both large and small cheesemakers. They found Listeria in the facilities of 24 cheesemakers and more than half were small, artisan-scale operations.

While these findings are a cause for concern and have resulted in at least one major recall, fortunately, cheesemaking associations such as the ACS have an infrastructure to address food safety. For example, the ACS advises their members to:

• take part in ongoing food safety education

• follow a HACCP plan

• regularly conduct their own product and environment testing

• maintain accurate and up-to-date records

• seek third party certification

• build relationships with local regulators

Conclusions

Artisanal raw milk cheeses are distributed around the world and revered by fans for their unique sensory characteristics, as well as the art and tradition of making these cheeses.   Cheeses, especially fresh and soft or semi-soft styles, are susceptible to contamination with pathogens such as Campylobacter, E. coli O157:H7, Listeria monocytogenes, and Salmonella.  Countries where raw milk cheeses are popular take different approaches in their regulations.  Experimental and epidemiological evidence suggests that the 60-day aging rule used in the US and Canada is not a fail-safe approach to cheese safety, which has prompted the FDA to re-evaluate the efficacy of the rule and conduct a national survey of cheesemaking facilities.

There are at least four potential outcomes that may result from FDA’s recent actions:  1) a ban on all cheeses made from raw milk, 2) an extension of the 60-day aging period to 90-days or longer depending on evidence from the literature, 3) adoption of a European-type approach with intense regulation of animal health and hygiene during processing, but no aging rule, or 4) no change in the 60-day aging rule in the US.

While the future of the 60-day aging rule for cheeses made from raw milk in the US remains to be determined, the openness of cheesemakers to working with state and federal regulatory agencies will hopefully foster a science-based approach to cheese safety that both protects the public’s health and preserves the unique characteristics and tradition of artisanal cheeses.

APPENDIX

Outbreaks, illnesses and recalls linked to cheeses made from raw (unpasteurized) and pasteurized milk, United States, 2010 (through November 2010):

February 2010, Washington, Listeria monocytogenes, 5 ill, queso fresco cheese, pasteurized milk used to make the cheese, FDA

February 2010, Washington, Listeria monocytogenes, 0 ill, various raw milk cheeses. 60-day aged raw milk cheeses from Montesano plant, FDA

March 2010, Washington, Listeria monocytogenes, 0 ill, Tomme raw milk cheese. Expanded recall of 60-day aged raw milk cheeses from Montesano plant, FDA

April 2010, Washington, Listeria monocytogenes,queso fresco cheese.Pasteurized milk used to make the cheese; recall with no illnesses reported, FDA

May 2010, Nevada, Campylobacter, 1 ill, illegal Mexican-style cheese. Type of milk used to make the cheese unknown, Washoe County

May 2010, Minnesota, Shiga toxin-producing E. coli, 0 ill, raw milk cheese. Non-O157 found in dairy’s cheese during raw milk outbreak investigation, MDA/MDH

June 2010, Delaware, Brucella and Listeria monocytogenes, 2 ill, raw dairy products including cheese. Two separate incidents, DE DHHS

July 2010, Pennsylvania, Staphylococcus aureus, raw milk hard cheddar cheese, 60-day aged cheese, recall with no illnesses reported, PDA

July 2010, New York, Listeria monocytogenes, queso fresco cheese, pasteurized milk used to make the cheese, recall with no illnesses reported, NY AGMKT

August 2010, Rhode Island, Listeria monocytogenes, queso fresco cheese, pasteurized milk used to make the cheese, recall with no illnesses reported, RI DOH

Aguust 2010, Misssouri, multiple Listeria monocytogenes and Staphylococcus aureus, raw milk
cheese, 60-day aged raw milk cheese from plant in Missouri, recall with no illnesses reported, MO AG

September 2010, Washington, Listeria monocytogenes, 0 ill, raw milk cheeses, expanded recall of 60-day aged raw milk cheeses from Montesano plant, FDA

October 2010; Washington, Listeria monocytogenes; 0 ill; raw milk cheeses expanded recall of 60-day aged raw milk cheeses from Montesano plant, US AG

November 2010, AZ, CA, CO, NM, NV; E. coli O157:H7 and Listeria monocytogenes, 38 ill, raw Gouda cheese, other cheeses, 60-day aged Gouda, E. coli outbreak linked to Costco “Cheese Road Show;” recall expanded to all company cheeses on 11/17/10,  no Listeria illnesses reported, CDC

November 2010, Colorado; E. coli O157:H7, gorgonzola cheese, cheese imported from Italy, made from pasteurized milk, no illnesses reported, FDA

November 2010, Washingotn, Listeria monocytogenes, fresh (queso and ricotta) Mexican-style cheeses, made from pasteurized milk, no illnesses reported (previous recall from same plant in April 2010),  FDA

Here is the full article by PDF – “The Raw Milk Beat Goes On: A Look at the Literature and the 60-Day Raw Milk Cheese Aging Rule”

References (more…)

CDC Weighs in on Vulto Cheese Listeria Recall

On March 7, 2017, Vulto Creamery recalled all lots of Ouleout, Miranda, Heinennellie, and Willowemoc soft wash-rind raw milk cheeses. On March 10, Vulto Creamery expanded its recall to include all lots of four additional cheeses, by the name of Andes, Blue Blais, Hamden, and Walton Umber.

The raw milk cheeses were distributed nationwide, with most being sold at retail locations in the northeastern and Mid-Atlantic States, California, Chicago, Portland, Oregon, and Washington, D.C.

Consumers should not eat, and restaurants and retailers should not serve or sell, recalled raw milk cheeses made by Vulto Creamery.

  • The recall includes all lots of the following types of raw milk cheeses:
    • Heinennellie
    • Miranda
    • Willowemoc
    • Ouleout
    • Andes
    • Blue Blais
    • Hamden
    • Walton Umber
  • The raw milk cheeses were distributed nationwide, with most being sold at retail locations in the northeastern and Mid-Atlantic states, California, Chicago, Portland, Oregon, and Washington, D.C.
  • This advice is particularly important for consumers at higher risk for listeriosis, including pregnant women, adults 65 and older, and people with weakened immune systems.

Follow these steps if recalled cheese is in your home or establishment:

  • Throw the cheese away in a closed plastic bag placed in a sealed trash can. This will prevent people and animals from eating it.
  • Wash the refrigerator drawer and other areas where the cheese was stored with hot water and soap.
  • Wash cutting boards, surfaces, and utensils used to cut, serve, or store recalled cheese. If possible, use a dishwasher; otherwise, use hot water and soap, followed by sanitizing with a solution of one tablespoon chlorine bleach added to one gallon of hot water.
  • Wash your hands with warm water and soap after cleaning up.

What should you do if you ate recalled cheese?

  • If you have eaten a recalled cheese and do not have any symptoms, most experts believe that tests or treatment are not needed, even for people at higher risk for listeriosis.
  • People who develop symptoms of listeriosis after eating possibly contaminated products should consider seeking medical care and telling a healthcare provider about eating that product. Although people can sometimes develop listeriosis up to 2 months after eating contaminated food, symptoms usually start within several days.

Who is most at risk for listeriosis?
People at higher risk for listeriosis include:

  • Pregnant women and their newborns,
  • Adults 65 and older, and
  • People with weakened immune systems.

Marler Clark to File 2nd E. coli Lawsuit against I.M. Healthy and John Doe Manufacturer on Monday

map-big-3-7-17-640x432CDC, multiple states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Shiga toxin-producing Escherichia coliO157:H7 (STEC O157:H7) infections.

Sixteen people infected with the outbreak strains of STEC O157:H7 have been reported from nine states. Washington, Oregon, California, Arizona, Wisconsin, Missouri, Virginia, Maryland and New Jersey

Eight ill people have been hospitalized. Five people developed hemolytic uremic syndrome, a type of kidney failure, and no deaths have been reported.

Fourteen of the 16 ill people in this outbreak are younger than 18 years old.

Epidemiologic evidence indicates that I.M. Healthy brand SoyNut Butter is a likely source of this outbreak. I.M. Healthy brand SoyNut Butter may be contaminated with E. coli O157:H7 and could make people sick.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products.

CDC recommends that consumers do not eat, and childcare centers, schools, and other institutions do not serve, any variety or size of I.M. Healthy brand SoyNut Butter, or I.M. Healthy granola coated with SoyNut Butter, regardless of the date of purchase or the date listed on the container.

Even if some of the SoyNut Butter or granola was eaten or served and no one got sick, throw the rest of the product away. Put it in a sealed bag in the trash so that children, pets, or other animals can’t eat it.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne Kiner, Stephanie Smith and Linda Rivera.

If you or a family member became ill with an E. coli infection or HUS after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark E. coli attorneys for a free case evaluation.

So, who is the “real” manufacturer of I.M. Healthy SoyNut Butters and I.M. Granola? And, where was it sold?

Today the SoyNut Butter Co. released the following:Please note that the SoyNut Butter Co. has expanded our voluntary recall to include ALL I.M. Healthy SoyNut Butters and I.M. Granola effective immediately. Regardless of Best Buy date or variety, we recommend that you do not consume I.M. Healthy SoyNut Butter or I.M. Healthy Granola and return it to the store full a full refund.

For over 20 years, the SoyNut Butter Co. has tried to make nut free products that help those with allergies eat like everyone else. Likewise, we chose our contract manufacturer because of their integrity and knowledge of food safety and quality. Unfortunately, we feel that is better to be cautious regarding public safety and urge our customers to heed the expanded recall. We have enjoyed serving you and will do everything we can possibly do to assist the FDA in this outbreak.

With 16 people with E. coli O157:H7, mostly children, many with life-threatening hemolytic uremic syndrome, a broad and expanded recall was warranted.  However, what struck me most was the bolded and italicized sentence above.  My guess is that most, if not all, customers purchasing these SoyNut Butter products thought it was not being “contract manufacture[d].”

So, who is the “real” manufacturer?

Why has not I.M. Healthy disclosed it?

Why has the FDA not disclosed it?

Why has neither I.M Healthy nor the FDA disclosed where all products were sold?

What to Know About Listeria During an Outbreak and Recall

What is Listeria?

Listeria monocytogenes (Listeria) is a foodborne disease-causing bacteria; the disease is called listeriosis. Listeria can invade the body through a normal and intact gastrointestinal tract. Once in the body, Listeria can travel through the blood stream but the bacteria are often found inside cells. Listeria also produces toxins that damage cells. Listeria invades and grows best in the central nervous system among immune compromised persons, causing meningitis and/or encephalitis (brain infection). In pregnant women, the fetus can become infected, leading to spontaneous abortion, stillbirths, or sepsis (blood infection) in infancy.

Approximately 2,500 cases of listeriosis are estimated to occur in the U.S. each year. About 200 in every 1000 cases result in death. Certain groups of individuals are at greater risk for listeriosis, including pregnant women (and their unborn children) and immunocompromised persons. Among infants, listeriosis occurs when the infection is transmitted from the mother, either through the placenta or during the birthing process. These host factors, along with the amount of bacteria ingested and the virulence of the strain, determine the risk of disease. Human cases of listeriosis are, for the most part, sporadic and treatable. Nonetheless, Listeria remains an important threat to public health, especially among those most susceptible to this disease.

Listeria is often isolated in cattle, sheep, and fowl, and is also found in dairy products, fruits, and vegetables.

What are the Symptoms of Listeria Infection?

It is thought that ingestion of as few as 1,000 cells of Listeria bacteria can result in illness. After ingestion of food contaminated with Listeria, incubation periods (from time of exposure to onset of illness) are in the range of one to eight weeks, averaging about 31 days. Five days to three weeks after ingestion, Listeria has access to all body areas and may involve the central nervous system, heart, eyes, or other locations.

A person with listeriosis usually has fever, muscle aches, and gastrointestinal symptoms such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, loss of balance, confusion, obtundation (decreased consciousness) or convulsions can occur. With brain involvement, listeriosis may mimic a stroke. Infected pregnant women will ordinarily experience only a mild, flu-like illness; however, infection during pregnancy can lead to miscarriage, infection of the newborn or even stillbirth. Pregnant women are about 20 times more likely than other healthy adults to get listeriosis; about one-third of listeriosis cases happen during pregnancy. The incidence of listeriosis in the newborn is 8.6 cases per 100,000 live births. The perinatal and neonatal mortality rate (stillbirths and early infant deaths) from listeriosis is 80%.

How to Diagnosis and Treat a Listeria Infection?

If you have symptoms of listeriosis, a health care provider can have a blood or spinal fluid test done to detect the infection. During pregnancy, a blood test is the most reliable way to find out if your symptoms are due to listeriosis. If you are in a high-risk group, have eaten the contaminated product, and within 2 months become ill with fever or signs of serious illness, you should contact your health care provider and inform him or her about this exposure. 

There are several antibiotics with which Listeria may be treated. When infection occurs during pregnancy, antibiotics given promptly to the pregnant woman can often prevent infection of the fetus. Babies with listeriosis receive the same antibiotics as adults, although a combination of antibiotics is often used until physicians are certain of the diagnosis.

How to Prevent a Listeria Infection?

General recommendations include: thoroughly cook raw food from animal sources; keep uncooked meats separate from vegetables and from cooked and ready-to-eat foods; avoid unpasteurized (raw) milk or foods made from unpasteurized milk; wash hands, knives, and cutting boards after handling uncooked foods; wash raw vegetables thoroughly before eating; and consume perishable and ready-to-eat foods as soon as possible.

Recommendations for persons at high risk, such as pregnant women and persons with weakened immune systems, in addition to the recommendations listed above, include: do not eat hot dogs, luncheon or deli meats, unless they are reheated until steaming hot, and wash hands after handling those products; do not eat soft cheeses (such as feta, Brie, Camembert, blue-veined, or Mexican-style cheese), unless they have labels that clearly state they are made from pasteurized milk; and do not eat meat spreads or smoked seafood from the refrigerated or deli section of the store (canned or shelf-stable products may be eaten).

What to Know About E. coli O157:H7 During an Outbreak and Recall

What is E. coli O157:H7

E. coli O157:H7 was identified for the first time at the CDC in 1975, but it was not until seven years later, in 1982, that E. coli O157:H7 was conclusively determined to be a cause of enteric disease. Following outbreaks of foodborne illness that involved several cases of bloody diarrhea, E. coli O157:H7 was firmly associated with hemorrhagic colitis.

The Centers for Disease Control and Prevention (CDC) estimated in 1999 that 73,000 cases of E. coli O157:H7 occur each year in the United States. Approximately 2,000 people are hospitalized, and 60 people die as a direct result of E. coli O157:H7 infections and complications. The majority of infections are thought to be foodborne-related, although E.coli O157:H7 accounts for less than 1% of all foodborne illness.

E. coli O157:H7 bacteria are believed to mostly live in the intestines of cattle but have also been found in the intestines of chickens, deer, sheep, goats, and pigs. E. coli O157:H7 does not make the animals that carry it ill; the animals are merely the reservoir for the bacteria.

While the majority of foodborne illness outbreaks associated with E. coli O157:H7 have involved ground beef, such outbreaks have also involved unpasteurized apple and orange juice, unpasteurized milk, alfalfa sprouts, and water. An outbreak can also be caused by person-to-person transmission of the bacteria in homes and in settings like daycare centers, hospitals, and nursing homes.

Symptoms of E. coli O157:H7 Infection

E. coli O157:H7 infection is characterized by the sudden onset of abdominal pain and severe cramps, followed within 24 hours by diarrhea. As the disease progresses, the diarrhea becomes watery and then may become grossly bloody – bloody to naked eye. Vomiting can also occur, but there is usually no fever. The incubation period for the disease (the period from ingestion of the bacteria to the start of symptoms) is typically 3 to 9 days, although shorter and longer periods are not that unusual. An incubation period of less than 24 hours would be unusual, however. In most infected individuals, the intestinal illness lasts about a week and resolves without any long-term problems.

Hemolytic Uremic Syndrome (HUS) is a severe, life-threatening complication of an E. coli O157:H7 bacterial infection. Although most people recover from an E. coli O157:H7 infection, about 5-10% of infected individuals goes on to develop HUS. E. coli O157:H7 is responsible for over 90% of the cases of HUS that develop in North America. Some organs appear more susceptible than others to the damage caused by these toxins, possibly due to the presence of increased numbers of toxin-receptors. These organs include the kidney, pancreas, and brain. Visit the Marler Clark sponsored Web site about Hemolytic Uremic Syndrome for more information.

Thrombotic Thrombocytopenic Purpura (TTP) is a clinical syndrome defined by the presence of thrombocytopenia (low blood platelet counts) and microangiopathic hemolytic anemia. This has generally been recognized as “adult HUS.” There are many possible causes, including E. coli O157:H7, all of which act through the common mechanism of inducing endothelial cell damage. The damage triggers a cascade of biochemical events that ultimately leads to the characteristic feature of TTP – widespread dissemination of hyaline thrombi, composed predominantly of platelets and fibrin, which block the terminal arterioles and capillaries (microcirculation) of most of the major body organs, commonly, the heart, brain, kidneys, pancreas and adrenals. Other organs are involved to a lesser degree. The pathophysiology of this disease results in multisystem abnormalities and the clinical manifestations of the syndrome.

Detection and treatment of E. coli O157:H7

Infection with E. coli O157:H7 is usually confirmed by detecting the bacteria in the stool of the infected individual. Antibiotics do not improve the illness, and some medical researchers believe that medications can increase the risk of complications. Therefore, apart from good supportive care, such as close attention to hydration and nutrition, there is no specific therapy for E. coli O157:H7 infection. The recent finding that a toxin produced by E. coli O157:H7 initially greatly speeds up blood coagulation may lead to medical therapies in the future that could forestall the most serious consequences. Most individuals recover within two weeks.

Preventing E. coli O157:H7 Infection

Eating undercooked ground beef is the most important risk factor for acquiring E. coli O157:H7. Cook all ground beef and hamburger thoroughly. Because ground beef can turn brown before disease causing bacteria are killed, use a digital instant read meat thermometer to ensure thorough cooking. Hamburgers should be cooked until a thermometer inserted into several parts of the patty, including the thickest part, reads at least 160? F. Persons who cook ground beef without using a thermometer can decrease their risk of illness by not eating ground beef patties that are still pink in the middle. If you are served an undercooked hamburger or other ground beef product in a restaurant, send it back for further cooking.

Avoid spreading harmful bacteria in your kitchen. Keep raw meat separate from ready-to-eat foods. Wash hands, counters, and utensils with hot soapy water after they touch raw meat. Never place cooked hamburgers or ground beef on the unwashed plate that held raw patties. Wash meat thermometers in between tests of patties that require further cooking.

Drink only pasteurized milk, juice, or cider. Commercial juice with an extended shelf life that is sold at room temperature (such as juice in cardboard boxes or vacuum-sealed juice in glass containers) has been pasteurized, although this is generally not indicated on the label. Most juice concentrates are also heated sufficiently to kill pathogens.

Wash fruits and vegetables thoroughly, especially those that will not be cooked. Children younger than 5 years of age, immunocompromised persons, and the elderly should avoid eating alfalfa sprouts until their safety can be assured. Methods to decontaminate alfalfa seeds and sprouts are being investigated.

Drink municipal water that has been treated with chlorine or other effective disinfectants, or bottled water that has be sterilized with ozone or reverse osmosis (almost all major brands use one or the other method).

Avoid swallowing lake or pool water while swimming, especially pool water in public swimming facilities.

Avoid petting zoos and other animal exhibits unless there are good hand washing facilities available and other sanitation measures have been taken. Wash your hands and your children’s hands after handling animals.

Make sure that persons with diarrhea, especially children, wash their hands carefully with soap after bowel movements to reduce the risk of spreading infection, and that persons wash hands after changing soiled diapers. Anyone with a diarrheal illness should avoid swimming in public pools or lakes, sharing baths with others, and preparing food for others.

2 Dead with 6 Ill in Listeria Cheese Outbreak Linked to Vulto Creamery in Connecticut, Florida, New York and Vermont

big-map-3-8-173 ill in New York, 1 each in Connecticut, Florida and Vermont.

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local officials, has identified Ouleout cheese from Vulto Creamery of Walton, New York, as the likely source of an outbreak of listeriosis in six people from four states. Two of the six people have died.

The agencies have been investigating this outbreak since January 31, 2017. After gathering evidence about various cheeses eaten by the people who became ill, CDC identified Ouleout cheese from Vulto Creamery as the likely cause of the outbreak.

After being informed of a positive test conducted on a retail sample of Ouleout cheese by the FDA, Vulto Creamery began contacting its customers to return Ouleout cheese on March 3, 2017, and on March 7 announced a recall of its Ouleout cheese along with its Miranda, Heinennellie, and Willowemoc cheeses.

On March 8, 2017, FDA received positive test results from the New York State Department of Agriculture and Markets confirming samples of Ouleout cheese that matched the genetic fingerprint of Listeria monocytogenesin the outbreak.

The CDC reports that six people infected with the outbreak strain of Listeria monocytogenes have been reported from Connecticut, Florida, New York and Vermont. Illnesses started on dates ranging from September 1, 2016, to January 22, 2017. All six people were hospitalized and two people died. Ill people ranged in age from less than one year to 89, with a median age of 55.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Listeria outbreaks. The Listeria lawyers of Marler Clark have represented thousands of victims of Listeria and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Listeria lawyers have litigated Listeria cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, cheese, celery and milk.

If you or a family member became ill with a Listeria infection after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Listeria attorneys for a free case evaluation.