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Food Poison Journal Food Poisoning Outbreaks and Litigation: Surveillance and Analysis


Plastic in Chicken do not Mix

Screen Shot 2017-04-27 at 7.55.28 PMFoster Poultry Farms, a Farmerville, La. establishment, is recalling approximately 131,880 pounds of frozen, ready-to-eat breaded chicken patty products that may be contaminated with foreign materials, specifically plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat breaded chicken patty items were produced on February 15, 2017. The following products are subject to recall: [View Labels (PDF only)]

  • 5-lb. bags containing 20 pieces of “FOSTER FARMS Chicken Patties BREADED CHICKEN BREAST PATTIES WITH RIB MEAT” with Best By date of 02/15/18.

The products subject to recall bear establishment number “P-33901” inside the USDA mark of inspection. These items were shipped to distribution centers in Alaska, Arizona, California, Utah and Washington.

The problem was discovered when the firm received three consumer complaints on March 22, April 3, and April 15, 2017 reporting foreign materials in the chicken patty products. The foreign materials were pieces of clear, soft plastic that originated from the establishment’s packaging materials.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them.

Fore! Golf Balls in Wegman’s Potatoes

UCM555390McCain Foods USA, Inc. announced today it is expanding the voluntary recall of retail, frozen hash brown products that may contain golf ball materials, specifically hard plastic or rubber pieces, that despite our stringent supply standards may have been inadvertently harvested with potatoes used to make this product. Consumption of these products may pose a choking hazard or other physical injury to the mouth. There have been no reported injuries associated with the consumption of this product.

McCain Foods, USA Inc. is taking this action as a result of two additional consumer complaints of the hard plastic or rubber pieces. The original April, 21, 2017 recall that included Roundy’s and Harris Teeter Brand Hash Browns has been expanded to include the Wegman’s Brand 28-ounce bag of frozen O’Brien Hash Browns (UPC 07789036523). The Wegman’s product being voluntarily recalled were manufactured on October 21, 2016. The production code date that can be found on the bag is B161021. The Wegman’s product was distributed in the states of Maryland, Massachusetts, New Jersey, New York, Pennsylvania and Virginia. Distribution occurred after the date of October 21, 2016.

Any Wegman’s O’Brien Hash Browns product with a different production code date is not impacted by this voluntary recall.  No other products under the Wegman’s brand are impacted by this voluntary recall. The McCain Foods product recall is contained to only product produced and sold within the United States.

Consumers who have purchased these products are urged not to consume them.

Golf Ball parts found in Hash Brown Potatoes – Choking Hazard

ucm554453McCain Foods USA, Inc. announced today it is voluntarily recalling retail, frozen hash brown products that may be contaminated with extraneous golf ball materials, that despite our stringent supply standards may have been inadvertently harvested with potatoes used to make this product. Consumption of these products may pose a choking hazard or other physical injury to the mouth.

The impacted products include the following: Roundy’s Brand, 2 lb. Bag of Frozen Southern Style Hash Browns (UPC 001115055019) and Harris Teeter Brand, 2 lb. Bag of Frozen Southern Style Hash Browns (UPC 007203649020).

The Roundy’s products were distributed at Marianos, Metro Market, and Pick ‘n Save supermarkets in the states of Illinois and Wisconsin. The Harris Teeter products were distributed in the states of North Carolina, South Carolina, Virginia, District of Columbia, Delaware, Florida, Georgia and Maryland. Distribution occurred after the date of January 19, 2017. No other products under the respective brands are impacted by this recall.

The products being recalled were manufactured on January 19, 2017. The production code date is B170119 and can be found on the back of the packaging. Any product with a different production code date is not impacted by this recall.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

There have been no reported injuries associated with the consumption of this product.

Fresh Express Recalls Organic Marketside Spring Mix with Bat

IMG_0900The Centers for Disease Control and Prevention (CDC) announced this evening that it is working with the Florida Department of Health and the U.S. Food and Drug Administration (FDA) to support an investigation of a dead bat that was found in a Fresh Express packaged salad purchased from a Walmart grocery store in Florida. Two people in Florida reported eating some of the salad before the bat was found. The bat was sent to the CDC rabies lab for laboratory testing because bats in the United States sometimes have been found to have this disease. The deteriorated condition of the bat did not allow for CDC to definitively rule out whether this bat had rabies.

Transmission of rabies by eating a rabid animal is extremely uncommon, and the virus does not survive very long outside of the infected animal. CDC is supporting Florida local and state health officials in evaluating the people who found the bat in the salad. In this circumstance, the risk of rabies transmission is considered to be very low, but because it isn’t zero, the two people who ate salad from the package that contained the bat were recommended to begin post-exposure rabies treatment. Both people report being in good health and neither has any signs of rabies. CDC is not aware of any other reports of bat material found in packaged salads.

On April 8, 2017, Fresh Express issued a recall of a limited number of cases of Organic Marketside Spring Mix. The salads were sold in a clear container with production code G089B19 and best-if-used-by date of APR 14, 2017 located on the front label. The recalled salads were distributed only to Walmart stores located in the Southeastern region of the United States (AL, FL, GA, LA, MS, NC, SC, VA). All remaining packages of salad from the same lot have been removed from all store locations where the salad was sold.

Consumers who may have already purchased the recalled product should discard and not consume it.

What six things a Food Safety Lawyer does not eat

Bill-Marler-B-W-headshot-640x441Unpasteurized (“raw”) milk and packaged juices. Unpasteurized milk, sometimes called “raw” milk, can be contaminated with bacteria, viruses and parasites. Between 1998 and 2011, there were 148 food poisoning outbreaks linked to raw milk and raw milk products in the US—and keep in mind that comparatively few people in the country ever consume these products, so 148 outbreaks is nothing to ignore. As for unpasteurized packaged juices, one of Marler’s earliest cases was the 1996 E. coli outbreak from unpasteurized Odwalla apple juice. As a result, he won’t go near raw milk or juice. There’s no benefit big enough to take away the risk of drinking products that can be made safe by pasteurization,” he says.

Raw sprouts. Uncooked and lightly cooked sprouts have been linked to more than 30 bacterial outbreaks (mostly of Salmonella and E. coli) in the US since mid-1990s. As recently as 2014, salmonella from bean sprouts sent 19 people to the hospital. All types of sprouts—including alfalfa, mung bean, clover and radish sprouts—can spread infection, which is caused by bacterial contamination of their seeds. “There have been too many outbreaks to not pay attention to the risk of sprout contamination,” Marler says. “Those are products that I just don’t eat at all.” He did add that he does eat them if they’re cooked.

Meat that isn’t well-done. Marler orders his burgers well-done. “The reason ground products are more problematic and need to be cooked more thoroughly is that any bacteria that’s on the surface of the meat can be ground inside of it,” Marler says. “If it’s not cooked thoroughly to 160°F throughout, it can cause poisoning by E. coli and Salmonella and other bacterial illnesses.” As for steaks, needle tenderizing—a common restaurant practice in which the steak is pierced with needles or sliced with knives to break down the muscle fibers and make it more tender—can also transfer bugs from the surface to the interior of the meat. If a restaurant does this (Marler asks), he orders his steak well-done. If the restaurant doesn’t, he’ll opt for medium-well.

Prewashed or precut fruits and vegetables. “I avoid these like the plague,” Marler says. Why? The more a food is handled and processed, the more likely it is to become tainted. “We’ve gotten so used to the convenience of mass-produced food—bagged salad and boxed salads and precut this and precut that,” Marler says. “Convenience is great but sometimes I think it isn’t worth the risk.” He buys unwashed, uncut produce in small amounts and eats it within three to four days to reduce the risk for Listeria, a deadly bug that grows at refrigerator temps.

Raw or undercooked eggs. You may remember the Salmonella epidemic of the 1980s and early ’90s that was linked mainly to eggs. If you swore off raw eggs back then, you might as well stick with it. The most recent salmonella outbreak from eggs, in 2010, caused roughly 2,000 reported cases of illness. “I think the risk of egg contamination is much lower today than it was 20 years ago for salmonella, but I still eat my eggs well-cooked,” Marler says.

Raw oysters and other raw shellfish. Marler says that raw shellfish—especially oysters—have been causing more foodborne illness lately. He links this to warming waters, which produce more microbial growth. “Oysters are filter feeders, so they pick up everything that’s in the water,” he explains. “If there’s bacteria in the water it’ll get into their system, and if you eat it you could have trouble. I’ve seen a lot more of that over the last five years than I saw in the last 20 years. It’s simply not worth the risk.”

William “Bill” Marler is a nationally recognized American personal injury lawyer and food safety advocate. He is the managing partner of Marler Clark, a Seattle, Washington, based law firm that specializes in foodborne illness cases.

First published at http://bottomlinehealth.com/health-insider/6-things-this-food-safety-expert-wont-eatand-one-surprising-food-he-will/ Copyright © 2016 by Boardroom Inc., 281 Tresser Blvd., Stamford, Connecticut 06901-3229. www.BottomLineHealth.com

2016 – Civil Beat News, Rui Kaneya August 22, 2016

2016 – This genius lawyer is our best hope against deadly food poisoning Kiera Butler Mother Jones May 20, 2016

2015 – Profile in Obsession: Bill Marler, By Naomi Tomky March 24, 2015

2015 – The New Yorker – A Bug in the System
The New Yorker, Wil S. Hylton, February 2, 2015.

2014 – Q&A: Food Safety Lawyer Bill Marler on What Not to Eat
The National Law Journal, Interview with Jenna Greene, November 3, 2014.

2012 – Bill Marler, Attorney, Blogger, and Food Safety Advocate, Talks Turkey (Or Spinach, Rather)
Miami New Times, Interview with Ily Goyanes, November 2.

2012 – Bill Marler Interview, Part Two: His Most Difficult Cases and Lobbying Congress
Miami New Times, Interview with Ily Goyanes, November 14.

2012 – Profiles in Public Health Law: Interview with William “Bill” Marler CDC Public Health Law News, July.

2012 – Food Safety Lawyer Bill Marler On Sprouts, Raw Milk, and Why “Local” Isn’t Always Safer Blisstree.com, Hanna Brooks Olsen, March 5.

2011 – Listeria outbreak draws Seattle lawyer to battle
Associated Press, Shannon Dininny, October 9.

2011 – Food-Borne Illness Attorney: Top Foods to Avoid
ABC News, Neal Karlinsky, September 29.

2011 – How to Keep Food Free of Salmonella: Lawsuits
The Atlantic, Barry Estabrook, August 31.

2011 – More Stomach-Churning Facts about the E. Coli Outbreak
New York Times, Mark Bittman, June 8.

2011 – Bill Marler: A Personal Injury Attorney and More
The Xemplar, Nicole Black, June 1.

2011 – Good Food Hero: Bill Marler, Food Safety Attorney
Good Food World, Gail Nickel-Kailing, May 23.

2011- Poisoned: The True Story of the Deadly E. coli Outbreak that Changed the Way Americans Eat.
Inspire Books, Jeff Benedict, May 15

2011 – New Book Chronicles Islander Marler’s Work.
Bainbride Island Review, Connie Mears, May 13.

2010 – Food Safety Lawyer Puts His Money Where Your Mouth Is
AOL News, Andrew Schneider, September 29

2009 – Food Safety Lawyer’s Wish: Put Me Out of Business
Seattle Times, Maureen O’Hagan, November 23

2009 – WSU Discourse on Food Safety, Courtesy Seattle Lawyer
Kitsap Sun, Tristan Baurick,  August 29

2009 – When Food Sickens, He Heads for Courthouse
Minneapolis Star-Tribune, Matt McKinney, June 24

2009 –  Bill Marler, The Food-Safety Litigator
Culinate, Miriam Wolf, April

2009 – Food Fight:Bill Marler’s Beef (PDF)
Washington Law & Politics, David Volk, May

2009 – Candidate for Top FSIS Job talks E. coli Testing, Irradiation, Education
The Meating Place, Ann Bagel Storck, February 6

2009 – Five Minutes with Bill Marler, Well Known Lawyer, Food Safety Activist
CattleNetwork, Chuck Jolley, February 5

2009 – Heath Surveillance the Key to Fresh Produce
The Packer, Tom Karst, February 3

2008 – Seattle Food Contamination Expert in China as Tainted Milk Sickens Thousands of Kids
Seattle Health Examiner, September 23

2008 –  E. Coli Lawyer Is Busier Than Ever
Associated Press, February 4

2007 –  Legally Speaking: The Food Poisoning Lawyer
The Southeast Texas Record, John G. Browning, November 20

2007 –  The Nation’s Leading Food-borne Illness Attorney Tells All
Washington State Magazine, Hannelore Sudermann, August

2007 –  Back to Court: Burst of E. coli Cases Returns Jack in the Box Litigator to the Scene
Meat and Poultry News, Steve Bjerklie, June 8

2007 – Food Fight
Portland Oregonian, Alex Pulaski, March

2007 –  Mr. Food Illness Esquire
QSR Magazine, Fred Minnick, February

2006 –  Seattle Attorney Dominates Food-Borne Illness Litigation
KPLU, October 20

2006 –  How a Tiny Law Firm Made Hay Out of Tainted Spinach
The Wall Street Journal, Heather Won Tesoriero and Peter Lattman, September 27

2005 – Bill Marler – Education Holds Key in Tainted Food Fight
King County Bar Association Bar Bulletin, Ross Anderson, November

2001 –  THE INSIDE STORY: How 11 Schoolkids Got $4.75 Million in E. coli Lawsuit
MeatingPlace.com, Bryan Salvage, March 7

2001 –  Hammer Time: Preparation Pays When Disputes Escalate to Lawsuits
Meat & Poultry Magazine, David Hendee

2001 –  For Seattle Attorney, A Bacterium Brings Riches—and Enemies
The Wall Street Journal, Rachel Zimmerman

2001 –  The Bug That Ate The Burger
Los Angeles Times, Emily Green, June

1999 –  Courting Publicity, Attorney Makes Safe Food His Business
Seattle Post, Maggie Leung, September 7

Consumer Complaints of Metal Objects Prompts Chicken Fries Recall

Screen Shot 2017-03-25 at 1.21.34 PMOK Food, Inc., an Oklahoma City, Okla. establishment, is recalling approximately 933,272 pounds of breaded chicken products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat (RTE) breaded chicken items were produced on various dates from Dec. 19, 2016 through March 7, 2017. A list of the products subject to recall can be found here PDF

The products subject to recall bear establishment number “P-7092” inside the USDA mark of inspection. These items were shipped to retail locations and institutions nationwide.

The problem was discovered on March 21, 2017 after OK Foods Inc. received five consumer complaints stating that metal objects were found in the ready-to-eat chicken products and by FSIS inspection personnel during verification activities. After an internal investigation, the firm identified the affected product and determined that the objects in all the complaints came from metal conveyor belting.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them.

Lead in Thyme?

UCM547268-420x600Aroma Imports Inc. of Dearborn Heights, MI, is recalling 450 g and 4.5 kg packages of Nabelsi brand Thyme because the products have the potential to contain excessive levels of lead.  The recall was initiated after it was discovered that product contained high levels of lead (422 PPM) based on sampling by U.S. Food and Drug Administration and Illinois Department of Public Health, Environmental Health Protection.  Based on the product’s 30 g serving size, the calculated lead result is 12,660 µg per serving.  This level exceeds the daily limit guidelines of 6 µg per day for children, the 25 µg per day for pregnant women, and the 75 µg per day for other adults.

The recalled Nabelsi Thyme was distributed from Nov. 7, 2016 until Feb. 22, 2017 to retailers, food service establishments, and wholesalers in Michigan, Illinois, Ohio, New Jersey and Virginia.

The 450 g size (UPC: 4670000205314) is packaged in a mostly green foil/mylar bag that is not transparent on either side. The 4.5 kg size (UPC: 6670000205374) packaging is a silver foil/mylar bag. The production date for both sizes is 08/20/2016 and the expiration date is 08/20/2018. The production and expiration dates can be found on the back lower left corner of the 450 g package and back lower right of the 4.5 kg package.  The 450 g packages are packed 24 per case and the 4.5 kg packages are packed 2 per case.

Lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences.  People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing.

There have been two cases of high blood levels of lead associated with this product to date. Both cases have been reported through the Illinois Department of Public Health, Environmental Health Protection.

Consumers who have purchased any packages Nabelsi Thyme should not consume the product.

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


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.”


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.


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.


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:



•salt content




•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


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.


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…)

Attorney Bill Marler Named to America’s 50 Most Powerful People in Food for 2017

The food safety advocate and attorney is number 40 on the annual list.

The Daily Meal has included prominent food safety attorney Bill Marler, of Marler Clark LLP, on their annual list of America’s 50 Most Powerful People in Food for 2017. Marler has made the list over the last several years, coming in this year at number 40. This ranking acknowledges Marler’s status in the field of food safety law, most notably his advocacy for the improvement of food safety standards and the defense of foodborne illness victims.

Marler joins the likes of industry CEOs, food and restaurant critics, and celebrity chefs on the seventh annual iteration of the list. “I’m deeply honored to be included on the list again for 2017,” said Marler. “The importance of prioritizing the health and standards of our nation’s food has never been higher, and I’m glad to continue to spread the message of food safety.” “It is unclear at this point what impact the Trump Administartion policies will have on food safety,” Marler added.

Seattle-based attorney Bill Marler rose to international prominence representing Brielle Kiner in the Jack-in-the-Box E. Coli outbreak of 1992. Since then, Marler has represented countless victims of foodborne illness, as well as serving as a lecturer for numerous legal and food safety conferences. In addition to representing clients and speaking to industry professionals, his blog keeps abreast of food poisoning outbreaks, legal outcomes of foodborne illness cases, and updates on food safety policy nationwide.

Marler Clark, LLC has been an advocate for victims of foodborne illnesses for decades. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Marler Clark attorneys have litigated cases stemming from outbreaks traced to a variety of foods. The firm has brought lawsuits against companies such as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.

If you would like to speak with Bill Marler about his site and selection to the America’s 50 Most Powerful People in Food list, please contact Colleen McMahon (colleen@quinnbrein.com), Samantha Jones (Sam@quinnbrein.com) or call (206) 842-8922.

Florida Gateway College Science Olympiad Tied to Food Poisoning Event

Florida_Gateway_College_(emblem)News4 reports that 30 people were taken to the hospital Saturday for what officials believe was a foodborne illness.

Multiple agencies were called to Florida Gateway College in Lake City, where 28 minors and two adults attending the Science Olympiad competition were suffering from what is believed to be food poisoning.

Due to the volume of people needing treatment, ambulances were called in from neighboring counties, and were taken Lake City Medical Center and Shands Lake Shore. 

Officials said the only common denominator was the catered lunch provided to those participating in the competition. A witness said everyone who had eaten the pork was taken to a hospital.