September 2013

Pretrial notice of 404(b) material is required so that Defendants, Jensen brothers, are not subjected to a “trial by ambush.” See, United States v. Kelly, 420 F.2d 26, 29 (2nd Cir. 1969). To prevent the introduction of such evidence, and to head off time-consuming and potentially prejudicial contests before the jury over the admissibility of such evidence, the Prosecution routinely sets forth the facts and evidence it intends to rely on. The right of the accused to be advised of such evidence prior to trial arises from basic rights under the Fifth and Sixth Amendments. These include the right to notice of the nature and cause of the accusation, the right to prepare a defense, the right to confrontation of witnesses, the right to effective assistance of counsel, and the right to trial in accordance with due process of law.  See, United States v. Baum, 482 F.2d 1325 (2nd Cir. 1973).  Here is the Jensen Farms 404(b) Notice.

Dupage County’s Report of the E. coli O157:H7 outbreak from earlier this Summer, just landed in my inbox.

The outbreak associated with Los Burritos Mexicanos ended after the restaurant was closed on 6/14/2013.  A total of 52 ill non-food handlers were identified during this investigation.  Of these 52 cases, 17 were lab-confirmed with E. coli O157:H7, 20 were probable cases, one was a secondary probable case, and 14 were suspect cases.  One individual became ill as a result of secondary transmission of the organism from a family member who was a patron associated with the outbreak.  Ten of these cases were hospitalized (one developed HUS); 11 made an emergency room visit; and another 10 visited their healthcare provider.

None of the menu items analyzed for food specific attack rates displayed a statistically significant association between having been eaten and illness.  Lack of proper hand washing, handling ready-to-eat food with bare hands, improperly washing and sanitizing food contact surfaces, failure to wash fruit and vegetables prior to processing and poor facility sanitation were all noted during the Environmental Assessment of the facility.  One food handler, a cook, was found to be positive for E. coli O157:H7 with a PFGE pattern matching the patron samples. Since this food handler reported not having any symptoms of illness at any time a month prior to or after the investigation began, it is difficult to ascertain when this individual became infected and whether this individual contributed to the outbreak or was simply a victim, since he reported eating food made at the facility in his interview.  All other employees were found to be lab-negative for E. coli.  Food prepared prior to the initial onset dates was not available for testing. DCHD Environmental Health staff continued to monitor food preparation processes and provide additional training after the facility reopened. No other complaints of illness associated with Los Burritos Mexicanos in Lombard, IL have been received since the facility re-opened.

From US Attorney Press Release:

Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, located in Granada, Colorado, presented themselves to U.S. marshals in Denver today and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation, United States Attorney John Walsh and Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent in Charge Patrick Holland announced.

The Information charges the brothers with introducing adulterated food into interstate commerce. The defendants were scheduled to make their initial appearance this afternoon at 2 p.m. before U.S. Magistrate Judge Michael E. Hegarty. At that hearing they were to be advised of their rights as well as the charges pending against them.

According to the six-count Information filed under restriction on Sept. 24, 2013, as well as other court records, Eric and Ryan Jensen allegedly introduced adulterated cantaloupe into interstate commerce. Specifically, the cantaloupe bore a poisonous bacteria, Listeria monocytogenes.

The Information further states that the cantaloupe was prepared, packed and held under conditions which rendered it injurious to health.

Court documents state that the defendants set up and maintained a processing center where cantaloupes were taken from the field and transferred to a conveyor system for cleaning, cooling and packaging. The equipment should have worked in such a way that the cantaloupe would be washed with sufficient anti-bacterial solutions so that the fruit was cleaned of bacteria in the process.

In May of 2011 the Jensen brothers allegedly changed their cantaloupe cleaning system. The new system, built to clean potatoes, was installed, and was to include a catch pan to which a chlorine spray could be included to clean the fruit of bacteria.

The chlorine spray, however, was never used. The defendants were aware that their cantaloupes could be contaminated with harmful bacteria if not sufficiently washed. The chlorine spray, if used, would have reduced the risk of microbial contamination of the fruit.

Investigation by the FDA and the Center for Disease Control (CDC) determined that the defendants failed to adequately clean their cantaloupe. Their actions allegedly resulted in at least six shipments of cantaloupe contaminated with Listeria monocytogenes being sent to 28 different states.

The CDC tracked the outbreak-associated illness and determined that people living in 28 states consumed contaminated cantaloupe, resulting in 33 deaths and 147 hospitalizations.

Further, one woman pregnant at the time of her outbreak-related illness had a miscarriage. Ten additional deaths not attributed to Listeriosis occurred among persons who had been infected by eating outbreak-related cantaloupe.

“As this case so tragically reminds us, food processors play a critical role in ensuring that our food is safe,” said Walsh. “They bear a special responsibility to ensure that the food they produce and sell is not dangerous to the public. Where they fail to live up to that responsibility, and as these charges demonstrate, this office and the Food and Drug Administration have a responsibility to act forcefully to enforce the law.”

“U.S. consumers should demand the highest standards of food safety and integrity,” said Special Agent in Charge Patrick J. Holland of the FDA-Office of Criminal Investigations, Kansas City Field Office. “The filing of criminal charges in this deadly outbreak sends the message that absolute care must be taken to ensure that deadly pathogens do not enter our food supply chain.”

Both defendants have been charged with six counts of adulteration of a food and aiding and abetting. If convicted, each faces not more than one year in federal prison, and a fine of up to $250,000 per charge.

This case was investigated by the FDA Office of Criminal Investigations, the Center for Disease Control and the State of Colorado Department of Public Health and Environment.

The defendants are being prosecuted by Assistant U.S. Attorney Jaime Pena.

See 404B Notice

On behalf of my 46 clients, 25 family members of people who died from Listeria and 21 sickened who survived, I am pleased that the US Attorney’s office recognizes that some form of criminal sanctions were appropriate against Jensen Farms for sickening at least 147 people and killing over 33 in 2011 from tainted cantaloupe grown in Colorado.

That being said, I would urge the US Attorney to consider leveling criminal charges against the retailers, such as Walmart and Kroger, as well.  The US Attorney should also consider the same against the auditor, Primus.

These retailers set the specifications for the “fresh fruits” and ignored them. These retailers required audits that they knew full well would generate a glowing inspection, all the while ignoring what was there to be seen. These retailers then used their market power to squeeze the supply chain of any profit that could have been invested in food safety.

The relationship between retailers and auditor is simply a conspiracy to keep product flowing through the chain of distribution at the lowest costs, and an attempt to shield retailers from responsibility for the products that they sell.

We will never have safe food from “Farm to Fork” until the entire chain of distribution is held accountable for the food that they make a profit from.

I would suggest taking a look at – “A look at the Safety – or not – of Raw Milk Cheese and the “60 Day Rule”

The Public Health Agency of Canada, along with its health and food safety partners, is investigating 21 cases of E. coli O157:H7 illness; 9 in British Columbia, 9 in Alberta and 1 each in Saskatchewan, Manitoba and Quebec.

These individuals became ill between mid-July and early September. Most people who become ill from E.coli bacteria will recover within 5 to 10 days.

Certain contaminated cheese products manufactured by Gort’s Gouda Cheese Farm in Salmon Arm, British Columbia, have been identified as the source of the illnesses. The Canadian Food Inspection Agency (CFIA) has issued a Health Hazard Alert warning the public not to consume the affected product. Should additional products be recalled as part of the ongoing food safety investigation, the CFIA will immediately inform the public.

As of September 20, 2013, 162 people have been confirmed to have become ill from hepatitis A after eating ‘Townsend Farms Organic Antioxidant Blend’ in 10 states: Arizona (23), California (79), Colorado (28), Hawaii (8), New Hampshire (1), New Jersey (1), New Mexico (11), Nevada (6), Utah (3), and Wisconsin (2). [Note: The cases reported from Wisconsin resulted from exposure to the product in California, the cases reported from New Hampshire reported fruit exposure during travel to Nevada, and the case reported in New Jersey was a household contact of a confirmed case from Colorado.] Currently, 6 of the confirmed cases are household contacts of confirmed cases (secondary cases).

90 (56%) ill people are women

Ages range from 1 – 84 years;

94 (58%) of those ill were between 40 – 64 years of age.

11 children age 18 or under were also ill. None were previously vaccinated.

Illness onset dates range from 3/31/2013 – 7/26/2013

71 (44%) ill people have been hospitalized, and no deaths have been reported

Update:  Quebec adds one illness to growing list.

“I can’t undo it. God is in control, not man.”

Gort’s co-owner, Kathy Wikkerink, in an interview with Canadian Press.

The Public Health Agency of Canada, along with its health and food safety partners, has been investigating thirteen cases of E. coli O157:H7 illness; four in British Columbia, eight in Alberta and one in Saskatchewan.  These individuals became ill between mid-July and early September.

Certain contaminated cheese products manufactured by Gort’s Organic Gouda Cheese Farm in Salmon Arm, British Columbia, have been identified as the source of the illnesses. The Canadian Food Inspection Agency has recalled these products from the marketplace.

Province / Territory

Total cases

British Columbia

4

Alberta

8

Saskatchewan

1

Total

13

 

One of the cases in British Columbia has died as a result of E. coli O157:H7 infection.

So much for faith-based food safety.

Image (c) Dennis Kunkel Microscopy, Inc.

Kentucky:

Kentucky press reports, that there have been seven culture confirmed cases of Salmonella in Hopkins County including a death from the illness.  Four people have been hospitalized including the person that died, said Hopkins County Health Department Director Denise Beach.

“There are always cases of salmonella in the county,” said Beach. “Those cases are reported to the health department and we’re looking for anything is outside the norm.”

Beach said the outbreak is under investigation and names of the victims are privacy protected.

“We have our epidemiology nurse working on it, who has been since we first got reports,” said Beach. “Having seven cases in a week is definitely outside the norm.”

Beach said the cultures are also being typed for the subclasses of Salmonella.

North Carolina:

According to North Carolina new reports, 71 people have now reported illnesses linked to the Sandy Plains Baptist Church barbecue fundraiser on Sept. 7.

As of Friday, 71 people had reported getting sick after visiting the barbecue. Among those, 37 people are Rutherford County residents and 34 are Cleveland County residents.

Thirteen people have been hospitalized, with nine of those in Cleveland County, according to a news release from the health department.

Health officials say the most recent date someone has reported first getting sick was Sept. 14.

Health Department Warns Patrons Of New Hawaii Sea Restaurant In The Bronx Of Possible Exposure To Hepatitis A From September 7th To September 19th

Customers who ate food from New Hawaii Sea Restaurant in the Bronx (1475 Williamsbridge Road) Between Those Dates Should Get Hepatitis A Vaccine as soon as possible

Five Cases of Hepatitis A at the Restaurant; One Employee, Four Patrons

In response to cases of hepatitis A infections in an employee and four customers at New Hawaii Sea restaurant, located at 1475 Williamsbridge Road in the Bronx, the Health Department is urging customers who ate at the restaurant, either in-store, through catering or delivery, between September 7th and September 19th to receive hepatitis A vaccine as soon as possible. Any leftover food from this restaurant should also be discarded.

Any person who ate at New Hawaii Sea, either in-store, through catering or delivery, between September 7th and September 19th is considered at risk and is recommended to receive hepatitis A vaccine as soon as possible. Any person who ate food from this restaurant before September 7th should be evaluated if they have symptoms suggestive of infection. The Health Department is working with the restaurant to ensure that all the food handlers are vaccinated. The restaurant is cooperating fully with the Health Department and will remain closed until enough employees are vaccinated to reopen safely.

People can visit their regular doctor to receive this shot. The Health Department will offer hepatitis A vaccinations starting tomorrow, September 21st at the Herbert Lehman High School, 3000 East Tremont Avenue, Bronx, NY 10461 at the following times:

Saturday, September 21, 2013 from 2-8 pm

Sunday, September 22, 2013 from 2-8 pm.

People who were exposed but have already received two doses of hepatitis A vaccine sometime in their life do not need another shot; all others should be vaccinated.

This is the 4th Hepatitis A scare in New York in 2013.  Here are the other three:

Hamptons Drivers Seat Restaurant

Manhattan Alta Restaurant

Westside Market

After more news of the E. coli O157:H7 outbreak linked to raw milk cheese, it reminded me of a post from 2001:

After the recent E. coli O157:H7 outbreak linked to Bravo raw milk gouda cheese that sickened 38 (one with HUS), the New York Times is quickly becoming the go to newspaper for cheese lovers.

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 1, Part 2, Part 3, Part 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.

Continue Reading A look at the Safety – or not – of Raw Milk Cheese and the “60 Day Rule”