Food Policy & Regulation

Congresswoman Rosa DeLauro (CT-03) today released the following statement regarding the United States Department of Agriculture’s (USDA) response to the ongoing antibiotic resistant Salmonella outbreak linked to raw turkey products, which has caused more than 160 illnesses and one death across 35 states.

“The public entrusts the USDA to keep our nation’s meat and poultry products safe. That is what makes the ongoing Salmonella outbreak so troubling. Congress and the public have no indication that the USDA is any closer to resolving this outbreak today than they were nearly one year ago when the first illness was reported. Instead of providing more information—like naming implicated plants—the USDA has attacked consumer safety advocates for seeking answers. That is wrong, and it is not the type of behavior a government agency or its employees should be engaged in.”

“This outbreak is just another example of the USDA putting corporate interests over the health of American families. That is why I have long advocated for changes to food safety law that would define antibiotic-resistant Salmonella as an adulterant in poultry products. Congress needs to act on this bill immediately. More than that, with Thanksgiving just one week away, the public deserves transparency from the USDA and to know if their families are being put at risk.”

DeLauro’s legislation, the Pathogen Reduction and Testing Reform Act, would strengthen the ability of the USDA to keep Americans safe from contaminated meat, poultry, and eggs. Among other reforms, the bill would define Salmonella strains that are associated with serious illness or death, or that are drug-resistant, to be an adulterant in poultry. This change in definition would subject such contaminated products to the USDA’s mandatory recall authority.

SEATTLE, Washington – Marler Clark, the food safety law firm, commends the Food and Drug Administration’s (FDA) recent statement committing to disclose retailer information to improve consumer safety. This commitment to transparency is especially important where the source of the specific contaminated product is not easily identifiable to consumers, as in the recent Romaine lettuce E. coli O157:H7 or in the  Pre-cut fruit Salmonella Outbreak. Releasing retailer information increases consumer knowledge for all parts of the supply chain.

Marler Clark represents 100 people sickened in the E. coli O157:H7 outbreak and has represented victims of every major foodborne illness outbreak for the past 25 years. In addition to working with health departments to collect information, Marler Clark conducts its own traceback investigations to help hold companies accountable to providing contaminated food to consumers.

“Greater transparency from the FDA not only increases consumer safety by providing more information to consumers about foods to avoid, it also increases accountability to insure similar outbreaks do not happen again,” said Bill Marler, Managing Partner ad Marler Clark.

Marler Clark, The Food Safety Law Firm, has represented thousands of individuals in claims against food companies whose contaminated products have caused life altering injury and even death. Managing partner, Bill Marler began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the historic Jack in the Box E. coli O157:H7 outbreak, in her landmark $15.6 million settlement with the company.  For the last 25 years, Marler Clark has represented victims of nearly every large foodborne illness outbreak in the United States, filing lawsuits against such companies as Cargill, Chili’s, Chi-Chi’s, Chipotle, ConAgra, Dole, Excel, Golden Corral, KFC, McDonald’s, Odwalla, Peanut Corporation of America, Sheetz, Sizzler, Supervalu, Taco Bell and Wendy’s. The firm has secured over $650,000,000 for victims of E. coli, Salmonella, Listeria and other foodborne illnesses.

Superior Foods Company located in Kentwood, Michigan is voluntarily recalling a specific lot of Smoked Salmon Spreads (487 lbs.) that were produced on March 26, 2018. This voluntary action is being undertaken in cooperation with the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development.

Listeria monocytogenes was identified through routine inspection and testing by MDARD.

The products in question could potentially be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages, stillbirths and fatal infection in pregnant women. People experiencing these problems should seek immediate medical attention.

Products covered by this voluntary recall were distributed in Michigan, Indiana, Illinois, Ohio, and Minnesota, and include only those products listed below, currently in distribution and for sale. Products were sold in retail grocery stores and some food service businesses. Specific product names and further product information is listed below.

No other Superior Foods Company retail or food service-branded products are impacted by this voluntary recall.

The following products are included in this product recall:

Smoked Salmon Spread
5 lb. bulk units – Code Number: 68487 – Sell by Date: 4/25/18 – Lot Number 0728-2
UPC #043823684873

Simply Superior Smoked Salmon Spread
6X5 oz units – Code Number: 92379 – Sell by Date: 4/25/18 – Lot Number 0728-2
UPC #043823923798

Morey’s Smoked Salmon Spread
6×6 oz units – Code Number: 92503 – Sell by Date: 4/25/2018 – Lot Number 0728-2
UPC #043823925037

A New York raw milk cheese company whose products were linked to a multi-state outbreak of Listeria monocytogenes (L. mono) has been ordered by a federal court not to manufacture its ready-to-eat aged soft, semi-soft and hard cheeses until it complies with food safety regulations.

On March 30, 2018, the U.S. District Court for the Northern District of New York entered a consent decree of permanent injunction against Vulto Creamery LLC (Walton, N.Y.) and its owner and manager Johannes “Jos” H. Vulto. The defendants cannot prepare, process, manufacture, pack and/or hold FDA-regulated food products until they can ensure that L. mono is not present in their facility and their food.

“We have an obligation to make sure that foods are safe for people to consume. The FDA moved quickly after an L. mono outbreak to get the company to recall and destroy all its cheese products and cease production to prevent any more tainted food from harming consumers,” said FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. “FDA investigators also found unsanitary conditions at Vulto Creamery’s facility and this consent decree prevents the company and its owner from resuming operations until they can demonstrate to the FDA that their products are safe.”

Vulto Creamery’s ready-to-eat cheeses are considered adulterated because they contain L. mono—a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis. In addition, the products were prepared, packed and/or held under unsanitary conditions and the food may have become contaminated with filth or otherwise be harmful to health.

Before the company can resume operations, the consent decree requires it, among other things, to retain an independent laboratory to collect and analyze environmental and finished samples for the presence of L. mono, retain an independent expert and develop a program to control L. mono, and eliminate unsanitary conditions at its facility.

Earlier this year, the FDA, in collaboration with the Centers for Disease Control and Prevention, state and local officials, investigated a multi-state outbreak of listeriosis that was eventually linked to soft cheese produced by Vulto Creamery. Eight people were infected from four states, and two people died.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.

Saginaw County has joined a growing number of counties affected by an ongoing hepatitis A outbreak in southeast Michigan that has hospitalized hundreds and killed more than two dozen.

Officials with the Saginaw County Department of Public Health announced there have been two confirmed cases of the disease in Saginaw County linked to the outbreak.

Across Michigan, there had been 736 cases of hepatitis A linked to the outbreak as of Feb. 6, resulting in 24 deaths in 596 hospitalizations, according to health department officials.

The counties and cities with the most cases include Macomb County, with 208 cases; city of Detroit, with 160 cases; Wayne County, with 128 cases; and Oakland County, with 100 cases.

The Lenawee County Health Department has a confirmed case of hepatitis A.

A Lenawee County resident tested positive for Hepatitis A. It is believed to be linked to an outbreak in southeast Michigan.

The health department says the individual is not considered to be at high risk of spreading the disease to other people.

Hepatitis A is a vaccine-preventable disease, an infection of the liver caused by the hepatitis A virus, or HAV.

As the outbreak continues to spread across the state, health officials remind people the most effective way to prevent hepatitis A is through vaccination and hand washing with soap and water.

HAV is found in feces of people with hepatitis A and is most commonly spread by consuming contaminated food or water, during sex, or by living with an infected person. Symptoms of HAV infection include:

·       Nausea and vomiting

·       Stomach pain

·       Feeling tired

·       Fever

·       Loss of appetite

·       Yellowing of the skin and eyes

·       Dark urine

·       Pale-colored feces

·       Joint pain

The hepatitis A virus is a contagious liver disease most commonly spread by the ingestion of food or water contaminated with
feces or by oral contact with contaminated objects.

Most infections result from contact with an infected household member
or sex partners. It is not spread through coughing or sneezing.

Hepatitis A can range from mild to serious, lasting a few weeks to several months. Anyone who has hepatitis A can spread the
virus to others starting 1-2 weeks prior to symptoms appearing.

Symptoms may include fatigue, abdominal pain, nausea/
vomiting,fever, yellow skin (jaundice), dark urine, pale stool and joint pain. Some people have no symptoms.

Vaccination is strongly encouraged for all eligible individuals, as multiple counties in southeast Michigan have seen outbreaks of hepatitis A in recent months. Children ages 1 through 18 should receive the vaccine as part of the routine vaccination schedule.

The vaccine has been available since 1996, but it did not become a routine recommendation for children until 2006.

Clay County and Arkansas health officials will be hosting a series of walk-in clinics over the next few days to give vaccinations to people who may have been exposed to Hepatitis A while eating at a local restaurant last month.

According to the Arkansas Department of Health, the clinics will be held:

  • Feb. 16, from 8 a.m. to 4:30 p.m. at the Corning and Piggott locations of the Clay County Health Unit.
  • Feb. 17, from 10 a.m. to 2 p.m. at the Corning location.
  • Feb. 18 from 1 p.m. to 3 p.m. at the Corning location.
  • Feb. 19 from 9 a.m. to 3 p.m. at the Corning location.

The Corning location is at 301 North Missouri Ave., while the Piggott location is at 1009 South Garfield Ave., officials said in the announcement. People can call 870-857-6281 for the Corning office and 870-598-5719 for the Piggott office for more information.

People are being asked to contact their local healthcare provider or go to the clinics if they have not been vaccinated for Hepatitis A.

On Wednesday, state health officials began warning of a possible Hepatitis A exposure after a Taco Bell employee in Corning tested positive for the virus.

In a statement Wednesday, officials asked that anyone who has eaten food at the restaurant between Jan. 24 and Feb. 7, 2018 and is having symptoms should call their doctor immediately.

Also, officials said they believe there is no known risk for anyone who ate at the restaurant after Feb. 7 at this time.

There are no specific treatments available once a person gets the virus, officials say.

However, the virus can be prevented by vaccination or through getting immune globulin medicine.

The medicine, officials say, includes antibodies from people who are immune to the virus and is effective if a person receives it within two weeks of exposure. If a person at the restaurant on Feb. 1, they would need to get medical help by Feb. 15.

The symptoms of Hepatitis A are fever, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, joint pain, clay-colored bowel movements or jaundiced skin.

The virus, which can cause people to be sick within two to seven weeks of exposure, can also be transmitted to other people up to two weeks before and a week after the symptoms happen, officials say.

The Clay County Health Unit in Piggott will have immune globulin and Hepatitis A vaccine medicine available for people, upon request with an appointment or after Feb. 15.

At least 4 to 5 people have been stricken by hepatitis A and over 3,000 have been forced to take blood tests, and/or a hepatitis A vaccine or immune globulin after dining at Bartaco in Port Chester New York.  My strong suspicion is that the owners of Bartaco wish they had employees who had been previously vaccinated against the potentially deadly virus.

Restaurant owners need to think hard about vaccinating employees given what is happening throughout the United States.

In the Detroit, Michigan area there have been 486 cases of hepatitis A, including 19 fatalities,  identified as related to an outbreak in Southeast Michigan, according to the Michigan Department of Health and Human Services.

In October, health officials said they were investigating cases at Firewater Bar and Grill and a Little Caesars Pizza location in Detroit and a restaurant worker in Ann Arbor. Cases last year were linked to Whole Foods in Detroit and Social Kitchen in Birmingham and recently at Champs Rotisserie and Spirits in Wayne County.

In San Diego, California, the county Health and Human Services Agency published new weekly totals, which add one to the number of deaths recorded since the health crisis started in November 2016. The running tally of confirmed cases also continues to increase, reaching 536 from a previous total of 516 – including 20 deaths. On September 15th the county notified the public that a worker at World Famous restaurant in Pacific Beach had tested positive.

And, thanks to the Huffington Post, you can see the problem in the whole country:

This is all preventable – especially, those caused by contact with a food service worker.

In 2006, health officials recommended routine hepatitis A vaccination for all children ages 12 to 23 months. They also recommended hepatitis A vaccinations be integrated into the routine childhood vaccination schedule, and that children not vaccinated by two years of age be vaccinated subsequently.

The vaccine is also recommended for the following people:

  • Travelers to areas with increased rates of hepatitis A;
  • Men who have sex with men;
  • Injecting and non-injecting drug users;
  • Persons with clotting factor disorders;
  • Persons with chronic liver disease;
  • Persons with occupational risk of infection;
  • Children living in regions of the U.S. with increased rates of hepatitis A; and
  • Household members and other close personal contacts.

The vaccine may also help protect household contacts of those persons infected with hepatitis A. Although generally not a legal requirement at this time, vaccination of food handlers would be expected to substantially diminish the incidence of hepatitis A outbreaks.

Although outbreaks continue to occur in the United States, no one should ever get infected if other preventive measures are taken. For example, food handlers must always wash their hands with soap and water after using the bathroom, changing a diaper, and certainly before preparing food. Food handlers should always wear gloves when handling or preparing ready-to-eat foods, although gloves are not a substitute for good hand washing. Ill food handlers should be excluded from work.

Hepatitis A is a communicable — or contagious — disease that often spreads from person to person. Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water.

Food-related outbreaks are usually associated with contamination of food during preparation by a HAV-infected food handler. Food handlers are generally not ill when they are at peak infectivity — which is when the highest levels of the virus are present in the stool of an infected individual — because that occurs two weeks before illness begins.

HAV is relatively stable and can survive for several hours on fingertips and hands. It can live up to two months on dry surfaces. The virus can be inactivated by heating to 185 degrees F (85°C) or higher for one minute, or disinfecting surfaces with a 1:100 dilution of sodium hypochlorite (household bleach) in tap water. Freezing does not kill the virus.

Also, it must be noted that HAV can still be spread via cooked food because the food can become contaminated after cooking.

So, for goodness sake, vaccinate against hepatitis A.

The Food and Drug Administration knows the names and locations of supermarkets and other retailers which sold Maradol papayas that are contaminated with Salmonella and that are the subject of a nationwide recall.

But the agency is suppressing public release of that list of retailers—even after a Freedom of Information Act request filed by the nonprofit Center for Science in the Public Interest.  Today the nonprofit nutrition and food safety watchdog group is appealing the government’s denial of its request.

“The typical consumer isn’t going to recognize the brand of papaya they buy or the farm it was grown on, but they know where they bought it,” said CSPI chief regulatory affairs counsel Sarah Sorscher.

The Salmonella outbreak linked to Maradol papayas imported from Mexico is ongoing.  To date, 200 people from 23 states have become infected with Salmonella.  65 patients have been hospitalized.  One has died.  CSPI filed its request for the list of retailers on August 17.  The FDA admitted this week it has 451 pages of documents that are responsive to CSPI’s request.  But it is withholding them, citing exemptions for “trade secret and confidential information” and others.  Consumers, the FDA said on its website, would have to ask retailers where the papayas came from.

“The typical consumer isn’t going to recognize the brand of papaya they buy or the farm it was grown on, but they know where they bought it,” said CSPI chief regulatory affairs counsel Sarah Sorscher.  “The FDA is supposed to be helping Americans avoid foodborne illness.  It could improve by consistently disclosing retailer names and locations, along with brand names, dates of sale, lot numbers, and other useful information when it communicates with the media or with the public about recalls.”

The FDA’s reluctance to disclose retailers who might have sold contaminated products is not new, but it is also not consistent.  In May, the FDA did disclose the names of retailers that sold tuna, imported from Indonesia, that tested positive for Hepatitis A.  The Consumer Federation of America, Pew Charitable Trusts, CSPI, and other health groups wrote to FDA Commissioner Scott Gottlieb in August, explaining why lists of retailers of recalled food are not exempt from disclosure under FOIA.

RELATED LINKS AND DOWNLOADS: 

Read CSPI’s appeal here

13909134_GLa Nica Products, Inc. is recalling 6,000 pounds of white cheese with the names “Quesos de la Costa,” “Queso Duro Blando,” and “Hard Soft Cheese.”

The cheese was sold in one pound opaque plastic bags with an expiration date of August 31, 2017.

According to the Food and Drug Administration, a sampling of the cheese by the Florida Department of Agriculture revealed listeria bacteria in the finished products.

No illnesses have been reported.

Consumers who purchased the cheese should return it to the store for a refund.

Listeria can cause symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. It can also sometimes cause serious and sometimes fatal infections in young children, frail or elderly people, and miscarriages and stillbirths among pregnant women.

ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., today pleaded guilty to a criminal misdemeanor charge alleging the shipment of contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of salmonellosis, or salmonella poisoning, the Department of Justice announced today.  Following its guilty plea, the company was sentenced to pay an $8 million criminal fine and forfeit an additional $3.2 million in assets.  The sentence represents the largest fine ever paid in a food safety case.  ConAgra Grocery Products LLC is based in Omaha, Nebraska, with a manufacturing facility in Sylvester, Georgia.

The company pleaded guilty pursuant to a plea agreement filed last year in federal district court in the Middle District of Georgia.  Senior U.S. District Court Judge W. Louis Sands accepted the company’s guilty plea and imposed the sentence proposed in the plea agreement.  In pleading guilty to violating the federal Food, Drug and Cosmetic Act, the company admitted that it introduced Peter Pan and private label peanut butter contaminated with salmonella into interstate commerce during the salmonellosis outbreak.

“This case demonstrates companies – both large and small – must be vigilant about food safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “We rely every day on food processors and handlers to meet the high standards required to keep our food free of harmful contamination.”

In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Peter Pan and private label peanut butter produced and shipped from the company’s Sylvester, Georgia, peanut butter plant.  The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004.  The CDC eventually identified more than 700 cases of salmonellosis linked to the outbreak with illness onset dates beginning in August 2006.  The CDC estimated that thousands of additional related cases went unreported.  The CDC did not identify any deaths related to the outbreak.

The criminal information specifically alleged that on or about Dec. 7, 2006, the company shipped from Georgia to Texas peanut butter that was adulterated, in that it contained salmonella and had been prepared under conditions whereby it may have become contaminated with salmonella.  The company admitted in the plea agreement that samples obtained after the recall showed that peanut butter made at the Sylvester plant on nine different dates between Aug. 4, 2006, and Jan. 29, 2007, was contaminated with salmonella.  Environmental testing conducted after the recall identified the same strain of salmonella in at least nine locations throughout the Sylvester plant.

“Consumers are at the mercy of food merchants when it comes to the wholesomeness and healthiness of the food we consume and, as the result, a great responsibility is imposed by law on those merchants and manufacturers,” said U.S. Attorney G. F. “Pete” Peterman III for the Middle District of Georgia.  “Likewise, agriculture is Georgia’s largest industry and peanuts and peanut products are a major factor in the health of that industry.  While ConAgra did take corrective action eventually, by failing to timely recognize and rectify the problem of salmonella contamination, this company damaged the health of both public consumers and of the agricultural industry overall.  I commend my staff, that of the Consumer Protection Branch of the Civil Division of the U.S. Department of Justice, and the investigators of the FDA, for the excellent work by all in bringing this incident to this conclusion and I hope that it will serve as a reminder to others in the industry of the high cost of failing to protect the public that relies on them to properly meet this responsibility.”

As part of the plea agreement, the company admitted that it had previously been aware of some risk of salmonella contamination in peanut butter.  On two dates in October 2004, routine testing at the Sylvester plant revealed what later was confirmed to be salmonella in samples of finished peanut butter.  Company employees attempting to locate the cause of the contamination identified several potential contributing factors, including an old peanut roaster that was not uniformly heating raw peanuts, a storm-damaged sugar silo, and a leaky roof that allowed moisture into the plant and airflow that could allow potential contaminants to move around the plant.  As stated in the plea agreement, while efforts to address some of these issues had occurred or were underway, the company did not fully correct these conditions until after the 2006 through 2007 outbreak.  In public statements after the 2007 recall, company officials hypothesized that moisture entered the production process and enabled the growth of salmonella present in the raw peanuts or peanut dust.

The company also admitted in the plea agreement that between October 2004 and February 2007, employees charged with analyzing finished product tests at the Sylvester plant failed to detect salmonella in the peanut butter, and that the company was unaware some of the employees did not know how to properly interpret the results of the tests.

“Product safety has to be a high priority for every manufacturer of foods sold in the United States” says Stephen M. Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at the FDA. “FDA is working with food producers to promote compliance with food safety requirements, but if problems occur and are willfully ignored, we will use all available resources to protect American consumers from unsafe food.”

Following the outbreak and shutdown, the company made significant upgrades to the Sylvester plant to address conditions the company identified after the 2004 incident as potential factors that could contribute to salmonella contamination.  The company also instituted new and enhanced safety protocols and procedures regarding manufacturing, testing and sanitation, which it affirmed in the plea agreement it would continue to follow.

The case was prosecuted by the U.S. Attorney’s Office of the Middle District of Georgia and the Civil Division’s Consumer Protection Branch.  This matter was investigated by the FDA’s Office of Criminal Investigations.