Here is a great way to step on the National Doughnut Day message.

Health officials in New Jersey’s Gloucester County are warning Dunkin’ Donuts customers about possible Hepatitis A exposure and urging people to get vaccinated.

A worker at the Dunkin’ Donuts at 460 Hurffville-Crosskeys Rd. in Turnersville tested positive for the communicable liver disease, the Gloucester County Department of Health said Friday, which coincides with National Doughnut Day.

“This individual worked while they were potentially infectious between May 18 through June 1,” the GCDOH said in a news release.

County health officials said the risk to anyone who ate or drank beverages at the store during the contamination period is low, but they are recommending “post-exposure prophylaxis,” or PEP, for unvaccinated people.

Hepatitis A:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Hepatitis A outbreaks. The Hepatitis A lawyers of Marler Clark have represented thousands of victims of Hepatitis A and other foodborne illness outbreaks and have recovered over $650 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Hepatitis A lawyers have litigated Hepatitis A cases stemming from outbreaks traced to a variety of sources, such as green onions, lettuce and restaurant food.  The law firm has brought Hepatitis A lawsuits against such companies as Costco, Subway, McDonald’s, Red Robin, Chipotle, Quiznos and Carl’s Jr.  We proudly represented the family of Donald Rockwell, who died after consuming hepatitis A tainted food and Richard Miller, who required a liver transplant after eating food at a Chi-Chi’s restaurant.

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

Today is World Food Safety day.

I got this email from Jeff Benedict, author of “Poisoned,” this AM after he gave a speech to a food service business yesterday – I cut out the names to protect the “innocent.”

…was a great experience in Chicago.  I spoke to 400 or 500 attendees at the __________ Foodservice conference.  The cover of POISONED was on two giant screens throughout my remarks.  Lots of people were walking around the hotel with the book in hand.  I talked for an hour about the experience of writing the book.  Shared some great stories about working with you.  The __________ of the company said some nice things about you.  And ___________ relayed a very nice compliment about you from __________.  ___________ told __________ that you have “great integrity” and that you are unlike other plaintiffs attorneys in the sense that you are in it because you care as opposed to being in it for the money. 

One of my best lawyers lives in Kentucky.  He makes Marler Clark within a few hours flight of anyone in the United Sates.  But, what is happening in his home state makes me worry about him and his family.  According to the Kentucky Department of Health, Kentucky’s latest death from hepatitis A reported this week by the state health department raised the toll to 58 in the nation’s largest outbreak of the contagious liver virus.  This is in addition to 4,682 ill and 2,262 hospitalized.

The vaccine-preventable disease, spread mostly among drug users, has sickened 4,682 Kentuckians since the outbreak was declared in November 2017. Spread most likely person-to-person, the virus has hospitalized 48% of its victims and has hit 90% of Kentucky’s 120 counties, with 10 counties reporting new cases in the week ending May 25.

And, then there is the rest of the USA:

Kentucky certainly has been hit hard, but the numbers of unnecessarily ill and dead in the USA are shocking.  Here are the current statistics from the CDC:

Drug use – mostly likely opioids – and homelessness – both issues that morally we need to deal and which we are failing at – have been the main driver of the spread of hepatitis A amount unvaccinated people..

However, in addition, a full 1/3 of the cases are attributable to neither drugs nor homelessness (can I remind you again of the nearly daily announcement of an ill restaurant (unvaccinated) worker exposing customers?).  At this point restaurants that are not offering hepatitis A vaccination to employees are treading in the punitive damages area.  I shall see you in court.

Summary

Public Health investigated an outbreak of Shiga toxin-producing E. coli (STEC) associated with I Love Sushi and Café Mario at Nintendo of America campus in Redmond. Café Mario is operated by Sodexo and is not open to the public. I Love Sushi is a food establishment that operates out of Café Mario once a week.

This outbreak appears to be over. After a thorough investigation, we do not have enough evidence to connect I Love Sushi to this outbreak.. No single food item prepared by Café Mario has been identified as the source of the illnesses. Everyone who reported illness has recovered.

Illnesses

Since July 2, 2018, we have learned of 22 people in WA (20 in King County and 2 in Snohomish County) who developed symptoms consistent with an STEC illness, including diarrhea (bloody or non-bloody) and abdominal cramps. All 22 of these ill people are adults who work at the Nintendo of America campus in Redmond. Illness onsets occurred during June 11-July 5, 2018.

The 22 people who got sick all ate food from Café Mario on multiple days before becoming ill. Only four people who got sick also ate at I Love Sushi.

We learned of two additional people from King County who tested positive for E. coli infections with the same bacterial strain as the cases associated with Café Mario. However, these two people had no known connection to Café Mario or Nintendo, and we could not identify any other potential sources of exposure in common with any of the other people who got sick. We are not including these two people in the overall case count of this outbreak.

Public Health actions

On July 3, 2018, Environmental Health investigators visited Café Mario. Inspections were completed for both Café Mario and I Love Sushi.

At Café Mario, investigators identified possible risk factors for cross contamination and spread of bacteria, including improper hand washing practices and improper cold holding temperatures of food; corrective actions were addressed with Café Mario’s management. At I Love Sushi, possible risk factors were also identified and discussed, including improper temperature storage of foods. Both restaurants were not open on the July 4 holiday.

On July 5, 2018, investigators closed Café Mario and the onsite I Love Sushi food services. Investigators revisited both food establishments on July 11, 2018, and both were allowed to reopen the same day. Café Mario and I Love Sushi both completed a thorough cleaning and disinfection of their facilities before reopening, and any remaining processed ready-to-eat food products were discarded.

We did not identify any employees of either restaurant who had a recent diarrheal illness. Investigators also reviewed with management of both food establishments the Washington State Retail Food Code requirement that staff are not allowed to work while having vomiting or diarrhea.

Laboratory testing

Four of the 22 people who got sick tested positive for STEC O26 with the same genetic fingerprint, suggesting that they have a common source of infection. The remaining people who got sick were not tested for STEC, but their symptoms are suggestive of STEC.

Environmental swabs were collected from both I Love Sushi and Café Mario for laboratory testing and all came back negative for STEC at the Washington State Public Health Laboratory.

As of May 30, 2019, 27 people infected with the outbreak strain of Salmonella Typhimurium have been reported from 17 states.

Illnesses started on dates from October 22, 2018 to April 8, 2019. Ill people range in age from 2 to 95 years, with a median age of 14 years. Fifty-five percent are female. Of 17 people with information available, 2 (12%) have been hospitalized. No deaths have been reported.

In interviews, ill people answered questions about animal contact in the week before they became ill. Of 20 people interviewed, 18 (90%) reported contact with hedgehogs before becoming ill. Ill people reported buying hedgehogs from various sources, including pet stores, breeders, or online.

The outbreak strain of Salmonella Typhimurium was identified in samples collected from 10 hedgehogs in Minnesota, including 5 hedgehogs from the homes of five ill patients. A common source of hedgehogs has not been identified.

Regardless of where hedgehogs are purchased, these animals can carry Salmonella germs that can make people sick. Hedgehog owners should always follow steps to stay healthy around their pet.

May 6, 2019

Warning Letter 575444

VIA UPS

Luconda M. Dager, President
Velvet Ice Cream Company, Inc.
11324 Mount Vernon Road
Utica, OH 43080

Dear Ms. Dager:

The United States Food & Drug Administration (FDA) inspected your Ready-to-Eat (RTE) ice cream manufacturing facility, located at 11324 Mount Vernon Road, Utica, Ohio from January 23 to February 14, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2018 inspection. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the ice cream manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.

In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.

FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).

Nine environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in three swabs within your facility. Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples identified twenty-one isolates representing six different strains of L. monocytogenes. The same strain of L. monocytogenes was identified in seven isolates from environmental samples collected during the 2019 inspection and eight isolates collected during the 2018 inspection. We advised you of those WGS results via a conference call on February 27, 2019. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in your facility since 2018. Additionally, that strain of L. monocytogenes was genetically identical to one clinical isolate collected in 2018, which indicates this strain has the capability of causing human illness.

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

Furthermore, from (b)(4) through (b)(4), you performed (b)(4) environmental monitoring for Listeria spp. During the referenced time period, your facility found Listeriaspp. in your environment seven times on surfaces adjacent to Zone 1 locations and other non-food contact surface locations within your processing environment including areas within your RTE room. Review of your records finds that your written corrective action procedures were followed each time a positive swab was found in your facility; however, these repeated findings of Listeria in your environment are further evidence that additional measures may be needed in your facility to address Listeria.

We acknowledge you have committed to performing corrective actions in written responses which we received on February 7, February 27, March 16, and April 24, 2019. In your written responses, you indicate that you have conducted a root cause analysis to identify the source of our findings, cleaned and sanitized your production environment, conducted environmental swabbing to verify the effectiveness of your cleaning, and completed other activities to address the problems. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure the foodborne pathogen does not contaminate your RTE food products. We will verify the effectiveness of your corrective actions during our next inspection.

Current Good Manufacturing Practice (Subpart B):

1. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination, as required by 21 CFR 117.35(e). Specifically, on January 30, 2019, our investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day.

Your corrective action indicates that you will lower the water pressure and retrain your employees on the use of water and clean up procedures. We will verify the adequacy of this corrective action during our next inspection.

2. Your plant was not constructed and designed to facilitate maintenance and sanitary operations, as required by 21 CFR 117.20(b). Specifically, the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria.

Your corrective actions indicate that you have re-sloped your floor to address the observations of pooling water. We will verify the adequacy of this corrective action during our next inspection.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.

If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, 6751 Steger Drive, Cincinnati, OH. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700, extension 2163 or Stephen.rabe@fda.hhs.gov.

Sincerely,
/S/

Steven B. Barber
Director, Division 5
Office of Human and Animal Foods Operations East

As of May 24, 2019, 17 people infected with the outbreak strain of E. coli O26 have been reported from 8 states.

Illnesses started on dates ranging from December 11, 2018 to April 18, 2019. Ill people range in age from 7 to 86 years, with a median age of 23. Sixty-five percent of ill people are female. Of 17 people with information available, 3 have been hospitalized. No deaths have been reported

Illnesses might not yet be reported due to the time it takes between when a person becomes ill with E. coli and when the illness is reported. This takes an average of two to three weeks.

Epidemiologic and laboratory evidence indicates that flour is a likely source of this outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Of seven people who were interviewed, four (57%) reported eating, licking, or tasting raw, homemade dough or batter. Two people with detailed information reported eating raw dough or batter made with flour or baking mixes from ALDI.

Investigators with the Rhode Island Department of Health collected records and flour samples at a bakery where an ill person reported eating raw dough. Records indicated that the bakery used Baker’s Corner All Purpose Flour from ALDI. The outbreak strain was isolated from an unopened bag of Baker’s Corner All Purpose Flour collected at the bakery.

WGS results showed that the E. coli O26 strain identified in the Baker’s Corner All Purpose Flour sample was closely related genetically to the E. coli O26 strain identified in ill people. These results provide additional evidence that people in this outbreak got sick from eating flour.

On May 23, 2019, ALDI, in association with ADM Milling Co., recalled 5 lb. bags of Baker’s Corner All Purpose Flour sold at retail locations in the following states because they may be contaminated with E. coli: Connecticut, Delaware, Massachussetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, and West Virginia.

This investigation is ongoing. FDA is working to determine whether other brands or lots of flour may be potentially contaminated and need to be recalled.

In the Spring of 2017, the CDC reported that thirty-two people infected with the outbreak strains of E. coli O157:H7 were reported from 12 states – Arizona 4, California 5, Florida 2, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 11, Virginia 2, Washington 2 and Wisconsin 1.

Twelve people were hospitalized. Nine people developed hemolytic uremic syndrome, a type of kidney failure. No deaths were reported.

Twenty-six (81%) of the 32-ill people in this outbreak were younger than 18 years.

Epidemiologic, laboratory, and traceback evidence indicated that I.M. Healthy brand SoyNut Butter manufactured by Dixie Dew was the likely source of this outbreak.

Kim Kardashian West blew up Twitter yesterday with her tweet below to Jack in the Box.

I do not know if it was food borne illness related. It seems, however, whatever the issue was, it appears too have been resolved to Ms. Kardashian West’s satisfaction.

Ms. Kardashian West, if you want a long version of why Jack in the Box is now considered a leader in food safety, please read “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat.”

If you want the shorter version, read here:

On January 13, 1993, the Washington Department of Health (WDOH) was notified that a cluster of children suffering hemolytic uremic syndrome (HUS) secondary to E. coli infection was being treated in a Seattle-area hospital and that there had been an increase in emergency room visits from patients with bloody diarrhea. In response to the apparent outbreak, WDOH began interviewing case-patients for an epidemiologic investigation and learned that nearly all patients had consumed hamburgers purchased from Jack in the Box restaurants in the days before becoming ill.

The WDOH E. coli outbreak investigation led to the discovery that regular-sized hamburger patties and “jumbo” hamburger patties produced by Von Companies of California and sold by Jack in the Box were the source of the E. coli outbreak. The outbreak strain of E. coli O157:H7 was isolated from 11 lots of patties produced on November 29 and 30, 1992, and Jack in the Box issued a recall of all ground beef produced on that day that was still in restaurants. About 20 percent of the implicated ground beef was recovered through the recall.

Since the ground beef identified as the source of the outbreak had been distributed to Jack in the Box restaurants in Washington, Idaho, California, and Nevada, all states investigated cases of bloody diarrhea that had been reported since November 15, 1992 to determine whether patients had eaten hamburgers from Jack in the Box in the days before becoming ill. By the end of February 1993, the states had reported the following:

  • Washington reported 602 patients with bloody diarrhea or HUS. 477 Washingtonians were culture-confirmed with E. coli infections, with illness onset peaking between January 17 and January 20, 1993. 144 people were hospitalized; 30 developed HUS, and three died.
  • Idaho reported 14 culture-confirmed E. coli O157:H7 cases with illness onset dates between December 11, 1992 and February 16, 1993. Four people were hospitalized; one developed HUS
  • California reported six culture-confirmed cases, with 34 patients meeting the outbreak-case definition with illness onset dates between November 15 1992 and January 31, 1993. Fourteen people were hospitalized; seven developed HUS, and one child died.
  • Nevada reported only one culture-confirmed case, with 58 other patients meeting the outbreak-case definition with illness onset dates between December 1, 1992 and February 7, 1993. Nine people were hospitalized; three developed HUS.

Seventy-three Jack in the Box restaurants were ultimately identified as part of the outbreak and recall. A trace-back was conducted, and five slaughter plants in the United States and one in Canada were identified as the likely sources of beef used by Von Corporation in the production of the hamburger patties sold to Jack in the Box. No one slaughter plant or farm was ever identified as the source.

Over the course of the outbreak investigation and the litigation that followed, documents from Foodmaker, the San Diego-based parent company of Jack in the Box, revealed that the company had been warned by local health departments and by their own employees that they were undercooking their hamburgers prior to the outbreak, but the company had decided that cooking beef to 155 degrees, the standard set by WDOH, made the meat too tough.

Jack in the Box reported that in the 18 months following the outbreak the company lost approximately $160 million. It faced hundreds of lawsuits from ill customers, and stockholders filed suit against the company for court costs and lost sales due to adverse publicity. President Clinton called congressional hearings regarding the safety of the food supply and the Secretary of Agriculture testified before the Washington State legislature. FDA raised the recommended internal temperature of cooked hamburgers to 155 degrees Fahrenheit and FSIS also declared E. coli O157:H7 an adulterant in raw ground beef.

Lawyers now at Marler Clark handled most of the litigation, which resulted in individual and class-action settlements totaling more than $50 million – the largest payments ever involving food-borne illness. The most severely injured victims of the outbreak were mostly younger children, including four who died. William Marler represented a nine-year-old Seattle girl who recovered after suffering kidney failure and other complications, including being in a coma for 42 days, and won a $15.6 million settlement from the company.

The Wisconsin Department of Health Services, Wisconsin Department of Agriculture, Trade and Consumer Protection, Minnesota Department of Health, and Wisconsin local health departments are working with the Food and Drug Administration and Centers for Disease Control and Prevention to investigate an ongoing multi-state outbreak of salmonellosis linked to consumption of certain Del Monte vegetable trays. To date, all ill patients associated with this outbreak, three in Wisconsin and one in Minnesota, have reported consuming a Del Monte vegetable tray purchased from a Wisconsin or Minnesota Kwik Trip location prior to their illness.  Kwik Trip is cooperating with regulatory officials and has removed all Del Monte vegetable trays from their stores. These patients reported becoming ill between April 13 and April 27, 2019. It is possible additional illnesses will be reported due to the delay from when a person becomes ill to when it is reported to public health agencies.

The Del Monte vegetable trays associated with the investigation contain broccoli, cauliflower, carrots, and dill dip. Del Monte vegetable trays may also have been distributed to other retailers in Wisconsin. Investigation for product distribution is ongoing. Consumers are advised to not eat the following products:

Del Monte Vegetable Tray (containing broccoli, cauliflower, carrots, and dill dip) 6 oz.
Del Monte Vegetable Tray (containing broccoli, cauliflower, carrots, and dill dip) 12 oz.

Del Monte Vegetable Trays, where have I heard that before:

As of September 5, 2018, 250 people were infected with Cyclospora reported from 4 states.

Illnesses started on dates ranging from May 14, 2018 to June 20, 2018. Ill people ranged in age from 13–79 years with a median age of 45. Among ill people, 52% were female. Eight people (3%) were hospitalized. No deaths were reported.

Epidemiologic evidence indicated that pre-packaged Del Monte Fresh Produce vegetable trays containing broccoli, cauliflower, carrots, and dill dip were the likely source of these infections.

In interviews, ill people answered questions about the foods they ate in the 2 weeks before they became ill. Ill people reported eating pre-packaged Del Monte Fresh Produce vegetable trays containing broccoli, cauliflower, carrots, and dill dip. Ill people reported buying pre-packaged Del Monte Fresh Produce vegetable trays containing broccoli, cauliflower, carrots, and dill dip in the Midwest. Most people reported buying the trays at Kwik Trip convenience stores

On June 15, 2018, Del Monte Fresh Produce recalled 6 oz., 12 oz., and 28 oz. pre-packaged vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip. Recalled products were sold in clear, plastic clamshell containers.