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.

As they say “down under” – “good on ya”

However, if history is a guide, please remain vigilant.

Date Vehicle Etiology Confirmed
Cases		 States/Provinces
July 1995 Lettuce (leafy green; red; romaine) E. coli O157:H7 74 1:MT
Sept. 1995 Lettuce (romaine) E. coli O157:H7 20 1:ID
Sept. 1995 Lettuce (iceberg) E. coli O157:H7 30 1:ME
Oct. 1995 Lettuce (iceberg; unconfirmed) E. coli O157:H7 11 1:OH
May-June 1996 Lettuce (mesclun; red leaf) E. coli O157:H7 61 3:CT, IL, NY
May 1998 Salad E. coli O157:H7 2 1:CA
Feb.-Mar. 1999 Lettuce (iceberg) E. coli O157:H7 72 1:NE
Oct. 1999 Salad E. coli O157:H7 92 3:OR, PA, OH
Oct. 2000 Lettuce E. coli O157:H7 6 1:IN
Nov. 2001 Lettuce E. coli O157:H7 20 1:TX
July-Aug. 2002 Lettuce (romaine) E. coli O157:H7 29 2:WA, ID
Nov. 2002 Lettuce E. coli O157:H7 13 1:Il
Dec. 2002 Lettuce E. coli O157:H7 3 1:MN
Oct. 2003-May 2004 Lettuce (mixed salad) E. coli O157:H7 57 1:CA
Apr. 2004 Spinach E. coli O157:H7 16 1:CA
Nov. 2004 Lettuce E. coli O157:H7 6 1:NJ
Sept. 2005 Lettuce (romaine) E. coli O157:H7 32 3:MN, WI, OR
Sept. 2006 Spinach (baby) E. coli O157:H7 and other serotypes 205 Multistate and Canada
Nov./Dec. 2006 Lettuce E. coli O157:H7 71 4:NY, NJ, PA, DE
Nov./Dec. 2006 Lettuce E. coli O157:H7 81 3:IA, MN, WI
July 2007 Lettuce E. coli O157:H7 26 1:AL
May 2008 Romaine E. coli O157:H7 9 1:WA
Oct. 2008 Lettuce E. coli O157:H7 59 Multistate and Canada
Nov. 2008 Lettuce E. coli O157:H7 130 Canada
Sept. 2009 Lettuce: Romaine or Iceberg E. coli O157:H7 29 Multistate
Sept. 2009 Lettuce E. coli O157:H7 10 Multistate
April 2010 Romaine E. coli O145 33 5:MI, NY, OH, PA, TN
Oct. 2011 Romaine E. coli O157:H7 60 Multistate
April 2012 Romaine E. coli O157:H7 28

1:CA

Canada
June 2012 Romaine E. coli O157:H7 52 Multistate
Sept. 2012 Romaine E. coli O157:H7 9 1:PA
Oct. 2012 Spinach and Spring Mix Blend E. coli O157:H7 33 Multistate
Apr. 2013 Leafy Greens E. coli O157:H7 14 Multistate
Aug. 2013 Leafy Greens E. coli O157:H7 15 1:PA
Oct. 2013 Ready-To-Eat Salads E. coli O157:H7 33 Multistate
Apr. 2014 Romaine E. coli O126 4 1:MN
Apr. 2015 Leafy Greens E. coli O145 7 3:MD, SC, VA
June 2016 Mesclun Mix E. coli O157:H7 11 3:IL, MI, WI
Nov. 2017 Leafy Greens E. coli O157:H7 67 Multistate and Canada
Mar. 2018 Romaine E. coli O157:H7 219 Multistate and Canada
De. 2018 Romaine E. coli O157:H7 91 Multistate and Canada

 

I am sure the idiom, “you sound like a broken record,” is a bit unfamiliar to those 40 and younger, but it means repeating yourself again and again and again.  So, here I go again – “Restaurant workers should be vaccinated to combat spread of hepatitis A.”  Some restaurants are getting the message – although, generally after an infectious episode.

This month the CDC reported that since March 2017, CDC’s Division of Viral Hepatitis (DVH) has been assisting multiple state and local health departments with hepatitis A outbreaks, spread through person-to-person contact.  Since the hepatitis A outbreaks were first identified in 2016, more than 17,000 cases reported and at least 170 deaths as a result of hepatitis A virus (HAV) infection have been reported.

Just in the last week three unvaccinated hepatitis A infected food service workers exposed hundreds to the virus.

Florida: The Florida Department of Health in Sarasota County said the employee, a part-time dishwasher at Duval’s seafood restaurant at 1435 Main St., may have exposed people who ate or drank at the restaurant between April 26 and May 10. Shortly after the employee tested positive for the virus, the restaurant had all of its staff members vaccinated for hepatitis A. The restaurant will make the vaccine mandatory for all new employees, Abrams said. DOH Sarasota is offering the hepatitis A vaccine for free at its Sarasota and North Port Immunization Clinics. The Sarasota office at 2200 Ringling Blvd. will be open Sunday from 9-11 a.m. to administer vaccines.

Maine: Health officials are recommending Hepatitis A vaccinations for some customers and workers at a Burger Boy restaurant in northern Maine.The Maine Center for Disease Control and Prevention says an employee at the Caribou restaurant had an acute case of the contagious liver disease while preparing food in late April and the first two weeks of May. Because the virus can spread through food or water, officials are recommending vaccination for anyone who ate or worked there between May 3 and May 13.

Massachusetts: Massachusetts health officials say a seafood restaurant worker has tested positive for hepatitis A and are warning customers they may have been exposed to the disease. The state Department of Public Health and local health officials are urging customers who ate cold or uncooked food at Roy Moore’s Fish Shack in Rockport between April 21 and May 12 to contact their health care providers and receive treatment for possible exposure to hepatitis A. A posting on the restaurant’s Facebook page on Saturday said the restaurant has temporarily closed for disinfecting and to ensure no other workers have the disease.

Vaccinating food service workers will not solve the entire hepatitis A problem — we need a nationwide focus on homelessness and drug use as well.

The CDC data show about 65 percent of the individuals sickened have been linked to drug use and/or homelessness. The remaining 35 percent have been Epi-Linked — people infected who are not drug users or homeless — or the cause of their infections is unknown.

People infected with Hepatitis A can pass the virus to others, as well as contaminate foods or beverages they handle, before they develop symptoms. Some infected people do not develop symptoms. These two facts make it even more important for foodservice workers and employees in the food industry to be vaccinated.

In 2000, I said this:

“In the last six months Hepatitis A exposures have been linked to two Seattle-area Subways, a Carl’s Jr. in Spokane, WA, Hoggsbreath, a Minnesota restaurant, and three restaurants in Northwest Arkansas, IHOP, U.S. Pizza, and Belvedeers. Restaurants and food manufacturers must take action and voluntarily vaccinate all of their employees.”

Since then — especially recently — hardly a day goes by that the press does not report another food service worker possibly exposing thousands of patrons to HAV. Yet, neither the CDC nor any restaurant association has recommended HAV vaccination for such workers — until after the exposure. This is not an acceptable public health response.

What is Hepatitis A?

Hepatitis A is one of the five hepatitis viruses that are known to cause inflammation of the liver. The Centers for Disease Control and Prevention estimates that 150,000 people in the U.S. are infected each year by hepatitis. The illness is characterized by sudden onset of fever, malaise, nausea, anorexia, and abdominal pain, followed by jaundice. The incubation period for Hepatitis A, which varies from 10 to 50 days, is dependent upon the number of infectious particles consumed.

Where does Hepatitis A come from?

Hepatitis A spreads from the feces of infected people and can produce disease when individuals consume contaminated water or foods. Cold cuts, sandwiches, fruits, fruit juices, milk, milk products, vegetables, salads, shellfish, and iced drinks are also implicated in outbreaks. Water, shellfish, and salads are common sources. Contamination of foods by infected workers in food processing plants and restaurants is increasingly common.

How can a Hepatitis A infection be prevented?

  • Get vaccinated.
  • If exposed, the illness can be prevented by a shot of immune globulin or Hep A vaccine within two weeks of exposure.
  • Wash hands thoroughly with soap and warm water after using the bathroom; changing diapers; and before preparing, serving or eating food.
  • Clean and disinfect bathrooms and diaper-changing surfaces frequently.
  • Never change diapers on eating or food preparation surfaces.
  • Cook shellfish thoroughly before eating it.
  • Drink water only from approved sources.

Vienna Beef Ltd., a Chicago, Ill. establishment, is recalling approximately 2,030 pounds of beef frank links 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 beef frank links items were produced on May 2, 2019. The following products are subject to recall:

  • 10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 8’s 10#” with case code 013180 and package code 9122 represented on the label.
  • 10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 11’s 10#” with case code 013312 and package code 9122 or 9123 represented on the label.
  • 10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 7” 9’s 10#” with case code 013490 and package code 9122 or 9123 represented on the label.

The products subject to recall bear establishment number “EST. 1” inside the USDA mark of inspection. These items were shipped to food service locations in Illinois, Indiana, and Wisconsin.

The problem was discovered by the establishment and reported to FSIS.

The United States Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a multistate outbreak of Salmonella Concord illnesses linked to “Karawan Tahini and Halva” brand tahini imported from Israel.

The FDA has been working with the state of New York and New York City. The New York City Department of Health and Mental Hygiene tested samples of Karawan tahini and found that the product contained Salmonella.

Total Illnesses: 4
Hospitalizations: 1
Deaths: 0
Last illness onset: March 23, 2019
States with Cases: New York (2), Massachusetts (1), Texas (1)

Based on the positive product sample, the available epidemiological data, and traceback data from the investigation, the FDA has requested that the product be voluntarily recalled. Discussions with the U.S. agent for the firm, as well as foreign public health partners are ongoing and additional information will be provided as it becomes available.

The label of the product that tested positive for Salmonella identified Brodt Zenatti Holdings, LLC, of Jupiter, Fla., as the importer of that specific tahini, however, other importers may have also imported “Karawan Tahini and Halva” branded tahini. The investigation is ongoing, but at this time the current outbreak does not appear to be related to the previous 2018-2019 outbreak of Salmonella Concord linked to tahini.

The tahini of concern may be labelled as either “Karawan Tahini” or as “El Karawan Tahini.”  Consumers should avoid eating this tahini. This tahini was sold in bulk to retailers and restaurants and was also available to consumers at retail locations and online. It may have also been used in other food products sold to consumers. Consumers should be aware that this product has a shelf life of two years and should check their homes for tahini with either label. Consumers with this tahini in their home should not eat it and should discard it. Consumers with concerns about tahini consumed outside the home should ask their restaurant or retailer if the product they have purchased contains this tahini. Retailers and restaurants should throw the product out and sanitize any surfaces that may have come in contact with this tahini.

Tahini is made from sesame seeds and can be served on its own or used as an ingredient in Mediterranean and Middle Eastern style dishes, such as hummus, falafel, and baba ganoush.

The definitive article on the devastating 2017-2018 Listeria Outbreak linked to Tiger Brand Polony dropped into my inbox by Anthony M. Smith, Nomsa P. Tau, Shannon L. Smouse, Mushal Allam, Arshad Ismail, Ntsieni R. Ramalwa, Bolele Disenyeng, Mimmy Ngomane, and Juno Thomas – Foodborne Pathogens and Disease – http://doi.org/10.1089/fpd.2018.2586

In South Africa, a progressive increase in listeriosis cases was noted from mid-June 2017, heralding what was to become the world’s largest listeriosis outbreak. A total of 1060 cases were reported for the period January 1, 2017 to July 17, 2018. We describe laboratory activities, experiences, and results of whole-genome sequencing (WGS) analysis of Listeria monocytogenes isolates associated with this outbreak. Bacteria were identified using the VITEK-2 COMPACT 15 microbial identification system. WGS was performed using Illumina MiSeq technology. WGS data were analyzed using CLC Genomics Workbench Software and free-to-use on-line analysis tools/pipelines. Multilocus sequence typing (MLST) showed that 91% of clinical isolates were sequence type 6 (ST6), determining that the outbreak was largely associated with L. monocytogenes ST6. Epidemiological and laboratory findings led to investigation of a large ready-to-eat processed meat production facility in South Africa, named Enterprise Foods. L. monocytogenes ST6 was found in environmental sampling swabs of the production facility and in ready-to-eat processed meat products (including polony, a product similar to bologna sausage) manufactured at the facility. ST6 isolates, sourced at the Enterprise Foods [Tiger Brands] production facility and from Enterprise food products, were shown by single nucleotide polymorphism (SNP) analysis to be highly related to clinical isolates; these nonclinical ST6 isolates showed <10 SNP differences when compared to clinical ST6 isolates. Core-genome MLST showed that clinical ST6 isolates and Enterprise-related ST6 isolates had no more than 4 allele differences between each other, suggestive of a high probability of epidemiological relatedness. WGS data interpreted together with epidemiological data concluded that the source of the listeriosis outbreak was ready-to-eat processed meat products manufactured by Enterprise Foods. Listeriosis has now been added to the South African list of mandatory notifiable medical conditions. Surveillance systems have been strengthened to facilitate prevention and early detection of listeriosis outbreaks.

Full Article