This Week in Mislabeled Products for Week Ending July 20, 2019

Breaded Chicken Labeled as Unbreaded Creates Allergen Issue - Koch Foods, a Fairfield, Ohio establishment, is recalling approximately 743 pounds of fully cooked boneless chicken bites due to misbranding and undeclared allergens, the products contain soy, milk, and eggs, known allergens, which are not declared on the product label.  The problem was discovered when the firm received a customer complaint reporting that the product was incorrectly labeled.  The 'frozen, fully cooked breaded boneless chicken bites' were labeled as 'fully cooked chicken strips' (unbreaded) and were produced on May 31, 2019

Fish Cakes Have Undeclared Allergens - Wismettac Asian Foods, Inc., Santa Fe Springs, CA is issuing a voluntary recall for eight (8) types of Shirakiku brand imported fish cake products because of the possible contamination of some allergens (Milk, Egg and Crustacean shellfish).  The recall was discovered through testing conducted by the Canadian Food Inspection Agency discovered the presence of the listed allergens that were not listed on the product label. The manufacturer in Kagoshima, Japan has been made aware of the issue and is conducting an investigation to determine the cause of the issue so corrections can be implemented.

Missing Wheat in Marinade - Fieldsource Food Systems, Inc., a Brea, Calif. establishment, is recalling approximately 12,953 pounds of diced beef and chicken products due to misbranding and undeclared allergens - the products contain wheat, an allergen, which is not declared on the product label.  The problem was discovered during routine label verifications being performed by FSIS.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-075-2019-release
Koch Foods Recalls Breaded Poultry Products Due to Misbranding and Undeclared Allergens 
Class I
Recall  075-2019 
Health Risk: High 
Jul 18, 2019

CDC Report - 2017 Norovirus Outbreak Highlights the Need for Facility Controls

In CDC MMWR, a report discusses an outbreak of Norovirus that occurred at an Nebraska Event Center in 2017.  This outbreak continued for over two weeks with 159 people suffering from norovirus infection (three confirmed and 156 probable).  In the period of  the outbreak, October 27–November 18, 2017, nine events were held at the facility.  Two issues were cited...improper decontamination of facilities after the onsite of initial illness at the facility and then allowing people to come back to work too soon after being ill.

"The investigation revealed a public vomiting episode at the facility on October 27 and at least one employee involved with preparing and serving food who returned to work <24 hours after symptom resolution, suggesting that a combination of contaminated environmental surfaces and infected food handlers likely sustained the outbreak."

Norovirus is an issue in these settings when someone has become ill because:

1. The virus is highly contagious, requiring only a small amount of virus to be present in order to cause illness (infectious dose capable of causing infection with as few as 18–2,800 virus particles) 
2. Infected people shed a large numbers of virus particles, even those with asymptomatic infections. 
3. Norovirus is resistant to many common commercial disinfectants and is able to persist on environmental surfaces for up to 2 weeks or longer.

Strict controls are needed when someone onsite becomes ill.  The area must be completely disinfected and anyone exposed must be excluded from the workplace.

CDC MMWR
https://www.cdc.gov/mmwr/volumes/68/wr/mm6828a2.htm
Successive Norovirus Outbreaks at an Event Center — Nebraska, October–November, 2017
Weekly / July 19, 2019 / 68(28);627–630
Rebecca J. Free, MD1,2; Bryan F. Buss, DVM2,3; Samir Koirala, MBBS2; Monica Ulses4; Anna Carlson, PhD2; Brianna Loeck, MPH2; Tom Safranek, MD2 (View author affiliations)

FDA Issues Warning Letter To Candy Company - Allergen Control Issues and GMPs

FDA issued a Warning Letter to a chocolate company highlighting allergen control and other GMP issues.   This recall highlights the concern when a supplier has not controlled allergens in their product, and even states that, but the processor uses that ingredient anyway.  We are seeing this more often, when a supplier puts a precautionary statement on the ingredient which is purchased....then that issue becomes the purchasing company's issue.
Internally, the company's allergen control program was not implemented properly.

The inspection was started after an allergen complaint where someone reacted to a milk allergen in dark chocolate.

"The inspection was initiated in response to a consumer complaint regarding an allergic reaction and subsequent sampling conducted by FDA, which revealed elevated levels of milk protein in your Ultra Dark Chocolate Amaretto Rainier cherries"

This issue was primarily due to a supplier issue where milk was present in the dark chocolate where the purchasing company did not have milk listed.

"Although milk is not used as an ingredient in your dark chocolate covered nut and fruit products.   FDA found elevated levels of milk protein in these products.  Further, FDA found elevated levels of milk protein in the chocolate ingredients you use to produce your dark chocolate covered nut and fruit products.  These chocolate ingredients do not include milk as an ingredient.  Subsequently, you conducted voluntary recalls for the finished product lots associated with the FDA samples."

First, the company did not recognize this supply issue in the hazard analysis, even though the supplier stated it could be an issue.

"Your hazard analysis did not identify the unintentional presence of milk allergens as a hazard requiring a supply-chain applied control in the bittersweet, (b)(4) chocolate you obtain".....The need to consider milk allergens as a hazard requiring a supply-chain-applied control was highlighted by your supplier’s allergen policy indicating the possible presence of undeclared milk allergens.  Specifically, your supplier’s policy states that “dark items that do not have milk intentionally added as an ingredient may contain milk from cross contact due to processing on shared equipment.”

Once the company became aware of the issue, they did not revise their Preventive Control Plan.

"You became aware of new information when you received a consumer complaint regarding an allergic reaction to your Ultra Dark Chocolate Amaretto Rainiers (Best By 09/2019) and subsequent test results from a third-party laboratory and FDA.  Specifically, you received results from the third-party laboratory indicating the presence of milk protein in the finished product and raw ingredients on September 14, 2018, and September 19, 2018.  Subsequently, you received finished product sample results from FDA indicating the presence of milk protein at levels as high as 7000 ppm in your covered nut and fruit products.  You also received FDA test results of the chocolate that you obtained from your supplier indicating milk protein levels as high as 4300 ppm.  However, after receiving these results, you did not conduct a reanalysis of your food safety plan dated September 12, 2018, to consider whether food allergens are a hazard requiring a supply-chain-applied control."

And they did not determine what activities needed to be in the Supply Chain Preventive Control.

"You did not determine and conduct appropriate supplier verification activities,"

The company had internal issues as well:
4.  The company stated they would put a schedule run process in place to run products with specific allergens, but did not follow this run schdule.

"You did not implement a preventive control, as required by 21 CFR 117.135(a).  Specifically, your food safety plan dated September 12, 2018, contains the preventive control of “run order of allergenic materials” for the food safety hazard of “food allergens from other products."

5. Mishandling of rework that leads to cross contact
6. Did not conduct visual inspection for allergen control

"our investigators observed apparent chocolate powder and residue on the outside and inside of the air vents for pan #(b)(4) and #(b)(4).  These vents are used to blow air over all varieties of chocolates including milk, tree nut, and non-milk, non-tree nut products, which could cause cross contact of milk and tree nuts in products that do not contain milk and tree nut ingredients during the (b)(4) process.  ​​​​​​​And  b.    On November 7, 2018, our investigators observed apparent chocolate residue on the pouch machine within approximately three inches of open pouches of a non-chocolate product....", 

7. Did not document the monitoring of  allergen control cleaning processes

"..your food safety plan identified environmental monitoring as a verification activity for your sanitation preventive controls.  However, you did not implement an environmental monitoring program."  

8. Did not "verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."

9. Employees were not washing hands
10. No backflow prevention devices.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chukar-cherry-company-inc-573446-06272019
Chukar Cherry Company Inc. 
MARCS-CMS 573446 — Jun 27, 2019

Bison Ground Meat Recalled After Linked to Pathogenic E. coli Outbreak

Northfork Bison Distributions Inc., a Quebec Canada based company, is recalling its ground bison, referred to as Bison Ground, and its ground bison patties, referred to as Bison Burgers and/or Buffalo Burgers, produced between February 22 and April 30, 2019 due to potential linkage to an foodborne illness outbreak of E. coli O103.  This outbreak has affected 21 people with 8 hospitalizations.

The bison meat is under FDA, not USDA jurisdiction.*

If frozen patties, there is always the concern for under cooking, especially when people do not use a thermometer to verify the product is properly cooked (160F internal temp).

Interesting, the cooking instructions do not specifically say that the meat has to be cooked to 160F...unless I missed it.  Cooking temperatures are listed on the website, but going through the blog, there is certainly a miss for cooking (https://www.northforkbison.com/best-bison-burger-tips) as well as their video (https://www.youtube.com/watch?v=TjzZOgXyAw0) which when you add foie gras, the temperature should technically be 165F.

*  From USDA website

How is bison inspected?
Bison may be inspected under voluntary federal inspection or FDA equivalent inspection. FDA equivalent inspection includes state inspection. Under voluntary federal inspection by USDA's Food Safety and Inspection Service (FSIS), businesses pay an hourly rate for inspection services. Voluntary inspection is handled under the Agriculture Marketing Act, which gives the Secretary of Agriculture the authority to take whatever steps are necessary to make the product marketable.
Federal inspection is done on a carcass-by-carcass basis by FSIS. The FSIS inspector must have knowledge about that particular species and the carcass must fit available equipment in the plant. Each bison and its internal organs are inspected for signs of disease. The triangle shaped "U.S. Inspected and Passed" seal ensures the bison is wholesome and free from disease. Note: Some states require all exotic animals be inspected in order to be sold in commerce.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-linked-ground-bison-northfork-bison-distributions-july-2019
Outbreak Investigation of E. coli Linked to Ground Bison from Northfork Bison Distributions, July 2019
Consumers should avoid recalled Northfork Bison Distributions, Inc. ground bison and bison patties/burgers imported from Canada

Case Counts
Total Illnesses: 21
Hospitalizations: 8
Deaths: 0
Last illness onset: June 18, 2019
States with Cases: CT, FL, MI, MO, NJ, NY, PA

Hummus Recalled by TX Establishment After FDA Finds Listeria in Production Facility

Pita Pal Foods, LP of Houston, TX is recalling certain hummus products made between May 30, 2019 and June 25, 2019, after FDA identified Listeria in the manufacturing facility (not in finished product) during an FDA inspection.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pita-pal-foods-lp-recalls-various-hummus-and-dips-due-possible-health-risk
Pita Pal Foods, LP Recalls Various Hummus and Dips Due to Possible Health Risk
Summary
Company Announcement Date: July 15, 2019
FDA Publish Date: July 16, 2019
Product Type:Food & Beverages
Reason for Announcement:  Due to potential Listeria monocytogenes
Company Name: Pita Pal Foods, LP
Brand Name:  Bucee’s, Fresh Thyme, Harris Teeter, other
Product Description:  hummus products

Growers Express Expands Recall of Fresh Processed Vegetable Product After Additional Listeria Positive

Growers Express is expanding its original recall of frozen vegetables posted on July 1 originating from their Biddeford Maine production facility.   The release states, "After further testing of an additional product lot from the suspected source of the recall, a single retail sample was found to be positive for Listeria monocytogenes. The company has expanded the list of recalled products to include certain specific fresh Brussels sprouts, fresh cauliflower florets and fresh green beans products with the “best by” or “pack dates” identified in the chart below."

So basically, they held four days of production (Best by 6-26 to 6/29) thinking they had captured the issue, but after testing, they found an additional positive sample in a different production lot.  Being that they found one positive, one would guess that this indicates that the contamination level is low.   This is a challenge with Listeria contamination.....a small amount getting into production of product, probably a  difficulty-to-find point source that contributes a few cells throughout production.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/growers-express-expands-voluntary-recall-select-fresh-vegetable-products-due-potential-contamination
Growers Express Expands Voluntary Recall of Select Fresh Vegetable Products Due to Potential Contamination of Listeria monocytogenes

Michigan Establishment Recalls Frozen Meatloaf Due To Complaint of Metal Bits

Ada Valley Gourmet Foods, Inc., an Ada, Mich. establishment, is recalling approximately 3,490 pounds of raw ground beef meatloaf products that may be contaminated with extraneous materials, specifically broken metal bits.  The problem was discovered on July 11, 2019, when a customer notified the plant of the problem.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-073-2019-release
Ada Valley Gourmet Foods, Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
Class I Recall 
073-2019 
Health Risk:High 
Jul 13, 2019 

Over 100 with E. coli after Visiting Minnesota Lake on 4th

Between 120 and 150 people have become infected with pathogenic E. coli after boating on Lake Minnetonka in Minnesota. Environmental factors are the most likely source.

Star Tribune
http://www.startribune.com/at-least-140-report-sickness-after-lake-minnetonka-boating-on-july-4th/512542682/
Nearly 120 report sickness after Lake Minnetonka boating on July 4th
Five beaches in the metro area remain closed due to high bacteria
counts.
By Katy Read (http://www.startribune.com/katyread/
131074183/) Star Tribune
JULY 11, 2019 — 5:07AM

Woman Charged After Video of Her Child Licking a Tongue Depressor and Placing it Back

A woman was charged with tampering, a felony, after she posted a video of her 10 year old daughter licking a tongue depressor in the doctor's office examination room and then returning it to the same jar.  This comes after last week's ice cream tampering issues when on two different occasions, stupid people opened, licked, and replaced cartons of ice cream.

PennLive
https://www.pennlive.com/nation-world/2019/07/woman-charged-after-recording-daughter-licking-tongue-depressor-in-doctors-office-and-putting-it-back.html
Woman charged after recording daughter licking tongue depressor in doctor’s office and putting it back
7/12/19   8:17 AM