This Week In Mislabeled Products for Week Ending July 27, 2019

Consumer Complaint Reveals Missing Milk and Wheat Allergens in Meatballs -  Home Market Foods, Inc., a Norwood, Mass. establishment, is recalling approximately 53,217 pounds of frozen ready-to-eat beef and pork meatball products due to misbranding and undeclared allergens, the products contain milk and wheat which are not declared on the product label.   The problem was discovered when the firm received a consumer complaint reporting that the product was incorrectly labeled.

Consumer Complaint Reveals Missing Milk and Wheat Allergens in Beef Sticks -  CM&R Inc., a St. Paul, Minn. establishment, is recalling approximately 25 pounds of ready-to-eat beef stick products due to misbranding and undeclared allergens - the products contain milk which is not declared on the product label.   The problem was discovered when FSIS inspection program personnel determined that the firm had received a consumer complaint reporting that the product was incorrectly labeled.

Dried Fruit Missing Sulfites - Euphoria Fancy Food Inc of Brooklyn, NY is recalling its 500gram packages of “Tainy Vostoka Assorted Dry Fruits-Apple” because they contain undeclared sulfites.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 500gram packages of “Tainy Vostoka Assorted Dry Fruits-Apple” which were not declared on the label.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-078-2019-release
Home Market Foods, Inc. Recalls Frozen Ready-To-Eat Beef and Pork Meatball Products due to Misbranding and Undeclared Allergens 
Class I Recall 
078-2019 
Health Risk:High
Jul 25, 2019 

Canada - Recall of Eclairs for Salmonella and Smoked Salmon for Listeria

Associated Grocers is recalling certain Celebrate brand frozen profiteroles and eclairs from the marketplace due to possible Salmonella contamination.  This recall was triggered by findings from an investigation into a foodborne illness outbreak

 Delta Pacific Seafood Ltd. is recalling Western Family brand Original Wild Sockeye Smoked Salmon Nuggets from the marketplace due to possible Listeria monocytogenes contamination.  This recall was triggered by the company [Internal testing?]

http://www.inspection.gc.ca/about-the-cfia/newsroom/food-recall-warnings/complete-listing/2019-07-25/eng/1564102652457/1564102654776
Food Recall Warning - Certain Celebrate brand frozen profiteroles and eclairs recalled due to Salmonella

Kansas Spice Company Recalls Taco Seasoning After Notified by Ingredient Supplier of Potential Salmonella Contamination

Williams Foods issued a recall for their taco seasoning after their cumin supplier notified them that another cumin customer had tested and found Salmonella in a lot of cumin product, the same lot sold to Williams.

"These items contain cumin spice involved in a recall initiated by our supplier, Mincing Spice Co. Mincing has issued a recall for a specific lot of cumin they produced because a sample from that lot was tested by one of Mincing's customers and was found to be potentially contaminated with Salmonella. A portion of the lot recalled by Mincing was supplied to Williams Foods, LLC".

What were the supplier verification activities and now how does the company change them to reflect the increased risk?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/williams-foods-llc-initiates-voluntary-recall-taco-seasoning-product-due-possible-presence
Williams Foods LLC Initiates a Voluntary Recall of Taco Seasoning Product Due to Possible Presence of Salmonella Contamination
Summary
Company Announcement Date: July 25, 2019
FDA Publish Date: July 25, 2019
Product Type:Food & Beverages
Reason for Announcement:  Due to possible presence of Salmonella contamination
Company Name: Williams Foods LLC
Brand Name:  Great Value, HEB
Product Description:  Taco Seasoning Products

TX Establishment Expands Recall of Hummus Product Due to Listeria

Pita Pal Foods, LP of Houston, TX has expanded their initial recall (posted on July 17) of  hummus products to add a month more of production dates, now made between May 15, 2019 through July 11, 2019...originally May 30 to June 25.   The recall is "due to concerns over Listeria monocytogenes, which was identified at 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-0
Pita Pal Foods, LP Recalls Various Hummus and Dips Due to Possible Health Risk

Ongoing Cyclospora Outbreak in Northeastern US....FDA Warns Fresh Basil May Be a Source.

Cyclospora, the single celled parasite has caused numerous cases of infection in the northeastern states.   Massachusetts is reporting over 100 cases since May and Virginia has had 39 cases and Maryland has had 42 according to the Washington Post (June 25).

FDA issued a warning for fresh basil in that it may be potentially related to the outbreak.  The exporting firm, Siga Logistics de RL de CV of Morelos, Mexico,  has agreed with the FDA to issue a recall of their product

Symptoms for this parasite include diarrhea, abdominal cramps, nausea and fatigue and can last from a few days to over a month.

Fresh raw produce is often the source with the parasite getting onto the produce through irrigating with contaminated water.  Like cilantro which has been the source food for Cyclospora, basil is a herb that is used fresh and must be more washed more gently in order to preserve leaf integrity.

The Packer
https://www.thepacker.com/article/northeastern-cyclospora-outbreak-source-investigated
Northeastern cyclospora outbreak source investigated 
Chris Koger
July 25, 2019 11:24 AM

Alabama Facility Issues Recall Due to Employee Injury Leading to Possible Human Blood Contamination of Raw Meat Products

US Foods, a Birmingham, AL, establishment, is recalling approximately 712 pounds of raw beef and pork products that may be adulterated due to possible product contamination after it was discovered by the facility that an employee may have cut himself during production (potential for bloodborne pathogens).  There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-076-2019-release
US Foods Recalls Raw Beef and Pork Products Due to Possible Product Contamination 
Class I Recall 
076-2019 
Health Risk: High 
Jul 20, 2019 

Milk form NE PA Creamery May Be Linked to 17 Confirmed Yersinia Infections

Pennsylvania Dept of Health released a health advisory for those who may have purchased milk from Creamworks Creamery in Waymart, PA (Wayne County) because the product may contain  Yersinia enterocolitica, a food borne bacterial pathogen.   Product from this establishment may be linked to 17 laboratory-confirmed illnesses caused by Yersinia enterocolitica.

Y. enterocolitica

• Gram negative, short rods
• Can grow at refrigeration temperatures and has been an issue in products such as pasteurized whole milk and tofu.  Commonly found in pork and can be an issue in undercooked pork.
• Heat sensitive, so easily eliminated by proper pasteurization.  Poor sanitation and improper sterilization techniques by food handlers, including improper storage, may be a source of contamination.  
• Has a high infectious dose (>10E4 cu), so a small level of contamination would need time for growth.
• It causes fever, diarrhea and abdominal pain, which is often mistaken as a appendicitis.  It may also lead to some autoimmune complications.
• Symptoms develop after 4 to 7 days and may last 1 to 3 weeks.
• Cases of infection are fairly rare in the US.

In this outbreak, a good bet would be post-process contamination with time between the contamination event and consumption to allow for growth.  The dairy makes, pasteurizes, and bottles their own milk and that milk is sold  there onsite or through local retailers.

Pennsylvania Dept of Health News Release
https://www.media.pa.gov/Pages/Health-Details.aspx?newsid=626

07/19/2019

Department of Health Warns Residents Not to Consume Milk from Wayne County Dairy, Harmful Bacteria May Be Present

Egg Salad and Similar Salad Items Recalled After Sampled Product Tests Positive for Listeria

A Tennessee food establishment, Elevation Foods, is recalling containers of Archer Farms-brand egg salad; Freskëtbrand egg salad, tuna salad, and Thai lobster salad; and Archer Farms-brand deviled egg sandwiches produced on June 18, 2019 after testing by Florida Dept of Ag found  positive Listeria monocytogenes in 3 samples.  The state shelf life dates on the product vary, but are generally about 6 weeks, plenty of time for growth of Listeria at refrigerated temperatures.  (6 week old egg salad or tuna salad sounds less than desirable.)

It will be interesting to see if additional lot codes are recalled.  Having 3 positives in a given sampling could mean a more serious issue and with that, more additional date codes may need to be recalled.   While no illnesses have been reported, whole genome sequencing may unveil some linkage, hopefully not.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/elevation-foods-recalls-packaged-egg-salad-tuna-salad-thai-lobster-salad-and-archer-farms-deviled
Elevation Foods Recalls Packaged Egg Salad, Tuna Salad, Thai Lobster Salad, and Archer Farms Deviled Egg Sandwiches Because of Possible Health Risk
Summary
Company Announcement Date: July 19, 2019
FDA Publish Date: July 19, 2019
Product Type:  Food & Beverages
Reason for Announcement:  Due to possible contamination with Listeria monocytogenes
Company Name:  Elevation Foods, LLC
Brand Name:  Archer Farms, Freskët
Product Description:  egg salad, tuna salad, Thai lobster salad, and deviled egg sandwiches

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

This Week in Mislabeled Product for Week Ending July 13, 2019

Consumer Allergic Reaction Triggers Recall of  Meal Bars -  PROBAR LLC of Salt Lake City, UT has initiated a voluntary recall of select flavors and lots of Meal® bars, including Chocolate Coconut, Peanut Butter Chocolate Chip, Original Trail Mix, Wholeberry Blast and Superfood Slam due to the possible presence of undeclared milk and soy allergens. PROBAR learned of the issue after receiving a complaint of an allergic reaction in a consumer after eating a PROBAR: MEAL Peanut Butter Chocolate Chip bar. Our investigation determined that an ingredient potentially contained milk and soy. To date, PROBAR has received this one report of illness.

Someone Missed that Worcestershire Sauce Contains Fish (anchovies) - .Baumer Foods, Inc. of Metairie, LA is recalling 10 oz PICS Soy Sauce, because it may contain undeclared fish   The recall was initiated after it was discovered that product was labeled as Soy Sauce without the known fish allergen but the bottle actually contained Worcestershire sauce. Worcestershire Sauce has the known allergen fish. Subsequent investigation indicates the problem was caused by a temporary oversight during the packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/probar-llc-issues-allergy-alert-undeclared-milk-and-soy-select-flavors-meal-r-bars
PROBAR LLC Issues Allergy Alert on Undeclared Milk and Soy in Select Flavors of Meal ® Bars
Summary
Company Announcement Date:  July 11, 2019
FDA Publish Date:  July 11, 2019
Product Type:  Food & Beverages  Meal Replacements
Reason for Announcement:Undeclared Milk and Soy
Company Name:PROBAR
Brand Name:PROBAR
Product Description:Multiple flavors of Meal Bars

Hamburger Buns and Hot Dog Buns Recalled Due to Potential for Hard Plastic

Flowers Foods, Inc. is voluntarily recalling hamburger and hot dog buns and other bakery products due to the potential presence of small pieces of hard plastic that may have been introduced during production.  The company initiated the recall following the discovery of small pieces of hard plastic in production equipment.No related injuries or illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flowers-foods-issues-voluntary-recall-hamburger-and-hot-dog-buns-and-other-bakery-foods-due-plastic
Flowers Foods Issues Voluntary Recall of Hamburger and Hot Dog Buns and Other Bakery Foods Due to Plastic Pieces Found in Products
Summary
Company Announcement Date: July 09, 2019
FDA Publish Date: July 10, 2019
Product Type:Food & Beverages  Bakery Product/Mix
Reason for Announcement: Potential Presence of Small Pieces of Hard Plastic
Company Name:Flowers Foods, Inc.
Brand Name: Multiple brands
Product Description:  Hamburger and Hot Dog Buns

Meat and Gravy Product Recalled After Complaint of Clear Pliable Plastic

Fairmont Foods, Inc. of Fairmont, Minn. is recalling approximately 35,145 pounds of ready-to-eat pork and beef gravy products that may be contaminated with extraneous materials, specifically clear pliable plastic (ingredient packaging material??).  The firm contacted FSIS after they received a report that a consumer found a piece of the soft pliable plastic in the product.  There have been no confirmed reports of adverse reactions due to consumption of these products. 

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-072-2019-release
Fairmont Foods, Inc. Recalls Ready-To-Eat Pork and Beef Gravy Products Due to Possible Foreign Matter Contamination
Class II Recall 
072-2019 
Health Risk: Low 
Jul 9, 2019

Restaurant in FL Linked to Cyclospora Outbreak

A restaurant in Florida has been linked to a Cyclospora outbreak.  The source has yet to be identified, but in many cases related to this parasite, it tends to be produce which was watered or washed with water contaminated with the parasite.

Cyclospora is a single cell parasite where humans are the only definitive host.  From the CDC:

People become infected with Cyclospora by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) Cyclospora oocysts in the feces. The oocysts are thought to require at least 1–2 weeks in favorable environmental conditions to sporulate and become infective. Therefore, direct person-to-person transmission is unlikely, as is transmission via ingestion of newly contaminated food or water.

 In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce, such as raspberries, basil, snow peas, mesclun lettuce, and cilantro; no commercially frozen or canned produce has been implicated to date.

So while many may blame the restaurant, that restaurant was unlikely to have had much impact on removing the parasite if already on the produce.   And this is the challenge with Cyclospora.  Last month, a panel was put together to investigate how this parasite can be controlled.  While some preventive measures were discussed, no specific source was identified.

https://www.news4jax.com/news/local/jacksonville/attorneys-2-dozen-sick-after-food-poisoning-at-popular-restaurant
Attorneys: About 2 dozen sick after food poisoning at popular restaurant
Group claims to have contracted parasite from Cooper's Hawk Winery & Restaurant
By Vic Micolucci - I-TEAM reporter, anchor
Posted: 3:10 PM, July 09, 2019
Updated: 12:41 PM, July 10, 2019

FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food 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 become contaminated with filth or 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))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

FDA Warning Letter Issued to Pet Food Company for Inadequate Food Safety Plan

A pet food facility based in Tupelo MS (birthplace of Elvis) received a Warning Letter from FDA regarding making product with high Vitamin D levels.   In a nutshell, their Food Safety Plan did not sufficiently consider that their supplier could provide product with a different Vitamin D content than what their formulation called for, thus they ended up making product with excessive Vitamin D, which is harmful to pets.  In this case, they used an ingredient with over 60X the Vitamin D level

A few important points here: 1) When requiring COAs, one needs to be specific to the hazard they are looking for, and the level.  Too many people collect COAs just to collect them.  2) If one asks for a COA, then it must be reviewed, and in many cases verified.  3) All incoming materials should be checked for ingredient / raw material numbers to make sure they match.
Care must be taken when writing the Preventive Control Plan because it will be used to evaluate the facility.  Unfortunately, emphasis provided in the Animal Feed courses is not as good as in the Human Food courses in that it allows many ingredients to be lumped together.

Specifically, you identified vitamin and mineral toxicity and deficiency as a hazard requiring a preventive control in your food safety plan. However, as evidenced by the toxic levels of vitamin D found in some of your dog foods, you failed to implement adequate preventive controls to ensure your inclusion of vitamin D did not result in a nutrient toxicity or deficiency.

Your hazard analysis determined that a preventive control was not necessary at ingredient receiving for “wrong levels” of vitamins in ingredients due to your “internal programs.” .........

Your “internal programs” consist of SOP number (b)(4) and SOP number (b)(4).” With regard to micro ingredients, SOP (b)(4) states that “all bagged raw materials will provide a Certificate of Analysis (COA), which will be maintained in the ingredient purchasing office.” (b)(4) says that “it is the policy of Sunshine Mills that all incoming shipments of raw materials used in our products, including bulk grains, bulk protein and other meals, bulk fats and tallows, salt, packaged vitamin and mineral supplements, color additives, and other ingredients will be examined at the time of receipt to assure that they are of good quality and meet product specifications. This examination will consist of a visual inspection for identity and gross visible defects, a test for moisture content as may be indicated, and sampling for assay of protein, fiber, vitamin and mineral levels or other purchase specifications, and also to check for contaminants.” It is also your policy that “vendors, from time to time, provide a COA for such things as vitamin and mineral content when this is part of the puce-chase [sic] specifications.”

However, these SOPs did not ensure that vitamin D levels in incoming ingredients met established ingredient specifications. For example, the vitamin D levels were not analyzed at a laboratory facility on a routine basis to ensure that the vitamin D met your firm’s pre-set formulation. You did not question any difference in appearance of the packaging or the ingredient. In addition, your firm did not obtain Certificates of Analysis (COA) upon receipt of each shipment of vitamin D. Furthermore, there is no indication of who is responsible for performing these actions listed in the SOPs or verifying that they have been performed or what steps are to be taken if an incoming ingredient does not meet specifications.

Your “batching/mixing” preventive control includes no measures that would prevent the use of an ingredient that is the wrong concentration.

Consequently, you used five shipments of an ingredient that you were unaware contained a higher concentration of vitamin D (500,00 IU/g) instead of the vitamin D with a lower concentration (7,500 IU/g) consistent with your firm’s formulation.

2. ......Your firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 507.33(a)(1).

Specifically, your firm manufactures cat food that includes thermal processing (extrusion) as a manufacturing step. Your hazard analysis did not identify inadequate thiamine in extruded dry cat food as a known or reasonably foreseeable hazard.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-576411-06252019
WARNING LETTER
Sunshine Mills Inc 
MARCS-CMS 576411 — Jun 25, 2019

Risks Associated with Metal Straws - Puncturing Your Face and Improper Sanitation

An English woman died when she fell and the metal straw she was carrying in her glass punctured her eye and entered her brain.

The face-puncture risk was not one that was on the radar, but probably should be, especially for little kids or for those consuming adult beverages such as in bars and restaurants.

The risk of contamination from improperly cleaned metal straws is another consideration.  Consider germs being passed from another person who used that straw or a mass of mold growing in a food-clogged straw.  As a reusable food utensil, the interior of the straw must be cleaned and sanitized since that is a food contact surface.  From the website of a metal straw manufacturer, they state cleaning procedures to be followed:

SOAKING & CLEANING: When Server Clears A Finished Drink, They Should Collect The Straw, And Place It In A Tub Of Hot Soapy Water To Soak. If The Straw Was Used For A Drink That Might Have Pulp Or Other Beverage Reside, Then It Should Be Scrubbed With A Cleaner Brush To Remove Any Such Debris. Rinse The Straws Thoroughly In Clean, Hot Water, To Remove All Soap.

This is followed by a sanitation step

SANITIZING: Soak Straws For At Least One Minute In Tube Filled With An Approved Restaurant Sanitizing Cleaning Formula. This Step Is Recommended For Commercial Establishments Cleaning Any Type Of Reusable Utensil — Including Spoons, Forks And Knifes — To Assure That Any Germs Are Destroyed.

Cleaning your own straw is not an issue, but in foodservice operations where hundreds of straws may need to be cleaned, then proper sanitation (cleaning and sanitizing) can be a major task.

Anyone who has had to clean glass pipettes knows that this is not an easy process and that the tubes can get easily blocked (and at least with glass, you were able to see which tubes were blocked).  For one, you won't know that a given metal straw is blocked unless you run a brush through each or at least, visually examine down each barrel.  Second, dropping the straws into a cleaner or a sanitizer solution will not guarantee that the cleaner sanitizer will come in contact with the entire surface due to air bubble blocks.  With pipet cleaning, the tubes are stacked vertically, not horizontally, in a cylindrical cleaner where waters is added and then flushed repeatedly. 

Metal straws and cleaning brushes

pipet cleaner

 (One other point to make - the potential loss of flavor with certain beverages like coffee in stainless steel.  Did you ever notice how coffee flavor is lost in a stainless steel cup vs a ceramic cup?)


https://www.foxnews.com/world/metal-straw-death-eye-impaled-brain
English woman died after falling on metal straw that went through her eye, impaled brain, inquest hears
By Travis Fedschun | Fox News
July 9, 2019

People Licking Ice Cream and Putting Back in the Display - Food Tampering is a Felony

A Texas youth has been identified for allegedly licking a tub of ice cream and then putting it back in the freezer.  The video of the young woman completing the act went viral.  Adulterating food, which this act is certainly that, is a felony offence that could result in an extensive stay in jail as well as hefty fines.  As a juvenile offender, she is not likely to face charges as an adult, so the penalty will be less severe.

A copycat incident occurred in LA when a 36 year old man also popped open a container of ice cream on the store shelf, licked it, and then placed it back.  The man claims to have then purchased the ice cream.

Time for manufacturers to review their packaging with an eye towards product security.

Insider.com
https://www.insider.com/police-identify-ice-cream-licking-culprit-from-viral-video-juvenile-2019-7
Local police have identified the suspected ice cream-licking culprit from viral video

June 8, 2019

Because of Health Concerns, FDA States CBD from Hemp Still Illegal as an Additive to Food

CBD from hemp has received an incredible amount of attention from those who would like to see it added to food.  However, "Other than one prescription drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body."  One of the biggest concerns is liver damage which has been shown by studies in mice.   Other issues are the impact on mental health.

"Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)."  While the "Farm Bill removed hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act", "CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance."

FDA Public Health News Release
https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
Content current as of:
06/19/2019

Death of Australian Man After Eating Gecko Likely Due to Parasite

An Australian man died a horrific death after eating a gecko on a dare.  Initially thought it was a massive Salmonella infection, it is now believed that it was a parasite that led to such dramatic symptoms as "vomiting green bile, his testicles each swelled to the size of a grapefruit with a strange fluid leaking from them — and his stomach was so badly bloated".  All of this within days after eating gecko.  From the article, a taxonomist and ecologist who is an expert in Asian house gecko parasites says a Spirometra tapeworm — which can group to about 4ft — could be what ravaged and ultimately killed the young dad."

Key - Ignore the dares and double dares when it comes to eating raw snails, reptiles, etc


The Sun
https://www.thesun.co.uk/news/9429635/dared-eat-gecko-australia-dead-tapeworm/
GRIM TWIST Man who died in agony after ‘gecko eating dare’ may have been killed by a parasitic Spirometra tapeworm, doctors say
Patrick Knox
3 Jul 2019, 16:19

Salmonella Outbreak May be Linked to Pig Ear Dog Treats

CDC identified pig ear dog treats as the likely source of an Salmonella outbreak.  To date, there have been 45 cases with 34 of 38 people interviewed having claimed contact with a dog with 17 of 24 claiming contact with pig ear treats or contact with a dog who had pig ear treats.

Testing done thus far has not identified the outbreak strain,  but they have found other strains of Salmonella.  Testing of the outbreak strain found that the organism is antibiotic resistant.

(Champ's snack of choice is Penn State Summer Sausage....luckily he is a little dude and doesn't eat mass quantities....plus his owner gets to enjoy some as well...all Salmonella free...can't put a price on that.)

https://www.cdc.gov/salmonella/pet-treats-07-19/index.html
Outbreak of Multidrug-Resistant Salmonella Infections Linked to Contact with Pig Ear Dog Treats
Published on July 3, 2019 at 2:45 PM ET

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDAexternal icon) are investigating a multistate outbreak of multidrug-resistant Salmonella I 4,[5],12:i:- infections linked to contact with pig ear dog treats.

At A Glance
Reported Cases: 45
States: 13
Hospitalizations: 12
Deaths: 0

A Distributor of Salmonella Contaminated Papayas Identified

FDA released an update regarding the ongoing Salmonella outbreak associated with papayas.  At this point, the FDA investigation "indicates that Agroson’s LLC of Bronx, New York, is the exclusive distributor of the imported papayas that likely made consumers from this outbreak sick. The papayas are sold under the brand name Cavi. To date, there have been no positive product samples."

With this, FDA lifts the hold on Mexican papayas.  There was no indication in the notice where the NY distributor sourced the papayas.

To date, there have been 71 cases with 27 hospitalizations,  All cases originated in the northeastern section of the US.

https://www.fda.gov/food/outbreaks-foodborne-illness/salmonella-uganda-likely-linked-whole-fresh-papayas-june-2019
Salmonella Uganda Likely Linked to Whole, Fresh Papayas, June 2019
Consumers in all states warned to avoid Cavi brand whole, fresh papayas distributed by Agroson’s LLC
Case Counts
Total Illnesses: 71
Hospitalizations: 27
Deaths: 0
Last illness onset: June 16, 2019
States with Cases: CT (14), FL (1), MA (5), NJ (18), NY (27), PA (4), RI (1), TX (1)

July 5, 2019

Growers Express Recalls Fresh Processed Vegetable Products After Positive Listieria Finding

Growers Express production facility in Biddeford, Maine is recalling  select fresh vegetable products  including packaged varieties of butternut squash, cauliflower, zucchini and a butternut squashed based veggie bowl due to the potential for contamination with Listeria monocytogenes.  According to the report, the recall was issued after being notified of a single positive sample by the Massachusetts Department of Health

"Most of the affected products are labeled with a “Best If Used By” Date of June 26 – June 29, 2019"...so a three day production window....and it should be noted that product has already its expiration date.  The company has stopped production and is "deep sanitizing the entire facility and our line equipment, as well as conducting continued testing on top of our usual battery of sanitation and quality and safety tests before resuming production."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/growers-express-issues-voluntary-recall-multiple-fresh-vegetable-products-due-potential
Growers Express Issues Voluntary Recall of Multiple Fresh Vegetable Products Due to Potential Contamination of Listeria monocytogenes
Summary
Company Announcement Date: June 30, 2019
FDA Publish Date: July 01, 2019.
Product Type:Food & Beverages
Produce Reason for Announcement:  Listeria monocytogenes
Company Name: Growers Express
Brand Name:  Green Giant Fresh, Growers Express, Signature Farms, Trader Joe’s
Product Description:  Butternut squash, cauliflower, zucchini, and butternut squash based veggie bowl products

Are You Using A Thermometer for Cooking Your Burger on the 4th? Why You Are Probably Not

Thermometers are the most effective way to determine if food is safe.  That is, to determine if specific temperatures have been reached to ensure leathality for pathogens of concern.  A recently published study looked at 85 studies from the past 21 years to see why thermometers are used or not used.  For those using thermometers, the motivators for thermometer use were to protect
those for whom the food is prepared and to improve food quality.

However, the majority of people do not use thermometers with the barriers being categorized into two major groups: “the belief that a thermometer is not necessary” and “the difficulty of selecting and using a thermometer.”

Barrier type 1 - Belief that a thermometer is not necessary -

1. Preference for alternative techniques. 

"Many consumers (47 to 51%) responded that it is unnecessary to use a cooking thermometer to check the doneness of an egg or meat dish. The most frequently reported alternative to food thermometer use was use of color to determine the doneness of the meat. Consumers also determined the doneness of egg or meat dishes by touch, taste, recipe cooking time, inserted a knife to examine the internal texture, inserting a toothpick or other utensil to see whether it came out clean, or other indications of texture, such as shaking an egg dish and considering it done when the item was firm.

2. Mainstream media and food professionals seldom serve as role models and often negate the need for food thermometers. 

Food workers indicated they were less likely to use a food thermometer when the managers were perceived as not caring about or monitoring this activity; some workers reported that their managers were bad examples when using thermometers. Food workers who were less likely to use a thermometer also believed that their boss, coworkers, customers, and the health inspector would not support thermometer use. Some culinary preparations seldom incorporate temperature measurement. Young Asian consumers reported not seeing a food thermometer used in their daily lives.

3.  Limited awareness of potential health issues associated with current practices.

4. Limited knowledge and awareness related to thermometer use for specific food groups.

Barrier type 2 - Difficulty of selecting and using a thermometer.

1. Difficulty in selecting the type of food thermometer.
2. Availability of food thermometers.
3. Lack of skills related to use of food thermometers.
4. Limited knowledge related to endpoint temperatures.
5. Inability to calibrate food thermometers.
6. Lack of knowledge of food thermometer cleaning and sanitation.

Are you making excuses or are you going to control your process?


Journal of Food Protection, Vol. 82, No. 1, 2019, Pages 128–150
doi:10.4315/0362-028X.JFP-18-245
Copyright , International Association for Food Protection

ABSTRACT

Motivators and Barriers to Cooking and Refrigerator Thermometer Use among Consumers and Food Workers: A Review

FDA Invetigating Link Between Salmonella Outbreak and Fresh Papayas from Mexico

FDA issued a Investigation Notice on potential link of Salmonella to fresh papayas from Mexico.  FDA is "investigating a multistate outbreak of 62 Salmonella Uganda illnesses potentially linked to whole, fresh papayas imported from Mexico.  These illnesses have been reported in eight states: Connecticut, Massachusetts, New York, New Jersey, Pennsylvania, Rhode Island, Florida, and Texas."

No product has be been recalled at this point.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-uganda-potentially-linked-whole-fresh-papayas-june-2019
Outbreak Investigation of Salmonella Uganda Potentially Linked to Whole, Fresh Papayas, June 2019
Consumers in six states warned to avoid whole, fresh papayas from Mexico

June 28, 2019