Popcorn Mix Recalled for Undeclared Wheat Allergens as Part of the Pretzels

AMB Food Inc. in Brooklyn NY is recalling 8 oz bags of Pop a Nosh Mix Munch Regular and Honey BBQ snacks because it contains pretzels, but does not list Wheat as an allergen.  The recall was initiated after it was discovered that the pretzels included in both snack mixes contain wheat and both flavors were distributed in packaging that did not reveal the presence of wheat. The firm continues to investigate and make appropriate corrections.

The product is in a prelabeled bag, so the allergen listing was missed when designing the label.


AMB Food Inc. Issues Allergy Alert on Undeclared Wheat in Product
Summary
Company Announcement Date:  May 23, 2024
FDA Publish Date:  May 24, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - wheat
Company Name:  AMB Food Inc
Brand Name:  Pop a Nosh
Product Description:  Mixed Munch Regular and Honey BBQ

NC Seafood Company Recalls Crab Cakes for Undeclared Egg Contained in the Mayo

County Road Seafood, LLC., of Belhaven, NC – May 21, 2024, is voluntarily recalling County Road Seafood Crab Cake 2 Pack 4 Ounce package because this product contains undeclared egg.  
On 5/15/24 the firm was notified by the North Carolina Depart of Agriculture and Consumer Services that the product does not list egg on the label. The product contains mayonnaise which is made from eggs and utilizes whole eggs as a binder.

County Road Seafood Issues Allergy Alert of Undeclared Egg in 4 Oz Packages of County Road Seafood Crab Cake
Summary
Company Announcement Date:  May 21, 2024
FDA Publish Date:  May 22, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Egg
Company Name:  County Road Seafood Inc.
Brand Name:  County Road Seafood
Product Description:  Crab Cake 2 Pack

CDC - Outbreak of Trichinellosis from Eating Bear Meat 2022

Trichinellosis is a parasitic disease transmitted through the consumption of meat from animals infected with Trichinella spp. nematodes.  It is rare to see such cases, and when there are such cases in recent years, it is often associated with eating undercooked bear meat.  This is the case reported in CDC MMWR where a group of family member gathering and ate bear kabobs.

"The and eight extended family members from three states (Arizona, Minnesota, and South Dakota) had gathered for several days in South Dakota and shared a meal that included kabobs made from the meat of a black bear (Ursus americanus), which had been harvested by one of the family members in northern Saskatchewan, Canada in May 2022. The hunting outfitter had recommended freezing the meat to kill parasites. The meat was frozen in a household freezer* for 45 days until being thawed and grilled with vegetables. The meat was initially inadvertently served rare, reportedly because the meat was dark in color, and it was difficult for the family members to visually ascertain the level of doneness. After some of the family members began eating the meat and noticed that it was undercooked, the meat was recooked before being served again. The family reunion concluded before onset of illness in the index patient."

So can we rely on freezing to eliminate the Trichinella parasite?  More difficult with those strains found in cold regions.  Plus, freezing conditions can also impact reduction (article below).

"Although freezing kills Trichinella species commonly implicated in pork-associated outbreaks, freeze-resistant Trichinella species, including T. nativa and the T6 genotype (9), predominate in Arctic and sub-Arctic regions (6). Larval motility was observed in bear meat that had been frozen for nearly 4 months (110 days). Persons who consume game meat, especially that harvested in northern latitudes, should be informed that adequate cooking is the only reliable way to kill Trichinella parasites. Cooking wild game meat to an internal temperature of ≥165°F (≥74°C) is recommended by public health authorities**; temperatures should be verified with a meat thermometer. As demonstrated in this outbreak, the color of meat is not a good indicator of cooking adequacy. Safe handling of raw meat (i.e., separating raw or undercooked meat and its juices from other foods) is recommended to prevent trichinellosis; this investigation and previous investigations suggest that Trichinella-infected meat can cross-contaminate other foods"

What symptoms were exhibited?

Abdominal pain, diarrhea, myalgias (muscle pain), fever, eosinophilia (high white blood cell count) and periorbital edema (swelling around the eyes)

https://www.cdc.gov/mmwr/volumes/73/wr/mm7320a2.htm

Outbreak of Human Trichinellosis — Arizona, Minnesota, and South Dakota, 2022
Weekly / May 23, 2024 / 73(20);456–459
Shama Cash-Goldwasser, MD1; Dustin Ortbahn, MPH2; Muthu Narayan, DO3; Conor Fitzgerald, MPH4; Keila Maldonado5; James Currie, MD6; Anne Straily, DVM7; Sarah Sapp, PhD7; Henry S. Bishop7; Billy Watson, PhD7; Margaret Neja7; Yvonne Qvarnstrom, PhD7; David M. Berman, DO8; Sarah Y. Park, MD8; Kirk Smith, DVM, PhD9; Stacy Holzbauer, DVM9,10 (VIEW AUTHOR AFFILIATIONS)

Summary
What is already known about this topic?
Human trichinellosis cases in the United States are rare and are usually acquired through consumption of wild game.

What is added by this report?
Among eight persons who shared a meal that included the meat of a black bear harvested in Canada and frozen for 45 days, six trichinellosis cases were identified. The meat was grilled with vegetables and served rare; two cases occurred in persons who ate only the vegetables. Motile freeze-resistant Trichinella nativa larvae were identified in remaining meat frozen for >15 weeks.

What are the implications for public health practice?
Cooking meat to an internal temperature of ≥165°F (≥74°C) is necessary to kill Trichinella spp. parasites. Trichinella-infected meat can cross-contaminate other foods, and raw meat should be kept and prepared separate from other foods to prevent cross-contamination.

HPAI, Highly Pathogenic Avian Influenza - What Do We Know About Risk from Milk and Eggs

HPAI or Highly Pathogenic Avian Influenza is a hot topic after it was found to have infected dairy cows in multiple states (as of today, 58 dairy herds in nine states).  Remnants of the virus were found in milk which raised questions of risk.

Research released today in New England Journal of Medicine (link below) stated that milk, if not pasteurized, can be potentially infectious.  The study also looked at reduction of virus at pasteurization temperatures ( 181 degrees Fahrenheit, for 15 or 20 seconds) and determined that there was log reduction, but not complete elimination.

Researchers summarized, "HPAI H5–positive milk poses a risk when consumed untreated, but heat inactivation under the laboratory conditions used here reduces HPAI H5 virus titers by more than 4.5 log units. However, bench-top experiments do not recapitulate commercial pasteurization processes."

“But, we emphasize that the conditions used in our laboratory study are not identical to the large-scale industrial treatment of raw milk,” senior study author Dr. Yoshihiro Kawaoka, a virologist who specializes in the study of flu and Ebola, said in an email."

Added to this is that milk from cows found to be infected is diverted.  The question is whether all infected cows are detected.

FDA released results of their market survey of milk samples tested for the virus.  FDA "collected 297 samples at retail locations in 17 states between April 18-22, but the retail samples represented products made at 132 processing locations in 38 states."   "The FDA had said on May 10 that no live virus was found in retail milk samples. It has also said that pasteurized milk is safe to drink but has cautioned against consuming raw milk."

What about eggs?  Are eggs in the retail market safe to eat?

From the FDA

Yes. The likelihood that eggs from infected poultry are found in the retail market is low and proper storage and preparation further reduce the risk. In 2010, the U.S. Food and Drug Administration (FDA) participated in a joint risk assessment with the USDA Food Safety and Inspection Service (FSIS) to examine the human health impact of HPAI in poultry, shell eggs, and egg products. The risk assessment determined that the risk of humans becoming infected with HPAI through the consumption of contaminated shell eggs is low. For instance, when a case of HPAI is detected in the US, the chance of infected poultry or eggs entering the food chain is low because of the rapid onset of symptoms in poultry as well as the safeguards in place, which include testing of flocks and federal inspection programs.

Additionally, when food is properly prepared and stored, the risk of consumers becoming infected with HPAI is reduced even further. For more information of HPAI and human health visit the Centers for Disease Control and Prevention (CDC) website.

What about infecting humans?

From the CDC

• Although avian (bird) influenza (flu) A viruses usually do not infect people, there have been some rare cases of human infection with these viruses. 
• In late March 2024, a human case of influenza A(H5N1) virus infection was identified after exposure to dairy cows presumably infected with bird flu. On May 22, CDC reported a second human case in a person who had exposure to infected dairy cows in Michigan. Some bird flu infections of people have been identified in which the source of infection was unknown.
• The spread of bird flu viruses from one infected person to a close contact is very rare, and when it has happened, it has only spread to a few people. However, because of the possibility that bird flu viruses could change and gain the ability to spread easily between people, monitoring for human infection and person-to-person spread is extremely important for public health.

CNN

https://www.cnn.com/2024/05/24/health/new-experiments-milk-h5n1-infected-cows-raise-questions-flash-pasteurization/index.html
New tests confirm milk from flu-infected cows can make other animals sick — and raise questions about flash pasteurization
By Brenda Goodman, CNN

FDA Warning Letter Focuses on Allergen Control in Mislabeling Error by Salad Dressing Company

FDA issued a Warning Letter to Simple Truths for misbranding product after a mislabeling issue resulted in a allergen related recall.  In this case, Ranch dressing containers were filled with Caesar Dressing in which case the label did not declare soy as an allergen.  The issue stated by the company occurred "because the work in progress bulk containers used to produce the recalled Plant Based Ranch Dressing were mislabeled."

FDA also found issue in the corrective action provided by the company to FDA.  In the Warning Letter, FDA states that the company's corrective action documentation indicates "that [the company] updated task instructions and will improve (b)(4) communication, limit formulation operators to pumping out (b)(4), require employees to (b)(4), and (b)(4) on the new task instructions. [The company] did not provide updated procedures, task instructions, or training records. [FDA} will verify implementation of any corrective actions during FDA’s next inspection of [the] facility."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/litehouse-inc-662949-11292023

WARNING LETTER
Litehouse, Inc.
MARCS-CMS 662949 — NOVEMBER 29, 2023

Warning Letter to Cookie Dough Processor Highlights FDA's Attention to Allergens and Supplier Controls

In this Warning Letter issued to a cookie dough manufacturing company, it is important to see the approach FDA is taking with regard to allergens and supplier-controlled hazards.

 Cookies-n-Milk, LLC, a processor of ready-to-eat (RTE) cookie dough located in McKinney, TX received an inspection.  The inspection was in response to using incorrect packaging, which resulted in undeclared peanut allergen in the product, as containers of Chocolate Chip Edible Cookie Dough which do not declare the allergen peanuts were filled with Peanut Butter Edible Cookie Dough which contain peanuts.  Basically, the company put peanut butter dough into chocolate chip dough containers.

First on the lack of allergen preventive controls at the labeling step.  As part of the hazard analysis, the company did not identify and determine that undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard that requires a preventive control at the packaging/labeling step.  With that, the company did not monitor or verify that these preprinted labels are applied to the correct product during production (such as at the packaging/labeling step). The firm’s own investigation indicated that a lack of packaging controls resulted in containers of “Chocolate Chip Edible Cookie Dough,” which do not declare the allergen peanuts on the product label, being filled with Peanut Butter Edible Cookie Dough which contain peanuts

The next issue noted, and an item seen in recent Warning Letters, was the company did not identify and evaluate mycotoxins  in the incoming peanut butter as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The "facility manufactures RTE edible cookie dough products containing peanut butter, which has been associated with mycotoxins such as aflatoxin. A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in peanut butter and peanut butter-containing ingredients.  With not identifying mycotoxins as a hazard requiring a preventive control, the company did not conduct supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.

FDA then cited the lack of supporting documentation for corrective action as written in the company's  response to the inspection  In a response letter, the company indicated that the "dough hazard analysis will be revised to identify undeclared allergens due to mislabeling/packaging as a potential hazard with controls at packaging implemented with monitoring and verification procedures defined” and “The Edible Cookie Dough hazard analysis will be revised to identify Mycotoxins as a potential hazard for Wheat Flour and Peanut Butter with controls at the supplier level implemented with monitoring and verification procedures defined.” FDA responded, "However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions. In addition, the response did not include a complete updated hazard analysis (to identify mycotoxins as a hazard requiring a preventive control for peanut butter and peanut butter-containing ingredients, and to identify undeclared allergens as a hazard requiring a preventive control at the packaging/labeling step) or revised food safety procedures."

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cookies-n-milk-llc-672621-04222024
Cookies-n-Milk, LLC
MARCS-CMS 672621 — APRIL 22, 2024

Alabama Seafood Processor Recalls Crabmeat Product After Positive Listeria Testing Results

Irvington Seafood of Irvington, AL, is recalling its 1 lb. packages of "Crabmeat: Jumbo, Lump, Finger, and Claw meat" because they have the potential to be contaminated with Listeria monocytogenes,  From the report, "Kevin Sakprasit received Finish Product Testing results on May 17, 2024, at 4:31pm Central from EMSL Analytical, Inc. Crabmeat was processed on May 12, 2024, Batch #133 tested positive for L. monocytogenes. 94 samples were taken on May 13, 2024: 23 samples of Jumbo, 24 samples of Lump, 24 samples of Fingers, and 23 samples of Claw meat. Based on the lab report, 12 samples of Claw meat, and 2 samples of Fingers that were taken came back positive. "

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/irvington-seafood-recalls-crabmeat-jumbo-lump-finger-and-claw-meat-because-possible-health-risk-0
Irvington Seafood Recalls "Crabmeat: Jumbo, Lump, Finger, and Claw Meat" Because of Possible Health Risk
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 20, 2024
Product Type:  Food & Beverages  Shellfish
Reason for Announcement:  Potential Foodborne Illness - Listeria monocytogenes
Company Name:  ISF, Inc. Dba Irvington Seafood
Brand Name:  Irving Seafood
Product Description:  1 lb. packages of Crabmeat: Jumbo, Lump, Finger, and Claw meat

FDA Cites Detroit Tortilla Baker for Inadequate Controls

FDA issued a Warning Letter to Hacienda Mexican Foods, a Detroit MI processor of ready-to-eat (RTE) soft wheat flour tortilla products.  Like so many Warning Letters recently issued, the hazard analysis  did not properly identify or evaluate all known or reasonably foreseeable hazards.  

The company "did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, to determine whether it is a hazard requiring a preventive control in [the] RTE soft flour tortillas, as required by 21 CFR 117.130(a)(1). Specifically, [the] firm’s written hazard analysis did not consider the hazard of recontamination with environmental pathogens at the “(b)(4)” and “(b)(4) steps."

With that, there were inadequate sanitation controls in the post-processing environment.

Also, FDA felt that mycotoxins in incoming flour was not addressed as well as survival of pathogens in baking.

The last item is interesting.  FDA states "your food safety plan does not include written baking procedures or established parameters for baking time and/or temperature. Your firm’s Food Safety Assistant informed our investigators that your firm does not have a documented established critical limit for baking time and temperature or any validation for the adequacy of the baking process."

It did not help the firm with this statement, "you do not have controls in place to address the hazard of survival of bacterial pathogens such as Salmonella and E. coli in the baking process. While our investigators observed production of RTE soft flour tortillas, they noted that the digital temperature display for the oven did not appear to be functioning. Your firm management confirmed that it was not functioning, and it could not provide a temperature readout. Your firm’s Production Manager indicated that the digital temperature display has not functioned at any point while he had worked at your firm, which is approximately 20 years."

Finally, there are issues with the allergen preventive controls as well as a host of GMP violations.


Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hacienda-mexican-foods-llc-663221-04042024
Hacienda Mexican Foods, LLC
MARCS-CMS 663221 — APRIL 04, 2024

FDA Cites California Seafood Processor After Inspection Yields Listeria Positive Environmental Samples

FDA issued a Warning Letter to a California seafood processor who makes ready-to-eat (RTE) salmon and tuna.  As part of the inspection, FDA conducted sampling and analysis of the environmental samples (1195789 and 1239088) confirmed that thirty-four (34) of one hundred (100) environmental swabs were positive for pathogenic L. monocytogenes.

Further, "The analysis of the WGS data of the referenced samples showed three (3) strains of L. monocytogenes are present in your facility. Most notably, one of these strains was identified in twenty-eight (28) isolates and matched four (4) clinical isolates (2017, 2018, 2019, and 2023), indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility."


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-675713-04172024

Ocean Group Inc.
MARCS-CMS 675713 — APRIL 17, 2024