Europe - Challenges with Increasing Level of Mycotoxins in Wheat

An article from University of Bath (UK) discusses the rise in fungal toxins in wheat and other cereal grains in Europe, specifically those toxins associated with Fusarium Head Blight.

Their findings - "Fusarium mycotoxins were discovered in every European country. Half of the wheat intended for human food in Europe contains the Fusarium mycotoxin “DON” (commonly referred to as vomitoxin) while in the UK, 70% of wheat is contaminated. Governments set legal limits on DON contamination levels in wheat that is to be consumed by humans. These regulations provide effective protection, with 95% of wheat destined for the table meeting the safety limits for DON concentration. However, the finding that mycotoxins are ubiquitous is concerning, as the effect of constant, low-level exposure to mycotoxins in our diet over the course of a lifetime is not known."

Penn State Extension has a piece on Fusarium Head Blight - Fusarium Head Blight (psu.edu)

So what may have led to this this increase?  Speaking with our European expert on grain Mold, Dr. Voloshchuk, she said two factors that need investigation are  weather conditions associated with global climate change and along with that, the push to decrease the use of fungicides.

Harmful fungal toxins in wheat: a growing threat across Europe (bath.ac.uk)
Harmful fungal toxins in wheat: a growing threat across Europe
Harmful fungal toxins are on the rise in Europe’s wheat and affect almost half of crops, according to a new study led by the University of Bath.

FDA Food Fraud - Economically-Motivated Adulteration - Honey

FDA recently issued a report on sampling and testing of imported honey for economically motivated adulteration.

• More than 70% of honey consumed in the US is imported.
• Adulteration is the addition of undeclared cheaper sweeteners to honey, such as syrups derived from cane, corn, rice or sugar beets
• Of the 144 import samples collected and tested, the FDA found 14 (10%) to be violative. The remainder were in compliance.
• Of the 144 import samples, 75 were collected from bulk shipments and 69 were collected from retail shipments.
• Violative samples are subject to compliance actions, such as recalls and import refusal, consistent with the FDA’s mission to ensure that food is safe, wholesome, and properly labeled. When appropriate, the agency may consider pursuing criminal investigations. 
• When other sweeteners are added to honey, the Federal Food, Drug & Cosmetic (FD&C) Act requires that the resulting product be labeled as a “blend,” and not as “honey,” and have an ingredient statement.

https://www.fda.gov/food/economically-motivated-adulteration-food-fraud/fy2122-sample-collection-and-analysis-imported-honey-economically-motivated-adulteration
FY21/22 Sample Collection and Analysis of Imported Honey for Economically Motivated Adulteration

Case Studies - Allergen Root Cause Analyses

An article in Food Safety Magazine, titled Anatomy of Food Allergen Recalls,  sheds light on the root cause of six different allergen-related recalls.  Key points from that article:

Egg residue in pasta product - Line spillover form one product to another

• "The pasta in this product was obtained from a pasta supplier. The manufacturer of the implicated product decided to conduct an inspection of the pasta supplier's facility. In the course of that inspection, a location was discovered where a line transporting egg noodles crossed over a line transporting this company's non-egg product. The inspector was able to discern that egg noodles would periodically drop from the noodle line into the non-egg pasta. Subsequently, a tote of the finished non-egg pasta ingredient was found to contain several egg noodles on visual inspection. Since these noodles were discrete particulates, they were not likely present in every container of the manufacturer's retorted product. Thus, the presence of egg evaded detection when only a few containers were selected for egg analysis."
• "The line crossover was identified as the root cause, and a shield was placed over the non-egg line to prevent egg noodles from dropping into the non-egg pasta."

Peanut in Chocolate Ice Cream - Rework Issue

• "A review of rework records at the manufacturing facility clearly and astonishingly showed that peanut butter swirl ice cream had been incorporated into the chocolate ice cream. The use of rework as an ingredient explains why consistent and moderately high levels of peanut residues were detected in the chocolate ice cream. Further investigation revealed that a key employee had interpreted the like-into-like as permitting the use of any flavor in rework that would not affect the color or flavor of the chocolate ice cream."
• "The use of peanut-containing rework was identified as the root cause of this recall. Corrective actions included more specific and detailed employee training on preventive allergen controls and implementation of a new rework policy (exact-into-exact), where rework was only allowed to be incorporated into the same SKU of product from which it had been generated."

Peanut in Spice Mix - Poor Supplier

• "Due to the very high levels of peanut found in the cumin, the manufacturer suspected intentional adulteration; however, such allegations are difficult to prove. Other spice mix companies that were customers of the same Turkish supplier were also found to have received and distributed seasoning mixes and ground cumin with high levels of undeclared peanut. Initially, no consumer complaints were received, but several complaints ultimately were linked to products associated with the implicated cumin. Hundreds of product recalls ensued."
• "The root cause was the presence of undeclared peanut in cumin obtained from a specific supplier. The corrective action was the cessation of the import of ground cumin from the particular Turkish supplier. Some affected companies began to source ground cumin from U.S. suppliers that imported whole cumin seeds and ground the spice in U.S. facilities."

Cumin with peanut - Farming practices

• "The cumin-growing region of India is also home to peanut farms. An observation was made by inspectors in India that many of these farmers were reusing burlap bags that may have been previously used for peanuts or peanut meal. Peanuts in India are sometimes processed into peanut oil, leaving behind peanut meal that farmers might transport in burlap bags to feed cows; those same bags might be later used to carry cumin."
• "This root cause was never fully documented, but several spice manufacturers began supplying the farmers with new burlap bags. This practice coincided with fewer cumin or cumin-containing spice mixes testing positive for peanut residues."

Undeclared Almond in Paprika - Testing failure

• "In the EU, retail paprika samples were recalled for the presence of undeclared almond. The source of the ground paprika was a Middle Eastern supplier. This supplier had no almonds in its facility, although the supplier indicated that it used shared equipment to grind both paprika and mahaleb, a popular Middle Eastern spice made from the pits of a variety of mahaleb cherries."
• "Subsequent analysis revealed that mahaleb residues would test positive in the almond ELISA methods, and mass spectrometric analysis revealed that the residues in the ground paprika had come from cherry pits and not almonds. Canada rescinded its recalls for undeclared almond in paprika. Allergen ELISA methods are typically quite specific; however, in the case of botanical cousins such as almond and mahaleb cherries, cross-reactivity is possible."
• "The root cause of these recalls was a faulty analytical method. The corrective action involved the use of a more specific analytical method to distinguish between almonds and cherry pits. Due to the close relationship between almonds and mahaleb cherries, the proteins from these two foods are likely to be highly homologous, suggesting that ingestion of mahaleb might cause reactions in almond-allergic individuals."

Cereal with undeclared milk - Overspray transfers allergens

• "A breakfast cereal manufacturer used shared processing and packaging equipment for the processing of one cereal product with milk and another with no milk-derived ingredients."
• "The manufacturer realized that droplets from the wet washing procedure were transferring onto the roll stock plastic packaging used as the inner liner for the boxes of cereal. Corrective actions involved moving the packaging equipment further away and shrouding it during allergen cleaning."

Animal Feed Recall - Alfalfa Blocks Recalled, Linked to Death of 45 Horses Due to Botulism Poisoning

Manzanola Feeds is voluntarily recalling certain lots of Top of the Rockies Alfalfa Cubes because it has the potential to be contaminated with Clostridium botulinum.  The recalled Top of the Rockies Alfalfa Cubes are approximately 1 inch cubes, packaged in a 50 pound bag,  There have been 45 horse deaths associated with this issue, to date.

According to the FDA Advisory - "Some of the alfalfa cubes have been reported to contain what appears to be fur and animal tissues, indicating that material from an animal or animals may have been incorporated into the cubes during alfalfa harvesting. Some people have reported a foul odor in some of the bags. Clostridium botulinum, the bacterium that causes botulism, is commonly present in decaying animal carcasses. Testing of the alfalfa cubes and other feed and tissue samples is in progress."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manzanola-feeds-recalling-certain-lots-top-rockies-alfalfa-cubes-due-possible-clostridium-botulinum
Manzanola Feeds is Recalling Certain Lots of Top of the Rockies Alfalfa Cubes due to Possible Clostridium botulinum Health Risk
Summary
Company Announcement Date:  December 16, 2022
FDA Publish Date:  December 16, 2022
Product Type:  Animal & Veterinary  Livestock Feed
Reason for Announcement:  Potential to be contaminated with Clostridium botulinum
Company Name:  Manzanola Feeds
Brand Name:  Top of the Rockies
Product Description:  Alfalfa Cubes

Texas Firm Recalls Cat Food Due To Salmonella Contamination

TFP Nutrition announced today that it is issuing a voluntary recall of a dry cat food - HEB Texas Pets Indoor Complete Dry Cat Food  due to potential Salmonella contamination.   The product was manufactured on November 13, 2022, at its Nacogdoches, Texas facility.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tfp-nutrition-initiated-voluntary-recall-16-lb-bags-heb-texas-pets-indoor-complete-dry-cat-food
TFP Nutrition Initiated Voluntary Recall of 16 lb. Bags of HEB TEXAS PETS Indoor Complete Dry Cat Food Because of Possible Salmonella Health Risk
Summary
Company Announcement Date:  December 16, 2022
FDA Publish Date:  December 16, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential Salmonella contamination
Company Name:  TFP Nutrition
Brand Name:  HEB TEXAS PETS
Product Description:  HEB TEXAS PETS Indoor Complete Dry Cat Food

RTE Crispy Chicken Entrée Recalled After Consumer Finds Shrimp in Product

Mountain View Packaging, LLC, a Boise, Idaho establishment, is recalling approximately 6,013 pounds of frozen, ready-to-eat Crispy Chicken with Almonds entrée products due to misbranding and an undeclared allergen - the product contains shellfish (shrimp), a known allergen, which is not declared on the product label.  The problem was discovered when the firm notified FSIS that they received a consumer complaint reporting shrimp in a product labeled as Crispy Chicken with Almonds entrée.


https://www.fsis.usda.gov/recalls-alerts/mountain-view-packaging-llc-recalls-frozen-ready-eat-crispy-chicken-almonds-entree
Mountain View Packaging, LLC, Recalls Frozen Ready-To-Eat Crispy Chicken with Almonds Entrée Products Due to Misbranding and an Undeclared Allergen
MOUNTAIN VIEW PACKAGING, LLC

FSIS Announcement

WASHINGTON, Dec. 15, 2022 – Mountain View Packaging, LLC, a Boise, Idaho establishment, is recalling approximately 6,013 pounds of frozen, ready-to-eat Crispy Chicken with Almonds entrée products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains shellfish (shrimp), a known allergen, which is not declared on the product label.

Seattle Company Recalls Long Pepper Product After Mold and Mycotoxin Detected in Sample

Something South African LLC of Seattle, WA is recalling the Peppercorn Collection Gift Set, affected Best Before End (BBE) date of JUN/2024, Batch 494951-T, because mold (Aspergillus brasiliensis) and Ochratoxin A were detected in the Malaysian Long Pepper.

"The recall was initiated when our supplier notified us that mold (Aspergillus brasiliensis) and Ochratoxin A were detected in the Malaysian Long Pepper. The company has ceased the production and distribution of the product as our supplier continues with their root cause investigation."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/something-south-african-llc-recalls-peppercorn-collection-gift-set-because-possible-health-risk
Something South African LLC Recalls the Peppercorn Collection Gift Set Because of Possible Health Risk
Summary
Company Announcement Date:  December 15, 2022
FDA Publish Date:  December 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Mold (Aspergillus brasiliensis) and Ochratoxin A contamination
Company Name: Something South African LLC
Brand Name:  World Market

Product Description:   Pepper Collection Gift Set

Protein Powder Recalled for Milk Allergens Due to Mislabeling

Power Life Nutrition of Woodland Hills, CA is voluntarily recalling a limited amount of its High Impact Plant Protein due to a labeling error. For a brief period during the manufacturing process, jars containing High Impact Whey Protein were mislabeled as High Impact Plant Protein. The mislabeled product is safe to consume for consumers who ordered High Impact Whey Protein, but it does not contain an allergen declaration for the milk allergen in the product.

"The recall was initiated after it was discovered that a limited quantity of units of High Impact Whey Protein incorrectly contained the label for High Impact Plant Protein. Subsequent investigation indicates the problem was caused by an error in the manufacturer’s packaging process manufacturer." [?]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/thgh-partners-llc-issues-allergy-alert-undeclared-milk-power-life-plant-protein
THGH Partners LLC Issues Allergy Alert on Undeclared Milk in Power Life Plant Protein
Summary
Company Announcement Date:  December 15, 2022
FDA Publish Date:  December 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  THGH Partners LLC
Brand Name:  Power Life
Product Description:  High Impact Plant Protein

Just Another Recall of Enoki Mushrooms After Listeria Detected in Sample

Utopia Foods Inc of Glendale, NY, is recalling its 200g packages of “Enoki Mushrooms”, imported from China and distributed nationwide in the US, because they have the potential to be contaminated with Listeria monocytogenes.  The recalled “Enoki Mushrooms” were distributed nationwide in produce wholesale companies.  No illnesses have been reported to date in connection with this problem.

The potential contamination was noted by a routine sampling conducted in the State of Missouri revealed the presence of Listeria monocytogenes in the 200g packages of “Enoki Mushrooms”.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/utopia-foods-recalls-enoki-mushrooms-because-possible-health-risk
Utopia Foods Recalls “Enoki Mushrooms” Because of Possible Health Risk
Summary
Company Announcement Date:  December 13, 2022
FDA Publish Date:  December 13, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes contamination
Company Name:  Utopia Foods Inc
Brand Name:  Utopia Foods Inc
Product Description:  Enoki Mushrooms

Infant Formula Recalled After Cronobacter-Postive Sample Detected at Copacker

ByHeart, a next-generation baby nutrition company, is voluntarily recalling five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii.  No distributed ByHeart product has tested positive for the bacteria.

"ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager. ByHeart is taking this precautionary measure because one test sample collected from the third-party packaging facility tested positive for Cronobacter sakazakii. All product packaged that day, and the first production on the next day, was isolated for destruction and not distributed. Out of an abundance of caution, we are now recalling all product produced during the entire production run."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-issues-voluntary-recall-five-batches-its-infant-formula-because-possible-health-risk
ByHeart Issues Voluntary Recall of Five Batches of Its Infant Formula Because of Possible Health Risk
Summary
Company Announcement Date:  December 11, 2022
FDA Publish Date:  December 11, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential for cross-contamination with Cronobacter sakazakii
Company Name:  ByHeart
Brand Name:  ByHeart
Product Description:  Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months

Rat Sightings Have Been Rising in Large Cities

New York City recently listed a job posting for Director of Rat Mitigation, with a six figure salary to get NYC increase rat problem under control.   But NYC is not alone, nor is at the top of cities having rat problems.  An article in Axios Boston states that Boston state that Boston has the highest level of rat sightings with 21.6% of homes with a rodent sighting...followed by Philadelphia (19.5%), and then New York City (15.3%).

Why the increasing problem?  An article in the Washington Post provided this: "Rats are a fixture of urban life, but early in the pandemic, their populations in urban cores shrank as restaurants, parks and offices shut down — and their access to trash did too.  But many adapted, desperate to survive. They ate off the bottom of restaurant doors in search of food, alpha male rats ate weaker ones, and a large number, to residents’ frustration, migrated."   Basically, rats had to move where prospects for food were greater, and that unfortunately is where people live, store their food and place their trash.

NYC War on Rats: Can 4 New Rodent Laws Fix the Crisis?
NYC believes four rodent-related bills may be the solution to the city's longstanding rat problem. Here are some of the changes you can expect in your community

By Erica Byfield • Published November 18, 2022 • Updated on November 18, 2022 Four new bills were signed into law on Friday, each designed to target one of New York City's longest and strongest enemy: the rat.

CDC Report - Appliances Used to Cook Frozen Stuffed Chicken Products

Frozen breaded stuffed chicken products are viewed as a Salmonella risk due to multiple Salmonella outbreaks over the past decade.  

"These products are partially cooked to set the breading, often making them appear cooked (2). Despite their appearance, these products need to be cooked to an internal temperature of 165°F (74°C) to ensure that they are safe to eat. Producers began implementing labeling changes in 2006 to more clearly identify these products as raw; many warn against using microwave ovens (microwaves) to prepare them and provide validated cooking instructions solely for conventional ovens (ovens) (3,4). However, outbreaks continued to occur after implementation of these labeling changes (4)"

A study was conducted to see how people normally cook this product.  "Although ovens were the most commonly reported appliance used to cook frozen stuffed chicken products, more than one half of respondents (54.0%) reported using other appliances instead of or in addition to ovens, including microwaves (29.0%), a circumstance that historically has been reported frequently by ill persons in outbreaks associated with frozen stuffed chicken products (1). Respondents with lower incomes and who live in mobile types of homes reported lower oven use and higher microwave use. Persons within these groups might be at increased risk for illness related to both challenges in preparing these foods and access to appliances."

 "Studies indicate that microwaves, air fryers, and toaster ovens inconsistently heat frozen stuffed chicken or frozen raw breaded chicken (4,6,7). Therefore, cooking instructions often do not include information about cooking the product in air fryers or toaster ovens and might warn against using microwaves. However, previous studies have found that some consumers infrequently read package instructions (8,9), including one report that found some consumers discarded packaging when the products were brought home and never saw cooking instructions (9). In this survey, 30% of respondents reported using an air fryer, 29% a microwave, and 14% a toaster oven. These findings suggest that relying on labeling and cooking instructions might not be sufficient to prevent illness. Further, even when cooking these products in an oven, verifying the temperature of the finished product is important (7). However, food thermometer usage can be low; one study found that even among persons who owned a food thermometer, only 38% typically used them to check doneness of frozen chicken products (2)."


https://www.cdc.gov/mmwr/volumes/71/wr/mm7148a2.htm?s_cid=mm7148a2_w#contribAff
Appliances Used by Consumers to Prepare Frozen Stuffed Chicken Products — United States, May–July 2022
Weekly / December 2, 2022 / 71(48);1511–1516

Katherine E. Marshall, MPH1,*; Michelle Canning, MPH1,2,*; Michael Ablan, MPH1; Tamara N. Crawford, DBH1; Misha Robyn, DVM1 (VIEW AUTHOR AFFILIATIONS)

Summary

What is already known about this topic?
Frozen stuffed chicken products remain a source of Salmonella outbreaks despite changes to packaging instructing consumers to cook these products in ovens and to avoid using microwaves.

What is added by this report?
More than one half of respondents to an Internet panel survey reported using an appliance other than an oven to cook frozen stuffed chicken products; 29% used a microwave. Respondents with lower incomes and who live in mobile types of homes reported lower oven use and higher microwave use.

What are the implications for public health practice?
Economic and other factors might influence access to recommended cooking appliances. Companies could consider implementing interventions that rely less on labeling and consumer preparation practices to ensure safety.

Border Guards Find $3 Million of Meth in Shipment of Carrots

US Customs and Border Protection detained a shipment of carrots after finding close to 1,500 lbs (over $3 million in street value) of meth within the shipment.

Produce News
https://theproducenews.com/headlines/shortsighted-smuggler-busted-3m-carrot-and-meth-shipment
Shortsighted smuggler busted with $3M carrot and meth shipment

December 8, 2022

U.S. Customs & Border Protection officers at the Otay Mesa Cargo Facility in San Diego found over $3 million worth of methamphetamine hidden in a shipment of carrots.

Packages of Jujube Recalled for Undeclared Sulfites

Northern Food I/E Inc. of Westbury, NY is recalling all lots and codes of its 8.3-ounce (235-gram) packages of “Lukai sweetened jujube” because they may 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 that the sulfite containing product was distributed in packages that did not reveal the presence of sulfites.

Jujube is a small fruit similar to a date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/northern-food-ie-recalls-sweetened-jujube-due-undeclared-sulfites
Northern Food I/E Recalls “Sweetened Jujube” Due to Undeclared Sulfites
Summary
Company Announcement Date:  December 06, 2022
FDA Publish Date:  December 07, 2022
Product Type:  Food & Beverages  Fruit/Fruit Product
Reason for Announcement:  Undeclared Sulfites
Company Name:  Northern Food I/E Inc.
Brand Name:  Lukai
Product Description:  Sweetened Jujube

Advent Calendars with Chocolate w/ Creamy Filling Recalled After Testing Finds Salmonella

Lidl US has announced a voluntary recall for the 8.4 oz Favorina branded Advent Calendar (Premium Chocolate with a Creamy Filling) due to potential Salmonella contamination.  This issue was found during routine testing, which Lidl performs on an ongoing basis to help ensure safe and quality products for our customers. Lidl US has received no reports or complaints of illness related to this product to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lidl-voluntarily-recalls-84-oz-favorina-branded-advent-calendar-premium-chocolate-creamy-filling-due
LIDL Voluntarily Recalls 8.4 Oz Favorina Branded Advent Calendar (Premium Chocolate with a Creamy Filling) Due to Potential Salmonella Contamination
Summary
Company Announcement Date: December 06, 2022
FDA Publish Date:  December 06, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of Salmonella
Company Name:  Lidl US
Brand Name:  Favorina
Product Description:  Advent Calendar (Premium Chocolate with a Creamy Filling)

Recall Issued After Meltaway Mixup - Peanut Butter Packaged Instead of Mint

Cranberry Sweets & More of Coos Bay, Oregon is voluntarily recalling its 4 and 8 ounce packages of "Mint Meltaways" candies because they may contain undeclared peanuts.  The recall was initiated after it was discovered that the Peanut Butter Meltaways product was mis-labeled as Heirloom Mint Meltaways and peanut was not declared on finished product label. The firm’s subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging process. The process has been corrected and the company has instituted additional safety checks and corrective actions.

Labeling verification as part of the Allergen Preventive Controls could entail continuous organoleptic testing.  Any volunteers?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cranberry-sweets-more-issues-allergy-alert-undeclared-peanuts-mint-meltaways
Cranberry Sweets & More Issues Allergy Alert On Undeclared Peanuts In “Mint Meltaways”
Summary
Company Announcement Date:  December 06, 2022
FDA Publish Date:  December 06, 2022
Product Type:  Food & Beverages  Chocolate/Cocoa Product
Reason for Announcement:  Potential or Undeclared Allergen/Peanut
Company Name:  Cranberry Sweets & More
Brand Name:  Cranberry Sweets
Product Description:  Mint Meltaways

USDA Issues Health Alert for Ground Meat After Positive Pathogenic E. coli Test

USDA is issuing a public health alert for ground beef sold at La Michoacana Meat Market, in Greenville, Tex., after a sample of the product tested positive for the presence of Escherichia coli (E. coli) O157:H7. A recall was not requested because there is no product currently available for sale to consumers; however, the ground beef product may remain in consumers’ homes and could cause illness if eaten.  The problem was discovered during routine FSIS product testing when a sample confirmed positive for the presence of E. coli O157:H7. There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ground-beef-products-tested-positive-e--coli-o157h7
FSIS Issues Public Health Alert for Ground Beef Products That Tested Positive for E. Coli O157:H7

FSIS Announcement

WASHINGTON, Dec. 5, 2022 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ground beef sold at La Michoacana Meat Market, in Greenville, Tex., after a sample of the product tested positive for the presence of Escherichia coli (E. coli) O157:H7. A recall was not requested because there is no product currently available for sale to consumers; however, the ground beef product may remain in consumers’ homes and could cause illness if eaten.

Ham and Cheese Loaf Products Recalled After Being Sliced on Equipment Exposed to Under-processed Product

Kraft Heinz Foods Company, a Kirksville, Mo. establishment, is recalling approximately 2,400 pounds of ready-to-eat ham and cheese loaf products due to possible cross-contamination with under-processed products.  The problem was discovered when the establishment notified FSIS that the product was sliced on the same equipment as product that had been under processed, and the equipment was not cleaned between runs of the under-processed and fully cooked product. This has led to concerns of possible cross-contamination of the fully cooked ham and cheese loaf product.

This scenario is easy to imagine.  Product is produced that is under-processed and put on hold.  But the post-processing equipment, now exposed to under-processed meat potentially containing pathogens like Salmonella or Listeria, is not completely cleaned prior to running good product.

When under-processed product touches the equipment on the post-process side of the operation (what is considered the RTE side or clean side of the operation), then all that equipment must receive a complete sanitation.

https://www.fsis.usda.gov/recalls-alerts/kraft-heinz-foods-company-recalls-ready-eat-ham-and-cheese-loaf-products-due
Kraft Heinz Foods Company Recalls Ready-To-Eat Ham and Cheese Loaf Products Due to Possible Cross-Contamination From Under-Processed Products
KRAFT HEINZ FOODS COMPANY

FSIS Announcement

WASHINGTON, Dec. 5, 2022 – Kraft Heinz Foods Company, a Kirksville, Mo. establishment, is recalling approximately 2,400 pounds of ready-to-eat ham and cheese loaf products due to possible cross-contamination with under-processed products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Chilean Frozen Raspberries Recalled After FDA Detects Hepatitis A

Exportadora Copramar is recalling 1260 cases of James Farm frozen raspberries due to the potential of the product being contaminated with Hepatitis A.  U.S. Food and Drug Administration (FDA) testing indicated the presence of Hepatitis A in James Farm branded frozen raspberries identified by UPC Code: 76069501010 and Lot Code - 22-165.  The product is exclusively sold through Restaurant Depot/Jetro locations in New York, New Jersey, Connecticut, Massachusetts, Rhode Island, Pennsylvania, Maryland, Virginia and Delaware.  Product is from Chile.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exportadora-copramar-recalls-james-farms-frozen-raspberries-due-possible-health-risk
Exportadora Copramar Recalls James Farms Frozen Raspberries Due to Possible Health Risk

Summary

Company Announcement Date:  December 03, 2022

FDA Publish Date: December 03, 2022

Product Type: Food & Beverages Fruit/Fruit Product

Reason for Announcement:  Hepatitis A

Company Name:  Exportadora Compramar

Brand Name:  James Farms

Product Description:  Frozen Raspberries

Low Fat Pet Food Recalled After Consumers Notice Product with Gravy

"Nestlé Purina PetCare Company is voluntarily recalling a limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food in 13.4 oz cans due to a labeling error. For a brief period on September 15, 2022, cans of a different complete and balanced adult dog food, Purina ONE True Instinct Tender Cuts In Gravy With Real Turkey & Venison wet dog food, were labeled as PPVD EN Low Fat in one of our factories. The mislabeled diet is safe to feed, but it is not the intended formula for dogs requiring a prescription PPVD EN Low Fat diet, who may have sensitivities to traditional diets or difficulty digesting fat."  The company became "aware of the issue after being contacted by several pet owners who observed the texture of food in their PPVD EN Low Fat cans was not the same as previous meals. The mislabeled product contains chunks in gravy, while the correct product looks more like a pate consistency."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-purina-petcare-company-voluntarily-recalls-limited-amount-purina-pro-plan-veterinary-diets-en
Nestlé Purina PetCare Company Voluntarily Recalls a Limited Amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat Wet Dog Food Due to Labeling Error

Summary
Company Announcement Date: November 30, 2022
FDA Publish Date:  December 02, 2022
Product Type:  Animal & Veterinary  Pet Food 
Reason for Announcement:  Mislabeling
Company Name:  Nestle Purina PetCare Company
Brand Name:  Labeling error
Product Description:  Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food

FDA Warning Letter to CA Bakery for Having No Food Safety Plan and Having GMP Issues

FDA issued a Warning Letter to The Bonami Baking Company, Inc. of  Pittsburg, CA, a manufacturer of ready-to-eat (RTE) bakery products.  Basically, the company did not have a Food Safety Plan, so there was no evaluaiton for allergens or pathogens or mycotoxins.   On top of that, there was numerous GMP issues with a high number of insect-related sightings.  Finally, there were some misbranding issues.

Now, if one looks at the compay website, it looks like a legitimate operation. 

Bonami Bakery – Bay Area Bakery Shop (thebonamibakery.com)

FDA Warning Letter

The Bonami Baking Company, Inc.
MARCS-CMS 633746 — SEPTEMBER 07, 2022

FDA Issues Warning Letter to MA Fudge Processing Company

FDA issued a Warning Letter to Winfrey's Olde English Fudge, Inc. of  Rowley, MA, a producer of ready-to-eat (RTE) enrobed chocolates and fudge, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs.

1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control - 

• "Did not identify and evaluate the hazard of allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The company manufactures multiple products with different allergen profiles on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls"

FDA Issues Updated Version of Allergen Guidance for Comment

FDA issued updated Q&A guidance documents (5th edition) on allergen labeling.   The original document (4th edition) was spit into two sets....one being the updated set of Q&A which is labeled as 5th ed. Draft, and the other being those original Q&A are in the document labeled 5th ed. Final.  (Why you may ask?  So the updated or Draft set of Q&A can be made available or open to comment while the Final set of Q&A is not.)

So for our discussion, the Draft version is more important as that represents new or updated thinking by FDA.  (Draft - https://www.fda.gov/media/163454/download)

Here are the primary items discussed in the Draft Guidance:
Sesame is now included, although this fact is not up for comment.
Ingredients and bulk ingredients used in further manufacturing must have allergen declarations.

Incidental allergens must be declared (soy lecithin, for example, used as a processing aid)

Spice and seasoning mixes must declare allergens.

Dietary supplements using roots, leaves stems and bark from tree nuts do not.

Genetic engineering - if allergen is produced, it must be stated.

Specific tree nuts must be listed - the entire list is provided.

The allergen statement as placed on the package is discussed.

The use on multipacks of food within a master pack.

Food ingredients that are derived from allergenic foods (highly refined oils, etc)

Incidental additives is discussed.

Also a section on Dietary supplements.


https://www.fda.gov/media/163454/download
Constituent Updates

Center for Food Safety and Applied Nutrition

________________________________________

FDA Issues Guidances on Food Allergen Labeling Requirements

Today, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list.

FDA Issues Warning Letter to VA Spout Operation

FDA issued a Warning Letter to Happy Sprout Inc. of Springfield, VA after determining that the mung bean and soybean sprout products were adulterated (prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health).

1. "Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes.  "The cleaning and sanitizing methods that you use are not adequate to control Listeria species, as evidenced by FDA findings of Listeria species (not monocytogenes) in seven (7) environmental swabs collected during the inspection and a finished product sample collected from a retail location.""
2. "Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 and in accordance with 21 CFR 112.144(b). You stated that you do not sample SSIW or in-process sprouts and that you were unsure if your sprouting operation has ever tested SSIW or in-process sprouts for any pathogen, including Escherichia coli O157:H7 or Salmonella spp."
3. "Did not sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR 112.143(b). On May 23, 2022, investigators observed your sanitation practices after packaging ready-to-eat soybean sprouts. You did not apply sanitizer solution on any food contact surface. Instead, your employees rinsed equipment with water and (b)(4). Investigators observed your firm packing mung bean sprouts on May 24, 2022, without applying sanitizer prior to packing the sprouts. In addition, when an employee was asked about the frequency of sanitation activities, the employee stated that sanitizer is applied, “(b)(4).” Your General Manager also stated that while (b)(4) cleaning is conducted (b)(4), the (b)(4) is deep cleaned and sanitized"
4. "Did not train personnel who handle (contact) covered produce or food contact surfaces, as required by 21 CFR 112.21, and personnel who conduct covered activities or who supervise personnel who handle covered produce or food contact surfaces as required by 21 CFR 112.22. For example, farm management stated that employees were trained approximately ten (10) years ago. The timeframe of (b)(4) for employee training does not meet the requirement of at least once annually, as required by 21 CFR 112.21(a). In addition, training must be conducted in a manner that is easily understood by the personnel being trained (21 CFR 112.21(c)). Your employees stated that (b)(4). Your supervisor did not demonstrate a means to communicate with employees in order to correct their food handling practices. Further, farm management stated that they have not successfully completed a food safety training at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as required by 21 CFR 112.22(c). This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019."
5. "Personnel at your firm did not use hygienic practices, as required by 21 CFR 112.32. Specifically:
1. On May 23 and 24, 2022, four (4) employees handled sprouts without first washing their hands before donning single-use gloves when returning from break or handled sprouts when gloves may have been soiled.
2. On May 24, 2022, employees handled the bottom of a bin kept on the floor and then handled sprouts without washing their hands or changing gloves.
3. On May 24, 2022, a gloved employee picked up a hose lying on the floor, used the hose, and then rinsed their gloved hands with only water in the production room hand sink before returning to the production line to skim mung bean sprout particles from the production line water bath.
4. On May 23, 2022, two employees were packaging sprouts wearing watches that were not covered by their gloves or clothing. An employee was wearing a dangling necklace while packaging sprouts."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-sprout-inc-638237-10272022
WARNING LETTER

Happy Sprout Inc.
MARCS-CMS 638237 — OCTOBER 27, 2022
Recipient:
Hyo Young Lee
Owner
Happy Sprout Inc.
7954 Twist Lane, Unit H
Springfield, VA 22153-2823
United States

A Meat-alternative Plant Receives Scrutiny After Employee Leaks Information to Press

An employee leaked information and pictures to a news reporter regarding unsanitary conditions at facility that produces alternative-meat products.  Listeria-testing data indicated a high prevalence of Listeria in the facility, which may not be overly surprising for a facility that was once a meat operation until it was purchased to produce meat-alternative products.  While the meat-alternative products are not RTE, that is, they will be cooked, one would not expect to see this level considering the ingredients used to make the meat-alternative product.  Couple this with unsanitary procedures creates a higher risk status for the consumer.

"In a response to Bloomberg, Beyond pointed out that the plant had passed inspections by both state and federal authorities. Bloomberg, however, stated that the state “inspection” was a routine annual visit that did not include a comprehensive examination of food safety, and that the USDA said it hadn’t inspected the plant since Beyond bought it."

Food Processing Magazine
https://www.foodprocessing.com/food-safety/cleaning-sanitation-hygiene/news/21438201/report-beyond-meat-plant-had-sanitation-problems
Report: Beyond Meat Plant Had Sanitation Problems
Nov. 22, 2022

Ice Cream Recalled After Packaging Error Results in Undeclared Allergens

Weis Markets today said it has issued a recall for 108 containers of Weis Quality Sea Salt Caramel Ripple Ice Cream (48oz) since the product may contain undeclared soy and coconut allergens.  The recall was initiated after it was discovered that product containing soy and coconut was distributed in packaging that did not reveal the presence of soy and coconut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weis-markets-issues-allergy-alert-weis-quality-premium-sea-salt-and-caramel-ripple-ice-cream-due
Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens
Summary
Company Announcement Date:  November 23, 2022
FDA Publish Date:  November 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Coconut Allergens
Company Name:  Weis Markets
Brand Name:  Weis Quality
Product Description:  Premium Sea Salt and Caramel Ripple Ice Cream

QA Director Pleads Guilty to Concealing Conditions That Lead to Salmonella Outbreak Linked to Cereal

A QA Director has pleaded guilty for concealing food facility conditions that led to a Salmonella outbreak where 130 people were infected. "Ravi Chermala overlooked unsanitary conditions that led to the Salmonella outbreak linked to Kellogg's Honey Smacks cereal in 2018.

From the Justice report, "Ravi Kumar Chermala, 47, pleaded guilty to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala, Kerry’s Director of Quality Assurance until September 2018, oversaw the sanitation programs at various Kerry manufacturing plants, including a facility in Gridley, Illinois, that manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company. In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility. In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions."

Don't be this guy.


https://www.foodprocessing.com/food-safety/news/21438121/former-kerry-qa-director-pleads-guilty-in-2018-salmonella-outbreak-from-kelloggs-honey-smacks-cereal
Former Kerry QA Director Pleads Guilty in 2018 Salmonella Outbreak
Nov. 20, 2022

Ravi Chermala overlooked unsanitary conditions that led to Kellogg's Honey Smacks cereal recall and 130 illnesses.

Just Another Recall for Enoki Mushrooms After MI Lab Detects Listeria

Green Day Produce, Inc. of Vernon, CA is recalling its 200g/ 7.05oz packages of ENOKI MUSHROOM (Product of Korea) sold from September 2022 - October 2022 because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample was collected and analyzed by Michigan Department of Agriculture and Rural Development (MDARD) and revealed the presence of Listeria monocytogenes in 200g/7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-day-produce-inc-recalls-enoki-mushrooms-because-possible-health-risk
Green Day Produce, Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria Monocytogenes
Company Name:  Green Day Produce
Brand Name:  Green Day Produce
Product Description:  Enoki Mushrooms

Wheat-free Power Pancakes Recalled for Containing 1% Wheat

Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat.  All 5 varieties of pancakes contain rye flour that contains 1% wheat. Labels on the product distributed state “wheat free” and new labels will read “99% wheat free”.

1) That 1% present does not allow one to say 'free' from that.

2) Power pancakes are a thing.....just have to douse them with plenty of maple syrup I guess to get them to slide on down.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake
Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Phil’s Power Pancake
Brand Name:  Phil’s Power Pancake
Product Description:  Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed

Australia - Poppy Seed Mix-up Results in Illness as People Consume Poppy Seed Tea Containing Seeds Grown for Medicine

In Australia, 19 people suffered toxic contamination after drinking poppy seed tea.  The poppy seeds in the product contained non-food-grade seeds that were grown for their medical attributes, namely they contain high amounts of the controlled drug thebaine.

As you may know, poppy seeds come from the poppy flower, which is the source of the narcotic drug opium which is used to produce painkillers like morphine and codeine.  "Australia is one of the largest global producers of poppy seeds, with Tasmania at one point estimated to have supplied half of global stocks.  The crop is tightly controlled, because the plant's capsules can be deadly if ingested. Overdoses from drinking poppy have been fatal."

https://www.abc.net.au/news/2022-11-16/poppy-seed-warning-recalled-thebaine-toxic-tea-opiates/101659048
There is a nationwide recall of toxic poppy seeds. What is thebaine? And how do you get sick from poppy seeds?
Posted Tue 15 Nov 2022 at 9:24pmTuesday 15 Nov 2022 at 9:24pm, updated Wed 16 Nov 2022 at 6:04pm

Tyson Recalls 50 Tons of Ground Meat After Complaints of Mirror-like Foreign Material

Tyson Fresh Meats, Inc., an Amarillo, Texas establishment, is recalling approximately 93,697 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically reflective mirror-like material.  The problem was discovered when the firm notified FSIS that they received consumer complaints reporting findings of “mirror-like” material in ground beef products purchased from grocery stores.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/tyson-fresh-meats-inc--recalls-raw-ground-beef-products-due-possible-foreign-matter
Tyson Fresh Meats, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination
TYSON FRESH MEATS, INC.

FSIS Announcement

WASHINGTON, Nov. 16, 2022 – Tyson Fresh Meats, Inc., an Amarillo, Texas establishment, is recalling approximately 93,697 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically reflective mirror-like material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

NY Firm Recalls Fudge After Packaging Mix-up Results in Undeclared Walnuts

Fudgeamentals of Melville, New York has voluntarily recalled one lot of Chocolate Fudge Bites packaged in 8 oz. plastic containers. The Chocolate Fudge Bites products may contain Chocolate Walnut Fudge Bites products instead, resulting in the presence of undeclared tree nut (walnut) ingredient.  The issue was discovered after one of the store employees discovered Chocolate Walnut Fudge Bites were incorrectly labeled as Chocolate Fudge Bites.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fudgeamentals-recalls-chocolate-fudge-bites-because-undeclared-walnuts
Fudgeamentals Recalls Chocolate Fudge Bites Because of Undeclared Walnuts
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 17, 2022
Product Type:  Food & Beverages  Chocolate/Cocoa Product
Reason for Announcement:  Undeclared walnuts
Company Name:  Fudgeamentals
Brand Name:  Fudgeamentals
Product Description:  Chocolate fudge bites

Closure of Local Pizza Shop Gains Media Attention

Canyon Pizza has been a State College staple for late night pizza since 2001. Not necessary an award winning pizza, but with its large pies and cheap price, it have endured the ever changing restaurant scene in this college town. After an inspection by the local health authority this week, however, it received a lot of press, although not the good kind.

The inspection noted 13 violations.  None by itself that would store-closing, but in total, it paints the picture of a dirty operation, one that is definite need of a good scrubbing and repair.  How did it get to this point?  Didn't management look closely and think that things are not as they should be?  Why do some have to wait until an inspection in order to do the necessary work?  And now, to have the brand damaged for all to see.

PDA website for results of restaurant inspections
https://www.pafoodsafety.pa.gov/Web/Inspection/PublicInspectionSearch.aspx

4 - 301.14 Explain Code Submit
Inspector Comments
--Hood system is not adequate to remove heat and/or grease, as evidenced by condensate and/or grease collecting on the walls, ceilings, and fixtures. Hood is in need of a professional cleaning as required by the Centre Region Property Maintenance Code.

Ending the Thanksgiving Meal Controversies

Thanksgiving.   A time to gather with family and friends.  A time to feast.   A time to time to argue….umm….converse about important stuff ...like stuffing. Indeed, there are some age-old controversies surrounding the Thanksgiving meal.  Questions such as.....Is it stuffing or is it dressing? ......White meat vs dark meat? ......What is the best temperature for cooking the turkey?

To help foster a harmonious atmosphere during your holiday gathering, we will provide you with some next-level input for resolving these questions. We have assembled a Blue Ribbon Panel….Yes, I know what you are thinking….really, a Blue Ribbon Panel? Yes, a Blue Ribbon Panel indeed and that means this s**t is about to get serious. The make-up of this esteemed panel includes the tri-country turkey basting champion from Rebersburg PA, a state inspector from the top turkey-growing state of Minnesota (I too thought it was North Carolina…I guess the frigid weather saves on freezing costs), a decorated Blue Ribbon Panelist from Shickshinny, PA who has served on over 30 Blue Ribbon Panels, a faculty member who did not want to share NIL information (name, image, likeness) without proper compensation, a bearded guy named Jeb, and a few others who were loitering in the hall. 

They are ready, so let’s get on to it.

Stuffing vs Dressing? Some call it stuffing. Some call it dressing. Some people say it depends on whether it is in the bird, stuffing, or cooked as a casserole, dressing. However, it is the same stuff, regardless.  What you call it depend on where you are from….a regional thing. So to settle this, we go to a source that knows no boundary….Walmart. We took a look at the bags of product sold at Walmart (including Martin’s Stuffing Cubes and Pepperidge Farms Stuffing Mix) and what do you notice….these bags are labeled stuffing. And the listed directions do not have different names for how it is made….that is, whether making it inside the bird or doing it straight up in the casserole dish, they call it stuffing. 

Blue Ribbon Panel – Stuffing.

FDA Rolls Out Traceability Rule as Part of FSMA Regulations

FDA released (11/15/22) their latest rule, Food Traceability as a means to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.  (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods)

Basically, if the food item is on the FTL, the Food Traceability List, there are traceability requirements.

The items that are currently on the list (below) require a Food Traceability Plan (except for those where there is an exemption)

1. A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records. 
2. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold; 
3. A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable; 
4. A statement identifying a point of contact for questions regarding your traceability plan and records; and 
5. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods. 
• Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
• For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container

You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.

Specific records (KDE) must be kept for each Critical Tracking Event (CTE) -  harvesting, cooling, initial packing, shipping, receiving, and transforming the product.

There is more information summarized on the FDA website for what needs to be recorded for each of the steps (below)  However, one can expect that most processors will already have the required tracking systems in place including lot coding.  So the KDEs for the CTL of Transformation (processing).

Transformation KDEs  (Key Data Elements)

FTL food(s) used as ingredient(s)

KDEs must be linked to the new traceability lot for the food

• Traceability lot code for the food

• Product description for the food to which the traceability lot code applies

• For each traceability lot used, the quantity and unit of measure of the food used from that lot

Transformation KDEs for New food produced

KDEs must be linked to the new traceability lot for the food

• New traceability lot code for the food

• Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) 

the traceability lot code source reference

• Date transformation was completed

• Product description for the food

• Quantity and unit of measure of the food

• Reference document type and reference document number

So for the the items on the FTL, you will need KDEs for each of the CTLs  (oh brother).

So what items are on the FTL for now. (And items can be added to this list over time by FDA)

FDA Warning Letter Issued to Bakery for Lack of Allergen Preventive Controls

FDA issued a Warning Letter to a Chicago bakery, Third Synthesis Inc., dba Chicago Sweet Connections, Inc..  FDA determined that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility were adulterated within the meaning of the regulation because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they 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. 

The facility did not consider allergens a significant hazard within the food safety plan although the "facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production." FDA concluded "Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control."  Further, "Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg."

Another issue with the Food Safety Plan was not utilizing a Sanitation Preventive Control for pathogens in post-process environment.  The report also criticizes the plan development for not identifying mycotoxins as a hazard in the hazard analysis.

There were also a number of label design issues that resulted in a number of products being mislabeled.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/third-synthesis-inc-dba-chicago-sweet-connections-inc-633453-09062022
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 — SEPTEMBER 06, 2022

Recipient:
Anthanasios Kailis
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
United States

The Importance of Reanalysis of the Food Safety Plan

An article in Food Safety Magazine discusses the importance of conducting the reanalysis of the food safety plan.  For many organizations, the reanalysis process is put off until the time it is required to be completed.  Rather, it should be an active process that is ongoing with specific triggers, including process change or failure, complaint data, or industry developments.

https://www.food-safety.com/articles/8051-reanalysisa-critical-component-of-verification
Reanalysis—A Critical Component of Verification

The Food Safety Plan/HACCP Plan is a living document that requires ongoing maintenance, including reanalysis at appropriate time intervals

CDC Investigating a Listeria Outbreak Linked to Deli meat and Cheese

CDC is investigating an Outbreak of Listeria linked to deli meat and cheese. There have been 16 illnesses and 1 death from 6 states, with NY showing the highest level (7 cases).  " Sick people range in age from 38 to 92 years, with a median age of 74, and 62% are male. Of 13 people with ethnicity information available, 11 are of Eastern European background or speak Russian. Of 14 people with information available, 13 have been hospitalized, including one Maryland resident who died. One person got sick during their pregnancy, resulting in pregnancy loss."

"In 2021, health officials in New York state and New York City found the outbreak strain of Listeria in several environmental and food samples: 1) Environmental samples from a NetCost Market deli in Brooklyn, 2)Several open packages of mortadella and ham that were sliced at the same NetCost Market deli in Brooklyn and 3) Sliced salami that a sick person bought from a NetCost Market deli in Staten Island.  In September 2022, the outbreak strain was found at the same Brooklyn NetCost Market deli; however, the most recent illness with NetCost Market exposure was in October 2021. After a deep cleaning, additional environmental testing did not identify Listeria in the deli."

https://www.cdc.gov/listeria/outbreaks/deli-11-22/index.html
Listeria Outbreak Linked to Deli Meat and Cheese
Fast Facts
Illnesses: 16
Hospitalizations: 13
Deaths: 1
States: 6
Recall: No

Non-Federally-Inspected CA Establishment Recalls Beef Dumplings

Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling products that were produced without the benefit of federal inspection. The product subject to recall does not bear the USDA mark of inspection because Menu19 LLC is not a federally inspected establishment. These items were shipped to restaurants and retail locations in California. The problem was discovered during routine FSIS surveillance activities in retail stores when it was determined that the Mantu beef dumpling products did not have the USDA mark of inspection and were produced in an establishment that was not inspected by USDA.

https://www.fsis.usda.gov/recalls-alerts/menu19-llc-recalls-frozen-beef-dumpling-products-produced-without-benefit-inspection
Menu19 LLC Recalls Frozen Beef Dumpling Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, Nov. 9, 2022 - Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

IA Company Recalls Granola Product Due to Undeclared Milk

Big Sky Bread Company of Urbandale, IA is recalling their Big Sky Chocolate Chunk Granola and Big Sky Chocolate Chunk Peanut Butter Chip Granola because it may contain undeclared milk.  The recall was initiated after it was discovered during a routine inspection that a product containing milk was distributed in packaging that did not reveal the presence of milk.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate
Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola
Summary 
Company Announcement Date:  November 09, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Big Sky Bread Company
Brand Name:  Big Sky Bread Company
Product Description:  Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola

Whole Food Supplier Recalls Crumb Cakes Due to Undeclared Pecans

BOSTON BAKING, Inc. of Boston, MA, is recalling its 3-ounce, individually wrapped packages "Boston Baking Mini Cinnamon Crumb Cakes" food snacks sold exclusively at Whole Foods Market stores because they may contain undeclared pecans.  The recall was initiated after it was discovered by Whole Foods Market team member that the pecan-containing product was distributed in packaging that did not include pecans in the ingredient list. Subsequent investigation indicates the problem was caused by an isolated error in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes
Boston Baking Issues Allergy Alert on Undeclared Pecans in "Boston Baking Mini Cinnamon Crumb Cakes"
Summary
Company Announcement Date:  November 14, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared pecans
Company Name:  Boston Baking, Inc.
Brand Name:  Boston Baking
Product Description:  Mini Cinnamon Crumb Cake

RTE Smoked Salmon Recalled After Sample Tests Positive for Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 540 cases of Giant Food Private Label Sockeye Smoked Salmon, because it has the potential to be contaminated with Listeria monocytogenes.  The product was distributed by Giant Food in Maryland, Virginia, Washington D.C. and Delaware.  The issue was discovered through routine regulatory testing conducted by the Maryland Department of Health.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan
Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  November 08, 2022
FDA Publish Date:  November 08, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Seven Seas International USA, LLC
Brand Name:  Giant
Product Description:  Smoked Salmon

Marshmallow Cookies Recalled After Routine Sampling Finds Salmonella Positive Sample

Comercializadora PepsiCo S. de R.L. de C.V. today issued a voluntary recall for 15.5 oz, 6 count box of Gamesa Arcoiris Marshmallow Cookies due to the potential presence of Salmonella.  The recall was initiated as the result of a routine sampling program by the company, which revealed the finished product may contain Salmonella.  The company initiated the voluntary recall on the product below out of a commitment to and concern for consumers. The product covered by this recall was distributed to warehouses in California and Texas and may have reached consumers through select retail stores.  No illnesses related to Salmonella have been confirmed to date.

Recalls like this are the reason why you need to make sure your laboratory is doing a good job by having controls in place to ensure accuracy of testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies
Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk
Summary
Company Announcement Date:  November 07, 2022
FDA Publish Date:  November 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of Salmonella
Company Name:  Comercializadora PepsiCo S. de R.L. de C.V.
Brand Name:  Gamesa
Product Description:  Arcoiris Marshmallow Cookies

Interagency Report for 2020 on Foodborne Illness Attributed to Salmonella, E. coli O157, and Listeria monocytogenes

An interagency collaboration of FDA, CDC, and USDA, identified as IFSAC, released their yearly report on foodborne illness source attribution estimates based upon outbreak surveillance data.  The goal of this is to "provide a harmonized analytic approach for estimating foodborne illness source attribution  from outbreak data can provide consistency in the use and interpretation of estimates across public health and  regulatory agencies."

The information provides information on outbreaks caused by Salmonella, E.coli O157 and Listeria monocytogenes.

https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2020-report-TriAgency-508.pdf
Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States
The Interagency Food Safety Analytics Collaboration (IFSAC)
November 2022

IFSAC derived the estimates for 2020 using the same method used for the previous estimates, with some modifications. The data came from 1,287 foodborne disease outbreaks that occurred from 1998 through 2020 and for which each confirmed or suspected implicated food was assigned to a single food category. The method relies most heavily on the most recent five years of outbreak data (2016 – 2020). Foods are categorized using a scheme IFSAC created to classify foods into 17 categories that closely align with the U.S. food regulatory agencies’ classification needs.

Salmonella illnesses came from a wide variety of foods.
More than 75% of Salmonella illnesses were attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef, and Turkey.
E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef.
More than 80% of illnesses were linked to these two categories.
Listeria monocytogenes illnesses were most often linked to Dairy products, Fruits, and Vegetable Row Crops.
More than 75% of illnesses were attributed to these three categories, but the rarity of Listeria monocytogenes
outbreaks makes these estimates less reliable than those for other pathogens

Overall Key Results

FL Company Recalls Lettuce After Testing Lab Finds Potential for Salmonella

Kalera Public Limited Company (“Kalera” or the “Company”) (Nasdaq: KAL), is voluntarily recalling 633 cases of Krunch, Butter and Romaine whole head variety lettuce with lot codes 001293 and 001294 on the label and sold under the Kalera brand because it has the potential to be contaminated with Salmonella.  Kalera’s food safety testing procedures indicated the potential presence of Salmonella in some of its whole head lettuce SKUs. The Company promptly reported this issue to the FDA, and, to the Company’s knowledge, no illnesses have occurred or been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalera-voluntarily-recalls-fresh-lettuce-products-because-possible-health-risk
Kalera Voluntarily Recalls Fresh Lettuce Products Because of Possible Health Risk
Summary
Company Announcement Date:  November 03, 2022
FDA Publish Date:  November 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Kalera Public Limited Company
Brand Name:  Kalera
Product Description:  Fresh Lettuce Products

Edible Cookie Dough Recalled for Foreign Material - Soft Plastic Film

Nestlé USA is initiating a voluntary recall of a limited quantity of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® due to the potential presence of soft plastic film.  This voluntary recall is isolated to three batches of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® that were produced August 1-3, 2022. These products were distributed to retailers nationwide.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs
Nestlé USA Announces Voluntary Recall of Limited Quantity of Edible Chocolate Chip Cookie Dough Tubs from NESTLÉ® TOLL HOUSE® Due to Potential Presence of Foreign Material
Summary

Company Announcement Date: November 03, 2022
FDA Publish Date: November 03, 2022
Product Type: Food & Beverages
Reason for Announcement: Potential for Soft Plastic Film
Company Name: Nestle USA
Brand Name: NESTLÉ® TOLL HOUSE®
Product Description: Edible Chocolate Chip Cookie Dough

Popcorn Recalled After Packaging Design Issue Has Gluten Free Statement on Product with Gluten

Cedar Creek Popcorn of Sac City, Iowa is recalling its 18 oz. Old-Fashioned Caramel Holiday Popcorn Box because the side of the box features a Gluten Free claim when there are elements with gluten contained in the product.  The recall was initiated because the Gluten Free claim on the side of the packaging did not match with the product’s ingredient label and allergen information. Procedures are being put in place to assure that food safety issues are taken into consideration for the design and approval of all future packaging.

This appears to be a packaging design issue where someone did not catch the Gluten Free statement on the side of product, although it is clearly stated in the ingredient statement.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/issue-gluten-free-labeling-cedar-creek-popcorn-box-containing-gluten
Issue With “Gluten Free” Labeling on Cedar Creek Popcorn Box Containing Gluten
Summary
Company Announcement Date:  October 28, 2022
FDA Publish Date:  November 01, 2022
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared Wheat
Company Name:  Cedar Creek Popcorn
Brand Name:   Cedar Creek Popcorn
Product Description:   Old-Fashioned Caramel Holiday Popcorn Box

FDA Warning Letters Issued to Three Importers for Lack of FSVP - Nov 1 2022

Three importers were issued Warning Letters by FDA for lacking a FSVP for imported foods.

Facema, LLC. of Laurel, MD did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any imported foods, including the following food:  Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);  Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and 
Peanuts imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/facema-llc-640528-10182022

ARYZ Trading, LLC of  Dearborn, MI did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following foods:  Dried mint: imported from (b)(4)
Tahina: imported from (b)(4) Extra virgin olive oil: imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aryz-trading-llc-639322-09212022

Minuti Coffee Llc, of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following:  a. Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy b. Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minuti-coffee-llc-635961-08232022

FDA Warning Letter - NC Processor of RTE Product with Listeria Issue

FDA issues a Warning Letter to Bakkavor Foods facility in Charlotte, NC, a processor of ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products.

First, this company that processes RTE foods did not recognize environmental pathogens as a significant risk requiring a Preventive Control.  From the report, the" hazard analysis for “Ready to Eat Cold Salads, Sauces, Sides, and Dressings” at various processing steps (e.g., cold mixing, filling) determined that pathogens from “Environmental Cross-contamination” is a “Hazard Not Reasonably Likely To Occur due to lack of history with Food Contact Surface contamination with Listeria spp.” You also reference “Pre-Operational and Operational Sanitation Inspections” and “Good Manufacturing Practices” as “Control Measures in place.” Your sanitation inspections and GMPs are not preventive controls."

Indeed, FDA conducted environmental sampling and found Listeria.  Also of note, based upon WGS identification, the same strains had been found in the facility in 2019....an indication that this is a persistent strain.  

"To underscore the L. monocytogenes risk in your facility: FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on February 8, 2022, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas where products are exposed to the environment prior to packaging in your production room, (b)(4) room, work in progress (WIP) cooler, and (b)(4) room. This was not the first time L. monocytogenes was found in environmental samples collected at your facility."

FDA noted that the company had been finding Listeria in their testing.  However, there was insufficient corrective action taken.

FDA goes on to state, "Given the history of our findings and the presence of L. monocytogenes in your facility, we continue to be concerned about your ability to maintain a sanitary environment. Your written responses did not fully explain how you investigated the source of the resident L. monocytogenes, demonstrate that you have located and eradicated the harborage site(s), or provide supporting documentation to show implementation and verification of adequate corrections (e.g., revised Food Safety Plan or routine environmental sampling results)."

GMP issues

• "Hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (b)(4) area, between the (b)(4) lines in the production room, next to a trash cart in the production room, and in the kettle room."
• "Excessive condensation on the ceiling and evaporators throughout your facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (b)(4) washroom. Also, condensation was observed on the ceiling above the (b)(4) hopper for the (b)(4) machine where RTE (b)(4) and (b)(4) are manufactured."
• "While walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue."
• "Apparent rust on the food-contact parts of the Cheese Grinder (b)(4) and its outlet port. They also observed that the (b)(4) on the (b)(4) tumblers which hold RTE food were damaged, making them difficult to clean."
• "Apparent food residue remaining on the inside cup holder framework of the (b)(4) machine where RTE (b)(4) and (b)(4) dip are packed, as well as on the conveyor belts and framework for (b)(4) lines (b)(4), after pre-op inspection and release by quality assurance "
• "Apparent old and fresh product and black residue on the wheels of the conveyors for the (b)(4) line and the (b)(4) lines after pre-operation inspection and release by quality assurance on February 10, 2022. The wheels contact the outer/food-contact surface of the belts."

There were also issues with the Seafood HACCP plan including temperature control issues with finished product.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakkavor-foods-usa-inc-630545-08082022
Bakkavor Foods USA Inc.

Needing to Update The Environmental Sampling Program?

A recent article in Food Safety magazine ( FDA Environmental Monitoring Tactics Have Changed—Have Yours? Bryan Armentroutasks (2022)) asks if your Environmental Sampling Program can hold up to an FDA inspection's sampling regiment. It highlights aspects of the recently updated FDA Investigation Operational Manual - Chapter 4 - Sampling, specifically from this, Section 4.3.7.7.1 Environmental Sampling.

First, one should be aware and somewhat knowledgeable about the FDA Investigations Operations Manual (IOM) and within that, Chapter 4. Sampling.

The author of the Food Safety Magazine article points out keys of what FDA within their environmental sampling regiment may do that may be different than what a company's sampling plan may do.

• "They will not tell you that they are going to sample, until they are ready to start"
• "They are going to sample food contact and indirect contact surfaces"
• "They are not going to sample floors and drains"
• "They are going to sample during production, with a target of four hours of activity after a wet clean"
• "If a positive is found, they are sending it out for identification, adding it to the U.S. Centers for Disease Control and Prevention (CDC) database, and cross-referencing for any outstanding or past food safety incidents."

This does not mean that a company needs to do exactly what FDA does.  We certainly will maintain a focus on Zones 2 to 4 as a way of understanding contaminants with the facility, and focusing on preventing contamination from getting to food contact surfaces (Zone1).  But a company needs to know that Zone 1 is not contaminated and that contamination does not leak out into the facility once production is in full swing.

Selected items from 4.3.7.7.1
INVESTIGATIONS OPERATIONS MANUAL 2022 (https://www.fda.gov/media/75243/download)

4.3.7.7.1 - Environmental Sampling

• Every effort should be made to conduct Listeria sampling when the facility has been in production for at least four hours and before any wet cleaning is performed. In instances with smaller firms that have short production periods, swabbing should be conducted during the mid to tail end of their production schedule.
• In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is exposed and being processed, particularly post-treatment/pasteurization.
• A large majority of the environmental samples collected should be taken from Zones 1 (when directed and depending on the organism in question) and 2, and to a lesser degree Zone 3 areas. Very few, if any, environmental samples should be taken from Zone 4 areas.
• Swab subsample numbers for each organism are as follows:
• For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more
• subs
• For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs.

Also, there can be samples taken for food samples.

Here are the FDA Zone definitions:

IL Restaurant Norovirus Outbreak with 173 Reported Ill

McHenry County Department of Health (IL) issued their investigative report into a Norovirus outbreak associated with 173 people becoming ill.

"It could not be determined during this outbreak investigation exactly how Norovirus was introduced into the food establishment. Typically, Norovirus is introduced into a food establishment through a contaminated food product or through an ill individual. The epidemiological investigation confirmed that there were multiple food items associated with illness, and multiple sources of illness. MCDH is also aware of Norovirus infection in the community at the time of the outbreak, through investigation of an unrelated, confirmed outbreak  of Norovirus at a local school. Therefore, the likelihood a food item was received at the food establishment already contaminated with Norovirus is low, and this is unlikely to be the source  of the outbreak."

https://www.mchenrycountyil.gov/home/showpublisheddocument/109263/638024843979870000
Acute Gastroenteritis (AGE) Outbreak:
D.C. Cobb’s
McHenry, Illinois
September 2022

Investigated by:
McHenry County Department of Health
2200 North Seminary Avenue
Woodstock, Illinois 6009

LA Establishment Recalls Cooked Chicken Breast Patty Product for Extraneous Clear Hard Plastic

Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic.  The problem was discovered when the firm notified FSIS that it received consumer complaints reporting hard clear plastic embedded in fully cooked, frozen, breaded chicken breast patty products with a best by date of Aug. 11, 2023.

https://www.fsis.usda.gov/recalls-alerts/foster-farms-recalls-fully-cooked-frozen-chicken-patty-products-due-possible-foreign
Foster Farms Recalls Fully Cooked Frozen Chicken Patty Products Due to Possible Foreign Matter Contamination

FSIS Announcement

WASHINGTON, Oct. 29, 2022 – Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

TX Establishment Recalls Meat-containing Potstickers That Were Repacked Without Inspection

JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker products that were repackaged, relabeled, and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.  The problem was discovered during routine FSIS verification activities. FSIS determined that the firm repackaged and relabeled the potsticker products without the benefit of federal inspection.

Another instance of a company repackaging meat-containing products and not getting USDA-FSIS inspection.

https://www.fsis.usda.gov/recalls-alerts/jyc-enterprise-inc--recalls-chicken-and-pork-potsticker-products-produced-without
JYC Enterprise, Inc. Recalls Chicken and Pork Potsticker Products Produced Without Benefit of Inspection

FSIS Announcement
WASHINGTON, Oct. 28, 2022 – JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker products that were repackaged, relabeled, and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Whole Foods Recalls Dipping Caramel for Undeclared Wheat

Whole Foods Market is voluntarily recalling Dipping Caramel from five stores in Colorado, Kansas, and Nebraska because the product may contain wheat, which is not declared on the product label.  The mislabeling issue was discovered by a store employee. No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-dipping-caramel-sold-five-stores-colorado-kansas-and
Whole Foods Market Issues Allergy Alert for Dipping Caramel Sold in Five Stores in Colorado, Kansas and Nebraska
Summary
Company Announcement Date:  October 27, 2022
FDA Publish Date:  October 27, 2022
Product Type: Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Whole Foods Market
Brand Name:  Whole Foods Market
Product Description:  Dipping caramel

FDA Updates on FSMA Inspections for FY22

FDA inspections are beginning to pick back up after a slow down during COVID pandemic.

Specialty Foods Association
https://www.specialtyfood.com/news/article/fda-reveals-fsma-experience-fspca-annual-conference/
10/26/2022

FDA Reveals FSMA Experience at Annual Conference

Author:  Ron Tanner

FDA Reveals FSMA Experience at Annual Conference

FDA has emerged from the pandemic with a renewed emphasis—and a new approach—to inspecting manufacturers for compliance with the Preventive Controls for Human Food regulations of the Food Safety Modernization Act and to inspecting importers to determine whether they are following the Foreign Supplier Verification Program.

“Our inspections are still ebbing and flowing but we are moving in the right direction,” said Glenn Bass, deputy director, human and animal food operations—west, Office of Regulatory Affairs, FDA, during last week's Food Safety Preventive Controls Alliance Annual Conference. “We continue to rethink our field activities based on what we learned during the pandemic.”

FDA Issue Warning Letter to Spice Repacker

FDA issued a Warning Letter to El Gordo Spices of Dallas TX,  where herbs, spice, and seafood are repacked and warehoused.  During our inspection, FDA investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation - failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Based on the inspectional findings, the shelf stable ready-to-eat (RTE) Whole Dried Shrimp and Ground Dried Shrimp were found to be adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Further, FDA reviewed labels of repacked products (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-gordo-spices-llc-639957-09302022
WARNING LETTER

El Gordo Spices, LLC
MARCS-CMS 639957 — SEPTEMBER 30, 2022

CA Firm Recalls Cookies for Undeclared Almonds and Hazelnuts

Daiso California LLC of La Mirada, CA is recalling its Tiramisu Twist Cookies (sku 4562138450820) because the product contains almonds and hazelnuts, ingredients that are not identified on the packaging.   The recall was initiated after it was discovered that the Tiramisu Twist Cookie packaging did not adequately disclose the presence of the nuts. Sale of the product has been suspended, and Daiso California has pulled the product from store shelves.  There has been one reported case of allergic reaction to this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-tiramisu-twist-cookies-almonds-and-hazelnuts-not-identified-ingredients
Daiso Issues Allergy Alert on Tiramisu Twist Cookies Almonds and Hazelnuts Not Identified as Ingredients on Packaging
Summary
Company Announcement Date:  October 27, 2022
FDA Publish Date:  October 28, 2022
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Undeclared almonds and hazelnuts
Company Name:  Daiso California LLC
Brand Name:  Daiso
Product Description:  Tiramisu Twist Cookies

TX Establishment Recalls Shepard's Pie for Foreign Material - Copper wire

Lone Star Bakery, Inc., a China Grove, Texas establishment, is recalling approximately 5,740 pounds of beef shepherd’s pie products that may be contaminated with extraneous materials, specifically copper wire pieces.  The problem was discovered when the firm notified FSIS that they received consumer complaints reporting entwined copper wire embedded in beef shepherd’s pie products with a use by date of Sept. 23, 2023.  (Copper wire would indicate a maintenance related issue?)


https://www.fsis.usda.gov/recalls-alerts/lone-star-bakery-inc--recalls-beef-shepherds-pie-products-due-possible-foreign
Lone Star Bakery, Inc. Recalls Beef Shepherd’s Pie Products Due to Possible Foreign Matter Contamination
LONE STAR BAKERY, INC.

FSIS Announcement

WASHINGTON, Oct. 27, 2022 – Lone Star Bakery, Inc., a China Grove, Texas establishment, is recalling approximately 5,740 pounds of beef shepherd’s pie products that may be contaminated with extraneous materials, specifically copper wire pieces, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.