Expansion of Recall for Soft Ripened Cheeses with Potential for Listeria

Savencia Cheese USA expanded its recall of select soft ripened cheeses manufactured in the Lena manufacturing facility after an environmental sample was found to be positive for Listeria monocytogenes.  "Through routine testing, it was identified that processing equipment at the site may have been contaminated with Listeria monocytogenes. While finished product testing has not identified contaminated product, we have initiated a voluntary recall to retrieve the potentially affected product."

The initial recall was issued on November 4, and the expansion issued the following day to include an additional product -  Glenview Farms Spreadable Brie MFG Date 10/15/2024.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/savencia-cheese-usa-announces-expanded-voluntary-recall-select-soft-ripened-cheeses
Savencia Cheese USA Announces an Expanded Voluntary Recall of Select Soft Ripened Cheeses
Summary
Company Announcement Date:  November 04, 2024
FDA Publish Date:  November 05, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Savencia Cheese USA
Brand Name:  Aldi, La Bonne Vie and others
Product Description:  Soft ripened cheeses

Soft Ripened Cheeses Recalled after Environmental Sample Positive for Listeria

Savencia Cheese USA  is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes.  Through routine testing, it was identified that processing equipment at the site may have been contaminated with Listeria monocytogenes. While finished product testing has not identified contaminated product, the company initiated a voluntary recall to retrieve the potentially affected product.  At this time, there have been no confirmed reports of adverse health events due to consumption of these products.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/savencia-cheese-usa-announces-voluntary-recall-select-soft-ripened-cheeses
Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses
Summary
Company Announcement Date:  November 02, 2024
FDA Publish Date:  November 04, 2024
Product Type:   Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Savencia Cheese USA
Brand Name:  Aldi, La Bonne Vie and others
Product Description:  Soft ripened cheeses

FDA Issues Supplement to the 2022 Food Code - What Has Changed?

The FDA issued a supplement to the 2022 Food Code.  The changes of note by the FDA are listed here:

• Addressing food protection with new provisions that improve awareness of food defense measures;
• Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; 
• Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
• Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces; 
• Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
• Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

A detailed listing of the changes are found on the FDA website

https://www.fda.gov/media/183271/download?attachment

I provided some detail on each of these changes.
First, some definitions were added.

Definitions Added or modified include:

“Active Managerial Control” means the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness RISK factors. It embodies a preventive rather than reactive approach to FOOD safety through a continuous system of monitoring and verification.

“Disinfection” means the application of a substance, or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi, and viruses, but not necessarily bacterial spores

“Food Defense” is the effort to protect FOOD from acts of intentional ADULTERATION or tampering

Food Safety Management System

(1) “FOOD SAFETY MANAGEMENT SYSTEM” means a specific set of actions taken by the EMPLOYEE to prevent the occurrence of foodborne illness RISK factors based on the type of operation, type of FOOD preparation, and FOODS prepared within the FOOD ESTABLISHMENT.

(2) “FOOD SAFETY MANAGEMENT SYSTEM” includes written procedures, training plans, and monitoring records to control specific operational steps in a FOOD ESTABLISHMENT that contribute to foodborne illness.

Reduced oxygen packaging” includes:

(d) Cook chill PACKAGING, in which cooked FOOD is hot filled into impermeable PACKAGING (such as a bag or film on trays) that is then sealed or crimped closed. The PACKAGED FOOD is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychotropic pathogens;

Addressing food protection with new provisions that improve awareness of food defense measures;

2-103.11

Persons in Charge adding in component for Food Defense - first there is a focus to have the person in charge maintain active managerial control (see changes in 8.201 below) in their operation and then Food Defense was added to ensure that employees are trained on this topic.

Additional information on Food Defense is providing in Annex 2  4. FOOD DEFENSE GUIDANCE FROM FARM TO TABLE and Annex 3 1-201.10 and 2-103.11 Person in Charge.

Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; 

2-201.13

Changes to exclusions and restriction of employees diagnosed with illness - specifically Shigella, STEC, nontyphoidal Salmonella with more specific conditions on which the person may be reinstated into the operation.

Expanding and clarifying how and when containers can be refilled and reused in a food establishment;

3-304.17

Reusable food containers - Expanding and clarifying how and when containers can be refilled and reused in a food establishment.

Explained in detail in Annex 3.  3-304.17

Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;

Disinfectants-  Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;  This is added to take care of situations like a potential norovirus contamination event. 

Disinfectants added into these sections.

4-302.14 Sanitizing and Disinfecting Solutions, Testing Devices. 

4-501.116 Warewashing Equipment, Determining Chemical Sanitizer or Disinfectant Concentration. 

4-1001.11 Food-Contact, nonFood-Contact Surfaces and Utensils EQUIPMENT, FOOD-CONTACT SURFACES, nonFOOD-CONTACT SURFACES, and UTENSILS shall be DISINFECTED when pathogens of concern are not controlled by available SANITIZERS.

4-1002 Frequency

4-1002.11 Disinfectant Use

When pathogens of concern are not controlled by available SANITIZERS, EQUIPMENT, FOOD-CONTACT SURFACES, nonFOOD-CONTACT SURFACES, and UTENSILS shall be DISINFECTED: 

(A) When contaminated with vomitus, fecal matter, blood, or any other bodily fluid that can lead to disease transmission; or 

(B) During a FOODBORNE DISEASE OUTBREAK or IMMINENT HEALTH HAZARD.

4-1003 Methods

4-1003.11 Chemical

(A) FOOD-CONTACT SURFACES and nonFOOD-CONTACT SURFACES shall be DISINFECTED in accordance with the EPA-registered label use directions.

(B) DISINFECTANTS applied to a FOOD-CONTACT SURFACE shall be rinsed with potable water, unless otherwise specified on the EPA-registered label use directions.

7-102.11 to add the term DISINFECTANTS

Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;

8.201

Food Safety Management System - replaces the term standard operating procedure

8-201.12 Contents of the Plans and Specifications. 

The plans and specifications for a FOOD ESTABLISHMENT, including a FOOD  ESTABLISHMENT specified under § 8-201.13, shall include, as required by the  REGULATORY AUTHORITY based on the type of operation, type of FOOD preparation, and FOODS prepared, the following information to demonstrate conformance with Code provisions: 

(E) Evidence that a FOOD SAFETY MANAGEMENT SYSTEM that ensures compliance with the 

requirements of this Code are developed or are being developed; and

8-201.15 When a Food Safety Management System is Required. 

(A) Within 4 years of the REGULATORY AUTHORITY’S adoption of this Code, a written FOOD 

SAFETY MANAGEMENT SYSTEM shall be:

(1) Developed and maintained to ensure compliance with requirements of this Code as specified in 2-103.11.

(2) Implemented in the FOOD ESTABLISHMENT during all hours of operation, and 

(3) Made available to the REGULATORY AUTHORITY upon request.

(B) This section does not apply to certain types of FOOD ESTABLISHMENTS deemed by the 

REGULATORY AUTHORITY to pose minimal RISK of causing, or contributing to, foodborne 

illness based on the nature of the operation and extent of the FOOD preparation.

Additional information on Food Safety Management Systems in Annex 2 - Amend 3 and Annex 3 1-201.10

Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

 Annex 6 - 4 Acidification Sushi Rice

Cooked rice is a Time/temperature control for safety food (TCS) with known hazards  associated with it. For a TCS product to be stored without temperature control, there must be processes in place to assure that the rapid and progressive growth or toxin production of infectious or toxigenic microorganisms cannot occur. This is commonly done by modifying the pH of the cooked rice to a pH of <4.2 or below. Proper acidification and distribution of acid is essential to prevent bacterial growth, especially Bacillus cereus. 

Acidification of TCS foods with the intent of making them non-TCS is considered a special process in the Food Code. In the case of sushi rice, this process takes a TCS food (cooked rice) and adds acid (typically vinegar) to drop the pH and allow the cooked rice to be held without time or temperature controls. This acid addition needs to adjust the equilibrium pH to less than 4.2 to control the identified hazards. Addition of vinegar for flavor only, when pH is not monitored, is not considered a special process and rice must be temperature controlled just like any other TCS food.

https://www.fda.gov/food/hfp-constituent-updates/fda-releases-supplement-2022-food-code
Constituent Update
FDA Releases Supplement to the 2022 Food Code
November 4, 2024

Canadian Food Agency Releases Investigation Report on 2024 Listeria Outbreak Linked to Plant-based Milks

The Canadian Food Inspection Agency (CFIA) issued a report of their investigation into the August 2024 Listeria outbreak linked to plant based milks produced by Joriki, Inc, a third-party manufacturer based in Pickering, Canada producing product for Danone, Canada.  The company issued a recall for almond, coconut, and oat milks after 15 hospitalizations and 3 deaths.

The report stated:

• "The investigation was not able to confirm the primary source of the contamination within the establishment, which is not uncommon with investigations regarding pasteurized products like plant-based beverages – listeria cannot survive pasteurization – however, cross-contamination could have occurred after processing."
• "During the course of its investigation, the CFIA discovered that the facility did not properly implement environmental swabbing and finished product testing in adherence to Health Canada's Policy on Listeria monocytogenes in ready-to-eat foods, which is why the CFIA is closely following up to ensure corrective actions are completed and necessary safety measures are in place."
• "As a result of the food safety investigation, production at Joriki Inc. in Pickering has been fully halted, and significant cleanup and renovations are underway. Manufacturing will not resume until all necessary safety measures are in place, and until we are confident that the risk of contamination has been eliminated."

https://www.canada.ca/en/food-inspection-agency/news/2024/10/statement-on-the-conclusion-of-the-food-safety-investigation-related-to-the-recall-of-various-silk-and-great-value-brand-plant-based-refrigerated-b.html
Statement on the conclusion of the food safety investigation related to the recall of various Silk and Great Value brand plant-based refrigerated beverages
From: Canadian Food Inspection Agency

Imported Enoki Mushrooms Recalled for Listeria After Sample Tests Positive

HH Fresh Trading Corp of California is recalling its 200g of Taiwan Enoki because they have the potential to be contaminated with Listeria monocytogenes.  The recalled “Enoki mushrooms 200 gram” were distributed in West Virginia in multiple retail store locations and were sold on 8/20/2024 and 8/23/2024 with 240 cases for each date. HH Fresh Trading received notice on 10/11/2024 and that the Enoki 200 gram test revealed the presence of Listeria monocytogenes on 9/9/2024. 

FDA Recalls
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hh-fresh-trading-corp-recalls-taiwan-enoki-200gx25pk-because-possible-health-risk
HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk
Summary
Company Announcement Date:  November 01, 2024
FDA Publish Date:  November 02, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes.
Company Name:  HH Fresh Trading Corp of California
Brand Name:  HH Fresh Trading
Product Description:  Enoki Mushrooms

Update on E. coli Outbreak Linked to Slivered Onions on Burgers - October 30, 2024

On October 30, 2024 FDA and CDC updated information on E. coli STEC linked to slivered onions used on McDonald Quarter Pounders. There are now 90 cases with 27 hospitalizations and 1 death.  2 people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure.  There are 15 more cases than reported in the October 25th update.

"On October 22, 2024, Taylor Farms recalled yellow onions that were supplied to McDonald’s and other food service customers. FDA is working with Taylor Farms and their direct customers to determine if additional downstream customer recalls are necessary. According to available information, it is unlikely that recalled yellow onions were sold to grocery stores or directly to consumers. Food service customers who received recalled onions were contacted and should no longer be using or serving recalled onions. These customers should also ensure that they did not freeze recalled onions or foods containing recalled onions."

Fast Facts
Cases: 90 (15 new)
Hospitalizations: 27 (5 new)
Deaths: 1 (0 new)
States: 13 (0 new)

FDA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-onions-october-2024
Outbreak Investigation of E. coli O157:H7: Onions (October 2024)

FDA is investigating slivered onions served at McDonald’s as the likely source of this outbreak. Onions have been recalled and are no longer being used.

Florida Firm Recalls Frozen Croquette Produced Without Inspection and Failure to List Allergens

A Tu Gusto, LLC, a Lehigh Acres, Fla. firm, is recalling approximately 7,630 pounds of frozen meat and poultry croquette products that were produced without the benefit of federal inspection and may contain undeclared allergens - the product contains soy, sesame seed and wheat, known allergens, which are not declared on the product label.  The problem was discovered when FSIS was performing surveillance activities at a retailer and observed labeling irregularities. After further investigation it was determined that the items were produced at a facility that does not have a grant of inspection and contained allergens not declared on the product label. Therefore, the items were produced without the benefit of FSIS inspection and are mislabeled.

https://www.fsis.usda.gov/recalls-alerts/a-tu-gusto-llc-recalls-frozen-croquette-products-produced-without-benefit-inspection
A Tu Gusto, LLC Recalls Frozen Croquette Products Produced Without the Benefit of Inspection and Undeclared Allergens
FSIS Announcement

WASHINGTON, Oct. 29, 2024 – A Tu Gusto, LLC, a Lehigh Acres, Fla. firm, is recalling approximately 7,630 pounds of frozen meat and poultry croquette products that were produced without the benefit of federal inspection and may contain undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, sesame seed and wheat, known allergens, which are not declared on the product label.

Seafood Salad Recalled for Undeclared Soy After Label Printer Ships Wrong Labels

Danvers, Massachusetts. R. Walters LLC dba Elevation Foods is recalling 1,668 units of mislabeled Hannaford Seafood Salad 12oz because it contains an undeclared Soy allergen.  The recall was initiated after it was discovered that the printer of the labels for Hannaford Seafood Salad had provided Elevation Foods with labels that did not match the current product formulation. These labels were created for an upcoming formulation change and were shipped to Elevation Foods in error.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/elevation-foods-issues-recall-due-undeclared-soy-hannaford-seafood-salad
Elevation Foods Issues Recall Due to Undeclared Soy in Hannaford Seafood Salad
Summary
Company Announcement Date:  October 31, 2024
FDA Publish Date:  October 31, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Contains an undeclared soy allergen.
Company Name:  R. Walters LLC dba Elevation Foods
Brand Name:   Hannaford
Product Description:  Seafood Salad

Baby Powder with Talc Recalled Due to Potential Asbestos Contamination

Dynarex Corporation is expanding the recall initiated on September 19, 2024 to include an additional 373 cases of item number 4875, Dynacare Baby Powder, 14 oz., as well as 647 cases of item number 4874, Dynacare Baby Powder, 4 oz., because they have the potential to be contaminated with asbestos. Asbestos is a naturally occurring mineral that is often found near talc, an ingredient in many cosmetic products. Asbestos, however, is a known carcinogen and its health risks are well-documented. If talc mining sites are not carefully chosen or if proper steps are not taken to adequately purify the talc ore, it may contain asbestos.

From the American Cancer Society:

• Talc is mined from the earth. In this natural form, some talc contains asbestos, a substance known to cause cancers in and around the lungs when inhaled.
• In 1976, the Cosmetic, Toiletry, and Fragrances Association (CTFA), the trade association representing the cosmetic and personal care products industry, issued voluntary guidelines stating that all talc used in cosmetic products in the United States should be free from detectable amounts of asbestos according to their standards.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dynarex-corporation-expands-recall-include-additional-products-due-possible-health-risk
Dynarex Corporation Expands Recall to Include Additional Products Due to Possible Health Risk
Summary
Company Announcement Date:  October 28, 2024
FDA Publish Date:  October 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Metal or Chemical Contaminant
Company Name:  Dynarex Corporation
Brand Name:  dynacare
Product Description:  Baby Powder