FDA Releases Guidance on Allergen Management as Part of Hazards Guide

The FDA Hazards Guide is a document intended to help with the compliance of meeting specific Preventive Controls for Human Food regulations. It has been an ongoing effort, with FDA releasing sections as they are completed. This week, FDA released two new sections, one of those focused on allergen control. Chapter 12, Food Allergen Program, sets out to "is to explain how to establish and implement a food allergen program".

The Guidance can be found here - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food

From this Draft Guidance [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food]:

A food allergen program could include, as appropriate to the facility and its food products:

• CGMP measures that you take to comply with the requirements of part 117, subpart B, to prevent allergen cross-contact due to personnel, design and construction of the plant, sanitary operations, equipment and utensils, raw materials and other ingredients, manufacturing operations, and warehousing and distribution. Your hazard analysis should consider how your CGMP measures prevent allergen cross-contact, and the preventive controls that you establish and implement to address a food allergen hazard should complement and enhance your CGMP measures for preventing allergen cross-contact.
• Food allergen controls to provide assurances that any food allergen hazards requiring a preventive control will be significantly minimized or prevented. (See 21 CFR 117.135(a) and (c)(2).) Food allergen controls include procedures, processes, and practices that are: 
• Allergen cross-contact controls – i.e., procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling, and use (21 CFR 117.135(c)(2)(i)); and 
• Label controls – i.e., procedures, practices, and processes employed for labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). (21 CFR 117.135(c)(2)(ii).)
• A supply-chain program as required by part 117, subpart G for those raw materials and other ingredients for which a manufacturing/processing facility has identified a food allergen hazard that is controlled before its receipt. (See 21 CFR 117.405(a)(1).) See Chapter 15 for comprehensive guidance on how to comply with the requirements of part 117, subpart G for all hazards, not just food allergen hazards.

Breaking this down
A facility will have GMP measures that will mitigate, or apply basic control. One would take these into account as they conduct the hazard analysis. These measures will taken into account as one conducts their hazard analysis.

The Food Allergen Program
There are four primary areas to address.

Oregon - State Agency Rules that Cannabis Can Be Sold with Mold (Aspergillus)

An Oregon State Court ruled that cannabis product that was being withheld from sale due to mold fungus (Aspergillus) contamination, could be sold.  

https://www.opb.org/article/2023/09/25/oregon-cannabis-products-marijuana-mold-recall/
Oregon cannabis products recalled over Aspergillus contamination will soon be sold
By Nathan Wilk (KLCC)
Sept. 25, 2023 1:36 p.m.
Oregon cannabis products recalled over a pathogenic mold will soon be approved for sale.

Last month, a court suspended state restrictions on four strains of the fungus Aspergillus in marijuana. The cannabis industry had argued that the mold was too common to avoid.

The decision left over 2,000 pounds and 60,000 pre-rolls of recalled cannabis in limbo, as the Oregon Liquor and Cannabis Commission awaited further guidance from the Oregon Health Authority.

On Sept. 20, the OLCC announced it would begin clearing those recalled products for sale.

“OLCC is working to coordinate the release of any such items that have been on hold in [the state’s Cannabis Tracking System],” the agency wrote in a press release.

Mike Getlin, the Board Chair for the Cannabis Industry Alliance of Oregon, celebrated the news but said the wait has been frustrating.

“This should have been done within a matter of days, if not, frankly, hours of the judge’s ruling,” Getlin said. “There are potentially businesses failing even though the court has ordered that this impediment be lifted.”

The suspension of the state’s restrictions will expire in February, giving the Oregon Court of Appeals time to review arguments.

Aspergillus spores can cause fungal infections in the immunocompromised, but no cases in Oregon have been linked to cannabis.

Supermarkets Dealing with Pest Infestation Issues

Within the past month, there were serious reports of three different supermarkets facing pest infestation issues.  I find these things shocking.

• A Harris Teeter store in Baltimore reopened after a thorough cleaning and implementing enhanced sanitation protocols after temporarily closing  last week due to an ongoing mouse infestation.
• A Lucky grocery store in Novato, Calif., was shut down by the Marin County Health Department after evidence of rats.  "Public health officials reportedly received complaints about rodents and rodent droppings throughout the store, including the pet food aisle, deli section, produce section, and behind items in the office and restroom areas."
•  An Atlanta Kroger - the "Georgia Department of Agriculture identified rodent droppings and urine spots in the storage area of a Kroger store in the Atlanta area. The inspector also identified where rats had been gnawing on products, creating burrows. After the inspection, workers were reportedly cleaning the loading dock area and patching up drain holes to keep out the rodents."
  

I wonder to what point does this get to before action is taken. When rodent activity is at a point where customers are seeing signs of rodents, or actually seeing rodents, it has gone too far.  Are employees not aware, or not concerned, or not empowered?   

Progressive Grocer
https://progressivegrocer.com/harris-teeter-baltimore-reopens-after-dealing-mouse-infestation
Harris Teeter in Baltimore Reopens After Dealing With Mouse Infestation
Kroger banner closed last week to initiate thorough cleaning and enhanced sanitation protocols

Recent USDA Research on Consumer Food Safety Shows Lack of Proper Food Safety Behaviors

A recently released study funded by USDA shows that consumers still struggle with food safety basics.

Handwashing -  The "data shows that 87% of participants self-reported they washed their hands before starting to cook in the test kitchen. However, only 44% of participants were observed doing so before meal preparation. Additionally, handwashing was not attempted 83% of the time when it should have been done (e.g., touching raw sausage and unwashed cantaloupe, cracking eggs, contaminated equipment or surfaces). Throughout the study, 96% of handwashing attempts did not contain all necessary steps."  It is important to note that this is self-reporting...how many are actually going to claim that they do not wash their hands.

Thermometer Use - "50% of participants used a food thermometer to check the doneness of the sausage patties".  My guess is that this number is higher than what occurs for consumers in general.

Cross-Contamination - Using a bacterial tracer, investigators found that of the "surfaces tested, the kitchen sink was most often contaminated, with 34% of participants contaminating the sink during meal preparation. The next highest was the cantaloupe, with 26% of participants introducing contamination when cutting the cantaloupe during meal preparation." 

This and other consumer based studies can be found at the USDA Consumer Research page.

https://www.usda.gov/media/press-releases/2023/09/19/new-usda-study-consumer-kitchen-behavior-underscores-importance
New USDA Study on Consumer Kitchen Behavior Underscores the Importance of Food Safety Education Month
Lack of Handwashing Continues to be a Concern

Release & Contact Info
Press Release
Release No. 0189.23
Contact: USDA Press
Email: press@usda.gov

WASHINGTON, Sept. 19, 2023 – The U.S. Department of Agriculture (USDA) is releasing during Food Safety Education Month the results from the final year of a five-year study that observed how consumers prepared meals. The study was produced by USDA’s Food Safety and Inspection Service (FSIS) as part of their efforts to highlight the importance of safe food handling practices.

Chicago Taqueria Source of Salmonella Outbreak with Over 50 Infected

A Chicago taqueria, Carniceria Guanajuato, has been shut done after being identified as the source of a Salmonella outbreak.  To date, there have been 56 cases of Salmonella infection with Of those, 17, or 30%, have been hospitalized

From the news report, "The restaurant and grocery store were inspected on Sept. 8 after a report of food poisoning, according to city records. Inspectors reported raw beef and raw shelled eggs were stored above ready-to-eat sliced lettuce and found other items stored at improper temperatures.  The restaurant was instructed to clean and sanitize certain food preparation areas, install working thermometers inside restaurant coolers, and correct labeling of prepared foods, among other fixes, city records showed. "

ABC News & - Chicago
https://abc7chicago.com/salmonella-outbreak-chicago-carniceria-guanajuato-poisoning-avondale/13814359/
Salmonella outbreak Chicago: Avondale taqueria facing lawsuits after 56 fall ill
Sun-Times Media Wire
Friday, September 22, 2023 11:48AM

NY Ag and Markets Issues Warning for NY Raw Milk Cheese After Product Tests Positive for Listeria

New York State Department of Agriculture and Markets  warned consumers not to consume Connecticut Hill Melter raw milk cheese from Nathaniel Thompson, doing business as (DBA) Remembrance Farm, due to possible Listeria monocytogenes contamination.  This product was sold and distributed to members of Full Plate Farm Collective Community Supported Agriculture (CSA) in Ithaca, NY.

A sample of the cheese collected by an inspector from the Department was discovered to be contaminated with Listeria monocytogenes. On September 15, 2023 the producer was notified of a preliminary positive test result. Further laboratory testing, completed on September 19, 2023, confirmed the presence of Listeria monocytogenes in the cheese sample.

https://www.morningagclips.com/listeria-contamination-in-remembrance-farm-connecticut-hill-melter-raw-milk-cheese/
Listeria Contamination in Remembrance Farm Connecticut Hill Melter Raw Milk Cheese
Remembrance Farm is located at 6294 Searsburg Road, Trumansburg in Tompkins County

PUBLISHED ON SEPTEMBER 25, 2023

ALBANY — New York State Department of Agriculture and Markets Commissioner Richard A. Ball warned consumers not to consume Connecticut Hill Melter raw milk cheese from Nathaniel Thompson, doing business as (DBA) Remembrance Farm, due to possible Listeria monocytogenes contamination. Remembrance Farm is located at 6294 Searsburg Road, Trumansburg in Tompkins County. To date, no illnesses have been reported to the Department associated with this product.

ND Establishment Recalls Frozen Meat Pizza Products For Undeclared Soy

Green Valley Foods, a Devils Lake, N.D. establishment, is recalling approximately 4,062 pounds of frozen meat pizza products due to misbranding and undeclared allergens - the product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered during routine FSIS testing when in-plant personnel identified and verified that the product contained soy, which was not declared on the label.

https://www.fsis.usda.gov/recalls-alerts/green-valley-foods-recalls-frozen-meat-pizza-products-due-misbranding-and-undeclared
Green Valley Foods Recalls Frozen Meat Pizza Products Due to Misbranding and Undeclared Allergens
GREEN VALLEY FOODS

FSIS Announcement

WASHINGTON, Sept. 23, 2023 – Green Valley Foods, a Devils Lake, N.D. establishment, is recalling approximately 4,062 pounds of frozen meat pizza products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which is not declared on the product label.

SC Firm Expands Recall Ice Cream Product After State Lab Detects Listeria in Additional Lot

Life Raft Treats is expanding their recall of their Not Fried Chicken 64 oz bucket, Not Fried Chicken 2.5 oz bar UPC 8 60006 18210 6 and Life Is Peachy 6 count box ice cream products, to include the BEST BY DATES up to and including AUG 08282024 due to a potential contamination of Listeria monocytogenes. 

 The initial recall was issued on Sept 6 and included all with BEST BY DATES up to and including AUG 8212024.

On September 18, 2023, the firm was notified by South Carolina Department of Health and Environmental Control (SCDHEC) that they needed to include an additional lot of their Not Fried Chicken ice cream treat which also test positive for Listeria monocytogenes. The firm also decided to recall their Life Is Peachy Ice Cream treats because both products were manufactured in the same room.

No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/life-raft-treats-has-expanded-their-recalls-ice-cream-products-not-fried-chicken-and-life-peachy-due
Life Raft Treats has Expanded their Recalls of Ice Cream Products, Not Fried Chicken And Life Is Peachy, Due to Possible Listeria Monocytogenes Contamination
Summary
Company Announcement Date:  September 19, 2023
FDA Publish Date:  September 22, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness
Company Name:  Life Raft Treats
Brand Name:  Life Raft Treats
Product Description:  Ice Cream Products

FL Firm Recalls Cachapas de Maiz Paisa Due to Undeclared Allergens and Yellow #5

Tama Corp. of Doral, FL, is recalling its 24-ounce packages of "Cachapas de Maiz Paisa" because they contain undeclared wheat, soy and Yellow #5. The recall was initiated after it was discovered during an inspection that the allergens-containing product was distributed in packaging that did not reveal the presence of them, due to a labeling error.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tama-corporation-issues-allergy-alert-undeclared-wheat-soy-and-yellow-5-cachapas-de-maiz-paisa
TAMA Corporation Issues Allergy Alert for Undeclared Wheat, Soy and Yellow #5 in "Cachapas de Maiz PAISA"
Summary
Company Announcement Date:  September 21, 2023
FDA Publish Date:  September 21, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and soy allergens; undeclared yellow #5
Company Name:  TAMA Corporation
Brand Name:  PAISA
Product Description:  Sweet Corn Pancakes "Cachapas de Maiz"