Update - E. coli Outbreak Linked to Quarter Pounders, Onions Recalled

CDC provided an update of the E. coli outbreak linked to McDonalds quarter pounders. There are now 77 cases with 22 hospitalizations and 1 death across 13 states. With the federal inspectors focusing in on sliced onions, the supplier, Taylor Farms has recalled whole peeled and diced onions.

This is not the first foodborne illness outbreak linked to onions. 

In 2023, there was a Salmonella outbreak linked to chopped fresh onions from a CA processor. (link)

In 2021, a Salmonella outbreak with 652 was linked to imported onions. (link)

In 2020, a Salmonella outbreak with 1,127 cases (link) 

FDA published their investigation into the 2020 outbreak, and stated potential causes.  If considering how contamination events can occur to an item like onions, one can reflect on this.

While our investigation did not occur during any harvesting activities, visual observations of the implicated red onion growing fields suggested several plausible opportunities for contamination including irrigation water, sheep grazing on adjacent land, as well as signs of animal intrusion, such as scat and large flocks of birds which may spread contamination. Similarly, the investigation did not occur while packing activities were ongoing. However, visual observations and records review of packing house practices confirmed numerous opportunities for spread of foodborne pathogens such as Salmonella, including signs of animal and pest intrusion as well as food contact surfaces which had not been inspected, maintained, cleaned, or sanitized as frequently as necessary to protect against the contamination of produce. 

CDC information on this outbreak.

Fast Facts
Cases: 75 (26 new)
Hospitalizations: 22 (12 new)
Deaths: 1 (0 new)
States: 13 (3 new)

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-mcdonalds-quarter-pounders-october-2024?utm_medium=email&utm_source=govdelivery

Outbreak Investigations & Safety Advisories

FDA Human Foods Program

Waffle Recall Expanded to Include All Pancakes and Waffle Products

TreeHouse Foods, Inc. (NYSE: THS) is expanding its voluntary recall (initially posted on 10/18) to include all products manufactured at one facility and still within their shelf-life. The recall is expanded to include frozen toaster waffle, Belgian waffle and pancake products, due to the potential to be contaminated with Listeria monocytogenes.  This recall was expanded based on additional testing at the manufacturing facility.  There have been no confirmed reports of illness linked to the recalled products to date. Anyone concerned about an illness should contact a healthcare provider.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/treehouse-foods-announces-expansion-voluntary-recall-include-all-waffle-and-pancake-products-due
TreeHouse Foods Announces Expansion of Voluntary Recall to Include All Waffle and Pancake Products Due to the Potential for Listeria monocytogenes Contamination
Summary
Company Announcement Date:  October 22, 2024
FDA Publish Date:  October 23, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  TreeHouse Foods, Inc.
Brand Name:  Multiple brand names
Product Description:  Frozen toaster waffles, Belgian waffles and pancakes

Salmonella Outbreak Linked to Wisconsin Egg Producer, Firm Recalls Eggs

A Salmonella outbreak has been linked to Milo's Poultry Farms.  CDC and FDA are investigating this outbreak of  Salmonella Enteritidis infections with 65 reported cases with 24 hospitalizations  covering 9 states.  FDA conducted an inspection at Milo’s Poultry Farms and collected samples. FDA’s analysis showed the outbreak strain of Salmonella was found in the packing facility and the hen egg laying house.

Milo’s Poultry Farms, LLC. of Bonduel, WI is recalling all “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs because these eggs have the potential to be contaminated with Salmonella.  Milo’s Poultry Farms, LLC. has ceased production and distribution at this time and will undergo appropriate testing and sanitization of farms and processing equipment.

CDC Food Safety Alert
https://www.cdc.gov/salmonella/eggs-09-24/index.html
Salmonella Outbreak Linked to Eggs

Fast Facts
Illnesses: 65
Hospitalizations: 24
Deaths: 0
States: 9
Investigation status: Active

Recent Food Safety Issues with Raw Milk and Raw Milk Cheese in PA, NY, WA and ID

There have been five recent food safety warnings issued by state regulators for raw milk and raw milk cheese.

• Pennsylvania Department of Agriculture issued a warning for raw milk produced by Meadow View Jerseys brand raw milk after testing confirmed that the milk was contaminated with Shigatoxin-producing E. coli bacteria
• PA Department of Ag issued a warning for raw milk cheese  distributed by BeiHollow Farm, Elizabethville, PA, after testing confirmed that the cheese was contaminated with listeria monocytogenes bacteria.
• Idaho Department of Health and Welfare, reported that 18 people have tested positive for campylobacteriosis, after 17 reported drinking raw milk produced by Paradise Grove Dairy in Jefferson County, Idaho.
• New York State Department of Agriculture and Markets issued a Warning about unpasteurized raw milk from HuHill Farm after samples of that product tested positive for Campylobacter jejuni contamination Fort Plain, New York.
• The Washington Department of Health reported that two people were infected with the same, highly related strain of Campylobacter jejuni after both drank Jim’s Jerseys raw milk produced by Old Silvana Creamery (Arlington, WA).

https://www.pa.gov/en/agencies/pda/newsroom/agriculture-department-warns-consumers-to-discard-contaminated-r.html
Agriculture Department Warns Consumers to Discard Contaminated Raw Milk from Meadow View Jerseys Dairy
August 14, 2024
Harrisburg, PA – The Pennsylvania Department of Agriculture warns consumers to immediately discard Meadow View Jerseys brand raw milk purchased between August 5 and 12, 2024, with a sell-by date of August 19, 2024. Routine testing for pathogens confirmed that the milk was contaminated with Shigatoxin-producing E. coli bacteria.

FDA Warning Letter to NV Spice Company for Inadequate Supply Chain Preventive Controls

FDA issued a Warning Letter to High Quality Organics, a ready-to-eat (RTE) spice facility, located in Reno, NV.  The company processes and packages RTE organic herbs, spices, dried fruit and peels, and dried vegetables.  The main issue was the company relies on others to process products so that they are considered RTE, but does not manage this through the Supply Chain program.

The supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required per 21 CFR 117.410(c). 

• The company receives untreated herbs, spices, dried fruits and peels, and dried vegetable products and then directs the untreated products to (b)(4) third-party providers that apply a lethality process. 
• The "preventive control measure is “Validated lethality ‘kill step’ with Treatment Certificate”, however, the company's supply chain program does not verify that the parameters selected and applied by 3rd party treatment providers are adequate to control the hazard of vegetative pathogens such as Salmonella. 
• There is no review of the process parameters identified in the treatment certificate from the (b)(4) providers, as identified as a preventive control measure required within Hazard Analysis, and you 
• Did not comprehensively evaluate whether the parameters are appropriate for all your products undergoing the treatment. 
• Did not maintain documentation that the untreated spices you purchase and send to the third-party (b)(4) providers are treated under a validated process that delivers an appropriate destruction of Salmonella.

The company did not conduct a reanalysis of your food safety plan when needed after Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)).

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/high-quality-organics-inc-677503-07082024
WARNING LETTER
High Quality Organics, Inc.
MARCS-CMS 677503 — July 08, 2024

Update on Salmonella Outbreak Linked to Cucumbers

FDA provided an update on the Salmonella outbreak linked to cucumbers. To this point in time, there have been 449 reported cases with 125 hospitalized. The date of onset of the last illness was June 4, 2024.

CDC and FDA combined two outbreak investigations because of similarities, "including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and Thomas Produce Company, of Boca Raton, Florida, are likely sources of illnesses in this outbreak; however, these growers do not account for all the illnesses in this outbreak."

"Based on traceback information collected, Thomas Produce Company supplied cucumbers to multiple points of service where ill people reported eating cucumbers. As part of the investigation, FDA conducted an onsite inspection at Thomas Produce Company and collected samples. Salmonella Braenderup was detected in samples of canal water used by Thomas Produce Company. Whole Genome Sequencing analysis determined that the water used by Thomas Produce Company contained the Salmonella that is a match to a strain of Salmonella Braenderup that is causing some of the illnesses in this outbreak."

"Additional types of Salmonella were detected in both soil and water samples collected at both Bedner Growers, Inc. and Thomas Produce Company. Multiple other strains of Salmonella, unrelated to this outbreak investigation, found at Bedner Growers, Inc. matched clinical isolates from illnesses in the National Center for Biotechnology Information’s (NCBI) database that occurred in previous years."

Case Counts
Total Illnesses: 449
Hospitalizations: 125
Deaths: 0
Last Illness Onset: June 4, 2024
States with Cases: AL, AR, CT, DE, DC, FL, GA, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-june-2024
Outbreak Investigation of Salmonella: Cucumbers (June 2024)
Cucumbers linked to illnesses of Salmonella Africana and Salmonella Braenderup.
Current Update
August 14, 2024

VA Establishment Expands Recall As Testing Determines Outbreak Strain in Liverwurst Product

CDC and USDA-FSIS have identified Boar's Head liverwurst as having the outbreak strain of Listeria that has resulted in 34 cases with 33 hospitalizations and 2 deaths. From the CDC, "As of July 26, 2024, a total of 34 people infected with the outbreak strain of Listeria have been reported from 13 states (see map). Sick people’s samples were collected from May 29, 2024, to July 12, 2024 (see timeline). Of 33 people with information available, all 33 have been hospitalized. One person got sick during their pregnancy and remained pregnant after recovering. Two deaths have been reported, 1 in Illinois and 1 in New Jersey."

Whole genome sequencing results show that a liverwurst sample collected by the Maryland Department of Health tested positive for the outbreak strain of Listeria monocytogenes.

Boar's Head Provisions Co., Inc., a Jarratt, Va., establishment, is expanding its July 26, 2024, recall of deli meat products that may be adulterated with Listeria monocytogenes. The establishment is recalling approximately 7 million additional pounds of ready-to-eat meat and poultry products.

https://www.cdc.gov/listeria/outbreaks/delimeats-7-24/index.html
Listeria Outbreak Linked to Meats Sliced at Delis
Posted July 31, 2024

Fast Facts
Illnesses: 34
Hospitalizations: 33
Deaths: 2
States: 13
Recall: Yes
Investigation status: Active (First posted on July 19, 2024).

FDA Issues Warning Letter to SC Processor for Continued Listeria Presence

FDA issued a Warning Letter to Discover Fresh Foods, LLC of Greenville, SC, a manufacturer of refrigerated ready-to-eat (RTE) dips and spreads.  This issue is that the company had a ongoing contamination issue of the same Listeria strain.

According to the report, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for L. monocytogenes. The positive swabs were recovered from non-food-contact surfaces in Production Room (b)(4), and (b)(4)) during the production of Taste of the South Fried Pickle Dip, and the underside of the top level of the red cart in (b)(4). FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for Listeria innocua (L. innocua). These swabs were obtained from the (b)(4) transfer pump bottom frame, trash bin wheel, and bottom of sanitation squeegee.

The same organism had been found in the 

• three (3) L. monocytogenes isolates obtained from FDA environmental sample 124288 in 2023;
• four (4) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2023;
• one (1) L. monocytogenes isolate obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2023;
• two (2) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2018;
• one (1) L. monocytogenes isolates obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2018; and
• one (1) L. monocytogenes isolate obtained from Chipotle Chicken Salad collected by FDACS in 2017.

Based on these results of the WGS analysis, the twelve (12) isolates represent a single strain of L. monocytogenes. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in the facility since at least November 2017. 

Then in 2024, additional sampling by USDA found Listeria.  "USDA FSIS notified FDA L. monocytogenes was detected in two (2) additional environmental swabs collected from non-food-contact surfaces (e.g., cart wheels) at [the] facility".  The company got rid of a chopper that they felt was the source, however, is the issue resolved?   When contamination becomes then endemic within a facility, it can now be very wide spread, locating in numerous niches.

It is surprising that USDA was not more aggressive, and for that matter, the company was not more aggressive in solving this issue.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/discover-fresh-foods-llc-677021-06262024
Discover Fresh Foods, LLC
MARCS-CMS 677021 — JUNE 26, 2024

RTE Granola Facility Issued Warning Letter in Wake of Salmonella-related Recall

FDA issued a Warning Letter to PepsiCo for their Quaker Oats  manufacturing facility located in Danville, IL, a facility that manufactures RTE granola bars and RTE cereals.  This facility issued a recall of product for Salmonella in December of 2023.  In April of 2024, the facility was closed.

Noted in the report was timing, which is interesting.

• On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023.
• The positive sample was later confirmed on December 11, 2023, following an investigation of a suspected (but not confirmed) laboratory error concerning the initial results. 
• On December 12, 2023, your corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. 
• On December 14, you notified FDA of your decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report.
• On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp. The swab was collected in a crack on the floor in the (b)(4); the investigator noted that apparent food residue was observed at the sampling location. Whole genome sequencing (WGS) was conducted on the Salmonella isolate obtained from the FDA environmental swabs. The WGS analysis confirmed the isolate to be Salmonella Cubana and the isolate did not match other food, environmental, or clinical isolates in the database. 
• January 3, 2024 - We advised you of the WGS results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020.
• On January 11, 2024, your laboratory analysis identified that Salmonella Cubana that originated in the (b)(4) Room and contaminated the granola line had spread to (b)(4) areas of the extruded RTE cereal line, (b)(4). This included areas where extruded material is exposed to the environment without an additional kill-step. That same day you expanded your recall to cover all RTE cereals, bars, and snacks within shelf-life manufactured at the Danville facility or manufactured with ingredients manufactured at the Danville facility.

Items to note:

• A long delay from presumptive positive to confirmed...about two weeks.
• Had found previous environmental positives from the RTE area - "the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. But the organism had been in the facility since 2020.

Issues

• One of the biggest issues was lack of proper corrective action.  "records of corrective actions included cleaning/sanitizing the affected area and additional (b)(4) swabbing,  but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, your “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated September 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (b)(4) and at the “sandwich point” (b)(4) in the (b)(4) Room on the (b)(4) floor (zone (b)(4) areas) but did not consider other areas as potential sources of contamination.

{[FDA}  recommend the company consider incorporating WGS as a tool to investigate pathogen isolates obtained in the environmental monitoring program and/or  finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

• GMPs were also an issue - plant equipment and utensils used in manufacturing and processing were not designed and of such material and workmanship as to be adequately cleanable, or adequately maintained to protect against contamination

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pepsico-inc-679972-06122024
WARNING LETTER
PepsiCo, Inc.

MARCS-CMS 679972 — JUNE 12, 2024

Overseas Operations Using Potentially Contaminated Cooking Oil

A Chinese state media investigation found "tank trucks were delivering chemicals and edible oil interchangeably without cleaning."  "The furor follows a bombshell investigation published on July 2 by the state media outlet Beijing News, which found multiple cases of tank trucks transporting edible cooking oil immediately after delivering chemicals used for coal-to-liquid processing."

It appears that this is a widespread issue done primarily for cost savings.

In HACCP or Preventive Controls training, we discuss the need to reevaluate your plan when new information becomes available.  This would be the type of issue that when you learn about, you check to see whether this issue impacts your own operation.  Perhaps you are buying imported oil roasted nuts or frozen pre-fried breaded chicken nuggets.   Does this issue affect those items?

https://www.msn.com/en-us/news/world/china-is-freaking-out-over-an-open-secret-that-its-cooking-oil-was-ferried-for-years-in-chemical-tanks-that-weren-t-cleaned/ar-BB1pE693
China is freaking out over an 'open secret' that its cooking oil was ferried for years in chemical tanks that weren't cleaned
Story by mloh@businessinsider.com (Matthew Loh) • 15h

China has been hit by another major food scandal, this time involving cooking oil in chemical tanks.

Salmonella Outbreak Linked to Cucumbers - Outbreak Strain Found in Grower's Canal Water

Bedner Growers, Inc. in Florida has been identified as the source of Salmonella contaminated cucumbers that have caused 449 reported cases of illness.  FDA found the outbreak Salmonella strains in the canal water.

"FDA collected samples at the grower in Florida and identified Salmonella Braenderup in untreated canal water. WGS determined that the Salmonella found in the water is the same strain of Salmonella Braenderup that made people in this outbreak sick. Additional soil and water samples collected at Bedner Growers, Inc. were positive for other strains of Salmonella. CDC and FDA are looking to see if these strains have caused illness in people."

Of the 449 reported cases, 125 people have been hospitalized.

"As of July 2, a total of 449 people infected with one of the outbreak strains of Salmonella Africana and Salmonella Braenderup have been reported from 31 states and the District of Columbia (see map). Of these illnesses, 215 people were infected with the newly added Salmonella Braenderup strain. Illnesses started on dates ranging from March 11, 2024, to June 4, 2024 (see timeline). Of 360 people with information available, 125 have been hospitalized and no deaths have been reported."

CDC
https://www.cdc.gov/salmonella/africana-06-24/index.html
Salmonella Outbreak Linked to Cucumbers
Posted July 2, 2024

Fast Facts
Illnesses: 449 (38 new Africana, 215 Braenderup new)
Hospitalizations: 125 (11 new Africana, 50 Braenderup new)
Deaths: 0
States: 31 states and the District of Columbia (1 new Africana, 26 Braenderup)
Recall: Yes
Investigation status: Active (first posted on June 5, 2024)

Outbreak Investigation Summary
Epidemiologic, traceback, and laboratory data show that cucumbers were contaminated with Salmonella and made people sick. Testing identified the Salmonella Braenderup strain in untreated canal water used by a grower in Florida. Cucumbers from this grower are no longer in season and any sold previously are no longer on shelves.

Lancaster Country (PA) Bakery Issued Warning Letter

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507.  McClure's is a self-described Amish bakery.  (Located in the heart of Amish Country, McClures Bakery has been bringing delicious Amish baked goods to our customers for more than 50 years. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)

• Did not have a hazard analysis completed for all products.
• Did not identify Salmonella as a hazard requiring a preventive control.
• Did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard
• did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control
• Duct tape is not a sanitary fix - Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper.
• Added allergen to Contains statement although not used in formulation - "labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact."
• A number of labeling-related issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcclures-lancaster-old-fashioned-llc-670611-05162024
McClure’s Lancaster Old Fashioned, LLC
MARCS-CMS 670611 — MAY 16, 2024

Recipient:
Mr. Thomas Keenan
Owner & President
McClure’s Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville, PA 17507
United States

FDA Issue Warning Letter to Bakery for Bad Labeling Decisions

FDA issued a Warning Letter to a PA bakery operation.  The primary issue was putting allergens in the Contains statement, but not including those items in it the formulation.

The "bread loaf products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls."

The company also tried to say brown sugar was a natural flavor.  "Flavor were not declared on the label, and you stated that the Brown Sugar Powder and the (b)(4) ingredients meet the definition of “Natural Flavors” and are considered to be included as that on the label. According to 21 CFR § 101.22(a)(3), the term “natural flavor” means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §§ 182.10, 182.20, 182.40, and 182.50 and Part 184, and the substances listed in 21 CFR § 172.510. If these ingredients do not meet the definition of natural flavor contained in 21 CFR § 101.22(a)(3), they may not be declared as such on the label."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bimbo-bakeries-usa-inc-672140-06172024
WARNING LETTER

Bimbo Bakeries USA, Inc.
MARCS-CMS 672140 — JUNE 17, 2024

Minnesota Establishment Recalls Egg Products for Undeclared Milk Due to Mis-packaging Issue

M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg products due to misbranding and undeclared allergens...the product contains dairy (milk) which is not declared on the label.  The problem was discovered during a routine carton inventory evaluation. The establishment notified FSIS when it discovered that a limited amount of Whole Egg with Citric Acid cartons was unaccounted for, and there was a corresponding excess of Breakfast Blend Scrambled Egg carton in inventory. The establishment investigated and determined that the unaccounted Whole Egg with Citric Acid cartons were inadvertently utilized during a single short Breakfast Blend Scrambled Egg production run. The Breakfast Blend formulation contains an allergen, a dairy ingredient (milk), which is not declared on the Whole Egg with Citric Acid label.

USDA does not have the same allergen preventive control requirements as FDA, however, this is an example where those types of controls could prevent this type of issue.  However, it was an inventory check that informed the company that something was wrong.

https://www.fsis.usda.gov/recalls-alerts/michael-foods-inc--recalls-fair-meadow-foundations-liquid-egg-products-due
Michael Foods Inc. Recalls Fair Meadow Foundations Liquid Egg Products Due to Misbranding and Undeclared Allergens

WASHINGTON, June 30, 2024 – M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg 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 dairy (milk), a known allergen, which is not declared on the product label.

Warning Letter Issued to Iowa Acidified Food Processor

FDA issued a Warning Letter to Midwest Foods, LLC, of Ankeny, IA. a manufacturer of salsas, sauces, dressings, and jams, with some of these products being acidified.
Failed to file scheduled process to FDA for some of the acidified foods

Failed to follow scheduled process for some acidified products.  .
A few other items related to Preventive Controls, misbranding, and labeling.

Overall, nothing really major...probably not killing anyone.

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/midwest-foods-llc-677464-05212024
Midwest Foods, LLC
MARCS-CMS 677464 — MAY 21, 2024

How the Moon Landing Led to HACCP

This story is always reflected upon at the start of HACCP training.  If you are interested in more of the details on how the HACCP concept originated, here it is.


NASA
https://spinoff.nasa.gov/moon-landing-food-safety
How the Moon Landing Led to Safer Food for Everyone

System created for Apollo astronaut food has become the global standard for hazard prevention

Originally published 11/23/2020

As many Americans prepare for a socially distanced Thanksgiving meal, some may be aware that NASA helped develop the tiny, highly efficient video cameras in the devices that will allow virtual family dinners, and a few may know it was the space agency that first modernized conference calling. But NASA has made an even more important contribution to the holiday: no one is likely to worry about the safety of the food on their table.

Today, outbreaks of food poisoning from packaged supermarket food are exceedingly rare, thanks in part to the food industry’s near-universal adoption of an approach that’s little-known outside the business, called the Hazard Analysis and Critical Control Point (HACCP) system. Even less-known is the fact that HACCP was created for astronaut food in the early days of the Apollo program.

CDC - Outbreak of Trichinellosis from Eating Bear Meat 2022

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

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

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

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

What symptoms were exhibited?

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

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

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

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

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

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

FDA Cites Detroit Tortilla Baker for Inadequate Controls

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

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

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

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

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

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

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


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

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

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

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


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

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

California Bread Company Cited for Inadequate Allergen Controls

FDA issued a Warning Letter to a California bread company after the company had a recall for undeclared allergens.   In the inspection, FDA found inadequate allergen controls. 

"Your hazard analysis for your various bread products (part of your HACCP Plan dated November 2, 2023) identified allergens as a significant hazard requiring a Critical Control Point (CCP) at the packaging/labeling step. However, your Allergens Management Program did not specifically identify the milk allergen in your sweet whey ingredient. You did not declare the milk allergen on your label for La Torta (Telera) bread products, lot # TAN NOV15, on November 2, 2023"

There were also issues with the use of Yellow No. 5.

",...the listing regulation for FD&C Yellow No. 5 requires that this certified color additive be listed as “FD&C Yellow No. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No. 5 [21 CFR 74.705(d)(2)]. Your Egg Bread product is manufactured with (b)(4) Egg Shade which contains FD&C Yellow No. 5; however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement."

There were also label misbranding issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-bread-co-674283-04252024
WARNING LETTER

California Bread Co.
MARCS-CMS 674283 — APRIL 25, 2024