MA Seafood Company Recalls Salmon Burgers for Undeclared Sesame and Milk

Raw SeaFoods, Inc. of Fall River, MA is recalling Farm Raised Lightly Seasoned Atlantic Salmon Burgers due to undeclared sesame and milk allergens.   The recalled product was sold in the seafood department of Whole Foods Market stores nationwide from August 25, 2023 through November 15, 2023.  The problem was discovered after a vendor reported visible sesame seeds present on the product. An investigation is currently under way to discover the cause. No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raw-seafoods-inc-issues-allergy-alert-undeclared-sesame-and-milk-farm-raised-lightly-seasoned
Raw SeaFoods, Inc. Issues Allergy Alert for Undeclared Sesame and Milk in Farm Raised Lightly Seasoned Atlantic Salmon Burgers
Summary
Company Announcement Date:  November 16, 2023
FDA Publish Date:  November 16, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sesame and Milk
Company Name:  Raw SeaFoods, Inc.
Brand Name:  Raw SeaFoods
Product Description:  Farm Raised Lightly Seasoned Atlantic Salmon Burgers

Additional Recalls Issued After AZ Company's Recall for Cantaloupe Due to Salmonella

 SOFIA PRODUCE, LLC, of Nogales, Arizona which does business under the name “Trufresh” (“Trufresh”) has expanded its recall of all sizes of fresh cantaloupes packaged in cardboard containers labeled with the “Malichita” label, to include the following additional sales order numbers distributed between October 16, 2023 and October 23, 2023 because they have the potential to be contaminated with Salmonella

Vinyard Fruit and Vegetable Company, located in Oklahoma City, OK, has initiated a voluntary recall of all fresh-cut cantaloupe products due to the potential for contamination with Salmonella.  This comes in response to the 11/8/2023 recall of fresh, whole cantaloupes by Sophia Foods, LLC (DBA Trufresh) of Nogales, AZ, which was triggered by testing conducted by the Canadian Food Inspection Agency which found the potential contamination with Salmonella, Vinyard Fruit and Vegetable Company is issuing this recall. Cantaloupes recalled by Sophia Foods LLC were used as a raw material in Vinyard cantaloupe products listed below.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sofia-produce-llc-dba-trufresh-expands-recall-include-additional-order-numbers-fresh-cantaloupe
Sofia Produce, LLC dba Trufresh Expands Recall to Include Additional Order Numbers of Fresh Cantaloupe Because of Possible Health Risk Due to Salmonella
Summary
Company Announcement Date:  November 15, 2023
FDA Publish Date:  November 16, 2023
Product Type:  Food & Beverages  
Reason for Announcement:  Potential Salmonella contamination
Company Name:  Sofia Produce, LLC dba Trufresh
Brand Name: Malichita
Product Description: Fresh Cantaloupe

Articles on Shelf-life Dating Fail to Educate

Expiration dates and food waste....the current arguments that food expiration dates lead to food waste is one that is so singular in focus that blame food company practices for being  responsible instead of purchaser of the food who fails to manage properly.  In an article Is It Really Expired? The Truth About Food ‘Expiration’ Dates, we see many of the same complaints about code dating, but a failure to recognize the real issue...failure to manage according to those dates.

Face it, when you spend $3.00 on a bag of chips, your expectation is that the bag of chips within code date is going to meet your expectations...100% of the time.  Not 50% of the time.  A manufacturer does not want to disappoint a customer and have them return the product (which in the end costs the manufacturer for that bag... at retail price, and the potential of a lost customer).  The date that is set is that guarantee of that quality.  But there are those that say....well, that bag of chips is still safe past that date, but may not be as good.  What is that probability?  Maybe 5 days past the code date it is 90%....two weeks 80%.   Quality continues to deteriorate by the day, and while still safe, 80% quality was certainly not worth 100% of the $3.00 you spent on the bag of chips.

Products, and the processes that produce these products, are all different.  The conditions in which products are distributed and then stored also vary greatly, impacting the deterioration of product.  The manufacturer has an interest to set that code date out as far as they can, for distribution purposes, but to a point where they can guarantee that the quality is still acceptable 100% of the time.  There are  numerous factors taken into account when setting a date.  No one can do this but the manufacturer because in the end, their livelihood is dependent upon it.

But instead of us focusing on educating people on using food in a timely fashion, we look to force companies to potentially sell products that have a chance to fail before they are consumed.   Food is a expensive resource that must be used wisely.  Along with that, we should have a system that can capture any remaining value for product that is not exactly at the standard it was when paid for at full price.  

For the consumer, it should come down to managing the resource properly.  Use food before it gets close to date...buy only what you can use in a reasonable time period....only prepare what you plan to consume immediately or within a few days if not adverse to eating leftovers.

Do not make me buy something at full price that does not meet 100% of my expectations.  Do not put in regulations forcing companies to set dates where product failure is a possibility just because somebody may misplace a food item on the shelf only to find it 3 months later.

There is agreement that there needs to be better adherence to code dating standards. A standard was initiated by Food Marketing Institute (FMI) and the Grocery Manufacturers Association (GMA, now the CBA).  "The new voluntary initiative streamlines the myriad date labels on consumer products packaging down to just two standard phrases. “BEST If Used By” describes product quality, where the product may not taste or perform as expected but is safe to use or consume. “USE By” applies to the few products that are highly perishable and/or have a food safety concern over time; these products should be consumed by the date listed on the package – and disposed of after that date."

Educate people on the correct reason for these dates and for the need to use food wisely.  And then give them a way to handle this product if it has not used wisely to start (with the understanding that it is not as good from a quality perspective as it once was).  In the end, it comes down to the consumer for managing their food and using that resource in a mindful way.

EcoWatch
https://www.ecowatch.com/food-expiration-labels-dates-safety-ecowatch.html

Is It Really Expired? The Truth About Food ‘Expiration’ Dates

Forgot about that container of yogurt in the back of the fridge? A bag of granola lost in the pantry? A glance at the expiration date might tell you that it’s time to toss it, but in fact, “expired” food might still be perfectly safe and enjoyable to eat..

CDC MMWR - 2021 Salmonella Outbreak in Canada Linked to RTE Tofu

In CDC MMWR, a report on a 2021 Salmonella outbreak linked to tofu.  "During May–July 2021, an outbreak of S. Typhimurium involving 38 cases in 10 public health districts in Ontario, Canada was linked to consumption of tofu, suggesting a novel outbreak-associated S. Typhimurium food vehicle. Lapses in sanitation and recommended heat processing likely resulted in product contamination."

While tofu had not previously been the source of a Salmonella outbreak, it is not a stretch to think it could be.  So with that, a food safety plan would need to address Salmonella on the soybeans used to make the tofu, and then as a contaminant in the environment.  For the latter, sanitation controls, hygienic controls, and verification by environmental monitoring.

From the report:

• "Food safety investigations revealed that seasoned tofu from the same manufacturer was served across all 14 restaurants. The tofu was identified as a ready-to-eat food product that was produced by a manufacturer in Ontario and commercially sold in 250-g (8.8-oz) and 500-g (17.6-oz) packages. Restaurants purchased the product as a 500-g vacuum-sealed package."
• "Food safety investigations identified the absence of a heat treatment process after the addition of seasoning to the packaged 500-g product, which was also sold online to other provinces including Quebec; the 250-g packaged product did undergo additional heat treatment. No illnesses were linked to the 250-g packaged product. Several infractions were observed at the manufacturing plant, including poor sanitation of the processing equipment and the absence of a food safety plan or a food sampling program."
• "Tofu was identified as the source of an outbreak of S. Typhimurium in Ontario in 2021. Investigators hypothesized that unsanitary conditions at the production facility could have led to contamination of the tofu after production and before packaging, but the absence of an additional heating step during production likely resulted in failure to eliminate the pathogen. "
• "Tofu is a novel outbreak-associated food vehicle for this pathogen and has not been implicated in previous outbreaks. Soy products, including tofu, are uncommon vehicles for foodborne illnesses. Among previously published outbreaks linked to soy products, only one outbreak involved Salmonella (Salmonella enterica paratyphi) (2). "
• "Although tofu has been implicated in outbreaks associated with other pathogens, there are no published reports of tofu-associated nontyphoidal Salmonella outbreaks (3,4); however, the growth or presence of S. Typhimurium on soy products has been detected in microbiological food studies (5,6)."

CDC - MMWR

https://www.cdc.gov/mmwr/volumes/72/wr/mm7232a1.htm
An Outbreak of Salmonella Typhimurium Infections Linked to Ready-To-Eat Tofu in Multiple Health Districts — Ontario, Canada, May–July 2021
Weekly / August 11, 2023 / 72(32);855–858

CDC MMWR - 2022 E.coli (STEC) Outbreak Among Farm Camp Participants at Goat Farm

In CDC MMWR, a report on a 2022 E.coli (STEC) outbreak linked to a farming camp in Tennessee where children got to interact with baby goats.  There were 12 ill camp attendees.  "TDH concluded that this outbreak was associated with STEC O157:H7-infected kids and involved secondary transmission. Hand-to-mouth contact has been observed to occur almost three times per hour among children aged 6–10 years,** supporting the potential for STEC ingestion from contaminated environmental surfaces."

https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a6.htm
Notes from the Field: An Outbreak of Shiga Toxin–Producing Escherichia coli O157:H7 Associated with a Farming Camp — Tennessee, 2022
Weekly / July 21, 2023 / 72(29);805–806
Lindsey Ferraro, MPH1; D. J. Irving, MPH1; Jack Marr, MPH1; Kelly Orejuela, MPH1; Erin Murray1; Mugdha Golwalkar, MPH1; Lisa M. Durso, PhD2; Julie Viruez, MLS3; Robin Rasnic, MT3; Katie Garman, MPH1; John Dunn, DVM, PhD1 (VIEW AUTHOR AFFILIATIONS)

FDA Updates Ongoing Investigation into Hepatitis A Associated with Frozen Strawberries

FDA provided an update of the Hepatitis A outbreak that was linked to frozen strawberries. As of July 18, 2023, there are now ten cases of Hepatitis A linked to frozen strawberries with 4 of those hospitalized. All cases are on the West Coast of the US. The last reported case was on June 4, 2023.

FDA last reported on this outbreak in mid-June. At the time, there was one less case than was reported now.  The problem is of course, with frozen product, people may still have these frozen strawberries in their freezer.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-infections-frozen-strawberries-february-2023
Outbreak Investigation of Hepatitis A Virus Infections: Frozen Strawberries (February 2023)
Do not eat recalled Frozen Strawberries. FDA’s investigation is ongoing.

Current Update
July 20, 2023

Case Counts
Total Illnesses: 10
Hospitalizations: 4
Deaths: 0
Last Illness Onset: June 4, 2023
States with Cases: CA (2), HI (1), OR (1), WA (6)

Product Distribution: Nationwide

As of July 18, 2023, a total of 10 outbreak-associated cases of hepatitis A have been reported from four states. Based on epidemiological data collected by CDC, 10/10 (100%) people who provided information about what they ate before becoming ill reported eating frozen organic strawberries.

PA Ag Issues Warning for Raw Goat Milk After Campylobacter Detected

The Pennsylvania Department of Agriculture warns that consumers should immediately discard raw goat milk sold from Dove Song Dairy doe to possible contamination with Campylobacter. Three people who consumed this product and became ill with campylobacteriosis were reported by the Pennsylvania Department of Health. Raw milk samples tested by the Pennsylvania Department of Agriculture are presumptively positive for Campylobacter.

People with Campylobacter infection usually have diarrhea (often bloody), fever, and stomach cramps. Nausea and vomiting may accompany the diarrhea. Symptoms usually begin two to five days after infection and last about one week

Daily Review
https://www.thedailyreview.com/news/consumers-should-discard-dove-song-dairy-brand-raw-goat-milk-due-to-possible-contamination-pa/article_fb94a95c-dc8b-5de3-8449-ad2ac629785d.html
Consumers should discard Dove Song Dairy brand raw goat milk due to possible contamination: Pa. Ag. Dept.

For The Review Pennsylvania Department of Agriculture Jul 19, 2023

DC Establishment Recalls Tubs of Spicy Hummus for Undeclared Sesame After Incorrect Lid Applied

Cava Foods, Inc., a subsidiary of Cava Group, Inc. in Washington D.C., is issuing a voluntary recall of one lot of its packaged CAVA Spicy Hummus due to the potential for the product to contain undeclared sesame, which is a food allergen.   CAVA voluntarily initiated the recall after a single retail store notified the company that packaging lids for CAVA Spicy Labneh (which do not declare sesame as an ingredient) were applied to containers of Spicy Hummus, which contains sesame, a common allergen. The wrong lid was applied to a limited number of Spicy Hummus containers by a third-party supplier.

Here is another recall related to mislabeling where a lid label is applied to the wrong product.  Seems like an easy enough issue to prevent through development and implementation of a good Allergen Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cava-foods-inc-subsidiary-cava-group-inc-issues-allergy-alert-undeclared-sesame-cava-spicy-hummus
Cava Foods, Inc., a Subsidiary of Cava Group, Inc. Issues Allergy Alert for Undeclared Sesame in Cava Spicy Hummus
Summary
Company Announcement Date:  July 17, 2023
FDA Publish Date:  July 18, 2023
Product Type:  Food & Beverages Prepared Food  
Reason for Announcement:  Undeclared sesame allergen
Company Name:  Cava Foods, Inc.
Brand Name:  CAVA
Product Description:  Spicy Hummus, 8 oz tub

California Recall of Asian Chopped Salad Due to Undeclared Allergens Packed With Wrong Condiment Pack

In California, Braga Fresh is recalling a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit 12oz bag purchased from Whole Foods Markets stores.  The product is being recalled because it contains incorrect condiment ingredients resulting in undeclared milk and egg that was not listed on the product label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/braga-fresh-issues-precautionary-recall-365-whole-foods-market-brand-organic-asian-inspired-chopped
Braga Fresh Issues Precautionary Recall of 365 By Whole Foods Market Brand Organic Asian Inspired Chopped Salad Kit 12oz Bag Due to Potential Presence of Undeclared Allergens
Summary
Company Announcement Date:  July 11, 2023
FDA Publish Date:  July 12, 2023
Product Type:  Food & Beverages  Prepared Food  
Reason for Announcement:  Undeclared milk and egg allergens
Company Name:  Braga Fresh
Brand Name:  365 By Whole Foods Market
Product Description:  Potential or Undeclared Allergen - milk and egg

Products Containing Pineapple Recalled After Supplier Recall

Sunrise Growers issued a recall of cut pineapple product due to Listeria. This led to Scenic Fruit Company of Oregon to also recall product since they used that as an ingredient in their product.   While there have been no illnesses associated with this, the recall has extended to product sold at many of the top retailers including Walmart, Target, Trader Joe's, and Aldi.

Is Listeria a risk in cut pineapple?  Not overly so.  One study (Huang, etat, 2018) found that Listeria decreased on cut pineapple when stored at various temperatures. "Under chronic temperature abuse, three different pathogen growth patterns emerged on five test products: both S. enterica and L. monocytogenes grew significantly on cut cantaloupe, honeydew and watermelon at 8 and 12 °C; but only survived on cut radish, and even declined in population on cut pineapple under the same conditions."  Another study (Zeigler, etal, 2018) showed similar impact of pineapple on Listeria, but stated that the biggest issue was final product pH, and this can be an issue with a fruit mixture, such as when blended with items like melon or bananas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scenic-fruit-company-recalls-organic-pineapple-because-possible-health-risk
Scenic Fruit Company Recalls Organic Pineapple Because of Possible Health Risk
Summary
Company Announcement Date: June 22, 2023
FDA Publish Date: June 23, 2023
Product Type: Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes.
Company Name: Scenic Fruit Company
Brand Name: Cadia and Trader Joe’s
Product Description: Organic Frozen Pineapple and Frozen Fruit Blend Containing Organic Frozen Pineapple

USDA Approves Cell Cultivated Meat Product

As seen across the mass media universe this week, USDA approved cell-cultured meat to be made by two "processors".

So a few questions....

"

What does it taste like?  Like chicken, as provided in an AP News article.  According to the article, "The taste was richer than a chicken breast, more like the dark meat of a thigh. And the texture was both tender and chewy, like a well-cooked chicken thigh should be."    More like meat than Beyond Meat sausage and the Impossible Burger.

Who regulates this?  Well, both FDA and USDA.  In FSIS directive 7800.1

• FDA and FSIS have agreed to jointly oversee the production of cell-cultured meat and poultry food products and to share information necessary to carry out their respective oversight responsibilities in establishments that harvest cells for cell-cultured meat or poultry food products.
• FDA has jurisdiction over the preharvest production phase of the animal cell culture technology process. During this phase, living cells are collected from species amenable to the Acts and stored. These living cells are later placed in a controlled environment, such as a bioreactor, and introduced to inputs (e.g., amino acids, glucose, and inorganic salts) and other factors that encourage their growth, multiplication, and differentiation into various cell types.
• Jurisdiction transfers to FSIS at harvest, i.e., when the cell-culture establishment commences the process of removing the cells from the controlled environment, thereby halting their ability to further grow, multiply, or differentiate into various cell types.
• FSIS also has jurisdiction over the postharvest processing and labeling of cell-cultured meat and poultry food products. Postharvest, establishments that produce cells for cell-cultured meat or poultry food products may distribute the raw harvested cells in commerce or process the harvested cells into finished products that contain ingredients, such as spices, flavorings, binders, or other ingredients. Some of these establishments may send harvested cells to other establishments for further processing, rather than processing these cells at the harvest facility.
• Ingredients, including processing aids, used in cell-cultured meat or poultry food products postharvest (including substances used preharvest that remain in the harvested cells) must be considered safe and suitable by FSIS and used in accordance with the intended use listed in 9 CFR 424.21(c) or FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products.

Will you be one of the first to try Test Tube Chicken? As for me, no.

ABC News
https://abcnews.go.com/GMA/Food/fda-approves-1st-cell-cultivated-meat-upside-foods/story
USDA approves 1st ever 'cell-cultivated meat' for 2 American manufacturers

UPSIDE will cultivate and sell chicken grown from animal cells in bioreactors.

After years of research and rigorous testing, cell-cultivated meat will officially become part of the U.S. food system.

Emeryville, California-based manufacturer UPSIDE Foods, which gave ABC News a look inside its facilities earlier this year, and Good Meat a cultivated meat division of the plant-based egg substitute food technology company Eat Just, are the first U.S. Department of Agriculture-approved cell-cultivated chicken meat producer and has been fully approved by the U.S. government for commercial sales nationwide.

FDA Reports on Sampling Project for Pathogens in RTE Dips and Spreads

FDA released a report on their sampling of RTE dips and spreads for Listeria and Salmonella. The concern is that these products will have post-lethality (after pasteurization) exposure during additional  processing such as mixing before packaging where they can be subject to recontamination.  (Ingredient contamination can also be an issue of course)  Once packaged, the product is held under refrigeration conditions, generally having a long shelf-life, and then consumed, as is, by the consumer...often served with chips or veggies as a vehicle to scoop the product and deliver it by hand to the mouth   (I think you know the process.)  FDA points out the issue with these products.

"Over the past few years, there have been a few outbreaks and many recalls of dips and spreads. In FY2019, there were two outbreaks of Salmonella linked to Tahini (12 confirmed cases, 1 hospitalizations). In FY2017, there were two outbreaks of L. monocytogenes linked tohummus (31 confirmed cases, 26 hospitalizations, 3 fetal losses); one of the outbreaks may have contributed to 3 deaths. These past outbreaks and recalls are what prompted FDA to initiate this surveillance sampling assignment to survey the industry, perform follow-up inspections to positive samples to identify potential routes and sources of contamination, when possible, and ensure potentially contaminated product was removed from the retail market to protect public health."

The top items sampled included hummus (336), cheese spread (82) cheese and vegetable spread (65), dairy [sour cream type?] (63), cheese and pepper (54), dairy and vegetable [sour cream and oinion?], and salsa (37).

Out of the 747 samples tested in this assignment, four were detected to have a human pathogen

Salmonella - The agency detected Salmonella spp. in one hummus sample collected from a retail establishment in Kingsburg, CA. The FDA detected the serovar Salmonella Havana in one of the two composites. Upon detecting Salmonella spp., the FDA performed Whole Genome Sequencing (WGS) analysis on the organism and determined that it did not match any known human illnesses and was not linked to any other product or environmental samples.

Listeria - The FDA detected Listeria monocytogenes in three dips and spreads samples – two cheese samples, one cheese and pepper sample – collected from a retail establishment in Colorado Springs, CO. All three of the samples contaminated with L. monocytogenes were produced by the same manufacturer. After detecting L. monocytogenes, the agency conducted WGS analysis on the organisms and determined they did not match any known human illnesses and were not linked to any other product or environmental samples.

The agency’s finding of three positive product samples and over 23 positive environmental samples all from one firm indicates that the controls that firm established were not effective at significantly minimizing or preventing L. monocytogenes from contaminating their RTE finished products. The large number of positive environmental samples found in the follow-up inspection indicates the firm had not implemented effective sanitation controls. 

Dairy Free Gelato Recalled After a Consumer Tastes Milk in the Product..and is Right

Gelato Boy of Boulder, Colorado is recalling 728 cases / 5,824 units of Chocolate Chunk Gelato [a 'dairy free product] because it may contain undeclared MILK.  The recall was initiated after a customer notified Gelato Boy that the pint did not have its normal appearance and that it “tasted like there’s dairy in it”. Gelato Boy immediately located a pint with the same lot code and brought it to a lab for testing. It was confirmed that the product containing MILK was distributed in packaging that did not reveal the presence of MILK.

So my guess is that this was not a trace of milk (cross contact), but a whole lot of milk.  Either that, or this person has some serious milk-tasting chops.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gelato-boy-issues-allergy-alert-undeclared-milk-chocolate-chunk-gelato
Gelato Boy Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Gelato
Summary
Company Announcement Date:  June 14, 2023
FDA Publish Date:  June 14, 2023
Product Type:  Food & Beverages  Ice Cream/Frozen Dairy
Reason for Announcement:  Undeclared milk
Company Name:  Gelato Boy
Brand Name:  Gelato Boy
Product Description:  Chocolate Chunk Ice Cream

FDA Report on Outbreak Investigation of Hepatitis A Virus Infections - Frozen Strawberries (February 2023)

FDA reported on the ongoing investigation into an outbreak of Hepatitis A linked to organic frozen strawberries from Baja California, Mexico. A number of retailers which received product from Willamette Valley Fruit Co. 

• Walmart: Great Value Sliced Strawberries, Great Value Mixed Fruit, and Great Value Antioxidant Blend distributed to select Walmart stores in AR, AZ, CA, CO, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WI, WV, and WY from January 24, 2023, to June 8, 2023.
• Costco Wholesale Stores: Rader Farms Organic Fresh Start Smoothie Blend distributed to Costco Wholesale stores in CO, TX, CA, and AZ from October 3, 2022, and June 8, 2023.
• HEB: Rader Farms Organic Berry Trio distributed to HEB stores in Texas

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-infections-frozen-strawberries-february-2023

Outbreak Investigation of Hepatitis A Virus Infections: Frozen Strawberries (February 2023)
Additional recalls for products sold at Walmart, Costco, and HEB. Do not eat recalled Frozen Organic Strawberries. FDA’s investigation is ongoing.
Case Counts

Total Illnesses: 9
Hospitalizations: 3
Deaths: 0
Last Illness Onset: April 12, 2023
States with Cases: WA (6), CA (2), OR (1)
Product Distribution: Nationwide

Update on Hepatitis A Outbreak Linked to Frozen Organic Strawberries - Additional Companies Issue Recalls

CDC and FDA updated the information on a the Hepatitis A outbreak associated with frozen organic strawberries from a supplier in Baja California, Mexico.  To date, there have been 7 reported cases from 2 states with 2 of those cases resulting in hospitalizations.

Product recalls began for one company, California Splendor, on March 16, 2023.  "In response to this investigation, Scenic Fruit Company of Gresham, Oregon voluntarily recalled frozen organic strawberries, sold to Costco, Trader Joe’s, Aldi, KeHE, Vital Choice Seafood, and PCC Community Markets in certain states."

https://www.cdc.gov/hepatitis/outbreaks/2023/hav-contaminated-food/index.htm
Multistate Outbreak of Hepatitis A Virus Infections Linked to Frozen Organic Strawberries
At a Glance
Reported cases: 7
States: 2
Hospitalizations: 2
Deaths: 0

Outbreak Information
As of April 7, 2023, there are:

• 7 outbreak-associated cases of hepatitis A reported from 2 states (California and Washington).
• Illnesses started on dates ranging from November 24, 2022, to March 26, 2023.
• 2 people have been hospitalized. No deaths have been reported.
• Epidemiologic and traceback evidence indicate that frozen organic strawberries are the likely source of this outbreak.

MI Indoor Farm Recalls Products Due to Potential Listeria Contamination

Recall Expanded (FDA April 7, 2023) to include additional products.

Revolution Farms of Caledonia, Michigan is voluntarily recalling the listed products packed between 3/3/23 and 3/11/23, because they have the potential to be contaminated with Listeria monocytogenes.  The recall was initiated when the Michigan Department of Agriculture and Rural Development (MDARD) received a positive result for Listeria monocytogenes in a random sample test of a single package of Revolution Farms Green Sweet Crisp – 5oz Retail with Best By date of April 2, 2023.  To date, there have been no illnesses.

The recalled products were sold to the following retailers and food service distributors in the states of MI, OH, IN, IL, KY, and WI

Revolution Farms is indoor farm, falling in the realm of CEA, or Controlled Environment Agriculture.

"The term controlled environment agriculture (CEA) encompasses a variety of systems that take a technology-based approach to farming. CEA can range from simple shade structures and hoop houses through greenhouses to full indoor or vertical farms. The most advanced systems are fully automated, closed loop systems with controlled lighting, water and ventilation. CEA also encompasses common practices such as plastic film over field-grown crops, nets or shade structures and aquaponics systems that integrate fish or aquaculture with plant production."

"CEA systems are designed to provide optimal growing conditions for crops and prevent disease and pest damage. In indoor systems with artificial lighting, crops may be grown hydroponically, in which roots are bathed in nutrient-dense water, or aeroponically where roots are regularly misted with water and nutrients". (Source UC Davis)

Closed farming systems may pose more Listeria risk than conventional farms.  These environments are not much different than a wet processing facility.  As an example, in 2021, Old Soul's Farms had a Listeria-related recall that linked to Listeria build-up in the rainwater-capture holding tanks.  

Other facilities have had issues with different pathogens including Salmonella and pathogenic E.coli.  Because of these issues, CEAs must address pathogen hazards through risk assessment and enacting preventive controls where needed and verifying GMP type controls, especially if these facilities contain a transition to 'processing' within the scope of their operations.

Interesting note that today, an article appeared in Food Safety Magazine (Apr-May, 2023), "Is CEA a Safer Way to Grow and Process RTE Vegetables? "  The article is not overly insightful in terms of providing a broad perspective of risk, but it does provide these quotes by the author that are interesting... 

• "Unfortunately, my experience with CEA practitioners is not encouraging with regard to risk mitigation efforts. In my view, CEA growers assume that because they do not have dirt and are enclosed, they are safe. This attitude seems similar to the prevailing attitudes in 2006."
• "Most, if not all, traditional RTE operations are cold, wet environments. Listeria monocytogenes is of particular concern. Salmonella is generally of greater concern in drier operations. Given that CEA operations can have both wet and dry areas, it is reasonable to consider the development of tailored environmental monitoring programs that address both hazards."
• "Control of the wash system in a traditional RTE processing facility is an important focus of the food safety program. Washing value-added product has reduced illnesses. CEA, however, has largely bypassed the washing step. Some CEA operations are grappling with the decision to wash or not wash. A handful of operations are washing as a point of differentiation. Since 2006, the science and technology behind washing RTE product have advanced tremendously. Each CEA operation must consider how the safety of its system compares to the current standards of the RTE industry as a whole to support its claims of safety."
• "CEA farming presents some unique food safety challenges that traditional operations do not face. The recycling of nutrition solutions as part of irrigation has the potential to contaminate an entire production facility. Given the tendency toward continuous production, there are no discrete lots or clean breaks when a problem occurs."
• "Food safety needs to be designed into operations. The current designs of CEA operations are tailored for optimum operational performance. These designs will evolve in the same way that traditional process plants evolved. Traditional operations are no longer packing sheds. This evolution has taken time. However, given the achieved safety in traditional operations, CEA operations will need to evolve faster and make fewer mistakes."

And finally this regarding the ability to do a good risk assessment:

• "Unfortunately, the ability to execute a complete risk assessment is still evolving. The standards for risk assessments in the traditional RTE sector are soft. Third-party audits are very prescriptive and often focus on minor details without addressing the fundamentals that must be improved to advance food safety. Given the developmental stage of CEA, it will be difficult to execute a complete risk assessment of CEA operations at present. I expect someone will attempt a risk assessment of a farm in an RTE plant in the near future. It will probably be denounced and attacked; however, it will provide a starting point for a much-needed effort."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/revolution-farms-announces-voluntary-recall-lettuce-because-possible-health-risk
Revolution Farms Announces the Voluntary Recall of Lettuce Because of Possible Health Risk
Summary
Company Announcement Date:  April 05, 2023
FDA Publish Date:  April 05, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Revolution Farms
Brand Name:  Multiple brand names
Product Description:  Lettuce & Salad Kits

MI Cheese Producer Issued Warning Letter for Food Safety Plan Misses That Led to 2022 Listeria Outbreak

FDA issued a Warning Letter to Old Europe Cheese, a Michigan cheese producer.  The inspection was prompted by a 2022 Listeria outbreak linked to their cheese where six (6) ill people from six (6) states were infected with the outbreak strain of L. monocytogenes.

Here is a summary of that report highlighting the big misses that occurred within the Company's Preventive Control Program.  This is an excellent example why a proper Food Safety Plan is needed.

• Presence of Outbreak Strain of Listeria "FDA collected samples (environmental swabs) of the production environment and confirmed that (1) swab collected from a hole in the (b)(4) floor was positive for L. monocytogenes.  WGS analysis was conducted of the above referenced L. monocytogenes isolate and it was determined that the environmental isolate matched the six (6) clinical isolates that were part of an illness outbreak cluster.
• Presence of Listeria Indicator Organisms - In addition to L. monocytogenes, the presence of Listeria innocua (L. innocua) was also found in your facility during the FDA environmental swabbing that occurred on September 13 and 14, 2022. L. innocua was detected in two (2) environmental swabs taken from the floor in the (b)(4) Room and a floor drain between the (b)(4) Room and (b)(4) Hallway where the cheese products are RTE (post-pasteurization) and exposed to the environment. The presence of non-pathogenic Listeria species suggests that conditions are suitable for survival and/or growth of L. monocytogenes which, as noted above, has been found in your facility.
• Hazard Analysis Does Not Consider Environmental Contamination by Pathogens a Significant Hazard - "The "hazard analysis for soft and semi-soft cheese products determined that “Post-Pasteurization Contamination” did not require a preventive control because it was “Unlikely to occur as purity plating of production samples is performed and plant performance history indicates good process control.” In addition, your hazard analysis determined that “Environmental Contamination (Listeria)” did not require a preventive control because an “Environmental program is in place to test for listeria spp. Finished product testing is also performed with positive release program.” However, RTE soft and semi-soft cheese products manufactured in your facility were exposed to the environment at various post-pasteurization processing steps (e.g., (b)(4))"
• Hazard Analysis Does Not Consider Finished Product Cooler Temperature as a Process Preventive Control - "Hazard analysis did not require a preventive control at the “Cooler Storage” step because a “Program for Cooler Temperature [sic] Control is in place. Plant does not have a history of problematic room temperatures.” However, if not properly time/temperature-controlled, the RTE soft and semi-soft cheese products stored in your facility are likely to support the growth and toxin formation of bacterial pathogens (such as ingredient-related pathogens either surviving pasteurization or added post-pasteurization, or environmental pathogens introduced in your facility). "
• Deviation to Cooler Temperature - "Through record review during the inspection, we detected two (2) dates where temperatures were recorded as 51.2°F, 52°F and 53.1°F with no record of a corrective action documented. Soft cheeses can support the growth of pathogens, including L. monocytogenes, when not stored at proper refrigeration temperatures."
• The Hazard Analysis Does Not Properly Address Post-Process Ingredient Additions with Supply Chain Preventive Controls  - The "hazard analysis for soft and semi-soft cheese products determined that bacterial pathogens in many ingredients added after pasteurization (e.g., peppercorns, 1/8” flaked tomato, chives, basil, garlic salt, and parsley) did not require a preventive control because “Product is tested for Salmonella – COA Received per lot.” These ingredients did not undergo a kill step in your facility. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control (i.e., supply-chain program)."
• Sanitation Procedures Not Fully Implemented - with respect to the production of soft cheeses when they are RTE (post-pasteurization). For example:
• The "sanitation procedures, as described in the document titled, “GMP Manual,” instructed employees to wash their hands “following practices that may compromise hand cleanliness.” However, on September 13, 2022, our investigators observed two (2) different employees’ hands come into contact with unclean surfaces (e.g., a hose that had been in contact with the floor); these employees (b)(4) their hands into a (b)(4) and returned directly to handling RTE brie cheese without washing their hands."
• The "Master Sanitation Schedule directed employees to clean-in-place (CIP) the brie vats with both (b)(4) solution according to the production schedule. However, our investigators observed during the CIP on September 15, 2022, that the vat was only filled to approximately (b)(4) of its volume, which resulted in the food-contact surfaces inside not being fully submerged, as would be needed to facilitate effective cleaning. One of your employees also indicated that (b)(4) solution is not always used in the vats during the week, contrary to the instructions in the Master Sanitation Schedule."
• Not Following the Environmental Monitoring Program - "Environmental Swabbing program required collection of a minimum of (b)(4) samples from designated zone 2-4 locations every (b)(4). However, you collected ten (10) swabs on or around May 25, 2022, and then you stated that you did not collect any more swabs until the week of this inspection, on or around September 14, 2022."
• Improper Cleaning - "did not conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, on September 13, 2022 employees were observed spraying the outside of brie vats and the floor around the vats with a hose in such a manner that spray from the hose was observed contacting the floor and subsequently contacting the adjacent cheese molding machine."
• Condensation Issues - "Condensation was observed throughout the facility including on areas above cheese molding equipment and RTE brie cheese. For example, condensation and dark reddish-brown stains were observed on the ceiling directly over at least ten racks of stacked food-contact cheese molds stored in the Clean Room. Clear condensation was also observed on pipes and the ceiling within two feet of exposed RTE brie cheese in (b)(4) Room (b)(4). Condensation was also visible on the walls and windows near the ceiling of the (b)(4) Room where food-contact cheese molds were observed sitting on racks exposed to the environment in this room for approximately three hours before being moved to the (b)(4) Room."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/old-europe-cheese-inc-644539-03172023
WARNING LETTER

FDA Issues Warning Letter to CA Seafood Processor for Salmonella Contamination

FDA issued a Warning Letter to a CA seafood processing operation after an inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by the facility.  "According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. "

"FDA laboratory analyses found the presence of the outbreak strain of S. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in [the] facility. On October 20, 2022, [the] firm recalled various types of fresh fish processed at [the] facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at [the]  facility was the likely source of this multistate S. Litchfield outbreak"

Salmonella was found throughout the facility, which indicates poor sanitation among other poor practices.  Even though this is raw fish, Salmonella should not be present.

"Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mariscos-bahia-inc-646401-02072023
WARNING LETTER

Mariscos Bahia, Inc.
MARCS-CMS 646401 — FEBRUARY 07, 2023

FDA Issues Warning Letter to Salad Dressing Bottler After Recall for Mislabeling

FDA issues a Warning Letter to Vanlaw Food Products after their Whole Foods 365 Organic Creamy Caesar Dressing sold in 10 fl. oz. clear glass bottles was mislabeled with the finished product back label having Classic Ranch Dressing and Dip and thus not declaring major food allergens, wheat and soy.
The company had similar recalls.  

• One being on September 19, 2022, where the expanded this recall after being notified by the customer of another lot of 365 Organic Creamy Caesar mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that do not declare wheat and soy. 
• On April 4, 2022, 365 Organic Creamy Caesar Dressing was recalled because of an incorrect back panel for Whole Foods Market Organic Blue Cheese applied to the product, which did not declare the allergens of wheat and soy

This is a pretty easy problem to fix if utilizing a properly designed Allergen Preventive Control for label application.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vanlaw-food-products-inc-641010-01052023

Vanlaw Food Products, Inc
MARCS-CMS 641010 — JANUARY 05, 2023
Recipient:
Mr. Pablo Gallo Llorente
President
Vanlaw Food Products, Inc
1851 North Delilah St.
Corona, CA 93879
United States

FDA Warning Letter - FL Catering Company with History of Listeria

FDA issued a Warning Letter to Wise Spice Catering Company, of Hialeah, Florida, a facility producing ready-to-eat (RTE)  products including sandwiches and meals.

Listeria in facility and in product

• FDA "found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs."
• "Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility."
• Many of these strains were found in different product samples tested since 2015.

GMP issues

• Ineffective measures to exclude pests from  packing and holding areas with sightings of cockroaches and flies.
• Drip / condensate falling from from fixtures, ducts and pipes 
• Improper cleaning including the use of unclean utensils
• Inadequate temperatures control

As of this issuance, the company looks to be be permanently closed.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wise-spice-catering-company-640715-03082023
FDA Warning Letter - Wise Spice Catering Company