Ice Cream Product Recalled After Customer Finds Metal Filler Equipment Part

Weis Markets today said it has issued a recall for: 10,869 containers of Weis Quality Cookies and Cream Ice Cream (48 oz.), and 502 bulk containers of Klein’s Vanilla Dairy Ice Cream after "one report of a customer who discovered an intact piece of metal equipment in the Weis Quality Cookies and Cream Ice Cream (48 oz). There is concern of an additional piece of equipment present in the ice cream product(s) possibly presenting a choking hazard."  Product was distributed in 7 states - Pennsylvania, Maryland, Virginia, New Jersey, New York, Delaware and West Virginia.

Weis Markets Issues Recall for Possible Foreign Matter Contamination in Weis Ice Cream Products
Summary

Company Announcement Date:  January 08, 2021

FDA Publish Date:  January 10, 2021

Product Type:  Food & Beverages  

Reason for Announcement:  May be contaminated with extraneous material

Company Name:  Weis Markets

Brand Name:  Weis, Klein’s, Nelson’s

Product Description:  Ice cream products

Company Announcement

USDA Issues Alert on Mislabeled Chicken Enchiladas

USDA FSIS issued a Public Health Alert for Chicken Enchilada products after a retail employee found a labeling issue.  The product was sold through HyVee retail stores in eight midwestern states.  The product is a NRTE product and thus requires cooking, and past its stated shelf-life date.  Because of this, USDA FSIS issued an alert rather than a recall in the event someone had frozen the product.  

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2021/pha-01072021-01
FSIS Issues Public Health Alert for Not-Ready-to-Eat, Heat Treated, Not Fully Cooked Chicken Enchilada Products Due to Misbranding and an Undeclared Allergen

Mislabeled Product - Salad Packed with the Wrong Dressing/Topping Pack

Dole Fresh Vegetables, Inc. is recalling a limited number of cases of Dole™ Sesame Asian Chopped Salad Kit because the wrong dressing and topping kit (masterpack) was unintentionally used during a portion of the production of the Sesame Asian Chopped Salad.  In short, the dressing/topping kit used had egg  which did not match the salad being produced.  As stated in the release, only a portion of the production run was affected, so someone grabbed the wrong packets and control checks did not catch the mix-up.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-announces-limited-voluntary-recall-doletm-sesame-asian-chopped-salad-kit-due
Dole Fresh Vegetables Announces Limited Voluntary Recall of Dole™ Sesame Asian Chopped Salad Kit Due to Undeclared Allergens
Summary
Company Announcement Date:  January 05, 2021
FDA Publish Date:  January 05, 2021
Product Type:  Food & Beverages  Prepared Food
Reason for Announcement:  Undeclared eggs  Allergens

Company Name:   Dole Fresh Vegetables, Inc.
Brand Name:  Dole
Product Description:  Sesame Asian Chopped Salad Kit

Report on Persistent Listeria Contamination Issue in a Swiss Cheese Facility

An article published in Emerging Infectious Diseases titled Listeriosis Caused by Persistence of Listeria monocytogenes Serotype 4b Sequence Type 6 in Cheese Production Environment discusses an ongoing Listeria outbreak in Switzerland that occurred in two waves, 2018 and 2020.

"Of the 34 human isolates, 30 were from blood samples and 1 each from an abscess, ascites, maternal placenta tissue, or stool sample (Table). One case of perinatal transmission and 10 deaths (29%) were reported."

A Swiss cheese manufacturer had reported the detection of Listeria monocytogenes in the facility and this was matched to the outbreak strain using whole genome sequencing.  "These findings prompted extensive environmental sampling on the production site of the manufacturer. A total of 50 swab specimens from locations, such as vats, cheese harps, skimming devices, sink drains, brushes, scrub sponges, trays, door handles, ripening cellar floors, and walls were obtained....L. monocytogenes was identified in 11 (22%) of 50 environmental samples, and all 5 sequenced isolates matched the outbreak strain CT (Table; Figure 2). These results lead to a recall on May 5, 2020, of 26 items, including brie, sheep and goat cheese, and organic cheeses; production was stopped immediately. " 

In conclusion, the report states "This outbreak highlights the risk for recontamination of pasteurized cheese products during manufacturing and emphasizes the need for routine sampling of products, manufacturing equipment, and the production environment. Routine quality controls should include WGS typing of environmental L. monocytogenes isolates to enable early recognition of potential food contamination and to ultimately mitigate the risk for listeriosis."

Proposal to Remove Standard of Identity for Frozen Cherry Pie

 A few weeks back, we discussed the push to remove the Standard of Identity for French Dressing.  There is also a proposal to remove the Standard of Identity for frozen cherry pie.  Posted in the Federal Register, the proposal looks to revoke the standards for cherry pie by a citizens petition from the ABA - the American Baking Association.  The reasoning is that  "frozen cherry pie is the only fruit pie, either frozen or non-frozen, that is subject to standards of identity and quality" and that it limits what a baker can do with this pie, but not with other pies, including non-frozen cherry pies.  And since we have not had issues with other pies regarding a standard over time, then removing this should not result in a cascade of deception involving frozen cherry pies in the market.

There is probably a history of why this specific standard was written in the first place.  Perhaps devious bakers were making low quality cherry pies and offering these at a lower price compared to the price for higher quality frozen cherry pies and the quality bakers complained.  Perhaps a baker was producing pies at a lower price by using bruised cherries.   Or perhaps there was a consumer complaint from people who felt duped because they bought a frozen cherry pie with little or no cherries.  Can this issue still arise?  Sure, but as consumers, we would be unlikely to buy a lower quality pie at an unreasonable price.  We may not really care if the cherries have bruises.  Consumers will have the choice of the frozen pie brand they purchase based upon price and the quality they expect.

FDA Warning Letter Issued to Texas Importer of Frozen Sliced Strawberries for Lack of FVSP

A Texas based importer was issued a Warning Letter by FDA for not being in compliance with the  FSVP requirements for Frozen Sliced Strawberries   The company had not identified or evaluated biological, chemical or physical hazards potentially present before your suppliers load the products.  There were no established  and written procedures to ensure that  import foods only come from foreign suppliers previously approved based on evaluation conducted to determine a foreign supplier’s performance and the risk posed by the food,  The company did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the imported foods.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/campimex-inc-610730-12112020
Campimex, Inc.
MARCS-CMS 610730 — December 11, 2020 

Pet Food Recalled for Elevated Levels of Aflatoxin.

Midwestern Pet Foods, Inc., of Evansville, IN is issuing a voluntary recall of the below listed dog and cat food products due to tests indicating levels of Aflatoxin that exceed acceptable limits.  Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.  There have been reports of illnesses and deaths in dogs associated with the below listed lots of Sportmix High Energy.  There are reports of at least 28 deaths and 8 illnesses.

With dry pet foods, corn is often the source of aflatoxin.  This occurs when the corn used in processing the pet food had mold growth prior to harvest.  Processors normally do extensive testing of incoming corn.   Suppliers of the corn will do their own testing as well plus will track crop conditions that can lead to mold growth.  There are tolerances for low levels of alfatoxin - 20ppb for corn to be used for pet food.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/midwestern-pet-foods-voluntarily-recalls-pet-food-recall-aflatoxin-health-risk
Midwestern Pet Foods Voluntarily Recalls Pet Food Recall for Aflatoxin Health Risk
Summary
Company Announcement Date:  December 30, 2020
FDA Publish Date:  December 30, 2020
Product Type:  Animal & Veterinary  Food & Beverages Pet Food
Reason for Announcement:  Elevated levels of aflatoxin
Company Name:  Sportmix
Brand Name:  Sportmix
Product Description:  Dog and Cat Food

Imported Herring Product Recalled Due to Listeria

B&I Overseas Trading Inc from Van Nuys, CA is recalling frozen “Veladis herring in oil with Italian spices” because they have the potential to be contaminated with Listeria monocytogenes,  The product was imported from Ukraine.  There was no information on how the Listeria was determined to potentially be in the product.

Listeria would have contaminated the product during handling.  Although frozen which would prevent growth during frozen storage, the directions of  "Defrost before use and keep refrigerated for up to 30 days", would have provided opportunity for growth.  This product would then be consumed as a ready-to-eat product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bi-overseas-trading-recalls-product-due-potential-contamination-listeria-monocytogenes
B&I Overseas Trading Recalls Product Due to Potential Contamination with Listeria Monocytogenes
Summary
Company Announcement Date:  December 23, 2020
FDA Publish Date:  December 24, 2020
Product Type:  Food & Beverages  Fish
Reason for Announcement:  Listeria Monocytogenes
Company Name:  B&I Overseas Trading, Inc
Brand Name:  Veladis
Product Description:  Herring in oil 

This Week in Mislabeled Products for Week Ending December 31. 2020

Ravioli Product Recalled After Using Siracha Chili Sauce From a Different Supplier That Now Contains Soy - The USDA-FSISI is issuing a public health alert for approximately 49 pounds of frozen, fully cooked, not shelf stable chicken sriracha ravioli products due to misbranding and an undeclared allergen. The product may contain soy, a known allergen, which is not declared on the product label.  The product labeled as “FRESH THYME FARMERS MARKET CHICKEN RAVIOLI Ovals” was formulated with a different sriracha chili sauce than normally utilized in the product formulation because the firm was unable to obtain the usual brand from their supplier. The sriracha chili sauce used on Dec. 8, 2020 contains soy, while the sauce normally used in the formulation does not. The following products are subject to the public health alert: [View Labels (PDF only)]

Label of Cajun Spiced Snack Misses Milk  on Label - Lipari Foods of Warren, MI is recalling its 9 ounce packages of Backroad Country Spicy Cajun Mix because it contains undeclared milk.   The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

Supplier Issue Results in Undeclared Milk and Eggs - Divvies of Trumbull, CT is recalling Vanilla Cupcakes with Vanilla Frosting and Vanilla Cupcakes with Chocolate Frosting because they may contain undeclared milk and eggs.  The recall was initiated after it was discovered that an ingredient containing milk and eggs had gotten into the ingredient mix which is used specifically for the vanilla cupcakes. This happened when the mix was packaged by the ingredient supplier. Subsequent investigation indicates the problem was caused by a temporary breakdown of a piece of equipment on the supplier’s packaging line. The problem has been corrected.

Pecan Pies Labeled Mislabeled using Print-and-Apply Labels - Legendary Baking of Chaska, MN is voluntarily recalling a single lot of item number 7545 - French Silk Pie. This product is being recalled due to a potential undeclared pecan allergen. Caramel Pecan Silk Supreme pies may have been packaged in containers that otherwise identify the product as French Silk Pie and did not reveal the presence of pecans.

Bacon Bits Labeled as Garlic Powder - B&G Foods announced today it is voluntarily recalling individual containers of 5.37 oz. Food Club Garlic Powder, with “best by” dates of NOV 19 22 and NOV 20 22, because they mistakenly contain bacon-flavored bits, which contain soy, an allergen undeclared on the garlic powder labels. It was determined that 1,301 cases of bacon-flavored bits, which contain soy, an allergen undeclared on garlic powder labels, may contain some individual containers inadvertently labeled as garlic powder. Containers labeled as Food Club Bacon Flavored Bits correctly indicate that the containers include bacon-flavored bits and correctly declare the presence of soy.

Wrong Back Label - Fresh Orlando, FL., is recalling a limited number of cases of product containing a vegetable tray with ranch dip due to a possible health risk from an undeclared allergen in a product. The product contains egg, which is not declared on the label.

Pecan Kringles Labeled as  Almond Kringles - O&H Danish Bakery, Inc. of Racine, WI is recalling 3,173 units of Almond Kringle (1lb 8oz) with batch code 26720 sold in Trader Joe’s retail stores because it may contain undeclared Pecans. The recall was initiated because it was discovered that four pecan filled kringles were incorrectly labeled as Almond Kringle and delivered to the Trader Joe’s distribution center as a part of a larger order. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's baking and icing processes.

FDA Issues Warning Letter to Whole Foods for Ongoing Series of Allergen Recalls

FDA issued a Warning Letter to Whole Foods after a long series of recalls. FDA cited 32 recalls over the past year. (Certainly, it is about time.)

"These recalls demonstrate that your corporation engaged in a pattern of receiving and offering for sale misbranded food products. For the time period of October 2019 to November 2020, your firm recalled 32 food products due to undeclared allergen(s). We noticed similar patterns of numerous recalls for undeclared allergens in previous years as well."

Here is a sampling of the reasons why allergen labeling errors occurred.

• F‐0925‐2020 - mislabeling occurred because your internal labeling system for the repackaging of food products was not updated to reflect the current ingredient listing for the product.
• F‐0408‐2020 - contract manufacturer packaged a Butter Cookies & Sweet Cream Italian Gelato product with the incorrect Raspberry Cheesecake Italian Gelato label thereby causing the product to have the incorrect ingredient declaration and undeclared egg.
• F‐0131‐2020 - mislabeling occurred because your retail employees applied a label which did not reflect the ingredient listing on the manufacturer’s label. This caused the product to have undeclared milk and eggs.
• F‐1048‐202 -  mislabeling occurred because the ingredient statement, which included almond flour, on the master carton was not fully transferred to the scale label used for the individual containers.
• F‐1354‐2020 to F‐1362‐2020 -  mislabeling occurred because not all of your regions had updated their scale ingredient statement to include the egg allergen. This caused the product to have undeclared eggs.

It comes down to this.....the mass retailer buys and sells a lot of specialty products.  Information must be passed from the manufacturer down through to the distribution centers and stores (wherever the items are labeled,  often use print-on-demand label printers).  If communication and technology input procedures are not tight, there is a lot of room for error.  But not impossible, as many other retailers do the same thing with far fewer issues.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whole-foods-market-610862-12162020?utm_medium=email&utm_source=govdelivery
Whole Foods Market
MARCS-CMS 610862 — December 16, 2020 

USDA Issues Health Alert for Chinese Chicken Wings with False USDA Mark of Inspection

USDA FSIS issued a public health alert for raw frozen New Orleans -Roasted Chicken Wings products imported and labeled with a false USDA mark of inspection. A recall was not requested because the known affected product is no longer available in commerce for consumers to purchase.

"Di-Da Di-Da USA Corp., a Saratoga, Cal., establishment received and distributed ineligible imported frozen chicken wings products from The Peoples Republic of China to U.S. commerce for retail sale. The frozen chicken wings products are labeled with a false USDA mark of inspection bearing “P-40478”, an establishment number that does not exist. The problem was discovered when FSIS received a consumer complaint reporting a product suspected of being illegally imported being sold at a location. After investigation, FSIS determined that the product was ineligible and misbranded with a false USDA mark of inspection."

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-12192020-01
FSIS Issues Public Health Alert for Ineligible Imported Raw Frozen New Orleans - Roasted Chicken Wings from the Peoples Republic of China 

Frozen Meals Recalled Due to Complaints of White Plastic Pieces, Broken Conveyor May Be to Blame

Nestlé Prepared Food facility in Springville, Utah is recalling approximately 92,206 pounds of LEAN CUISINE Baked Chicken meal products "after receiving five consumer complaints involving hard white plastic found in the product. The firm believes the mashed potatoes used in the production of the baked chicken meals products had pieces of a plastic conveyor belt that broke during production."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-030-2020-release
Nestlé Prepared Foods Recalls Lean Cuisine Baked Chicken Meal Products Due to Possible Foreign Matter Contamination
Class I Recall
030-2020
Health Risk: High
Dec 19, 2020 

FDA Issues Advisory on Green Gorilla Root Juice

FDA issued an Advisory for consumer to avoid Green Gorilla Root Juice.

Green Gorilla Root Juice is made by the Green Gorilla Root Juice Company in St. Louis, MO. It contains Cayenne Pepper, apple juice, and a proprietary blend of natural herbs. One of those "natural herbs" was discovered by FDA to be Yohimbine.

Yohimbine is botanical compound extracted from the bark of the Pausinystalia yohimbe tree. It has been used to treat ED, with varying degree of success. It has been looked at for treating other health issues as well. However, it does have side effects.  "Yohimbine has been associated with heart attacks, seizures and other serious side effects, as well as confusion, dizziness, anxiety, tremors, headaches and skin flushing, and may interact with medications."

In the case of Green Gorilla Root Juice, the ingredient Yohimbine was not declared on the label and product "samples tested by the FDA contained 147 milligrams of Yohimbine in one 16 ounce bottle, which is at least several times higher than what would normally be recommended for use by a physician."

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-avoid-green-gorilla-root-juice-due-potentially-harmful-undeclared-ingredient
FDA Advises Consumers to Avoid Green Gorilla Root Juice Due to a Potentially Harmful Undeclared Ingredient
December 18, 2020

FDA Warning Letter - Acidified Food Processor Fails

FDA issued a warning letter to an acidified food manufacturing facility (salsas and sauces) located in Albuquerque, New Mexico.  

First, the firm failed to file an updated scheduled process are they are required to do as part of the Acidified Foods regulations.  "The critical parameters [the company] are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65."    It also seems that they were not following the process as required.

A pH of 6.65 is far from good. 

Then along with that, the firm failed to handle the process deviation when the pH was high or when the process was not followed.  Finally,  when these deviations did occur, the process was not under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.

Good reminder for those who pack acidified foods of the necessity to follow the regulations.  These items are too often considered bulletproof, but they can be botulism death bombs if the process is not properly controlled. The regulations are there for a reason.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desert-premium-group-llc-612030-12022020

WARNING LETTER
Desert Premium Group, LLC
MARCS-CMS 612030 — December 02, 2020

This Week in Mislabeled Product for Week Ending December 17, 2020

Online Sales of Improperly Packaged Snack Sticks - The U.S. USDA FSIS is issuing a public health alert for ready-to-eat (RTE) pork snack stick products due to misbranding and an undeclared allergen. The product may contain milk which is not declared on the product label.   The RTE product labeled as “Country Meats HOT BBQ Flavor Smoked Pork Snack Sticks” may actually contain Chili Cheese flavor pork snack sticks and was produced on November 6, 2020. These items were sold online to individual customers who further sold the product as a fundraiser item. The problem was discovered when the producing establishment received consumer complaints reporting cheese in the Hot BBQ flavored snack sticks. 

Pecans in Cookies but Not on Label - George DeLallo Co., Inc. of Mt. Pleasant, PA is recalling Publix Bakery 20 OZ Holiday Cookie Platters because they may contain undeclared pecans.  The recall was initiated after it was discovered that the pecan-containing product was distributed in packaging that did not reveal the presence of pecans. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes.

Report - Foodborne illness source attribution estimates for 2018 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter

CDC issued a report "Foodborne illness source attribution estimates for 2018 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States" that uses outbreak data to identify the sources of foodborne illness. "

The report is from the Interagency Food Safety Analytics Collaboration (IFSAC), a tri-agency group created by the US CDC), FDA, USDA-FSIS. IFSAC developed a method to estimate the percentages of foodborne illness attributed to certain sources using outbreak data from 1998 through the most recent year for four priority pathogens: Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter.

They analyzed outbreaks that were confirmed or suspected to be caused by the four priority pathogens from 1998 through 2018. (Excluded outbreaks that met one or more of the following conditions: occurred in a U.S. territory; had no identified food vehicle or contaminated ingredient; were caused by more than one pathogen (including pathogens not included in this report); were caused by both E. coli O157 and another E. coli serogroup; or were caused by both Salmonella serotype Enteritidis and another Salmonella serotype.)

Quick take-aways...

• First, nothing really new was presented in this report.
• Salmonella had the largest amount of cases and there were cases in nearly every category.  Why? Salmonella is so prevalent in the environment.
• E.coli was predominately an issue in row crops (leafy greens) and beef.  Why? Ruminants carry it and it gets onto the row crops through irrigation of those crops with contaminated water.
• Listeria cases were primarily in dairy, fruit, and raw crops.  Meat items are further down the list, much of this due to how well the meat and poultry industry has focused on controlling it.
• Campylobacter - Chicken and raw milk (although numbers from raw milk were excluded).  People focus on Salmonella in raw chicken, but Campylobacter is an equal or greater concern.  Both handled through the same ways...proper handling and cooking.

Directly from that report:
Overall Key Results

• The results are based on 905 outbreaks caused or suspected to be caused by Salmonella, 255 by E. coli O157, 44 by Listeria, and 104 by Campylobacter (after 151 outbreaks due to Dairy were excluded).
• Estimated Salmonella illnesses were more evenly distributed across food categories than illnesses from Campylobacter, E. coli O157, and Listeria; most of the illnesses for the latter pathogens were attributed to one or two food categories.
• The credibility intervals overlap for the Salmonella and Listeria categories with the highest attribution percentages, indicating no statistically significant difference among them.

Salmonella Key Results

• Over 75% of illnesses were attributed to seven food categories: Chicken, Seeded Vegetables (such as tomatoes), Pork, Fruits, Other Produce, Eggs, and Turkey.
• The credibility intervals for each of the seven food categories that account for 75.6% of all illnesses overlap with some of the others

E. coli O157 Key Results 

• Over 75% of E. coli O157 illnesses were attributed to Vegetable Row Crops (such as leafy greens) and Beef. 
• Vegetable Row Crops had a significantly higher estimated attribution percentage than all other categories. • Beef had a significantly higher estimated attribution percentage than all categories other than Vegetable Row Crops. 
• No illnesses were attributed to Eggs or Oils-Sugars.

Listeria monocytogenes Key Results 

• Over 90% of illnesses were attributed to non-meat food categories. 
• Over 75% of illnesses were attributed to Dairy and Fruits. 
• The credibility intervals for the Dairy, Fruits, and Vegetable Row Crops categories were quite wide, partly due to the small total number of outbreaks (44). The credibility intervals overlapped each other, and the intervals for the Fruits and Vegetable Row Crops categories overlapped those for some food categories with much smaller estimated attribution percentages, such as Sprouts. 
• No illnesses were attributed to Other Meat/Poultry, Game, Eggs, Other Seafood, Grains-Beans, OilsSugars, Seeded Vegetables or Other Produce.

Campylobacter Key Results 

• Over half of non-Dairy Campylobacter illnesses were attributed to Chicken (58.3%). 
• The credibility interval for Chicken did not overlap with the credibility intervals for the other categories, indicating a significantly higher estimated attribution percentage for Chicken than for any other food category. • No significant differences in the estimated attribution percentages were found among most other food categories. 
• The majority (33/56, 59%) of chicken-associated Campylobacter outbreaks were attributed to chicken liver products, which are not widely consumed in the United States. All six chicken-associated Campylobacter outbreaks caused by both C. jejuni and C. coli were attributed to chicken liver products. • No illnesses were attributable to Eggs, Grains-Beans, or Sprouts.
•  An attribution percentage for Dairy is not presented partly because most foodborne Campylobacter outbreaks were associated with unpasteurized milk, which is not widely consumed in the United States. The attribution percentages before removing Dairy were Dairy 56.5%, Chicken 25.4%, Other Seafood 4.6%, Turkey 3.6%, and Other Meat/Poultry 3.0%, and were less than 2% for each of the other categories. The Chicken attribution percentage increased to 58.3% after removing Dairy.
• Note - The attribution percentages for Dairy are not presented in the figures for Campylobacter for several reasons. Most Campylobacter Dairy outbreaks included in the database were associated with unpasteurized milk, which is not widely consumed by the general population. Moreover, an analysis of 38 case-control studies of sporadic campylobacteriosis found a much smaller percentage of illnesses attributable to consumption of raw milk than chicken.

https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2018-report-TriAgency-508.pdf

Trader Joes Branded Frozen Edamame Imported from Asia Recalled for Potential Listeria

Trader Joe's frozen edamame (soy beans) is being recalled for potential Listeria contamination. The product was imported form southeast Asia through Tesoros Trading Company / Food Company.  The notice does not provide information on how the issue was discovered.

Not much information on Tesoros Trading Company, but likely linked to Teroros Foods.  While certain lots are listed, there would be concern for other lots or products packed in the same facility, especially if the packer did not have a robust Listeria control program.  As part of the importer's FSVP , they would have needed to identify Listeria as a hazard and then had sufficient verification support that the packer had adequate and verifiable environmental controls in place.

Tesoros Trading Company Recalls Product Because of Possible Health Risk

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tesoros-trading-company-recalls-product-because-possible-health-risk
Summary
Company Announcement Date:December 16, 2020
FDA Publish Date: December 16, 2020
Product Type: Food & Beverages Vegetable Protein Product
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Tesoros Trading Company
Brand Name: Trader Joe’s
Product Description: Frozen Lightly Salted Edamame

FDA Proposes Removing Standard of Identity for French Dressing

The US FDA announced that it was proposing to remove the Standard of Identity for French Dressing. The Standard of Identity, as we know, provides a standardized definition for a food item, in this case, French Dressing, so that when a consumer buys it from the store, they sort of know what they are buying.

"This proposed rule, if finalized, would revoke the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS) (petition). We tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers and revoking the standard could provide greater flexibility in the product’s manufacture, consistent with comparable, nonstandardized foods available in the marketplace.

"So what is French Dressing?
According to the online dictionary, French Dressing is:

n.
1. A salad dressing of oil, vinegar, and seasonings.
2. A commercially prepared creamy salad dressing that is usually pale orange to reddish-orange in color and often sweet.
From the US  Code of Federal Regulations, the Standard of Identity for French Dressing (entire listing below) states that it contains acidifying agents, vinegar and/or lemon juice, and has not less than 35 percent by weight of vegetable oil. Optional ingredients include egg and tomato juice.

The FDA proposal to remove this standard reasons:

"The petition states that there has been a proliferation of nonstandardized pourable dressings for salads with respect to flavors (Italian, Ranch, cheese, fruit, peppercorn, varied vinegars, and other flavoring concepts) and composition (including a wide range of reduced fat, “light,” and fat-free dressings) (petition at page 3). The French dressing standard of identity, according to the petition, no longer serves as a benchmark for other dressings because of the wide variation in composition to meet consumer interests (id.). Instead, the petition claims that the standard of identity has become marginalized and restricts innovation (id.). Therefore, the petition states that the French dressing standard of identity no longer promotes honesty and fair dealing in the interest of consumers (id.).

One key factor in the standard is the required level of oil.  With the demand for lower fat varieties, this standard limits that.  

When the standard of identity was established in 1950, French dressing was one of three types of dressings we identified (15 FR 5227). We generally characterized the dressings as containing a fat ingredient, an acidifying ingredient, and seasoning ingredients. The French dressing standard allowed for certain flexibility in manufacturers’ choice of oil, acidifying ingredients, and seasoning ingredients. Tomatoes or tomato-derived ingredients were among the seasoning ingredients permitted, but not required. Amendments to the standard since 1950 have permitted the use of additional ingredients, such as any safe and suitable color additives that impart the color traditionally expected (39 FR 39543 at 39554-39555).
Most, if not all, products currently sold under the name “French dressing” contain tomatoes or tomato-derived ingredients and have a characteristic red or reddish-orange color. They also tend to have a sweet taste. Consumers appear to expect these characteristics when purchasing products represented as French dressing. Thus, it appears that, since the establishment of the standard of identity, French dressing has become a narrower category of products than prescribed by the standard. These products maintain the above characteristics without a standard of identity specifically requiring them.

Additionally, French dressing products are manufactured and sold in lower-fat varieties that contain less than the minimum amount of vegetable oil (35% by weight) required by 21 CFR 169.115(a). We are unaware of any evidence that consumers are deceived or misled by the reduction in vegetable oil when these varieties are sold under names including terms such as “fat free” or “low-fat.” By contrast, these varieties appear to accommodate consumer preferences and dietary restrictions. Therefore, after considering the petition and related information, we tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act. "

Should we care?  This is such a non-specific standard to begin with, brand specific variations may not make much difference to the consumer.  But FDA is "interested in any information, including data and studies, on consumer expectations regarding French dressing and whether the specifications in § 169.115 are necessary to ensure that French dressing meets these expectations."

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 169
[Docket No. FDA-2020-N-1807]

RIN 0910-AI16
French Dressing; Proposed Revocation of a Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

Lawsuit Filed Against Washington State Juice Processor for Mold Toxins and High Arsenic Levels

A lawsuit was filed against a now-defunct company for selling substandard juice made from rotting fruit.  The company processed juice that made its way into the school lunch program.

(perhaps they should have called it kombucha.....) 

City Herald 
https://www.tri-cityherald.com/news/state/washington/article247154559.html
‘Putrid and decomposed’ fruit used in juice for students, Washington lawsuit says
By Brooke Wolford
November 13, 2020 02:04 PM

A Washington company that is no longer in business used rotting fruit to make juice for school children, the Food and Drug Administration said in a lawsuit filed in federal court in Washington.
The Valley Processing plant in Sunnyside, Washington supplied nearly 3 million servings of apple juice a year to the federal school lunch program, the lawsuit said. 

Colorado Issues Health Alert After Uptick in Botulism Cases

Reports of botulism poisoning are very rare, much due to food safety practices that focus on preventing this deadly foodborne disease. So Colorado health officials became concerned when there was five cases of botulism poisoning since September. While there is no source for three of the cases in the report, two of the cases were related to improperly processed home-canned foods.


https://cdphe.colorado.gov/press-release/increase-in-foodborne-botulism-cases-prompts-warning-from-health-officials-about-home
Increase in foodborne botulism cases prompts warning from health officials about home food safety 

This Week in Mislabeled Products for December 7, 2020

Print and Apply Label Missing Almonds - Market of Choice of Eugene, Oregon, is recalling its in-house Sour Cherry Baked Brie because of undeclared almonds.  The recall was initiated after it was discovered that almonds were present but were not declared on the ingredients list.

Testing Finds Gluten in Gluten-Free Product - Flowers Foods, Inc. (NYSE: FLO) is recalling certain Canyon Bakehouse Mountain White Bread and Canyon Bakehouse Everything Bagels due to the potential presence of gluten .  The recall was initiated after finished product testing revealed the possible presence of gluten.

Mislabeled Chocolate Misses Dairy - Maribel’s Sweets of Brooklyn New York is recalling its 5oz Cacao Market Cylinder Dark Chocolate Pearls, because they contain undeclared milk.  The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

Testing Finds Presence of Dairy - Hong Thai Foods Corp. of Brooklyn, NY issued 2 recalls, recalling its 7.76 ounce packages of Golden Boy Custard Muffin Original because they may contain undeclared milk allergens and are adulterated with Uranine- Acid Yellow 7 and 7.76 ounce packages of Golden Boy Custard Muffin Pandan because they may contain undeclared milk allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens

Leaky Valve Bleeds In Egg Nog - Prairie Farms has issued a limited voluntary recall of its Prairie Farms Premium Flavored Chocolate Milk gallons and Prairie Farms 1% Lowfat Chocolate Milk gallons (Best by Date: Dec. 4, 2020) that were not labeled for an egg allergen that may be present.  The recall was initiated after cross-contamination with egg nog was discovered following a valve malfunction at the Rockford, Illinois plant.

Mislabeling of Banana Chocolate Chip Muffins - Riverside Natural Foods, of Vaughan, ON is voluntarily recalling its 8 ounce packages of " Good & Gather Banana Chocolate Chip Date & Nut Bar " because they were improperly labelled and may contain undeclared almonds. The product is labelled to may contain tree nuts; however, people who have allergies to almonds may experience a serious or life-threatening allergic reaction   The recall was initiated after it was discovered that the almond-containing product was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the issue was caused by an error in the company's packaging processes.

Baby Spinach from Canada Recalled for Potential Salmonella Contamination

A Canadian company has recalled is recalling Fresh Attitude baby spinach (5oz and 11oz)  because it has the potential to be contaminated with Salmonella.  "The recall was initiated after it was discovered that the product was possibly contaminated with Salmonella subsequent investigation indicates that the problem may have been caused by contamination of a part of a lot of Baby Spinach." [not really sure what that means...perhaps testing of a specific lot of baby spinach was positive for Salmonella?]  There have been no reported illnesses, indicating it was not an investigation but rather routine testing?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vegpro-international-issues-recall-fresh-attitude-baby-spinach-because-potential-salmonella-health
Vegpro International Issues a Recall of Fresh Attitude Baby Spinach Because of Potential Salmonella Health Risk
Summary
Company Announcement Date:  November 27, 2020
FDA Publish Date:  November 28, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Vegpro International
Brand Name:  Fresh Attitude
Product Description:  Baby spinach

FDA Issues Warning Letter to Potato Chip Manufacturer for Allergen Mislabeling

FDA issued a Warning Letter to Frito Lay for two allergen related issues that resulted in recalls.    One occurred when at the Bakersfield, CA facility when  incorrect seasoning containing undeclared milk was applied to Lay’s Barbecue Flavored Potato Chips  and the other was a mislabeling issue at the Vancouver, WA facility when  bags of Ruffles Cheddar & Sour Cream Potato Chip potato chips were labeled “Ruffles Original Potato Chips”.  Basically, the two facilities had procedures but did not follow them.

Mislabeling at WA facility

According tot the report , the facility did not adequately implement food allergen controls at the packaging step allowing incorrect labeling where Ruffles Cheddar & Sour Cream Potato Chips were bagged as Ruffles Original bags, thus an undeclared major food allergen, milk. 

In this case, the facility did not implement their roll change procedure - they were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, the bagmaker operator incorrectly used the Ruffles Original film. 

The allergen control procedure, “Film Splice Tracking,” is in place to indicate that at roll change the person will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and then a second person will verify the labeling film code. 

• These splice operations were not documented on the form. 
• Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. 
• Further, the firm discontinued attaching the labeling film splice to the form in June of 2020.

Additionally, there was a procedure to verify the correct product is in the correct package and bag coding/case coding information is accurate. "The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.”   Further wo employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted."

Allergen Cross Contact at the Bakersfield CA facility

The firm did not adequately implement the "Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. "These procedures indicate that [the firm] will verify that all visible evidence of prior seasoning is removed [after] cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk."

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frito-lay-inc-611243-11242020
WARNING LETTER
Frito-Lay, Inc.
MARCS-CMS 611243 — November 24, 2020 

Research - Those Darn Wooden Pallets Can Lead to Injuries

A research study out of Penn State brings to light what we have known all along - those darn wooden pallets can be an injury hazard in non-occupational settings.  "The first-ever investigation of non-occupational injuries that occur due to unintentional contact with pallets yielded startling statistics, Michael noted. From Jan. 1, 2014, to Dec. 31, 2018, there were an estimated 30,493 people who visited hospital emergency rooms for pallet-related injuries."

Certainly those professionals who work in warehouse settings know the issues, but there is an increase use of pallets in retail settings, such as in warehouse stores and retail settings where product is displayed on pallets.  Often times, these pallets are not new pallets, or grade A pallets, but those overly used pallets that are one nail from falling apart.  Then there is the consumer use of those worn-out pallets.  According to the authors...."The immense number of pallets allows for broken or beaten-up pallets to be lost from the system and grabbed by homeowners for DIY projects.....Or they break up pallets for firewood or stack firewood on them. They’re not careful and they get hurt.”

Penn State News
https://news.psu.edu/story/640525/2020/12/02/research/after-shipping-pallets-pose-big-risk-public-cause-many-accidents
After shipping, pallets pose big risk to public, cause many accidents, injuries
Pallets were responsible for sending more than 30,000 people to ER in five-year span
PUBLISHED ON December 3, 2020

Research - Desensitizing Children with Peanut Allergies Through Oral Immunotherapy

Research out of the University of British Columbia found that children with peanut allergies can be desensitized through "exposing children to a small, regular dose of an allergen (in this case, peanuts) in a real-world setting (outside of a clinical trial)" and this is "effective in reducing the risk of allergic reactions."  We are familiar with the process of preventing peanut allergies through the process of feeding infants doses of peanut allergen, but this is for those children who have developed peanut allergies.

"The treatment method, known as oral immunotherapy, involves gradually increasing the amount peanuts (or peanut products) given to the child. One treatment aim is to reach desensitization, whereby the child can ingest a full serving of peanuts without triggering a dangerous reaction. Another goal is protection in the event of an accidental exposure, and lessening or eliminating the need for epinephrine injections in response to reactions. To sustain their level of immunity, the child must continue to eat peanut products on a regular basis."

University of British Columbia

https://news.ubc.ca/2020/12/03/peanut-allergy-treatment-significantly-lowers-risk-of-life-threatening-reactions-in-preschoolers/
Peanut allergy treatment significantly lowers risk of life-threatening reactions in preschoolers
Science, Health & Technology
Dec 3, 2020 | For more information, contact Kerry Blackadar

FDA Issues Reminder to Facilities for Biennial Registration

FDA issued a reminder that U.S. and foreign human and animal food facilities under FDA jurisdiction must renew their registration this year before December 31.

"The FDA will consider the registration of a food facility to be expired if the facility does not renew its registration by December 31, 2020. There is no fee associated with registration or renewal. Owners and operators of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission."

https://www.fda.gov/food/cfsan-constituent-updates/fda-reminds-human-and-animal-food-facilities-about-years-biennial-registration-renewal-period-and
FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number

Constituent Update
December 1, 2020

U.S. and foreign human and animal food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year before December 31.

This Week in Mislabeled Food Products for November 24, 2020

Shrimp Labeled as Chicken...Those Darn In-Store Print-and-Apply Labels - Whole Foods Market is voluntarily recalling packaged popcorn chicken with sweet chili sauce across 26 stores in Northern California and Reno, Nevada. The product is being recalled because it may contain undeclared shellfish (shrimp) that was not listed on the product label due to mislabeling. The product was sold in plastic containers in the prepared foods department and was labeled as “Popcorn Chicken Shaker with Sweet Chili” with sell by dates through Nov. 27, 2020. 



How many issues have we had now related to store level errors on these labels?

Fresh-Pack Basil Recalled After State Laboratory Finds Cyclospora

Shenandoah Growers, Inc (Harrisonburg, VA) is recalling of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora after a retail sample was tested by Florida Department of Agriculture on 11/2/2020 from a retail store in Florida indicated the potential presence of Cyclospora.  These were packed under branded and private label fresh cut organic certified basil clamshells at its Jefferson, GA facility and Harrisonburg, VA facility with the following lot codes, all with the country of origin of Colombia. 

Shennandoah Growers are one of these upcoming greenhouse operations that rely on indoor growing for controlled environment. (https://www.shenandoahgrowers.com/innovation).  However, this product was from Colombia.  The source of the cyclospora would be the irrigation water, and once there on the delicate leaves of the basil, it will not likely be removed through the gentle washing systems used.  It is on SG to ensure that their supplier is using a good water source.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shenandoah-growers-inc-issues-limited-voluntary-recall-certain-imported-organic-basil-because
Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Possible Cyclospora contamination
Company Name:  Shenandoah Growers, Inc
Brand Name:  The Fresh Market, Good & Gather and more
Product Description:  Organic Basil

Fresh-Pack Chopped Vegetable Packs Recalled for Listeria

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered during routine safety sampling at Hy-Vee’s Short Cuts production facility. To date, no illnesses have been reported in connection with these products.

This is a fresh vegetable mix that is designed to be used in a cooking application.  In the case here, either for use as grilled or in a stew.  Those processes, if properly cooked, would eliminate the Listeria organism.  But it is hard to know whether the consumer will actually do that.  

In chopping/slicing operations, Listeria can be a challenge.  While there will be sanitizing steps in place for the vegetables, the sheer amount of moisture and organic material that is generated within that processing environment as well as the intricate nooks and crannies in the processing equipment (choppers and slicers), can create opportunities for this organism to become established.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hy-vee-voluntarily-recalls-two-short-cuts-vegetable-mix-products-because-possible-health-risk
Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk
Summary
Company Announcement Date:  November 24, 2020
FDA Publish Date:  November 24, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Hy-Vee, Inc.
Brand Name:  HyVee
Product Description:  Short Cuts vegetable mix products

FDA Publishes Table of Foodborne Illness Investigations

FDA published a table or "list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion"

There are three E. coli outbreaks that we have reported on previously (1 and 2, 3),as well as a Salmonella outbreak linked to peaches occurring back in August. There are three other outbreaks of Salmonella that are still being investigated - one that is considered over, one linked to juice bar in Minnesota occurring in October, and then one other Salmonella case.

Popping over to the CDC website for ongoing foodborne illness outbreaks....the CDC also has a table listing more outbreaks that are being investigated, but even less information is provided. There are 5 Listeria outbreaks, 14 Salmonella outbreaks, and 4 E. coli outbreaks. Perhaps many of these occurred long ago, but the investigation continues?

It would be better to have additional information, where every item listed links to what is known including when the outbreak started or when it was first identified (we don't care about the posting date), when the last reported case occurred, the location of the cases, a link between FDA, CDC, and USDA tables, and impact of those affected.

The presented information is good, but it leaves one with more questions that need to be addressed.

FDA - Investigations of Foodborne Illness Outbreaks
https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks

The following is a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.

A public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. If a source and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

Canada - Pumpkin Pie Jam Recalled Due to Botulism Concerns

The Canadian Food Inspection Agency issued a recall notice for My Grandfather's Farm's Pumpkin Pie Jam after the agency indicated that the product would be able to support the growth of Clostridium botulinum. While not stated in the notice, one would guess that the pH was too high for the type of processing used - it was probably processed as an acidified food which requires a product pH of 4.6 or lower.

My complaint with the CFIA notices is that they lack information. Because of this, news reports vary in what they report, such as this report (https://cfox.com/news/7475321/pumpkin-pie-jam-recall-botulism-risk/) which states "The Canadian Food Inspection Agency (CIFA) says a Nova Scotia brand is recalling jam after a potential toxic bacteria was detected." Well, not exactly if you read the CFIA report below. CFIA can use these recalls as an opportunity to educate.

Canadian Food Inspection Agency Recall Notice
https://www.inspection.gc.ca/food-recall-warnings-and-allergy-alerts/2020-11-20/eng/1605894173720/1605894179669
Food Recall Warning - My Grandfather's Farm brand Pumpkin Pie Jam recalled due to potential presence of dangerous bacteria
From: Canadian Food Inspection Agency
Recall date:  November 20, 2020
Reason for recall:  Microbiological - Other
Hazard classification:  Class 1
Company / Firm:  My Grandfather's Farm
Distribution:  Nova Scotia
Extent of the distribution:  Retail
Reference number:  14094

Romaine Hearts Recalled After Sample Tests Positive for E. coli

Dole Fresh Vegetables, Inc. is recalling a limited number of cases of organic romaine hearts due to a possible health risk from E. coli in the two products. The recall comes after "an isolated instance in which a package of Dole™ Organic Romaine Hearts – 3pk yielded a positive result for pathogenic non-O157 E.coli STEC in a routine sample collected at a retail store by the Michigan Department of Agriculture and Rural Development."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-announces-limited-recall-organic-romaine-hearts
Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts
Summary
Company Announcement Date:  November 21, 2020
FDA Publish Date:  November 21, 2020
Product Type:  Food & Beverages   Produce   
Reason for Announcement:  Potential for Pathogenic non-O157 E. coli
Company Name:  Dole Fresh Vegetables Inc.
Brand Name:  Dole and Wild Harvest
Product Description:  Organic Romaine Hearts

Date Expired Salad Kits Recalled After Sample Yields Positive E. coli Result

Fresh Express is recalling a limited number of cases of expired 10.5 oz. Fresh Express Kit Caesar Supreme with the Use-by Date of November 8, 2020 (already expired by 8 days) as it may be contaminated with Escherichia coli STEC 026 bacteria.  The recalled product was distributed primarily in Western and Southwestern U.S. states.  The recall was issued after a random test discovered the organism in a sample.  There have not yet been any reported illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-recalls-limited-quantity-expired-fresh-express-kit-caesar-supreme-due-potential-health
Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
Summary
Company Announcement Date:  November 17, 2020
FDA Publish Date:  November 17, 2020 

Product Type:  Food & Beverages
Reason for Announcement:  Escherichia coli STEC 026 bacteria
Company Name:  Fresh Express
Brand Name:  Fresh Express
Product Description:  Fresh Express Kit Caesar Supreme.

FDA Warning Letter - Inadequate Controls to Prevent Allergen Mislabeling

FDA issued Ventura Foods facility in Birmingham, AL a Warning Letter following the company's recall of Garlic Parmesan Sauce that was labeled as Garlic Sauce. In this case the Garlic Sauce finished product labels did not declare major food allergens of milk and wheat. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule)

The firm discovered that the Garlic Parmesan Sauce labeled as Garlic Sauce was at store level after being notified by a customer. According to the documentation issued to FDA, the mislabeling occurred because an operator brought an incorrect roll of labels to the line. Although the firm identified the mislabeling issue before the product left the facility, the firm did not re-label all affected jugs of product.

In an email from the firm, the firm causes and provided corrective and preventive actions. In particular, the firm indicated that they will use an improved label management process to pre-stage labels for each line and limit label room access; update procedures for label conversions and storage of new labels; require barcode scanning of gallon jugs; update a procedure to include details on how to properly escalate and manage nonconforming product; update a procedure to outline details regarding the proper handling of relabeling tasks; and will conduct training on all updated procedures by July 1, 2020.

The Warning Letter was issued on the fact the firm had not identified and implemented food allergen controls at the labeling step adequate to prevent mislabeling of allergen containing product. And the firm did not implement effective corrective action procedures to ensure that all affected product was evaluated for safety and prevented from entering commerce as evidenced by mislabeled Garlic Parmesan Sauce that reached customers.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ventura-foods-llc-609201-10282020
WARNING LETTER
Ventura Foods LLC
MARCS-CMS 609201 — October 28, 2020

FDA Issues Warning Letters to Three Food Importers for FSVP Issues

FDA issued Warning Letters to three food importers for issues involving the Foreign Supplier Verification Program (FSVP).  Two of these were remote audits.

• E & H Distributors LLC of , San Diego, CA  did not have FSVPs for soft tamarind flavored candy from one supplier and candy imported from another foreign supplier.
• World Candy Store LLC, of Brownsville, Texas 78521. did not have FSVPs for these products, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4). 
• WCS Trading Inc, of  Los Angeles, CA 90032 did not complete a review of the supplier's hazard analysis and did not perform verification activities for dried crushed chili, dried black fungus and dried mushrooms

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020 

FDA Warning Letter - RTE Salad Manufacturer Cited for Not Following Food Safety Plan

FDA issued a Warning Letter to Etai's Food, Inc of Denver Colorado, a manufacturer of RTE salad, sandwich, burritos, wraps, pasta and snack items.  One of the primary themes is having items in the Food Safety Plan, but not doing them.  If it is in the Plan, then you have to do it.

Issues

• Had not completed environmental sampling as they had detailed in the Food Safety Plan.  They set a frequency, but did not have results to show to match that frequency as stated..
• Environmental samples completed showed some results as “indeterminate".  The company had no corrective action written for indeterminate results nor did they take corrective action.  FDA had "concerns based on these results (including the frequency of “indeterminate” results) and your lack of subsequent action that your procedures are not adequate to verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."
• The Environmental Monitoring Program stated that the company would “Identify and Maintain a Master Site List” .  There was no list.
• Regarding the Supplier Preventive Controls - the facility did not complete all of the items as stated in the plan including collecting audits and surveys.
• GMPs - poor personnel practices that can contribute to cross contact and cross contamination (improper glove usage, water hose usage)  There were a number of items associated with allergen control including how products were stored.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/etais-food-inc-607977-11052020

WARNING LETTER
Etai's Food, Inc.
MARCS-CMS 607977 — November 05, 2020 

Are Outdoor Dining Areas Any Less Risky for COVID as Indoor Eating Areas?

An interesting article in Business Insider discusses the use of outdoor eating structures that many restaurants have erected to provide service during this COVID pandemic. While it does provide extra seating for the restaurant to help expand what was lost indoors when social distancing actions were put in place to separate tables, there are some drawbacks.

For one, the thought this is actually outdoor is not necessarily true. Especially as the weather cools, these structures are probably not much different than indoor structures. These areas are essentially four walls and a ceiling and thus there is no advantage providing as would be had by truly being outside.

On top of that, there may be no air circulation thus not providing an escape for potential virus. Or air circulation may not be controlled, resulting in one person's exhaust being blown onto another person.

Sitting in these outside structures may give a person a false sense of security in thinking that they are really outside, so those individuals may be less attentive to the need for social distancing or mask wearing.

Business Insider
https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
Restaurants are setting up tents and temporary structures to extend outdoor dining during the winter. But they come with their own hazards, and in some cases, could be riskier than eating indoors.

As the temperature drops in many parts of the US, restaurants are coming up with creative solutions to allow for outdoor dining. But in some cases, these solutions may increase diners' coronavirus risk.

Since the onset of the pandemic, outdoor dining has allowed restaurants and bars to stay open while offering customers a way to continue eating, drinking, and socializing in a low-risk environment. Outdoor dining has become so popular and lucrative that it's becoming a more permanent fixture everywhere from Milwaukee to Boston. But as we head into the winter months, restaurants will be hard-pressed to convince diners to sit outdoors, exposed to chilly temperatures, wind, and possibly even snow.

Enter: tents, enclosed patios, and even curbside cabanas.

City and state governments across the country seem somewhat split on what types of structures are safe. In Chicago, for example, the city mandates that temporary outdoor structures must have 50% of the sides open in order to ensure air flow. New York City has the same rule, but will allow fully enclosed structures — they'll just be regulated like indoor dining and capped at 25% capacity. Cities in Connecticut and Colorado have similar mandates.

Rest of article - https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11

This Week in Mislabeled Products for Week Ending November 14, 2020

Wrong Package - Stuffed Foods LLC, a Wilmington, Mass., establishment is recalling approximately 1,818 pounds of snack products due to misbranding and an undeclared allergen - the product contains soy which is not declared on the product label.  The problem was discovered after the firm received a customer complaint that a “Mac & Cheese Bite” carton contained “Buffalo Style Chicken Poppers.”

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-026-2020-release
Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Class II Recall
026-2020
Health Risk: Low

Nov 11, 2020 

FDA Issues Warning Letters to Two Importers for Lack of FSVP

FDA issued Warning Letters to two different companies for FSVP.  Neither company had a FSVP in place.

• Italfoods, Inc., of South San Francisco, CA did not have it in place for cheese products improted from Italy including Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese.  One of the products had been found to have Listeria monocytogenes contamination.
• Handylee USA Corp. of Maspeth, NY did not have FVSP for imported canned corn. canned mushrooms and canned bamboo.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/italfoods-inc-610183-10272020
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020 

FDA Issues Warning Letter on Supply Chain Controls for Cyclospora in Salad Items

FDA issued a Warning Letter to Fresh Express regarding their Illinois processing facility that was linked a the 2020 Cyclospora outbreak.  In this outbreak, there were a reported 701 cases in 14 states that were linked to bagged salad mixes containing iceberg lettuce, carrots, and red cabbage.  The notice points out that the facility was also involved in a 2018 outbreak that affected over 500 people.

In short, FDA states that the normal supplier controls have not been sufficient, and that the company must do more to control a difficult-to-control pathogen.  This is worth a read in how far FDA pushes the idea of Supply Chain Preventive Control.

The FDA first states this product is considered adulterated - "bagged salad mixes are also adulterated within the meaning of section 402(a)(4) [21 U.S.C § 342(a)(4)] in that they have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health."  

In the hazard analysis, the facility did have parasites listed as a hazard with the preventive control being a Supply Chain Preventive Control where the facility will "have written procedures which describe your supplier approval of growers and harvesters and your verification of your supply-chain controls, such as food safety record reviews, GFSI third-party audits, second-party audits conducted by Fresh Express, and periodic supplier questionnaires."  The facility did do testing, but initially, just to more or less keep an eye on the situation.  At the time of the outbreak, the company started to test more product.

FDA essentially points out that product testing is not a good control because it is hard to find this contaminate because it is at such low levels.  Rather FDA states that the company needs to ensure the adequate controls by the supplier and doing surveillance of the growing area - "We recommend that you reanalyze your Food Safety Plan to determine whether your preventive controls and grower/harvester verification activities are adequate to ensure control of the hazard of Cyclospora cayetanensis, particularly focusing on potential sources and routes human fecal contamination that would allow partially and fully mature oocysts to contaminate produce in the field before and during harvest. This should include additional focus on handwashing as part of the evaluation for harvesting crew audits, as well as sanitation and cleaning practices for portable toilets, worker health and hygiene, harvest practices, and employee foot traffic through fields, all which may contribute to Cyclospora contamination in the field. In addition, you should consider seasonal environmental surveillance for Cyclospora to determine potential sources of contamination near growing regions where you source your produce."

Next, FDA states that the company needs to enhance traceability - FDA "encourage[s] Fresh Express to improve its traceability systems and processes, thus improving the speed and accuracy by which the company complies with records and information requests from the Agency in the future. Greater expediency on the part of Fresh Express in providing the requested traceback records might have aided in tracing back to potential sources of contamination sooner. Our hope is that improved traceability records on the part of industry will allow the FDA to more quickly and accurately investigate foodborne outbreaks, helping to avoid human illnesses and unnecessary, costly recalls."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresh-express-inc-609899-div-chiquita-brands
Fresh Express Inc - Div of Chiquita Brands
MARCS-CMS 609899 — October 20, 2020 

FDA Outbreak Notice of Third E. coli Outbreak Occurring This Fall

FDA issued notice that they are investigating on third E. coli outbreak.  The notice goes on to discuss the sample of Romaine lettuce contaminated with E. coli O157:H7.  The company in this case had issued a recall the day before this notice was released.

This notice is a bit confusing.  It reports that there is a third outbreak and states this:

On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.

Then the Notice states this:

At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.

The notice is a little vague on the outbreak itself, but does provide the CDC information.

From the CDC

Case Counts

Total Illnesses: 12

Hospitalizations: 5

Deaths: 0

Last Illness Onset Date: October 14, 2020

States with Cases: CA (2), IL (4), MI (2), OH (1), PA (2), VA (1) 

US FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-unknown-food-fall-2020
Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

FDA Issues Draft Guidance on the Voluntary Labeling of Sesame

FDA issued a voluntary Draft Guidance for the labeling of sesame to "encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame."

Sesame is not currently included in the group of eight major allergens specified in the regulation to be declared in clear terms if included on the label.  "The FDA does not have the authority to amend the eight major food allergens established by FALCPA; however, it has the authority under the Federal Food, Drug, and Cosmetic Act to require labeling for other food allergens not covered by the requirements in FALCPA."

This is a draft, so comments can be made by stakeholders.

US FDA Constituent Updates  Center for Food Safety and Applied Nutrition
https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-industry-voluntary-disclosure-sesame-when-added-flavoring-or-spice
FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice
Constituent Update
November 10, 2020

Romaine Lettuce Recalled After State Laboratory Finds E. coli O157:H7

Tanimura & Antle Inc. is recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, after the State of Michigan test and found a sample with E. Coli 0157:H7.   Product was distributed in the United States to the following states: AK, OR, CA, TX, AR, OK, IN, NE, MO, TN, WI, NM, SC, WA, NC, OH, VA, MA, PR, and IL

The statement states that this product has not been linked to reported cases of E. coli infection, which would seem to indicate that this product is not liked to the two E. coli outbreaks reported in the last few weeks.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tanimura-antle-voluntary-recalls-packaged-single-head-romaine-lettuce-due-potential-e-coli-0157h7
Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
Summary
Company Announcement Date:  November 06, 2020
FDA Publish Date:  November 06, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Possible contamination with E. Coli 0157:H7
Company Name:  Tanimura & Antle Inc.
Brand Name:  Tanimura & Antle
Product Description:  Single head romaine lettuce

USDA Issues Warning on Meatballs Potentially Contaminated with Metal Pieces

USDA-FSIS issued a public health alert for heat treated, not fully cooked, not shelf stable, spaghetti and meatballs in marinara sauce products due to concerns that the products may be contaminated with metal pieces. USDA did not issue a recall because they believe that most product is not available to consumers any longer, however it is important for consumer to be aware. The product was from Kwik Trip of La Crosse, WI (Est 20852) and was distributed in WI, IA, and MN.

"The problem was discovered when the firm received consumer complaints reporting findings of metal embedded in meatballs in Kwik Trips, Inc., Spaghetti and Meatball in Marinara Sauce product. There have been no confirmed reports of adverse reactions due to consumption of these products."


https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-11042020-01
FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter Contamination 

November 4, 2020

VA Creamery Recalls Product Packed in Returnable Glass Bottles With Potential Residual Sanitizer

A Virginia creamery is recalling various products packed in returnable glass bottles after it was discovered that here was an issue with the bottle sanitizing process. According to the notice, "Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk associated with the issue at this time.....The recall was initiated after it was discovered that product smelled like cleaning agent."

Product was shipped to multiple states including Pennsylvania, New York, and Georgia.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homestead-creamery-issues-voluntary-glass-bottled-product-recall
Homestead Creamery Issues Voluntary Glass Bottled Product Recall
Summary
Company Announcement Date:  October 28, 2020
FDA Publish Date:  October 30, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Potential for residual chlorine from the sanitizing process
Company Name:  Homestead Creamery
Brand Name:  Homestead Creamery
Product Description:  Lemonade half gallon

Colorado Market Recall Elderberries After Notification from Supplier

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella.  According to the recall notice, "After initially certifying that this product had tested negative for Salmonella and was fit for human consumption, our supplier subsequently notified the company of the potential presence of Salmonella in specific lots of organic elderberries."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-grocers-issues-voluntary-recall-organic-elderberries-due-potential-presence-salmonella
Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
Summary
Company Announcement Date:  October 29, 2020
FDA Publish Date:  November 02, 2020
Product Type:  Food & Beverages  
Reason for Announcement:  Salmonella
Company Name:  Vitamin Cottage Natural Food Markets, Inc.
Brand Name:  Natural Grocers
Product Description:  Organic Whole Elder Berries