RTE Smoked Salmon Recalled After Sample Tests Positive for Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 540 cases of Giant Food Private Label Sockeye Smoked Salmon, because it has the potential to be contaminated with Listeria monocytogenes.  The product was distributed by Giant Food in Maryland, Virginia, Washington D.C. and Delaware.  The issue was discovered through routine regulatory testing conducted by the Maryland Department of Health.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan
Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  November 08, 2022
FDA Publish Date:  November 08, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Seven Seas International USA, LLC
Brand Name:  Giant
Product Description:  Smoked Salmon

Marshmallow Cookies Recalled After Routine Sampling Finds Salmonella Positive Sample

Comercializadora PepsiCo S. de R.L. de C.V. today issued a voluntary recall for 15.5 oz, 6 count box of Gamesa Arcoiris Marshmallow Cookies due to the potential presence of Salmonella.  The recall was initiated as the result of a routine sampling program by the company, which revealed the finished product may contain Salmonella.  The company initiated the voluntary recall on the product below out of a commitment to and concern for consumers. The product covered by this recall was distributed to warehouses in California and Texas and may have reached consumers through select retail stores.  No illnesses related to Salmonella have been confirmed to date.

Recalls like this are the reason why you need to make sure your laboratory is doing a good job by having controls in place to ensure accuracy of testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies
Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk
Summary
Company Announcement Date:  November 07, 2022
FDA Publish Date:  November 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of Salmonella
Company Name:  Comercializadora PepsiCo S. de R.L. de C.V.
Brand Name:  Gamesa
Product Description:  Arcoiris Marshmallow Cookies

Interagency Report for 2020 on Foodborne Illness Attributed to Salmonella, E. coli O157, and Listeria monocytogenes

An interagency collaboration of FDA, CDC, and USDA, identified as IFSAC, released their yearly report on foodborne illness source attribution estimates based upon outbreak surveillance data.  The goal of this is to "provide a harmonized analytic approach for estimating foodborne illness source attribution  from outbreak data can provide consistency in the use and interpretation of estimates across public health and  regulatory agencies."

The information provides information on outbreaks caused by Salmonella, E.coli O157 and Listeria monocytogenes.

https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2020-report-TriAgency-508.pdf
Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States
The Interagency Food Safety Analytics Collaboration (IFSAC)
November 2022

IFSAC derived the estimates for 2020 using the same method used for the previous estimates, with some modifications. The data came from 1,287 foodborne disease outbreaks that occurred from 1998 through 2020 and for which each confirmed or suspected implicated food was assigned to a single food category. The method relies most heavily on the most recent five years of outbreak data (2016 – 2020). Foods are categorized using a scheme IFSAC created to classify foods into 17 categories that closely align with the U.S. food regulatory agencies’ classification needs.

Salmonella illnesses came from a wide variety of foods.
More than 75% of Salmonella illnesses were attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef, and Turkey.
E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef.
More than 80% of illnesses were linked to these two categories.
Listeria monocytogenes illnesses were most often linked to Dairy products, Fruits, and Vegetable Row Crops.
More than 75% of illnesses were attributed to these three categories, but the rarity of Listeria monocytogenes
outbreaks makes these estimates less reliable than those for other pathogens

Overall Key Results

FL Company Recalls Lettuce After Testing Lab Finds Potential for Salmonella

Kalera Public Limited Company (“Kalera” or the “Company”) (Nasdaq: KAL), is voluntarily recalling 633 cases of Krunch, Butter and Romaine whole head variety lettuce with lot codes 001293 and 001294 on the label and sold under the Kalera brand because it has the potential to be contaminated with Salmonella.  Kalera’s food safety testing procedures indicated the potential presence of Salmonella in some of its whole head lettuce SKUs. The Company promptly reported this issue to the FDA, and, to the Company’s knowledge, no illnesses have occurred or been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalera-voluntarily-recalls-fresh-lettuce-products-because-possible-health-risk
Kalera Voluntarily Recalls Fresh Lettuce Products Because of Possible Health Risk
Summary
Company Announcement Date:  November 03, 2022
FDA Publish Date:  November 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Kalera Public Limited Company
Brand Name:  Kalera
Product Description:  Fresh Lettuce Products

Edible Cookie Dough Recalled for Foreign Material - Soft Plastic Film

Nestlé USA is initiating a voluntary recall of a limited quantity of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® due to the potential presence of soft plastic film.  This voluntary recall is isolated to three batches of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® that were produced August 1-3, 2022. These products were distributed to retailers nationwide.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs
Nestlé USA Announces Voluntary Recall of Limited Quantity of Edible Chocolate Chip Cookie Dough Tubs from NESTLÉ® TOLL HOUSE® Due to Potential Presence of Foreign Material
Summary

Company Announcement Date: November 03, 2022
FDA Publish Date: November 03, 2022
Product Type: Food & Beverages
Reason for Announcement: Potential for Soft Plastic Film
Company Name: Nestle USA
Brand Name: NESTLÉ® TOLL HOUSE®
Product Description: Edible Chocolate Chip Cookie Dough

Popcorn Recalled After Packaging Design Issue Has Gluten Free Statement on Product with Gluten

Cedar Creek Popcorn of Sac City, Iowa is recalling its 18 oz. Old-Fashioned Caramel Holiday Popcorn Box because the side of the box features a Gluten Free claim when there are elements with gluten contained in the product.  The recall was initiated because the Gluten Free claim on the side of the packaging did not match with the product’s ingredient label and allergen information. Procedures are being put in place to assure that food safety issues are taken into consideration for the design and approval of all future packaging.

This appears to be a packaging design issue where someone did not catch the Gluten Free statement on the side of product, although it is clearly stated in the ingredient statement.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/issue-gluten-free-labeling-cedar-creek-popcorn-box-containing-gluten
Issue With “Gluten Free” Labeling on Cedar Creek Popcorn Box Containing Gluten
Summary
Company Announcement Date:  October 28, 2022
FDA Publish Date:  November 01, 2022
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared Wheat
Company Name:  Cedar Creek Popcorn
Brand Name:   Cedar Creek Popcorn
Product Description:   Old-Fashioned Caramel Holiday Popcorn Box

FDA Warning Letters Issued to Three Importers for Lack of FSVP - Nov 1 2022

Three importers were issued Warning Letters by FDA for lacking a FSVP for imported foods.

Facema, LLC. of Laurel, MD did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any imported foods, including the following food:  Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);  Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and 
Peanuts imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/facema-llc-640528-10182022

ARYZ Trading, LLC of  Dearborn, MI did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following foods:  Dried mint: imported from (b)(4)
Tahina: imported from (b)(4) Extra virgin olive oil: imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aryz-trading-llc-639322-09212022

Minuti Coffee Llc, of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following:  a. Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy b. Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minuti-coffee-llc-635961-08232022

FDA Warning Letter - NC Processor of RTE Product with Listeria Issue

FDA issues a Warning Letter to Bakkavor Foods facility in Charlotte, NC, a processor of ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products.

First, this company that processes RTE foods did not recognize environmental pathogens as a significant risk requiring a Preventive Control.  From the report, the" hazard analysis for “Ready to Eat Cold Salads, Sauces, Sides, and Dressings” at various processing steps (e.g., cold mixing, filling) determined that pathogens from “Environmental Cross-contamination” is a “Hazard Not Reasonably Likely To Occur due to lack of history with Food Contact Surface contamination with Listeria spp.” You also reference “Pre-Operational and Operational Sanitation Inspections” and “Good Manufacturing Practices” as “Control Measures in place.” Your sanitation inspections and GMPs are not preventive controls."

Indeed, FDA conducted environmental sampling and found Listeria.  Also of note, based upon WGS identification, the same strains had been found in the facility in 2019....an indication that this is a persistent strain.  

"To underscore the L. monocytogenes risk in your facility: FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on February 8, 2022, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas where products are exposed to the environment prior to packaging in your production room, (b)(4) room, work in progress (WIP) cooler, and (b)(4) room. This was not the first time L. monocytogenes was found in environmental samples collected at your facility."

FDA noted that the company had been finding Listeria in their testing.  However, there was insufficient corrective action taken.

FDA goes on to state, "Given the history of our findings and the presence of L. monocytogenes in your facility, we continue to be concerned about your ability to maintain a sanitary environment. Your written responses did not fully explain how you investigated the source of the resident L. monocytogenes, demonstrate that you have located and eradicated the harborage site(s), or provide supporting documentation to show implementation and verification of adequate corrections (e.g., revised Food Safety Plan or routine environmental sampling results)."

GMP issues

• "Hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (b)(4) area, between the (b)(4) lines in the production room, next to a trash cart in the production room, and in the kettle room."
• "Excessive condensation on the ceiling and evaporators throughout your facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (b)(4) washroom. Also, condensation was observed on the ceiling above the (b)(4) hopper for the (b)(4) machine where RTE (b)(4) and (b)(4) are manufactured."
• "While walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue."
• "Apparent rust on the food-contact parts of the Cheese Grinder (b)(4) and its outlet port. They also observed that the (b)(4) on the (b)(4) tumblers which hold RTE food were damaged, making them difficult to clean."
• "Apparent food residue remaining on the inside cup holder framework of the (b)(4) machine where RTE (b)(4) and (b)(4) dip are packed, as well as on the conveyor belts and framework for (b)(4) lines (b)(4), after pre-op inspection and release by quality assurance "
• "Apparent old and fresh product and black residue on the wheels of the conveyors for the (b)(4) line and the (b)(4) lines after pre-operation inspection and release by quality assurance on February 10, 2022. The wheels contact the outer/food-contact surface of the belts."

There were also issues with the Seafood HACCP plan including temperature control issues with finished product.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakkavor-foods-usa-inc-630545-08082022
Bakkavor Foods USA Inc.

Needing to Update The Environmental Sampling Program?

A recent article in Food Safety magazine ( FDA Environmental Monitoring Tactics Have Changed—Have Yours? Bryan Armentroutasks (2022)) asks if your Environmental Sampling Program can hold up to an FDA inspection's sampling regiment. It highlights aspects of the recently updated FDA Investigation Operational Manual - Chapter 4 - Sampling, specifically from this, Section 4.3.7.7.1 Environmental Sampling.

First, one should be aware and somewhat knowledgeable about the FDA Investigations Operations Manual (IOM) and within that, Chapter 4. Sampling.

The author of the Food Safety Magazine article points out keys of what FDA within their environmental sampling regiment may do that may be different than what a company's sampling plan may do.

• "They will not tell you that they are going to sample, until they are ready to start"
• "They are going to sample food contact and indirect contact surfaces"
• "They are not going to sample floors and drains"
• "They are going to sample during production, with a target of four hours of activity after a wet clean"
• "If a positive is found, they are sending it out for identification, adding it to the U.S. Centers for Disease Control and Prevention (CDC) database, and cross-referencing for any outstanding or past food safety incidents."

This does not mean that a company needs to do exactly what FDA does.  We certainly will maintain a focus on Zones 2 to 4 as a way of understanding contaminants with the facility, and focusing on preventing contamination from getting to food contact surfaces (Zone1).  But a company needs to know that Zone 1 is not contaminated and that contamination does not leak out into the facility once production is in full swing.

Selected items from 4.3.7.7.1
INVESTIGATIONS OPERATIONS MANUAL 2022 (https://www.fda.gov/media/75243/download)

4.3.7.7.1 - Environmental Sampling

• Every effort should be made to conduct Listeria sampling when the facility has been in production for at least four hours and before any wet cleaning is performed. In instances with smaller firms that have short production periods, swabbing should be conducted during the mid to tail end of their production schedule.
• In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is exposed and being processed, particularly post-treatment/pasteurization.
• A large majority of the environmental samples collected should be taken from Zones 1 (when directed and depending on the organism in question) and 2, and to a lesser degree Zone 3 areas. Very few, if any, environmental samples should be taken from Zone 4 areas.
• Swab subsample numbers for each organism are as follows:
• For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more
• subs
• For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs.

Also, there can be samples taken for food samples.

Here are the FDA Zone definitions: