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

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

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

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

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

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

FSIS Issues Health Alert for Salad Items After Supplier Recalls Lettuce for Listeria

USDA-FSIS is issuing a public health alert for ready-to-eat (RTE) fresh salad products with chicken and ham that contain Food and Drug Administration (FDA) regulated lettuce that has been recalled for possible Listeria monocytogenes (Lm) contamination.  The problem was discovered when the firm notified FSIS that they used FDA-recalled lettuce to produce the fresh salad with chicken and ham products.  Recalled items, produced by Russ's Commissary of Holland MI,  were shipped to retail locations in Illinois, Indiana, Kentucky, Michigan, Ohio, Tennessee, and Wisconsin.

While not directly stated, the lettuce was likely produced by Revolution Farms, an indoor farm in MI, that just had issued a recall.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-fresh-salads-chicken-and-ham-containing-lettuce
FSIS Issues Public Health Alert for Fresh Salads With Chicken and Ham Containing Lettuce Recalled by FDA for Possible Listeria Monocytogenes Contamination
RUSS' COMMISSARY
FSIS Announcement

WASHINGTON, April 7, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) fresh salad products with chicken and ham that contain Food and Drug Administration (FDA) regulated lettuce that has been recalled for possible Listeria monocytogenes (Lm) contamination.

Salad Produced in GA Facility Recalled After Testing of Product Finds Listeria

Fresh Express Incorporated is recalling a limited quantity of three varieties of already-expired branded and private label salad kit products produced at the company’s Morrow, Georgia facility out of an abundance of caution due to a possible health risk from Listeria monocytogenes.  The recall was initiated when it was learned a random sample test of a single salad kit with a Use-By Date of March 31, 2023 collected by the Georgia Department of Agriculture yielded a positive result for the Listeria pathogen.

Product was distributed through retailers in the states of Florida, Georgia, North Carolina, South Carolina and Virginia.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-incorporated-announces-precautionary-recall-expired-fresh-salad-kits-due-potential
Fresh Express Incorporated Announces Precautionary Recall of Expired Fresh Salad Kits Due to Potential Health Risk
Summary
Company Announcement Date:  April 07, 2023
FDA Publish Date:  April 07, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Fresh Express Incorporated
Brand Name:  Fresh Express & Publix
Product Description:  Salad Kits

MI Indoor Farm Recalls Products Due to Potential Listeria Contamination

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

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

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

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

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

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

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

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

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

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

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

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

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

Popped Water Lilly Seeds Recalled for Undeclared Milk

Karma Spices and Trading Company, LLC of Walled Lake, Michigan is recalling White Cheddar Cheese Popped Water Lily Seeds, because it may contain undeclared Milk.  The recalled White Cheddar Cheese Popped Water Lily Seeds were sold at retail stores in Michigan stores and online at www.karmawellnesskitchen.com.  The recall was initiated after it was discovered that product containing Milk was distributed in packaging that did not list “Contains:Milk” as a common allergen.

Yes, the cheddar cheese is a milk product.

So what is a popped water lily seed?  It is a snack derived from the seeds of the white lily plant, a native to Eastern Asia.  Seeds are collected and then roasted over high heat.  The high heat makes them 'pop'.  Some call these a super food in that it is high in protein and minerals such as magnesium and potassium.  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/karma-spices-and-trading-company-llc-issues-allergy-alert-undeclared-milk-white-cheddar-cheese
Karma Spices and Trading Company, LLC Issues Allergy Alert on Undeclared Milk in White Cheddar Cheese Popped Water Lily Seeds
Summary
Company Announcement Date:  April 05, 2023
FDA Publish Date:  April 05, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Karma Spices and Trading Company, LLC
Brand Name:  Karma
Product Description:  White Cheddar Cheese Popped Water Lily Seeds

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

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

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

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

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

Eyedrops Recalled Due to Contamination Leading to Severe Eye Infections, 483 Report Details QC Horrors At Foreign Manufacturer

Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination.  This product was identified by CDC as the source of "Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection."

The 483 Report (obtained from www.marlerblog.com) details an extremely bad operation.  

(https://www.marlerblog.com/files/2023/04/Global-Pharma-Healthcare-Ltd.-Tamilnadu-India-3.2.23-483.pdf)

This is an imported product.  We often wonder why some items are less expensive than branded products that are produced in the US.  Products produced in the US have to meet established sanitary standards.   

Observations from the report include:

Obs 1A.  Lack of validation support for demonstrating the equipment can be reliably sterilized.  And with that, the procedures were not followed for the required sterility filters.

Obs 1B. Improper filter testing

Obs 1C. Did not perform container closure integrity test adequately.

Obs 1D. Formulation not followed, specifically with inadequate preservatives.

Obs 1E Aseptic process lacked sterility assurance

Obs 1F. Airflow patterns insufficient (to demonstrate air control in aseptic environment)

Obs 1G Floors, walls, and ceilings were not appropriate for aseptic processing - cracks, holes, etc

Obs 1H Employees not qualified, did not follow appropriate procedures for aseptic environment.

Obs 2 - Test methods not established for accuracy, sensitivity, and reproducibility.
Obs 3 - Equipment does not have appropriate deisgn for how it is being used.

Obs 4 - Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic products.  Including (C) surfaces that contact the container closures is not cleaned.

Obs 5 - Failed to conduct test to verify identity of each component of the eye products.

Obs 6 - Failed to establish written procedures for cleaning and maintaining the equipment.

Obs 7 - Defient environmental monitoring.

Obs 8 - Laboratory controls  do not have specifications for conformance - what is acceptable.

Obs 9 - REcord reviews not completed and approved by QC 

Obs 10 - Stability samples not stored according to written procedures

Obs 11 - QC does not have responsibility and authority to approve, reject.

Yikes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
Summary
Company Announcement Date:  February 02, 2023
FDA Publish Date:  February 02, 2023
Product Type:  Drugs
Reason for Announcement:  Potential microbial contamination
Company Name:  Global Pharma Healthcare
Brand Name:  EzriCare & Delsam Pharma
Product Description:  Artificial Tears Lubricant Eye Drops

CDC - Salmonella Outbreak Linked to Flour - Investigation Notice 3-30-23

CDC and State partners are investigating a Salmonella outbreak that has been linked to raw flour. As of March 30, 2023, 12 people infected with the outbreak strain of Salmonella have been reported from 11 states (see map). Illnesses started on dates ranging from December 6, 2022, to February 13, 2023 (see timeline).

While an exact source is yet to be identified, it is important to follow proper practices when handling raw flour.

• Do not eat raw dough or batter.
• Clean surfaces and utensils that have residual raw flour with warm water or soap.
• Wash hands after handling raw flour, dough, or batter.
• Handle raw flour in a way that prevents it from cross contaminating surfaces that will not be cleaned immediately.
• Store raw flour properly, preventing it from getting over other surfaces or food.

Salmonella Outbreak Linked to Flour

https://www.cdc.gov/salmonella/infantis-03-23/index.html
Fast Facts
Illnesses: 12
Hospitalizations: 3
Deaths: 0
States: 11
Recall: No
Investigation status: Active

FDA Issues Warning Letter to CA Seafood Processor for Salmonella Contamination

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

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

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

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

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

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