In the past, the standard for recalls has been confirmation of a contaminant on actual finished product. In elevating their standards, with the requirement of environmental monitoring programs, including pathogen environmental monitoring programs (PEMPs), the FDA is expanding their criteria for recalls to include presence of contaminants in the general environment. More products are being recalled due to the finding of especially Listeria in the environment. In some cases this has caused a wave of recalls due to a contract manufacturer or a supplier that found Listeria in their environment, contact areas and products. This is part of the shift from reaction to prevention.
Sabra Hummus Recall
The FDAreported the voluntary recall by Sabra Dipping Co., LLC of certain hummus products made prior to November 8, 2016 due to concerns over Listeria monocytogenes, which was identified at the manufacturing facility but not in tested finished product.
The products recalled include Sabra Organic Hummus, Sabra Salsa, Sabra Guacamole and Sabra Greek Yogurt Dips.The company spokes person, Shali Shalit Shoval, said “We have invested heavily in technology and enhancing our processes and protocols, with guidance and input from external experts, … such as testing finished product from the production line every two minutes for pathogens including Listeria. We want to reassure our consumers that our procedures include extensive finished product testing, and no products tested positive for contaminants. Subsequent to the inspection conducted with the FDA, we implemented a thorough and extensive factory-wide cleaning and sanitation procedure, and beyond that, we continue to work very closely with internal and external food safety experts to identify any additional steps we can take to even further enhance our efforts.”
The Ripple effect of Aspen Hill Cookie Dough
In October we reported about the Ripple effect of Recalls due to Listeria Contamination Due to the potentially contaminated cookie dough withListeria monocytogenes from Aspen Hills (Garner, IA).The Aspen product has resulted in a number of recalls including Chocolate Shoppe, Blue Bunny, Blue Bell, Nutrisystem , cookie dough bars, and Publix ice cream. As predicted, it caused additional recalls because the cookie dough could be in dozens of secondary products. The additional recalls due to this product include:
Weight Watchers frozen desserts
TheFDA reported that Weight Watchers Smart Ones Chocolate Chip Cookie Dough Sundae frozen desserts was voluntarily being recalled due to possible Listeria monocytogenes contamination from Aspen Hills, Inc. Cookie Dough Pieces.This issue was identified when Aspen Hills, the supplier of the cookie dough pieces used as an ingredient in Weight WatchersSmart Ones Chocolate Chip Cookie Dough Sundae frozen desserts, reported positive test results for Listeria monocytogenes. There have been no consumer complaints or reports of illness related to this issue to date.The recall is for approximately 100,000 cases of Weight WatchersSmart Ones Chocolate Chip Cookie Dough Sundae frozen desserts.
Another company affected by the Aspen Hill recall was Ashby’s Sterling. Only Ashby’s Sterling Peanut Butter Landslide Ice Cream packaged In 3 gallon container were recalled. Like the other recalled products with the Aspen Hill ingredients, no illness was reported.
Chocolate Shoppe Ice Cream Company EXPANDS Recall
Additional products from Chocolate Shoppe Ice cream containing the Aspen Hill ingredients are being recalled, expending the original recall. The ice cream products were distributed to the following states AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI. The ice cream products were distributed to various ice cream shops around the country, online outlets and limited grocery stores.
Cedar Crest was notified on November 10 that the cookie dough in the products manufactured by Aspen Hills, Inc., has the potential to be contaminated with Listeria monocytogenes.The company is recalling Chocolate Chip Cookie Dough, Monster Cookie and Pirate’s Bounty ice cream flavors. The affected products were distributed in retail stores throughout the Midwest.
Recalls Due to contamination in Contract Manufacturer Dr. Bob’s
Pomona News reported that Dr. Bob’s, a California manufacturer of premium ice cream, closed down after FDA inspectors found Listeria monocytogenes in its manufacturing facility. This resulted in the recall of 5 brands of ice cream.Dr. Bob’s makes its own line of flavors, which has amazed some consumers with ingredients such as Scharffen Berger brand chocolate and strawberry, sour cream and brown sugar, as well as ice cream for several other high-end brands.The FDA had served recall notices for the following companies products produced at Dr. Bob’s Pomona kitchen, according to notices by the federal food safety agency. The recall notice wrote “ The U.S. Food and Drug Administration (FDA) found samples positive for Listeria monocytogenesin the contract manufacturer’s facility and in finished product of another company’s brand, leading the contract manufacturer to recall all ice cream products .”
The recalled “Manila Sky Purple Yumm Ice Cream” were distributed nationwide in retail stores and events such as; Florida Food & Lodging Show, Festival of Philippine Arts & Culture and California State University Pilipino American Student Association (CSUF PASA) Friendship Games. No illnesses have been reported to date in connection with this problem.
Seven flavors (mint chip, peppermint stick, salted caramel chip, sweet cream, Turkish coffee, vanilla bean and Dutchman’s chocolate) sold in pint-sized containers. The 7 affected flavors, available only in pints, account for approximately 15% of the pint-packaged ice cream products carrying the McConnell’s brand label. No illnesses have been reported.
The recalled products include: Nancy’s Fancy butterscotch Budino gelato and Nancy’s Fancy peanut butter with crunchy peanuts gelato with expiration dates of March 18, 2017. The products were distributed from March to October 2016 in California, Oregon and Texas. No illnesses have been reported to date, and no Nancy’s Fancy product has been found to be contaminated.
Recalled products are: L.A. Creamery salted caramel ice cream with expiration dates of March 18, 2017. The products were distributed from March to October 2016 in California, New York, New Jersey, Connecticut, Florida, Pennsylvania, Maryland and Massachusetts. No illnesses have been reported to date, and no L.A. Creamery product has been found to be contaminated.
The following flavors were recalled: all vanilla, chocolate, cappuccino, chocolate chip and lavender ice creams packaged in pint sized containers. The product was distributed across the United States through retail stores.
The requirement for environmental monitoring is mentioned under CFR 21 section 117.165 “Current Good Manufacturing Practice, hazard analysis, and risk based preventative controls for human foods”. It requires a facility to conduct validation and verification activities, as appropriate to the nature of the preventive controls, to ensure a clean facility.The validation efforts are based upon a safety plan that is related to hazard analysis. However, because of differences between facilities, the FDA does not define specific factors associated with developing an environmental monitoring program. Instead it is stated that they are required to “be adequate for their intended purpose.”Environmental monitoring can include monitoring of indicator organisms such as aerobic plate count (APC) but can also include testing of food pathogens such as Listeria or Salmonella. In facilities that are producing ready-to-eat (RTE) items, their environmental monitoring program will be much different from one that involves foods that will be cooked or further processed before being consumed.For RTEs it is critical that environmental pathogens are controlled to ensure that they do not contaminate the product. For these types of products, perhaps the greatest use of testing lies in environmental pathogen monitoring.
A non-pathogenic indicator organism may be used as a surrogate for a pathogen only if there is scientific evidence to support a direct relationship between the detection of the surrogate and the presence of a specific pathogen. To date, the only proven predictive surrogate is Listeria innocua or Listeria spp. which is taken as a direct indicator of the presence of L. monocytogenes.Environmental testing typically entails taking microbiological samples of food contact surfaces or nearby areas, testing for the presence of a pathogen or indicator organism. For dry foods where a raw product or ingredient could be introduced, Salmonella is generally the organism of concern. For RTE foods processed under wet conditions or environments, the organism of concern is generally Listeria monocytogenes.
Role of ATP Monitoring:
One of the most common tests for cleanliness is that of Adenosine triphosphate (ATP). Its detection after the manufacturing equipment has been cleaned, is an indicator that food debris, bacteria or other organisms have been left behind and the cleaning process was not completed. ATP can be an indicator of the amount of cellular-based organic residue left on a surface which could potentially contaminate the next manufacturing run.
Environmental monitoring programs can be used to identify hotspots, check the validity of food safety programs and indicate trends. It can be used to control, and find trending out of control (early warning), or requiring corrective action. It can give a rapid indication of the sanitary condition of the lines.If environmental testing detects an environmental pathogen or an indicator organism on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated.For an FDA Food Safety Plan, the focus is on pathogens, and making sure that pathogens are not in the finished product. Therefore, an environmental monitoring program used to verify sanitation and other environmental controls must seek out pathogens.
How to decide if pathogen environmental monitoring programs (PEMPs) is required?
Not all food manufacturers are required to test the environment for pathogens. To determine if PEMP is necessary and which organism to monitor, a thorough risk evaluation should be conducted.Timothy Freier and Joseph Shebuski write about the fact that in ready-to-eat (RTE) perishable refrigerated products (e. g., deli-meat, salads, certain soft cheeses, cooked seafood, fresh-cut produce and hot dogs) L. monocytogenes has the greatest risk. In RTE that are shelf stable (e.g., nuts, nut butters, soy products, dry pet food, breakfast cereals, snacks, chocolate), Salmonella PEMP has the best value.Salmonellosis has also been linked to raw unpasteurized products such as meat, poultry, eggs, dairy, grains, spices, and produce. However, these product contamination events were caused by the inherent presence of the pathogen in the raw products, and not by contamination originating from food manufacturing facilities. Salmonella PEMP is typically not necessary in facilities manufacturing these types of non-RTE products.
Evaluation of Results
The most important element of PEMP is the result evaluations, which should be done in a timely manner. If positives are found the results should be reviewed and corrective action must follow.The corrective action should target the root cause of the contamination. It should not only include re-cleaning or re-sanitizing of the areas found positive. It should include activities to achieve a permanent fix such as facility modification and process changes.
The 4 Zones
Zones are defined based on the probability of product contamination if a pathogen is present in the zone.A pathogen in zone 1 is certain to contaminate the product. For inspections focusing on the presence of Salmonellae, food contact surfaces are normally not sampled. In contrast, for inspections focusing on detection of Listeria monocytogenes, sampling of food contact surfaces is essential. Many companies do not test zone 1 because it is likely too late for prevention and will likely mean a need to recall the product.Zone 2 , the areas directly adjacent to Zone 1. For investigations focusing on Salmonellae, this is the area where environmental contamination is most likely to directly affect safety of the product and consequently it is the main focus for PEMP.Zone 3 is the area immediately surrounding Zone 2. Zone 3, if contaminated with a pathogen, could lead to contamination of Zone 2 via actions of humans or movement of machinery.Zone 4 is the area immediately surrounding Zone 3, if contaminated with a pathogen, could lead to contamination of Zone 3 via the actions of humans or machinery.As mentioned above many companies do not usually test Zone 1 because it is likely too late for prevention and will likely mean a need to recall the product. The sampling should focus on Zone 2 because it has greater access to the food product and warm and wet areas that encourage bacterial growth. Zone 3 is tested less that zone 2. Very few, if any, environmental samples should be taken from Zone 4.Any pathogen detection in zones 1-3 need to be addressed by corrective action.
The food industry is doing more PEMPs because the regulators are testing the environment in the plans. The industry needs better understanding on how pathogens move in a plant to prevent their spread.If a result comes back positive for a foodborne pathogen, production of the product may need to be put on hold and more testing may need to be done. In some cases, the product may even need to be reprocessed or destroyed completely.
The Hawaii State Department of Health is investigating 14 cases of Salmonella infection on Oahu. The infection is linked to raw fish called limus Poke (a raw fish salad containing seaweed Limu).Seaweed is frequently served as a side dish at meals in the Pacific Islands and is a common component in the diet of many persons living in the Pacific Rim. Seaweed is often harvested at beaches, gathered in near shore waters, or purchased at local markets.Reported cases include both children and adults. All of the cases developed diarrheal illness from mid- to late October and four have required hospitalization.The tainted limu has been linked to a seaweed farm on Oahu which was ordered by the department to halt operations and advise its customers to remove product from sale immediately. The preliminary investigation identified the consumption of raw fish, specifically poke that contains limu, as a common element among cases.State Epidemiologist Dr. Sarah Park said: “Although our investigation is still ongoing, our preliminary investigation has implicated limu, also known as seaweed, produced at a particular farm on Oahu,” she also said that “We found that the limu was being sourced from one farm. Moving on a hunch, while still looking at other sources of contents, we collected samples” from the farm, which tested positive for salmonella. “Whether it turns out to be different or the same (strain), it should not have come back positive,” Park said.According to Hawaii News Now the problem seaweed came from Olokai Hawaii, a seaweed farm in Kahuku. The owner, Dr. Wenhao Sun, said tainted water used in aquaponics may be to blame. Dr. Sun says in 10 years of operations, his farm has never experienced problems like this. “We will learn more and we will find the problem,” he said. “Then we can move on so we will satisfy our customers and make sure all the food is safe.”“If you’re going to consume limu, make sure that it is cooked appropriately,” said Park. “Do not eat it raw at this point because unfortunately, we don’t know the scope of the distribution, so we don’t know which limu is okay and which limu is not.” This outbreak could have been prevented if the water in the seaweed farm would have been tested for pathogens.
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