Ice Cream with Added Spinach Recalled After Listeria Positive Test

Ramar Foods of Pittsburg, CA, is recalling its 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product because of the potential contamination of Listeria monocytogenes, The potential for contamination was discovered after internal routine testing by Ramar Foods revealed the presence of Listeria monocytogenes in some packages of the ice cream.

First, it seems that "hiding" vegetables in ice cream is just wrong.

In the hazard analysis, one would need to recognize that cooked or blanched vegetables would have a Listeria monocytogenes risk. The report does not indicate whether the spinach was cooked/blanched at the establishment or by the supplier. As a post-process addition, the vegetables would need sufficient controls to prevent contamination by Listeria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ramar-foods-recalls-mint-chocolate-chip-hidden-spinach-ice-cream-because-possible-health-risk
Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk
Summary
Company Announcement Date: May 14, 2020
FDA Publish Date: May 14, 2020
Product Type: Food & Beverages Ice Cream/Frozen Dairy
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Ramar Foods
Brand Name:  Peekaboo
Product Description:  Mint Chocolate Chip with Hidden Spinach Ice Cream

FDA Warning Letter - Ice Cream Facility in MA

FDA sent a Warning Letter to an ice cream facility in MA.  Lots of good things to learn from this inspection.

One of the major issues was that the facility had a Listeria control issue.

One of the first citings was that the establishment said that it did not require a sanitation control for Listeria in the post process environment where the product is exposed.  The facility said that because it had SSOPs, GMPs, and environmental monitoring, these were reasons why it does not have to considered a preventive control.  Doesn't work that way.

our “FSMA/FOOD SAFETY PLAN” issued on June 10, 2019, lists pre-requisite programs (PP) and Sanitation Standard Operating Procedures (SSOP), “PP1- Environmental Monitoring,” “PP3-current Good Manufacturing Practices,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “PP7-SSOPs,” at processing steps where food is exposed to the environment, as reasons that a hazard (e.g., L. monocytogenes) does not require a preventive control. However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These measures should not be considered when determining whether sanitation preventive controls are needed. Environmental monitoring (e.g., Dean Foods’s corporate environmental monitoring program “PP1- Environmental Monitoring Preventive Control” and/or your facility specific “Pathogen Environmental Monitoring Program”) is needed to verify that environmental pathogens are being controlled by the sanitation control measures. 

 Listeria was found in the environment during the FDA inspection, the same strain in some cases that was found during an inspection in 2017.  The firm's own swabbing had found a high level of Listeria.

"from January 2019 through July 2019, 13.4% of all swabs taken were positive for Listeria spp.; from January 2018 through December 2018, 20.9% of all swabs taken were positive for Listeria spp.; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for Listeria spp."

GMP issues (continues)

FDA Issues Warning Letter to Ice Cream Facility for Inadequate Listeria Control

FDA issued a warning letter to an Ohio ice cream facility after finding Listeria monocytognes on consecutive inpections still in the facility.  From FDA's perspective, the facility had not done sufficient corrective action to reduce this environmental bacterial pathogen.

FDA stated "Nine environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in three swabs within your facility."  Further,  "FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes),...... including the same strain found during FDA’s 2018 inspection."

The facility conducted had their own testing and from their results,  "Listeria spp. [was found] in your environment seven times on surfaces adjacent to Zone 1 locations and other non-food contact surface locations within your processing environment including areas within your RTE room. Review of your records finds that your written corrective action procedures were followed each time a positive swab was found in your facility; however, these repeated findings of Listeria in your environment are further evidence that additional measures may be needed in your facility to address Listeria."

Along with this, the inspection noted items of risk including improper use of high pressure hoses which can cross contaminate back onto food surfaces.  "[FDA] investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day."

The other issue was poor drainage from the processing floor - "the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria."

Once Listeria becomes established in a facility, it can become difficult to eliminate.  The level of positive Listeria swabs are clear indication that corrective actions were not sufficient. The Blue Bell Listeria contamination issue where corrective action to Listeria positive findings were also inadequate. .


FDA WARNING LETTER
Velvet Ice Cream Company 
MARCS-CMS 575444 — 06/05/2019
  Delivery Method:VIA UPSProduct:Food & Beverages
Dairy
Current Good Manufacturing Practices (CGMP) 

Ice Cream Product Recalled After Listeria Illness Where Strain Matches A 2017 Environmental Sample

A Florida Ice cream company is recalling product after a case of Listeria occurred in May, where that Listeria strain had been found in the facility during a environmental sampling in 2017.  Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is recalling No Sugar Added Vanilla and Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018.

"This recall is being conducted in cooperation with the U.S. Food and Drug Administration (“FDA”) following notification of a recent consumer case in Florida which has been linked to a strain of Listeria monocytogenes found to be present at the Working Cow manufacturing facility during environmental sampling in 2017. Although subsequent environmental sampling has yet to yield positive test results, investigations are ongoing to ensure root cause has been properly addressed. No other illnesses have been reported."

This is interesting in that the recall is being issued on the premise that the Listeria found in 2017 in the plant was still there in 2018 even though internal testing did not find it.  One would guess that the epidemiological investigation found that the patient had eaten the ice cream in question.

https://www.fda.gov/Safety/Recalls/ucm622688.htm
Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk
For Immediate Release
October 4, 2018

Ben and Jerry's Changing Sourcing to Eliminate Glyphosate from Ingredients

Ben and Jerry's  announced that they are making changes to their sourcing to eliminate the chemical glyphosate from ingredients they purchase...by 2020.  Glyphosate, a main ingredient in the herbicide Roundup, was found to be present in their product (as well as other food products) at very low levels - far below what EPA would cause adverse effects (EPA has a limit of 2 mg/kg/day vs 1.75 ppb found) and EPA says that the chemical is not likely to be carcinogenic.  In 40CFR180, lists the tolerances for pesticide residues in food including glyphosate (180.364 - table below).   EPA's established tolerance for glyphosate in drinking water is 700 parts per billion (ppb).

So 1.75 ppb is pretty darn low, and based upon this EPA limit, a news article (below) determined that a kid would have to eat over 100,000 servings per day to get to this level.  And glypshate is common in the environment and as well other foods.  A study found that many cereal grain products had levels ranging from 25 to 1000 ppb - again, all well below EPA limits.  It is even in wine (in a 2016 report, the highest level found was 18.74 ppb).

But people get excited, especially once you link a herbicide to thier food.  I think the controversy is good.  It forces the science to prove its safety and for the agricultural industry to manage its use.  Where we fail is communicating to consumers the minimal risk associated with the amount that was found.

NECN

http://www.necn.com/news/new-england/Ben--Jerrys-to-Change-Ingredients-After-Weed-Killer-Discovery-450487113.html

Ben & Jerry’s to Change Ingredients After Weed Killer Discovery

By Jack Thurston

Warning Letter Issued to Manufacturer of RTE Cookie Dough Contaminated with Listeria

FDA issued a warning letter to Aspen Hills, the manufacturer of ready-to-eat (RTE) cookie dough that was used in ice cream. Aspen Hills conducted a recall of the product after the FDA audit, and along with that, a number of manufacturers who used their product as an ingredient, also issued recalls, including Blue Bell.

FDA found 4 positive Listeria monocytogenes (LM) samples. They appear to be zone 2 and 3 samples. Interesting is that we see that the zone 3 samples - wheels and ladders - are typical types of samples that scream Listeria is on the move in the facility. From the report ((b)(4) redacted text):

• On the second stair/rung of the ladder well leading to the elevated control room. This ladder is adjacent to the (b)(4) used on the cookie dough (b)(4).
• On the wheels of the pallet jack used to move food products within the production room. The pallet jack was located in the (b)(4) of the production room adjacent to the (b)(4) at the time of sampling.
• On the basket located in the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).
• In the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).

FDA saw that the firm was seeing Listeria put was not aggressive in cleaning it up. The firm found 10 positive environmental LM samples and one positive product samples

"indicates that your firm is not taking aggressive action to identify harborage sites for L. monocytogenes, to deep clean your facility effectively, and to prevent finished product contamination."

The isolates from the facility were stated as all being genetically the same. This indicates an organism that has become well adapted to that facility.

• As far as GMP issues which would contribute to cross contamination:
• Spraying of the floor with hoses while product was not covered (1a)
• Residue on the floor with pallet jacks and forklifts running through it. (1b)
• Poor employee practices with regard to protecting clothing and boots from cross contamination. (1c)
• Sparying floor and drain with overspray hitting equipment (1d)
• Inadequate cleaning of a scale used to weigh pasteurized egg (2a)
• Rust and missing bolts on processing equipment (3)

Preventing these issues is the goal of FDA's new draft guidance for Listeria control in facilities that manufacture RTE products. It comes down to putting good practices in place, monitoring the environment and thus how well those practices are working, and then having a seek-and-destroy mentality with regard to Listeria.

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm536757.htm

Aspen Hills, Inc. 1/10/17

Additional Companies Recall Ice Cream Due to Cookie Dough Pieces with Potential Listeria Contamination

A number of companies are recalling ice cream products after the supplier of cookie dough pieces, Aspen Hills, has had a Listeria contamination issue.  The Listeria issue in the cookie dough pieces supplied by Aspen Hills was first discovered by Blue Bell Ice Cream as part of their intensified Listeria control program back in September.  In this round of recalls, recalled brands include Weight Watchers, Ashby's Sterling, Cedar Crest Specialties and Chocolate Shoppe Ice Cream Company
 
It is hard to determine why there is such a time lapse from the intial Blue Bell Ice Cream recall related to the Aspen Hill cookie dough pieces that occurred in September and these recalls.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm529155.htm
Voluntary Recall of Weight Watchers Smart Ones Chocolate Chip Cookie Dough Sundae Due to Possible Health Risks from Cookie Dough Pieces Purchased from a Third Party Supplier
For Immediate Release
November 14, 2016

Ice Cream Co-Packer Ceases Operations After Listeria Recalls

A California ice cream company, Dr. Bob's, closed it operations after FDA recall notices were issued by companies for which Dr. Bob's copacked.  The initial recall was issued November 4th after FDA found Listeria in the product and in the production facility.

The company, owned by a former dean for the Hospitality Management Program at Cal Poly, is located at a fairground in California.

Inland Valley Daily Bulletin
http://www.dailybulletin.com/business/20161117/dr-bobs-ice-cream-company-closes-after-fda-recalls
Dr. Bob’s ice cream company closes after FDA recalls

Blue Bell Expands Recall After Supplier Expands Recall of Cookie Dough, Blue Bunny and Others Also Issues Recalls

Blue Bell is expanding its recall of cookie dough ice cream after its ingredient supplier of cookie dough expanded its recall for Listeria.   Just over two weeks ago, Blue Bell issued a recall for 5 lot codes of two flavors that contained the cookie dough ingredient.  That recall now includes all product made from February 2, 2016 through September 7, 2016.
Along with this, Blue Bunny is recalling its Hoppin' Hollidoodle ice cream because it also contains the suspect cookie dough.

 We have come to expect expansions of recalls when there is Listeria contamination issues.  These recalls get expanded because the facility finds that there are underlying issues which indicate that Listeria could have been around for some time in the facility.

Other recalls affected by this supplier of cookie dough.

Chocolate Shoppe Ice Cream Company Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk

Publix Recalls Publix Premium Chocolate Chip Cookie Dough Ice Cream Due To Possible Listeria monocytogenes Contamination From Aspen Hills, Inc. Cookie Dough Pieces

Nutrisystem Retail Division Voluntarily Recalls One Product Containing Chocolate Cookie Dough Pieces Purchased From Third Party Supplier Due To A Possible Health Risk
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524749.htm
Outside Supplier Aspen Hills Expands Cookie Dough Recall; Blue Bell Recalls All Products Made With Aspen Hills Cookie Dough Due To Potential Health Risk
For Immediate Release
October 10, 2016

Drumstick Sundae Cones Recalled Due to Positive LM Product Contact Surface

Nestle is recalling its ice cream treat, Drumstick cones, from Best before June 2, 2017 to June 19, 2017 after testing found the food contact surface positive for Listeria monocytogenes.  No product had tested positive.  No illnesses have been reported.

In the notice, it states "The products impacted by the voluntary recall were put into distribution inadvertently."  This may suggest that the product was on a test-and-hold and was released prior to the finalized test results.   Even though the positive was found on a surface that is classified as product contact, there is a risk that the product may have been contaminated as well, at least one has to consider it.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524634.htm
Nestlé USA Initiates Voluntary Recall Of Nestlé® Drumstick® Club 16 Count Variety and 24 Count Vanilla Pack Due to Possible Health Risk
For Immediate Release
October 7, 2016

Blue Bell Recalls Two Ice Cream Products due to Potential Listeria Contamination

Blue Bell Ice Cream is recalling two flavors of product for potential Listeria contamination.  There have been no illnesses reported.  According to the company's press release, product was shipped to 10 states, primarily in the Southeast US.

Last year, Blue Bell shut down its 3 plants after their ice cream product was linked to a Listeria outbreak where 10 people were infected.  The company reopened the plants with increased controls and under increased government scrutiny.  In January of 2016, the company issued a release that their controls were effective, although they were still finding Listeria in the environment.

In this particular case, it looks as though the supplier of the cookie dough, Aspen Hills, may be at fault.  Blue Bell discovered the issue through testing of incoming products and notified Aspen Hills who then issued a recall.  This recall notice is posted on the Blue Bell website.  Unfortunately, product was released before these test results came to light.  Although Blue Bell states they do test and hold (product is not released before results come back), that test and hold looks to have been focused on finished product testing (and perhaps not ingredient testing?).

Of course this cookie dough is not technically raw.  It is product that is made to resemble raw cookie dough, but is a ready-to-eat product.  Being that it is ready-to-eat, it should be free of pathogens such as Listeria.

KHOU News Release
http://www.khou.com/news/health/blue-bell-issues-recall-for-ice-cream-with-cookie-dough/323180943
Blue Bell recalls ice cream over listeria concerns
KHOU.com Staff , KHOU 11:59 PM. EST September 21, 2016

Warning Letter Issued to Facility with Recurring Strain of Listeria

Jeni's Splended Ice Cream was issued a warning letter by FDA.  Basically FDA inspected the firm in January, and during that inspection, they found 2 of 75 swabs positive for Listeria.  Both positives were from the floor - non-food contact surfaces.  They also found two GMP issues - 1) "our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored." and 2) observed an employee in the prep room placing  “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers.

Now, it is important to point out that an inspection had been done the previous year and that the 2 GMP violations were previously noted.  More impactful however, is that during that 2015 inspection, FDA had found 20 samples positive for Listeria.  It is also important to note that this audit had been done as a result of a state laboratory finding Listeria in a product sample.

Further, the Listeria was the same strain in all samples "Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015".  (Associated Recall)

So while the firm conducted corrective actions  (conducted a voluntary recall of ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers in 2015, made changes in the production flow including no longer manufacturing finished ice cream, frozen yogurt, or sorbet on-site (instead just manufacturing frozen flavor bases that are shipped to co-manufacturers, and conducted training for employees), the same organism is still in the facility.

"The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism."

A few things to note:

1) This is a reason for facilities to consider using Whole Genome Sequencing (WGS) when they find Listeria in their facility.  Too often the assumption is that it is reentering the facility, but it may be worth determining if there is a resident strain.

2) Although this firm went to great lengths to escape the problem, including changing the products they make, they did not solve the fundamental issue of systematic contamination in the facility.  Although the facility findings were not huge or overly impactful, that issue still existed and resulted in further scrutiny .  WGS had an impact on how FDA evaluated this facility, and making marginal issues bigger than they should have been.  Including finding 2 samples of Listeria in the facility.

3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..

4) This points out the long term impact of finding product in the field positive for Listeria.  It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.

5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage.  Below is an article in the Wall Street Journal countered by an article in Columbus Business First.

Blue Bell Provides Update on Listeria Control Efforts

Blue Bell provided an update on their enhanced Listeria control systems in the aftermath of the Listeria related recall.   In their press release, they state their products are safe and that they have identified sources where the organism may be present and that corrective actions have been taken.

We have identified locations where suspected Listeria species may be present in our facility, and we continue to extensively clean and sanitize those areas and make additional enhancements to the facility and our procedures based on the environmental test results. To confirm that our robust environmental program is effective, and that our “seek and destroy” goals are being achieved, we expect to periodically find microbiological indications in our facilities.

So while the company indicates that they found locations where Listeria may be positive, they provide assurance that there is no issue.  Finding positives for Listeria species in the environment can be expected, provided that those sites are not close to product or process.  This is actually the case in many food facilities.  Rarely is Listeria completely eliminated, but rather it is a case of ongoing control.  The key is continually searching and completing corrective action for any potential positives to prevent reoccurrence, as well as ensuring the product has not been affected.  The facility seems to be following through on both.  I would be more suspect if they said that they found absolutely none.

It is interesting, however, to see how the media portrays this.  In a web search on the topic, we see the headlines Blue Bell finds signs of listeria in plant, Blue Bell: Suspected Listeria found in facility, not in product, and of course the highly cited Food Safety News -  Blue Bell says it’s still got Listeria in its facility .  While their articles downplay the risk to the product, the headlines create a sense of higher risk.

Blue Bell News Release
http://cdn.bluebell.com/the_little_creamery/press_releases/facilities-update-1-7-16
An update on our enhanced procedures at our production facilities

Brenham, TX, January 7, 2016 – As we complete our final phase of distribution, we wanted to update our loyal customers on what has been going on in our production facilities. We continue to strictly adhere to our enhanced operations, policies, employee training and cleaning procedures to help give regulatory agencies and the public assurance that all aspects of our facilities and operations are resulting in a safe product.

Justice Department Investigating Blue Bell Regarding Listeria Outbreak

Blue Bell is back in the news as CBS News is reporting that the US Justice Department has started an investigation into the conditions that led to the 2015 Listeria outbreak and what company executives knew and when they knew it.

Similar to what was seen with PCA Salmonella outbreak, there may be concern that the company knew of substandard conditions and Listeria contamination within the processing environment, and did not take sufficient action.

CBS News
http://www.cbsnews.com/news/dept-of-justice-investigating-blue-bell-for-deadly-listeria-outbreak/
Dept. of Justice investigating Blue Bell for deadly Listeria outbreak
By Jim Axelrod CBS News

December 29, 2015, 7:43 PM

The Department of Justice has started an investigation into Blue Bell after their ice cream was linked to a deadly Listeria outbreak earlier this year that killed three people.

Blue Bell to Conduct Trial Production Run in AL Facility

After ceasing operations in April / May to clean up their operation in light of product being linked to cases of Listeriosis, Blue Bell Ice Cream will run a trial production run in their Alabama facility.

The costs of this contamination event will be tremendous.  First and foremost, are the people who contracted Listeria and their associated costs.  Then the legal fees.  The cost to the people who were laid off or furloughed (roughly 1,400 in each category).  The company also has the cost of the recall and the lost revenues for 4 months of product.  Then there will be costs associated with resuming production....costs of improvements to the operation, retraining of employees, conducting trial runs, etc.  Getting back into the market place will not be cheap....regaining freezer shelf-space (you don't think those retailers let that space go empty for 4 months), restarting a distribution system, etc.  And then regaining sales....the loyal will be back, but many other will be hesitant or leery, while others have moved on to other brands....the lost customer is very difficult, if not impossible to recover.

And what if they find it again....certainly this has been the case in a number of facility-related contamination events......


CBS DFW
http://dfw.cbslocal.com/2015/07/08/blue-bell-to-begin-trial-runs-in-july/
Blue Bell To Begin Trial Runs In July
July 8, 2015 1:34 PM 

FORT WORTH (KRLD/CBSDFW.COM) – After a nearly four month absence from store shelves, Blue Bell ice cream could make a comeback before summer’s end.

The company will begin trial runs at its Sylacauga, Alabama plant during the week of July 20, as part of its plan to get the ice cream back in grocer’s freezers.

CDC Issues Final Report on Blue Bell, and the Response to FDA

CDC issued the final report on the Blue Bell / Listeria outbreak.  In the final report, 10 people in 4 states had contracted listeriosis.  Blue Bell has recalled all product from the marketplace.

All of the FDA inspection reports can be found here.  Included in this is the response to the FDA 483 report.  Blue Bell informed FDA of their plans to introduce tough measures to control Listeria.

While the organism was found in two of the facilities, it was not found in the Texas facility even though product from that facility was linked to illness.   This can be the case with Listeria in that it only surfaces once in a while.  Because of this, vigilant control measures are needed.

So you can think of what they had in terms of setting some mouse traps in your house.  The set some mouse traps around and in a few traps they caught a mouse.  They cleaned up a bit and reset the trap and caught another mouse.  Cleaned again, reset the trap.  No mouse.  Done?  Not really.  The problem is that when you catch a mouse, you have to understand the potential for mice in other spots, especially around your food (zone 1).  Determination have to be made on where the mouse came from and whether that mouse got into your food.  With this, you have to put measures in place to prevent the mouse from getting anywhere in your house.

Houston Chronicle
http://www.houstonchronicle.com/news/houston-texas/houston/article/Blue-Bell-can-t-identify-listeria-source-at-6319817.php
Blue Bell can't identify listeria source at Brenham plant

By Mark Collette

June 10, 2015 Updated: June 10, 2015 11:04pm

Blue Bell may never learn how listeria got into the ice cream at its Brenham plant, according to documents released Wednesday by the U.S. Food and Drug Administration, but the company plans to introduce some of the toughest bacterial control measures in the industry.

Brenham is the largest of Blue Bell's three plants and its sheer size may have hampered the hunt for contamination points. FDA inspectors swabbed 186 surfaces in the plant in March and didn't find any listeria species. That's despite ice cream from the plant being definitively linked to illnesses.

FDA Inspectional Reports From Blue Bell Production Facilities

FDA published the inspectional observations from the Blue Bell production facilities in their three plants.  This comes after their product was linked to Listeria illnesses and product recalls.

• Blue Bell Creameries Inc, Sylacauga, AL 483 Issued 04/30/15 (PDF - 1MB)
• Blue Bell Creameries, L.P. Brenham, TX, 483 Issued 05/01/15 (PDF - 1023KB)
• Blue Bell Creameries, LP, Broken Arrow, OK 483 Issued 04/23/15 (PDF - 2.6MB)

Here is a list of finding, primarily the OK facility, but many of the same issue were identified in all three facilities.  It is important to remember that these facilities are producing a ready-to-eat product, and should be maintaining a high hygiene environment.  However these findings would not suggest high hygiene zones (or high care zones).

Blue Bell Ice Cream Recalls All Products, Additional Cases Linked Through Retrospective DNA Matching

The CDC is reporting that 10 Listeria related illnesses dating back to 2010 have been attributed to Blue Bell Ice Cream.  While 8 cases had been reported, the additional 2 cases were identified through a 'retrospective analysis' using DNA data (verified via whole genome sequencing) to match isolates to different illness cases.

Blue Bell had recalled all of its products at all of its facilities.  A very bold move done due of the uncertainty of findings in the facility and inability to find the exact source.

 

 

CDC News Release

http://www.cdc.gov/listeria/outbreaks/ice-cream-03-15/index.html
Multistate Outbreak of Listeriosis Linked to Blue Bell Creameries Products
Posted April 21, 2015 11:45 AM ET
Highlights
Read the Advice to Consumers, Institutions, and Retailers>>(http://www.cdc.gov/listeria/outbreaks/ice-cream-03-15/advice-consumers.html)
Read the Information for Health Professionals>>(http://www.cdc.gov/listeria/outbreaks/ice-cream-03-15/health-professionals.html)
On April 20, 2015, Blue Bell Creameries voluntarily recalled all of its products currently on the market made at all of its facilities, including ice cream, frozen yogurt, sherbet, and frozen snacks, because they have the potential to be contaminated with Listeria monocytogenes. Blue Bell announced this recall after sampling conducted by the company revealed that Chocolate Chip Cookie Dough Ice Cream half gallons produced on March 17, 2015 and March 27, 2015 contained the bacteria.

Listeria Contamination of Ice Cream and Hummus - What Can Be Learned

As reported by the news, the Blue Bell Ice Cream facility that produced the ice cream with Listeria contamination had a stellar inspection.  Surprising....no.  Inspections are good for determining that procedures are being followed, the facility is clean, as well as other things that can be ascertained in a snapshot view of an operation, but low levels of contamination in these type of production facilities may not likely to be seen, and may even be hard for the facility to detect unless they were specifically looking...hard.

In many of the Listeria contamination issues we encounter, the issue is with post-lethality exposure of the product to the environment, or where the product receives no thermal treatment, but rather a wash (apples or cantaloupes).  Listeria is a environmental pathogen that establishes itself in processing facility niches...in drains, in cooler air handling systems, in conveyor rollers, in washing flumes, and weighing equipment.  A facility controls Listeria through good sanitation and verifies that cleanliness through monitoring the environment by environmental sampling/testing for Listeria.

But in the case of humus or ice cream, they are primarily closed systems.  That is, after heating, the product is pumped through pipes, cooled to some degree, and filled.  The product has little exposure to the external environment, except for perhaps open hoppers or at the filler.  (This would not be a hazard of concern in hot filled product because the hot product provides lethal treatment all the way to the container).

Let's take a look at the hummus - Listeria issue.  If you look at the process of making hummus (a video of the process, not Sabra, but probably similar), the opportunities for cross contamination are limited.  Looking at this video, the facility may not look sterile, but it is more important however that the pipes, transfer hopper, and filler are clean and sanitized, and that there are no niches where Listeria could gain a foothold.   Thus, the fact that this product was found to be positive for Listeria probably indicates this type of in-line contamination.  If that is the case, then it could either be improper cleaning of the process lines after a contamination event, or some niche developed within the line or at the filler (worn or torn gaskets in the filler or in the pumps, etc).  Under-processing could also be an issue, but at least with the hummus, if this were the case, the product would be subject to spoilage.

Because these are closed systems, many facilities do not focus their testing as much on Listeria in finished product.  They may test finished product to verify the pasteurization process is working properly,  using general plate counts such as APC or coliforms, and maybe even Salmonella.  But these will probably not necessarily give an indication of Listeria contamination.  If Listeria is tested in the finished product, it is probably done using a small sample size, unlikely to detect a low level contamination issue.  As for environmental testing, again the focus would probably be on verification of cleanliness by using ATP (an indicator used for microorganisms) or even general bacterial counts such as APC (aerobic plate count).  Listeria testing, if done in the environment, would probably focus on non-contact surfaces.  The presence or absence of Listeria in areas such as the drain may not raise a flag for indicating a contamination issue in finished product.

There are many who avoid doing finished product testing to any great degree for organisms like Listeria.   But this is the type of organism, if present in a niche within this type of closed system, can grow due to the product / process type and serve as an ongoing contamination issue.  To eliminate such a contamination, proper cleaning and sanitizing are critical, along with the removal of any niches including replacing gaskets and seals, filling cracks, etc.

To detect low level contamination, small sized samples (25 gram) may not be sufficient to accomplish detection.  Large size samples (300 gm or 375gm) composited over the production run, or focused at the end of the run will be better for detection of such an issue.  Another method, often cited by our good friend Dr. Steve Goodfellow, is to collect waste samples for analysis.  Waste sample analysis uses the drips and drops that accumulate on the floor or on the exterior of the equipment throughout the production run.  These can provide a worst-case-scenario for product and can be useful in determining a contamination issue.

Swabbing potential in-line harborage sites may also be helpful.  This would include pinch points, dead ends in pipes, gaskets, seals, and filler nozzles.  The downside of this is that contamination may emerge until the process has been running for a number of hours.

These two events are a reminder that Listeria contamination can be an issue where there is little to no environmental exposure of the product, and that detection of low level of contamination can be an issue.

Note - This supposition is based upon general practice and may not reflect the actual practices of the facilities mentioned.

MySanantonio.com
http://www.mysanantonio.com/news/texas/article/Number-of-people-sickened-by-listeria-outbreak-6188629.php
Inspection found no problem at Oklahoma ice cream plant
By DAVID WARREN and JUAN A. LOZANO, Associated Press : April 9, 2015 : Updated: April 9, 2015 7:26pm

DALLAS (AP) — Days after a foodborne illness was linked to Blue Bell ice cream products, a state inspection of an Oklahoma plant later tied to the infection praised the facility for having no violations and doing a "great job," according to a copy of the inspection report.

Inspectors had no reason to check for listeria during the routine March 18 review as no problems were detected and the facility didn't have a history of issues linked to the illness, said Stan Stromberg, director of the food safety division for the Oklahoma Department of Agriculture, Food and Forestry..

Blue Bell Creamery Expands Recall, Suspends OK Operation

Blue Bell Creamery shut down their Oklahoma operation and expanded their recall in light of FDA test that indicated additional products produced on the same manufacturing line had Listeria.  As of 4/8/15, the CDC  reports that 8 individuals have become infected, 3 additional illnesses in Texas to those 5 that have already been reported in the hospital related illnesses that started the investigation.  A number of samples have been found to be positive for Listeria.

One question that can be asked is why all product from that production line was not recalled initially.   If a manufacturing line has contamination for Listeria, one can bet that the contamination will have a good likelihood of being in a little of all product produced on that manufacturing line.  Like so many other Listeria recalls that have occurred in the past, companies issue the first recall, and then a second and even third recall expanding the scope of the recall to eventually get all product produced in that facility.  

FDA Recall Noticehttp://www.fda.gov/Safety/Recalls/ucm441620.htm
Blue Bell Creameries Expands Recall of Products Produced in Broken Arrow, Oklahoma Due to Possible Health Risk

Contact:  Consumer: 979-836-7977
Media: Gene Grabowski 202-270-6560

FOR IMMEDIATE RELEASE — April 7, 2015 — Brenham, TX — Blue Bell Creameries is expanding its recall of products that were produced in the Broken Arrow, Okla., plant to include Banana Pudding Ice Cream pints which tested positive for Listeria monocytogenes, and additional products manufactured on the same line. These items have the potential to be young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.