Thursday, October 25, 2012

Problems at NECC facility that led to meningitis outbreak

This is not food related, but the issues seen at this facility that made the contaminated epidurals that led to the fungal meningitis outbreak provide lessons in product and environmental control.

 · Firm shipped product before receiving sterility results (results were negative however).

· Firm didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility

· Firm didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications
· Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.

In the report below, Massachusetts Governor Patrick states that over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.

Not sure I want my local pharmacy making medicine, especially ones that can be injected in me. Dispensing medicine is one thing, but making it, no thanks.  

We see this type of thing in food companies as well…the firm expands into a niche outside of their core competency and grow the business, but never become technically competent in that new business. They fail to spend the capital on the facility needed to meet the requirements of producing that product. Then, as more product is shipped, the inevitable production error occurs, impacting far too many.


Report airs problems at firm linked to fungal meningitis outbreak
Lisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/other/news/oct2412fungal2-jw.html

Oct 24, 2012 (CIDRAP News) – Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results. 

Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.

Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.

Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17. 

The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis. 

In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.

NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.

According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.

In addition, authorities found that the company didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility.

The report also says NECC didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications.

Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.

At the media briefing, Massachusetts governor Deval Patrick said federal officials have launched a criminal investigation into NECC's actions and he announced more steps the state and its Board of Pharmacy have taken in response to the steroid contamination, including permanently revoking NECC's operating license and those of its three principal pharmacists.

"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," he said.

Patrick said that, over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.

The state will now require compounding pharmacies in Massachusetts to submit annual production, volume, and distribution reports to make it easier for authorities to flag operations that are acting more like manufacturers, which require federal licensing and extra scrutiny, Patrick said. He added that the state will require compounding pharmacies to report interactions with federal regulators and will form a special commission to examine best practices in other states and what changes may be needed at the federal level.

Wednesday, October 24, 2012

Summary of the FDA Requirements for Food Facility Registration

The FDA has updated the registration process for food facilities and that registration is now open. According to the FDA, “Biennial Registration Renewal for Food Facilities began at 12:01 AM on October 22, 2012. The updated food facility registration system is accepting food facility registration renewals.” The registration, initially required under the Bioterrorism Act of 2002 was updated as part of the Food Safety Modernization Act of 2011.  

· It is required for any facilities, domestic or foreign that manufacture, process, pack, or hold food for human or animal consumption in the US, including those companies who produce products that do not enter interstate commerce.

· If you registered before, you must re-register

· Facilities must register from Oct 1 to Dec 31 of even numbered years (2012, 2014, etc) 

· Who does not need to register? Farms (that do not process), retail food establishments, restaurants, and non-profit that complies with 21 CFR 1.227(b) (7) and facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act the Poultry Products Inspection Act or the Egg Products Inspection Act.);

· Email address for facility contacts now must be included.

· Registration information http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm


Food Facility Registration Requirements under the FDA Food Safety Modernization Act
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm324801.htm
October 19, 2012

The U.S. Food and Drug Administration (FDA) today issued further information and guidance regarding registration requirements for domestic and foreign manufacturers, processors, packers or holders of food for human or animal consumption based on changes made by the FDA Food Safety Modernization Act (FSMA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The updated food facility registration system will become available at 12:01 a.m. Monday morning, October 22, 2012.

Food producers and manufactures have long been required to register with the Food and Drug Administration. There is no fee to register or renew the registration of a food facility. Facilities can register online, via mail or fax. FDA encourages online registration as a quick and efficient means for food facility registration.

The Food Safety Modernization Act improves the registration process by ensuring, among other things, that the FDA has accurate contact information for each facility. The new registration form also includes new categories of foods. These new categories will help FDA rapidly communicate with the right facilities in the event of an emergency.  

Biennial registration renewal will become available at 12:01 a.m. Monday morning, October 22, 2012. To submit a registration renewal to FDA, a food facility is required to submit required registration information to FDA, including the additional registration information described above. To facilitate this process, the agency is offering technical assistance online and through the help desk. Please check FDA’s food facility registration website for more information and to register online.

Friday, October 19, 2012

Sunland Peanut Butter Recall Impacts Uncrustables

The Sunland Peanut Butter recall continues to drag on. The latest product recalled due to the use of the Sunland Peanut Butter – Smucker’s Uncrustables. Smucker’s points out that the recall only impacts the Uncrustables that were sold for USDA School Lunch Program, and not their other peanut butter related products. In fact, the Sunland product was only used for limited production runs of the Uncrustables. It is also important to not that there have been no illnesses linked to the Smucker’s product.

Companies often supplement their own supply with ingredients produced by others. When this occurs, especially with ingredients to be used in ready-to-eat applications, that purchaser has to make sure that the supplier has a stout food safety program. Companies spend countless millions of dollars establishing a well-respected brand, and can see it tarnished quickly by a less-than-stellar supplier.  

Smucker's Uncrustables sold to schools recalled

http://www.usatoday.com/story/news/nation/2012/10/19/smuckers-uncrustables-recall/1644249/



The J.M. Smucker Co. used peanut butter that was produced by Sunland, a company recently linked to salmonella illnesses.
12:44PM EDT October 19. 2012 - USAToday

 MINNEAPOLIS (AP) — Officials have told school lunch programs across the country to check to see whether they have any Smucker's Uncrustables sandwiches that might contain peanut butter made by a New Mexico company that is being recalled because of potential salmonella contamination.

The J.M. Smucker Co. used peanut butter that was produced by Sunland Inc. and supplied by the U.S. Department of Agriculture in "limited production runs" of 72-count bulk packs of the sandwiches that went to schools under the National School Lunch Program, Smucker's spokeswoman Maribeth Badertscher said in an e-mail Thursday.

Uncrustables are pre-made peanut butter and jelly, pocket-like, circular sandwiches.

 The Orrville, Ohio-based company tests all the incoming USDA-supplied peanut butter it gets, and tests finished products before distributing them, and found no problems, she said.

 But out of "an abundance of caution," and working with federal agencies, she said, Smucker's recently notified school customers that they should check to see if they still have any of the crustless frozen peanut butter and jelly sandwiches from the recalled lots, which all have either expired or will expire soon. They should not be served to students, the company said.

 No other Smucker's products contain peanut butter from Sunland or other outside suppliers, Badertscher said. She said she did not immediately know how many sandwiches were involved.

Sunland shut down its plant in Portales, N.M., last month and recalled more than 200 products made under a variety of brand names after salmonella was found in Trader Joe's Creamy Salted Valencia Peanut Butter. Thirty-five illnesses in 19 states have been linked to Sunland, but no illnesses have been linked to the Uncrustable sandwiches.

"When USDA learned of the FDA recall of certain products manufactured by Sunland, Inc., we coordinated with state agencies to immediately notify individual school districts and ensure that recalled products were identified and destroyed," USDA spokeswoman Alyn Kiel said in an e-mail.

The Smucker's recall was first reported by Food Poisoning Bulletin, a website published by Minneapolis-based food safety lawyer Fred Pritzker.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Tuesday, October 16, 2012

Fresh Express Recalls Bagged Lettuce Due to Potential Salmonella Contamination


Fresh Express, one of the leading manufacturers of ready-to-eat salads is recalling Romaine lettuce hearts.  Product tested as part of the FDA's random testing program was found to be positive for Salmonella.  No illnesses have been reported.

Fresh Express Issues Recall of Limited Quantity of 18 oz. Hearts of Romaine Salad Due to Possible Health Risk

FOR IMMEDIATE RELEASE - October 11, 2012 - Charlotte, North Carolina – Fresh Express Incorporated is conducting a voluntary, precautionary recall of a limited quantity of Fresh Express Hearts of Romaine Salad with a Use-by Date of October 11 and Product Code of S270A24 due to a possible health risk from Salmonella.

No illnesses or consumer complaints have been reported to Fresh Express at this time in association with this recall. No other Fresh Express products are subject to this recall.

The recall notification is being issued out of an abundance of caution based on an isolated instance in which a random sample yielded a positive result for Salmonella as part of the U.S. Food and Drug Administration’s random sample testing program. Fresh Express is coordinating closely with regulatory officials.

Fresh Express customer service representatives are already contacting relevant retailers to confirm the recalled product has been removed from store shelves and inventories and that none is available for consumer purchase. Customers with questions are instructed to contact their Fresh Express customer service representative. The recalled salads were distributed primarily in the West-Northwest and Midwest regions of the U.S.

Consumers who may have purchased the recalled salad are asked not to eat it, but to throw it out instead. Fresh Express is offering a full refund. Consumers with questions or who would like to secure a refund may call the Fresh Express Consumer Response Center at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Daylight Time.
Specific recall information follows:

 Product Being Recalled: Fresh Express Hearts of Romaine in 18 oz. package
Product Code: S270A24 (located in upper right corner on front of package)
Use-by Date: October 11 (also located in upper right hand corner of package)
Distribution: Primarily in West-Northwest and Midwest regions of the U.S. 

Salmonella is an organism that may cause fever, nausea, vomiting, abdominal pain and possibly bloody diarrhea in healthy individuals. It can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Consumers with these symptoms should consult their health care provider.
Fresh Express Precautionary Salad Recall- 10/11/12 (No other Fresh Express Salads are included in this recall)

BRAND PRODUCT NAME SIZE UPC Production
Code
Best If Used
By Date
POSSIBLE DISTRIBUTION
STATES
Fresh Express Hearts of Romaine 18 oz. 071279-262017 S270A24 OCT 11 AZ, AR, CA, CO, HI, ID, KS, LA, MN, MT, NV, NM, ND, OK, OR, TX, UT, WA, WI, WY

###

Monday, October 15, 2012

Dog Biscuits Recalled Due to Possible Salmonella Contamination

Dog Biscuits are being recalled due to possible Salmonella contamination.  There have been no reported illnesses.

 Nature's Recipe Voluntarily Recalls Nature's Recipe Oven Baked Biscuits With Real Chicken Due to Possible Salmonella Contamination
http://www.fda.gov/Safety/Recalls/ucm323823.htm?source=govdelivery

FOR IMMEDIATE RELEASE - October 13, 2012 - Nature’s Recipe brand is voluntarily recalling a limited supply of Nature’s Recipe® Oven Baked Biscuits with Real Chicken, manufactured in one of its U.S. production facilities. This is being done as a precautionary measure, as the product has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products.

Healthy people infected with Salmonella should monitor themselves for some, or all, of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

No pet or consumer illnesses from this product have been reported to date. However, because of its commitment to safety and quality, the Company is conducting a voluntary recall of this product.

The potentially affected lots of Nature’s Recipe Oven Baked Biscuits with Real Chicken were distributed nationally, primarily through pet specialty retailers.

Nature’s Recipe Oven Baked Biscuits with Real Chicken is sold in 19-ounce stand-up resealable pouches. The product affected by this recall is identified below and has the following "Best If Used By" dates:
Lot Code:
UPC Code:
Size:
Product Name/Description:
Best If Used By Date:
2199TP
30521 51549
19-ounces
Nature’s Recipe Oven Baked Biscuits with Real Chicken
10 11 13
2200TP
30521 51549
19-ounces
Nature’s Recipe Oven Baked Biscuits with Real Chicken
10 12 13



Product and product lots that do not appear on the list above are not subject to this recall.

Consumers who have purchased the above lots of Nature’s Recipe Oven Baked Biscuits with Real Chicken should stop feeding the product and discard immediately. For further information about the recall and for instructions on obtaining replacement product, consumers can use the Contact Us form at www.naturesrecipe.com1 or call the Consumer Hotline, 24 hours a day, at 800-237-3856.


About Nature’s Recipe®

Nature’s Recipe®, a brand of Del Monte Foods, markets a complete line of natural dog food and treats and recently introduced a line of natural cat food. Nature’s Recipe® has been making better pet food where “Every Ingredient Counts® ” for more than 30 years. For additional information about Nature’s Recipe®, visit www.naturesrecipe.com2. 

Sunland Recall Expands Again, Now Includes In-shell Peanuts

The Sunland Food Recall was once again expanded to include in-shell peanut products produced at their Peanut Processing Facility.  This expansion was done as part of the on-going investigation.  According to the CDC, there have been 35 illnesses linked to the Trader Joe brand of peanut butter.(http://www.cdc.gov/salmonella/bredeney-09-12/index.html).  No other products have been found to have caused illness, so the expansion of the recall is due to what investigators are discovering in the two plants.

Other companies also continue to recall products with products supplied by Sunland. (below)
 
Sunland, Inc. Announces Voluntary Extension of Ongoing Recall To Include Raw and Roasted Shelled and In-Shell Peanuts Due to Possible Health Risk
http://www.fda.gov/Safety/Recalls/ucm323824.htm?source=govdelivery


FOR IMMEDIATE RELEASE - October 12, 2012 - Sunland, Inc. today announced that it is extending its ongoing voluntary recall to include raw and roasted shelled and in-shell peanuts processed in its Peanut Processing Plant because the products have the potential to be contaminated with Salmonella. Specifically, the recall is being extended to include raw and roasted peanuts, both in-shell and shelled, which were processed in its Peanut Processing Plant located in Portales, New Mexico, and which are within their current shelf life or have no stated expiration date.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and those with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The original recall initiated by the Company on September 24, 2012, included peanut butter and other nut butter products produced in a separate building from where raw and roasted peanuts are processed. The reason for the initial voluntary recall was the potential for the recalled products to be contaminated with Salmonella. At that time, twenty-nine (29) people had reported Salmonella Bredeney PFGE matching illnesses in approximately eighteen (18) states, and of those who had been interviewed at that time, twelve of fourteen reported having eaten the same single product made by the Company. Since the recall was announced, additional confirmed illnesses have been reported. As of October 5, 2012, the total number of confirmed illnesses reported was thirty-five (35). The most current information available from the Centers for Disease Control and Prevention (CDC), regarding confirmed illnesses is available at their website: http://www.cdc.gov/salmonella/bredeney-09-12/index.html1

The extension being announced today is the result of the continued joint investigation by the Company and FDA. The Company has ceased the production and distribution of all products from both its Peanut Butter Plant and its Peanut Processing Plant while FDA and the Company continue their investigation.

The raw and roasted peanuts available to retail customers were distributed primarily under the Company’s own label and were distributed primarily to produce houses and nationally to numerous large supermarket, grocery and retail chains. The products also were available for purchase on the internet. The roasted and roasted/salted peanuts being recalled were distributed during the six month period prior to the recall date (April 12, 2012 – October 12, 2012), and will have best by/expiration dates on the packaging from October 12, 2012 through April 12, 2013. The raw peanuts being recalled (shelled and in-shell), were distributed during the twelve months prior to the recall date (October 12, 2011 – October 12, 2012), and will have either best by dates from October 12, 2012 through October 12, 2013 on the packaging, or a “Crop Year” marking on the package of 2011 or 2012, up to and including October 12, 2012.

Consumers who have purchased any of the recalled products are urged not to eat them and to return products to the place of purchase for a full refund or dispose of them immediately. The “Best-If-Used-By” date or product expiration date is printed on the packaging. The UPC used to identify the recalled products is located below the bar code on all products. In-shell peanuts that were sold in 2, 5 and 10 pound mesh bags (raw, roasted and salted/roasted), do not include an expiration date on the mesh bags. All such products should not be eaten and should be returned to the place of purchase for a full refund or disposed of immediately. All expired products should be discarded. Customers who purchased products directly from the Company’s website should discard the products and contact the Company at 1-866-837-1018.

Consumers can contact the Company at 1-866-837-1018 for information on the recall. This toll-free number is operational 24 hours a day.

The recall is being conducted in cooperation with the United States Food and Drug Administration (FDA). The most current information available from FDA is posted at the following website: http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm320413.htm2

The specifics of the affected products are set forth below. Products being added to the list for the first time appear in the first table. All previously identified products follow in the second table.

Creative Energy Foods, Inc. Recalls Ridgebar Brand Nutrition Bars Due to Possible Health Risk Associated With Sunland Inc. Peanut Products
http://www.fda.gov/Safety/Recalls/ucm323818.htm?source=govdelivery

Due to Sunland Peanut Butter Recall, AdvancePierre Foods Initiates Voluntary Recall of Select Frozen Peanut Butter Products
http://www.fda.gov/Safety/Recalls/ucm323800.htm?source=govdelivery

Lin-Mar Partners Recalls Roasted Peanut With Chocolate and Peanut Butter Trail Longhorn Bars Because of Possible Health Risk
http://www.fda.gov/Safety/Recalls/ucm323803.htm?source=govdelivery

Purefit Inc. Announces Voluntary Recall of Purefit Peanut Butter Crunch Bars Because of Possible Salmonella Contamination
http://www.fda.gov/Safety/Recalls/ucm323825.htm?source=govdelivery

General Mills Voluntarily Recalls Limited Number of Cascadian Farm Snack Bars Containing Peanuts
http://www.fda.gov/Safety/Recalls/ucm323308.htm?source=govdelivery

Friday, October 5, 2012

Sunland Foods expands recall in light of Salmonella positive envrionmental samples

The peanut butter recall expanded again as Sunland Foods is recalling all products made in its manufacturing plant after March 1, 2010. The initial recall was started when peanut butter made for Trader Joe's was linked to a Salmonella outbreak. That outbreak includes 35 illnesses in 19 states.

The expanded recall includes close to 240 different products and encompasses 2 ½ years of production. The decision to expand the recall comes after investigators found Salmonella in the processing environment as well as in the product.  Impacted retailers now include Safeway, Target, and Whole Foods.

Why would the recall be expanded? After doing the sampling/testing of the processing environment, the FDA determined that the facility had a contamination issue in the facility as evidenced by the positive environmental samples. To push the recall so far back in time may be due to the fact there were inadequate controls in place to control Salmonella - including proper sanitation of the processing environment and environmental monitoring systems demonstrating control.

 As we know, Salmonella can exist for long periods of time in dry environments. If there is no evidence, or inadequate evidence, that the processing environment was properly cleaned over time and there was inadequate evidence that monitoring/testing was completed to verify that cleaning, they may have concluded that there is the potential risk of more products being contaminated over a longer period of time. A case of ‘how do you know?’. One can see the questions being asked during an investigation such as this – how do you know this contamination wasn’t here for a long time? How do you know that employees were properly cleaning? How do you know the right concentration of sanitizer was being applied? How do you know that the cleaning being done was actually controlling Salmonella? This is where record keeping and verification procedures are critical. A little paranoia also helps.

FDA records indicate that in 2010, an investigation found "objectionable conditions", but these were not significant enough to warrant action.

 Sunland, Inc. Announces Voluntary Expansion of Ongoing Recall To Include All Products Manufactured in its Peanut Butter Plant After March 1, 2010 Due to Possible Health Risk
http://www.fda.gov/Safety/Recalls/ucm322747.htm?source=govdelivery

FOR IMMEDIATE RELEASE – October 4, 2012 – Sunland, Inc. today announced a voluntary expansion of its ongoing recall of all products manufactured in its Peanut Butter Plant because the products have the potential to be contaminated with Salmonella. Specifically, the recall is being expanded to include all products manufactured in its Peanut Butter Plant after March 1, 2010.The scope of the initial recall covered one hundred one (101) products manufactured between May 1, 2012 and September 24, 2012. The expanded recall adds forty-nine (49) products that are currently within the manufacturer’s recommended shelf-life, that is, the “Best-If-Used-By” dates have not expired. The expanded recall also adds ninety (90) products consumers may still have in their homes which are older than the “Best-If-Used-By Date”. Distribution of many of the products being added to the recall was discontinued some time ago. The expanded recall covers all previously identified Peanut Butter, Almond Butter, Cashew Butter, and Tahini products as well as Roasted Blanched Peanut Products. New product categories being added to the list are several varieties of flavored butters and spreads, including Thai Ginger Butter, Chocolate Butter and Banana Butter.

The Company is voluntarily expanding the recall to cover all products manufactured in its Peanut Butter Plant since March 2010 because the products have the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and those with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Symptoms of Salmonella infection include diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in some cases, the diarrhea may be so severe that the patient requires hospitalization. Older adults, infants and those with impaired immune systems are more likely to have a severe illness from Salmonella infection.

Tuesday, October 2, 2012

Popcorn Recalled Due to Listeria

Dale and Thomas are recalling various brands of flavored popcorn after the company discovered Listeria through finished product testing.

 A discussion this morning prompted a review of how Listeria could become an issue in popcorn. In general, we would not consider Listeria a hazard in popped or unpopped popcorn. But based on pure conjecture, we would focus on the flavoring used. First, we would assume that the popcorn itself would not be an issue. The temperature used to pop the corn would eliminate Listeria - approximately 181C (357F) to 187C (369F) (Kinetics of Popping Popcorn, Byrd and Perona, 2005). The Listeria issue would be related to the enrobing or coating process, specifically related to the ingredients they are using. Looking at the ingredients for one of the products (below), Aged White Cheddar, there are ingredients that we would consider higher risk, specifically cheese and butter milk, in that these could serve as a growth medium for Listeria. However, once these ingredients are mixed and then enrobed on the popped kernel surface, growth would be unlikely. Other ingredients such as caramel would not likely be an issue.  Being that the cheddar and buttermilk are probably dry and are probably added as a dry mixture, areas where water are introduced increase risk.  This can be residual moisture from cleaning, or water used in and around the flavor mixing process.  Of course if the flavor mix uses added water, then handling from mixing through enrobing is more an issue.








So controlling Listeria would be prior to and including the enrobing step as well as within the post-popping environment – 1) purchasing higher risk ingredients (cheese and buttermilk) with assurance that are they are Listeria free, 2) properly storing and handling these ingredients to prevent contamination, 3) cleaning and sanitizing the mixing kettles, the enrobing equipment and all transfer pipes of enrobing mixture, 4) properly cleaning finished product transfer to packaging equipment and 5) maintaining a clean environment after the heat process.  

One would focus testing efforts on conducting Listeria monitoring through the use of a sponge sampling on the flavor mixing, enrobing, and packaging equipment as well as in the post-process environment. If a niche (a spot where there was product build-up) existed somewhere from the enrobing through packaging, it would unlikely support growth of Listeria, but if it the organism was present in the enrobing mixture at the start, it could get hung up in that post-heat processing equipment and then serve as a contamination source for finished product moving through. The key however, would be the control of high risk ingredients, - specifically their purchase, receipt, storage and handling.

In addition to Listeria as a hazard, Salmonella would be considered another important pathogen that would be considered a hazard.

 

Dale and Thomas Popcorn Issues Voluntary Recall of Certain Popcorn Products Due to Possible Health Risk

SOURCE Dale and Thomas Popcorn

ENGLEWOOD, N.J., Sept. 28, 2012 /PRNewswire/ -- Dale and Thomas Popcorn is voluntarily recalling a limited number of ready-to-eat bags of select flavors of Popcorn, Indiana-brand popcorn products (listed below) because of possible contamination by Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in 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 infection can cause miscarriages and stillbirths among pregnant women. Anyone who is concerned about a possible health problem or illness should contact a healthcare provider immediately.

Products involved in the recall should not be consumed and may be returned to the point of purchase for a full refund or replacement.

The recalled products were distributed to various retailers, vendors, distribution centers, and consumers through the Internet on or after August 8th, 2012 with Best By dates of February 4th, 2013 through March 12th, 2013. All recalled products were packaged in red bags of various sizes. Consumers can identify if they have purchased an impacted product by looking at the Best By date located in the front, top right corner of the package and the Bag UPC (Code) located in the nutritional panel found on the back, bottom left corner of the package.

(Photo:
http://photos.prnewswire.com/prnh/20120928/NY83405 )

All other Popcorn, Indiana-brand products are safe to consume. 

The potential for contamination was noted after testing by the company revealed the presence of Listeria monocytogenes in some ready-to-eat bags of Popcorn, Indiana-brand products.

Consumers with recalled product(s) should contact Dale and Thomas' dedicated recall hotline (866) 940-7936 Monday through Friday 9:00 a.m. to 4:30 p.m. Eastern Time, or email the company at:
recall@daleandthomaspopcorn.com for additional information.

Recalled Flavors - Aged white cheddar, Almond Biscoitti, American Cheese, Apple Crisp, Bacon Ranch, Black and White Drizzle, Caramel, Chocolate Roasted Peanuts, Cinnamon Sugar Drizzle, Dark Fudge Chocolate Chip Drizzle, Kettlecorn, Kettlecorn Multipack, Salat and Pepper, Wasabi



FDA News Release
Dale and Thomas Popcorn Issues Voluntary Recall of Certain Popcorn Products Due to Possible Health Risk

http://www.fda.gov/Safety/Recalls/ucm321955.htm

Monday, October 1, 2012

Peanut Butter Recall Continues to Expand

The Sunland peanut butter recall that was linked to the Trader Joe’s Peanut Butter Salmonella outbreak continues to expand. Sunland is recalling about 100 different products. This has also triggered other recalls where companies have used this product as an ingredient. To date, only the Trader Joe’s product has been linked to illnesses. From the FoodSafety.gov website – 
Sunland, Inc. today announced an expansion of its voluntary recall of its Almond Butter and Peanut Butter, to include its Cashew Butter, Tahini and Roasted Blanched Peanut Products. This recall is limited to products manufactured between May 1, 2012 and September 24, 2012.
While there has been no word as to the direct cause, we know that Salmonella has been a troublesome issue for nut based products. For one, Salmonella is much more heat resistant in dry products. While in moist products such as meat and bread, Salmonella can be eliminated with lower temperatures. In dry products such as nuts, temperatures in the 230F range are needed. So there have been issues with nut processors under-processing nuts resulting in Salmonella contaminated product. Another issue is that Salmonella can survive in dry environments for extended periods of time. So if Salmonella contaminates the process environment, it can remain there for months. Being around for a long time, Salmonella can then have extended opportunity to contaminate the product. Facilities can have a difficult time eliminating Salmonella contamination once it gains a foothold in a processing plant.

So why does this recall continue to expand?    If they can't decisively link the contamination to one lot of product, it will mean there is the possibility that more product may be contaminated.  So out of abundance of caution, companies will recall any products that were made in this facility, whether as an ingredient or as a finished product. This includes all products, both nut and seed based items. The latest recalls include peanut butter crackers and Crisp Mix.  (See Below)

If consumers have any of the recalled product, they should either dispose of the product or return to the store where they purchased it.


Peanut butter recall linked to salmonella illnesses now includes major retailers
By Associated Press, Updated: Monday, October 1, 11:57 AM Printed in Washington Post.comhttp://www.washingtonpost.com/politics/peanut-butter-recall-linked-to-salmonella-illnesses-now-includes-major-retailers/2012/10/01/603224be-0bdc-11e2-97a7-45c05ef136b2_story.html

WASHINGTON — A New Mexico company has expanded its recall of peanut butter and almond butter to include cashew butters, tahini and blanched and roasted peanut products.

Sunland Inc. sells its nuts and nut butters to large groceries and other food distributors around the country. The company recalled products under multiple brand names after salmonella illnesses were linked Trader Joe’s Creamy Salted Valencia Peanut Butter, one of the brands manufactured by Sunland.

The federal Center for Disease Control and Prevention says there are now 30 illnesses in 19 states that can be traced to the Trader Joe’s peanut butter. No other foods have been linked to the illnesses, but Sunland recalled other products manufactured on the same equipment as the Trader Joe’s product.

In addition to Trader Joe’s, the recall includes nut products sold at Whole Foods Market, Target, Fresh & Easy, Giant Food, Harry and David, Stop & Shop Supermarket Company and several other stores. Some of the stores used Sunland ingredients in items they prepared and packaged themselves.

Brand names recalled include Archer Farms, Earth Balance, Fresh & Easy, Late July, Heinen’s, Joseph’s, Natural Value, Naturally More, Open Nature, Peanut Power Butter, Serious Food, Snaclite Power, Sprouts Farmers Market, Sprout’s, Sunland and Dogsbutter, among others.

Sunland’s recall includes 101 products, and several retailers have issued additional recalls including items made with Sunland ingredients.

Those sickened reported becoming ill between June 11 and Sept. 11, according to the CDC. Almost two-thirds of those who became ill were children under the age of 10. No deaths have been reported.

Salmonella can cause diarrhea, fever and abdominal cramps 12 hours to 72 hours after infection. It is most dangerous to children, the elderly and others with weak immune systems.



FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Possibly Linked to Trader Joe's Valencia Creamy Salted Peanut Butter
Posted September 30, 2012 http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm320413.htm

The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multi-state outbreak of Salmonella Bredeney infections. We are moving quickly to learn as much as possible and prevent additional people from becoming ill. We recognize that people will be concerned about this outbreak, and we will continue to provide updates and advice.