FDA Enforcement Actions - December 2015

In the FDA's record of Enforcement Actions for December of 2015, there are a few product issues that were not identified in the public notice for recalls.  Included are sugar products for metal, frozen beans for Listeria, bottled juice for patulin, and peanut butter for metal.

For the full listing, use this link.

Deer Parts Removed from PA Restaurant During Inspection

A restaurant in Lititz, PA was found to have a large amount of deer parts including heads and brains.  In a joint investigation, the Pennsylvania Game Commission and  PA Dept of Ag removed this - "Amount of parts removed included: 4 trash bags, 2 boxes, 3 plastic tubs, one 5 gallon bucket and 9 trash bags of prepared foods."  The owner indicated that it was for his own consumption.

 The inspection was completed after a confidential tip was made to the authorities.  It is not legal to sell meat from wild game animals.  Having deer heads and brains in the establishment is also a risk for CWD - chronic wasting disease.

In addition, inspectors found numerous violations.

  

PennLive.com

http://www.pennlive.com/news/2015/12/deer_brains_heads_parts_confis.html

Deer brains, heads, parts confiscated from Chinese restaurant: Ag department inspection

  

The Pennsylvania Game Commission is investigating a large quantity of deer heads, brains and other, unidentifiable parts found at the New China House restaurant in Lititz Dec. 16, according to an agriculture department inspection report, but the eatery remains open.

 

The restaurant, at 721 S. Broad St., was listed as "out of compliance" by the state Department of Agriculture after an inspector Dec. 16 found 18 violations, including the following:

 

"PA Game Commission confiscated the following from facility walk-in cooler and freezer after operator was unable to provide documentation that game animal meats being used in the facility were from an approved source: deer brains, deer heads, skinned and whole tails, legs, muscle meat, spines, necks and other unidentifiable parts both raw and cooked. Amount of parts removed included: 4 trash bags, 2 boxes, 3 plastic tubs, one 5 gallon bucket and 9 trash bags of prepared foods. In addition, sampling of prepared food found in walk-ins were taken to be tested for species identification."

 

Cucumbers Recalled in GA and FL Due to Potential for Salmonella Contamination

A Florida produce company is recalling cucumbers after a random sampling and testing conducted by FDA produced a positive Salmonella result.  No illnesses have been reported.  Product was distributed in Florida and Georgia.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm479661.htm
Recall: Firm Press Release
Thomas Produce Recalls Cucumbers because of Possible Health Risk
For Immediate Release


December 31, 2015
Contact
Consumers Richard Wilson   1-561-482-1111
Firm Press Release

Thomas Produce Company of Boca Raton, FL is recalling 174 bulk-packed containers of Cucumbers. This product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella may experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain.

This product was sold to distributors in Florida and Georgia between 12/15/2015 and 12/16/2015. All distributors that received this product have been notified as of the time of this press release.

Boneless Pork Rib Entree Recalled for Foreign Material

An Ohio company is recalling boneless pork rib entrée products after receiving consumer complaints about glass or hard plastic.  Close to 300,000 pounds of Boston Market branded product spanning approximately 4 months of production are included in the recall.  There have been no reported injuries to date.

USDA Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-149-2015-release
Bellisio Foods, Inc. Recalls Boneless Pork Rib Frozen Entree Products Due To Possible Foreign Matter Adulteration
Class II Recall 149-2015
Health Risk: Low Dec 22, 2015

En Español
Congressional and Public Affairs
Kristen Booze
(202) 720-9113 

WASHINGTON, Dec. 22, 2015 – Bellisio Foods, Inc., a Jackson, Ohio establishment, is recalling approximately 285,264 pounds of boneless pork rib shaped patty frozen entree products that may be adulterated with extraneous materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Boston Market Boneless Pork Rib Shaped Patty with BBQ Sauce and Mashed Potatoes frozen entree items were produced on various dates between Sept. 09, 2015, and Dec. 14, 2015. The following products are subject to recall: [View Label (PDF Only)]
14-oz. boxed packages containing “Boston Market Home Style Meals Boneless Pork Rib Shaped Patty with BBQ Sauce and Mashed Potatoes” with Use By dates 09/09/2016; 09/22/2016; 10/08/2016; 10/30/2016; and 12/14/2016.

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.

A Second Outbreak of E. coli Associated with Chipotle is Being Investigated

The FDA and CDC are investigating a second outbreak of a different Shiga toxin-producing Escherichia coli O26 (STEC O26) that is being linked to Chipotle Mexican Grill restaurants during December 2015. Based on DNA fingerprinting, this outbreak is different that a larger E. coli outbreak which occurred in November as was primarily located in the northwestern part of the country (53 people in 9 states).   To this point, 5 people have become infected in this second outbreak. 

Unfortunately, most of the corrective actions for system improvements probably came after this second outbreak occurred.  But a point many have made is that more should have been done sooner.  Delayed reaction, due in part to an underestimation of the event, allowed more issue to occur in the meantime.  This now looks bad in that more issues are popping up after the big proclamation of a company wide food safety enhancement.

An interesting point in the NY Time article below is that there has been difficulty in tracking because of record keeping.

FDA Outbreak News Release
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm470410.htm
FDA Investigates Multistate Outbreak of E. coli O26 Infections Linked to Chipotle Mexican Grill Restaurants

December 22, 2015
On this page:

• Update
• What is the Problem and What is Being Done About It?
• What are the Symptoms of E. coli O26?
• Who is at Risk?
• What Do Consumers Need To Do?
• Who Should be Contacted?
• Additional Information

The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of E. coli infections.
Update: December 22, 2015

• The FDA, CDC, and state and local officials are investigating a second, more recent outbreak of a different, rare DNA fingerprint of Shiga toxin-producing Escherichia coli O26 (STEC O26) linked to Chipotle Mexican Grill restaurants.
• The CDC reports that five people have been reported with the new variant of STEC O26 from a total of three states: Kansas (1), North Dakota (1), and Oklahoma (3).
• The Kansas and North Dakota cases ate at the same restaurant in Kansas. The three separate Oklahoma cases all ate at the same Chipotle restaurant.
• As of December 18, 2015, 53 people infected with the previously reported outbreak strain of STEC O26 have been reported from nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (2), and Washington (27).
• The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of both outbreaks.
• The investigations are still ongoing to determine what specific food is linked to illness. .

FDA Concerned About Caffeinated Peanut Butter

Why put caffeine in peanut butter?   What are the risks?  That is what FDA is questioning about Steem Caffeinated Peanut Butter.  There is a 150MG per serving (2 tablespoons) which is equivalent to a 12 oz cup of coffee.   That can potentially be a lot of caffeine especially if you couple eating the peanut butter with drinking a cup of coffee.

FDA Web Site
http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm476361.htm
Added Caffeine in Peanut Butter
FDA Statement on Added Caffeine in Peanut butter
December 17, 2015

The FDA is concerned about the marketing of a peanut butter, a food popular with many children, containing added caffeine. The company has indicated in recent media reports its desire to behave responsibly, but has not submitted to the FDA any information about the safety of its use of caffeine in its peanut butter product. On Tuesday December 15, 2015 the FDA sent a letter to the company, STEEM Peanut Butter, Inc., requesting they provide us with information about their use of caffeine in peanut butter. This information will help us determine whether their product meets applicable scientific and legal standards for the lawful sale in the U.S.

USDA Finalizes Rule on Record Keeping for Ground Beef

USDA finalized its rule for record keeping requirements for retail and USDA regulated establishment needed for grinding ground beef.  Under this rule, FSIS will require that all official establishments and retail stores that grind raw beef products maintain these records:

• The establishment numbers of establishments supplying material used to prepare each lot of raw ground beef product;
• All supplier lot numbers and production dates;
• The names of the supplied materials, including beef components and any materials carried over from one production lot to the next;
• The date and time each lot of raw ground beef product is produced;
• The date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized.

These requirements also apply to raw beef products that are ground at an individual customer’s request when new source materials are used.

 

 

USDA News Release

http://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2015/nr-121415-01

USDA Finalizes Rule to Enhance Consumer Protection, Ensure Retailers Can Track Sources of Ground Meats

 

Congressional and Public Affairs  Josh Stull, (202) 720-9113

 

WASHINGTON, Dec. 14, 2015 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced a new measure that will improve the agency’s ability to determine the source of foodborne illnesses linked to ground beef, stopping foodborne illness outbreaks sooner when they occur. Based on lessons learned from previous outbreak investigations, FSIS is requiring that all makers of raw ground beef products keep adequate records of the source material, so that the agency can quickly work with the suppliers to recall contaminated product.

Beverage Drinks Recalled Due to Potential Bottle Breakage

Trader Joe's is recalling its Triple Ginger Brew product due to  'reports of unopened bottles potentially bursting."   This bottle uses a swing cap closure which is anchored into the glass.  If the product in the bottle becomes contaminated - either before closure or afterwards due to a poor seal (which can be the case if that rubber seal isn't seated properly against the glass during closure), then when that contamination grows, most likely in the form of yeast, the pressure formed due to the gas produced has a more difficult time releasing because of the metal clamp holding the cap down.

Another issue is when someone opens the bottle, takes a swig, and then clamps the lid shut.  They put the bottle on the counter and forget about it.  The problem is that they have introduced yeast into the bottle and those yeast go to town....multiplying and producing gas.  Again, with a clamp anchored into the glass, that pressure has no way to go but boom.

These closures are cool, popularized by Grolsh Brewery as well by home brewers who use this type of bottle with 'swing-cap-closure' because of ease of closing the bottle.  So it is easy to see why a commercial product trying to capture that 'home brewed' look would use this bottle.  But it appears now it may not have been a good choice for a product such as this.  If the cap cannot come off easily do to potential spoilage issues, then it probably shouldn't be used.

 


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm477562.htm
Trader Joe's Issues Voluntary Recall of Triple Ginger Brew
For Immediate Release
December 15, 2015