GAO Finds FDA Technical Assistance Network (TAN) Response Times Slow

The US Government Accountability Office (GAO) found that FDA's Technical Assistance Network (TAN), a system for answering questions regarding FSMA regulations including the produce rule, has been slow in responding to questions.

From the report:

"We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN."

While FDA is working on reducing the response times, there are questions that are not as easy to answer.  In some cases, the rule is still under development or the questions are more complex.

".....according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved."

These rules are new for many including the FDA, and many components of the rule have not yet been worked out for every permutation  So while delays in response times are completely understandable, I think that FDA officials and their surrogates need to acknowledge this when suggesting people go to the TAN for answers.  And considering that FDA technical support staff have a hard time answering these questions, this needs to be taken into account when inspectors are doing facility inspections.

GAO Release
http://www.gao.gov/products/GAO-17-98R
Food Safety:
FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule
GAO-17-98R: Published: Nov 28, 2016. Publicly Released: Nov 28, 2016.

Three Recalls of Cooked Meat Products After Customers Complained of Undercooked Appearance

In the past few weeks, there have been three recalls of cooked meat products after customers/consumers complained that the product appeared to be undercooked.  The recalls were for firms located in OK, GA, and MO.  It is interesting in that these companies must have not been able to demonstrate that the suspect products had been properly cooked, and thus, they felt the need to do a recall.

Of course if the meat had not been fully cooked, there is the potential for pathogens such as Salmonella.


http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-115-2016-release
National Steak and Poultry Recalls Food Service Ready-To-Eat Chicken That May Be Undercooked
Class I Recall115-2016
Health Risk: HighNov 23, 2016

Pumpkin Ice Cream Pies Recalled Because Peanut Ingredient Not Listed on Label

A Buffalo NY establishment, Anderson's Frozen Custard, is recalling Pumpkin Ice Cream pies because the product which contains peanuts did not list peanuts on the label.  So it was an undeclared allergen issue.

http://www.fda.gov/Safety/Recalls/ucm530645.htm
Anderson’s Frozen Custard issues Allergy Alert on Undeclared Peanuts in Pumpkin Ice Cream Pies
For Immediate Release
November 22, 2016

A 2015 Thanksgiving Luncheon Becomes Scene for C. perfringens Outbreak - A CDC Report

With Thanksgiving leftovers still in the fridge, it is a good time to review a 2015 outbreak that occurred during a Thanksgiving luncheon.  About 40 people who attended a catered company Thanksgiving lunch became ill with diarrhea and abdominal pain the following day (roughly 13 hours later).  C. perfrignes entrotoxin was found in the patient stool samples and C. perfrigens was isolated from the turkey as well as the patients.

According to the CDC report "The caterer had previously maintained a permitted facility, but reported having prepared the lunch food served at this event in an uninspected, residential kitchen. Turkeys were cooked approximately 10 hours before lunch, placed in warming pans, and plated in individual servings. Food was then delivered by automobile, which required multiple trips. After cooking and during transport, food sat either in warming pans or at ambient temperature for up to 8 hours. No temperature monitoring was conducted after cooking."

C. perfringens toxicoinfection is a foodborne illness caused by ingestion of toxin-producing bacteria where then the organism produces the toxin in the gut.  This type of foodborne illness is often associated with consumption of meat that has been improperly prepared and handled.

So store your leftover turkey at the proper temperatures (either below 40F or hot, above 140F).


Notes from the Field: Clostridium perfringens Gastroenteritis Outbreak Associated with a Catered Lunch — North Carolina, November 2015
Weekly / November 25, 2016 / 65(46);1300–1301

Sabra Hummus Recall Leads to Secondary Recalls

Greencore and Sky Chefs are recalling prepared sandwiches that were made with the recalled Sabra hummus.  Sandwiches were delivered to 7-Eleven stores in various markets including Pittsburgh, PA.

Taylor Farms is recalling various veggie trays and boxes that contain the Sabra humus.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm530607.htm
National Recall by Sabra Dipping Company Leads to Secondary Recall of Deli Sandwich in Pittsburg (PA), Cleveland (OH) and Buffalo (NY) Markets
For Immediate Release
November 23, 2016

Sabra Hummus Recalled Due to Listeria Discovery in Processing Facility

Sabra of Colonial Heights, VA is recalling hummus products, about 50 SKUs in all, after finding Listeria monocytogenes in their facility.  The product being recalled is all product manufactured before November 8, 2016 (Coded “Best Before” date up through January 23, 2017).   The statement says that product had not tested positive, but there is probably a concern of where they found it in the facility.

With what appears to be a shelf-life of 75 days, there is probably over 2 months of production potentially in the marketplace or in consumer's refrigerators.  As a ready-to-eat product, there can be significant risk if the organism is present, so it is important to dispose of product.

According to the FDA investigation...."27 swabs of the processing environment that contained Listeria monocytogenes. Analysis by pulse-field gel electrophoresis (PFGE) revealed that one of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment."

Sabra had another recall in 2015 when a positive product sample was found. Another company recalled hummus product in 2014.  Finding the same Listeria strain in the environment is a concern, and especially the large number of samples.
 
FDA Recall Noticehttp://www.fda.gov/Safety/Recalls/ucm529967.htm
Sabra Dipping Company Issues Voluntary Recall Of Certain Hummus Products Because Of Possible Health Risks
For Immediate Release
November 19, 2016

Worcestershire Sauce With Soy - Lots of BBQ Pork Recalled Due to Missing Allergen on Label

A North Carolina company is recalling over 200,000 lbs of pork BBQ after discovering an allergen mislabeling issue - soy was not declared on the label although it was used in the recipe in the form of
Worcestershire Sauce.  The issue was discovered by FSIS inspection personnel.

Worcestershire sauce contains many different ingredients and those ingredients can differ depending upon the manufacturer.  Normally, it contains anchovies, which is a fish allergen, but not always soy.  In this case, the soy was listed in as part of the flavorings. The Lea & Perrins brand from Heinz, which is considered the authentic Worcestershire Sauce, does not list soy as a component.

USDA Recall Notice
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-108-2016-release
Morty Pride Meats, Inc. Recalls Pork Barbeque Products Due To Misbranding and Undeclared Allergens

Class II Recall 108-2016

Health Risk: Low Nov 17, 2016

FDA Phone Survey Finds that Food Safety Knowledge Among Consumers Still Lacks

 FDA conducted a phone survey of consumers to gain an understanding of food safety knowledge and attitudes.  Phone surveys can be sketchy, so it is always important to review results with some skepticism.  Here are a few of the results that are interesting:

1. While the majority people owned a thermometer, not many people actually used them, especially on products where thermometer use would be most helpful - when cooking hamburgers (only 10%) and cooking chicken (19%).
2. Not everyone washes their hands - 15% surveyed don't when handling raw meats and 25% don't wash their hands before preparing food.
3. But it is interesting that about half the people think that they are more likely to get foodborne illness when eating out rather than in the home. 

Food Safety Survey Shows Consumer Knowledge Up, Still Room to Grow

November 17, 2016

Cheese Company Owner Sentenced 15 Months in Prison for Shipping Listeria Contaminated Cheese

The owner of a cheese company was sentenced to 15months in prison for knowingly shipping Listeria contaminated cheese.  The issue started in 2014 when Virginia regulatory officials found Listeria in the company's cheese products.   This triggered an FDA investigation which found numerous unsanitary conditions and additional products with Listeria.  While the owner agreed to clean his operation and recall product, he still went ahead and shipped product.

WFTV.com
http://www.wftv.com/news/local/florida-man-gets-15-months-for-selling-south-american-cheese-products-tainted-with-listeria/467770021
Florida man gets 15 months for selling South American cheese products tainted with listeria
Updated: Nov 16, 2016 - 11:36 AM