Warning Letter Issued to WA State Frozen Food Processor Responsible for Listeria Related Recall

FDA issued a warning letter in response to Oregon Food Company correction of inspection items as part of the Listeria recall of frozen produce.  A few things to note 1) the number of the issues the facility had in the inspection and the fact that they had a pretty big Listeria issue, and 2) their responses were rejected because while the facility addressed items they had to fix, they did not show that the fixes actually worked and that they implemented procedures for ongoing verification.  This is a good lesson in the issues that the plant faced, but also in how to, or how not to, respond to a FDA 483 report.
 
First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer).  These samples were linked via Whole Genome Sequencing to clinical isolates.  While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions."  So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.

 

On GMP issues, the facility was found to be not as clean as it should have been.  While the plant indicated it trained the employees, FDA found the response lacking.  ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."

 
The facility had many condensation issues, which is not good from controlling Listeria.  While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment."

 

The facility had poorly made food contact surfaces that would provide harborage.  While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "

 

In addition, there were steam ventilation issues and general facility issues.  Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.

 

 

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512776.htm

Oregon Potato Company 7/15/16

 

Organic Cheese Products Recalled After Linked to E. Coli Outbreak

Grassfield Cheese Company is recalling organic cheese products sold in Whole Foods and its own store in MI after the product was linked to an E. coli STEC outbreak where 7 people become ill.  Product was shipped into the Southeast and Midwest.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm514967.htm
Grassfields Cheese Recall Affects Select Whole Foods Market Locations; Grocer Recalls Product from Cheese Departments

Contamination Rates on Cucumbers, Hot Peppers, and Raw Milk Cheese from FDA Sampling

FDA released testing results for 3 commodity items they have been testing - Cheese made from raw milk and aged for 60 days, cucumbers, and hot peppers.

While the testing is still ongoing, the results they have to date:
Aged raw milk cheese - 1606 samples in 2014 and 2015, less than a one percent contamination rate for Salmonella, Listeria monocytogenes, E. coli O157:H7 and Shiga toxin-producing E. coli., and the overall contamination rate for generic E. coli was 5.4 percent.  (See chart below)

Hot peppers -  452 samples taken with 13 of those samples positive for Salmonella (2.8% ) and no samples were positive for STEC E. coli.

Cucumbers - 352 samples  taken with 3 of those samples positive for Salmonella (0.8%) and no samples were positive for STEC E. coli

Surprising...not so much for the produce.  Hot peppers and cucumbers grow near or on the soil and are subject to contamination from soil and animals such as birds.  Hopefully, and this is a good reminder, these items should be washed before consumption in order to reduce the risk. Peeling and other processing steps will also reduce or eliminate the contamination.  And it is also important to remember that just because the organism is there, it doesn't mean someone will get sick. Something the contamination is sufficiently low that a person's immune system will handle it, or the specific species found may not be overly virulent.

 As for cheese, this is going to be eaten as is, so this may be a bit more concerning.  Here, you are relying on the producing company to have good practices in place.  So raw milk cheese can be a risk, although low.


FDA News Release
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm512225.htm
FDA Shares Completed Survey and Data from Ongoing Sampling Program

Revised - Recall Of Turmeric Spice Due to Elevated Lead Levels

Update - Aug 5  GelSpice and JM Exotic expands recalls for turmeric due to lead levels.


Update - Aug 2.  JM Exotic Foods, Inc. is recalling ground turmeric because samples from our supplier were found to contain elevated levels of lead.
Gel Spice, an "importer and manufacturer of spices, seeds, bakery ingredients and specialty items, is recalling turmeric after the State of NY found elevated lead levels. Evidently, lead contamination has been an issue in turmeric. There was an issue with turmeric and lead in 2013 as well.

While the U.S. Food and Drug Administration (FDA) has not set a specific limit on lead in spices, there is a limit of 0.1 PPM in candy. The Environmental Protections Agency (EPA) has stated that lead levels of 0.015 PPM in drinking water require treatment.

How does the lead get there? In a Harvard report in 2014 (?), they stated this about one of the main sources for turmeric - Bangladesh ( Pakistan spice was involved in 2013 recall): "The production of turmeric involves many different methods and they explained that it’s possible that the lead contamination could be originating during the manufacturing and distribution of the common spice. There has also been much speculation about the possibility that distributors could be intentionally adding lead to increase the weight of the spice, but the team stressed the point that further study is needed to fully understand the issue."

So when evaluating ingredients for hazards, consider lead as a chemical hazard in turmeric.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm513844.htm
Gel Spice, Inc. Issues Alert on Elevated Lead Levels in One Lot of Fresh Finds Ground Turmeric Powder
For Immediate Release
July 28, 2016

Expanded Frozen Vegetable Recall Points to Poor Recall Procedures

ConAgra announced  an expanded recall of Watts Farms organic frozen vegetable products, these were sold in Costco.  The recall originated back in May as part of the CRF frozen vegetable recall.  According to the notice "As part of ConAgra’s internal recall follow-up procedures, additional package codes were recently identified."  That means that product purchased and used was not identified as part of the recall procedures when CRF made the announcement.   So there were some issues in identifying affected inventory.

An issue like this could be huge if it had been a riskier hazard.  They essentially let affected product out in commerce for an additional 3 months.  Luckily, the contamination levels were low and this is a product that is normally cooked.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm514090.htm
Updated: Additional Package Codes Of Watts Brothers Farms Organic Mixed Vegetables, Organic Super Sweet Corn, and Organic Peas Recalled Because of Possible Health Risk
July 28, 2016

MA Inspector Selling Phony ServSafe Certificates, Allowing Filthy Conditions

A Massachusetts city suspended its inspector after it found that the inspector had been issuing phony ServSafe certificates to establishments.  With this, the city's investigation found that these establishments were nasty with multiple sanitary violations including pests, improperly refrigerated TCS food items, and poor hand washing facilities.  In addition, one facility was selling Viagra and synthetic marijuana. 

Eagle Tribune
http://www.eagletribune.com/news/city-shuts-second-bodega-as-food-safety-investigation-widens/article_525b7a70-a44d-5d94-a5a1-3c995e6784ef.html
City shuts second bodega as food-safety investigation widens
Owner also charged with selling Viagra

NH Firm's Ground Meat Recalled After Linked to E. coli Outbreak Cluster

A New Hampshire establishment is recalling ground beef after that beef was like to a cluster of 14 E. coli O157:H7 infections.  Onset dates ranged from June 15 to July 10, 2016.

With summer grilling season, this is a stark reminder to use a thermometer to ensure doneness of your ground beef.  There is no better way to ensure the adequacy of your grilling process in destroying this awful, harmful pathogen.   You know who you are....go buy a thermometer.

USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-065-2016-release
PT Farm, LLC Recalls Beef Products Due To Possible E. Coli O157:H7 Contamination

Warning Letter Indicates Facility has Same Listeria Strains in Plant for Years

In an FDA Warning Letter recently issued to Resers Fine Foods in relation to investigation conducted around Listeria issues in 2013 and 2016, FDA indicated that they found the same strain in the facility.  This shows the difficulty in getting rid of Listeria in the environment, and the need to continuously control that environment, especially once LM is found.

From that Warning Letter:

"Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental samples (FDA 821317 and FDA 821318) collected during our 2013 inspection revealed L. monocytogenes in six (6) environmental subsample swabs in various locations within your facility, including in floor gaps, wheels of forklift and carts that are moved throughout the facility, and floor drains. Additionally, an environmental sample (FDA 862365) collected during our 2014 inspection revealed L. monocytogenes in two (2) environmental subsample swabs in locations within your facility, including on the wheel of a fork lift and v-mag number.

Whole Genome Sequencing (WGS) analysis was conducted on six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2015, two (2) L. monocytogenes isolates obtained from the FDA environmental samples collected in August 2014, and six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2013. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis found that there are at least three (3) different strains of L. monocytogenes present in the facility. The WGS results show that one (1) of these strains includes isolates that have been found over a period of time. Specifically, four (4) of the environmental isolates collected in November 2015, one (1) of the environmental isolates collected in August 2014, and four (4) of the environmental isolates collected in November 2013, were identical by WGS analysis.

The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since November 2013. The reoccurring presence of identical strains 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.

Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, humans or machinery can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. FDA acknowledges that one of the environmental swabs from the November 2015 inspection that tested positive for L. monocytogenes was taken from a food contact surface used to carry potato salad. As a result of this finding, your firm conducted a voluntary recall on December 1, 2015 of a single lot of potato salad product."

Supermarket Chain Recalls Bakery Items Due to Sugar Contaminated with Metal Pieces

Weiss Markets, a PA based store chain, has recalled bakery products due to the potential for metal fragments that came in with the sugar.  This recall is similar to the ConAgra recall for frozen entrees in that it is the same sugar supplier issue.