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Preventing these issues is the goal of FDA's new draft guidance for Listeria control in facilities that manufacture RTE products.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

FDA Releases Draft Guidance: Control of Listeria monocytogenes in Ready-To-Eat Foods

FDA released its Draft Guidance for the control of Listeria monocytogenes in RTE foods. This document applies to facilities that are subject to the Preventive Controls as well as smaller firms only subject to cGMPs. This document is open for comments before becoming finalized.

This is a necessary read for any FDA regulated company producing RTE product where there is exposure of the product to the environment before packaging. This document discusses control, environmental monitoring, and corrective action. While less prescriptive than the earlier version (it puts more responsibility on the processor for determining risk), it is more aggressive in terms of expected controls and monitoring.

The guidance does differentiate high risk from low risk product (low risk will not support more than one log of growth), and this impacts the monitoring regiment as well as corrective action, although both low risk and high risk product require both monitoring and corrective action.

The guidance discusses product formulating for control of Listeria where that formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and processes that are considered Listeria reduction must reduce by 5 logs.

Environmental monitoring should cover both food contact surfaces (FCS) and non-food contact surfaces (non-FCS) and they recommend Listeria ssp. FDA suggests 5 FCS and 5 non-FCS taken several hours into production. This is more aggressive than doing pre-operational swabs. They suggest a sampling frequency of monthly for low risk products and weekly for high risk products.

There is a lengthy discussion on corrective actions should an environmental sample be found positive, but much of this, as they point out, is dependent upon the particulars of the facility and the product. This passage is important to point out:

"As discussed in section II.C, L. monocytogenes is widespread in the environment, has been isolated from food packing and processing environments, and has been shown to persist in equipment and the processing environment in harborage sites. As a result, you should expect to detect the presence of Listeria spp. or L. monocytogenes on an occasional basis in environmental samples collected from your plant. As discussed in section XIII.A, the goals of an environmental monitoring program include finding L. monocytogenes and harborage sites if present in your plant and ensuring that corrective actions have eliminated L. monocytogenes and harborage sites when found in your plant. If you consistently see negative test results in environmental samples collected from your plant, we recommend that you revise your environmental monitoring procedures to add, substitute, or both add and substitute other surfaces in your plant for sample collection and testing to ensure you are not missing a source of contamination."

There is also a section on finished product testing.


Please contact us if you have any questions on this document.

Wrong Label on Soup Results in Recall Due to Allergens

A Mass. establishment is recalling soup after Italian Wedding soup was labeled as Chicken Soup.  Because of this, allergens such as eggs, milk, and wheat were not declared on the label. 


This establishment is most probably a dual jurisdiction facility (FDA and USDA) and so these products may not fall under Preventive Controls.  Even so, a Preventive Controls application for allergens would help add extra measures for preventing this type of issue.  If container labeling had been designated a Preventive Control, then monitoring of labels as well as verification could have been heightened.

USDA Recall Notice
https://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-004-2017-release
Kettle Cuisine, LLC Recalls Chicken Soup Product Due to Misbranding and Undeclared Allergens
Class I Recall 004-2017
Health Risk: High Jan 12, 2017

Still More Recalls Linked to Dairy Powder with Potential Salmonella Contamination

More recalls have been issued for the potentially contaminated dried dairy powder.
The recall list was last posted on January 2.  Since then, recalls have been posted by Hostess for their White Peppermint Twinkies,  Palmer for certain chocolate candies, HyVee for candy products,  Tupperware for a seasoning product, and Dutch Valley for a snack mix.  Thus far, there have been no reported illnesses and not product has testing positive for the Salmonella pathogen.

Hostess Brands, LLC Issues Voluntary Recall of Limited-Edition Holiday White Peppermint Hostess® Twinkies® because of Possible Health Risk
http://www.fda.gov/Safety/Recalls/ucm536055.htm
For Immediate Release - January 9, 2017

Frozen Breaded Okra Recalled for Potential Glass Contaminate

Pictsweet is recalling bagged frozen breaded okra after the company received complaints of glass contamination.  One injury has been reported.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm537117.htm
The Pictsweet Company Announces Voluntary Recall of Pictsweet Farms 12oz Breaded Okra due to Risk of Glass Contamination
For Immediate Release
January 13, 2017

Court Upholds FDA Not Negligent in Issuing Warning in 2008 Salmonella Outbreak

The US Court of Appeals upheld the ruling that FDA did not negligently issue a warning about tomatoes contaminated with Salmonella as part of the 2008 Salmonella outbreak. In this case where 1442 people reported illness after eating salsa. FDA initially issued a warning that tomatoes were the likely source, but later it was discovered it was the peppers. Of course, this warning resulted in many tomatoes going unsold as people avoided them. "The court determined that the warning properly fell within the discretionary function exception of the Federal Tort Claims Act and that the district court "ruling was essential to protect FDA's vital role in safeguarding the public food supply."

This case points to the pressure on reporting potential sources of contamination versus the economic impact of a misdiagnosis of the real source. In this case, the tomato industry last millions of dollars. The impact of newer technologies, specifically whole genome sequencing, will benefit these types of investigations.

Penn State Law - The Agricultural Law Brief
https://pennstatelaw.psu.edu/academics/research-centers/center-agricultural-and-shale-law/agricultural-law-brief
JANUARY 2017
Food Safety: Court Rules FDA did not Negligently Issue Salmonella Warning

Pennsylvania Dept of Ag Warns about Raw Milk Cheese Due to Staph Contamination

PA Dept of Ag is warning consumers who may have purchased raw milk cheese form a Centre County (PA) produce after the Department found the presence of Staphylocuccus aureus.

Pennsylvania Department of Agriculture News Release
http://www.media.pa.gov/pages/Agriculture_details.aspx?newsid=508
Agriculture Department Warns Consumers of Contaminated Cheese from Centre County Dairy
12/29/2016

CDC - 2106 Outbreak of Salmonella Linked to Cucumbers

CDC published a report regarding a 2016 outbreak of Salmonella enterica serotype Oslo.  The report links the outbreak to Persian or mini cucumbers.  "The investigation identified two Canadian Persian cucumber suppliers during the timeframe of interest, but a single grower was not identified."

"This is the fourth Salmonella outbreak since 2013 associated with cucumbers, with over 1,200 illnesses and 260 hospitalizations included in the previous three outbreaks (2–4). Two of these outbreaks were caused by cucumbers sourced from Mexico (2,4), whereas the other outbreak identified cucumbers sourced from Maryland as a major cause of illnesses (3). This outbreak supports the continued evaluation and sampling of produce by FDA with the Food Safety Modernization Act requirements intended to prevent and minimize contamination of produce with pathogens."

CDC - Morbidity and Mortality
https://www.cdc.gov/mmwr/volumes/65/wr/mm655051a3.htm?s_cid=mm655051a3_e
Outbreak of Salmonella Oslo Infections Linked to Persian Cucumbers — United States, 2016
Weekly / December 30, 2016 / 65(5051);1430–1433

Imported Canned Olives Recalled Due to 'Quality Issue' that Could Be a Safety Issue

A New York company is recalling canned olives that were manufactured in Spain due to quality issues that could result in a health issue.  While the notice comes short  of saying the issue, a likely reason would be swollen cans.  Swollen cans can be the result of under-processing or storing cans at an elevated temperature (and thus supporting the growth of thermophilic sporeformers that survived the thermal process).

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm534829.htm
American Roland Food Corp. Initiates A Recall Of Roland® Manzanilla Olives Stuffed With Anchovies Due To Product Quality Issue
For Immediate Release - December 27, 2016