FDA Closes Investigation into 2019 Fruit Mix Salmonella Outbreak

FDA closed their investigation into the 2019 Salmonella outbreak that was linked to fruit mix from a NJ facility.  The outbreak was first identified in PA health facilities where 31 became ill.  In the end, there were 165 cases with 73 hospitalizations.  While the investigation identified Tailor Cut Produce of North Brunswick, New Jersey as the source, and identified issues at that facility including:

"the inspectors observed these general deficiencies: the firm’s hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control; the firm did not identify a preventive control for a hazard when one was needed; and the firm did not maintain the plant in a clean and sanitary condition and keep the plant in repair",

they were not able to identify the origin of the Salmonella.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-javiana-fruit-mix-december-2019
Outbreak Investigation of Salmonella Javiana: Fruit Mix (December 2019)
FDA’s investigation is complete. CDC announces outbreak is over.
Case Counts
Total Illnesses: 165
 Hospitalizations: 73
 Deaths: 0
 Last illness onset: January 11, 2020
 States with Cases: CA, CO, CT, DE (49), FL, GA, IL, MA, MN, NJ (50), NY (7), PA (49), VA, WA
February 18, 2020

The Importance of Naming the Coronavirus - Covid-19

An interesting article in Vox about the naming of the novel coronavirus. It was given the name Covid-19, derived from COronaVIrus Disease 2019. Not very exciting, although giving it a technical name prevents it from being labeled with a name that can unintentionally create fear...such as tying it a location, tying it to an animal or a food. One just needs to look at swine flu that  resulted in the unneeded culling of some pigs.   Or worse, having the media label it, such as was done with Mad Cow (although that was a prion and not a virus).

VOX.com
https://www.vox.com/2020/2/14/21135208/coronavirus-wuhan-china-covid-19-name-sars-cov-2
The life-and-death consequences of naming the coronavirus

A bad name for an illness can be dangerous. That’s why it took so long to settle on Covid-19.
By Umair Irfan Feb 14, 2020, 10:40am EST

Coronavirus Update - February 14, 2020

In the Coronavirus outbreak, strain designated COVID-19, the case numbers continue to grow, but a testing change by officials in China has had a impact on those numbers, causing the total number to surge higher.  CNBC reports that there are now some 64,000 reported cases wit 1,380 deaths.  There have been 15 cases confirmed in the US, but patients are under quarantine.  The risk in the US is still considered low.

From a Market Watch article - "Health authorities in Hubei Province are now counting cases that have been diagnosed solely by a computed tomography (CT) scan, not a combination of a CT scan and an RNA test. The most recent update from China’s National Health Commission states there were 15,152 new cases, a sevenfold increase over the 2,015 new cases that had been reported the day before. "

The CT method is a quicker analysis compared to the RNA tests that takes days.  The CT scans reveal lung infection, so it is not as specific.  And with a shortage of RNA test kits, many cases were being missed.

From a business perspective, one of the big casualties is the cruise ship operations.  With passenger ships having to quarantine passengers when there is a suspect case, it is easy to see why many may not want to get aboard.

WHO RISK ASSESSMENT
China Very High Regional Level High Global Level High
Market Watch

Report on Food Recalls Fails

In a recent report put out by a public interest group, they claim that grocers do a poor job in communicating recall information.  In "Food Recall Failure Will your supermarket warn you about hazardous food?, the group gave the grocers a failing grade.  Their primary reason, so it seems, the grocers did not send the group the information they requested.  Then the firm conducted their one investigation based on their evaluation of a company's procedures.

Whatever.  This is more of a headline grab than a real evaluation.  Actual evidence will show that grocery stores do a pretty good job at removing items from the shelves, and contacting consumers as best they can.  Can they do better, sure, but it is not the catastrophic failure the article makes it to be.

This is the same group that released "New report: Meat recalls remain high; produce and processed food recalls drop".  One of their top findings - "The most hazardous meat and poultry recalls (Class I) have nearly doubled, up 85 percent percent since 2013. This is a slight increase from 2018. Total meat and poultry recalls are up 65 percent since 2013."  There was no evaluation into what the recalls were, but more of a insinuation that it is all extremely dangerous, when in fact, many of the recalls are either related to allergens or physical material contamination,  or are proactive due to a potential issue, not an actual issue.

FDA Releases Supplemental Draft Guidance on Food Defense Regulation

FDA released a supplemental 'draft' guidance to support the IA Rule (Intentional Adulteration or Food Defense).  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).

This supplemental guidance covers the elements for managing mitigation strategies - specifically corrective action, verification, and reanalysis.  It provides more detail on what FDA would be looking for when evaluating the mitigation strategies the facility has chosen.

As you know, the facility conducts a vulnerability assessment to determine which points in the process are most vulnerable, the actionable process steps.  For the actionable process steps, the facility must determine and implement mitigation strategies to reduce the vulnerability.  These strategies must be monitored, documented, verified, have corrective action, and be reanalyzed.

In general, the guidance allows a more basic and flexible approach than Preventive Controls regarding corrective action and verification activities. For example, if a mitigation strategy is having a tank hatch locked with a monitoring activity stated as checking the lock. The corrective action if a tank is not locked would be to lock it and retrain the employee.  Verification is simply checking records to make sure the lock check was taking place, and the corrective action of retraining the employee took place.  And of course, conducting analysis of the plan every 3 years (unless there is a process change or other special conditions).


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplemental-draft-guidance-industry-mitigation-strategies-protect-food-against-intentional
GUIDANCE DOCUMENT
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration 

This Week in Mislabeled Products for Week Ending February 15

Incorrect packaging sleeve - Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquartered in Hiram, Ohio.  The recall was initiated after it was discovered that a limited number of the Snackers contain peanuts, which, while visible through the packaging and identified on the top label of the individual Snackers tray, were not declared on the ingredient statement. This was due to an incorrect selling unit cardboard sleeve label packaged on a limited number of the Snackers.

FDA finds milk in product, but not on label - Gourmet International and Butlers Chocolates UC are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk.   The recall was initiated after FDA testing found high levels of milk present in the product and milk is not a listed ingredient of the product.

Almond in non-almond product, precautionary statement won't help this - Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”.  The company are certain that the problem has been corrected and no illnesses have been reported to date in connection with this problem.  LOTTE Int’l America Corp is working fully in partnership with FDA to fully investigate the matter and comply with all necessary recall procedures. The Company is also taking the necessary steps to address this issue and apologizes for any inconvenience caused by this product issue.

Poor label design or misformulation? - McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen.

Top label right, bottom label wrong - Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the packaging and identified on the top label, are not declared on the ingredient statement due to an incorrect bottom (ingredient) label on a limited number of the salads. The recall was initiated after it was discovered that a limited number of the salad bowls containing the eggs and wheat ingredients were distributed in packaging with incorrect bottom (ingredient) labels that did not indicate the presence of the two allergens. The company has taken immediate action to identify the cause of the error and implement a permanent fix to ensure it does not happen in the future.

Incorrect labels on product at packaging - Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The problem was discovered when cases were opened to put our for retail sale, and the label on the retail package did not match the label and description of the master case. Subsequent investigation indicates the problem was caused during the packaging process. The incorrect labels were applied to the product causing the product to be mislabeled.

Improper label design misses milk - Family Traditions Meat Company, an Ackley, Iowa establishment, is recalling approximately 270 pounds of ready-to-eat (RTE) beef stick products due to misbranding and an undeclared allergen - the product contains milk, a known allergen, which is not declared on the product label. The problem was discovered by a compliance officer with the Iowa Department of Agriculture during in-commerce surveillance activities at a retail store.

FDA Releases Interim Results of Pathogen Testing on Fresh Herbs and Processed Avocados

FDA released preliminary results of testing fresh herbs and processed avocados.  Although the levels of contamination are low, one would need to consider these as hazards as a risk when conducting the hazard analysis for these items.

Fresh Herbs - cilantro, parsley and basil

Fresh cilantro, parsley and basil are typically eaten without having undergone a ‘kill step,’ such as cooking, to reduce or eliminate bacteria. These herbs are grown low to the ground and therefore are susceptible to contamination (e.g., from irrigation water splashing off the soil).

From 1996 to 2015, the FDA reported nine outbreaks linked to basil, parsley and cilantro, which resulted in 2,699 illnesses and 84 hospitalizations. Four of the outbreaks were linked to basil, three to cilantro, and two to parsley. Of those same nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. T

Preliminary Findings - The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Domestic Fresh herbs - 

Salmonella  4  positive of 742 samples (0.5%)

E. coli O157:H7 - No positives from 746 samples 

Shiga toxin-Producing E.coli,  - 4 of 742 but these strains were determined to be non-pathogenic.

Cyclospora - 4 positive from 442 samples (0.9%)

Imported Fresh herbs - 

Salmonella - 9 positive rom 459 samples (2.0%)

E. coli O157:H7 - No positives from 468 samples

Shiga Toxin-producing E. coli - 5 positive from 463 although strains were determined to be non-pathogenic.

Cyclospora - 12 positive from 224 samples (5.4%)

Processed Avocados / Guacamole

"Avocados have a high lipid and moisture content, low carbohydrates, and non-acidic pH level, which can make them a favorable growth medium for harmful bacteria. Processed avocado products, including avocado that is fresh cut, refrigerated and frozen, may be packaged and eaten without having undergone a ‘kill step’ prior to consumption. In addition, processing fresh produce into fresh-cut products increases the risk of bacterial growth by breaking the fruit’s skin and allowing for the spread and potential growth of any pathogens that may be present."

"According to the CDC, there were 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those 12 outbreaks, nine involved Salmonella and three involved E. coli, resulting in 525 illnesses and 23 hospitalizations in all. Though no listeriosis outbreaks were reported in connection with avocados from 2005 to 2015, a recent sampling assignment by the FDA detected Listeria monocytogenes in samples collected from the fruit’s pulp and skin."

Preliminary Findings - The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Domestic Processed Avocado / Guacamole 

Salmonella in 2 positive of 775 samples  (0.25%) 

Listeria monocytogenes - 13 positive of 764 samples (1.7%)

Imported Processed Avocado / Guacamole

Salmonella and there were no positives in 110 samples

Listeria - 2  positives in 108 samples (1.8%)

https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling-fy18-19-fresh-herbs-cilantro-basil-parsley-and-processed
Microbiological Surveillance Sampling: FY18-19 Fresh Herbs (Cilantro, Basil & Parsley) and Processed Avocado and Guacamole Assignments

Frozen Smoothie Products Recalled Due to Potential Listeria

Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand Superfood Smoothie Kits because of potential contamination with Listeria monocytogenes. The company discovered the issue through its quality control processes. The issue is believed to be isolated to a supplied ingredient.

So what is a smoothie kit? From the website -
What is in one smoothie kit/pouch?
"Each smoothie kit contains organic frozen fruit and veggies as well as 1.5oz of frozen superfood chips. The superfood chips are comprised of our proprietary organic superfood blend + organic banana puree. All you have to do is empty the contents of the smoothie pouch into your blender, add 12oz of blending liquid and give your blender a whirl! One smoothie pouch/kit will make (1) 18oz or (2) 9oz smoothies."
Shipping
"We ship our smoothies in insulated packaging on dry ice so they stay frozen throughout the entire trip. Make sure to pop them in the freezer as soon as they arrive."

Blending Instructions:

"Remove superfood packet from pouch! Blend pouch + superfoods with 12oz liquid of choice. Plant-based milks such as almond milk or coconut milk are preferred."

An interesting concept.  As a product with no reduction step performed by the consumer, the ingredients must be free of any biological hazards and those ingredients must be assembled / handled in a way that does not contribute contamination to the finished product.  And if Listeria were present, such as in this case, the organism would not likely grow on the items in the packet, especially if frozen.  The risk would be proliferation occurring once the smoothie was made.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blendtopia-products-llc-voluntarily-recalls-frozen-smoothie-products-due-possible-health-risk
Blendtopia Products, LLC Voluntarily Recalls Frozen Smoothie Products Due to Possible Health Risk
Summary
Company Announcement Date: February 10, 2020
FDA Publish Date:February 10, 2020
Product Type:Food & Beverages Milk/Milk Product
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name:Blendtopia Products, LLC
Brand Name: Blendtopia
Product Description: Frozen smoothie products

RI Establishment Recalls Nut Butter After Testing Detects Listeria

Nuts ‘N More of East Providence, RI. is recalling 4143 jars of plain Peanut Spread because it has the potential to be contaminated with Listeria species and to protect the public from a potential health hazard. The recall was a result of potential Listeria species in a finished product found through routine testing conducted by an outside laboratory. The company has ceased the production and distribution of this product as State of Rhode Island and the company continue their investigation.

There was a similar issue last year involving Listeria in nut butter where a Wisconsin company detected Listeria in nut butter.   That recall expanded as it was found the company did not have control.  It will be seen if this recall is expanded beyond the one lot recalled.

How the Listeria got into the product is hard to know without knowing the process. This product is a concoction of ingredients including peanuts, pea powder, peanut oil, palm oil, flax, vanilla, maple flavor, sea salt and sunflower lecithin. It may lack a thermal process, thus having ingredients free of pathogens and having a clean process is critical.  While growth would not be expected in the product thus reducing the risk, we can never be certain how much of the organism may be present or how someone will use the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nuts-n-more-llc-recalls-plain-peanut-spread-because-possible-health-risk
Nuts ‘N More LLC. Recalls: Plain Peanut Spread Because Of Possible Health Risk
Summary
Company Announcement Date: February 07, 2020
FDA Publish Date: February 07, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential contamination with Listeria sp,
Company Name: Nuts ‘N More LLC
Brand Name: Nuts ‘N More LLC
Product Description: Plain Peanut Spread