Cereal Facility Issued Warning Letter for Inadequate Salmonella Control

FDA issued Kerry Inc a warning letter for their Illinois cereal facility after FDA testing found Salmonella and an FDA audit found that the facility had found numerous Salmonella positive environmental samples.  The FDA ruled that the product was "was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health".  This is a very interesting case study for product that was most likely used as an ingredient in further processing.

One of major issues was the Salmonella positive samples. From the report:  " Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

 A summary of the points made in the warning letter:

1. The hazard analysis of RTE cereal process did not list environmental pathogens when the finished product was exposed to the environment prior to packaging. This was especially concerning since the facility did find Salmonella in the environment
2. Environmental controls to prevent Salmonella were not implemented sufficiently to control Salmonella. FDA found Salmonella in the processing environment as well as the facility found Salmonella.
3. Corrective actions were not properly implemented to get rid of Salmonella. There were no steps taken to remove the root cause of the Salmonella from the enviromet. Basically, a root cause analysis was not completed even though Salmonella was constantly being found.
4. Sanitation controls were not verified. The company did not follow its own SOP for environmental monitoring

There was no further information regarding the facility, but as an ingredient manufacturer, it is likely that this cereal product is made for use as an ingredient  in foods that will be further processed.   Perhaps this is why a less-than-sufficient effort.  Regardless, 1) FDA viewed this as an RTE product and that may have been difficult to convince otherwise - including providing notice to customers 2) the company should have included it in the hazard analysis, and 3) a better effort should have been made in controlling it.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615073.htm
Kerry Inc 7/26/18

Date-Expired Salads Recalled for Cyclospora

USDA FSIS issued a health alert for beef, pork and poultry salads made by Caito Foods due to potential contamination with Cyclospora.  "The problem was discovered when Caito Foods LLC received notification from their lettuce supplier, Fresh Express, that the chopped romaine that is used to manufacture some of their salads and wraps was being recalled."

According to the warning, "The beef, pork and poultry salad and wrap items were produced between July 15 to 18, 2018, with the either “Best By,” “Enjoy by,” Best if Sold By” or “Sell By” dates ranging from July 18 through July 23, 2018."

It is important to note that this product is past its shelf-life.  While FSIS is concerned about someone storing the product past the shelf-life, one would guess that after an extra week, it is probably less than good.  And if someone had eaten product and had become ill, or becomes ill, this notice is out there.  So while we understand the need for recalling expired product, the problem is that unless you read into the notice, you don't see that this was expired product.

FSIS Issues Public Health Alert for Beef, Pork and Poultry Products due to Concerns about Contamination with Cyclospora 
Link

This Week in Mislabeled Product - Week Ending 7/29/18

Wrong Label Placed on Tea - A Minnesota firm  is recalling Roasted Chestnut loose leaf tea, because it may contain undeclared almonds.  The recall was initiated after it was discovered that this product containing almonds was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the problem was caused by a temporary mistake in the company's production and packaging processes

https://www.fda.gov/Safety/Recalls/ucm615023.htm
TeaSource Issues Allergy Alert on Undeclared Almonds in Product
For Immediate Release
July 26, 2018

Sandwiches Recalled After Company's Testing Program Detects Listeria

Lipari Foods, based in Michigan, is recalling pre-made sandwiches due to the potential to be contaminated with Listeria.  The testing was done by the company's fresh food manufacturing company, JLM Manufacturing, which was where the product was packed.  Product was packed underd the Premo and Fresh Grab labels.  Product was packed on the 17th of July and has an expiration date of August 8 (3 weeks..eww).

There have been no reported illnesses.

Currently, there is just one product day recalled.  So it will be interesting to see whether this follows the normal path these Listeria-related recalls go...that is, the recall is expanded because regulators find that there was inadequate control and more than one day's production may be implicated.


https://www.fda.gov/Safety/Recalls/ucm615055.htm
Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes
For Immediate Release
July 28, 2018

Should We Care About Food Product Standards of Identity?

A news release from FDA discussed the need to review and modernize the 'standards of identity' for food products, specifically in this case, dairy products.  With all of the FSMA regulations in addition to responsibility for drugs, food product 'standards of identity' just don't seem to be that much of a priority.  But should they be?

The standard of identity are used "in an effort to promote honesty and fair dealing for the benefit of consumers, the FDA is authorized to establish by regulation, a common or usual name, a reasonable definition and standard of identity, a reasonable standard of quality, and reasonable standards of fill of the container for any food"  (NDSU Law).  So it says what a product is so that when you buy it, you know what it is.  If you buy grape jelly, you are getting what is considered grape jelly.

One of the big issues has been related to milk.  From the FDA release, one of the primary issues is "plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk."

Basically, soy milk or rice milk is not really milk.  Milk is collected lactation from animals.  Soy beans don't have mammary glands. It's not milk, it is expressed bean juice.  So is this an issue?  Well, it can be because some people don't understand that milk and bean juice don't have the same nutritional parameters.  Just being white doesn't make it milk.    FDA used a few cases to demonstrate this issue, in one "case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition. There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk".

I like standards of identity. I like the structure that it creates within the marketplace.   Marketing people don't because they can blur the lines and make something seem to be what it's not.  If people took time to understand, that would be one thing.  But some out there do not.

For the most part, many of the standards in place have been there for decades.  This is not to say they should remain constant, but certainly there should be on ongoing review process to say what a given food is, and what it is not.

Take bacon as an example.  Bacon should be from an animal.  I am fine with turkey bacon, but eggplant bacon....no. 

FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614851.htm
Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
For Immediate Release
July 26, 2018

Developing A Food Defense Plan - Meeting Compliance Requirements in the FSMA Rule on Preventing Intentional Contamination

Penn State Extension
https://extension.psu.edu/developing-a-food-defense-plan

Developing a Food Defense Plan 

Meeting Compliance Requirements in the FSMA Rule on Preventing Intentional Contamination

The Food Safety Modernization Act, or FSMA, has 7 primary rules that have been enacted with a goal of improving food safety in the US.   The next FSMA rule with compliance dates on the horizon is the food defense rule which focuses on the prevention of intentional contamination.  This FDA rule, “Mitigation Strategies to Protect Against Intentional Adulteration”, or ‘IA’ rule, was finalized in May of 2016 with compliance is slated to begin next year.  The IA rule applies to food companies registered with the FDA who are involved in the production, transport, storage, or distribution of food for sale to the public.   Large companies, defined as having 500 or more employees, must comply by July 26th of 2019, while small companies’ compliance date is a year later, July of 2020.  Very small businesses, having less than $10,000,000 in annual sales, are exempt, but have to be able to demonstrate that they are classified as a very small company.

The goal of this rule is for companies to establish control measures to prevent or minimize the risk that a person or group intentionally contaminates food with the intent of public harm.    Intentional contamination includes 1) tampering, the intentional modification of a product in a way that would be harmful to the consumer, 2) terrorism, contamination by domestic or foreign aggressors for political or ideological reasons, and 3) contamination by disgruntled employees who may have a personal vendetta or have been bribed or manipulated by an outside source.

Savory Jellies and Jams are the Rage, But There Can be a Botulism Concern

Savory jams and jellies are trending...showing up as condiments in upscale restaurants, on cooking shows, and of course, on numerous websites with recipes for home preparation.  But as was seen last month in Denmark, there is a botulism risk.  In this case, nine people became deathly ill after consuming savory jelly product.

The issue is that many of the recipes are not scientifically validated, that is, tested to ensure safety.  The issue comes in when these items may not be shelf-stable but people treat it like a jam or jelly they buy from the store.  In these items, the savory component is of neutral pH, and if not properly acidified or preserved in some other way, that component within the jelly matrix can support the growth of Clostridium botulinum, the causative agent of botulism poisoning.  The savory component could also cause the overall pH to rise as well, again, allowing growth of C. botulinum.   The boiling process used in making the jam or jelly does not eliminate the spores of this bacterium, and when he product is left at room temperature, the spores germinate, and this bacterium then grows within the savory particulate.

So unless one is following approved recipes, such as the ones from the Center for Home Food Preservation, it is important to store your concoction at refrigeration temperature - from the time it is made until it is all used.  A additional concern then arisies when gifting this homemade item to a friend...they must be informed of the need to store in the refrigerator, even if not yet opened.

Food Safety News
http://www.foodsafetynews.com/2018/07/danish-botulism-outbreak-traced-to-homemade-savory-jelly/#.W1s-nE3rt9A
Danish botulism outbreak traced to homemade savory jelly 
By Joe Whitworth | July 26, 2018

Homemade savory jelly caused an outbreak of foodborne botulism in Denmark last month, according to the Statens Serum Institut (SSI).

Is Exposure to the Parasite Taxoplasma Gondii Linked to Entrepreneurial Individuals.

A study was recently published to look at a determining a correlation between whether a person has  Taxoplasma antibodies and career path, specifically majors that have an emphasis in ‘management and entrepreneurship' over other business-related emphasis as well as looking at business professionals and their chosen profession.  Basically, does the fact that someone has been exposed to the parasite Taxoplasma gondii increase their choice in a more entrepreneurial profession which is considered to be associated with increased risk taking.

Conclusions -

• "..found that students (n = 1495) who tested IgG positive for T. gondii exposure were 1.4× more likely to major in business and 1.7× more likely to have an emphasis in ‘management and entrepreneurship' over other business-related emphases" 
• "Among professionals attending entrepreneurship events, T. gondii-positive individuals were 1.8× more likely to have started their own business compared with other attendees (n = 197)." 
• "Finally, infection prevalence was a consistent, positive predictor of entrepreneurial activity and intentions at the national scale"

Surprising or far fetched...not really. We know that the parasite does the same with mice in that parasitic infection makes them less risk adverse, and thus more likely to be eaten by the other part of the parasitic cycle, the cat.

Now it does not say that being less adverse risk means more successful.  There is a link between infection and mental health., including schizophrenia. 

Proceedings of the Royal Society
Biological Science
http://rspb.royalsocietypublishing.org/content/285/1883/20180822
Risky business: linking Toxoplasma gondii infection and entrepreneurship behaviours across individuals and countries
Stefanie K. Johnson, Markus A. Fitza, Daniel A. Lerner, Dana M. Calhoun, Marissa A. Beldon, Elsa T. Chan, Pieter T. J. Johnson
Published 25 July 2018. DOI: 10.1098/rspb.2018.0822

CDC - Surveillance study on the cause of reported foodborne Outbreaks

CDC issued a surveillance study on the cause of reported foodborne Outbreaks.

• During 2009–2015, FDOSS received reports of 5,760 outbreaks, resulting in 100,939 illnesses, 5,699 hospitalizations, and 145 deaths 
• Where a single agent was confirmed (in 2,953 outbreaks) with a single confirmed etiology, 

1. Norovirus was the most common cause of outbreaks (1,130 outbreaks [38%]) and outbreak-associated illnesses (27,623 illnesses [41%]). 
2. Salmonella was the second most common single confirmed etiology reported, with 896 outbreaks (30%) and 23,662 illnesses (35%)
3. Shiga toxin-producing Escherichia coli (STEC) (191 outbreaks [6%]), 
4. Campylobacter (155 [5%]), 
5. Clostridium perfringens (108 [4%]), 
6. Scombroid toxin (95 [3%]), 
7. Ciguatoxin (80 [3%]), 
8. Staphylococcus aureus (35 [1%]), 
9. Vibrio parahaemolyticus (35 [1%]), and 
10. Listeria monocytogenes (35 [1%]). 

• Listeria, Salmonella, and STEC were the most common causes of hospitalizations (82%) and deaths (82%) reported among persons in outbreaks with a single confirmed etiology.
• Salmonella and STEC were two of the most common causes of large outbreaks.
• Restaurants accounted for the largest percentage followed by Catering, Private Home, and then Institutional.
• The food categories responsible for the most outbreak-associated illnesses were chicken (3,114 illnesses [12%]), pork (2,670 [10%]), and seeded vegetables (2,572 [10%]).
• The pathogen-food category pairs that caused the most outbreak-associated illnesses were Salmonella in eggs (2,422 illnesses), Salmonella in seeded vegetables (2,203), and Salmonella in chicken (1,941

Limitation of analysis:

1. "Because CDC’s foodborne outbreak surveillance is dynamic and agencies can submit, update, or delete reports at any time, the results of this analysis might differ slightly from previous or future reports". 
2. "Not all outbreaks are identified and the majority of foodborne illnesses occur outside the context of a recognized outbreak. The degree to which the food vehicles, etiologies, and locations implicated in outbreaks represent the vehicles, etiologies, and locations of sporadic foodborne illness is unknown." 
3. "Some outbreaks have an unknown food vehicle, an unknown etiology, or both, and analyses and conclusions drawn from outbreaks with an identified food vehicle and confirmed etiology might not be representative of all outbreaks." 
4. "Pathogens that are not known to cause illness sometimes are reported as a confirmed or suspected etiology."

https://www.cdc.gov/mmwr/volumes/67/ss/ss6710a1.htm?s_cid=ss6710a1_e
Surveillance for Foodborne Disease Outbreaks — United States, 2009–2015
Surveillance Summaries / July 27, 2018 / 67(10);1–11