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

Salmonella Outbreak Associated with Sliced Melons Over, 77 Infected

CDC announced that a Salmonella Outbreak associated with sliced melons that occurred in June is now over.  In this outbreak, there were 77 cases with 36 hospitalizations.   While no particular source was identified, product from Caito Foods was the only identified company issuing a recall.

 "The FDA worked with state partners to trace back the pre-cut melons to identify the source of the pathogen, to determine the full distribution of the pre-cut melons, and to learn more about how the contamination occurred. No common source was identified"

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm610301.htm
FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons
July 26, 2018

Jars of Con Queso Cheese Dip Recalled Due to Product Separation

KraftHeinz issued a recall for Taco Bell Con Queso Cheese Dip after the product separated in the jars.  The stated issue would be the potential for Clostridium botulinum growth.

The issue here is related to separation that creates a liquid phase and a solid phase.  Product was designed to be consistent throughout, which means that the water activity (Aw), a measure of the available moisture needed for bacterial growth, would be uniformly low to prevent the growth of Clostridium botulinum.   But if it separates, then a fraction would possibly have a higher water activity, sufficiently high enough to support the growth of Clostridium botulinum, and with that, the production of botulinum toxin.

Clostridium is the primary pathogen of concern because as a sporeformer, the spores would survive the heat processing treatment.  Other sporeformers may also be a concern, even those that can cause spoilage.

https://www.fda.gov/Safety/Recalls/ucm614642.htm
Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers
For Immediate Release
July 24, 2018

Supplier Issues Recall for Whey Powder Used in Goldfish, Ritz Crackers, etc

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., issued a recall for dry whey powder packaged produced in the cooperative’s Blair, Wis., due to the potential to be contaminated with salmonella.   This product was responsible for recalls of Ritz crackers, Gold fish, Swiss Rolls, and chicken wings issued within the last week.

As noted, this was a precautionary recall that was issued after one test out of a number of tests performed on the product, came back with a positive result.  From the FDA release from the company: "All products shipped to the marketplace tested negative for salmonella.  However, because additional product tested positive for salmonella under AMPI’s routine test and hold procedures, the company is recalling product as a precautionary measure."   Further, "AMPI has ceased production at its Blair, Wis., dry whey plant, is currently investigating the cause for the positive samples, and will take all necessary remedial actions."

So if Salmonella present in the ingredient, based on the amount of testing said to have been completed, we would say that Salmonella would be at very low levels in the ingredient, and once processed (baking), there would be essentially no risk of it being present in finished product.

This shows the implications of one bad test even though many negative results may be found beforehand.  It also shows the impact of an ingredients on products even though those products where processed in a way to eliminate the potential hazard.

https://www.fda.gov/Safety/Recalls/ucm614759.htm
AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk
For Immediate Release
July 25, 2018

This Week in Mislabeled Product - Week Ending July 21, 2018

Supplier Issue in Controlling Allergens - GiftTree, a gift basket company based in Vancouver, WA, is voluntarily recalling 94,000 units of “Sherman Candy Caramels” sold online in the several Gift Baskets because they may contain undeclared pecans, walnuts, almonds and/or peanuts.  The recall was initiated after it was discovered that the caramels ingredient potentially includes pecans, walnuts, almonds and/or peanuts but the finished “Sherman Candy Caramels” does not reveal the presence of those allergens on the product packaging. [One should not expect peanut or tree nut allergens in caramel, so if the supplier can't control it, it may be worth sourcing from a different supplier].

Packaging Label Misses Milk Allergen - Shearer’s Foods, LLC of Massillon, OH is recalling Food Lion brand 7.75 ounce packages of Dill Pickle Flavored Potato Chips because they may contain undeclared milk. The issue was discovered when a consumer suffered an allergic reaction and the incident was reported to Food Lion. Shearer’s Foods, LLC conducted an investigation which indicated that a product containing milk was distributed in packaging that did not reveal the presence of milk.

Packaging Label Misses Soy Allergen - LabelPortland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY.  The labeling problem was discovered during a label and packaging review by firm. The recall was initiated after it was discovered that product containing soy was distributed in packaging that did not reveal the presence of soy

Mislabeled Chips - Utz® Quality Foods, LLC., is voluntarily recalling select expiration dates of Utz® Carolina Style Barbeque Potato Chips due to undeclared soy allergen. This recall was initiated after learning a certain number of packages were mislabeled.

Packaging Label Misses Peanut Allergens - An Ore. establishment, is recalling an undetermined amount of ready-to-eat sesame noodle chicken salad products due to misbranding and undeclared allergens, The products contain peanuts, known allergens, which are not declared on the product label. On July 14, 2018, a New Seasons Market employee discovered the problem at the company’s retail store, and the company notified FSIS of the problem.

https://www.fda.gov/Safety/Recalls/ucm614189.htm
GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels "
For Immediate Release
July 20, 2018

Authorities Investigating Salmonella Outbreak Associated with Raw Turkey Products

CDC issued a news release about an ongoing investigation into a Salmonella outbreak linked to raw turkey products.  In this outbreak, 90 people have become infected with 40 hospitalizations.  The strain of Salmonella Reading is multidrug resistant.  The strain has been identified in samples taken from raw turkey pet food, raw turkey products, and live turkeys, however, according to this report, a single, common supplier of raw turkey products or of live turkeys has not been identified.

https://www.cdc.gov/salmonella/reading-07-18/index.html
Outbreak of Multidrug-Resistant Salmonella Infections Linked to Raw Turkey Products
Posted July 19, 2018 at 12:00 PM EDT