Intentional Contamination - Man Arrested for Putting Razor Blades in Pizza Dough

In Maine, a 38 man was arrested for putting razor blades in pizza dough sold at the supermarket.  The man was a former employee of the company which makes the dough.  

The razor blades were discovered by a customer who purchased the product.  The supermarket reviewed surveillance video and were able to identify the suspect.  "Authorities immediately released a physical description of Mitchell as well as a description of his car in an appeal to the public to help them track down the suspect as quickly as possible. They were able to arrest him within about two hours approximately 50 miles away in Dover, New Hampshire, according to a separate police statement announcing his arrest."

ABC News
https://abcnews.go.com/US/man-arrested-stuffing-razor-blades-consumers-pizza-dough/story?id=73559166
Man arrested for stuffing razor blades into consumers' pizza dough
The supermarket chain has now issued a full product recall.
ByJon Haworth
October 12, 2020, 6:20 AM

A man has been arrested after he was reportedly caught putting razor blades into pizza dough that was then sold to customers, according to the Saco Police Department in Maine.

England - Farmer Convicted of Contaminating Baby Food With Metal Shards

In England, a farmer was convicted of contaminating baby food with metal shards in an attempt to extort money in exchange for revealing where the jars were placed.  He will serve between 8 and 17 years in prison.

https://news.sky.com/story/sheep-farmer-guilty-of-contaminating-baby-food-with-metal-and-blackmailing-tesco-staff-12053014

Sheep farmer guilty of contaminating baby food with metal and blackmailing Tesco staff

Nigel Wright, 45, tried to extort £1.4m in bitcoin from the supermarket, the Old Bailey heard

Thursday 20 August 2020

FDA Releases Supplemental Draft Guidance on Food Defense Regulation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  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).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 

FDA to Start Inspections for Food Defense Plan Compliance in March of 2020

As part of the Food Safety Modernization Act, or FSMA, FDA's Rule Mitigation Strategies to Protect Food Against Intentional Adulteration, or IA Rule, requires facilities to write and implement a Food Defense Plan.  For facilities not considered small or very small,  the compliance date begins on July 2019.  Small facility compliance date will be the next year.  The list of exempted companies is listed below.

FDA announced this past week that it will begin to conduct compliance inspections in March of 2020.  The rule requires the facility "to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working".

In March of this year, FDA released an updated draft guidance titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.  A summary of that document is provided here.  Penn State will be conducting basic workshops on developing a Food Defense Plan.

FDA Food Safety Modernization Act (FSMA)
https://www.fda.gov/fsma
FDA Announces Intentional Adulteration Inspections to Begin March 2020
April 17, 2019

RTE Meat Snacks Recalled Due to Potential Product Tampering

Monogram Meat Snacks, LLC, a Martinsville, Va. establishment, is recalling approximately 191,928 pounds of ready-to-eat pork sausage products that may be adulterated due to possible product contamination, according to the report, "initiated due to product tampering, following the production process."

No further information is available at this time including how it was discovered.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-029-2019-release
Monogram Meat Snacks, LLC Recalls Pork Sausage Products Due to Possible Product Contamination
Class I Recall
029-2019 
Health Risk:High 
Mar 13, 2019 

FDA Release Guidance on Food Defense - Mitigation Strategies to Protect Food Against Intentional Adulteration

The FDA published a draft guidance for food defense titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry in support of the Prevention of Intentional Adulteration rule. The draft guidance provides ways to meet the requirements in the rule specifically conducting the vulnerability assessment and putting mitigation strategies in place for ‘actionable process steps’ or APS. These APS are defined as “a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability”.

To summarize the 159 page document - a Food Defense Plan is essentially conducting a HACCP type of analysis where the goal is to find steps in the process where significant vulnerability exists and to put in measures, or the mitigation strategies’ to reduce the vulnerabilities. These vulnerable points are points where there is access to product where the product can then be contaminated.

There is flexibility in how one conducts a vulnerability assessment, but the guidance provides some basic ways. The elements that must be considered include 1) the potential public health impact (e.g., severity and scale) if a contaminant were added, 2) the degree of physical access to the product; and 3) the ability of an attacker to successfully contaminate the product. The analysis must consider an attack by an insider, a person working in the company. The written assessment must document why each step was considered, or not considered, an APS.

For steps designated as an APS, mitigation strategies are put in place. These strategies may limit access to the step, or may reduce the likelihood that someone can contaminate product at that step. Like critical controls points, each mitigation strategy must have monitoring, verification, and corrective action.

While many may ask about facility wide measures – items such as exterior fencing, employee access to the facility and such – these are not included within the plan unless they can be tailored to impact a specific Actionable Process Step. Sure, they are important, but many have these in place already for other purposes and in reality, they are harder for regulators to regulate.

Australia - Woman Charged in the Needle-in-Strawberry Case

A 50 year old Queensland woman have been charged with the needle-in-strawberry contamination case in Australia.  The issue resulted in stores removing strawberries from shelves and having a huge impact the half billion dollar industry.  While a motive has not been yet listed, it was stated that the woman could receive 3, perhaps a 10 year sentence.  Doesn't seem nearly long enough.

news.com.au
https://www.news.com.au/national/queensland/police-arrest-woman-over-strawberry-contamination/news-story/fbe4e890572060b129c6c100a2fcca62#.yfmcm
Police arrest woman over strawberry contamination
A 50-year-old Queensland woman has been charged over a strawberry needle contamination that sparked a nationwide crisis.

November 11, 20189:47pm
Shireen Khalil

Australia - Needle-In-Strawberry Scare

In Australia, there is a scare involving sewing needles inserted into fresh strawberries as a act of intentional contamination.  According to a report (below), "The scare had spread across the nation by Monday, with needles reported found in strawberries in all six Australian states. No injuries have been reported."  Major retailers have pulled strawberries from the store shelves while police are offering a reward on information that could lead to the apprehension of the culprit(s).

Whether this is one person causing multiple issues, or a number of false complaints, or a series of copy cat  cases, it has cost the industry millions of dollars in lost product and lost sales.

Tampa Bay Times
https://www.tampabay.com/ap/world/needle-in-strawberry-scare-spreads-across-australia-ap_worldff3e058738e64533bbb4417ff8a74593
Needle-in-strawberry scare spreads across Australia
Published: September 17, 2018

FDA Releases Food Defense Plan Guidance

FDA released a guidance document on developing and implementing a Food Defense Plan for mitigating against intentional contamination.  LINK.

The Food Defense Plan is required as part of FSMA.
The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):

1. 1. A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations
• Mitigation strategies and associated explanations
• Procedures for food defense monitoring
• Procedures for food defense corrective actions
• Procedures for food defense verification
2. The rule requires training for certain personnel. See “EDUCATION, TRAINING, AND QUALIFICATIONS” section (21 CFR 121.4)
3. The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
4. The rule requires reanalysis of the food defense plan. (21 CFR 121.157)

For most companies, the compliance date is July of 2019. Smaller companies have more time.

Investigation Continues into Chemical Contamination in Juice that Injured Two Children

In a very bizarre case, two children ingested a toxic chemical while at a restaurant.   According to the report, a 10 year old boy threw up blood and his half sister, aged 4, vomited after drinking apple juice out of foam cups at a Lancaster eating establishment.  

So far, methanol was one of the identified chemicals.  So this is not your typical food operation cleaning chemical.  Also, since only two children at the same table became ill, the contamination event occurred from point of dispensing to point of consumption.  So thus the criminal investigation.

Lancaster online
http://lancasteronline.com/news/local/east-lampeter-police-investigate-if-incident-of-children-drinking-caustic/article_cc170c5e-02a3-11e7-b682-8bd62449c9a2.html
East Lampeter police investigate if incident of children drinking caustic substance at restaurant was criminal or accidental

Man Arrested After IntentionallyContaminating Salad Bar

A California man was arrested after he intentionally contaminated a salad bar with an unknown substance.  A twelve year old reported being sick after eating at the establishment.

ABC10 , KXTV Lake Tahoe, CA
http://www.abc10.com/news/local/california/man-arrested-for-poisoning-food-in-lake-tahoe/355219270
Man arrested for poisoning food in Lake Tahoe
11:17 PM. PST November 22, 2016