FDA Releases Supplemental Draft Guidance on Food Defense Regulation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  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).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Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration 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

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 - 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

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.

Cyber Security for Automated Food Processing Equipment

A recent article in Food Safety Magazine discusses the concern of cyber attacks on the supply chain.  Basically, the issue would be when somebody gains control over your automated processing equipment.  This could result in processing changes or formulation changes that can lead to contamination issues.

A division of Homeland Security, ICS-CERT (Industrial Control Systems Cyber Emergency Response Team), monitors and reports such attacks.  In April, they reported such an attack on a food processing system.  In 2016, this group reported 3 incidents on the food and agriculture sector.

As a food safety professional, this is just another concern to keep you awake at night.
Of course, the big concern is that somebody turns your automatic palletizer into this:

Damn, that Skynet software package.

Food Safety Magazine
https://www.foodsafetymagazine.com/signature-series/when-food-safety-meets-cyber-risk/
Signature Series | September 14, 2017
When Food Safety Meets Cyber Risk

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.

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

Employee Faces Charges for Tampering After Company Recalls Product for Foreign Matter

A Minnesota firm is recalling 55,000 pounds of product for foreign material and announces that a company employee has been fired for product tampering.  The material, verified to be soil and sand, was found in some of the products.


Meating Place
http://www.meatingplace.com/Industry/News/Details/66992?loginSuccess
GNP recalls chicken tampered with foreign matter, fires employee

FDA Releases Final Rule on Food Defense - Preventing Intentional Contamination of Food - Summary

The rule, titled Mitigation Strategies To Protect Food Against Intentional Adulteration, applies to domestic and foreign food companies that are registered with the FDA to address hazards that may be introduced with the intention to cause wide scale public health harm. . Basically, if you are producing food for sale and have registered your facility with FDA, then you have to have a food defense plan. There are a few exemptions to who has to apply.

Commentary - this is very broad/open and care must taken when preparing this program  A concern would be claiming too many vulnerabilities and then having to correct too much (and the expense of that).

Below is a summary of the major sections of the document.

Requirements - "Each covered facility is required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented. " .

1.  You must prepare, or have prepared, and implement a written food defense plan.

This includes:

Case of Intentional Contamination in Michigan - Man Sprays Salad Bars with Chemical Mixture

In Michigan, a person was arrested after intentionally contaminating salad bars in local restaurants with a chemical mixture that included mouse poison.  There have been no injuries reported.

This is a reminder that intentional contamination can occur and that employee in food establishments must always be on the lookout.

 

 

Michigan Department of Agriculture and Rural Development News Release

https://www.michigan.gov/mdard/0,4610,7-125-1572_3628-383985--,00.html

Advisory: Consumers Urged to Throw Away Potentially Contaminated Foods

Agency: Agriculture and Rural Development

Drug-laced Bread Sickens 40 in LA

A bread made in celebration of Three Kings Day was contaminated with synthetic cannabinoid, or synthetic pot.  It affected at least 40 people with the symptoms that included heart palpitations, dizziness, numbness and hallucinations. 

This specific chemical, JWH-122, was developed for research and would be illegal to have, but other forms of synthetic pot, known as Spice or K2, can be purchased legally.

Police continue to investigate how the chemical got into the food, most likely a case of intentional contamination.

Orange County Register
http://www.ocregister.com/articles/bread-648036-synthetic-people.html
Testing: Three Kings Day bread laced with 'substantial' amount of synthetic pot
Jan. 13, 2015    Updated Jan. 14, 2015 9:56 p.m.

A holiday sweet bread that caused dozens in Orange County to become ill might have been deliberately laced with a synthetic drug that mimics the active ingredient in marijuana, the president of a Santa Ana-based lab said Tuesday.

Neil Spingarn, a pharmacologist who heads up S&N Laboratories, tested a sample of the Three Kings Day bread and found it contaminated with “a substantial” amount of a synthetic cannabinoid – an artificial THC with intensified effects. THC is the main chemical ingredient in marijuana.

“The levels in the cake are not small.” Spingarn said. “What is most striking is that this was not inadvertent.”

In Japan, man arrested in frozen food conatamination case; over 2800 ill

In Japan, a man was arrested for contaminating frozen food products with the pesticide malathion. The deliberate contamination resulted in over 2800 becoming ill, many of them children. The company was forced to recall over 6 million units of frozen food including frozen pizza and lasagna. It is suspected that the perpetrator added the contaminate immediately before the packaging process. 9 products are reported as having been contaminated.

It is interesting in that, according the news reports, that the company had restrictions on bringing personal items into the production area....so much so, that one person, according the news reports, was astonished that someone was able to get the chemical out on the floor. He also worked as part of a team when on the production floor - there were 4 people assigned to the crust area including the accused.

Another interesting note is that the President of the company as well as the President of the subsidiary will resign in March due to this incident. Salaries of these and other top officials will be cut for a period of time.

The accused is reported as being a contract worker, although he worked at the same facility for 8 years.

This case shows the amount of damage one person can cause through deliberately contaminating food, especially considering it occurred in what appears to be a facility with decent controls.



Arrest made over tainted frozen food
http://the-japan-news.com/news/article/0000973903
Japan NewsMonday, January 27, 2014

The Yomiuri Shimbun

A man in his late 40s was arrested on Saturday on suspicion of obstructing business by lacing frozen foods with a pesticide at a major food maker’s subsidiary plant in the town of Oizumi, Gunma Prefecture.

The man, Toshiki Abe, 49, is a contract employee working at the plant of AQLI Foods Corp., a subsidiary of Maruha Nichiro Holdings Inc., police said.

Investigators detected malathion on clothes he wore at the plant. He had been missing since Jan. 14, but was discovered in Saitama Prefecture on Friday.

FDA's Proposed Rule on Prevention of Intentional Contamination (Food Defense)

On December 20, 2013, FDA rolled out the proposed rule on food defense – Proposed Rule for Protecting Food against Intentional Adulteration. In this rule, facilities will need to develop and implement a food defense plan. In doing this, they will identify any actionable process steps and implement mitigation strategies that will protect food from intentional contamination.

 

Of the FSMA sections proposed thus far, this is one that should receive sufficient debate. Requiring facilities to have a written food defense plan is one thing, but the sticking points will be on enacting mitigation strategies for actionable steps is where there can be some controversy. Adulteration is a low risk event, so how much resources should a facility commit to putting in control measures. And there can be significant difference of opinions on which steps truly represent a risk, and then which control measures should be used for those steps.

 

For example, a facility may have a bulk mixing tank. People who work in the facility may not see any significant risk due to the fact that it is out in the open and only employees have access. But from the CARVER analysis, this process step was deemed the highest risk area within the facility. The facility management may not think that further mitigation is needed, outside of limiting visitors in the facility. But an inspector may want more control, like a cover (which would making cleaning difficulty), a gate to limit access (not practical if the batch operator has to constantly access the batch area), or hire an extra employee for two batch operators. Maybe all would be suggested.

 

In doing a Food Defense Plan, there are a number of factors that come into play in preventing adulteration in a facility. But a motivated assailant can pose a risk to even the most secure facilities. So in the case of the mix tank, what if a subversive terrorist was hired, what if they paid an employee millions of dollars, what if…..

 

So it is important that facility management and regulatory inspectors understand the true risks associated with intentional adulteration and that resources be judiciously applied. Otherwise, the ‘what ifs’ that can be posed the security of any operation or any process can get way out of hand and pose a significant financial burden to the facility, or create a bigger food safety risk.

 

 

Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

 

Link to the proposed regulation.

http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1425-0002

 

 The Link to the proposed rule website.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#summary

 

Here are a few sections from that summary page:

 

Summary

 

FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Modernization Act, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.

 

The FDA is proposing that the requirements be effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size. The proposed rule was published on December 24, 2013, and comments are due by March 31, 2014. The FDA will hold a public meeting on February 20, 2014, to explain the proposal and provide additional opportunity for input.

 

FDA / USDA release Food Defense Plan Builder

FDA / USDA released a Food Defense Plan Builder – This is a downloadable program for developing a Food Defense Plan. It was  found to be very easy to use. Once you enter in your data, it prints off a nice little food defense plan.   It is actually worth giving it a shot.

http://www.fda.gov/Food/FoodDefense/ToolsEducationalMaterials/ucm349888.htm

Intentional Contamination Attempt in a Retail Store

Fortunately, we rarely see cases of intentional contamination. But when they occur, we like to point them out as a learning opportunity.

In this case, a woman contaminated orange juice bottles with rubbing alcohol, snuck them into a Starbucks store by hiding those bottles in her purse, and then placed the two contaminated bottles into a store's refrigerated display case. Lukily, another customer saw this and alerted store employees who promptly removed the contaminated bottles.

The motive of the woman is not known at this time.

Police: Woman charged over poisoned juice at California Starbucks store

By Chelsea J. Carter, CNN
updated 9:12 PM EDT, Tue April 30, 2013http://www.cnn.com/2013/04/30/justice/california-starbucks-tainted-juice/

 CNN) -- A California woman who police say planted two bottles of tainted orange juice at a San Jose Starbucks has been charged with attempted murder, a police spokesman said Tuesday. 

Ramineh Behbehanian, 50, is accused of adding rubbing alcohol to the contents of the bottles and then placing them into a refrigerated display case, Police Sgt. Jason Dwyer told reporters.

Employee Fired after Posting a Photo of Himself Standing on Food

This summary is not available. Please click here to view the post.