In his FDA Voice blog post on March 28, 2018, Commissioner Scott Gottlieb discussed the Food Safety Modernization Act’s Mitigation Strategies to Protect Food Against Intentional Adulteration (commonly referred to as the Food Defense Rule or IA Rule).
This rule applies to both domestic and foreign companies required to register with the Food and Drug Administration (FDA) as food facilities. It primarily covers large facilities producing products that are widely distributed. The Food Defense Rule is relatively flexible, but requires every covered facility to implement a written food defense plan. If you own a large facility, you must comply with the rule by May 27, 2019, while small and very small companies have until 2020 and 2021, respectively, to be compliant. Unlike the food safety plan required by the Preventive Controls for Human Food Rule, which focuses on accidental contamination, the Food Defense Rule is concerned with intentional contamination and sabotage of the food supply. In a press release on June 19, 2018, Dr. Gottlieb announced the release of the first of a three-part industry guidance for the rule. The goal of this guidance is to provide greater clarity and predictability to assist facilities to come into compliance with the rule. The second and third parts of this guidance are expected later this year.
While farms are not required to have a food defense plan, having one is a smart choice. In March 2013, I wrote an article about the benefits of having a food defense plan and discussed how terrorists can consider America’s agriculture and food production as tempting targets to impact the U.S. economic welfare and its standing as a leading exporter of agricultural products to the world. In 2002, the United States and allied forces discovered agricultural documents and al Qaeda training manuals targeting U.S. agriculture. More recently, an incident of chemical terrorism took place in Germany in 2017, when blackmailers added ethylene glycol to baby food and demanded a ransom of 10 million euros to stop. This and other incidents underscore the importance of intentional contamination awareness and prevention. An intentional attack to our food supply represents a very serious threat and can have devastating public health consequences.
Fortunately, the FDA, under the Homeland Security and Presidential Directives, has begun to work with several government agencies, local, tribal, territorial and private sector partners to implement coordinated efforts to prevent, prepare and respond to threats against the food supply. In addition, the FDA’s new Food Defense Rule contains requirements and information that food facilities can utilize to develop and implement a food defense plan. Preventing intentional contamination plays a critical role in ensuring the safety of consumers, the integrity of our food supply and market stability. FDA’s Food Defense Rule requires a food defense plan for facilities and addresses four steps for evaluating and protecting food products:
1. Assessing vulnerabilities for each step of the facility’s process by considering the severity and scale of the potential impact on public health, the ability for the product to be physically accessed, and the ability for product to be successfully contaminated. The FDA defines vulnerability as the susceptibility of a point in a facility’s food process to intentional adulteration.
2. Identifying and implementing mitigation strategies to ensure vulnerabilities will be minimized or prevented. Following the vulnerability assessment, mitigation strategies and protective measures need to be established and implemented to protect facilities, personnel, and operations.
3. Taking steps to ensure the mitigation strategies are being implemented properly. The Food Defense Rule requires written procedures for monitoring mitigation strategies so they can be managed and corrected as needed. If a mitigation measure is not implemented at all or is not properly implemented, the food defense plan requires corrective action procedures.
4. Ensure personnel receive appropriate training and keep records of monitoring, corrective action, and verification activities. Company-wide cooperation is needed for preventing an intentional adulteration incident. Once the food defense plan is established, it should be explained to all personnel. A food defense plan must be reviewed every three years and records must be maintained and retained for two years after they are prepared.
How to get started?
Mandating companies to have a food defense plan is new regulatory territory for the FDA. However, for more than a decade, both the FDA and the USDA have been encouraging companies they regulate to voluntarily establish food defense plans. To facilitate plan development, they created numerous resources for helping companies establish and maintain effective plans. The FDA’s Food Defense Rule requirements closely follow USDA’s food defense plan recommendations making USDA’s resources quite suitable and applicable for produce companies wanting to get started on developing a plan. In addition, to the FDAs’ Food Defense Rule Guidance, published last June, following is a list of helpful tools for companies to use in establishing and implementing a plan as well as training employees in food defense.
• The Food Safety Preventive Controls Alliance (FSPCA) offers food defense awareness training. This course is intended to assist companies in complying with the FDA’s Food Defense Rule training requirements.
• The FDA initiative, “Employees FIRST” (Follow company food defense plan and procedures; Inspect your work area and surrounding areas; Recognize anything out of the ordinary; Secure all ingredients, supplies, and finished product, Tell management if you notice anything unusual or suspicious), focuses on increasing food defense awareness and provides resources and training tools for employees.
• The Food Safety and Inspection Service (FSIS) Food Defense 101 tool includes five free, online courses your company can use to understand the Food Defense Rule. The courses will prepare your team for establishing a facility-specific plan.
• To help companies build a personalized food defense plan, the FDA developed a free, user-friendly software program, the Food Defense Plan Builder that walks them through the evaluation of the accessible and vulnerable steps in their production or areas within their facility and develop focused mitigation strategies.
• The Mitigation Strategies Database, developed by the USDA, aids the food industry by providing a range of diverse countermeasures companies could consider implementing in their facility. This database identifies possible prevention methods for material receiving, storage, and transportation as well as general recommendations for security.
• The FDA, in collaboration with the Center for Disease Control and Prevention (CDC), the USDA’s FSIS and Animal and Plant Health Inspection Services (APHIS) developed the Food Related Emergency Exercise Bundle (FREE-B). The FREE-B provides eight different scenarios based on both intentional and unintentional food contamination events to assist companies in testing their defense plans and procedures.
To conclude, the importance of taking steps towards preventing intentional contamination of our food supply cannot be overstated. Building a strong food defense plan goes a long way. Contact Western Growers Science and Technology Staff if you have any questions or comments related to this important topic.
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