FDA’s May 27 publication of the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Defense rule) brings with it another requirement for a written plan, this time focused on food defense rather than food safety. Intended to prevent wide-scale public health harm by requiring companies to take steps to prevent intentional adulteration of the food supply, the rule requires both domestic and foreign food facilities to complete and maintain a written food defense plan which assesses potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. The rule does not pertain to tampering or economically motivated adulteration (the latter being part of the Preventive Controls Rule) but is totally focused on preventing situations that would cause mass casualty. Rather than targeting specific foods or hazards, the rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities to: Identify and implement mitigation strategies to address these vulnerabilities. Establish food defense monitoring procedures and corrective actions. Verify that the system is working. Ensure that personnel assigned to the vulnerable areas receive appropriate training. Maintain records. Changes from the proposed rule (issued in December 2013) primarily address comment requests for additional information, and provide greater flexibility for food facilities in complying with the rule. While FDA acknowledges that intentional adulteration may take many forms, this rule is to prevent acts intended to cause wide-scale harm (vs singular acts, such as disgruntled worker contamination, or economic adulteration, which is addressed in the preventive controls rule). As such, the rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies, this includes 3,400 covered firms that operate 9,800 food facilities. The rule does not apply to farms. The Written Plan Each covered facility is required to prepare and implement a food defense plan, with reanalysis every three years or when certain criteria are met (e.g., mitigation strategies are determined to be improperly implemented). The plan must include: Vulnerability assessment: Identification of vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, the facility must assess the severity and scale of the potential impact on public health (e.g., volume of product, number of servings, number of exposures, distribution speed, potential agents of concern and their infectious/lethal dose, possible number of illnesses and deaths); degree of physical access to the product (e.g., are there gates, railings, doors, lids, seals, shields, etc.?); the ability to successfully contaminate the product. Mitigation strategies. Tailored to the facility and its procedures, mitigation strategies must be developed for each actionable process step to provide assurances that vulnerabilities will be minimized or prevented. Mitigation management. Steps must be taken to ensure the proper implementation of each mitigation strategy, as appropriate to your operation and product, to include monitoring (establishment, implementation, and determination of frequency); corrective action; and verification activities that ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made. Training to ensure that personnel assigned to the vulnerable areas receive appropriate training. Recordkeeping. Maintaining records for food defense monitoring, corrective actions, and verification activities Exemptions and Compliance Dates Exempted from the rule are: Very small businesses. However, the business must have, within 5 years, documentation to demonstrate that the business is very small to provide to FDA upon request. (See FDA’s Compliance Date and Exemptions for the very small business description.) The holding of food, except when in liquid storage tanks. The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact. Activities that fall within the definition of “farm.” Manufacturing, processing, packing, or holding of food for animals. Alcoholic beverages under certain conditions. On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices (e.g., certain types of eggs and game meats) – but only if these are the only activities conducted by the business subject to the rule. The rule is effective July 27, but because FDA recognizes that this rule is a first of its kind, requiring education and outreach and food facilities are concurrently working on other FSMA rules, the Agency is providing a longer timeline for compliance. After publication of the final rule: Small Businesses (fewer than 500 employees) – 4 years. Other Businesses – 3 years. Additionally, FDA established an Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance to develop food defense training resources for industry and regulators, intends to publish guidance, and is planning a webinar for June 21, 2016, to present key pieces of the final rule. Tools and resources currently available on FDA’s Food Defense website (previously developed for the voluntary food defense program) include a Mitigation Strategies Database, providing a searchable listing of strategies that can be applied to different steps in a food operation and the FDA FSMA Food Safety Technical Assistance Network, where questions can be submitted for response by information specialists or subject matter experts. FDA has done an excellent job of developing a range of tools since 9/11 to help food companies build food defense plans. My advice to food companies who have to comply with the Food Defense Rule is to take a good look at these FDA resources. They are easy to use and will drive you toward compliance, so make use of them and make compliance with this last of the seven major rules easier on yourself. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
