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126 ❘ SPECIALTY FOOD MAGAZINE specialtyfood.com 3 Fundamental Elements The three fundamental elements are another means to identify vulnerability. They are: • Potential public health impact • Degree of physical access • Ability of an attacker to contaminate the product Even though it is uncomfortable for family-owned and employee-friendly specialty food businesses, FSMA stresses that the food defense plan must address the possibility of an insider attack and protect against that threat. Insiders are more danger- ous because they have access to the facility and understand how it operates. FDA has put together a worksheet that can assist manufac- turers in determining the potential public health impact. Element 1 utilizes aspects of production such as batch size, amount of product in final servings, servings per batch, and so on. FDA has put together a template so they can calculate vulnerability. For instance, a 10 represents over 10,000 people and/or servings at risk; a 5 means between 100 and 1,000 people and/or servings at risk. Element 1 also takes into account information on contami- nants that could be used to adulterate the product. Element 2 addresses the degree of physical access to the product. Again, a score is assigned. A 10 would mean that the product is easily accessible, such as: • Inside attacker can easily touch the product • There are no inherent characteristics that make access to the product difficult • Product is open and unsecured by packaging, equipment, or other physical barriers • Product is handled, staged, or moved in easily accessible manner Element 3 relates to the ability of an attacker to contaminate the product. Bulk liquid receiving and breading score high in that a contaminant could easily spread in these steps. After scoring the 3 Elements, manufacturers can determine their vulnerability to an attack. FDA also accepts a Hybrid Approach, which combines the 3 Fundamental Elements and Key Activity Types. The Agency stresses that there is f lexibility in each facility's approach, and that the person making the food understands where and how a product can be adulterated better than anybody. Mitigation Strategies The mitigation strategies requirement states that manufacturers must identify and implement mitigation strategies at each actionable process step to provide assurances that the vulnerability at each step will be significantly minimized or prevented. FDA defines mitigation strategies as "risk-based, reasonably appropriate measures that a per- son knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at action- able process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis." Minimizing accessibility is the primary goal of the mitiga- tion strategies. These can start as facility-wide security measures to protect personnel, property, or product. Security can serve as a foundation for a mitigation strategy but, by itself, is not a mitigation strategy. It needs to be supplemented with other strategies, which can be personnel, operations, or technology-based. Examples in the guidance include techniques such as using tamper-evident tapes or seals for partially used ingredient containers, installing locking mechanisms on equipment access points, and so on. Other examples include requiring workers at actionable process steps to wear uni- forms or clothing without pockets or other means to conceal items and increased observation of highly vulnerable areas. Placing cam- eras in the facility is not a mitigation strategy unless the cameras are monitored regularly. In the food defense plan, each mitigation strategy must include an explanation of how it significantly minimizes or prevents the vulnerabilities associated with the actionable process step. Food Defense Monitoring Food defense monitoring consists of observa- tions or measurements that assess whether miti- gation strategies are operating as intended. The monitoring must be written recorded. FDA recommends that monitoring be periodic but is more effective at irregular intervals, so a potential attacker cannot determine when the monitoring is taking place. The guidance states that facilities must: • Document monitoring in records that are subject to verification • Record information at time of observation, and • Capture observations and actual values, along with the time and date observation was made, and the signature or initials of the person who made the observation FDA's Food Defense Plan Builder FSMA requires that many people involved in the production of food be made aware of the Intentional Adulteration Rule. The Food Safety Preventive Controls Alliance has developed several programs FDA recommends that manufacturers put together a food defense team, which could include people from security, maintenance, food production, sanitation, etc. article bug specialtyfood.com ❘ SPECIALTY FOOD MAGAZINE 126 specialty food maker