Nor should the examples provided be considered an inclusive list of all potential approaches to achieving the goal of the preventive measure. These examples should not be regarded as minimum standards. Example approaches are provided for many of the preventive measures listed in this document. FDA recommends that operators review the guidance in each section that relates to a component of their operation, and assess which preventive measures are suitable. Not all of the guidance contained in this document may be appropriate or practical for every food establishment, particularly smaller facilities and distributors. Accordingly, FDA recommends that both management and staff participate in the development and review of such measures. To be successful, implementing enhanced preventive measures requires the commitment of management and staff. This guidance is designed to focus operator's attention sequentially on each segment of the farm-to-table system that is within their control, to minimize the risk of tampering or other malicious, criminal, or terrorist action at each segment. FDA recommends that the review include consideration of the role that unit and distribution packaging might have in a food security program. Operators of food establishments are encouraged to review their current procedures and controls in light of the potential for tampering or other malicious, criminal, or terrorist actions and make appropriate improvements. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. It is not intended as guidance for retail food stores or food service establishments.įDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. It is relevant to all sectors of the food system, including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, and warehouses. This guidance identifies the kinds of preventive measures operators of food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. This is a very diverse set of establishments, which includes both very large and very small entities. This guidance is designed as an aid to operators of food establishments (firms that produce, process, store, repack, relabel, distribute, or transport food or food ingredients). We encourage users to become familiar with the guidance document before using this tool. Please note that the Food Defense Self Assessment Tool is derived from the above referenced guidance and we have deleted examples and references to other agencies and their regulations. Appendix: Food Defense Self Assessment Tool for Food Producers, Processors, and Transporters.Incoming Materials and Contract Operations.Storage and Use of Poisonous and Toxic Chemicals (for example cleaning and sanitizing agents, pesticides).Visitors (for example, contractors, supplier representatives, delivery drivers, customers, couriers, pest control representatives, third party auditors, regulators, reporters, tours).Screening (pre-hiring, at hiring, post-hiring).Preparing for the possibility of tampering or other malicious, criminal, or terrorist actions.If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.
If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. 中國傳統 (Traditional - Chinese PDF, 244KB).The agency intends to publish guidance documents to provide information relevant to the provisions of the final rule. FDA issued a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration in May 2016. NOTE: The guidance below is out of date and no longer represents FDA’s current thinking.
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