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3820997074?profile=RESIZE_710xThe FDA has launched its Food Defense Plan Builder (FDPB) Version 2.0 software programme, which is a user-friendly tool, designed to help owners and operators of food facilities create a detailed food defence plan specific to their facility and products. It is designed to assist food operators with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121) (IA rule). The software provides a simple-to-use, fill-in-the-blanks system that—when finished—can generate a complete report that is consistent with FDA’s existing regulations and guidance on food defence. While the finished report that the software generates does not constitute FDA approval of a food defence plan, the tool certainly goes a long way in helping a processor organise, create and document a detailed food defence program and strategy.

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The FDA has issued its second installment of how companies should take measures and mitigation strategies to protect themselves against intentional adulteration (IA rule), which is a requirement of the recent Food Safety Modernization Act (FSMA). The draft document is out for consultation, which closes on 5 July 2019. The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the USA. There are some exceptions including farms, except farms producing milk. Companies are required to develop/implement a food defence plan identifying vulnerabilities, and how to deal with them, and ensure they are working. The FSMA covers attacks intended to cause wide scale public health harm to humans including acts of terrorism focused on the food supply, and these are ranked as the highest risk. There is also intentional adulteration for economic gain with or without any safety implications; acts of disgruntled employees, consumers, or competitors. The IA rule is focused on addressing only acts causing wide scale public health harm, and not acts of disgruntled employees, consumers, or competitors, or acts of economic gain without public health implications. 

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The new guidance from the U.S. Food and Drug Administration aims to help food businesses understand and comply with the new Intentional Adulteration Rule, which comes into effect in July 2019. The IA Rule requires businesses to implement strategies to reduce the risk of intentional adulteration at food facilities that are particularly vulnerable.

The 94-page draft guidance, which is the first of three installments, includes chapters on the Food Defense Plan, vulnerability assessment, and mitigation strategies. The other installments will be released later in the year.

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The FDA is responsible for food safety enforcement of all food production except any product with a meat or poultry ingredient. This often leads to duplication of inspection by the two agencies for many producers manufacturing a range of foods. A new formal agreement between the FDA and USDA will lead to better coordination and collaboration between the two agencies in food safety inspections, the update of biotechnology regulations and the implementation of new preventative safety inspections on produce farms.


Read the full article at: USDA FDA Coordination

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