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Food Safety FSMA Proposed Rule for Hazard Analysis and Risk-Based Preventative Controls for Human Food UVM Extension Fact Sheet- January 2013 More information, including the complete text of the Produce Safety and the Preventative Controls proposed rules, how to comment, etc. is available from: www.fda.gov/food/foodsafety/fsma/default.htm What is the intent of the rule? Prevent problems that can cause foodborne illness Who does it apply to? Domestic and foreign firms that manufacture, process, pack or hold human food. Am I exempted? See back side for details on exemptions. What would be required? Written food safety plans that: a) identify hazards, b) specify the steps (preventative controls) that will be put in place to minimize or prevent those hazards, c) identify monitoring procedures, d) record monitoring results and e) specify what actions will be taken to correct problems that arise. Facilities would also need to comply with the updated Good Manufacturing Practices (see UVM Extension Fact Sheet on GMPs). How does a “preventative controls plan” compare to a HACCP plan? The general concepts are very similar. However, these “preventative controls plans” also cover monitoring, records, and corrective actions for items that are considered pre-requisite programs in HACCP, including food allergen controls, sanitation controls, and a recall plan. Preventative controls plans do NOT have a requirement for a Critical Limit as in HACCP plans. What oversight will the FDA have of my plan? FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. When would I need to comply (if I am not exempted)? *Large businesses (> 500 employees): 1 year after the FINAL rule is published *Small businesses (