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for comments (closed at this time) are listed as well as the date for finalization of each specific regulations, the effective date when the food processing industry must be in compliance and FDA’s date for beginning to enforce each regulation. Note that the “Final Rule Publication” date in the table above is based on US FDA agreeing to meet the court-ordered deadline, based on the consumer’s group’s successful lawsuit against US FDA. The regulation that is of largest concern to most food processors is the “Preventive Controls for Human Food” which if finalized in its proposed form, would: • Define “processors” and “farms” with farms not required to comply with the Preventive Controls proposed requirements. • Require every food processing plant to designate a “qualified individual” that has primary responsibility for the plant’s food safety program and compliance with all FSMA provisions. 18 3/14 eFOOD-Lab international • Require all non-exempt food processors to have a written food safety plan, a written hazard analysis, identify preventive controls to significantly reduce or eliminate identified food safety risks and hazards. Preventive controls must be written by the processing plant and address at a minimum: - Supplier controls - Allergen controls - Processing controls - Traceability - Recall Plan - Intentional Contamination/Food Defense - Processing plant employee training - Validation of processing equipment functionality and cleanability - Validation of the processing plant’s pathogen reduction method FSMA Regulation Comment Period Closure Final Rule Publication Effective Date Industry Compliance Date(s) Preventive Controls for Human Food - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food November 22, 2013 No later than August 30, 2015 60 days after publication of final rule Small Business (fewer than 500 persons & does not qualify for exemption) – 2 years after publication Very Small Businesses – 3 options – 3 year after publication: 1. Less than $250,000, or 2. Less than $500,000, or 3. Less than $1,000,000 All Other Businesses –1 year after publication. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals March 31, 2014 No later than August 15, 2015 60 days after publication of final rule Very Small Businesses – 3 years after the publication Option 1 less than $500,000 in total annual sales of animal food Option 2 less than $1 million in total annual sales of animal food; or Option 3 less than $2.5 million in total annual sales of animal food. Small Businesses – fewer than 500 persons – 2 years after publication. All Other Businesses – 1 year after the publication. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (Produce Rule) November 22, 2013 October 31, 2015 60 days after publication of final rule. Farms covered by the proposed rule: Very Small Businesses – (average annual monetary value of food sold during the previous three years of no more than $250,000) – 4 years after publication, for some water requirements, 6 years. Small Businesses – (average annual monetary value of food sold during the previous three years of no more than $500,000) – 3 years after publication, for some of the water requirements, 5 years. Other Businesses – 2years after publication, for some of the water requirements, 4 years. Farms would be partially exempt from the proposed rule if they meet two requirements. First food sales must average less than $500,000 per year during the last three years (adjusted for inflation). Second, their sales to qualified end-users must exceed their sales to others during the same period. A qualified end-user is either a consumer (in any location) or a restaurant or retail food establishment located in the same State as the farm or not more than 275 miles away from the farm. Intentional Adulteration - Docket Number March 31, 2014 No later than May 31, 2016 60 days after publication of final rule Very Small Businesses – less than $10,000,000 in total annual sales of food – 3 years after the publication. Small Businesses – fewer than 500 persons – 2 years after the publication. All Other Businesses – 1 year after the publication. Sanitary Transportation of Human & Animal Food - Docket Number May 31, 2014 No later than March 31, 2016 60 days after publication of final rule Small Businesses – employs fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts – 2 years after the publication. All Other Business – 1 year after the publication. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals January 27, 2014 No later than October 31, 2015 60 days after publication of final rule The importer would have to comply 6 months after the domestic compliance date for the Preventive Controls Regulations Accreditation of Third- Party Auditors January 27, 2014 No later than October 31, 2015 The FDA intends to implement the program at the earliest date possible after publication of the final rule and the final Model Accreditation Standards. Qualit y Management


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