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Follow on Google News |  US FDA Releases Changes in Four of the Core Food Safety Modernization Act RulesOn 19 September 2014 the United States Food and Drug Administration (US FDA) released to the public the changes in four of the core Food Safety Modernization Act (FSMA) rules. (1)
Major Changes in Produce Safety Rule (2, 3) - Making the water quality standard and testing of the water more flexible. - Removing the nine month minimum time interval between the application of untreated manure and harvesting and 45 day minimum application interval for compost manures. - Farms covered better defined as greater than $25,000 USD annual produce sales. - Clarify the withdrawal of the qualified exemption process. - Clarify the provision on excluding wild animals from the fields. - Compliance dates – four years for very small businesses, three years for small businesses and two years for other businesses, after the effective date. Compliance dates for water quality standards, testing and record keeping, are an additional two years after the main compliance date. Major Changes to Preventive Control Rule for Human Food (4, 5) - Farms that pack or hold food from other farms are exempt from the Preventive Control rule. - Definition of a very small business is less than $1 million USD sales. - Clarify the withdrawal of the qualified exemption process. - Product testing, environmental monitoring and supplier control monitoring added to the proposal. - Requirement to address economically motivated adulteration as part of the hazard analysis. - Compliance dates – three years for very small businesses ($1 million US annual sales) modified requirements, two years for small businesses (fewer than 500 people) and one year for other businesses, after the effective date. Major Changes to Preventive Control Rule for Animal Food (6, 7) - Current Good Manufacturing Practices (cGMPs) made more applicable to animal food. - Definition of a very small business is less than 2.5 million USD annual sales. - Clarify the withdrawal of the qualified exemption process. - Product testing, environmental monitoring and supplier control monitoring added to the proposal. - Requirement to address economically motivated adulteration as part of the hazard analysis. - Should feed mills associated with fully vertically integrated farming operations be registered as a food facility. - Compliance dates – three years for very small businesses ($2.5 million US annual sales) modified requirements, two years for small businesses (fewer than 500 people) and one year for other businesses, after the effective date. Major Changes to the Foreign Supplier Verification Program (8, 9) - Proposal for the importer to combine hazard analysis of each food with the already proposed requirement of a compliance status review for each food and supplier. This will involve importers taking into account whether there is a current and/or previous history of violation of US regulations, including: -Hazards in food -Who applies the hazard control (the manufacturer, importer or buyer) -Foreign supplier’s procedures related to food safety -Applicable US regulations and supplier’s compliance to them -The supplier’s food safety history - Supplier verification option 1 and option 2 are now combined: -“When there is reason to believe that a hazard will cause serious injuries or deaths, a clear, rigorous verification standard is required in the form of annual on-site auditing of the supplier. Importers would be allowed to use a different approach (possibly including less frequent auditing) only if they can establish that it will provide adequate assurance that the hazard is controlled”. - Definition of a very small importer is less than $1 million US annual sales. - The compliance date is 18 months after the publication of the final FSVP regulations, with exceptions. Where food imports are subject to Preventive Controls or Produce Safety rules, then the importer’s compliance dates are 6 months after the Produce Safety or Preventive Control compliance date. The comment period begins 29 September 2014 and ends after 75 days (13 December 2014). The US FDA will evaluate all comments from the proposals and these re-proposals in finalizing these rules. For more information on FSMA and how to comment on the proposed regulations visit the US FDA website (http://www.fda.gov/ References: (1) US FDA Constituent Update (http://www.fda.gov/ (2) US FDA Standards for Human Consumption (http://www.fda.gov/ (3) US Federal Register (https://www.federalregister.gov/ (4) US FDA Preventive Controls for Human Food (http://www.fda.gov/ (5) Federal Register Preventive Controls for Human Food (https://www.federalregister.gov/ (6) US FDA Preventive Controls for Animal Food (http://www.fda.gov/ (7) Federal Register Preventive Controls for Food for Animals (https://www.federalregister.gov/ (8) US FDA FSVP for Importers of Food for Human and Animals (http://www.fda.gov/ (9) Federal Register FSVP for Importers of Food for Human and Animals (https://www.federalregister.gov/ About SGS Food Safety Services SGS is committed to keeping readers informed of regulatory news and developments. Leveraging a global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical testing, audits, certifications, inspections and technical support (http://www.sgs.com/ For further information please contact an SGS expert. Website: www.foodsafety.sgs.com SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world. End
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