Reaction to FDA finalising 2 FSMA rules
The Preventive Controls for Human Food rule and Preventive Controls for Animal Food rule have compliance dates for some businesses from September 2016.
The FDA published final rules in the Federal Register will be available from September 17.
Under the food-relevant rule, facilities must have a food safety system that includes an analysis of hazards and risk-based preventive controls.
FSMA, signed into law in January 2011, represents the first major overhaul of the nation’s food safety system in more than 70 years.
Mark Mansour, a litigation partner at Mayer Brown LLP, focuses his practice on FDA regulatory matters.
"In this set of rules, FDA clarified the rules as they apply to animal producers, with the main components of those tweaks being phased-in implementation that allows animal food facilities time to develop and execute Current Good Manufacturing Practices before implementing hazard analysis and preventive controls," he said.
"Large firms will implement their CGMP plans by September 2016 and will have until September 2017 to implement another year to implement preventive controls. Feed plants will not be required to implement preventive controls, and pet food manufacturers will be asked to focus on microbial controls.
"A major concern of the industry during the comment period centered around what it believed was insufficient distinction in the rules between preventive controls for human food and animal food, despite marked differences in their respective production processes.”
For more coverage on the impact of the feed rule visit our sister site FeedNavigator.
AFFI and CSPI reaction
Kraig Naasz, American Frozen Food Institute (AFFI) president and CEO, said it commends FDA for its current approach to FSMA implementation.
FDA will finalize the produce safety, foreign supplier verification program and third-party certification of auditors for foreign suppliers rules by 31 October.
“We appreciate and value the collaborative working relationships cultivated by FDA during the development of these rules, and we believe a comprehensive, systemic approach to food safety will continue to provide Americans with the safest possible food supply," he said.
“AFFI has invested significant resources to develop best-in-class tools and strategies to assist food and beverage makers prepare for and comply with the new food safety paradigm created by FSMA.
“We also stand ready to work with the administration and Congress to ensure sufficient federal resources are allocated to FDA’s critical food safety activities without imposing new costs on food makers and consumers through user fees."
David Plunkett, CSPI senior food safety attorney, said under the preventive controls rules manufacturers must develop food safety plans for how they will mitigate or prevent contamination during processing.
“Also, FDA inspectors will have access to more information about conditions in the food facility. This will help them ensure that companies are complying with their food safety plans," he said.
“CSPI is disappointed, however, that the FDA exempted thousands of companies that Congress intended to be covered by the new requirements.
“It has been a long slow slog, but our country has now taken a major step toward creating a truly modern food safety system, and that’s good news for consumers.
“Now Congress must fund FDA so that it could actually conduct inspections and help industry comply with the new requirements.”
GMA and FMI comment
Pamela Bailey, president and CEO of the Grocery Manufacturers Association (GMA), said it welcomed the final FSMA rules and commended FDA for the approach in developing the regulations.
“GMA is proud of its work to support FSMA and has taken a leadership role on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, in the US and along the entire global supply chain," she said.
“FSMA represents a comprehensive system of preventative measures so it is essential that FDA be appropriately resourced to effectively implement and enforce all of the food safety mandates set forth in the law.
“The food and beverage industry is committed to working with Congress, the Obama Administration and all stakeholders to ensure that Congress appropriates the necessary funding for FDA to fully implement FSMA.”
Hilary Thesmar FMI VP of food safety programs commended the agency for its commitment throughout the rulemaking process.
“FSMA represents the most sweeping change to our food safety laws in over in 70 years, and we will continue to work with FDA to analyze the rules and assess implications for the grocery industry.”
Keller and Heckman LLP is reviewing the final rules and implications for clients and interested parties, and will provide more detailed summaries soon.
The law firm said it would host a complimentary webinar to summarize the implications of these rules for the food industry, focusing on food processors and ingredient suppliers.
The Acheson Group (TAG) is also working on insight into the rules after the delay between being sent to the Federal Register and publication.
