AFIA Applauds FDA Decision to Extend Some FSMA Compliance, Inspection Deadlines

The American Feed Industry Association praises the Food and Drug Administration’s announcement yesterday to extend its deadlines and inspection timeframes for when certain-sized facilities should come into compliance with some Food Safety Modernization Act (FSMA) rules and regulations. By extending the deadlines, the FDA will have more time to release the final FSMA guidance documents and train its inspectors, while the regulated animal food industry will have greater opportunity to perform the necessary retrofits to animal food safety plans and processes to ensure full compliance with federal regulations.

 

“Throughout the rulemaking process, AFIA has asked the agency to take a staggered approach to implementation to allow the industry time to focus on current good manufacturing practice (CGMP) implementation and also to receive the necessary guidance to properly implement the hazard analysis and risk-based preventive controls (HA/PC) requirements,” said Leah Wilkinson, AFIA’s vice president of public policy and education. “AFIA applauds the agency for continuing to offer this staggered approach and flexibility as the industry implements these broad sweeping regulations.”

Small-sized animal food facilities (i.e., firms with fewer than 500 employees) will need to come into compliance with the HA/PC regulations by Sept. 17, with the FDA delaying inspections until the fall of 2019. Initially, inspections were set to begin in January 2019, but the additional nine-months provides small-sized facilities the same opportunity that the FDA granted to large-sized facilities (i.e., those with more than 500 employees) to learn and implement the rules and regulations. The FDA intends to delay compliance for very small businesses (i.e., those with sales totaling less than $2.5 million and certified to the FDA) from the requirements applicable to qualified facilities until the fall of 2020.

 

Starting Sept. 17, all three sizes of animal food businesses must comply with at least one portion of the FSMA regulations. Very small facilities must comply with the CGMPs for the first time. Large-sized facilities came into compliance with the HA/PC regulations last September, and the FDA will soon focus its inspection resources on CGMP inspections for all-sized facilities and preventive controls inspections only at large-sized facilities.

While the FDA has delayed inspections, compliance with the rules and regulations per the compliance date as previously published is still required for all animal food manufacturing facilities. The FDA reserves the right to take regulatory action should an animal food safety event occur during this time.

Signed into law Jan. 4, 2011, FSMA provides the FDA with sweeping new authorities and requirements for the animal food industry. The food and feed industries originally supported the bipartisan law, which, among other provisions, authorized the FDA to: promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, recall adulterated products and hire more than 4,000 new field staff. It is estimated that if fully implemented, the law will cost the U.S. feed and pet food industries more than $1 billion with little improvement to animal health, animal food safety or other real benefit. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.