FDA’s Daniel McChesney explains CGMPS and preventive controls, and other factors outlined in the final animal food rule.

ATLANTA, GEORGIA, U.S. — The American Feed Industry Association (AFIA) hosted a full-day Phase III “Food Safety Modernization Act — Preparing for Implementation for the Animal Food Industry” seminar at the International Production & Processing Expo (IPPE) in Atlanta, Georgia, U.S., on Jan. 27. More than 250 expo attendees were in attendance.

The third of a three-phase training set over two years, covered various components of the new FSMA final rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals,” and focused on the implementation process.

“FDA estimates the cost of FSMA to be between $135 to $170 million per year,” said Richard Sellers, AFIA senior vice-president of public policy and education. “FDA suggests firms keep electronic records and use existing history or past records in supply-chain management to help reduce costs.

“However, AFIA maintains the costs of FSMA implementation to the industry to total more than $1 billion.”

Presentations from various AFIA staff members covered the creation of an animal safety plan, how to develop an effective supply-chain program, recordkeeping for FSMA compliance and an overview of the Foreign Supplier Verification Program and third-party rules.

“There is not always a bright line between current good manufacturing practices (CGMPs) and preventive controls,” said Daniel McChesney, U.S. Food and Drug Administration’s Center for Veterinary Medicine director of office of surveillance and compliance. “Think of CGMPs as observational, routine, facility and staff focused, whereas preventive controls occur in the process and controls or eliminates hazards.”

The FSMA final rule was published on Sept. 17, 2015. The first implementation period will affect firms with more than 500 employees (regular firms) and begins Sept. 19. Facilities in those firms must be in compliance with the current good manufacturing practice provisions of FSMA.

Small firms (less than 500 total firm employees) must begin CGMP implementation on Sept. 19, 2017. Large firms must complete implementation of preventive controls (PCs) by this date and small firms must complete implementation of PCs by Sept. 18, 2018. Very small firms, those with under $2.5 million in sales annually (as determined by the last three years’ average), that have notified the U.S. Food and Drug Administration of their size, have until Sept. 17, 2019, to complete CGMPs.

AFIA is planning a series of webinars for later this year to provide this complete training in a different format. Also, preventive control qualified individual training will be set when the lead instructor training is established for trainers.