AFIA Issues Statement on Long-Awaited FDA Guidance

October 19, 2017

Contact Victoria Broehm

The American Feed Industry Association applauded the Food and Drug Administration today for taking a step in the right direction in issuing long-awaited guidance for the feed industry to comply with several parts of the Food Safety Modernization Act (FSMA). AFIA urges the agency to provide time for compliance as the industry fully reviews the guidance and implements the necessary, and sometimes costly, changes at its facilities.

Richard Sellers, AFIA’s senior vice president of public policy and education, provided the following statement:

“For the past year, federal regulators have been inspecting our “large” (over 500 employees) member companies’ facilities using draft guidance for FSMA’s Current Good Manufacturing Practices (CGMPs), and the FDA required that our “small” (less than 500) member companies be in compliance with the CGMP regulations as of Oct. 1 this year. Our members have been at an unfair disadvantage over the past year complying with the CGMP regulatory requirements as many questions have arisen with regard to what improvements need to be made at the facilities and the areas for evaluation during inspections. We have heard from members about discrepancies in the issues raised from inspection-to-inspection and submitted a Freedom of Information Act request two months ago asking for the FDA to share its CGMP inspection tools and documents used by state officials so that we could provide more clarity to our members. We are hopeful that the final guidance issued today will clarify the requirements as well as ensure consistency among future inspections, but urge the agency to give the industry time to implement any changes necessary, given FDA’s delay in publishing its final guidance.

AFIA is also pleased to see the FDA moving forward with issuing draft guidance for facilities exempt from FSMA’s Preventive Controls for Animal Food rule. Although this is a step in the right direction in providing our members with more information about what is and what is not required of them based on their business types, the FDA needs to pick up the pace with issuing more guidance documents on other regulatory requirements within FSMA, including for the hazard analysis and risk-based preventive controls portion, which our large facilities are already required to be in compliance with and inspections will start on next year.

As noted in a Sept. 19 letter to FDA Deputy Commissioner of Food and Veterinary Medicine Dr. Stephen Ostroff, we stand firm that the FDA should grant additional compliance time to the feed industry as we are still learning FDA’s interpretations of the FSMA regulations and will need to make the necessary modifications at facilities across the country. With the steep estimated price tag of nearly $1 billion annually for the collective feed industry to comply with the animal food rule, which was geared more toward the human food industry, it is essential that the agency ensure these regulations are right and will bring about needed animal food safety improvements. We urge the agency to reopen the animal food rule to address the many issues our members have raised, given no other options for industry have been offered as required by federal law with regulations this cost-prohibitive.”