NGFA Provides Comments on FDA's Draft Guidance For FSMA Supply-Chain Program

This article has been reprinted from the NGFA Newsletter.

NGFA has submitted several recommendations to the U.S. Food and Drug Administration (FDA) that would clarify the agency’s draft animal food supply-chain program guidance being implemented under the Food Safety Modernization Act.

FDA’s draft guidance, when finalized, is intended to assist animal food facilities in complying with the requirements of the agency’s final rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal Food Rule) for establishing and implementing a supply-chain program for their suppliers.

In the Dec. 12 statement authored by NGFA Senior Vice President of Feed Services Dave Fairfield, NGFA outlined several sections of the FDA’s draft guidance (“Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program”) that could use further clarifications or definitions.

“Confusion still remains within the animal food industry about the supply-chain program regulatory framework as established by the Animal Food Rule, and how the provisions interface with existing supply-approval programs,” the statement noted.

NGFA recommended that FDA specifically note within its final guidance how the supply-chain program differs from how the industry historically has defined and used supplier programs.

The final guidance also should state clearly that the Animal Food Rule requires implementation of a supply-chain program only when a facility has determined that a hazard requiring a preventive control in a raw material or ingredient is to be controlled by the supplier prior to receipt by the facility.

The full statement outlines several specific areas in which the guidance document could be revised.

NGFA commended FDA for conducting an “open and collaborative process” during the rulemaking process for the agency’s final Animal Food Rule.

“We also appreciate the agency’s on-going commitment to providing a variety of resources – including guidance documents – to assist the industry in understanding and meeting regulatory expectations,” the statement noted.

“We believe that, once finalized, FDA’s Supply-Chain Program Guidance for Industry will be valuable to facilities when developing compliance strategies and assuring animal food safety.”