As part of the implementation of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) released proposed regulations for facilities that process animal food last fall.  The draft regulations propose to establish Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-based Preventive Controls (HARPC) requirements for animal food facilities.  The public comment period closed on Monday.

NSAC submitted comments on the animal food regulations that focused on many of the issues we previously raised about the Preventive Controls for Human Food Rule, including concerns about the scope of coverage, farmers being subject to multiple sets of regulations, the need for scale- and supply-chain appropriate requirements for smaller facilities,  and the need for training for farmers and for FDA inspectors.

Earlier this month, FDA announced that it will be revising and seeking additional public comment on portions of the animal food regulations this summer along with the revisions to regulations for produce safety and preventive controls for human food.  This will provide an important opportunity to consider and comment on the overlap and interactions between the three sets of rules and their impact on farmers.

Congressional Hearings

Member of Congress raised a number of issues about the animal food regulations at appropriations hearings in the past two weeks.  Part of the focus has been on the scope of the proposed rule because many agricultural by-products are used in livestock feed.  Under the proposed regulations, farms and facilities that produce food and sell the by-products for use as animal food would be now subject to the regulation.  This creates significant compliance issues for those producers and businesses.

One example of these by-products is the use of spent grains left over from brewing beer that are then often sold and used in animal feed.  Under the proposal, brewers would be considered animal feed facilities subject to the rules because the spent grains are used in livestock feed.

Last week, at the House Agriculture Appropriations Subcommittee hearing on the FDA budget, Representative Chellie Pingree (D-ME) raised this concern with FDA Commissioner Margaret Hamburg, and Senator Susan Collins (R-ME) raised the issue this week at the Senate FDA budget hearing, calling it regulatory overreach.  Commissioner Hamburg replied that there are ways to address this issue through more reasonable solutions and said that FDA will be trying to address the issue in its re-proposals.

What’s Next?

The underlying problem areas common to all the draft FSMA regulations continue to be the scope and coverage of the rules, whether producers will be subject to multiple rules, and for diversified operations, how to ensure that farms are not inappropriately categorized as facilities subject to regulations designed for industrial food facilities.

These are fundamental issues that must be addressed if the final regulations are going to work in accord with, and not in opposition to, sustainable food and farming systems.  Hopefully the revised set of re-proposed rules that FDA will be issuing in a few months time for produce safety and preventive control for human food and animal food will get much closer to the mark of working with rather than against sustainable food and farming systems.