Legislative Update

As of February 16, 2012, we are still waiting for the publication of several important new proposed rules from FDA in regard to FSMA implementation. What we know is that four proposed rules are currently under review by the Office of Management and Budget (OMB). The FDA fulfilled its mandate to write proposed rules for the Produce Safety Regulation (Section 105); Hazard Analysis and Risk-Based Preventive Controls (Section 103); Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (Section 103); and Foreign Supplier Verification Program (Section 301) by the January 4th, 2012, deadline but these rules are still under review by OMB.

This review process is one that FDA has no control over and, while those in leadership positions in FDA are saying they hope that the proposed rules will be out "soon," in reality they have little more direct insight than the rest of us.

Several other factors are relevant around this timing including how much the "effective" date will shift based on this delay. The legislation indicates the effective date for the preventive controls is July 2012 but this will likely slip somewhat due to the delay. Another question that is now being asked is whether the pending election will have an impact on timing of release of the proposed rules. At this stage of the election cycle I suspect not; but the longer the delay, the more likely that movement out of OMB will grind to a total halt.

Finally the President has just released the budget request for 2013 in which FDA has asked for an increase for Transforming Food Safety of $253,359,000—of which, interestingly, 97% will be raised by user fees—many of them new, including a new proposed registration fee.

Editor's Note: Watch for continuing updates on this at David Acheson's Food Safety Blog.