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OMB Struck Product and Environmental Testing, Supplier Verification Programs and Consumer Complaint Tracking – Why?

Food Chemical News reports that the preventive controls proposal that FDA sent to the White House Office of Management and Budget in November 2011 would have required food companies to conduct environmental and finished product testing, maintain supplier verification programs, and track consumer complaints. But the OMB struck the requirements and those documents were recently posted online – Transparency is good, but it would be good to get an explanation for the deletions.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Proposed Rule); Publication Date: January 16, 2013

The September 30, 1993, Executive Order 12866 (Regulatory Planning and Review) sets forth the principles and requirements for the Federal regulatory process. Under section 6(a)(3)(E) of the Executive Order, for “significant regulatory actions,” Federal agencies must make certain information available to the public after publication of the regulatory action in the Federal Register.

Pursuant to the Executive Order for significant regulatory actions, FDA has attached in this docket the following information:

1) A copy of the draft regulatory action as submitted to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) for review, including materials required by the Executive Order that accompanied the draft (TAB A, comprised of two documents – one and two);

2) The substantive changes between the draft submitted to OIRA for review and the regulatory action subsequently published are shown in track changes text review, including materials required by the Executive Order that accompanied the draft (TAB B, comprised of four documents – one, twothree and four); and,

3) A copy of the final regulatory action as published in the Federal Register, and a final version of the materials required by the Executive Order that accompanied the draft (TAB C, comprised of two documents – one and two).

Hey OMB, why were these provisions cut out?

Product and environmental testing reveals where gaps are in a HACCP plan.  Testing is never foolproof, but only fools do not test.  Supplier verification programs make sense too.  A manufactured food product is only as safe as its inputs.  And, finally, consumer complaint tracking is really an early warning system that helps identify food safety problems before they become a food safety outbreak.

It begs the questions:  Who at OMB made these cuts?  And, who at OMB is the expert on food safety?