FDA Reportedly Extends Comment Period on FSMA Rules; Comments Requested on Facility Registration CPG

April 22, 2013

By Ricardo Carvajal

FDA reportedly intends to extend the comment period on the preventive controls and produce safety proposed rules by an additional 120 days (the comment period was scheduled to expire on May 16).  The extension was requested in a letter by the United Fresh Produce Association and other stakeholders, which noted that the two rules are voluminous and “intersect at many different points.”  Further, the letter notes that FDA “requested comments on over 100 questions,” some of which “require scientific and economic analysis that could take months if not years to synthesize comments around.”  The letter requested an extension of at least 180 days after the issuance of the proposed rules on foreign supplier verification, preventive controls for animal feed, and accreditation of third-party certifiers so that industry has an opportunity to evaluate and comment on all of the proposed rules at the same time.  The three latter rules continue to be under review at OMB, which suggests that their issuance is not imminent.

Earlier in April, FDA requested comment on a draft compliance policy guide ("CPG") on food facility registration.  The CPG states FDA’s policy with respect to initial and biennial registration, as well as suspension of registration.  Comments are due by May 6.