For two days in October, the FDA convened an obscure panel named the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The general function of this committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The committee’s agenda included “sunlamp products including an update on the performance standards amendment.”
TEPRSSC last met in 2003 and discussed sunlamp products. At that meeting, the FDA proposed six amendments to the sunlamp standard. TEPRSSC approved all six with two modifications. These amendments were incorporated into the pending proposed rule amending the performance standard for sunlamp products (along with a number of other things that TEPRSSC did not consider).
Now that we are almost a year into the rulemaking process, it is not clear why the FDA convened this committee at this time and on such short notice. Repeated inquiries by multiple individuals asking the FDA why and for what purpose this committee was meeting shed zero light on the subject.
With the understanding that all the FDA staff with responsibility for the proposed rule would be present and that the public was invited to share its views with the committee, the ITA/ASA FDA team saw this meeting as an opportunity to once again get our views on the public record. In addition to submitting a comprehensive written summary of our concerns about the proposed rule, two members of our team requested and were granted time to address the committee.
Jim Shepherd explained to the committee how current science does not support the adoption of certain IEC standards for sunlamp products (including the recommended exposure schedule, equivalency codes, and protective eyewear transmittance requirements), and why FDA should be cautious “harmonizing” or “adopting by reference” IEC standards for sunlamp products that are often developed with a Eurocentric-focus. Jim asked the committee not to support the pending changes to the performance standard.
Allen Miller told the committee that here have been significant changes in the understanding of the benefits and risks related to sunlamp products since any FDA panel last met, and that the path which the FDA is now taking could actually harm public health. He also asked the committee to reject the proposed rule.
The committee asked good questions of our team, but did not give any feedback to the FDA regarding the proposed amendments to the performance standard. At this point, it is not clear if this meeting will slow, alter or have any impact on the FDA’s deliberations. In any event, we will continue pressing the FDA to start the rulemaking process over and convene a new panel to review the latest science before moving forward with any new regulations.
