The Perchlorate Study Group is highly concerned with the EPA’s proposed framework for assessing its approach to perchlorate regulation, as it is insufficient to assure the quality of the peer review process, and the omission of important scientific considerations casts doubt on the transparency of the entire regulatory effort.
At issue is EPA’s Draft Peer Review Charge Questions on the Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Containment Level Goal for Perchlorate in Drinking Water. There are five main areas of concern:
- There is not enough time for peer reviewers to properly review EPA’s approach, jeopardizing the quality of the peer review process. EPA has set an enormous task before its peer reviewers: conduct a critical review of more than 500 pages of dense scientific documentation within 45 days of its publication. This inadequate amount of time provided will jeopardize the quality of the peer review and undermine its credibility.
- EPA has not established a process to critically review the updated perchlorate model based on the criticisms of the first peer review panel. EPA is presenting a significantly-changed model in its draft report, but has failed to include the criticisms of the first peer review model, which results in an unclear process to critically review the new model. There must be a complete evaluation by those with expertise in PBPK modeling, maternal endocrinology, cognitive sciences, and epidemiology, and they must have adequate time to review the model fully.
- The manner in which EPA’s Charge Questions are written is inconsistent with the Agency’s own Peer Review Handbook. In short, all questions should be rewritten for the Agency to obtain the quality of scientific information it seeks.
- Omission of questions on specific subjects casts the transparency of the process into doubt and must be addressed with additional questions. It is not in the Agency’s best interest to focus peer reviewers on a small portion of a robust scientific database when the Agency needs a strong scientific rationale for deciding how to regulate perchlorate.
- Regarding the Interim List of Peer Reviewers, additional disciplines are required which are not represented by the scientists listed on the Interim List. These include Developmental Psychologists, Clinical Psychologists, Receptor Pharmacologists, and Thyroid Endocrinologists, all of which must be included for a meaningful review.
EPA only provided 15 days for public review and comments of its 500-page document. Based on the concerns identified in just this short time frame, it is clear EPA should provide much more time for peer reviewers to assess its approach, take additional steps to ensure it has the necessary disciplines and expertise on the panel, and provide panelists with all the information they need to conduct a thorough review.
Please visit www.perchlorateinfo.org for factual information on perchlorate, or contact Bill Romanelli at 916-212-1446 (cell).