Office of Advocacy

Summary of February 20, 2002 Presentation Regarding EPA Metals Assessment Framework

The Office of Advocacy presents its views with respect to how EPA should proceed with the agency assessment of the hazards and risks of metals and metal compounds. The Office became involved in this subject through the EPA rulemaking that established a lower threshold for the reporting of lead, which culminated with the January 2001 final rule.

The Acting Chief Counsel for Advocacy advised Governor Whitman in April 2001 that the Toxic Release Inventory (TRI) rule was not based on sound science, and that the required internal peer review procedures had not been followed. The final rule preamble includes a determination to seek review of the final TRI rule by the Science Advisory Board (SAB), although the scope of that review remains unclear at this time. The December 2001 letter from Deputy Administrator Fisher announced this stakeholder meeting today to address the new metals framework, which includes consideration of the TRI rule.

In this presentation, we submit information about the state of the science of persistent bioaccumulative and toxic substances (PBTs) and metals as currently known to EPA, and new information from the December 2001 report by the Inorganics Working Group (IWG) to Environment Canada on metals hazard categorization. In this report, a group of 10 inorganics experts from government, industry and academia was tasked by the Canadian government to provide the latest views about this issue. They concluded that bioaccumulation and bioconcentration factors are generally not useful for hazard categorization, in agreement with the other published literature on this subject.

The December 2000 SAB handbook provides that all major technical scientific works, including major rules, such as the TRI lead rule, should be peer reviewed. Major rules, such as the TRI lead rule, should be subject to review by an independent body, such as the SAB. The required peer review did not occur prior to the final rule promulgation. The handbook also specifies the applicable procedures. Such procedures include panelist selection, conflict of interest procedures, materials to be reviewed, and public participation in the peer review process. The public should also be permitted to comment on the draft SAB charges before they are sent to the SAB.

The presentation includes suggested SAB charge questions. It seems most appropriate to determine first the appropriate framework for all metals generally, before the SAB addresses the specific application of any framework to the lead rule. To the extent that the SAB determines the TRI/lead rule science foundation may be inadequate, in agreement with our position, the TRI/lead rule should naturally be revisited by the agency.

I can be reached at 202-205-6964, or kevin.bromberg@sba.gov.