Toxicology Excellence for Risk Assessment (TERA)

2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487

Email: TERA@TERA.org

Pilot Peer Consultation Panel to Review HPV Submissions


The HPV peer consultation pilot project will provide expert review of high production volume (HPV) chemical hazard robust study summaries and test plans prepared by industry sponsors under the HPV and Extended HPV (EHPV) Programs.  Under these programs, companies and consortia voluntarily sponsor chemicals that are manufactured or imported in the U.S. in quantities of 1 million pounds or more annually.  Sponsorship involves providing the U.S. Environmental Protection Agency (EPA) with a test plan and robust study summary, which is then posted on EPA’s public website for 120 days, during which time interested stakeholders and EPA may post comments on the content of the test plans and robust study summaries.  The industry sponsor is then free to incorporate or reject the comments made.  If the sponsor rejects the suggestions made, the sponsor prepares and provides a rationale for the rejection.   The American Chemistry Council (ACC), in cooperation with the broader chemical industry, the U.S. Environmental Protection Agency (EPA) and the Physician’s Committee for Responsible Medicine (PCRM), are launching this HPV Peer Consultation Pilot. 

About the Peer Consultation Pilot

The purpose of the pilot is to test a new approach to provide stakeholder and EPA input on the robust summaries and test plans.  The pilot will use in-person meetings of a small panel of stakeholder and expert scientists.  Panel meetings will be used to facilitate exchanging of expert opinions on the technical soundness of the RSS/TPs to better inform the ultimate stakeholder comments on the RSS/TPs, as well as insure completeness of comments for sponsor consideration.  The goal of a revised program is to expedite the review process for both EPA and stakeholder comments and present opportunities for the different parties to discuss scientific and technical comments with one another. 

Toxicology Excellence for Risk Assessment (TERA), an independent, non-profit scientific organization, has designed the pilot process and will convene and facilitate the technical peer consultation panel meetings.  The ACC is providing the funding to TERA for this project.  Click here for more details.

Meeting Reports
Peer Consultation Panel
Panel Meetings
HPV Submissions to be Reviewed
Public Comments
Guidance Documents

Meeting Reports

Two peer consultation panel meetings are planned.  The final reports from these meetings will be posted here when they are available.

The Peer Consultation Panel

The panel members will include expert scientists from PCRM, EPA, and a third expert who authored many of the comments submitted by Environmental Defense Fund on the original HPV submissions. 

  • Dr. Hazel B. Matthews, National Toxicology Program, retired

  • Dr. Chad Sandusky, Physician’s Committee for Responsible Medicine (PCRM)

  • Dr. Louis Scarano, U.S. EPA, Office of Pollution Prevention and Toxics

  • Facilitator: Dr. Michael L. Dourson, Toxicology Excellence for Risk Assessment

Panel Meetings

Meetings will be held on November 18-19, 2008 and December 15-16, 2008 at U.S. EPA facilities in the Washington DC area.  Meetings will be open to the public, but space is limited.  Click here for more information and to register to attend.

Meeting Agenda for Nov. 18-19 HPV Meeting (pdf)

Meeting Agenda for Dec. 15-16 HPV Meeting (pdf)

HPV Submissions to be Reviewed

The panel will review the robust study summaries and test plans on up to 40 EHPV and HPV chemicals.  Click here for a list of chemicals and schedule.  The robust summaries and test plans are available in the EPA EHPV docket. 

Public Comments

The public is encouraged to submit technical comments on the RSS/TPs that are scheduled for discussion by the peer consultation panel.  Public comments may be submitted directly to TERA.  TERA maintains an email list to provide those who are interested with announcements on the pilot project.  Click here to sign up for the email list.

Guidance Documents

The U.S. EPA has provided guidance documents to help companies prepare their submissions for the HPV Challenge program.  Click here to exit to EPA. 

The Organization for Economic Cooperation and Development (OECD) has guidance available for the Screening Information Datasets (SIDs) program.  Click here to exit to OECD.

 

 

                                 © 2008 Toxicology Excellence for Risk Assessment