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

Description of Peer Consultation Panel Pilot to Review HPV Submissions


Background

This pilot project will develop and test a process to review HPV Test Plan submissions.  Currently, EPA’s posts industry-developed Robust Study Summaries (RSS) and Test Plans (TP) on its website for 120 days to permit public comment.  During that comment period, EPA also reviews and comments on the RSS/TPs.  All comments are posted on EPA’s website.  Industry sponsors are free to accept or reject any particular comment, but must provide a written explanation or justification when rejecting comments.  These industry responses are also posted on EPA’s website.  This procedure was employed for almost all of the HPV Challenge submissions; however, there is a small number of Challenge chemicals that have not yet undergone this review and comment process.  Under the pilot, a number of those Challenge submissions in addition to a group of chemicals in the Extended HPV (EHPV) program [1] will be reviewed by panel members at one of two 2-day in-person meetings to be held before the end of 2008.  Approximately 40 chemicals will be selected by ACC and EPA to undergo review in this pilot project.   

Purpose of 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.  Panel meetings will be used to facilitate the exchange of expert opinions on the technical soundness of the RSS/TPs and to ensure full discussion 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 different parties to discuss scientific and technical comments with one another.

Approach

  • A panel of expert scientists will meet to discuss and comment on the adequacy of the test plans and robust study summaries submitted in the HPV Challenge or Extended HPV programs.  The panel members will include expert scientists from two organizations that have provided public comments on test plans submitted in the past (i.e., the Physician’s Committee for Responsible Medicine (PCRM) and EPA).  A third expert, who authored many of the comments submitted by Environmental Defense Fund on the original HPV Challenge submissions, will also serve on the panel.  A senior scientist from TERA will facilitate the panel meetings to ensure that all appropriate scientific issues are addressed.
  • The meetings will be open to the public and held at the U.S. EPA facilities in the Washington DC metro area.
  • Two 2-day meetings will occur before the end of 2008.
  • Panelists will provide individual comments and discuss their opinions.  Agreement or consensus is not required.
  • A meeting report will summarize comments and panelists’ opinions.
  • The meeting reports will be made available to the public via a TERA webpage.

Roles and Responsibilities

Sponsors

  • Sponsors will prepare and submit EHPV RSS/TPS to EPA.  Sponsor representatives will be invited to attend the meetings at which their RSS/TPs are scheduled for discussion.  They may participate in person or by conference call.  The sponsors should be prepared to answer clarifying technical questions from the panel members.  The sponsors will be permitted to ask panelists clarifying questions to ensure comprehension of panelists’ comments.
  • The sponsors will consider the panelists’ comments and revise their test plans accordingly, and/or prepare an explanation for rejecting comments.  The final test plan will be submitted to the EPA docket.

Panelists

  • Each panel member will review the RSS/TPs prior to the meeting and come to the meeting prepared to discuss the adequacy of the RSS/TP for HPV.
  • Panelists will be asked to send TERA initial comments or questions prior to the meeting so they may be distributed to the sponsors to aid them in their preparations for the meeting.  TERA will send these initial comments (omitting attribution) to the appropriate sponsors.  TERA will send initial comments (with attribution) to other panel members.  Because these are panelists’ initial thoughts, these comments will not be part of the official record and will not be distributed beyond the sponsors and panel members.
  • Individual panelists are not precluded from contacting the industry sponsor directly to ask for additional information or clarification prior to the meeting.  If a panelist does so, he or she will inform the other panelists (by email prior to the meeting), of the nature of the communication and describe or characterize the information obtained.  Outside parties, including sponsors, should not contact panel members, except through the TERA coordinator.  Consideration for such contact will be made on a case-by-case basis and any and all information gained from this contact will be shared at the meetings.
  • Panelists are encouraged to prepare written comments that will be raised at the meeting and included in the meeting report.
  • At the meetings, panel members will actively discuss the adequacy of the RSS/TP and address the charge questions:
    • Does the information [2] provided address the SIDS endpoints?
    • Is the information provided is adequate to support the conclusions for each relevant SIDS endpoint?
    • If a category is presented, is the rationale for the category reasonably appropriate, and is the use of read across scientifically defensible?
  • Brief conclusion statements for each charge question will be drafted and reviewed by panelists prior to the meeting conclusion.

Public

  • The public will be invited to participate and will be provided the opportunity to attend the meetings to observe, submit written comments on the test plans, and/or make brief technical comments at the meetings.  Comments can be submitted to TERA through the TERA website and TERA will email the comments as they are received to the panel members and appropriate sponsors.  TERA will make sure that the panel members also receive any public comments posted to the U.S.EPA docket.

ACC

  • Secure funding for the peer consultation process.
  • Participate in planning the pilot and evaluation of the pilot.
  • Facilitate participation of sponsor companies and consortia in the pilot.

TERA

  • The pilot will be administered by TERA, which will be responsible for:
    • Developing the pilot approach;
    • Organizing and conducting the meetings;
    • Announcing the meetings to interested persons;
    • Facilitating the meetings to ensure all agenda items are discussed and all panel members are fully heard;
    • Preparing a report that summarizes the comments and results of the discussions;
    • Posting the results; 
    • Developing evaluation criteria for the pilot; and,  
    • Conducting the evaluation.

Guidance to Panel

  • In preparation for the first consultation meeting, TERA will convene a conference call with panelists and ACC to discuss:
    • The pilot process;
    • Roles and responsibilities of ACC, EPA, panel members and TERA;
    • Meeting structure;
    • Schedule of meetings; and,
    • Scope and guidance for panel comments and discussions (i.e., the charge).
  • For the peer consultation meetings, panelists will be asked to comment on the adequacy of the RSS/TPs for the HPV program.  The panelist comments should focus on the charge questions outlined above.

Communication with the Public

  • An objective of the pilot is to design and implement a process that is transparent, allowing interested persons to be informed, as well as participate by way of submission of comments and observation of the meeting discussions.  TERA will communicate with the public to inform them about the HPV Peer Consultation Pilot through the following means:
    • TERA will prepare and maintain a web page that will provide key information on the pilot project and each meeting. 
      • The TERA web page will link to the appropriate EPA site to provide users with access to the RSS/TPs. 
      • A description of the pilot process and schedule will be made available.
      • Interested persons will be invited to submit comments, and information on how to submit technical comments will be provided.
      • Reports from the panel meetings will be posted.
    • TERA will develop and maintain an email list to send announcements on meetings, requests for public comment, and other pilot activities. 
      • Interested persons can sign up for this list via the TERA web page or by directly contacting TERA. 
      • An initial email will be sent to TERA’s peer consultation mailing list to inform them of this new project and invite them to sign up for future notifications. 
      • TERA will also encourage other stakeholders in the project to inform their constituents via press releases, email or list server notifications, or other means. 

Meeting Reports

  • A TERA senior scientist will take notes of the panel discussions and prepare a brief report in bulleted form of the panelists’ conclusions concerning the charge questions.  The report will append the individual panelist written comments, if available.  The draft report will be reviewed and approved by the panel.  The final report will be posted on the web page and a notification will be sent to the mailing list.   

Meeting Logistics

  • Meetings will be held at EPA offices in the Washington DC area.
  • If sponsors cannot answer all questions or provide needed information at the meeting, the Facilitator will suggest that the remaining discussion be postponed until the information is available.  This may be at a later time on the current meeting agenda or at the second meeting.  If this is not possible, TERA will consider distributing the answer/information to the panel post meeting for their consideration and revision to individual comments.

  Evaluation of the Pilot

  • The pilot process and results will be evaluated by participants in early 2009.
  • TERA will discuss evaluation criteria and process with ACC and EPA prior to the first meeting of the Panel and will conduct the evaluation.


[1] The original Challenge program involved chemicals reported to EPA on the 1990 Inventory Update Rule (IUR) as manufactured or imported in volumes greater than 1 million pounds per year.  The EHPV program is industry’s voluntary continuation of the Challenge program.  Under the EHPV, companies committed to sponsor chemicals reported under the 2002 IUR as manufactured or imported at volumes of 1million pounds or more annually that had not been produced or imported in quantities sufficient to qualify as HPV under the Challenge program. 

[2] Note that exposure and use information that is part of the HPV or EHPV submissions is not subject to review in this Pilot; however, panelists may use this information to help inform their opinions regarding the screening level hazard needs.  

 

 

                                 2009 Toxicology Excellence for Risk Assessment