Toxicology Excellence for
Risk Assessment (TERA)
2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Description of Peer Consultation Panel Pilot to
Review HPV Submissions
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 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.
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.
- 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.
meetings will be open to the public and held at the U.S. EPA
facilities in the
- Two 2-day
meetings will occur before the end of 2008.
will provide individual comments and discuss their opinions. Agreement or consensus is not required.
- A meeting
report will summarize comments and panelists’ opinions.
meeting reports will be made available to the public via a TERA webpage.
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’
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.
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.
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
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.
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:
the information provided address the SIDS endpoints?
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
conclusion statements for each charge question will be drafted
and reviewed by panelists prior to the meeting conclusion.
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.
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
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
preparation for the first consultation meeting, TERA will convene a
conference call with panelists and ACC to discuss:
and responsibilities of ACC, EPA, panel members and TERA;
- Meeting structure;
- Schedule of meetings; and,
and guidance for panel comments and discussions (i.e., the
- 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
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.
description of the pilot process and schedule will be
- Interested persons will be invited to submit comments,
and information on how to submit technical comments will
- 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
- 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
- TERA will
also encourage other stakeholders in the project to
inform their constituents via press releases, email or
list server notifications, or other means.
- 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.
will be held at EPA offices in the
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
of the Pilot
- The pilot
process and results will be evaluated by participants in early
- TERA will discuss
evaluation criteria and process with ACC and EPA prior to the
first meeting of the Panel and will conduct the evaluation.
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.
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.