Background Documents for VCCEP Peer Consultation

 

General Questions

Questions about Panel Membership and Nominations

Questions about Conflict of Interest and Bias

Questions about the Meeting Process and Panel Charge

Questions about the Meeting Report

 

 

General Questions

 

What is VCCEP?

 

The VCCEP (Voluntary Children's Chemical Evaluation Program) is one part of the U.S. EPA’s Chemical Right-to-Know Initiative.  The goal of this program is to provide data enabling a better public understanding of the potential health risks to children associated with certain chemical exposures.  EPA has begun a pilot study of the VCCEP by asking companies that manufacture or import 23 chemicals found in human tissues and the environment to Sponsor an evaluation of these chemicals.  Industry Sponsors have volunteered for 20 of the 23 chemicals.  Sponsorship requires the companies to collect or develop health effects and exposure information on their chemical(s) and then to integrate that information in a risk assessment and a “data needs” assessment.  More information about the VCCEP is available on the EPA’s VCCEP website.

 

What is Toxicology Excellence for Risk Assessment (TERA)?

 

TERA is an independent, non-profit, 501(c)(3) scientific organization with the mission to protect the public health.  TERA’s activities include sponsoring and/or conducting scientific consultations and peer reviews, developing risk assessment documentation, doing research to improve risk assessment methodology, managing a risk values database, and providing risk assessment education to others.  TERA works with both government and industry, building partnerships among diverse parties to help protect the public health.  More background information on TERA's website.

 

What is TERA’s role in VCCEP?

 

TERA will conduct VCCEP peer consultations under the TERA peer consultation and review program.  In the VCCEP pilot study, the assessments developed by the Sponsors will be evaluated by a group of scientific experts (Peer Consultation Panel) with experience in toxicity testing, exposure evaluation, and risk assessment.  TERA will select Peer Consultation Panel members, convene, and chair panel meetings to evaluate the Sponsors’ submissions, and prepare the meeting reports.  EPA will use this report in making its decision on whether additional data are needed.  TERA is well qualified for these responsibilities because of the experience it has gained through its successful ITER Peer Review program and the experience of its staff in toxicology, exposure assessment, and risk assessment.  TERA was awarded an EPA cooperative agreement to establish a peer consultation process for the development and review of risk assessment documentation.  The VCCEP reviews will help to demonstrate and refine the peer consultation process.  See EPA’s website for additional information. 

 

Will the VCCEP Peer Consultation be science-based?

 

Yes.  Peer consultation is a science-based process.  Members of the peer consultation panels will be selected based on their expertise in scientific disciplines relevant to the chemicals, test methodologies, and risk assessment issues that will be discussed.  Nominations for panel members are welcome from all interested parties.  TERA will select the panel members from among those nominated and qualified, supplemented when needed by other experts TERA may independently identify.  More information on the nomination process is available on the TERA VCCEP web page.

 

How can I keep current with VCCEP Peer Consultation activities?

 

Email messages are periodically sent to interested parties regarding VCCEP peer consultation activities.  You can sign up by contacting Ms. Patricia Nance (nance@tera.org); fax: 513-542-7487; phone: 513-542-7475 x25. 

 

When and where will VCCEP meetings occur?

Meeting generally are held at the Kingsgate Marriott Conference Center located on the University of Cincinnati campus in Cincinnati, Ohio.  Details about each meeting are posted on our the TERA Peer Review & Consultation website.

 

 

Questions about Panel Membership and Nominations

 

What is the difference between the “Core” and “Ad Hoc” panel members?

Core panel members are experts with sufficiently broad areas of expertise to qualify them for service on most or all of the VCCEP panels.  Core panel members add continuity to the peer consultation program and will be asked to commit to serve on panels for one year.

Ad hoc panel members are experts selected to serve on a particular VCCEP panel because of their focused area of expertise, either on the chemical or issues relevant to its review. 

Core and ad hoc panel members may be self-nominated, nominated by stakeholders, or identified by TERA.

 

Will “seats” be reserved for nominees from specific stakeholders?

 

TERA will make every effort to select experts with divergent viewpoints so that each panel will have a range of scientific perspectives.  However, the primary objective of the VCCEP peer consultation process is to answer the question, "Have the potential hazards, exposures, and risks to children been adequately characterized?"  Therefore, while nominations for panel members are solicited from all interested parties, a VCCEP peer consultation panel is intended to be comprised of a group of scientific experts, not necessarily a group of stakeholder representatives.  Panel members are selected based on their expertise in scientific disciplines relevant to the chemicals, test methodologies, and risk assessment issues that will be discussed, not on the organizations that nominated them.  TERA expects all panel members to present and defend their personal scientific opinions at the meetings, not those of a particular group.  We accept nominations of many highly qualified scientists who are not aligned with stakeholder groups.

 

What is the tenure for core panelists versus ad hoc panelists?

 

Core panelists have a term of one year that may be renewed.  Ad hoc panelists are chosen for single meetings, although a particular individual may be invited to serve on other panels. 

 

Will TERA pay for panel members’ travel expenses and time? 

 

TERA will offer to pay travel expenses and an honorarium of $2500 for each peer consultation meeting attended.  This offer is the same for both core and ad hoc panelists.  Because our funding is from the U.S. Environmental Protection Agency, employees of the U.S. Environmental Protection Agency are not permitted to accept travel expenses or honoraria for VCCEP.

 

How can I nominate an expert for a panel?  Will TERA accept self-nominations from potential core or ad hoc panel members?

 

Nominations for core panel members (those who serve on all panels for a set period of time) and ad hoc panel members (those who are selected for a particular meeting) are accepted from any interested party.  TERA will accept self-nominations for both core and ad hoc panel members.  When nominating candidates, nominators should confirm the candidate’s agreement to serve on a panel, with core members committing to a term of at least one year.  Nominations may be submitted to TERA via U.S. mail or email (email is preferred) and should include a letter describing the candidate’s qualifications and the candidate’s CV.  More information is available at TERA's VCCEP Nomination & Selection web page. 

 

What outreach does TERA conduct to request nominations for ad hoc members? 

 

Our outreach is via email to stakeholders who participated in EPA’s original meetings and all others who have asked to be on our email list.  (To sign up for the email notification list, please send email to Ms. Patricia Nance at nance@tera.org.; fax: 513-542-7478; phone: 513-542-7475 x25)  We also post this information on TERA’s website.  In selecting panel members, TERA considers those nominated by stakeholders and the general public, self-nominations, and scientists we independently identify.

 

If an individual serves on one VCCEP panel as an ad hoc member, is that person less likely to be selected for another panel?

 

No.  The ad hoc panel members for each VCCEP meeting are selected independently of the ad hoc panel members selected for other VCCEP meetings.  Therefore, serving as an ad hoc member on one panel will not make it less likely to be selected for another panel.  TERA will select 2-4 ad hoc panelists for each meeting to address the key needs of each individual chemical.  These ad hoc members will supplement the more general expertise of the core panel members.

 

 

Questions about Conflict of Interest and Bias

 

How are Conflicts of Interest and Biases defined for VCCEP and how will TERA manage them?”

 

TERA’s COI and bias policy for the VCCEP peer consultations is in accordance with the U.S. Office of Management and Budget, the National Academy of Sciences, and the U.S. EPA.  This policy is described in more detail at http://www.tera.org/peer/COI.html.  Additionally, TERA has identified specific items which are considered to be conflicts of interest or biases for VCCEP panel candidates.  These items are described at http://www.tera.org/Peer/VCCEP/VCCEPCOI.html.

 

Can experts be panel members if they have a Conflict of Interest (COI) with sponsors or chemicals?  How will this be managed?

 

If someone selected for the Core Group has a COI with a particular chemical (e.g., they work for the Sponsor or wrote part of the document), TERA would ask that individual to recuse him- or herself from that particular meeting.  TERA will be asking nominees to identify COI issues prior to selection, and if a nominee has a conflict with many chemicals, the probability of being selected as a core panel member would be impacted.  For ad hoc panel members, the COI question would be specific, so only those without conflict with that chemical would be eligible for consideration.

 

 

Questions about Meeting Process and Panel Charge

 

When will the Sponsor’s submitted assessment document and Panel Charge be available for each meeting?  

 

The Sponsor’s submitted assessment document and charge questions for each meeting will be available about 4 weeks prior to the meeting.  Both of these documents will be available on the TERA website for easy access. 

 

Where can I find a copy of the Sponsor’s submitted document?

 

TERA will post the sponsor's submitted document on TERA's website.  A copy of this document will also be available at the EPA docket.

 

Will the meetings be open to the public?  Can I make comments?  Can I submit comments if I cannot attend the meeting?

 

All of the VCCEP peer consultation meetings will be announced and open to public observers.  Since meeting room space may be limited, observers are asked to register with TERA in advance.  Meeting announcements, logistics, and registration information will be found on TERA’s Current Meetings website.

 

Members of the public will be invited to provide brief technical comments for the panel members to consider.  These comments should be in writing, and should address scientific and technical issues as outlined in the Panel Charge.  They should be sent to TERA prior to the meeting so that they can be shared with the sponsors and the panel.  TERA will also make them available to the other observers at the meeting.  During the meeting, a limited amount of time will be allotted for brief scientific comments.

 

Who presents the risk assessment documents and recommendations prepared by the Sponsor to the peer consultation panel?

 

The Sponsor and/or its representative will present the assessments and recommendations to the panel.  The Sponsor and/or its representative will also participate in the panel’s deliberations by answering any questions about the assessments and providing clarifications to the documentation as required.

 

What is the Panel Charge?

 

The Panel Charge is a list of questions and issues that TERA will develop to guide the panel’s review and discussions of the submissions for each chemical.  These questions will follow those items that are identified in the Federal Register notice (65 FR. 81700) as being important for the submission assessments to contain and for the Panel to consider.

 

Will the Charge questions be the same for every chemical evaluated by the VCCEP Peer Consultation Panel or will some charge questions be tailored to the specific chemical under review?

We will use a common list of charge questions for each peer consultation meeting, supplemented with specific questions and issues relevant to the chemical under review.

Will the Sponsors have an opportunity to comment on the charge questions before they are finalized?  What about the public?

TERA will post the draft charge questions on our web site and welcome comments from all parties, including Sponsors, panel members, and the public.  The VCCEP program is a pilot and as such, we anticipate refining the charge questions as needed.

 

 

Questions about the Meeting Report

 

Will there be a written report of the peer consultation meetings?

TERA scientists will be taking notes of the meeting in order to prepare a report of the results of the peer consultation.  The report will summarize the range of opinions and recommendations expressed by the panel.  The report will also include a summary of areas of agreement and disagreement, Sponsor presentations, and observer comments.  A draft of the complete report will be sent to panel members for comments and concurrence prior to finalization.  The Sponsors and observers will be provided the opportunity to review text on their presentations to make sure they are accurate.

 

Will this report contain a recommendation on the need for additional testing?

 

The report will include any recommendations for additional testing made by individual panel members, but the panel as a whole will not be asked to render group decisions or group recommendations on any topic.  The report will also include panel recommendations on other relevant issues discussed at the meeting.

 

Will the Sponsor’s Submitted Assessment Document be included as part of TERA’s Meeting Report to EPA? 

 

No.  The Sponsor’s document will have already been submitted to EPA’s docket and to TERATERA will make this document available on line prior to the meeting and will cite the document in the final meeting report.  Therefore, the submission document will not need to be appended or attached to the final meeting report.

 

Alternatively, will an overview of the Sponsor’s Submitted Document be prepared by the Peer Consultation Panel and included in their report to the EPA?

 

No.  We do not plan to have the peer consultation panel (or TERA) prepare an overview of the submission document to include in the report. 

 

Will TERA’s Meeting Report include the complete Sponsor presentations as presented to the Peer Consultation Panel on the day of the meeting for chemical review?

 

The meeting report will summarize the Sponsor presentations made at the meeting.  Sponsors will be given the opportunity to review a draft of this text to insure its accuracy.  However, TERA may determine that part of or all of the Sponsor slides/handouts (if provided) would be best presented in their original form as an appendix, and then referred to in the summary text.

 

How can I get a copy of the Meeting Report?

 

The final meeting report will be made available on TERA’s website.