OLEM DIRECTIVE 9200.1-162 U.S. Environmental Protection Agency Technical Review Workgroup for Metals and Asbestos Charter and Operating Principles The Technical Review Workgroup (TRW) for Metals and Asbestos is an interoffice and interagency workgroup composed of the lead, bioavailability and asbestos committees that are convened by the Office of Superfund Remediation and Technology Innovation (OSRTI). The TRW's goal is to develop, maintain, support and promote consistent application and improvement of the best science in the field of human health risk assessment for asbestos, metals and bioavailability of soil and soil-like (e.g., floodplains) contaminants at affected sites nationwide. Although the TRW's (and this Charter's) primary focus is on metals and asbestos, the TRW will support best science practices in risk assessment of other types of contaminants when TRW experience is applicable, such as evaluating and developing exposure parameters for human health risk assessments and methods for assessing bioavailability of contaminants in soil. TRW Roles and Responsibilities Develop and/or assist in creating new risk assessment tools and guidance for asbestos, metals and bioavailability of soil and soil-like (e.g., floodplains) contaminants. Continuously refine, update and validate existing national technical guidance and tools (e.g., analytical methods, IEUBK) for metals, asbestos risk assessment and bioavailability of soil and soil-like (e.g., floodplains) contaminants. Coordinate with and provide technical expertise, consultation and reviews to assist other EPA workgroups and committees (e.g., EPA Regions, workgroups, Office of Land and Emergency Management (OLEM) Human Health Regional Risk Assessors other Agency offices, OLEM/OSRTI, Agency for Toxic Substances and Disease Registry (ATSDR), the states, tribes and non-government groups) with technical support for site risk assessments related to asbestos, metals and bioavailability of soil contaminants by ensuring that personnel are effectively applying the best available methods for site risk assessment. Collect, disseminate and promote state-of-the-art approaches to asbestos, metals and bioavailability of soil and soil-like (e.g., floodplains) contaminants risk assessment. Promote and expand the best use of available scientific data for site (remedial or removal) assessments related to asbestos, metals and bioavailability of soil contaminants. Communicate to stakeholders, within and outside the Agency, EPA technical application of the best available science concerning risk assessment methods for asbestos, metals and bioavailability of soil contaminants. Provide science policy recommendations to OSRTI management for consideration. Advise OSRTI management on technical issues and concerns and represent the position of OSRTI to other parts of the Agency. Make recommendations for needed Office of Research and Development (ORD) research to OSRTI management. TRW Membership Full Members Page 1 100001549 ------- The principal members of the TRW are technical staff from the EPA Regions, OSRTI, OLEM, ORD, other EPA programs and invited members (e.g., state colleagues, tribes). TRW members have an active interest and scientific expertise in risk assessment. Members are expected to attend regular meetings called by the chairpersons and to actively contribute to the preparation of technical reviews and other scientific TRW committee work products. It is expected that the member's region or office would support his/her involvement in the TRW with a commitment of 10-15 percent of his/her time. Membership on the TRW does not imply that the member formally represents or is the spokesperson for the interests of his/her individual EPA region and office. Candidates are eligible for membership if they have expertise, engagement or interest in risk assessment, particularly for asbestos, metals and bioavailability of soil contaminants. Members with diverse technical backgrounds are welcome, as this would broaden the relevant topics the TRW committees can address. Membership selection and nomination should seek to provide adequate representation of the EPA headquarters offices and to reflect the interests of multiple EPA regions. Nomination for full membership is by EPA offices, scientific peers, or through other informal mechanisms. Selection for full membership is by the agreement of the TRW co-chairs and OSRTI management, with the support of the candidate's supervisor. Advisory Members Due to the time requirements of serving on TRW committees, it is expected that interest in, and availability for, active TRW membership will evolve. Long-standing full members who wish to continue to receive information related to committee activities may assume an advisory role with the approval of the co-chairs, thereby retaining historical perspective and expertise in the committee membership while recognizing time limitations of staff. Advisory members do not vote on TRW products. Ad Hoc Members In addition, TRW committees may seek input from outside the Agency on technical projects. Full membership in the TRW is primarily reserved for EPA employees, but ad hoc members may be recruited from both non-federal organizations (such as academia, medical educators and clinicians, and consultants) and other federal agencies (e.g., ATSDR/Centers for Disease Control and Prevention representatives, National Institutes for Environmental Health Sciences representatives). The inclusion of these individuals in workgroups, such as the TRW, is consistent with the partnership between EPA and these stakeholders. The use of experts from outside the Agency for consultation on technical issues is consistent with the Agency's goal to apply the best science available to risk assessment. Agency members who do not have a science or engineering background may be included on the TRW as ad hoc members and will serve at the discretion of the co-chairs, primarily to address specific consultation needs. Ad hoc members may advise in areas of their expertise and participate in discussions such as programmatic interests outside of OLEM or legal vulnerabilities. Generally, the ad hoc member should raise any concerns to the TRW co-chairs. It is at the discretion of the co-chairs to raise these concerns to the full committee. These experts serve as ad hoc members and will be called upon to temporarily advise the committee on specific issues as directed by the TRW committee. They serve in subcommittees that are led by a TRW full member. Upon the completion of its task it is expected that the subcommittee will be disbanded. Ad hoc members participate in subcommittee calls, but they will not vote on committee Page 2 ------- products, they may not receive drafts of all working documents or reviews, and will only participate in committee calls upon invitation. The time requirements and duration of service for ad hoc members will be determined on a case-by-case basis. Associate Members Nomination for associate membership is by EPA offices, scientific peers, or through other informal mechanisms. Selection for associate membership is by the agreement of the TRW co-chairs and OSRTI management, with the support of the candidate's supervisor. Associate members may be from other EPA programs, other federal agencies and stakeholders, including ATSDR, state and tribal staff. Associate members may be invited to participate in TRW committee calls and can lead subcommittees as determined by the co-chairs with management concurrence. Associate members would be involved as a collaborative member on a topic that relates to the mission of the stakeholder. The associate member may only collaborate on technical issues and topics that are for informational purpose. Associate members are generally not permitted to provide input on site consultations. The co-chairs shall be sensitive to associate member participation during discussion of sensitive matters, such as site enforcement, confidential matters, and EPA policy. Associate members do not generally vote on TRW products; however, their vote may be requested by the co-chairs in certain instances. TRW Leadership The leadership for TRW committees is provided by two (possibly three) co-chairpersons. Chair 1: OSRTI management designates an OSRTI-based co-chair to ensure coordination on scientific and policy issues with OSRTI management. The OSRTI co-chair is responsible for monitoring the allocation of resources of the TRW including contract support. Chair 2: Because the TRW committees strive for a balanced perspective on headquarters and regional issues, a regional member will fill the second co-chair position. Chair 3, if needed or desired: If more individuals from the committee are willing to serve in addition to the two co-chairs, a third co-chair position may be filled by a full or associate member from any EPA office, lab, or region. Co-chairs direct the committee and provide leadership for the workgroup in guiding group discussions, consulting with senior EPA managers, making presentations of workgroup findings and maintaining motivation and active participation of the TRW membership. The co-chairs are responsible for planning all teleconferences, meetings, workshops and other administrative matters. The co-chairs may serve as equal participants in the leadership of the TRW, or rotate in a chair/vice chair capacity, if they so elect. It is expected that each co-chair will have supervisory support for a commitment of approximately 15-25 percent his/her time to the TRW. The co-chairs of the committee's vote, regardless of their membership status (including associate members). Generally, the co-chairs are selected from full or associate members. Their responsibilities as co- chair supersedes those of the full or associate members. When needed, co-chairs oversee recusal of member involvement in discussions. Co-chairs have the authority to excuse members at any time. Page 3 ------- Nominations/Selection of Co-chairs Candidates for co-chairs are either self-nominated or peer-nominated. These nominations occur in response to a co-chair's request to all eligible members that those interested in serving as co-chairs express their interest in so doing. This request will be issued several months before a chairperson's term expires. The response will be sent via e-mail, which will be kept confidential (if requested). In the event that two or more members are nominated, the OSRTI co-chair is empowered to convene a panel of three TRW members (who are not candidates) to recommend a chairperson to OSRTI management. OSRTI management will make a selection from the nominees based upon the panel's recommendations. Terms of Office The terms of office for the co-chairs can be staggered, but, generally, should not exceed two years. However, there is no requirement that a co-chair must step down at the two-year period's end. Former co-chairs are eligible to serve again as co-chairs for a later term. Role of OSRTI in the TRW OSRTI provides the TRW's overall scope and direction, as well as providing the TRW's administrative, contractual and logistical support. OSRTI designates a senior staff member to serve as a co-chair. The TRW prepares for and presents to OSRTI management a calendar-year annual report of all committees' activities and accomplishments. This report should be delivered at the beginning of the calendar year; it documents the TRW's activities, and delineates the issues and concerns that the TRW expects to address during the next year. Additional reports are supplied as requested. The co-chairs and OSRTI senior management hold routine meetings to discuss progress on TRW projects and OSRTI clearance of projects. The TRW members' home offices are expected to fund travel expenses for regularly scheduled face-to-face TRW meetings. OSRTI does not typically fund travel for members to committee meetings unless it is for training purposes, then the hotel and per diem may be funded, with the regional members' needs taking first priority. However, OSRTI will generally pay the TRW co-chairs' entire travel costs to attend TRW annual (subject to resource availability). For relevant subject area conferences, it will be left to the OSRTI Science Policy Branch (SPB) Chief s discretion, depending on the availability of funds, as to whether OSRTI will cover the registration, hotel and per diem; regional members' needs take first priority. Site-specific travel costs or travel to non-Superfund sites for consultation are expected to be covered by the requesting office. TRW Standard Operating Procedures The TRW committees work primarily via teleconferences, video conferences or web conferencing, which the chairpersons schedule via e-mail. The TRW also conducts face-to-face committee meetings as needed to complete significant work products, to prepare for site visits/consultations by reviewing data, to establish a work plan for the coming year, and to support improvements to team functioning and building. Requests for Technical Assistance and/or Site Consultations All requests for support, assistance and review are submitted as proposals to the OSRTI TRW co- chair who, in consultation with the other co-chair(s), distinguishes between requests that require only deliberative recommendations and requests that may require formal site-specific document preparation Page 4 ------- (on TRW letterhead), which may entail literature searches, review of previous recommendations, input from non-TRW individuals, and at least one round of review during a regularly scheduled committee teleconference. The OSRTI co-chair advises the other co-chair(s) of the requests with recommendations based on resource availability and the timing of the request. In addition, a "fast track" mechanism for responses to focused and urgent requests for review of risk assessment documents or issues is available. Fast track reviews are reserved for emergency or time- sensitive situations that preclude following the "formal" review/comment process. The co-chairs institute the fast track mechanism at their discretion whereby they initiate an "ad hoc, time-sensitive subcommittee's" formation by way of a teleconference or e-mail request. Any fast track subcommittee recommendations will be forwarded without full TRW committee review on a teleconference (though the response will be on TRW letterhead if the comments are available for TRW review for at least five business days) with a disclaimer that the recommendations were prepared by a subcommittee of the TRW. In the event a request's timing does not permit five business days for TRW committee review of the subcommittee's draft memorandum, individual comments will be submitted by TRW members and comments are not provided on TRW letterhead. The OSRTI co-chair monitors the TRW committee's workload and maintains and monitors the schedule for documents' development and clearance. The TRW's goal is to issue deliberative recommendations within six weeks, clear short memoranda in two weeks and complete white papers within 12 weeks of initiation. In each case, the project is assigned to a single TRW member who outlines the project's goals and the resource requirements needed (within and outside the Agency). This information is communicated with the co-chairs who coordinate prioritization. In general, the TRW co- chairs prioritize addressing issues and satisfying requests according to time, urgency, implications and resources. Responses to technical assistance and/or site consultation requests commence with a subcommittee's formation, which should be composed of at least three-members. The subcommittee can include non-TRW members, but the subcommittee leader (and primary author of the work products) must be a TRW member. The subcommittee leader should work with the OSRTI co-chair to identify resource requirements, including contractor support, and should coordinate with the region in which the site resides (or the office from which the request was received if the request is not directly related to a particular site). During work product development, the subcommittee leader should regularly update the TRW co-chairs and should summarize the work product's key issues and progress at the next TRW meeting. After the subcommittee drafts its report, it sends the report to the full TRW committee for review (which will typically last two to four weeks, unless an expedited review [five business days] is requested). Discussions of the full report are limited to two TRW meetings that need not be consecutive. Full TRW committee consensus is expected after the initial review and discussion of comments. If a minority opinion is drafted, it may, in consultation with OSRTI management, be sent to the requestor. Development of Guidance Documents (White Papers, Technical Memoranda, Short Sheets, Guidance Manuals, and Directives) The co-chairs assess the need for additional guidance. General guidance documents are developed based on need, in response to site requests or other inquiries. If they determine it is needed, they assign a subcommittee. This newly-formed (led by the TRW representative but composed of experts from within and outside the Agency as described above), develops a plan for guidance development. The co-chairs determine and track the delivery target date, with periodic updates from the subcommittee leader. The full TRW's review takes place after the report is drafted and the TRW has had an adequate period of time to Page 5 ------- review it (typically four to six weeks). The full report's clearance and discussion will be appropriate to the guidance's scope as determined by the OSRTI co-chair in consultation with OSRTI management. TRW Deliberations Generally, the TRW intends to post on the TRW issue-specific website all final committee documents (including site consultation memos) suitable for public release. However, the TRW retains the discretion to not post certain documents on the Internet. In cases involving such information, it is the requesting party's responsibility to notify the TRW in writing of this restriction at the time of the request. The release of the document or material contained within the TRW report is then left to the requesting office's discretion. In general, TRW members and those parties consulting with the TRW should assume that any and all data submitted to the TRW will be made available to committee members, support contractors and other interested EPA offices. In general, information the TRW reviews is subject to FOIA. Data or information offered to the TRW that is expected to have a more restricted distribution than stated above (e.g., proprietary, intellectual property) should be appropriately marked. Recognizing that TRW discussions are potentially deliberative, all teleconference participants are asked to identify themselves and their affiliation during roll call or when they join the teleconference (if arriving late). Similarly, the teleconference agendas, any attachments and call-in information are not to be distributed outside the TRW without the co-chairs' prior consent. This consent includes instances where members request an alternate attend in their place. In addition, TRW members cannot invite non-members to attend conference calls or meetings without prior co-chair consent. The co-chairs may at their discretion utilize Robert's Rules of Order to facilitate discussion and decision making. This process will enable the Committee, "with due regard for every member's opinion, to arrive at the general will on the maximum number of questions of varying complexity in a minimum amount of time and under all kinds of internal climate ranging from total harmony to hardened or impassioned division of opinion"1 (see Attachment 1). TRW Consensus Review The TRW seeks to make recommendations on risk assessment issues based upon a consensus of the TRW (see Attachment 2). If a member of group of members authored, co-authored, managed or co- managed a document that is being reviewed, then they should disclose their role to the committee and recuse themselves from the comment document or preparation of a technical memo. In general, members will recuse themselves from voting on their own site-specific risk document. Despite their recusal, those members may be consulted with technical questions or for clarification. Also, the TRW co-chairs may allow those recused individuals editorial rights when appropriate. As with many scientific issues, full consensus among the TRW reviewers is not always attainable. Where appropriate, committee reports discuss the alternate scientific viewpoints considered and the basis for reaching the TRW's conclusions. The following is the general process by which the TRW will operate for consensus: On distribution of the first draft, reviewers choose one of three responses: a) no comments, b) comment later, or c) send comments. For subsequent revision, reviewers would have the option to; a) concur, b) concur with comments, c) do not concur, or d) abstain. The procedure for achieving consensus is a written (including e-mail or web poll) or voice statement of; a) concur, b) concur with comments, c) do not concur, or d) abstain. 1 Robert, Henry M.; et al. (2011). Robert's Rules of Order Newly Revised (11th ed.). Philadelphia, PA: Da Capo Press. Page 6 ------- Clearance requires a majority of those voting (not including those who have contacted the co- chairs to abstain or those who have recused themselves from the discussion). Lack of response by the deadline is considered to be a vote to abstain. Recused members should abstain from voting; they may abstain with comments. At the end of the voting period, concurrence voting is acceptable (achieves a quorum) when two-thirds of the total committee's full member (including co-chairs) vote concur, concur with comments or do not concur. If the minimum number of voting members is not met by the deadline, the co-chairs may elect to contact members to remind them to vote or to postpone the voting deadline for further discussion or consideration. Issues that lead to non-concurrence would be discussed by e-mail or teleconference. Consensus can be achieved even if every member is not fully satisfied with every element that has been considered as long as there are not strongly held positions in opposition. In addition, these members' alternative positions, who are not part of the majority, may be shared with OSRTI management (where appropriate) in terms of where those individuals agreed with the majority and where they disagreed. No one member should have the right for last review. When a subcommittee prepares the response, the subcommittee authors are generally acknowledged in the memo or document. Depending on the scope of the guidance, the subcommittee leader may request, in consultation with the co-chairs, review and consultation from experts outside of EPA. The OSRTI co-chair establishes a deadline for comments and ensures that adequate time for discussion and voting is scheduled on a TRW teleconference or meeting. For products that have an alternative position, at least one subsequent session (teleconference or meeting time) will be scheduled to allow for rebuttal comments and corrections. Following final TRW review, guidance documents will typically undergo the normal OSRTI document review and release process. Additional reviews may be scheduled, as required. (See OSRTI Management Review and Approval of TRW Work Products section below.) Once the guidance is finalized, it will be posted on the TRW websites. The TRW co-chairs may determine that a document requires further review and concurrence by EPA program offices to ensure quality and consistency with program policy. OSRTI Management Review and Approval of TRW Work Products The OSRTI SPB Branch Chief will review TRW work products and will determine if work products require additional OSRTI or OLEM management review. Any documents determined to have significant policy implication(s) as well as the TRW annual reports, will be sent to the OSRTI Office Director for review, approval and release. OSRTI's Assessment and Remediation Division director will review, approve and release technical guidance documents. The SPB Chief will generally review, approve and release technical reports. The manager providing final work product approval will distribute them to the appropriate EPA offices for final review before online posting. Page 7 ------- Attachment 1. Roberts Rules of Order Cheat Sheet (http://www.diphi.web.unc.edu/files/2012/02/MSG-ROBERTS RULES CHEAT SHEET.pdf) ROBERTS RULES CHEAT SHEET To: You say: kiterrupt Speaker Second Heeded Dtebaiabte Amendable Vote Adjourn "I move tfiat we adjourn* Mo Yes No No MRงปm (Recess "1 move that we recess untiL.." No Yes No Y'es Corrplam about noise, room temp. t etc. "Point of privilege" Yes No No No Chair Decides Suspend farther cxartsadcratkm of SOmethlrip "1 move thai we table it" Mo Yes No (to Majority End debate *1 move the previous question* No Yes No Mo 2m Postpone consideration of something "1 move we postpone this matter until No Yti Yes Yes Majority Amend a motion "*1 move that this fra#on be amended by Mo Yes Yes Yes Majority Inkodmx business (a primary motion) iikmm..: No Yes Yes Yes yapnty The above listed motions and points are listed in established order of precedence. When any arte of them m pencfenB, you may riot introduce another that is f isted below, but you may introduce another that is listed above ft. To: You say: Interrupt Speaker Second Needed Debatable Am-utaMe Vote Needed Qtjjeet Id prooedure or Dereoosl affront "Point of order" Yes No No No Chair decides Reauest information 'Point of information" Yes No Ms Mo None Ask far vote by actual count to verify waiee vote "1 call for a division of the house* Must be done before new motion No Mo No None unless someone objects Object to caresfcierwfli some undiplomatic or improper mater "1 object to consideration of In question* Yes No No Mo 2/3 Take up m^er previously tabSed *1 move we take from the table..." Yes Yes No No Majority Reconsider sonneHiing stealif disposed of "1 mow we now (or later) reconsider our action relative to .." Yes Yes Only if original motion was debatable Mo Majority Consider something out: of its scheduled outer *1 mows we suspend the rules and eonsHer...* No Yes No No 2/3 Vole or a niinn bv the Chair "1 aooeel fie Chair's decision" Yes Yes Yes No Makxfty The motions, points and proposals listed above have no established order of preference; any of them may be introduced at any time except when r is considering one of tfie top three matters feted from Hbe first dhart (Modern to Adjourn, Recess or Point of Privileged Page 1 of 5 Page 8 ------- Attachment 2: Types of Group Decisions OSRTI recognizes there are a variety of alternatives to group decision making. The following four alternatives were considered for use by the TRW committees. Consensus was selected as the best option for the TRW Committees. Unanimous agreement: All participants agree with the decision. Simple Majority: More than half of the participants agree or are willing to accept the decision. Consensus: All participants accept the decision even though they may not completely agree on the specifics involved. All are willing to accept the decision for the good of the group. Working Consensus: The decision is accepted by those participants whose cooperation is necessary to implement the decision. Page 9 ------- |