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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 4. Current Administrative Processes and Procedures for the Development of AEGL Values The primary purpose of the AEGL program and the NAC/AEGL Committee is to develop AEGLs for short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals. AEGLs are needed for a wide range of planning, response, and prevention applications. These applications may include many U.S. initiatives, such as the Environmental Protection Agency (EPA) Superfund Amendments and Reauthorization Act (SARA) Title III Section 302–304 emergency planning program, the Clean Air Act Amendments (CAAA) Section 112(r) accident prevention program, and the remediation of Superfund sites program; the Department of Energy (DOE) environmental restoration, waste management, waste transport, and fixed facility programs; the Department of Transportation (DOT) emergency waste response program; the Department of Defense (DOD) environmental restoration, waste management, and fixed facility programs; the Agency for Toxic Substances and Disease Registry (ATSDR) health consultation and risk assessment programs; the National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) regulations and guidelines for workplace exposure; the state CAA Section 112(b) programs and other state programs; the U.S. Chemical Manufacturer’s Association (now known as American Chemistry Council) Chemtrec program; and other chemical emergency programs in the U.S. private sector. From an international perspective, it is anticipated that the AEGLs will find a wide range of applica-
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals tions in chemical emergency planning, response, and prevention programs in both the public and private sectors of member countries of the Organization for Economic Cooperation and Development (OECD). It is hoped that the AEGLs also will be used by other countries in the international community. A principal objective of the NAC/AEGL Committee is to develop the most scientifically credible, acute (short-term) exposure guideline levels possible within the constraints of data availability, resources, and time. This objective includes highly effective and efficient efforts in data gathering, data evaluation, and data summarization, fostering the participation of a large cross-section of the relevant scientific community, both nationally and internationally, and the adoption of procedures and methodologies that facilitate consensus-building for AEGL values within the NAC/AEGL Committee. Another principal objective of the NAC/AEGL Committee is to develop AEGL values for approximately 400 to 500 acutely hazardous substances within the next 10 years. Therefore, the near-term objective is to increase the production of AEGL documents to approximately 50 chemicals per year without exceeding budgetary limitations or compromising the scientific credibility of the values developed. To reach these objectives, the NAC/AEGL Committee must adopt and adhere to specific processes and procedures both scientifically and administratively. This objective is accomplished through the development and maintenance of a comprehensive standing operating procedures (SOP) manual that addresses the scientific and administrative procedures required to achieve the objectives of the NAC/AEGL Committee. This section is devoted to those administrative processes and procedures deemed necessary to achieve the AEGL program objectives. 4.1 COMMITTEE MEMBERSHIP AND ORGANIZATIONAL STRUCTURE The NAC/AEGL Committee is composed of representatives of U.S. federal, state and local agencies, and organizations in the private sector that derive programmatic or operational benefits from of the AEGL values. Federal representatives are from EPA, DOE, ATSDR, NIOSH, OSHA, DOT, DOD, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Federal Emergency Management Agency (FEMA). States providing committee representatives include New York, New Jersey, Texas, California, Minnesota, Illinois, Connecticut, and Vermont. Private companies with representatives include Honeywell, Inc., ExxonMobil, and Arch Chemical, Inc. Other organizations with representatives include the
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals American Industrial Hygiene Association (AIHA), the American College of Occupational and Environmental Medicine (ACOEM), the American Association of Poison Control Centers (AAPCC), and the American Federation of Labor-Congress of Industrial Organizations (AFL-CIO). In addition, the committee membership includes individuals from academia, a representative of environmental justice groups, and representatives of other organizations in the private sector. A current list of the NAC/AEGL Committee members and their affiliations is shown on page 5. At present, the committee has 31 members. Recently, the Organization for Economic Cooperation and Development (OECD) and various OECD member countries have expressed an interest in the AEGL program. Several OECD member countries such as Germany and the Netherlands have been participating in committee activities and actively pursuing formal membership on the NAC/AEGL Committee. It is envisioned that the committee and the AEGL program in general will progressively expand its scope and participation to include the international community. The director of the AEGL program has the overall responsibility for the entire AEGL program and the NAC/AEGL Committee and its activities. A designated federal officer (DFO) is responsible for all administrative matters related to the committee to ensure that it functions properly and efficiently. These individuals are not voting members of the committee. The NAC/AEGL Committee chair is appointed by EPA and is selected from among the committee members. In concert with the program director and the DFO, the chair coordinates the activities of the committee and also directs all formal meetings of the committee. From time to time, the members of the committee serve as chemical managers and chemical reviewers in a collaborative effort with assigned scientist authors (noncommittee members) to develop AEGLs for a specific chemical. These groups of individuals are referred to as AEGL Development Teams, and their function is discussed in Section 4.8 of this manual. 4.2 THE AEGL DEVELOPMENT AND PEER-REVIEW PROCESS The process that has been established for the development of the AEGL values is the most comprehensive ever used for the determination of short-term exposure limits for acutely toxic chemicals. A summary of the overall process is presented in diagram form in Figure 4–1. The process consists of four basic stages in the development and status of the AEGLs, and they are identified according to the review level and concurrent status of the AEGL values. They include (1) “draft” AEGLs, (2) “proposed” AEGLs, (3) “interim” AEGLs, and (4) “final” AEGLs. The entire development process can
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals FIGURE 4–1 The AEGL development process.
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals be described by individually describing the four basic stages in the development of AEGL values. Stage 1: Draft AEGLs This first stage begins with a comprehensive search of the published scientific literature. Attempts are made to mobilize all relevant unpublished data through industry trade associations and from individual companies in the private sector. A more detailed description of the published and unpublished sources of data and information utilized is provided in Section 2.3 of this manual, which addresses search strategies. The data are evaluated following the guidelines published in the National Research Council (NRC) guidance document (NRC 1993a) and this SOP manual, and selected data are used as the basis for the derivation of the AEGL values and the supporting scientific rationale. Data evaluation, data selection, and the development of a TSD are all performed as a collaborative effort among the staff scientists at the organization that drafts TSDs, the chemical manager, and two chemical reviewers. This group is the AEGL Development Team. NAC/AEGL Committee members are specifically assigned this responsibility for each chemical under review. Hence, a separate team composed of different committee members is formed for each chemical under review. The product of this effort is a TSD that contains draft AEGLs. The draft TSD is subsequently circulated to all other NAC/AEGL Committee members for review and comment prior to a formal meeting of the committee. Revisions to the initial TSD and the draft AEGLs are made up to the time of the NAC/AEGL Committee meeting scheduled for formal presentation and discussion of the AEGL values and the documents. At the committee meeting, the committee deliberates and, if a quorum is present, attempts to reach a consensus or a two-thirds majority vote to elevate the AEGLs to “proposed” status. A quorum of the NAC/AEGL Committee is defined as 51% or more of the total NAC/AEGL Committee membership. If agreement cannot be reached, the committee conveys its issues and concerns to the AEGL Development Team, and further work is conducted by this group. After completion of additional work, the chemical is resubmitted for consideration at a future meeting. If a consensus or two-thirds majority vote of the committee cannot be achieved because of inadequate data, no AEGL values will be developed until adequate data become available. Stage 2: Proposed AEGLs Once the NAC/AEGL Committee has reached a consensus or a two-thirds majority vote on the AEGL values and supporting rationale, they are referred
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals to as proposed AEGLs and are published in the Federal Register for a 30-day review and comment period. Following publication of the proposed AEGLs in the Federal Register, the committee reviews the public comments, addresses and resolves relevant issues, and seeks a consensus or a two-thirds majority vote on the original or modified AEGL values and the accompanying scientific rationale. Stage 3: Interim AEGLs Following resolution of relevant issues raised through public review and comment and subsequent approval of the committee, the AEGL values are classified as interim. The interim AEGL status represents the best efforts of the NAC/AEGL Committee to establish exposure limits, and the values are available for use as deemed appropriate on an interim basis by federal and state regulatory agencies and the private sector. The interim AEGLs, the supporting scientific rationale, and the TSD are subsequently presented to the NRC Subcommittee on Acute Exposure Guideline Levels (NRC/AEGL Subcommittee) for its review and concurrence. If concurrence cannot be achieved, the NRC/AEGL Subcommittee will submit its issues and concerns to the NAC/AEGL Committee for further work and resolution. Stage 4: Final AEGLs When concurrence by the NRC/AEGL Subcommittee is achieved, the AEGL values are considered final and published by the NRC. Final AEGLs may be used on a permanent basis by all federal, state, and local agencies and private-sector organizations. It is possible that from time to time new data will become available that challenges the scientific credibility of final AEGLs. If that occurs, the chemical will be resubmitted to the NRC/AEGL Subcommittee and recycled through the review process. 4.3 OPERATION OF THE NAC/AEGL COMMITTEE The NAC/AEGL Committee meets formally four times each year for 2 1/2 days. The meetings are scheduled for each quarter of the calendar year and are generally held in the months of March, June, September, and December. Based on overall cost considerations, the meetings are generally held in Wash-
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals ington, D.C. However, from time to time, committee meetings may be held at other locations for justifiable reasons. At least 15 days prior to the committee meetings, a notice of the meeting is published in the Federal Register together with a list of chemicals and other matters to be addressed by the committee and provides dates, times, and location of the meetings. The agenda is finalized and distributed to committee members approximately 1 week prior to the meeting. The agenda also is available to other interested parties at that time, upon request, through the designated federal officer (DFO). All NAC/AEGL Committee meetings are open to the public and interested parties may schedule individual presentations of relevant data and information by contacting the DFO to establish a date and time. Relevant data and information from interested parties also may be provided to the committee through the DFO during the period of development of the draft AEGLs so that it can be considered during the early stage of development. Data and information may be submitted during the proposed and interim stages of AEGL development as well. The NAC/AEGL Committee meetings are conducted by the chair who is appointed by EPA in accordance with the Federal Advisory Committee Act (FACA). At the time of the meeting, both the chair and all other committee members will have received the initial draft and one or more revisions of the TSD and draft, proposed, or interim AEGL values for each chemical on the agenda. Reviews, comments, and revisions are continuous up to the time of the meeting, and committee members are expected to be familiar with the draft, proposed, or interim AEGLs, supporting rationale, and other data and information in each TSD and to participate in the resolution of residual issues at the meeting. Procedures for the AEGL Development Teams and the other committee members regarding work on AEGLs in proposed or interim status are similar to those for draft AEGLs. All decisions of the NAC/AEGL Committee related to the development of draft, proposed, interim, and final AEGLs and their supporting rationale are made by consensus or a two-thirds majority vote of members at a committee meeting. The highlights of each meeting are recorded by the scientists who draft the TSDs, and written minutes are prepared, ratified, and maintained in the committee’s permanent records. Deliberations of each meeting also are tape-recorded and stored in the committee’s permanent records by the DFO for future reference as necessary. All proposed AEGL values and supporting scientific rationale are published in the Federal Register. Review and comment by interested parties and
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals the general public are requested and encouraged. The committee’s response to official comments on Federal Register Notices on proposed AEGL values consists of the discussions and deliberations that take place during the committee meetings for elevating the AEGLs from proposed to interim status. This information is reflected on the tapes and in the minutes of the meetings and will be maintained for future reference. Changes in the proposed AEGL values and the supporting rationale that are considered appropriate by the NAC/AEGL Committee based on Federal Register comments will be made prior to elevating the AEGLs to interim status. As mentioned in Chapter 1, a Standing Operating Procedures Workgroup (SOP Workgroup), established in March 1997, documents, summarizes, and evaluates the various procedures, methodologies, and guidelines used by the committee in the gathering and evaluation of scientific data and information and in the development of the AEGL values. The SOP Workgroup performs a critical function by continually providing the committee with detailed information on the committee’s interpretation of the NRC guidelines and on its approaches used in the derivation of each AEGL value for each chemical addressed. This documentation enables the committee to assess continually the basis for its decision-making, ensure consistency with the NRC guidelines, and maintain the scientific credibility of the AEGL values and accompanying scientific rationale. This ongoing effort is continually documented in the SOP manual. 4.4 ROLE OF THE DIRECTOR OF THE AEGL PROGRAM The director has the overall responsibility for the AEGL program, including the NAC/AEGL Committee and its interface with other programs and organizations in the public- and private-sectors nationally and internationally. More specifically, he or she is responsible for the overall management of the AEGL program as it relates to the following: NAC/AEGL Committee and AEGL program objectives of scientific credibility, quality, productivity, and cost effectiveness. Resource needs of the AEGL program. Fostering of a collaborative spirit among committee members, staff scientists of the organization that drafts TSDs, and interested parties from all participating organizations in the public and private sectors. Matters related to the U.S. National Academy of Sciences-National Research Council.
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Expansion of the scope of the AEGL program, including international participation. 4.5 ROLE OF THE DESIGNATED FEDERAL OFFICER The designated federal officer (DFO) serves as the administrative officer of the committee to ensure that all operations, processes, and general procedures function properly and efficiently. The DFO serves as an executive secretariat to the NAC/AEGL Committee and is responsible for the following: Effective communication and coordination with NAC/AEGL Committee members, the committee chair, the organization that drafts TSDs, and interested parties in the public and private sectors. Day-to-day administrative management of the NAC/AEGL Committee with respect to the agenda for future meetings, distribution of TSDs and other correspondence with committee members, maintenance of meeting minutes, tapes of meetings and other important committee records, funding and other financial matters, and committee membership matters. Administrative management of quarterly meetings, including responsibility for all Federal Register Notices related to NAC/AEGL Committee activities, minutes, decision-making records, meeting venues, facilities, and equipment, as well as the assurance that the meetings are held in compliance with the Federal Advisory Committee Act (FACA). Compliance with FACA on all matters that extend beyond the quarterly meetings, such as the submission of appropriate reports to the U.S. Office of Management and Budget (OMB) and the Library of Congress. 4.6 ROLE OF THE NAC/AEGL COMMITTEE CHAIR The NAC/AEGL Committee chair is appointed by EPA as specified in FACA and selected from the NAC/AEGL Committee membership. The chair’s responsibilities include conducting and directing specific activities to ensure the effective and efficient conduct of business by the committee: Provide support in the planning and preparation of upcoming meet-
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals ings by collaborating with the AEGL program director, the DFO, and the organization that drafts TSDs, including the review of the meeting agenda. Manage the NAC/AEGL Committee meetings in an effective and efficient manner to ensure completion of the agenda for each meeting. Attempt to reach a consensus of the NAC/AEGL Committee by ensuring adequate time for presentation of differing opinions and focusing on the major issues to break deadlocks or stalemates. Participate in scientific matters on AEGLs related to the U.S. National Academy of Sciences-National Research Council. Participate with the AEGL program director and the DFO in evaluating and improving NAC/AEGL Committee activities and expanding the scope of the AEGL program. 4.7 CLASSIFICATION OF THE STATUS OF AEGL VALUES Draft AEGL values are AEGL values that have been proposed by the AEGL Development Team (see Section 4.8) before the full NAC/AEGL Committee discussion and approval. Proposed AEGL values are AEGL values that have been formally approved and elevated to “proposed” status by a consensus or a two-thirds majority vote of the NAC/AEGL Committee. Interim AEGL values are AEGL values that have been formally approved by the NAC/AEGL Committee and elevated to “interim” status after publication in the Federal Register, response to comments, and appropriate adjustments made by the committee. Interim AEGL values are forwarded to the Committee on Toxicology of the NRC for review and comment by the Subcommittee on Acute Exposure Guideline Levels (NRC/AEGL Subcommittee). Final AEGL values are AEGL values that have been reviewed, finalized, and published by the NRC. 4.8 FUNCTION OF AEGL DEVELOPMENT TEAMS Each AEGL Development Team consists of a staff scientist from the organization that drafts TSDs, a chemical manager, and two chemical reviewers who are members of the NAC/AEGL Committee. The primary function of the NAC/AEGL Development Team is to provide the NAC/AEGL Committee with draft AEGL values and a TSD containing relevant data and information on the chemical and the derivation of the draft AEGLs. The staff scientist
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals provides the initial effort by identifying and preliminarily evaluating available data from varied resources including on-line literature databases, other databases, journal reviews, secondary source reviews, unpublished data, federal and state documents and other sources, including accounts of accidents in the workplace or in the community (see Section 2.3). Interaction takes place among the chemical manager, the chemical reviewers, and the staff scientist during the development of the TSD and the draft AEGL values. The resulting document is then distributed and reviewed by committee members prior to a formal meeting, and attempts are made to resolve issues of concern expressed by committee members prior to distribution of the TSD to the NAC/AEGL Committee and formal presentation and discussion at a committee meeting. 4.8.1 Role of a Chemical Manager The chemical manager has the overall responsibility for the development of the draft, proposed, and interim AEGL values and their presentation to the rest of the NAC/AEGL Committee and to the NRC/AEGL Subcommittee for evaluation of final AEGLs. The chemical managers serve on a rotating basis as the committee’s principal representative on the AEGL Development Team for a specific chemical. The chemical manager in turn selects two committee members to serve as chemical reviewers. The chemical manager collaborates with the staff scientist and the chemical reviewers on the development of the AEGLs, the supporting rationale, and the TSDs. In instances in which the chemical manager has accepted the responsibilities, taken ownership for the AEGL values, resolved scientific issues, and led the discussions with committee members, the NAC/AEGL Committee has moved rapidly toward the development of a consensus. Where the chemical manager’s role has been less decisive, the committee’s deliberations have been more protracted, less focused, and highly inefficient. Implicit in the description of the chemical manager’s role is the expectation that he or she will work with the staff scientist, the chemical reviewers, and the rest of the committee members to develop exposure guidance levels that are appropriate and scientifically credible. It is expected that the chemical manager will achieve a consensus within the AEGL Development Team on the issues related to the development of the AEGL values prior to the meeting of the full NAC/AEGL Committee. Further, as time permits, the chemical manager will attempt to resolve issues raised by individual committee members prior to the scheduled committee meeting. The following is a summary outline of specific activities and responsibilities of the chemical manager within the NAC/AEGL Committee:
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Participate as the leader of the ad hoc AEGL Development Team. Select and utilize two chemical reviewers as technical support. Provide direct support to the staff scientist assigned to the chemical in the development of the TSDs, the draft AEGL values, and the supporting rationale. Serve as liaison between NAC/AEGL Committee members and the staff scientist during the development of draft AEGL values and the TSD. Resolve scientific issues prior to the NAC/AEGL Committee meetings, such as the following: Completeness of data gathering (published and unpublished). Selection of key and supporting data (following guidelines). Interpretation of data. Credibility of AEGL values (use of appropriate methodology). Validity of scientific rationale for AEGLs. Other (as necessary for development of scientifically credible AEGL values). Seek consensus of NAC/AEGL Committee members by resolving issues with individual committee members prior to the committee meeting. Frame important scientific issues related to the chemical and the AEGLs for presentation at the NAC/AEGL Committee meeting (i.e., significant issues that cannot be resolved before the meeting). Participate in the presentation of AEGL values, supporting the rationale and important issues at the NAC/AEGL Committee meeting in collaboration with the staff scientist. Oversee appropriate follow-up activities: Revisions as appropriate (AEGL values, TSD, rationales). Toxicity testing. Federal Register Notice comments (conversion of “proposed” to “interim” values). Preparation of AEGL proposal to the NRC. 4.8.2 Role of a Chemical Reviewer Participate as a member of the ad hoc AEGL Development Team. Conduct a detailed review of the assigned document and key references. Assist the chemical manager and staff scientist in evaluating the data, the candidate AEGLs, and the scientific rationale for their support.
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Participate actively in discussions of the document during NAC/ AEGL Committee meetings. Stand in for the chemical manager if he or she is unable to perform his or her duties. 4.8.3 Role of a Staff Scientist at the Organization That Drafts TSDs The staff scientist has the primary responsibility for data gathering, data evaluation, identification of potential key data and supporting data, identification of potential methodologies, calculations, and extrapolations, and the preparation of the TSD. The following tasks are included: Participate as a member of the ad hoc AEGL Development Team. Participate with the others on the AEGL Development Team in the development of draft AEGL values and their presentation at the NAC/AEGL Committee meetings. Prepare TSDs in a timely manner and make appropriate revisions based on discussions and decisions of the AEGL Development Team and later based on the discussions and decisions of the NAC/AEGL Committee. Develop and maintain a data file on the chemical substance. Present a summary of the data and information on the substance in collaboration with the chemical manager at the NAC/AEGL Committee meetings. Provide continuing support to an assigned chemical through the draft, proposed, interim, and final stages of AEGL development, including preparation for, and response to, Federal Register Notice review and comment. 4.9 ROLE OF NAC/AEGL COMMITTEE MEMBERS Review all TSDs in advance of meetings, and work out issues with the chemical manager at the earliest possible date. The importance of resolving issues before NAC/AEGL Committee meetings is greatly emphasized to increase the efficiency and productivity of the meetings. Circulate TSDs to other qualified scientists within their respective organizations or other organizations as appropriate to broaden the evaluation by the scientific community. Serve as experts in specific areas or on specific scientific issues (e.g.,
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals sensitive human subpopulations) as a member of an ad hoc task force under the SOP Workgroup chair. Volunteer as a chemical manager at least once a year, and select chemicals on the basis of special knowledge, expertise, or past experience, whereby a significant contribution can be made to the development of credible AEGL values. Assist in the application of AEGLs in appropriate programs within the organization represented by the NAC/AEGL Committee member. Make suggestions for modification or expansion of the Chemical Priority List by providing lists of chemicals and supporting rationale for their priority to the designated federal officer (DFO). Attend all scheduled NAC/AEGL Committee meetings, and participate in the discussions and decision-making of all AEGL values. AEGL values are approved or disapproved by a two-thirds majority vote of the committee quorum (51% or more of the committee members present). 4.10 ROLE OF THE ORGANIZATION THAT DRAFTS TSDs The role of the organization that drafts the TSDs is to provide the principal technical support in gathering and evaluating the relevant scientific data and information from all sources in the preparation and revision of the TSDs, following the guidance provided in this SOP manual. As a member of the AEGL Development Team, Collaborates with the chemical manager and chemical reviewers in the preparation and distribution of draft AEGLs, the supporting rationale, and the TSDs for the NAC/AEGL Committee members. Provides continuing technical and administrative support to assigned chemicals through the Draft, Proposed, Interim, and Final stages of AEGL development, with revisions based on the consensus or majority of the NAC/AEGL Committee and the NRC/AEGL Subcommittee. Provides the staff scientists and the administrative personnel with the facilities and equipment necessary for data gathering, maintenance of databases, dissemination of relevant information to committee members, presentations or co-presentations (with chemical managers) at the NAC/AEGL Committee meetings, development and revisions of TSDs, preparation of submissions to the Federal Register, summarization of Federal Register comments and identification of important scientific issues, presentations to the committee on Federal Register
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals comments, and preparation of technical information to be entered on the Internet. Distributes the TSDs to companies and other interested parties as directed by the DFO after review and comment by the NAC/AEGL Committee. Distribution to interested parties will be only by request through the DFO. The initial distributed version will be without the AEGL values and the rationale used to derive them and will occur between 1 and 14 days before the committee meeting.
Representative terms from entire chapter: