Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Keystone Convening Report
Regarding the Formation of the Endocrine Disruptor Screening And Testing
Prepared by The Keystone Center, October 1996
Table of Contents
I. Background . . . . . . . . . . . . . . . . . 1 II. Goals and Scope of Issues to be Addressed by the Committee . . . 2 III. Analysis of Affected Interests. . . . . . . . . . . . . . . . . . 3 A. U.S. Environmental Protection Agency . . . . . . . . . . . . . 4 B. Other Federal Agencies . . . . . . . . . . . . . . . . . . . . 4 C. State Agencies . . . . . . . . . . . . . . . . . . . . . . . . 6 D. Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 E. Water Providers. . . . . . . . . . . . . . . . . . . . . . . . 7 F. Labor/Worker Health and Safety Organizations . . . . . . . . . 7 G. Environmental, Environmental Justice, and Public Health Organizations . . . . . . . . . . . . . . . 8 IV. The Role of Science and the Need for Scientific Expertise in the EDSTAC Process . . . . . . . . . . . . . . . . . . . . . . 9 V. Structure of the Committee. . . . . . . . . . . . . . . . . . . . 9 VI. Coordination With Other Related Activities . . . . . . . . . . . 11 VII. Participant Selection Criteria. . . . . . . . . . . . . . . . . 12 VIII. EDSTAC Membership. . . . . . . . . . . . . . . . . . . . . . . . 13
A growing body of scientific research indicates that many man-made industrial chemicals and pesticides may interfere with the normal functioning of human and wildlife endocrine systems. These endocrine, or hormone, disrupters may cause a variety of problems with development, behavior, and reproduction.
Although many pesticides and some industrial chemicals have undergone extensive toxicological testing, it is unclear whether this testing has been adequate to detect the potential for these chemicals and pesticides to be endocrine disrupters or what additional testing is needed for the U.S. Environmental Protection Agency (EPA) to assess and characterize both human health and ecological risk. Notwithstanding recognition that the scientific knowledge related to endocrine disrupters is still evolving, there is widespread agreement that the development of a screening and testing program is appropriate. In addition, recent legislation including the reauthorization of the Safe Drinking Water Act (SDWA) and passage of the Food Quality Protection Act (FQPA) has mandated that such a screening and testing program be developed by EPA. Further, underlying authority for EPA to consider implementation of such a program is found in the existing Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and Toxic Substances Control Act (TSCA).
EPA's Office of Prevention, Pesticides and Toxic Substances proposes to establish the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). The purpose of EDSTAC will be to provide advice and counsel to the Agency on a strategy to screen and test chemicals and pesticides that may be the cause of endocrine disruption in humans, fish, and wildlife. This strategy will be aimed at reducing or mitigating risk to human health and the environment. EPA expects the EDSTAC to take a consensus approach to reaching their findings and recommendations.
The Keystone Center, a non-profit environmental policy facilitation and conflict management organization, was asked to conduct a neutral third-party convening assessment to assist all of the major stakeholder interests in sorting through a number of issues regarding the formation of the proposed EDSTAC. This report is the end product of The Keystone Center's convening assessment. The recommendations contained herein are solely those of The Keystone Center*. They are based on extensive consultation with representatives of affected interests, including telephone and in-person interviews, and numerous conference calls and facilitated discussions with approximately 100 people.
* For more information or clarification of the recommendations contained in this report, please contact Tim Mealey (telephone 970-468-5822, fax 970-262-0152, or email firstname.lastname@example.org) or Paul De Morgan (telephone 202-783-0248, fax 202-783-0348, or email email@example.com).
II. Goals and Scope of Issues to be Addressed by the Committee
The process used to develop our recommendations regarding the goals and scope of issues to be addressed by the EDSTAC included direct involvement of, and collaborative efforts with, several key stakeholder representatives. This collaborative effort began by using the draft mission statement developed at the May 15-16, 1996 public meeting as a starting point. The recommended goals outlined below are a refinement of the main points made in the May mission statement. They have been reviewed and are supported by representatives of several key stakeholder interests.
- Develop a flexible process to select and prioritize chemicals and
pesticides for screening, recognizing the need to obtain and utilize
appropriate exposure information in setting priorities;
- Develop a process for identifying new and existing screening tests
and mechanisms for their validation;
- Agree on a set of available, validated screening tests for early application;
- Develop a process and criteria for deciding when additional tests,
beyond screening tests, are needed and how any of these additional tests
will be validated.
These goals will be pursued sequentially and actions will be implemented as agreement is reached on each step. These goals will also be pursued in a manner that recognizes the data available as a result of the endocrine disrupter screening and testing program will be used to reduce or mitigate risk to human health and the environment. It is anticipated that this overarching risk management goal will eventually require the development of approaches to:
- synthesize exposure and hazard information; and
- incorporate synthesized exposure and hazard information into risk reduction and risk management decisions.
In developing its recommendations on an endocrine disrupter screening and testing program, the Committee will also need to address issues associated with how to effectively communicate the true intent of their substantive agreements and recommendations. The Committee will also need to develop recommendations on how EPA should communicate screening and testing information to the public if the Agency follows the Committee's recommended approaches to screening and testing.
Since circulating the proposed goal statement to affected stakeholders who were not directly involved in its development, several issues have become apparent:
- The assumption of a phased or tiered approach to screening and testing,
which is imbedded in the four primary goals, may not be shared by all
potential Committee members.
- Although the above language does not make this entirely clear, we
believe many people would agree that exposure information will be relevant
to setting priorities for all phases of screening and testing. However,
some have expressed concerns that such information not be equated with
the need for a risk assessment in order to move from one phase of screening
and testing to another.
- There are still some unresolved issues surrounding the language in the goal statement that reads: "These goals will also be pursued in a manner that recognizes the data available as a result of the endocrine disrupter screening and testing program will be used to reduce or mitigate risk to human health and the environment." Representatives of environmental groups have expressed the view that screening and testing data should not have to be subjected to a "risk assessment" before either moving from one phase of testing to another, or taking action to reduce or manage risk. While industry representatives appear to be willing to discuss this issue in more general terms (i.e., not necessarily relying on the use of "traditional risk assessments"), they are neverthless concerned that the issue of the appropriate use of screening and testing data be addressed as part of the development of an endocrine disrupter screening and testing strategy. Given the presumed phased approach to screening and testing, we believe the Committee will need to address the question of how screening and testing data will be used to move from one phase to another. Even if one does not assume a phased approach, the question of what is the appropriate use of the information that would be generated as a result of screening and testing is something the Committee will likely have to at least discuss, if not agree upon, in order to develop agreements on an endocrine disrupter screening and testing program.
We recommend that EPA introduce and utilize the goal statement outlined above as the starting point for the EDSTAC dialogue with the understanding that the Committee itself, once formed, will be tasked with refining the language as necessary to develop a goal statement they all support.
III. Analysis of Affected Interests
As noted above, the endocrine disrupter issue potentially has very broad and far reaching consequences for many segments of society. It will, of course, not be possible to include representatives of all these segments of society on the EDSTAC. In order to develop specific recommendations regarding advisory committee members it is necessary to conduct a very careful and thorough analysis of the interests affected by the issues to be addressed by the EDSTAC. Such an analysis should result in an advisory committee that is both balanced and fairly representative of the affected interests, as well as of a manageable size to accomplish its objectives. The broad categories of affected interests that we recommend for participation are listed below.
A. U.S. Environmental Protection Agency
A number of offices within EPA have specific interests in endocrine disrupter screening and testing including: the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) which is taking the lead for the Agency on this issue in addition to implementing the recently enacted Food Quality Protection Act; the Office of Water (OW) whose interests stem from its responsibilities to implement the recent reauthorization of the Safe Drinking Water Act; and the Office of Research and Development (ORD) which is playing a lead role in helping to determine the research needs related to endocrine disrupters for all federal agencies. We recommend that four seats be reserved for EPA participation, including two to serve as Chair and Vice Chair from OPPTS, one from OW and one from ORD.
B. Other Federal Agencies
Several other federal agencies have either a stake in the outcome of EDSTAC or expertise in relevant areas of science or policy that will be very helpful for the EDSTAC to draw upon. These include:
The Department of the Interior (DOI) whose interests stem primarily from its wildlife management, stewardship, and research responsibilities. Two subagencies of DOI-the Fish and Wildlife Service and the National Biological Service (now the Biological Resources Division of U.S. Geological Survey)-have responsibilities and personnel with expertise that may be particularly helpful to the Committee. As discussed in more detail below, we recommend that DOI be invited to participate in the EDSTAC in a coordinated fashion (i.e., through a single seat on the EDSTAC).
The Department of Health and Human Services (HHS) also has many subagencies that either have a stake in the outcome of the EDSTAC's deliberations or expertise in relevant areas of science or policy that will be very helpful for the EDSTAC to draw upon. However, because of the largely independent and diverse nature of these numerous subagencies, we do not believe it would be possible or prudent for HHS to participate in the EDSTAC in a unitary fashion. Thus, the relevant subagencies are listed separately below:
The Food and Drug Administration (FDA) has numerous people who have expertise in endocrine disruption in general and the issue of phytoestrogens in particular. FDA is represented in the National Toxicology Program (see below) by the National Center for Toxicological Research (NCTR) based in Arkansas. FDA's and EPA's respective statutory authorities are closely linked as it relates to the issue of endocrine disrupter screening and testing. We recommend that one seat be reserved for FDA/NCTR participation at the Committee level which could be used to allow for coordinated participation of appropriate FDA personnel in other levels of the EDSTAC process.
The Center for Disease Control (CDC) has many departments interested in the endocrine disrupter issues. The National Center for Environmental Health (NCEH), which conducts epidemiological studies all over the United States and has a massive database related to birth defects, offers public health expertise from the federal government's perspective. We recommend that one seat be reserved for CDC/NCEH participation.
The National Institute for Environmental Health Sciences (NIEHS), conducts research in a range of disciplines including epidemiology, cellular and molecular pharmacology, and environmental toxicology. NIEHS has a long-standing record of developing and validating new alternative methods for toxicological research and testing programs. We recommend that one seat be reserved for NIEHS participation.
The National Institute for Occupational Safety and Health (NIOSH) does research designed to assist efforts to set recommended worker exposure standards. They work closely with the Department of Labor's Occupational Safety and Health Administration, the policy side of the standards setting, though they are housed in different Departments. They are the only federal agency that conducts research on reproductive effects of worker exposure to chemicals and pesticides. We recommend that one seat be reserved for NIOSH participation.
The Agency for Toxic Substances and Disease Registry (ATSDR) conducts health assessments of communities impacted by hazardous waste sites. One of their programs, associated with fish consumption advisories in the Great Lakes region, offers a wealth of information regarding communicating risk and hazards to the public. However, their statutory authorities and mission are not directly related to the issue of screening and testing. Therefore, we recommend that ATSDR be given the opportunity to contribute to the EDSTAC process in a manner that utilizes their risk communication expertise, which would likely be at the work group level.
The National Toxicology Program (NTP), an inter-agency research program including representatives from NIEHS, NIOSH, FDA, EPA, Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC), focuses on developing screening and testing procedures for certain chemicals and pesticides. By coordinating toxicology research and testing activities within the Department of Health and Human Services, they can provide information about potentially toxic chemicals to health regulatory and research agencies, scientific and medical communities, and the public. The NTP will be represented through the participation of several of the agencies listed above.
The Department of Agriculture (USDA) has a couple of offices potentially involved in endocrine disrupter related issues. The soon to be formed Office of Public Health and Science monitors chemical and pesticide residues in meat, poultry, and eggs and designs specific testing procedures for meat and poultry. The Food Safety and Inspection Service (FSIS) is responsible for the inspection of meat and poultry in the United States. Through the National Residue Program, USDA identifies chemicals and pesticides likely to be in meat and poultry and then determines ways to eradicate them. Recently, substances chosen have been from lists of potential endocrine disrupters. In addition, the Agricultural Research Service may be doing some research on the issue. As with DOI, we are recommending that USDA be invited to participate in the EDSTAC in a coordinated fashion (i.e., through a single seat on the EDSTAC).
C. State Agencies
States have broad authorities, aimed at protecting the public health of its citizens and the environment, which sometimes overlap with the federal government's authorities. There are a variety of types of state agencies likely to have an interest in, or expertise related to, the issue of endocrine disrupter screening and testing. Among others, these include state environmental, public health, and agricultural agencies. Given the nature of the endocrine disrupter issue, it will also be important to obtain geographic diversity of state representation, including at least one state drawn from the Great Lakes Region due to persistent toxic exposure issues. Finally, it will be important to obtain diversity in the areas of expertise to be represented by state agencies. With these balancing criteria in mind, we recommend that three seats be reserved for participation by representatives of state agencies.
Numerous sectors of industry may potentially be affected by the endocrine disrupter issue. However, a distinction can be made between those sectors of industry that will ultimately be responsible for conducting (and therefore bearing the costs associated with) screening and testing, due to the products they manufacture, as compared to those that may be affected as a result of exposures to endocrine disrupting chemicals or pesticides. Some examples of the latter include food production, processing, and/or packaging companies that may be affected by the leaching of endocrine disrupting chemicals through food packaging or through environmental exposures and uptakes to livestock. We believe the first category of affected industry sectors can be considered to have a "core" interest in the issues to be addressed by the EDSTAC, whereas the other sectors might be thought of as being caught up in the "downstream" impacts of the core industries.
Notwithstanding the significant interests of these downstream industries, for a variety of reasons, the primary one being manageability of the process, we recommend that EDSTAC membership be limited to representatives of companies that have a direct and "core" interest in the issue of endocrine disrupter screening and testing. These will include chemical and pesticide manufacturers, as well as the manufacturers of some consumer products. We further recommend that the interests of the downstream industries receive special attention during the course of the Committee's deliberations through a variety of measures including identifying specific times in the agendas of EDSTAC meetings where comments are solicited from representatives of such downstream industries/companies and, if necessary, the establishment of an ongoing communication liaison with representatives of such industries/companies. Furthermore, in order to ensure balanced representation with other affected interests, we recommend that eight or no more than nine seats be reserved for industry participation. These would include three for chemical manufacturers, two for pesticide manufacturers, two for consumer product manufacturers, and one or two that represent a smaller company perspective and yet still meet the requirement of being drawn from a "core" affected industry. The small company seat (or seats) may be drawn from the chemical, pesticides, or consumer product manufacturing industries.
E. Water Providers
Public and private drinking water providers are affected by the endocrine disrupter screening and testing issue for two reasons. First, through environmental exposure pathways beyond their direct control, the drinking water they provide may contain chemicals and pesticides that may be endocrine disrupters. Second, the water disinfectant bi-products that are, in essence, produced by these agencies as a result of their mandated water purification activities may also be a source of endocrine disrupters. Using the analysis and criteria outlined above regarding affected industry sectors, we believe the first reason is equivalent to a "downstream" industry, whereas the second is more akin to a "core" industry. Therefore, we recommend that one seat be reserved for a member of the Association of Metropolitan Water Agencies (AMWA) and/or the American Water Works Association (AWWA).
F. Labor/Worker Health and Safety Organizations
Health and safety is a concern for many workers in a variety of industries that produce or utilize chemicals and pesticides that may be endocrine disrupters. As with the list of affected industries, the potential list of affected workers may indeed be quite lengthy, starting with the employees of chemical and pesticide manufacturers, and including farm workers, steel workers, forest and paper product workers, auto workers, teamsters, building trades workers, as well as others. Unlike the affected industries, in the case of worker health and safety concerns it is perhaps not as easy to make a distinction between workers who have a "core" interest versus those that may be subjected to a "downstream" impact. Workers in some of the "downstream" industries may actually be subjected to higher and more frequent levels of exposure then those who are involved in the actual production of chemicals and pesticides that may be endocrine disrupters.
We recommend that two seats be reserved for individuals knowledgeable about worker health and safety issues related to chemical and pesticide exposures with one of the seats being oriented toward the industrial sectors, in terms of the industries that may be affected, and one focusing on farm worker exposure issues. These EDSTAC members may or may not be representing the interests and concerns of specific labor organizations directly. If such direct representation is not possible, then efforts should be made to make sure that the selected individuals are considering the general interests and concerns of workers in these sectors.
G. Environmental, Environmental Justice, and Public Health Organizations
Environmental groups actively involved in the endocrine disrupter issue represent a broad base of constituencies, including individuals concerned about potential endocrine disruption effects on fish, birds, other wildlife, and humans. Environmental justice groups, in general, represent the interests and concerns of populations that many believe have been disproportionately affected by environmental contamination and harm, including low income communities and communities-of-color. Public health groups include those that have a broad concern about potential human health effects, as well as those who represent individuals and medical professionals whose concerns stem from specific diseases that may be caused by endocrine disruption.
Although many scientists, individuals, and organizations have been conducting research and advancing the theory of endocrine disruption for a number of years, representatives of environmental and public health groups can be said to have brought this issue to the attention of policy makers in recent years, including the 104th Congress through the passage of endocrine disrupter screening and testing provisions in both the SDWA and FQPA.
Through our convening efforts we have found that there is an emerging network of individuals affiliated with national, regional, and local, or what might otherwise be considered grassroots, environmental, environmental justice, and public health groups that have an interest in endocrine disrupter issues. Within this network, there appears to be a small cadre of respected national leaders and experts upon whom others rely. The broad based public health groups tend to be closely aligned with the environmental groups that focus on human health concerns.
There are many disease-specific public health groups, including those concerned with breast cancer, prostate cancer, infertility, birth defects, as well as other diseases. These groups include many whose members are either largely or exclusively individuals who are the victims/patients, largely or exclusively medical professionals or researchers, or a combination of victims/patients, medical professionals, and researchers. To our knowledge, an umbrella or coalition group that attempts to address the endocrine disruption interests and concerns of all disease-specific public health groups does not appear to exist.
Using the participant selection criteria outlined below, and in an effort to maintain overall balance on the Committee, we recommend that seven seats be reserved for representatives of environmental, environmental justice, and public health groups. We further recommend that one of these seven seats be reserved for a representative of a disease-specific public health group that is actively involved in the endocrine disrupter screening and testing issue and primarily oriented towards the interests of the victims/patients rather than medical professionals or researchers. In addition, this group should be willing to assist in the creation of a liaison function with other disease-specific public health groups, if necessary. Finally, similar to our recommendation above regarding the handling of "downstream" industries, we recommend that disease-specific public health groups that have an interest in endocrine disrupter screening and testing, not directly represented on the Committee, receive special attention during the course of the Committee's deliberations. This would be achieved through a variety of measures including the identification of specific times on the agendas of EDSTAC meetings where comments are solicited from representatives of such groups and, if necessary, the establishment of an ongoing communication liaison function.
IV. The Role of Science and the Need for Scientific Expertise in the EDSTAC Process
The legislative mandate for establishing an endocrine disrupter screening and testing program takes place in the context of an emerging body of scientific knowledge regarding endocrine disruption. A large number of questions remain to be answered about certain key hypotheses, including what might be the behavioral, developmental, and reproductive human health effects of known endocrine disrupters. In the context of this emerging body of scientific knowledge and the uncertainties that remain to be explored, the technical and substantive complexities inherent in developing an endocrine disrupter screening and testing program will be pronounced.
The EDSTAC will differ from other important and related efforts, some of which are described below, in that it will focus on the strategic dimensions of integrating science with policy. As such, the EDSTAC process will serve as a bridge between science and policy related issues. It will not be oriented toward the broader issues associated with furthering scientific research on endocrine disruption.
This view of the EDSTAC has probably had a greater impact on our recommendations than any other factor we have considered. For example, our recommendations regarding EDSTAC structure, coordination with other related activities, participant selection criteria, and the individuals whom we have recommended for EDSTAC membership (which follow), have all been heavily influenced by the need to create a bridge between the science and policy dimensions of the endocrine disrupter screening and testing issue.
Recognizing that many of the individuals who will represent the stakeholder interests described above will be scientists or individuals with scientific credentials, we recommend that five or six additional seats be reserved on the EDSTAC for scientists who are actively involved in endocrine disrupter research and are highly respected for their objectivity and the breadth of their scientific expertise. These seats should be reserved for senior scientists, drawn from relevant areas of scientific expertise, who have an ability to participate in broad based, cross-disciplinary discussions. These individuals would be asked to participate on the EDSTAC because of their knowledge and expertise not because they are considered to be representing an affected or "stakeholder" interest in the same way we would view the types of groups and organizations described above. The precise number and types of scientists to be asked to participate should depend in part upon the types of scientific expertise represented by other Committee members.
V. Structure of the Committee
It is our understanding that the EDSTAC will be a newly created, independent, "stand-alone" federal advisory committee, rather than a subcommittee to an existing federal advisory committee. We are supportive of this approach, even though it may take longer to become fully and officially "chartered," because it gives the EDSTAC complete flexibility, within the confines of the Federal Advisory Committee Act (FACA) and its underlying charter, to structure its activities so that it can most effectively achieve its goals.
At this juncture, we do not see the need for the EDSTAC to establish any "subcommittees," which in the parlance of FACA means subgroups that operate independently from, although within the bounds of the charter of, the "parent" committee. We do, however, see the need for the EDSTAC to establish a variety of "work groups" which, once again in the parlance of FACA, refers to subgroups that assist in the achievement of the goals of the parent committee but do not operate independently of the parent committee. Thus, whereas FACA "subcommittees" must meet in open public meetings that are publicly noticed, FACA "work groups" are free to meet in private. They must, however, pass all of their proposed recommendations through the parent committee before being forwarded to the chartering agency.
Given the EDSTAC's proposed goals, the intensely scientific nature of the discussions, and the proliferation of work related to endocrine disruption currently underway outside of the as-of-yet unchartered Committee, we recommend formation of a Science Integration and Coordination (SIC) Work Group early in the EDSTAC process. The purpose of the SIC would be to assist the Committee in defining the scientific questions that need to be researched and/or addressed, handling specific science-related information requests from the Committee, and serving as a conduit for bringing scientifically related information into the Committee's deliberations, including information being generated from activities that are related to, but outside of, the Committee's "umbrella." The EDSTAC would oversee such a work group and, in order to ensure consistency and facilitate communication and effective follow-through, we would further recommend that some small number of EDSTAC members who have scientific expertise should participate in both the EDSTAC and the SIC. Ideally these individuals would be some subset, or all, of the academic/research scientists who will participate on the EDSTAC. However, such a time commitment might be difficult to elicit from them. We also recommend that membership of the SIC should be augmented by additional scientific experts, some of whom might be considered as alternates or staff to some of the EDSTAC members, as determined necessary by the EDSTAC.
We anticipate that at various points in the EDSTAC process there will be a need to establish additional work groups, some of which will focus on specific or more narrowly framed scientific issues, as compared to the SIC, others might focus on issues that are more policy and/or communication oriented. Although we would see the SIC as identifying the need for additional, more narrowly focused science-related work groups, as well as developing recommendations for who might participate in such work groups, we recommend that decisions regarding the formation of and membership in any work groups, be they science-, policy-, or communications-related, be the sole purview of the EDSTAC. We further recommend that the Committee maintain the flexibility to allow work groups to be comprised of individuals who may not be EDSTAC members as well as EDSTAC members, but that the membership of all work groups be clearly defined.
We envision the SIC Work Group meeting fairly regularly early in the process but then reducing its responsibilities as the EDSTAC process evolves. In other words, we would hope that at least some of the other more narrowly focused science-related work groups might be able to relay information directly to the EDSTAC rather than funneling all of their outputs and draft recommendations through the SIC.
VI. Coordination With Other Related Activities
We are aware of several other significant activities related to the endocrine disrupter issue that will take place while the EDSTAC conducts its deliberations. The first is the endocrine disrupter interagency working group under the Committee on Environment and Natural Resources (CENR), which is part of the White House's National Science and Technology Council. This work group is currently conducting an inventory of on-going federal research programs, identifying research gaps, and facilitating a coordinated plan to address them. While this effort is important, and we would expect that the EDSTAC will draw from their work, the EDSTAC mission is to develop policy recommendations, grounded in science, regarding creation and implementation of a screening and testing program and strategy.
The second is The National Academy of Science's Board on Environmental Studies and Toxicology, Committee on Hormone-Related Toxicants in the Environment (hereafter referred to as the NAS panel) which was established in June of 1995 at the request of the EPA and DOI. This panel is working on completing a number of tasks related to endocrine disrupters including: reviewing the literature; identifying known and suspected mechanisms and impacts on fish, wildlife, and humans; and recommending research, monitoring, and testing priorities.
Within the last two weeks, as part of EPA's 1997 Fiscal Year Appropriations Bill, Congress directed the Agency to enter into an agreement with the National Academy of Science to expand its current work on endocrine disrupters to include addressing issues "central to the development of a cost-effective screening program, including how to select and prioritize chemicals for testing, which test or tests to include in a screening program, and the most appropriate way to use the resulting information in developing risk assessments." This recent addition to the work of the existing NAS panel appears to overlap significantly with the work of the EDSTAC.
The EDSTAC differs from the NAS panel in that the conclusions drawn by the EDSTAC will be formed by a broad and diverse multi-stakeholder group in an open and public process including individuals with both policy and scientific expertise. As with the CENR, we would expect that the EDSTAC will draw from the work of the NAS panel, to the extent that the NAS process will allow. We would also expect that there will be overlapping membership between the EDSTAC and the NAS panel.
The fourth builds on our understanding that the EDSTAC Chair intends to have the EPA Science Advisory Board (SAB) and the OPPTS Science Advisory Panel (SAP), which was statutorily created to review pesticides policy and science as it pertains to FIFRA, jointly review and provide comment on EPA's proposed action following the development of theEDSTAC's conclusions and recommendations. This joint review will occur after the EDSTAC has concluded its work but prior to EPA taking action. Given the consensus objective of the EDSTAC process, if consensus is achieved, then the joint SAB/SAP review of EPA's proposed action will essentially be a review of the consensus outcome. If consensus is not achieved, the SAB/SAP review will focus solely on whatever action EPA proposes to take.
Finally, there are efforts underway to harmonize the endocrine disrupter research and regulatory efforts of various countries through the Organization for Economic Cooperation and Development (OECD). We believe that the EDSTAC will need to stay aware of OECD activities and be prepared to consider their work, or vice versa, as appropriate.
Coordinating these various activities, among the federal agencies and other interested parties involved in each of them, will be an important component of ensuring that development of a screening and testing program and strategy is both well thought out and implemented efficiently. Given the multi-stakeholder and open, public nature of the EDSTAC process, and the range of policy and scientific expertise represented, we recommend that the EDSTAC be the focal point of whatever coordination the federal government and other stakeholders believe is necessary.
VII. Participant Selection Criteria
Based on the analysis of affected interests, the science/policy bridge nature of the EDSTAC goals, and a desire to ensure that the EDSTAC has the greatest chance of successfully completing its goals and objectives, we recommend that all individuals who are invited to participate as a member of the EDSTAC should meet the following participant selection criteria:
- They should represent a major "stakeholder" interest (i.e., those
who have a stake in the outcome or an ability to block or influence
the outcome of the deliberations of the Committee) or a necessary area
of scientific expertise;
- To the greatest degree possible, they should have both science and
policy expertise relevant to the issue of endocrine disrupter screening
and testing, and the ability and willingness to participate constructively
in discussions that will serve as a bridge between scientifically and
technically complex information and important policy level considerations
relevant to endocrine disrupter screening and testing;
- They should have the ability and willingness to participate in good
faith in a process that will be aimed at developing consensus recommendations
among representatives of diverse interests on an endocrine disrupter
screening and testing program; and
- They should be willing to commit sufficient time to attend and contribute to the discussions at EDSTAC meetings, prepare themselves for effective contributions between meetings, and, to the greatest extent possible, participate in work group meetings and preparations.
Based on the analysis of affected interests analysis, the proposed structure, and the proposed participant selection criteria, we recommend that EPA invite the following individuals to participate in the EDSTAC:
U.S. Environmental Protection Agency EPA (4)
- Lynn Goldman, EDSTAC Chair, Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances
- Penny Fenner-Crisp, EDSTAC Vice Chair, Deputy Director, Office of
Pesticide Programs, OPPTS
- Lawrence Rieter, Director, Health Effects Research Laboratory, Office
of Health Research, EPA Office of Research and Development
- Tudor Davies, Director, Office of Science and Technology, EPA Office of Water
Other Federal Agencies (6)
- Mark Schaefer, Deputy Assistant Secretary for Water and Science, Office
of the Secretary of the Interior
- Bernard Schwetz, Director, National Center for Toxicological Research,
Food and Drug Administration
- George Lucier, Director, Environmental Toxicology Program, National
Institute for Environmental Health Sciences
- Richard Jackson, Director, National Center for Environmental Health,
Centers for Disease Control
- Bryan Hardin, Senior Scientist, Office of the Director, National Institute
for Occupational Safety and Health
- Richard Ellis, Director, Chemistry Division, Office of Public Health and Science, US Department of Agriculture
State/Public Health Organizations (3)
- Henry Anderson, Chief Medical Officer, Wisconsin Bureau of Public Health
- Anna Fan, Chief, Pesticide and Environmental Toxicology Section, Supervising Toxicologist, California Environmental Protection Agency
- Nancy Kim, Director, Division of Environmental Health Assessment, New York State Department of Health, and Associate Chemistry Professor, SUNY Albany
Chemical, Pesticides, and Consumer Products Industries (8)
- Donald Lamb, Vice President, Product Safety and Regulatory Affairs, Bayer Corporation
- Joseph Lebeau, Vice President, Product Responsibility, Dow Chemical Company
- James Quance, Environmental Coordinator, Exxon Chemical Company
- Angelina Duggan, Registrations Manager, Agricultural Products Group, FMC Corporation
- Additional pesticide manufacturing company representative to be determined.
Consumer Products Industry
- George Daston , Principal Research Scientist, Miami Valley
Laboratories, The Proctor and Gamble Company
- Thomas Osimitz , Manager, Safety Assessment and Regulatory
Affairs, S.C. Johnson & Son, Inc.
- Small company representative drawn from a "core" industry, to be
- Small company representative drawn from a "core" industry, to be
Water Providers (1)
- A member of the Association of Metropolitan Water Agencies (AMWA)
and/or the American Water Works Association (AWWA). *
Worker Protection/Labor (2)
- David Parkinson , Chief Medical Consultant to The United
Steelworkers of America, State University of New York at Stoneybrook
- Marion Moses , Director, Pesticides Education Center
National Environmental\Environmental Justice\Public Health Groups (7)
- Theo Colborn , Senior Scientist, World Wildlife Fund
- Jane Reese-Colbourne , Vice President, National Breast Cancer
- Peter de Fur , Co-Chair, Science and Environmental Health
Network, and Associate Professor, Center for Environmental Studies,
Virginia Commonwealth University
- Lovell Jones , Professor and Director of the Department of
Gynecology and Oncology, M.D. Anderson Cancer Center, University of
- Ted Schettler , Co-Chair of the Committee on Human Health,
Physicians for Social Responsibility
- Ellen Silbergeld , Professor of Toxicology, University of
Maryland, and Consultant to the Environmental Defense Fund
- Gina Solomon , Senior Scientist, Natural Resources Defense
Research Scientists (6)
- William Benson , Director of the Research Institute of Pharmaceutical
Sciences, School of Pharmacy, University of Mississippi
- Ken Dickson , Director of Institute of Applied Sciences,
University of North Texas
- Claude Hughes , Associate Professor of Comparative Medicine,
The Bowman Grey School of Medicine, Wake Forest University
- John McLachlan , Director, Division of Intramural Research,
Tulane/Xavier Center for Bioenvironmental Research, Tulane University
- Rochelle Tyl , Research Triangle Institute
- Judy Weis , Professor of Aquatic Biology, Rutgers University
* As of 10\11\96 our work to indentify a specific nomination for this seat had not been completed, however, the nomination will take place prior to the organizational meeting.