Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Endocrine Disruptors Screening and Testing Advisory
October 31- November 1, 1996
Final Meeting Summary
On October 31, and November 1, 1996, a public, organizational meeting was convened by the U.S. Environmental Protection Agency (EPA) to discuss issues associated with the establishment of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC). Approximately 30 people who had been nominated for membership on the Committee and 200 members of the public met for the day and-a-half session (see Attachment A for a list of nominees in attendance). The Keystone Center, a non-profit, neutral, policy facilitation and consensus building organization, assisted in facilitating the meeting.
II. Welcome and Opening Comments
Dr. Lynn Goldman, the EPA Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) and the EDSTAC Chair, opened the meeting and expressed her thanks to the individuals who were able to attend. She also gave an overview of some of the reasons EPA is forming the EDSTAC. Specifically, she mentioned the May 15-16, 1996 EPA-sponsored Stakeholder Meeting, which was convened as a result of the concerns resulting from research generated over the last few years and the potential, at the time, for Congressional action. Field observations, by scientists and members of the public, of the potential effects of endocrine disruptors have also served to heighten concerns. At the May meeting, nominees told EPA that endocrine disruptor screening and testing is an important issue for the agency to address and that broad stakeholder involvement in agency efforts would be necessary.
In August, 1996 Congress passed the Food Quality Protection Act and revisions to the Safe Drinking Water Act, both of which contain provisions dealing with the development of a "screening program ... to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate." As a result of the advice given at the May meeting and the subsequent Congressional action, EPA is now forming the EDSTAC. EPA's OPPTS, Office of Water, and Office of Research and Development are collaborating in this effort. The committee's focus is on screening and testing and not on planning and coordinating endocrine disruption research and strategies.
EPA hopes that the EDSTAC will take a consensus approach to reaching their findings and recommendations. However, the EDSTAC does not have to reach consensus in order to submit their findings, or for EPA to take action to meet the congressional mandates laid out in the SDWA and FQPA. The EDSTAC recommendations will, however, have to be completed by late 1997 if EPA is to use them in developing the screening and testing program.
III. Overview of Convening Report
Tim Mealey of The Keystone Center, provided a brief overview of the Convening Report prepared by Keystone prior to the organizational meeting (see Attachment B). As stated in the Report, Keystone 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. The Convening Report is the end product of Keystone?s assessment 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.
The Convening Report includes the following sections: goals and scope of issues to be addressed by the Committee; analysis of affected interests; the role of science and need for scientific expertise in the EDSTAC process; structure of the Committee; coordination with other related activities; nominee selection criteria; and EDSTAC membership. Each of these sections of the Report were discussed at the meeting by the nominees, and the public was provided opportunities to discuss and comment on them as well.
IV. Agenda Review
The facilitator explained that while the intention is for the EDSTAC process to be consensus oriented, it was noted that the EDSTAC had not yet been chartered under the Federal Advisory Committee Act (FACA) and that EPA was not looking for consensus from the nominees attending the organizational meeting. Rather, two primary objectives were raised:
- to enable nominees to engage in dialogue and express individual opinions
about the recommendations contained in the Convening Report, as well
as other organizational matters; and
- to allow members of the public to offer comments on all aspects of the convening of the EDSTAC.
The underlying goal of the meeting was to surface issues of concern related to the formation of the EDSTAC, and possible ways to address those concerns, rather than to come to agreement on how to address those concerns. Throughout the majority of the agenda, EDSTAC nominees were given the opportunity to offer their thoughts on the convening recommendations laid out in the Convening Report. In addition, two public comment opportunities were built into the agenda to allow the public to offer their thoughts on the formation of the EDSTAC.
V. Overview of the Actions Leading up to Formation of Proposed Goals and Scope of Issues to be Addressed by the Committee
Dr. Penny Fenner-Crisp, Deputy Director of OPPTS, described in some detail what EPA has been doing and how Congress' actions have affected the formation of the EDSTAC. An overview of Dr. Fenner-Crisp's presentation was handed out for nominees (see Attachment C). The presentation addressed EPA's research activities; collaborative research efforts; related meetings taking place over the past few years; other EPA-led federal advisory committees; and the regulatory context of this effort and the specific legislative language.
Nominees were given the opportunity to ask clarifying questions, but since they would be discussing many of the issues raised by Dr. Fenner-Crisp's presentation throughout the meeting, in-depth discussions did not occur.
One question posed related to the relationship between the EPA, and EDSTAC, and the National Academy of Sciences (NAS) research panel as a result of recently passed language in the Appropriations Bill. EPA indicated that they had just begun their discussions with NAS and was still considering options. One option raised was that of expanding the existing NAS Panel, to include a broader mandate. EPA also indicated that the timelines laid out in the SDWA and FQPA are of utmost importance.
Another question regarding the NAS panel was whether the existing effort looked into ecological effects of endocrine disruptors. EPA explained that, according to Proposal No. 95-CLS-056-01, the NAS panel was asked to "... review critically the literature on hormone-related toxicants in the environment; identify the known and suspected toxicological mechansims and impacts on fish, wildlife, and humans; identify significant uncertainties, limitations of knowledge, and weaknesses in the available evidence; develop a science-based conceptual framework for assessing observed phenomena; and recommend research, monitoring, and testing priorites." Additional tasks may be completed to the extent practicable.
VI. Key Issues Raised During the Discussions of Proposed EDSTAC Goals and Scope of Issues
After reviewing the proposed goals and scope of issues to be addressed by the Committee, found on page two of the Convening Report, nominees discussed a number of issues including: definition of an endocrine disruptor screening and testing program; scope of the effort; validation; use of exposure information and prioritization questions; risk assessment; and communication. These issues were discussed following a presentation given by Tony Maciorowski, Chief of the Ecological Effects Branch, OPPTS, EPA (see Attachment D). His presentation, intended only to spur discussion, included suggestions for a definition of endocrine disruptors; the scope of the effort; how to set priorities; specific screening and testing strategies; and exposure assessments.
A. Definition of an Endocrine Disruptor Screening and Testing Program
Some nominees were unclear about the distinction between "screening" and "testing" in the context of the EDSTAC mission. Dr. Goldman explained that a screening process needed to be developed to assess which chemicals and pesticides should then be tested for their potential to affect the endocrine system.
EPA presented a potential definition of endocrine disruptors, one that they and other organizations have adopted, for the nominees to consider:
Endocrine disruptors are exogenous agents that interfere with the synthesis, secretion, transport, binding, action or elimination of natural hormones in the body leading to adverse effects.
The nominees made one grammatical suggestion (i.e., changing "which lead" to "leading"). Given the nature of the meeting, no consensus was reached on this definition, however, many people indicated support for the language. Some nominees raised the concern that the use of the term "in the body" in the current definition did not adequately capture the biological/ecological component. The idea of agreeing upon an endocrine disruptor definition was intended to help define the scope of the project. The suggestion was made that, after agreeing on a definition, the Committee could define a manageable scope within that context.
B. Scope of the Effort
In discussing the scope of the effort, nominees identified three threshold issues. These were, should the Committee consider:
- only estrogen effects or broaden the mandate to include other endocrine
disruptor effects (e.g., anti-androgens, thyroids, other?);
- only single compounds or mixtures of compounds as well; and
- only human effects or ecological effects as well.
Some nominees felt the Committee should not focus its overall efforts too narrowly simply because of legislative deadlines. At the same time, other nominees contended, in order for the Committee to develop some beneficial recommendations they would need to quickly determine what is manageable. Some suggested the Committee needs to prioritize its work in order to develop useful advice within the mandated timeframe, but added that Committee members should not discount their ability, if successful, to continue consensus efforts past the statutory deadlines.
In discussing the range of endocrine disruptor effects to consider, nominees recognized that existing legislation requires the EPA to develop a screening and testing program that addresses estrogen effects, while also allowing the EPA to address other hormonal effects as deemed appropriate by the Administrator. Some nominees felt, because of the statutory language and time constraints, the Committee should only focus on estrogen effects. Other nominees indicated the Committee should expand its mandate to include additional endocrine disruptor effects such as anti-androgens and thyroids, among others. They felt that the range of expertise on the EDSTAC and the interrelatedness of many of these effects on different systems add support to the idea that the Committee should expand beyond estrogen effects . Another point for consideration was that as knowledge has evolved, many scientists have recognized that what were originally considered estrogen effects are now thought to be anti-estrogen and anti-androgens effects.
Many nominees seemed to agree with the suggestion that the EDSTAC could address estrogen effects initially, but concurrently develop a set of principles that could be applied to screening and testing for other hormonal effects. As time permitted, these principles, it was suggested, could be applied to other effects. Some nominees, to strengthen this argument, expressed concern that if their efforts are defined too narrowly (i.e., only looking at estrogen effects) the recommendations might become obsolete as new science emerges. In addition, these individuals suggested, defining the effort too broadly (i.e., considering a longer list of potential hormonal effects in addition to estrogens) could also result in recommendations being considered out-of-date before they are released. These individuals reiterated the idea of developing a set of principles and criteria to be used in determining whether a particular screen or test is valuable for assessing hormonal effects.
Whether the Committee should examine only single compounds or mixtures as well was raised by a number of nominees. Some felt that trying to develop a screening and testing program for mixtures would be too difficult from both a manageability and validation perspective. Others said that recent tests on the effects of mixtures (e.g., the yeast culture test at Tulane University) seem to suggest examining mixtures is important, especially as related to their potential effects on ecological systems. One nominee, representing industry, felt the Committee might be able to identify a number of commonly found mixtures or classes of chemicals that could be included in the screening and testing program.
The question of whether the Committee should examine only human effects or ecological effects as well was considered by the nominees. One issue considered was whether time constraints precluded examining both. Another was that, while the FQPA and SDWA legislative mandate does seem to focus on human health, EPA responsibilities cover protection of human health and the environment so, as data is compiled, EPA will need to relate the impacts to both systems. Nominees noted that, from a scientific perspective, much of the existing data on endocrine disruption is found in the ecological fields. Further, similar responses to endocrine disruption in humans and other species have been observed. Nominees felt that although these similar responses would need careful assessment, opportunities exist to draw from the ecological studies already completed and to apply this knowledge to the human health field.
During the deliberations, Dr. Goldman indicated EPA's desire to look at both human and ecological effects. Many of the nominees indicated support for considering both effects and some recommended including additional expertise on the Committee.
Many of the nominees wanted to ensure that the Committee develops a validation process for the various screens and tests eventually proposed. Dr. Goldman mentioned that a recent EPA meeting took place to address the validation of alternative screening and testing methods and they derived a set of principles that would allow federal agencies to use these alternative methods. Committee nominees agreed that looking at these principles could be a place to begin their discussions regarding the issue of validation.
Some nominees discussed validation in terms of the ability of a specific screen or test to predict outcomes, while others defined validation in terms of the reproducibility of a specific screen or test. The concepts of predictability and reproducibility were seen as very different and the nominees agreed that the Committee will have to decide whether validation is one or the other or both.
D. Use of Exposure Information and Prioritization Questions
The first proposed EDSTAC goal related to selecting and prioritizing chemicals and pesticides for screening and the need to utilize "appropriate" exposure information in that process. Some nominees questioned the role of the Committee in setting criteria for applying the screening and testing program. Notwithstanding the recognized importance of exposure information, they felt that such information is developed through entirely different procedures than screening and testing programs and should be separated from this effort. A suggestion was made to drop the first goal. They were particularly concerned that this language not be interpreted to mean that some type of formal exposure assessment would need to occur, or that where exposure information does not exist, it would need to be developed, in order to subject a particular chemical or pesticide to screening and testing. Other nominees expressed the view that given the number of chemicals and pesticides found in commerce, some effort at prioritization would need to occur. They indicated that they did not interpret the reference to the use of "appropriate exposure information" as implying the use of formal exposure assessments or the collection of exposure information where it did not already exist. Dr. Goldman indicated that EPA would like to keep the language regarding the need for prioritization in the Committee's mission as a consensus on this policy issue would be helpful when EPA makes its final decisions on how to apply and utilize a screening and testing program.
E. Risk Assessment
Specific language in the goals section of the Convening Report (page two) states that the information to be gained from the screening and testing program "will be used to mitigate risk to human health and the environment." A number of nominees raised the issue of what role risk assessment will play in either moving through the various steps within the screening and testing program, or after screening and testing is completed but prior to when the Agency makes its risk management decisions. Some nominees indicated that while the need for exposure information, where it exists, may be important to set priorities regarding what chemicals and pesticides should be subjected to screening and testing, not enough exposure information exists to conduct a traditional risk assessment. Further, they said that the inability to complete such a risk assessment should not impede efforts to test chemicals and pesticides for their potential to affect endocrine systems or to take action to mitigate or reduce hazards, if they are found to exist as a result of the screening and testing program. One nominee pointed out that the screening and testing program will have value beyond whatever formal risk management actions EPA might take and that the information gained from the program will likely be used by industry to take action to reduce or mitigate risk independent of whether EPA takes action. Other nominees indicated that the results of screens and tests should be related to risk assessments. These nominees noted that recent changes to the EPA risk assessment guidelines that address developmental and reproductive effects should be examined for their relevance to this issue.
Several nominees raised questions about the language found in the last paragraph of the proposed goal statement found on page two of the Convening Report. It was explained that this language was an attempt to deal with two aspects of communication: 1) how the EDSTAC would publicly communicate the true intent of the substantive agreements and recommendations they submit to EPA; and 2) what suggestions the EDSTAC would make regarding how EPA should communicate screening and testing information to the public in the future. Some nominees expressed concern that the information regarding the Committee's proposals might be misrepresented or misinterpreted and wanted to develop ways to avert this potential problem.
VII. Proposal Regarding Development of Screening and Testing Principles
In an effort to synthesize some of the comments made during these sessions, a nominee proposed that the Committee, when it is officially chartered, should focus on developing a consensus product of maximum value. That product, it was suggested, should include, at a minimum, development of guiding principles that should cover topics such as:
- The purpose of screening and testing -- why is endocrine disruptor
screening and testing necessary both in general and specifically related
to each component of the program.
- Principles for:
- selecting screens and tests;
- establishing the order or logical relationships for different screens and tests;
- validating screens and tests; and
- interpreting the results of screens and tests.
- The utility of the information to be gained from screens and tests in deciding what happens both within the screening and testing arena and in the broader risk management/decision making arena.
Another nominee suggested that, in addition to the items listed above, the Committee should develop principles regarding how to expand screening and testing beyond whatever hormonal effects the Committee decides it will address during the EDSTAC process.
Many of the nominees expressed the view that all of these ideas would be a good starting point. Some nominees began to suggest some possible principles for specific components of the screening and testing program. For selection of screens and tests the ideas of results being published in peer review journals and requiring certain levels of specificity were suggested.
VIII.Proposed Structure of the Committee
The discussion of the possible structure of the EDSTAC began with the clarification that the EDSTAC will be an independent, "stand-alone" federal advisory committee rather than a subcommittee to an existing federal advisory committee. The Keystone Convening Report recommended against utilizing "subcommittees" within the context of EDSTAC (i.e., subgroups that operate independently from, although within the bounds of the charter of, the "parent" committee). However, the need for a variety of "work groups" (i.e., subgroups that assist in the achievement of the goals of the parent committee but do not operate independently of the parent committee) was seen as highly likely. A range of possible issue-specific work groups were raised including work groups oriented towards science, policy, and communication issues.
A. Science Integration and Coordination Work Group
One specific work group discussed in The Keystone Convening Report was the proposed Science Integration and Coordination (SIC) Work Group. The purpose of the SIC would be to assist the Committee in a number of science-related tasks such as defining the science-based questions to be answered, handling information requests, bringing scientific information into the Committee's deliberations, and coordinating the work of any additional science-based work groups. Some of the nominees indicated support for formation of such a group due to the Committee's scientific focus. They also felt that, in order to achieve its goals, the EDSTAC would need additional expertise to address specific questions as well as assistance given the time commitment that will be necessary to complete the EDSTAC mission in the time that is available. Without the proposed SIC, some argued, the transfer of information from the more narrowly focused, science-based work groups to the EDSTAC would be more difficult and the potential to have the EDSTAC members arguing over science-related issues more likely.
Other nominees felt that the SIC would only add an additional layer of "bureaucracy" to the EDSTAC that would slow the process down and create additional problems for an effort already strapped for time. In addition, they indicated that the Committee nominees' combined expertise would be enough to deal with many of the issues that would otherwise be handled by the SIC. Further, when additional expertise becomes necessary it could be included in the issue-specific work groups. As far as dealing with the transfer of information and framing of the scientific questions coming out of work groups, more of the burden could be placed on the issue-specific work group members.
Many nominees agreed that, regardless of the structure eventually chosen, how the Committee deals with a range of functions (e.g., integrating the work groups findings; avoiding duplication of effort; and focusing the Committee-level discussions on the right set of questions and issues) would need to be incorporated in the EDSTAC process.
Alternative models, that could creatively utilize the time and effort of the individuals in the EDSTAC, were also considered. The National Institute of Health was suggested as a possible model (i.e., individual Committee members could be assigned principle responsibility for specific work groups and participate on those, or designate someone else to, with the mandate of bringing back the findings of the work group to the other EDSTAC members). No decisions were reached and the nominees recognized that this issue would need to be revisited during the first EDSTAC plenary meeting.
B. Administrative Committee
Another discussion took place regarding the possible development of an Administrative Committee to help EPA and Keystone make decisions between plenary meetings of the full EDSTAC. The purpose of such a group would be to make decisions on "administrative matters" within a quick time frame to keep things moving. One example of the type of issue that might be addressed by such a group would be whether to form a new work group to address a specific need that arose between Committee meetings. Most EDSTAC nominees expressed support for such a group, especially given the time constraints under which the EDSTAC will be working. One concern raised had to do with the types of decisions that such a group could make. The idea of developing ground rules, agreed to by all EDSTAC members, for the Administrative Committee was raised as a way to deal with this issue.
IX. EDSTAC Membership Issues *
Discussions regarding EDSTAC membership focused on two questions: 1) How representative is the list of people who have already been nominated? and 2) Are there interests missing from, or underrepresented on, the Committee? The nominees generally had positive comments regarding the representativeness of the current list of nominees and especially the inclusion of research scientists on the EDSTAC.
A limited number of comments were made by the nominees regarding who might be added to the Committee. Recommendations included: an ecological effects perspective by NOAA and Fish and Game agencies; the National Cancer Institute; an additional environmental justice perspective, with a specific nomination of someone who has relevant expertise and works for the City of Chicago; more representation from the FDA; an international perspective; and small companies (seats were reserved for this perspective but as of the meeting individual representatives had not been identified). Nominees also recommended that manageability of the Committee be considered when thinking about adding additional interests. Dr. Goldman stated that while not all of these interests may be added, the EPA agreed to consider their inclusion.
* Additional comments on membership issues were received from participating members of the public. These comments can be found below.
X. Coordination With Other Related Activities
Given the number of ongoing activities related to endocrine disruptors, coordination among these activities 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. The other significant activities currently underway include the Committee on Environment and Natural Resources (CENR) interagency working group; the NAS Panel on Hormone-Related Toxicants in the Environment; any additional activities NAS and EPA agree to conduct that expands the scope of the NAS's current efforts; and the proposed joint review of the EPA Science Advisory Board and Science Advisory Panel.
Some nominees had further questions about the relationship between EPA and the current NAS panel. Regarding the current panel, nominees wanted to know how the study could be utilized by the Committee. While the report is not due to be released for some time, it was noted that one can ask for an overview of an NAS panel's current progress as well as receive information on the body of literature they have researched. Dr. Goldman explained that initial discussions between EPA and NAS are underway and then asked the nominees to give her feedback in the future on what would be the most helpful way to proceed with the new NAS process.
A question regarding the need for a peer review of the EDSTAC recommendations by the SAB/SAP was raised. In essence, some nominees thought the reason the EDSTAC was developed as a stand-alone Committee was so that their recommendations would not have to go through a review by either the NACEPT Committee or the SAB/SAP. Dr. Goldman indicated that the peer review by SAB/SAP is in the statutory language. She also added that after the proposal and recommendations are reviewed, there will be an opportunity for the EDSTAC to respond to the review. Regardless, the EDSTAC members will have the final word on the recommendations that will be contained in its Final Report and the SAB/SAP comments will be attached.
XI. Public Comments
As mentioned earlier, two opportunities were given for the members of the public observing the proceedings to comment on all aspects of the formation of the EDSTAC.
A. The First Day
Lynn Bradley, Director, Environmental Health, Association of State and Territorial Public Health Laboratory Directors, indicated that her organization has members interested in human monitoring and the related issues of how you deal with exposure. She recommended that EPA start thinking about addressing the human exposure concerns concurrently with the efforts to design a screening and testing program.
Chris Wilkinson of the Technology Sciences Group, Inc. related that, as a scientist, he is appalled with this process because law is mandating science and therefore science is under the gun. He also expressed concern about the perceived confusion surrounding the scope of the Committee. His advice was that since the law says EPA has to do one thing, develop a screen for estrogenicity, the Committee should deal with the law and then do the other tasks as time permits. The Committee's work could be utilized as a model for future efforts. He also suggested a set of steps the Committee should take: first, identify substances that have to go into a screen; second, complete the screens (a simple process that will raise flags); third, complete actual testing (dose-response issues); and fourth, bring in exposure because EPA will be doing a risk assessment.
Elizabeth Onon, who was not present at the meeting, asked that her comments be read into the record. Gary Timm of EPA read the letter. She asked the Committee to address the potential link between endocrine disruptors and the growing body of scientific knowledge regarding porphyria as relate to chemical disabilities. She further indicated that the nominees did not represent the victims of endocrine disruptors.
Stuart Cagen, Shell Chemical Company, indicated his support for the concept of what the Committee should produce. He suggested that the process has to include validation, interpretation, and an understanding of what EPA does with the results.
Steve Schraeder, National Institute for Occupational Safety and Health (NIOSH), expressed concern about the Committee only considering estrogens, especially as we now recognize that many of the effects we originally thought to be estrogens are actually anti-estrogens and anti-androgens. He suggested that the time is right for the Committee to go broader.
Mary Dadden, President, Long Island Breast Cancer Study, relayed her disappointment in how the information regarding the meeting was communicated. She requested that, in the future, notice be given at least four to six weeks in advance. In addition, she indicated her desire to see the discussions recognize the truly dangerous nature of chemicals and pesticides in the environment and their effects on humans. She suggested that the Committee consider opening at least two seats to consumer advocates who are not involved from a scientific perspective but can bring the concerns of the general public.
In response, the facilitator/convenor indicated that efforts to provide more notice will be made. He also indicated that the National Breast Cancer Coalition had offered to assist in coordinating efforts to involve disease-specific consumer interests in addition to breast cancer groups. One nominee added that the addition of consumer advocates to the Navy Breast Cancer Study had been very helpful and that this Committee should consider their inclusion. The idea of a communications work group, where concerns around the possibility of the public misunderstanding the results of screens and tests could be addressed, was raised. Another nominee added that the Committee seemed to be missing a representative of the people affected most by these chemicals and pesticides. The idea of moving the EDSTAC meetings around the country was raised as one way to include a wide range of perspectives and interests including consumer advocates. In addition, using the Internet to disseminate information was proposed, though its ability to disseminate information to a wide range of individuals was also recognized.
Alan Robeson raised the issue of testing mixtures. He indicated that a lot of people are concerned about pesticide runoff from agricultural lands and the combinations of pesticides. He recommended that, if the Committee moves its meetings around the country, they should go to a midwest city such as Chicago, Kansas City, or Des Moines in the spring.
John Berlau of Consumer Alert asked that the Committee consider consumer's interest, but added that there are different definitions of what constitute "consumer interests." He asked that the Committee look at the benefits of these substances as well as the negatives and said that consumers do not benefit from regulations developed without good science.
Miranda Henning, ChemRisk, suggested that, given the exposure issues as well as the fact that the information might be used in risk assessments, the Committee should involve a risk assessor.
Eric Juzenas, Health Policy Analyst, American Public Health Association, suggested that the Committee's environmental justice representation should be enhanced by adding some additional participants.
Rick Hind, Greenpeace, stressed that the Committee should keep in mind the issue of public disclosure and participants should volunteer information regarding their financial backing and/or interests as they relate to endocrine disruptor screening and testing if people want the process to be truly transparent. Relating to scope he said that the Committee should focus on looking at this through the lens of existing FIFRA and TSCA regulations. In addition, he felt that the Committee should not get caught looking at chemicals one-by-one.
Charlie Cray, Greenpeace, wanted the Committee to look at persistent organic pollutants. He also added that the Committee should incorporate, from an environmental justice perspective, some of the folks who represent the people who suffer as a result of the migration of these substances to the colder regions of the world (e.g., Alaska). He indicated that the public wants a list of products they should not buy and labeling that explains what is in a product. Other countries that have approached these issues, (e.g., Denmark) may be a useful source of information. If EPA is not going to develop these lists, he asked, who will?
Nelsa Ford asked whether all future meetings were going to be public now? EPA indicated that all EDSTAC meetings will be public, however, whether all work group meetings will be public remains to be determined.
B. The Second Day
Maurice Zeeman, OPPTS, EPA, raised the issue of the Committee balancing ecological and human health issues because so much uncertainty exists regarding human health effects whereas we are more certain about ecological effects.
John McCarthy, American Crop Protection Association, commended the Committee nominees, EPA, and Keystone on their efforts. He raised three points: first, focus equally on human and ecological effects; second, look at all possible hormonal effect endpoints raised during the deliberations in parallel, while recognizing the statutory importance of specific ones; and third, the Committee should get on with the task at hand without getting too bureaucratic and use the Science Integration and Coordination work group in the future if necessary.
Layla Patarsi, Center for Food Quality, Food and Drug Administration, explained that food additives comprise a set of chemicals not currently regulated under TSCA or FIFRA, and asked that the Committee consider them in their deliberations.
Robert Fisher, National Council of the Paper Industry for Air and Stream Improvement, talked about the structure of the Committee and recommended that the group consider looking at how the EPA structured a process dealing with the Gulf of Mexico where many similar issues were addressed. They used a tiered process and included issue committees, a technical steering committee, and a management committee/policy review board. He also added that the meetings of the working groups should be open to the public for observation for two reasons, first, the private sector is often involved in research relevant to the issues being discussed, and second, the private sector is often involved in the decision making process and needs to know about the findings coming out of these efforts.
Bill Kelley, the Institute for Regulatory Policy, recommended the nominees develop a list of what can be done between the organizational meeting and the December meeting before leaving. He also raised serious misgivings regarding the name endocrine "disruptors" and suggested changing it to "disruption" or "effects" as the Committee is talking about a hazard screening process rather than risk assessment.
Elizabeth Reeves, requested the Committee consider using cell culture testing rather than animal tests. She added that the Committee should remember the ultimate stakeholder is the American citizen and the ecological issues should not be overlooked.
Mary Ann Dodden, expressed support for the evolution toward a broader definition of endocrine disruptors than just hormone disruption. If the definition says "only affect the hormone system," she felt, the Committee will not examine the immune, reproductive, growth and neuro systems. She also stated that the Committee needs to recognize that other issues may be added to their discussions as their understanding of science evolves.
Elsa Ford, asked the Committee to commit to follow-up testing of past use and new use chemicals as pertains to endocrine disruption. Coordinated documentation, she added, is important in these types of efforts. Finally, she said that the public needs to know about the cumulative effects of chemicals and pesticides in the real world and asked the Committee not to focus only on single ones.
Patricia Fail, Research Triangle Institute, told the Committee nominees she had been working mainly on FIFRA issues for the past 10-15 years. After listening to the need for various screens and tests during the past two days, she indicated that the Committee needs to take already existing data (from FIFRA companies) and validate the tests that exist and see if the chemicals that test positive are actually endocrine disruptors.
John Hines, an independent consultant, told the nominees that they need to address what product(s) they expect as a result of this effort. He also indicated that the discussions on prioritization of what issues to address were good. Regarding membership, he added, the Committee nominations seem to be carefully structured and will result in a fairly large Committee, so do not add too many more people.
XII. Additional Information to Assist the Committee's Deliberations
Throughout the meeting a number of documents and were identified as tools that could potentially aid the Committee members in their deliberations. These included:
- an EPA-sponsored meeting at Duke that looked at estrogenicity, androgenicity, anti-estrogenicity, and anti-androgenicity;
- the CENR study has drawn from all of the federal agencies to compile a database of on-going activities;
- an inventory of screening and testing methodology;
- key regulatory and legislative language;
- general information on endocrine disruptors;
- the executive summary from the report on validation of test methods;
- background on how EPA manages the risks associated with FIFRA and TSCA; and
- materials from the NAS Panel such as an outline of their impending report or a bibliography.
XIII. Next Steps
Dr. Goldman thanked everyone for taking the time out of their busy schedules to assist in the EDSTAC organizational meeting. She indicated that EPA would need to think about the structure of the Committee and associated work groups. With regards to the openness of the work groups, EPA would have to consider resource limitations and logistical concerns. She added that the purpose of the EDSTAC and the goal of finishing within a year would guide what decisions are made about structure.
The EPA agreed that the strategy of moving EDSTAC meetings around the country was a good idea. To that end, Dr. Goldman stated that the next meeting would take place in San Francisco, California on December 12 and 13. Keystone agreed to find a hotel and disseminate logistical information to the Committee nominees and interested members of the public as soon as possible.
A request was made for all nominees to think broadly about the types of activities they felt could reasonably be accomplished in the Committee's life span and, more specifically, about the development of guiding principles for a screening and testing program before the first EDSTAC meeting. In addition, the nominees agreed to think about the work groups potentially needed to help the EDSTAC achieve its goals.
If Committee nominees know interested members of the public who want to be placed on the mailing, list they should have them contact The Keystone Center.