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Endocrine Disruption
by Chemicals:
Next Steps in Chemical Screening and Testing
--
Proceedings of a Meeting
Sponsored by the U.S. Environmental Protection Agency
Office of Prevention, Pesticides, and Toxic Substances
May 15 and 16, 1996
--
Day 1
- I. Introduction and Overview
Dr. Lynn Goldman, Chair
Assistant Administrator
EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS)
- Dr. Goldman opened the meeting with an overview of endocrine-disrupting
chemicals (EDCs) as an issue of fundamental importance -- one to which
some urgency must be applied. Congress is considering legislation that
would require the development and implementation of a screening and
testing strategy for EDCs. Outlining the potential impacts and risks
to humans and terrestrial and aquatic populations, Dr. Goldman reiterated
EPA's objectives in obtaining the input of key stakeholders to develop
a strategy to screen and test for known or suspected EDCs. Dr. Goldman
emphasized the importance of this objective to the Agency's work with
Congress, suggesting that the outcomes might facilitate a positive debate.
In formulating an approach to screening and testing for EDCs, stakeholders
were asked to consider a cost-effective process because resources are
limited for this endeavor. Existing test guidelines for reproductive
and developmental toxicity might be used, with a new focus on EDC hazards,
potential for exposure, dose, and risk. Despite the complexity of the
EDC issue, Dr. Goldman said that developing a screening and testing
program for environmental hormones -- including chemicals that affect
reproduction and development through endocrine disruption -- represents
an important first step in reducing exposures and risks.
Regulatory Requirements
To provide a framework for EDC policy discussions, Dr. Goldman reviewed two statutes implemented by OPPTS governing chemicals and pesticides: the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Each statute was outlined with respect to chemical screening and testing methods. Both of the statutes involve balancing risks and benefits, have requirements for informing EPA of possible effects, and provide a framework for reducing chemical risks. They differ in terms of their requirements for testing and the burden of proof of a product's suitability for the market. For example, under FIFRA, pesticides that are specifically developed to kill a pest carry more potential risk, a there is a greater burden of proof placed on manufacturers to demonstrate the safety of their products. In contrast, TSCA requirements are more streamlined, easing the chemical approval process. For example, if EPA cannot determine a chemical's suitability for the market within 90 days, then that chemical is automatically approved. Because there is no minimum data requirement under TSCA, structure activity relationships (SAR) are often used to screen for endpoints with which EPA is familiar, but determining health effects in emerging areas such as immunotoxicity and endocrine disruption is problematic. Conventional tests are not very effective for assessing the ecological effects of EDCs.
Suggested Approach
To date, EDC research has focused on chemicals that emulate or block male or female reproductive hormones. Some findings are of concern, such as the reported effects of DDT and PCBs on birds. From a regulatory standpoint, EPA will begin looking at the issue in areas where data are currently available and the emerging science can be useful for making decisions about managing risk. The Agency has managed risks from many endocrine disrupters in the past, and a reassessment of both pesticides and non-pesticide chemicals that act as EDCs is under way. These include four organochlorine pesticides still on the market: dicofol, methoxychlor, lindane, and endosulfan. As part of developing regulatory approaches to EDCs, EPA will work with the Chemical Manufacturers Association (CMA) and the World Wildlife Fund to review screening and testing assays and to determine those that might be scientifically valid and ready for peer review. Dr. Goldman cautioned that these assays must bear relevancy to the endpoints under EPA consideration and must be useful for regulatory decision-making. Dr. Goldman cautioned against adopting new tests too quickly, without first understanding how well they predict the effect and whether they capture all of the chemicals that produce that effect. The Agency is currently involved in a review of EDCs by the National Research Council (NRC) of the National Academy of Sciences (NAS). The review will help assess the scientific importance of EDCs and recommend further work.
International Discussions
EPA is participating in a wide range of international activities related to risk assessment and harmonization of test guidelines. Some of these activities touch on the issue of EDCs. For instance, the Organization for Economic Cooperation and Development (OECD) is developing test guidelines. We have a harmonized set of testing guidelines for chemicals that we developed along with other countries. Under that forum, the United Kingdom is leading an examination of EDCs. We will be meeting with the United Kingdom in July on this issue. Dr. Goldman emphasized the continued need for international cooperation from the beginning so that general agreement can be reached early on.
Conclusion of Introductory Remarks
Research is critical to continued progress on EDCs. Scientific uncertainties must be addressed, such as what effects are occurring among humans and wildlife; what classes of chemicals may affect the endocrine system; and how to screen and test for those effects. The issue of multiple exposures will be very important in this area. Dr. Goldman said in-vitro testing could be very useful as a relatively fast, inexpensive way to get data, and may provide information on whole-organism effects.
No schedule or process has yet been formulated for addressing EDCs. EPA will move forward with discussions on how to ensure participation from all interested stakeholders. A joint strategy is critical to the task.
- II. Overview of EPA Research and Draft Research Strategy
Dr. Lawrence Reiter, Director
National Health and Environmental Effects Research Laboratory, U.S. EPA
- Dr. Reiter presented an overview of activities conducted by EPA's
Office of Research and Development (ORD) and related federal programs.
He also provided information on ORD funding mechanisms and the status
of its research plan (undergoing review) on EDCs. Dr. Reiter reported
on a research needs workshop held in Raleigh, North Carolina in April
1995. The workshop evaluated the validity of the EDC hypothesis, defined
information necessary for adopting public policy, and described major
research needs. Those needs include improved hazard identification,
improved models for quantitative risk assessment, and more data collection
on real-world exposure, including multiple exposures. The CENR established
an EDC workgroup to develop and coordinate federal research into the
ecological and human effects of EDCs. Dr. Reiter outlined ORD's research
activities, stating that EDCs are a high- priority area. Activities
include a greater focus on risk assessment, models and their validation
for hazard identification, and validation of in-vivo testing to include
endocrine-system endpoints. Dr. Reiter also discussed ORD's participation
on the Committee on Environment and Natural Resources (CENR) of the
Office of Science and Technology Policy.
- III. Overview of EDC-related Activities of EPA's Office of Water;
Legislative Developments
Dr. Margaret Stasikowski, Director
Health and Ecological Criteria Division
Office of Water, U.S. EPA
- OW's involvement in EDCs began in 1994 during discussions to reauthorize
the Clean Water Act (CWA). The discussions included an administration
proposal for an NAS study to examine the current knowledge of chemicals
that exhibit endocrine, immune and nervous system effects (e.g., breast
cancer and decreased sperm counts). At the same time, a House bill asked
NAS to study the effects of pollution in navigable waters and how it
could be affecting aquatic and human life. Among other things, NAS also
was to develop a list of general criteria for identifying substances
that may cause significant and widespread effects on the developmental
system. Even though the CWA reauthorization failed, the Centers for
Disease Control and Prevention (CDC), the U.S. Department of the Interior
and EPA funded the NAS study. It will include a critical review of the
literature on hormone-related toxicants and identification of known
and suspected toxicological mechanisms and their effects on fish, wildlife,
and humans. NAS also will identify knowledge gaps and recommend research,
monitoring, testing priorities and possible approaches to mitigation.
NAS will submit its report to EPA in the spring of 1997. Dr. Stasikowski
also discussed new legislative developments such as the pending reauthorization
of the Safe Drinking Water Act (SDWA). Both the House and the Senate
bills contain EDC-related language. The Senate version would require
EPA to develop an estrogenic hormone screening program to determine
whether certain substances can affect humans. The House version, which
would require EPA to submit a report to Congress on the findings of
the NAS study, provides for a longer and more complicated estrogenicity
evaluation program. Dr. Stasikowski expressed OW's interest in influencing
the language of these bills.
- IV. Stakeholder Comments and Identification of Key Issues
Dr. Terri Damstra
Associate Director for Science Coordination
National Institute for Environmental Health Sciences
- Dr. Damstra provided an update of the activities conducted by the
National Institute for Environmental Health Sciences (NIEHS) under the
auspices of the U.S. National Toxicology Program. NTP is involved in
developing tests to study EDC activities. One of the tests uses a three-tiered
approach: an in-vitro test for receptor binding, an in-vitro test for
gene expression, and an in-vivo mouse uterotrophic test. Six chemicals
are currently being studied. Dr. Damstra said NTP, in conjunction with
the National Center for Toxicological Research (NCTR), is also initiating
some two- generation studies on EDC exposure both during pregnancy and
perinatally. Nine chemicals are being studied. Dr. Damstra concluded
the presentation by noting that NIEHS is researching the basic mechanics
of EDCs and is participating in the development and validation of alternative
testing methods for acceptance by regulatory agencies.
- Dr. Michael D. Fry
Center for Avian Biology
University of California at Davis
- Dr. Fry discussed the problems with testing EDCs within the framework
of FIFRA and TSCA test guidelines. Both statutes focus on mammalian
systems, yet the wildlife demonstrations of endocrine effects have largely
been seen in birds. Effects have also been reported in reptiles and
fish, but few effects have been reported in mammals. Endocrine control
of reproductive development in mammals and birds is quite different;
therefore, data from mammalian studies cannot predict the effects on
birds, except in very general ways. FIFRA testing protocols do not directly
address endocrine-related reproductive developmental abnormalities in
birds; nor do they include all stages of development in which EDCs may
exert an effect. For instance, we know that persistent organochlorines
in birds' eggs cause developmental abnormalities. Avian testing protocols
under FIFRA include only bobwhite quail and mallard ducks as recommended
test species. As such, testing is restricted to precocial birds. These
tests do not address effects on altricial birds. In-vitro tests are
extremely effective in predicting some estrogenic effects, such as effects
on breast cancer tumor cells, but such tests do not predict the effects
of chemicals as they metabolize or degrade. Cancer tests alone are inappropriate
for testing the effects of EDCs. With cancer tests, very high doses
are used to compensate for the evaluation of an infrequent event. With
EDCs, we are finding that the most significant doses of chemicals are
close to the physiologically active level of the hormone -- extremely
low concentrations. Dr. Fry concluded by saying that one of the most
important things to consider in looking at potential effects of EDCs
is to evaluate how well they bind to the estrogen receptor, if at all,
then to scale doses appropriately to evaluate the physiological levels
of these compounds.
- Timothy Kubiak
National Water Quality Coordinator
U.S. Fish and Wildlife Service
- Mr. Kubiak stated the importance of developing a consensus on the
best approach for marrying laboratory and environmental protocols and
methods for determining exposure effects and cause-effect relationships.
He outlined the difficulty inherent in translating laboratory data into
what we find in the environment. Because it also can be difficult to
tease apart the causes and effects of multiple exposures, the operative
definitions of endocrine disrupter and developmental toxins must be
broad. Mr. Kubiak said we must screen for the effects of EDCs by species,
choose broad classes of animals in both the laboratory and the environment
as sentinel species, and define key endpoints for each species. Finally,
Mr. Kubiak noted some environmental signals of potential endocrine disruption
that should be heeded, including behavioral effects, effects on migration,
and declining populations.
- Dr. Ronald J. Kendall
Director, The Institute of Wildlife and Environmental Toxicology
Clemson University
- Dr. Kendall, who in March 1996 chaired a conference entitled "Principles
and Processes for Evaluating Endocrine Disruption in Wildlife," said
the key issue in the debate over EDCs is exposure, and whether we can
correlate or identify cause-effect relationships. There are screens
available today that allow at least some assessment of estrogenicity,
such as MCF-7 cells, the E-screen, and vitellogenin induction. In the
future, yeast-based estrogen screens may allow another type of screening
for potential estrogenicity, and phagocytosis assays may help incorporate
immunotoxicological endpoints into the EDC debate. In the meantime,
a variety of sentinel species are providing evidence about the effects
of EDCs, including fish, invertebrates, birds, mammals, and reptiles.
Dr. Kendall addressed the different organizational levels affected by
EDCs (i.e., cells, individuals, populations). He also outlined a risk-based
approach to examining the effects of EDCs that would incorporate and
integrate laboratory and field information, QSARS, modeling and monitoring.
Such an approach would be consistent with EPA's risk assessment paradigm.
- Dr. John McCarthy
Vice President for Global and Scientific Regulatory Affairs
American Crop Protection Association
- Dr. McCarthy offered his view that the chronic/oncogenicity, developmental,
and two-generation reproduction studies required for food-use chemicals
provide a comprehensive assessment of potential adverse effects from
endocrine disruption. Proposed upgrades to the reproduction and developmental
tests would further enhance these methods by providing more subtle endpoints
and improving the quantification of existing ones. Dr. McCarthy said
validated short-term testing could be useful for mode-of-action studies
to follow up findings in the currently required tests. He concluded
by saying that for fish and wildlife testing, we need short-term screening
tests to determine what more advanced kinds of testing might be needed.
- Mr. James F. Quance
Environmental Coordinator
Exxon Chemical Company
- Mr. Quance expressed his commitment to the advancement of science
in understanding EDCs and reiterated some of the ongoing and planned
research efforts of industry and government agencies. Expressing his
concern that the work of public and private research programs has not
been coordinated, Mr. Quance called for a scientific consensus on the
most appropriate methodology for assessing the risk of endocrine-mediated
effects. The extent and complexity of the problem require the best efforts
of all stakeholders in designing a success-oriented process and reaching
agreement on which endocrine-related endpoints should initially be considered.
Mr. Quance highlighted three broad steps for a risk assessment process
as envisioned by CMA: identify and prioritize chemicals of concern;
screen chemicals of concern to identify those that represent potential
risk to either the environment or human health; and develop validated,
confirmatory tests to assess the extent of risk and the need for risk-management
decisions. A major research need is validation of existing approaches
and the development of a database on the relationship between in-vitro
data and results of short- and long-term in-vivo tests.
- Dr. Paul Foster
Chemical Industry Institute of Toxicology
- Dr. Foster told members of the workgroup that definition, detection,
and prioritization are central to the EDC debate. Given the broad definition
of the term "endocrine disrupters," greater focus is needed to develop
a screening strategy, and that strategy may need to distinguish the
needs of both wildlife and humans. Dr. Foster endorsed a mixed in-vivo/in-vitro
strategy for detection, and pointed out the need for debating the effectiveness
of a tiered screening strategy because of the lack of ability to detect
or produce false positives and false negatives. When considering prioritization
of chemicals and pesticides to examine, toxicity endpoints, human exposure,
and production volume must be considered. Dr. Foster called for a testing
strategy that would describe the biological effects of EDCs absent any
judgmental terms. Regulation of EDCs could then be based on whether
there actually is an adverse effect. The role of metabolism and determination
of which factors actually constitute adversity in a dynamic system (i.e.,
degrees of change that could occur within a given set of circumstances)
must also be discussed. Dr Foster concluded by asking how this information
on EDCs would be used in a risk assessment.
- Dr. Nancy Kim
Director, New York State Department of Health
Division of Environmental Health Assessment
- Dr. Kim cited the need to work together on an approach that all stakeholders
can agree on, and cautioned against underestimating the importance of
exposure when considering risk. Short-term processes for examining the
effects of EDC exposure could be instituted relatively quickly, while
a longer-term strategy is being developed. A short-term strategy could
include some simple additions to FIFRA testing requirements that would
not significantly affect industry or increase costs. Dr. Kim suggested
that such tests could be conducted on chemicals of known concern. As
a public-health official, Dr. Kim urged the workgroup not to neglect
public health concerns. She also emphasized the importance of communicating
with the public in a scientifically sound manner.
- Dr. Delores Lamb
Associate Professor of Urology
Baylor College of Medicine
- Dr. Lamb addressed the issue of human male fertility, citing reports
of a 50-percent decline in human sperm counts since the beginning of
World War II, with an associated increase in testis-related pathology.
It has been suggested that there has been a similar increase in male
infertility at the same time, and that these trends are due to environmental
estrogens. Dr. Lamb reported on the findings of a Baylor College of
Medicine panel on male fertility convened to address a number of issues
regarding the question of declining sperm counts. The majority, but
not the unanimous, opinion of the panel was that available data could
not be used to reach any conclusions regarding sperm counts in humans,
and it should only be used to raise concerns. The panel identified research
areas, recognized that many reproductive toxicants exist, and recommended
that methods be developed to measure those toxicants and potential toxicants
in the body to establish a cause-and-effect relationship.
- Dr. Judith Weis
Professor of Biology
Rutgers University
- Dr. Weis expressed her interest in sub-lethal effects of low doses
on development, behavior, and development of behavior. She offered her
view that EPA's and other agencies' interest in human health and cancer
neglects the effects of chemicals on organisms other than people. As
an example, Dr. Weis cited a meeting of a state environmental agency
in which dimilin (a gypsy moth control agent that inhibits exoskeletal
development) was declared safe for humans. What was not discussed was
the fact that dimilin was not safe for other crustaceans such as shrimp
and crabs. Non-human effects on nature must be addressed, she said,
adding that consideration of endocrine disrupters should be the first
step in considering other effects besides cancer, in other organisms
besides people.
- Dr. Peter deFur
Affiliate Associate Professor
Center for Environmental Studies, Virginia Commonwealth University
- Dr. deFur outlined the concerns of citizens, environmental groups,
non-profit organizations and others regarding the effects of EDCs. Those
concerns include reproductive, developmental, immunological, and behavioral
effects, as well as the connection with breast cancer and male reproductive
problems. He also noted a great deal of concern among the non-profit
community about effects on the developing fetus and effects that are
not evident until many years later, such as cognitive function. Dr.
deFur urged caution in designing screening and testing protocols so
that these effects are captured early, and suggested that efforts be
made to transcend the discussion beyond human reproductive hormones.
There are myriad hormones in a number of animals, but they all have
common features and they all lead to endpoints requiring protection.
Dr. deFur said that rather than attempting to perfect a screening system,
regulatory action could begin with existing knowledge of chemicals such
as DDT or PCBs. Resource dollars must be used carefully to identify
sources, exposure pathways and health effects. Dr. deFur also cited
citizens' right to know as an issue of importance to the non-profit
community. He closed by emphasizing the difficulty of developing a screening
protocol that can address so many concerns for so complex an issue.
- Dr. Barry Johnson
Agency for Toxic Substances and Diseases Registry
- Dr. Johnson urged prioritization of the chemicals that would be screened
and tested, noting that unfocused screening and testing efforts in the
past have proved expensive and ineffective. He opposed use of a risk
assessment paradigm for evaluating the effects of EDCs, suggesting a
disease-prevention approach or use of the risk-analysis paradigm developed
in 1992 by the Council on Environmental Quality. Both approaches include
a risk communication component, which the risk assessment approach does
not. He also suggested looking for ways to advance basic toxicologic
knowledge during the screening and testing process, which could include
greater use of SARs and testing of specific chemical classes. Dr. Johnson
concluded by saying the workgroup needs to consider how the results
of whatever strategy it decides upon would be used and for what purposes.
- Dr. Goldman reiterated the nature of the workgroup process, saying
that the development of a screening and testing strategy for EDCs is
not simply about producing risk assessments. Rather, the process is
about supporting EPA's efforts under TSCA and FIFRA to protect the environment
and human health. Risk assessment is a valid tool that must be used
in conjunction with other tools, including risk management and benefits
analyses. She reminded the workgroup that this process is embedded in
the broader concept of identifying risks, dealing with those risks,
and taking action under those EPA statutes, as much as possible in a
collaborative fashion.
- V. Observer Input (Open Microphone)
-
- Community right to know is an important aspect of the EDC dialogue.
Sometimes the public receives information that it does not know
how to digest, and that could be a disservice.
- Ecological risk assessments of new chemicals are routinely conducted
with little or no data to support them. There is a sense of urgency
to improve this process with data.
- Activities should transcend TSCA and FIFRA to reflect other concerns
such as public health, other laws such as the Clean Water Act and
the Safe Drinking Water Act, and other government agencies.
- Care should be taken not to use the terms estrogens and androgens
too loosely, and the creation of lists of such chemicals should
be avoided. These actions tend to mislead the public on the ubiquity
of the substances.
- The pharmaceutical industry makes products all the time out of
the sort of chemicals under discussion. What interactions are there
with FDA and EPA for regulating these types of chemicals?
- About $30 million is being spent on EDC research, with little,
if any, coordination of efforts. This can result in paralysis by
analysis. The real challenge is how to identify those EDCs that
are causing a problem. A chemical screening and testing strategy
is both daunting and challenging.
- Some EDCs may occur naturally, but we should be concerned about
the ones made by humans. We have some control over those.
- Congress is considering reauthorization of the Safe Drinking
Water Act over the next few days. The workgroup should consider
what types of questions Congress should be asking the scientific
community.
- Policy makers need to determine how to handle the scientific
uncertainties surrounding EDCs.
- Balance the mechanistic approach required of toxicology with
the holistic approach required of ecology. When considering cumulative
effects and multiple stressors, the mechanics of a chemical must
be known, and how the effects are manifested at the sublethal level
is exceptionally important. Integrity of an ecosystem and the health
of a human are not comparable.
- To start prioritizing chemicals by exposure, consider those that are most frequently used around the home.
- Community right to know is an important aspect of the EDC dialogue.
Sometimes the public receives information that it does not know
how to digest, and that could be a disservice.
- VI. Conclusions
Dr. Goldman acknowledged the major points brought forth by participants and observers. There is interest in collaboration among government, industry, academia, non-profit groups and others on the important issue of screening and testing chemicals for endocrine effects. Those involved in the EDC debate need to transcend past approaches and adopt a broader view, thinking outside the box of specific statutes and in terms of what can be done with available information. There is a need to examine not only human-health effects of EDCs, but also different approaches for examination of the ecological effects of pesticides and other toxic chemicals. Dr. Goldman noted that there are gaps in the ability to address most of these issues, including the relevancy of existing testing for mammals, birds, and aquatic species. How to prioritize possible EDCs is another significant challenge: Should we begin with chemicals available in the home, chemicals that may be affecting aquatic environments, or chemicals with high production volumes? Dr. Goldman said we should not duplicate the efforts of others, such as defining endocrine disrupters or compiling a research agenda; rather, the workgroup should find a way to tie in with existing efforts. One example would be the Food and Drug Administration's (FDA) research on phytoestrogens at its National Center for Toxicological Research.
Dr. Goldman concluded Day 1 by asking the workgroup to consider several issues for discussion the next day: how best to establish a process for addressing the issue of screening and testing for EDCs, whether all stakeholders were represented on the workgroup, and how to weave together the many threads discussed today. Dr. Goldman reminded participants that under federal law, if EPA were to establish a follow-up advisory group, a formal advisory committee would have to be established.
Endocrine Disruption by Chemicals:
Next Steps in Chemical Screening and Testing
--
Day 2
I. Remarks and Recap Of Basic Directions for Day 2
The workgroup accepted an agenda for Day 2 based on information generated the previous day. Dr. Goldman reviewed the basic directions for the second day's meeting, emphasizing the need to establish a process for testing and screening for endocrine disrupters and for seeking an appropriate forum in which to accomplish that task. Discussions would include a "strawman" Mission Statement for a follow-up workgroup(s) and desired outputs, composition of the follow-up workgroup(s), an organizational framework in which future workgroups could conduct their mission, and upcoming steps in EDC activities.
II. Discussion of the Mission of the Follow-up Group(s) and Desired Outputs
Workgroup members discussed and amended the strawman Mission Statement (see Attachment A). The statement emphasizes endocrine disruption in fish and wildlife, and to a limited extent, humans. The focus is on the need to identify and prioritize chemicals and pesticides that may pose significant risk in order to take action to reduce or mitigate that risk. The amended statement also calls for the formation of one or more multi-stakeholder groups to develop a strategy to accomplish that task. Suggestions were made to coordinate these activities throughout the scientific community, given the limited funds for research; to evaluate some of the efforts now under way in the United Kingdom, Canada, and the United States; and to move forward in an aggressive manner.
III. Structure and Function of Follow-up Activities
Because of the limited resources available for this effort, workgroup members identified as a major priority developing a concrete structure in which future workgroups could carry out their initiatives. Critical to the discussion was the actual composition of future workgroups, including size, professional representation and commitment levels. A preliminary, three- tiered organization chart was submitted and reviewed to address those points. The proposal included a policy/technical oversight committee to represent multi-stakeholder concerns and to synthesize information relative to communication, cooperation and broad guidance. The present workgroup could serve in that capacity. A technical assessment and integration coordinating committee would integrate and synthesize technical information and feed it back to the oversight committee. Finally, the proposal called for the technical assessment committee to coordinate workgroups, workshops, and other fora; human and ecological surveillance for effects of EDCs; and ad hoc science groups investigating various screening and testing initiatives. All activities would focus on setting priorities and developing a screening and testing strategy. Workgroup members agreed that environmental groups were important to the discussion and must not be fractured among numerous workgroups, but should have broad involvement across all issues. Further discussion concerned the structure and function of this proposed workgroup or any other follow-up work group(s). This discussion is summarized below.
Desired Outputs: Participants agreed that the follow-up workgroup must focus on developing a strategy for prioritizing and screening for EDCs. Under the three-tiered workgroup proposal, the policy/technical advice committee could also provide advice on funding and resource implications.
Scope of Issues: Suggested topics of discussion included immunological, behavioral and indirect effects associated with EDCs. However, the workgroup decided that the initial focus should remain solely on reproductive effects.
Structure, Function, and Process: The technical coordinating committee would have to stay focused rather narrowly on the workgroup's mission and not enter broader discussions of risk assessment in general. This committee also would have to help synthesize and present information in a useable form to the policy/technical committee. Finally, the technical coordinating committee, with guidance from the policy/technical oversight committee, should decide what workshops or workgroups it needs to accomplish its mission: a balance must be struck between having a manageable number of groups and segmenting the issues to the extent necessary to allow the best use resources. The ad-hoc science groups should be comprised of bench scientists, not program or policy people. Finally, after the screening and testing strategy has been developed and implementation has begun, some type of evaluation and reality check are necessary to adjust as needed and ensure that the workgroup produces useable material.
Participation and Representation: In discussing the professional representation for upcoming workgroups, participants determined that at least one endocrinologist should be included, as well as interested community groups. To ensure adequate participation from different stakeholders, grants or technical assistance should be considered. Other experts may be called upon as necessary while the workgroups proceed.
Communications: Experts in public communication need to be included and public involvement must be continued. Effective communications would play a key role in the activities of any follow-up EDC workgroups. Members agreed that an open process should be adopted; that balance must be established between laboratory and field scientists and decision-makers. Interested groups should be kept informed of any ongoing activities to facilitate their involvement in the issues of most importance to them.
Initial Timeframe: The workgroup recommended a six-month deadline for meeting initial objectives. Facilitation of follow-up activities was recommended to achieve faster results.
Type of Forum for EDC Activities: If EPA were to form an EDC follow-up group, it would be governed by Federal Advisory Committee Act (FACA) rules. This could be a cumbersome and slow process. However, a subgroup to an existing FACA committee could be formed much more quickly. In addition, EPA's Office of General Counsel pointed out that in certain circumstances, a subcommittee to a FACA group could submit its findings to EPA without formal approval of the parent FACA committee. Alternatively, some other stakeholder could convene the follow-up workgroup(s). Regardless of the type of forum for the follow-up workgroup(s), members agreed that if the follow-up group cannot reach consensus on some aspect of the issues, that should not preclude EPA from moving forward.
Other Considerations: Other factors to be integrated into this complex process were cost, at all junctions of the process, and definition of biological endpoints. The latter must be defined to avoid endless screening for unclear purposes.
IV. Next Steps
In concluding the two-day meeting, Dr. Goldman said a summary of the proceedings would be submitted to workgroup members and other participants within six weeks. EPA would assess the workgroup's direction and, based on stakeholder suggestions, examine the proposed mechanisms for forging an EDC initiative. Dr. Goldman noted that EPA would continue its program support, with participation by the Office of Research and Development, the Office of Water, the Office of Solid Waste, and EPA regional offices. Immediate actions to explore the proposed options would occur within two or three weeks via follow-up phone calls and letters to Gary Timm in the Office of Pollution Prevention and Toxic Substances, Denise Keehner in the Office of Pesticide Programs; and Richard Hill, OPPTS Science Advisor. Dr. Goldman concluded by welcoming further input, stressing EPA's interest in obtaining information on EDCs and emphasizing the importance of cooperating with NAS and NRC if topical recommendations were to be made.
Attachment A
Revised Mission Statement
Certain chemicals have caused endocrine disruption in fish and wildlife and, to a limited extent, in humans. A strategy is needed to identify and prioritize the chemicals and pesticides that pose significant risk in order to take action to reduce or mitigate that risk. Given the number of pesticides and chemicals, a necessary first step is to develop processes to: (1) prioritize chemicals and pesticides for screening and testing needs, and (2) complete the needed testing.
One or more multi-stakeholder groups would be formed to develop a strategy to accomplish the mission. The Follow-up Group would focus on human health and ecological impacts. The Follow-up Group would maintain a general awareness of ongoing related efforts and seek public input at appropriate times during strategy development. Additionally, the group will address risk reduction and mitigation issues, including communication with the public.