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Endocrine Disrupters Screening and Testing Advisory Committee (EDSTAC)
Fifth Plenary Meeting

February 5-6, 1997
Meeting Summary

I. Background

On February 5 and 6, the second plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in Houston, Texas. Please refer to Attachment A for a list of Committee members in attendance. During the first EDSTAC plenary meeting in San Francisco in December, 1996, the Committee approved: a set of ground rules for the operation of the EDSTAC's deliberations and activities; reached agreement on the EDSTAC's goals and objectives, as well as on the scope of the EDSTAC's focus and activities; and began discussions of the Committee's principles and work groups.

The goals for the Houston meeting included: (1) to provide educational tutorials for Committee members, as well as for interested members of the public; (2) to further the Committee's goal of reaching consensus on a set of principles to guide its work; (3) to discuss work group membership issues, primarily for the Screening and Testing and the Priority Setting Work Groups; and (4) to allow public comment for the benefit of the Committee members.

II. Welcome and Opening Comments

Dr. Penny Fenner-Crisp, the Deputy Director for the Office of Pesticide Programs in the Office of Prevention, Pesticides, and Toxic Substances for the U.S. Environmental Protection Agency (EPA), welcomed the Committee members to the meeting, and thanked them for their attendance.

Mr. Timothy Mealey, Associate Director of The Keystone Center's Science and Public Policy Program, reviewed the agenda for the two-day plenary session. He indicated that the agenda had been revised in order to allow the chair of the Committee, Dr. Lynn Goldman, who had unanticipated schedule conflicts, to participate in as much of the plenary discussions as possible.

Dr. Goldman, the Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) for EPA, upon her arrival, thanked the Committee members for their flexibility with respect to the agenda, noting that the release of the federal budget necessitated her presence before Congress. Dr. Goldman indicated that she was very pleased with the progress of the Committee thus far. She also commented that she was hopeful the work group issues of membership and guiding principles would soon be resolved so work group meetings could be scheduled. Dr. Goldman highlighted the timeliness of the Committee's deliberations in the context of current international coordination activities on issues related to endocrine disruption, including the coordinated efforts of the current Administration, EPA, the Smithsonian, and the Organisation for Economic Cooperation and Development (OECD).

III. Membership Issues

Mr. Mealey offered comments regarding additions and changes to the EDSTAC membership since the December plenary meeting. He noted that Florence Robinson of the North Baton Rouge Environmental Association had joined the Committee, and that Pat Basu had replaced Dick Ellis as a representative of the U.S. Department of Agriculture. Mr. Mealey also introduced Judy O'Brien of The Keystone Center, who will be assisting the EDSTAC as a facilitator.

IV. Approval of Meeting Summary of December 12-13, 1996, Plenary Meeting

The Committee discussed the December 12-13 San Francisco plenary meeting summary. A series of changes were made to the section concerning the EDSTAC scope to make clear that the sex steroids-related hormonal effects (i.e., estrogen, anti-estrogen, androgen, and anti-androgen) will not be considered a higher priority than thyroid-related hormonal effects. One Committee member stated his recollection of the discussion of scope at the San Francisco meeting, adding that he felt there had been some prioritization of the EDSTAC's scope. However, when other Committee members asked that the sex steroids and thyroid-related effects both be considered, as indicated above, he raised no objection. The facilitator reviewed other changes to the meeting summary that had been sent to The Keystone Center prior to the Houston plenary meeting. These changes were approved.

Some members of the EDSTAC felt that the definition of "endocrine disruptor" included in the San Francisco summary had not been tentatively agreed upon as indicated. Consequently, the language preceding the definition has been altered to address this concern. The original text read:

After discussing the definition of endocrine disruptor on both the first and second day of the meeting, the Committee tentatively agreed upon the following:

The new text reads:

After discussing the definition of "endocrine disruptor" on both the first and second days of the meeting, the following working definition of "endocrine disruptor" was offered for the Committee's consideration. The Committee did not agree to this definition, but felt that it was sufficient as a starting point for further discussions.

Several Committee members suggested it would be useful for future meeting summaries to have a greater level of detail so EDSTAC members could have a more specific record of meeting deliberations. Mr. Mealey indicated The Keystone Center would take steps to address this request. He noted that, as the Committee progresses in its work, materials produced by each work group would become more definitive vehicles for tracking the outcome of the Committee's deliberations and activities.

In response to some Committee members' concern and confusion over the process by which EDSTAC members should offer corrections to future draft meeting summaries, the Committee affirmed and further elaborated upon its previously agreed upon ground rule on this subject. Specifically, when sending out a draft meeting summary, it was agreed that Keystone facilitators will set a one week deadline for receiving explicit suggestions and corrections for amending the document from Committee members. The facilitators indicated that they preferred receiving suggested revisions in written form via fax or e-mail (including a marked-up copy), although conveyance of suggested revisions over the telephone will also be acceptable. Keystone also requested that Committee members clearly state their specific suggested revisions in any written or verbal communication.

The Committee clarified that if, in the view of the facilitator, suggested revisions to a draft meeting summary are not substantive or controversial, the facilitator will make the changes, mark the document as "final," and then make it available to the public via the EDSTAC Web Site and Docket. If, in the view of the facilitator, any suggested changes are substantive or potentially controversial, the facilitator will make the non-controversial changes, temporarily excise the text in question, make a note in the document that additional language will be added, mark the document as "draft," and then make it available to the public via the EDSTAC Web Site and Docket. The facilitators noted that in cases where meeting summaries are made available to the public in draft form, they will try to consult with an appropriate cross section of Committee members in an effort to revise the draft and make it final before the next meeting. If this is not possible, the draft will be reviewed and revised by the Committee as-a-whole when it meets again in plenary session.

In discussing the review procedures for meeting summaries, a more general question was raised about whether all written documents submitted to the facilitator by Committee members should be distributed to the full Committee. The facilitators noted they receive a steady stream of faxes, e-mail, and telephone communications from Committee members, much of which is not intended to be shared with the full Committee. It was agreed that when a Committee member wishes to have any communication with the facilitator shared with the full Committee they should indicate this in the correspondence or conversation. Thus, documents provided to the facilitator will not be shared with other Committee members unless the facilitators are explicitly instructed to do so.

V. Tutorials

Throughout two-day plenary meeting, a series of tutorials was offered for the purpose of mutual education. Committee members had the opportunity to ask questions following each of the nine presentations. Copies of materials furnished by each of the speakers, including overhead slides and supplementary documents, are not available on the Web site but are available as part of the EPA Docket. Because these materials constitute a more thorough and accurate summation of each presentation, this meeting summary contains only a list of the topics and their presenters, as well as a brief summary of both the content and the follow-up questions and comments for each of the tutorials.

Tutorial on Comparative Endocrinology: Joanne Richards, Baylor College of Medicine; and Bill Benson, Director of the Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi.

Joanne Richards presented an introductory overview of endocrine systems focusing on hormone production and interactions between the hypothalamus, pituitary, and gonads with emphasis on ovarian function. Hormone pulses (LH, FSH, estradiol ands progesterone) during menstruation were described and related to morphology of preovulatory follicular development and ovulation.

Biochemical pathways associated with follicular development amd ovulation were used to illustrate regulation of hormone receptors and their associated enzyme systems. The tutorial offered by Bill Benson focused on the response sensitivity of organisms, particularly mammals and fish, to hormonal (e.g., estradiol) stimulation. His presentation also discussed the hypothalmic-pituitary-gonodal axis in mammals and the hypothalmic-pituitary-gonodal-hepactic axis in fish.

Follow-up questions and comments to tutorials presented by Richards and Benson centered around: invasive versus non-invasive ways to measure hormonal responses; the accuracy of extrapolating results of relatively simple biomarker studies across species; the applicability of vitellogenin studies to invertebrates; the limitations of vitellogenin studies (e.g., with respect to specificity and utility); the hormonal response sensitivity and source of response variation across different species; and, the importance of testing organisms at different developmental stages.

Tutorial on the State of the Science Regarding Endocrine Disruption: Ron Kendall, Director, Institute of Wildlife and Environmental Toxicology, Clemson University; and John McLachlan, Director, Division of Intramural Research, Center for Bioenvironmental Research, Tulane University.

In his presentation, Ron Kendall described the historical context of the current state of the science with respect to endocrine disruption, including the available scientific database; major scientific findings related to estrogen; scientific research strategies for further study of endocrine disruption, including possible methodology and endpoints; and the utility, limitations, and uncertainties of using vitellogenin in studying endocrine disruption.

John McLachlan's presentation focused on environmental signaling (including signals within and between organisms and different signaling systems--endocrine, immune, and nervous); environmental endocrinology (including: receptor-mediated signals; the transport of homonally active chemicals; interactions between natural or synthetic chemicals; dose relationships; and phytoestrogens); development (including: ways in which estrogens and estrogenic compounds may act differently during development; doses and exposure times; "imprinting;" receptor concentration; senstitive and critical periods; reversible versus irreversible and short-term versus persistent effects; and developmentally responsive assays); and human considerations (including breast disease and testicular disease) related to endocrine disruption.

Follow-up questions and comments to tutorials presented by Kendall and McLachlan centered around: the importance of basing action on present levels of information while taking into account new information as it becomes available; the consideration of sex determination and differentiation in developing screens; limitations of available data, especially with respect to time and length of exposure and the size of impacted populations; the lack of specificity, with respect to levels of effects on receptors, of pharmacological terms such as "agonist" and "antagonist;" the need to engage accepted premises of appropriate models for study (e.g., mouse versus rat); the difficulty of translation issues across species (e.g., with respect to fertility and fecundity); neurological and behavioral effects of thyroid-mediated hormones; using mechanistic information from previous studies to improve and expand screens and tests to make them comprehensive; the challenges of screening mixtures and compounds; and racial and ethnic considerations related to screening and testing.

Tutorial on Quantitative Structure Activity Relationships (QSAR): Maurice Zeeman, Chief, Environmental Effects Branch, Office of Prevention, Pesticides, and Toxic Substances (OPPTS), U.S. EPA; and Steve Bradbury, Acting Associate Director for Science, Mid-Continent Research Lab, Office of Research and Development, U.S. EPA.

Maurice Zeeman's presentation centered on (Q)SAR as not focused, in the context of endocrine disruption, on pesticides, human health, or research/mechanisms, but the endpoint of which, rather, is acute toxicity data. His presentation also addressed the use of testing versus SAR within different offices of EPA; the role of (Q)SAR in the Office of Pollution Prevention and Toxics (OPPT) data hierarchy; the types and numbers of new and existing industrial chemicals; the required submission elements in new chemical notices; test data submitted with premanufacture notifications; the number of chemical notices received by EPA/OPPT; the new chemical review process; the eco-risk assessment process; the OPPT ecological testing scheme and environmental effects testing guidelines; chemical class linkages to (Q)SARs; QSAR estimations and validation; differentiation between SAR and QSAR; the use of octanol-water partition coefficient Kow; the use of QSAR for endocrine disruptors; and typical toxicity endpoints.

Steven Bradbury's presentation focused on modeling frameworks for identifying hazards of endocrine disruptors, including QSAR and Quantitative Molecular Similarity Analysis; predictive toxicology models; toxicology complexity related to endpoints and different modeling approaches; hormone and anti-hormone structure function relationships; modes of nuclear receptor activation; and a "dynamic" QSAR approach--an exploratory technique to rapidly generate and screen conformers in the context of a presumed mechanism.

Follow-up questions and comments to tutorials presented by Zeeman and Bradbury centered around: the applicability of structure activity relationships (SAR) to mixtures and compounds; the usefulness of SAR across mechanisms and across different types of receptors; the use of SAR when the mechanisms of hormone-mediated effects are unknown; the frequency of model alteration/reconfiguration to accommodate chemicals that do not "fit" the model's original design; the use of Kow in studying terrestrial and aquatic plants; the importance of viewing QSARs as limited and potential research tools, not as definitive, universally useful, or reliably predictive tools; that QSAR has not been developed for chronic toxicity and human health evaluation; and the degree of involvement played by professional judgment in decision-making. QSAR, as discussed, was related to ecosystem, rather than mammalian system, considerations.

Tutorial on Existing Screening and Testing Programs: Jeanette Wiltse, Director, Health and Ecological Criteria Division, Office of Science and Technology, Offices of Water, U.S. EPA; Penny Fenner-Crisp, Deputy Director, Office of Pesticide Programs, OPPTS, U.S. EPA; and Michael Shelby, Acting Chief, Laboratory of Toxicology, National Institute for Environmental Health and Safety.

Jeanette Wiltse's tutorial covered existing screening and testing programs and protocols, highlighting ecological risk assessment; risk characterizations--technical hazard, technical dose response, and technical exposure characterizations; tiers of tests and surrogate approaches; tiering sequences; sensitivity and specificity of tests; endpoints; the role of research in decisionmaking; determinations of planning and scoping teams; risk dimensions; and the dredged material tiered testing framework as an example of how these different processes interact and are applied.

Penny Fenner-Crisp's presentation outlined the testing requirements/decision logic used by EPA and the Food and Drug Administration (FDA). In particular, she addressed the EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)/Toxic Substances Control Act (TSCA) toxicology data requirements and FIFRA/TSCA wildlife and aquatic organisms data requirements; testing for different concern levels; FDA toxicity testing for food additives and indirect additives; the regulation of animal drugs; the test battery to which synthetic sex steroids are subjected; FDA non-clinical data requirements for drugs; and biocompatability issues related to the selection of toxicity tests. Michael Shelby's presentation addressed the NIEHS' National Toxicology Program (NTP) chemical nomination process, experimental design strategies for priority chemicals, and factors considered by NTP in moving from nomination to long-term toxicity studies.

Follow-up questions and comments to tutorials presented by Wiltse, Fenner-Crisp, and Shelby centered around: the use of peer-reviewed literature in TSCA considerations; the consideration of teratagenic effects in studies; the tendency for a testing protocol to be designed around the decisions intended to be made on the basis of the testing protocol; the toxicity equivalency factor decisionmaking model; EPA's data requirements for chemicals which undergo breakdown; the difference in testing methodologies between EPA's Office of Water and OPPTS (e.g., differences between testing mixtures and individual compounds); the use of behavioral endpoints in designing tests; and the number of chemicals evaluated under TSCA's authority that have resulted in formal test rules.

Following the presentations, Dr. Goldman thanked the presenters for their contributions to the meeting, and said she hoped that the increased level of understanding would facilitate future discussions of the Committee.

Two additional presentations were anticipated for the Houston plenary. However, due to the restructuring of the agenda the presenters agreed to postpone delivery of the tutorials until a later meeting if still deemed necessary. The topics and presenters include:

Short Tutorial on the Structure and Rules of Decisions: Douglas Crawford-Brown, Director, Institute for Environmental Studies, University of North Carolina. He provided some written materials on his postponed tutorial, and recommended that persons interested in decision analysis visit the World Wide Web site for the Institute (http://www.sph.unc.edu/ies), which includes additional information on the subject. He suggested that Committee members review both of these resources and contact him with any questions.

Tutorial on Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Screening and Testing: Abraham Tobia, Manager, Toxicology, BASF Corporation. He agreed to deliver this presentation at a subsequent meeting if requested.

In addition to these presentations, it was proposed that: (1) a tutorial be included in the next plenary meeting to familiarize Committee members with the use of Bayesian theory in its application to epidemiology; and (2) a tutorial on the origin and use of statistics and their relation to exposure and risk assessment.

VI. Status of the Draft Principles to Guide the Agency's Endocrine Disruptor Screening and Testing Program

(Note to reader: The draft conceptual framework document and brainstormed principles from San Francisco referred to below were reviewed at two different times during the course of the meeting. This section of the meeting summary covers both discussion periods.)

Larry Reiter, Director of the National Health and Environmental Effects Research Laboratory, U.S. EPA, and member of the Principles Work Group, provided an overview of the draft conceptual framework, which is an attempt to capture and reflect Work Group deliberations that occurred after the San Francisco plenary. The draft conceptual framework was distributed to Committee members in a memorandum dated January 31, 1997, and is attached hereto as Attachment B.

Dr. Reiter told the Committee that the Principles Work Group first met in mid-January and, based on these discussions, the facilitator developed the draft conceptual framework which was then reviewed and revised by Work Group members in subsequent weeks. Dr. Reiter indicated that the Work Group used the 60 draft principles identified at the San Francisco plenary as a basis for their deliberations. However, since they had not addressed them directly at their mid-January meeting, they decided to meet again the evening before the Houston plenary meeting to further review the list. The Work Group will make a determination as to whether the essence of each one is: (a) already incorporated in the conceptual framework; (b) important, but not yet addressed in the document; or (c) not understandable or relevant to the EDSTAC's tasks. The Work Group has reviewed approximately two-thirds of the draft principles.

In discussions about the list of 60 principles brainstormed in San Francisco, it was requested that specific principles from the list should not be rejected without full Committee consent. It was agreed that the Work Group would make it clear which principles they had "rejected" in conveying its work product to the full Committee.

One member of the Principles Work Group commented that she was concerned that the current draft of the conceptual framework document did not accurately reflect or include the language proposed at the Work Group's mid-January meeting. The facilitator explained that the document had been shared in draft with the Work Group after the mid-January meeting with a request for comments and revisions. Several suggestions for revision were received and incorporated into the draft and, due to time constraints, shared directly with the full Committee. Thus, he noted that the document should be viewed as a working draft for the purposes of focusing the discussion of the full Committee.

In general, the Committee voiced its support for including three basic components in a conceptual framework: (1) prescreening, which includes sorting and prioritizing; (2) screening, which includes detection of potential endocrine disruption; and (3) testing, which includes confirmation and characterization of endocrine disruption. However, some concerns and questions were also raised. Many of these concerns revolved around the "defer" boxes in both the prescreening and screening phases of the framework. Some Committee members felt that the definition of "defer" needed to be clarified, and that options needed to be incorporated into the conceptual framework to move directly from the prescreening phase to action options (including cessation of screening and testing) based upon available information and/or an "index of suspicion."

Other Committee members noted that the issue of whether a chemical would continue to be used if it was deferred on the basis of inadequate information was as yet unresolved. Dr. Reiter reminded the Committee that the schematic diagram of the conceptual framework was not intended to stand independently, and that it should be considered in conjunction with the accompanying text document which recognizes that these are unresolved issues which the other work groups would need to address.

Some Committee members suggested that the defer boxes should be revised to include two distinct possibilities: a) stop prescreening, screening, or testing, because the available data are adequate to make such a determination; or b) collect more information sufficient to make a determination about whether to stop or move forward with prescreening, screening, testing, or risk assessment and/or risk management.

Some Committee members felt the full group needed to more clearly state whether the EDSTAC was motivated by principles of conventional risk assessment or the "precautionary principle." In this context, one Committee member described an alternative conceptual framework, using a hand drawn flow chart, as an example of the application of a more precautionary approach. The alternative approach, it was suggested, could help scientists move away from the tendency to discuss what they already know and disregard what they do not know. The alternative approach made a clearer distinction between the handling of new versus existing chemicals and pesticides. In addition, it provided more of an opportunity to take risk management actions without waiting for the completion or undertaking of a fully comprehensive risk assessment (e.g., inclusive of dose response information and a detailed exposure assessment)

Some Committee members also urged the EDSTAC to come to resolution on definitions for words such as "stop," "defer," and "refer" in order to design the most comprehensive screening and testing program possible. Committee members also noted that the regulatory framework within which the Committee is operating, as well as the EDSTAC's decisions relating to its scope, should be included in the conceptual framework document.

Dr. Goldman pointed out that the use of the word "stop" has many different implications (e.g., cessation of screening and testing, deferral for reassessment contingent upon availability of additional data, and elimination of the chemical from the marketplace), and its definition would depend on the applicable statute. For example, for a new chemical on the market, a decision to "stop" could mean that the company would decide to stop production and marketing of the chemical. For an existing chemical (i.e., one that had been on the market before TSCA was put into place) a greater burden is placed on the EPA to obtain additional information prior to making a "stop" decision. Dr. Goldman stated her view that this would be an important point for the Committee to address. She commented that it would be helpful for the EDSTAC to provide guidance to EPA on whether it should or should not make the "stop" decision. She also stated that the Committee should focus its deliberations on providing advice that is scientifically grounded and let EPA work to match the Committee's recommendations to the Agency's statutory mandates.

Dr. Goldman stated that she saw in the draft conceptual framework the broad outlines of a possible consensus and she thanked the Principles Work Group for its efforts. Later in the meeting, it was noted that the Principles Work Group agreed to meet in mid-March (subsequently determined to be March 19) in Washington, D.C., to continue to refine the conceptual framework document and flow chart by incorporating comments from the Houston discussions, as well as the original list of draft principles developed at the San Francisco plenary, with a clear indication of those from the original list that have not been incorporated.

VII. Communications and Outreach Work Group

Although no Communications and Outreach Work Group documents were distributed to the full Committee during the plenary session, some communication issues were discussed. For example, EPA staff informed the Committee and the public that the World Wide Web site for the EDSTAC and endocrine disruption issues was operational and provided the address for the site (http://www.epa.gov/scipoly/oscpendo/index.htm). The facilitator noted that The Keystone Center would create electronic "list-serves" for the Committee and for each of the work groups. These list-serves will enable members of the respective groups to send information to specified lists of people via e-mail by using only one address for the entire group.

The members of the Communications and Outreach Work Group held a brief meeting during lunch on the second day to discuss next steps. They agreed to meet via conference call on February 21, to continue their discussions and to address outreach issues related to the upcoming Baltimore plenary.

VIII. Screening and Testing and Priority Setting Work Group Membership Issues

Committee members received a draft copy of both the Screening and Testing Work Group (STWG) and the Priority Setting Work Group (PSWG) membership rosters proposed by EPA.

It was explained that this list was the result of internal EPA deliberations based on the nominations submitted by both Committee members and non-Committee members. It was further explained that Dr. Goldman met over lunch (before she had to depart the meeting) with approximately eight members of the Committee, representing a cross-section of interests and perspectives, to discuss EPA's proposal. The result of this luncheon discussion was a goal to add two seats to the STWG proposed roster to address the need for greater ethnic and racial diversity and a need to include a clinical medicine perspective, while ensuring balance between industry and non-governmental organization perspectives; and to add one seat to the PSWG proposed roster to address need for greater ethnic and racial diversity and the need to include occupational health and additional academic perspectives.

During discussion of the proposed work group membership lists, many Committee members expressed specific concerns about the composition of the STWG, and of the PSWG to a lesser extent. In commenting upon the rosters, several Committee members asked why certain nominees were not included in the EPA proposed list. Dr. Fenner-Crisp explained that EPA was seeking to control work group size and to create a balance of perspective in the lists. She added that the expertise of those nominees not officially added to the work groups may still be utilized.

Overall, EDSTAC members expressed their desire for both Committee and non-Committee members of the work groups to have working knowledge of, and expertise in, the applicable issues related to the respective work groups. Committee members indicated this was important to bolster public acceptance of any EDSTAC products. The overriding concern about the STWG seemed to be that the proposed membership did not have the right kind of "hands-on" and "day-to-day" experience for the type of work the group needs to accomplish. Because this work group will be engaged in designing the screening and testing program, Committee members felt the work group should have direct experience and working knowledge of screens and tests.

From the discussions it was evident that additional deliberations regarding membership of these work groups would be needed. Committee members agreed to determine membership of both the STWG and the PSWG through a several step process which will include: (1) the submission of additional advice and recommendations from Committee members; (2) the compilation of the input by The Keystone Center, and the sharing of this input with Dr. Goldman and her staff, who will then propose revised membership lists for both work groups; (3) the sharing of these revised membership lists with only those Committee members who have signed up to participate on the respective work group; and (4) the discussion of these lists with each of the two sets of Committee members by means of teleconference with the goal of finalizing membership on the two work groups.

Several Committee members urged EPA to stay within, or possibly reduce, the total number of non-Committee work group members from the numbers on the draft membership lists distributed in Houston, while seeking to maintain an appropriate balance of expertise and perspective within the work groups. EPA indicated they may also be revisiting whether any and all Committee members who wish to serve on the STWG or the PSWG should be permitted to do so. It was explained that the reason for this possible change is to keep both the overall number of work group members, as well as the burgeoning supported participant travel costs of the EDSTAC process, to a manageable level.

Discussion took place regarding the ability of work group members to use alternates in the course of work group deliberations. Committee members agreed that work group members who accept their nomination should have the commitment and ability to serve on the work group and that, consequently, alternates for work group members should not be allowed to participate. However, it was agreed that the expertise of those not officially named to the work groups could be drawn upon, at a level sensitive to resource constraints, by work group members.

IX. Timeline, Next Plenary, and Desired Clarification of EPA's Expectations

Committee members agreed that the next EDSTAC plenary meeting will take place April 29- May 1, 1997, in Baltimore, Maryland. This represents a change from the April 14-16 dates and Orlando, Florida location that had been previously communicated. Committee members felt that a site visit (e.g., Lake Apopca) was not as critical as holding the meeting in a locale which would facilitate the fullest degree of participation as possible, including that of Dr. Goldman. The suggested plan for the three-day meeting was to have the first day-and-a-half devoted to work group meetings, and the second day-and-a-half devoted to a plenary session.

The Committee then discussed two options regarding the work schedule of the Committee. Both options assume a July date for the fourth plenary (with work group meetings in March and April, and then again in May and June). "Option A," as presented by the facilitator, would essentially provide for an October plenary to review a draft report, and a December date for a plenary to review and approve the final draft of the Committee's report, which would then be submitted to the EPA's Science Advisory Board (SAB) and Science Advisory Panel (SAP) for their joint review. "Option B" would take a slightly slower approach by targeting a November meeting to review a draft report and late January or early February, 1998, meeting to approve the final draft for submission to the joint SAB/SAP review panel.

The related discussion prompted concerns about "whether the schedule was driving the product," regardless of which option is selected. Specifically, questions were raised about whether the Committee is limited to only identifying the appropriate mix of existing, "off-the-shelf," validated or soon-to-be-validated screens and tests that EPA can then utilize starting in August, 1999 (as per the legislative mandate); or whether the Committee should feel free to be more creative and far-reaching in their recommendations by not limiting themselves to only identifying an appropriate mix of "off-the-shelf" screens and tests, but also making recommendations on areas of screening and testing research and development in which EPA should engage. Some Committee members felt the latter option would help in development of a more comprehensive and thorough endocrine disruptor screening and testing strategy. EPA staff indicated that Dr. Goldman would be made aware of the need to clarify EPA's expectations regarding these matters to the Committee.

X. Public Comment

Due to changes in the schedule, some members of the public were able to provide comments prior to Dr. Goldman's departure during the afternoon of the first day of the Houston plenary meeting. A period of two hours was also devoted to public comments later in the evening of the first day, during which nearly the entire Committee was present. A total of nineteen members of the public offered comments, twelve of whom also submitted written comments which can be found in the EPA Docket. This meeting summary attempts to capture the essence of the comments made by the public to the EDSTAC during both of those sessions. In addition, some members of the public who were not present at the meeting sent written comments to The Keystone Center. While these are not summarized below, they are also available through the Docket.

Sue Pope, a member of Downwinders At Risk and an advisory board member of the American Lung Association of Texas, expressed great concern over human health and ecological problems in her community seemingly attributable to endocrine disruption. In particular, Ms. Pope chronicled health problems of her family and livestock alleged to stem from hazardous waste incineration at a cement kiln in her area. Ms. Pope entered into the Docket a video which included a television show about hazardous waste-related problems in her town, Winona, Texas. This segment is entitled "Winona Residents Demand Justice for their Children" and is available through the EPA Docket.

LaNell Anderson, a citizen from Channelview, Texas, detailed health problems in her community and family as a result of the effects of dioxin releases along the Houston Ship Channel. Ms. Anderson asked that the Committee make explicit its goals and expected steps for the implementation of its recommendations, and that State authorities be involved in the EDSTAC as appropriate. She asserted that the EDSTAC process merited close public scrutiny and monitoring, as its effects will have national impacts. Ms. Anderson encouraged full, impartial, firm, and informed participation by each of the Committee members in the EDSTAC process.

Brandt Mannchen commented on the composition of the Committee and encouraged awareness that no specific interest in the Committee have the ability to unduly influence the process. He said that he felt the Committee was not broad enough in its composition, especially with respect to community-based group representation, specific health problem/developmental effects group representation, and minority representation. Mr. Mannchen encouraged the EDSTAC to develop a screening and testing program that would be flexible enough to accommodate chemical synergies, additive effects, and new information as it becomes available.

Chavel Lopez, a member of the Southwest Public Workers Union in San Antonio, Texas, commented on the health problems surrounding areas adjacent to Kelly Air Force Base due to fuel and toxic chemical storage and toxic chemical dumping. Mr. Lopez, a member of a group of approximately 500 concerned citizens in Bear and Medina counties, raised concerns regarding contamination of the Edwards Aquifer. He also urged that the Committee include more representation of people-of-color.

LaNell Anderson read a statement written by Ms. Phyllis Glazer, President of Mothers Organized to Stop Environmental Sins (MOSES), which raised concerns about the effects of a hazardous waste incineration facility near the town of Winona, and expressed dissatisfaction with the requirements of State agencies in requiring testing for dioxins. In addition, Ms. Glazer's statement offered concern about the effects of other hazardous waste sites shipping waste to the incinerator for disposal and/or storage.

Jane Elioseff, of the Galveston-Houston Association for Smog Prevention (GHASP), an organization devoted to improving the air quality of the Galveston-Houston area, noted that the Galveston-Houston area is a severe ozone non-attainment area with high levels of nitrogen oxide. She stated that this represented a large air quality problem for a suburban area. Ms. Elioseff said that GHASP, which receives funding from the W. Alton Jones Foundation to pursue its work, has determined that endocrine disruption is connected to air pollution and has just published a report on air quality in Houston, called "Danger in the Air," which she made available for the Docket.

Yolanda Johnson, a member of the Southwest Public Workers Union in San Antonio, Texas, expressed great concern with the generational effects of environmental contamination and endocrine disruption. Both she and her husband have experienced health problems, as have most members of their family raised near the fuel and chemical storage and disposal sites at Kelly Air Force Base. Ms. Johnson thanked the Committee for its work, and urged the EDSTAC to encourage greater communication and disclosure with respect to endocrine disrupting hazards.

Susan Pitman, Network Coordinator of The Chemical Connection, A Public Health Network of Texans Sensitive to Chemicals, commented that the Committee ought to consider chemically-sensitive persons and vulnerable populations in screening and testing for endocrine disruptors, rather than using healthy adult males as its benchmark.

Dominga Adams, a member of the Southwest Public Workers Union in San Antonio, Texas, detailed numerous ailments experienced by both herself and her husband, as well as by their children and grandchildren. Ms. Adams expressed doubt that her family's health problems were genetic, and indicated she felt they were caused by chemicals from Kelly Air Force Base. She also encouraged thorough governmental communication with the public in instances where health risks may or do exist.

Suzanne Martine Rohrer, of The Endometriosis Association, explained that she was diagnosed with endometriosis, discussed the effects of the disease, and outlined the consequent challenges in her life due to the disease. She urged the Committee to work diligently and asked that dioxin receive particular scrutiny, since high level exposure to dioxin has been associated with increased incidents of endometriosis.

Kim Phillips, former environmental chairman for the Texas PTA, said that she was grateful for and supportive of the Committee's work, and asked that children, rather than adult males, be used as guides for exposure effects. Ms. Phillips cautioned the EDSTAC that consensus processes can prove difficult, but that they are worth the effort. She outlined some of her organization's principal concerns with respect to endocrine disruptors, and urged the Committee to consider the synergistic effects of chemicals and to err on the side of caution.

Raul Villar, a retired welder from Kelly Air Force Base, commented on his family's health problems since living near Kelly Air Force Base, and expressed anger that the contamination of the area around his home had not been made publicly known prior to his purchase of the lot.

David Casen, of Save Whitewright and Tri-Counties (SWAT), said he was concerned about dioxins in his community, and deeply cynical about the consensus process of the EDSTAC. Mr. Casen stated that he feared the Committee's decisions would be made based on political considerations. He also expressed his concern caused by having representatives from chemical production companies on the Committee. Mr. Casen asked the EDSTAC to use mechanistic findings as suggestive but not limiting factors in screening and testing, and that the Committee adopt the "precautionary principle."

Virginia Castillo, a citizen residing near Kelly Air Force Base, asked that someone look into the causes of numerous health problems in the community adjacent to the Base. Davis Baltz, a Research Associate with Commonweal, outlined eleven points. These points covered: using caution to determine when an effect was "adverse;" the importance of the EDSTAC's Principles Work Group, its charge, and its composition; deferral of chemicals in the screening and testing process; the importance of recognizing new information on endocrine disruption and chemical effects; the need for "a new paradigm" with respect to timing and exposure information; a re-evaluation of quantitative risk assessment; the encouragement of the use of the "precautionary principle;" the need for EPA to identify and allocate material resources to permit full participation and expression of all points of view within work groups; his desire to have a defined schedule of meeting dates for the duration of the EDSTAC process; the need for encouraging public education and comment on matters related to endocrine disruption from other countries; the importance of studying sex steroid- and thyroid-related effects; and, the need for screening, testing, and evaluating endocrine disruptors to become an ongoing responsibility of EPA.

Neil Carman, Ph.D., of the Sierra Club and formerly of the Texas Air Quality Board, presented comments from people near a site in Jacksonville, Arkansas, which expressed doubts about the fairness of health studies by the EPA and the Agency for Toxic Substances and Disease Registry. Mr. Carman also said he had little faith in the regulatory process. He urged the EDSTAC to look at synergistic effects of chemicals and to use the "precautionary principle."

Winifred Hamilton, Ph.D., of GHASP, stated that she felt most affected communities are not represented adequately in decisionmaking processes related to endocrine disruption. She said it was difficult to buy a non-contaminated house in Houston due to the prevalence of chlordane. Dr. Hamilton urged the Committee to remain focused on health concerns, and offered caution that consensus processes not be misused. She continued by outlining principles she felt were important, including shifting the focus of acceptable levels of endocrine disruptors to protecting the most vulnerable populations (e.g., children and conceptuses in utero).

Judy Starns, a citizen from Channelview, Texas, outlined the impacts of contamination in her community, and expressed concern that her community has not been able to have a fair health study conducted. Karla Lamb, a citizen from Channelview, Texas, outlined personal health problems since moving to Houston in 1975. She expressed anger and frustration at the deleterious effects chemical exposure has had on her health, and urged the Committee to help others in similar situations.

XII. Response to Public Comment

Dr. Fenner-Crisp thanked the members of the public for their comments. She stated that due to the mandate under which the EDSTAC was operating, the scope of the Committee's deliberations would likely have to start by focusing on the sex steroids, but that such a focus was not indicative of the EPA's research priorities.

Regarding the public request for a document detailing the state of the science related to endocrine disruption, Dr. Fenner-Crisp stated that the EPA has been working on such a document for one and one-half years. The document is currently undergoing review by EPA's Science Policy Council, and should be available on the World Wide Web and in hard copy through conventional avenues shortly.

Referring to public comments on the EDSTAC process and concerns with respect to consensus processes in general, the facilitator stated that comments on the Committee's process, even critical ones, are very welcome. With respect to the availability of information, he said that he hoped the use of the World Wide Web site would help meet the needs of the public, and added that the pace of the EDSTAC would hopefully decrease, thereby allowing members of the public an easier opportunity to track its deliberations.

Members of the Committee spoke to the concerns citizens raised about having representatives from chemical producing industries sitting on the EDSTAC. Some members firmly stated that there was, in no manner, a conflict of interest. In fact, Committee members pointed out, it is only in places like the EDSTAC that representatives of all interested parties can speak and share commonalties as humans, and that a level of trust in the commonality of commitment would have to evolve.

Committee members also cautioned members of the public against putting all their hope in the EDSTAC as the solution to endocrine disruption or, more generally, to environmental contamination. They stated that the EDSTAC is only one part of a process to improve the situation, and that the limitations of science alone would likely present very real constraints to the effectiveness of the Committee.

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