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Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC)
Draft Meeting Summary(1)
On February 3-4, 1998, the seventh plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in Washington, D.C. Please refer to Attachment A for a list of Committee members in attendance.
The seventh plenary meeting consisted of a two day full Committee meeting, at which time the EDSTAC reviewed for the first time, the Draft Final Report in its entirety. The Communications and Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG), introduced their respective chapters and initiated discussions on the draft recommendations included for consideration by the EDSTAC.
During the first EDSTAC plenary meeting, held 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. During the second EDSTAC plenary, held in Houston in February, 1997, the Committee conducted a series of educational tutorials on scientific issues related to endocrine disruption, discussed a set of principles, tentative definitions, and a conceptual framework to guide its efforts, and defined membership issues related to the three primary work groups (the Communications and Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG)). At the third EDSTAC plenary meeting, convened in Baltimore in April, 1997, the Committee gained clarification on the EDSTAC's charge, provided sufficient guidance to have a tentative consensus on the draft Conceptual Framework (CF) document and flow chart, and provided each of the work groups with direction and guidance. At the fourth EDSTAC plenary, held in Chicago in July, 1997, the Committee confirmed the consensus goal of the EDSTAC, provided feedback and guidance to each of the three work groups on their accomplishments, and direction on how to proceed in future efforts, and gained information on the status and direction of activities by the Organisation for Economic Cooperation and Development (OECD) related to endocrine disruption issues. The fifth plenary session of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) was held in New York, New York, October 7-8. The meeting was well attended, and the Committee made significant progress in many areas. Most notably, each of the work groups received guidance and constructive feedback from the full Committee on the direction and substance of their efforts. The sixth plenary meeting of the EDSTAC was held in Orlando, Florida, December 2-3. At this meeting, each of the three primary workgroups made presentations to the Committee regarding recommended approaches in the respective areas, and received a substantial amount of feedback from the EDSTAC. The plenary session succeeded in furthering the Committee's efforts toward achieving consensus recommendations to submit to the EPA concerning an endocrine disruptor screening and testing program.
The EDSTAC will meet again in Baltimore, Maryland, March 17-18, 1998. The meeting will be held at the Sheraton BWI located at 7032 Elm Road in Baltimore. The phone number to the Sheraton BWI is 410/859-3300 and the guest fax number is 410/859-0565. Please note that as several public comment periods have previously been held and the work of the EDSTAC is reaching its final stages, there will be no public comment period at the Baltimore meeting. The meeting will, however, be open for public observation.
II. Overview of the Washington, D.C. Plenary Meeting
The Washington plenary brought the Committee substantially closer to achieving a consensus on its recommendations to EPA regarding an endocrine disruptor screening and testing program. Below you will find information about the major points discussed at the plenary meeting. Please note issues not resolved at the February meeting are being addressed by Committee members and a revised draft of the Final Report will be reviewed at the March plenary meeting, March 17-18.
[Note to reader: This memo is intended to provide you with a brief summary of the discussions that took place at the plenary. We have not included copies of the documents that were distributed in advance of the meeting and were the basis of the discussions that took place at the meeting. These documents will, however, be included as attachments in the official summary of the meeting that will be posted to the EDSTAC Web Site; the web site address is http://www.epa.gov/scipoly/oscpendo/index.htm.]
III. Definition of "Endocrine Disruptor"
The Committee made significant progress toward reaching consensus on a definition of "endocrine disruptor". The basis of discussion was an EPA memo listing different definitions for endocrine disruption. Please see Attachment B for a copy of this document. Deliberations during the February 3, morning session resulted in a draft definition of "endocrine disruptor," however, discussion was put on hold until the following day. Please see Attachment C for the February 3 draft definition. During the afternoon session of February 4, the Committee spent time reworking the definition and, except for one member, temporarily agreed on a draft definition. Please see Attachment D for a copy of the temporarily agreed to definition of "endocrine disruptor".
The primary challenge facing the Committee was whether or not and if so, to what extent, to include the concept of adversity in the definition of "endocrine disruptor". While some members felt it was imperative to include the concept, others disagreed. Eventually, there was agreement to include the word "adverse" in a "clarification sentence" immediately after the definition. While some members still expressed the view that the wording did not adequately capture the concept that endocrine disruption is not necessarily adverse, only one member dissented from accepting the language. The issue of whether to include the word "irreversible" was also raised and the Committee decided not to include the term. Other concerns raised by members during the course of discussions included the length and clarity of the definition. The Committee agreed to continue to rework the definition and present a revised draft at the March plenary meeting.
III. Screening and Testing Work Group Low-Dose Workshop
The STWG held a meeting the afternoon of February 2 to specifically consider the issue of low dose testing of potential endocrine disruptors. The meeting was open to members of the PSWG and the COWG as well as all Committee members. The first part of the meeting consisted of presentations by several experts in the field and was followed by discussion among panel members and attendees. Penny Fenner-Crisp, Chair of the STWG and EDSTAC member, summarized the low dose workshop during the morning session of the first day of the plenary meeting. Please see Attachment E for a copy of the low dose workshop summary.
IV. Chapter 3 - Conceptual Framework
During the morning session of the first day of the plenary and at various points throughout the two day meeting, proposed revisions to Chapter 3, Conceptual Framework, were considered by the Committee. It was agreed to incorporate additional text and a Venn Diagram in Chapter 3 to clarify where the mandate EDSTAC has chosen (i.e., to focus on estrogen, androgen, and thyroid activity) fits into the large scheme of the hormonal system. Please see Attachment F for a copy of the proposed text and Attachment G for a copy of the Venn Diagram distributed at the meeting. Other revisions were suggested and the Committee asked various members to draft language reflecting the EDSTAC's discussions. The revised draft of Chapter 3 will be reviewed at the next plenary meeting. Please see Attachment H for the Draft Conceptual Framework flow chart distributed at the meeting.
V. Chapter 4 - Priority Setting
On the first day of the plenary meeting, the Committee spent approximately four hours discussing the key issues of Chapter 4, Priority Setting, of the draft final report. Additional time was set aside the following morning for further discussions. Discussions began after Rich Liroff, a member of the Priority Setting Work Group, provided an overview of Chapter 4. In order to address issues still unresolved by the close of the two day meeting, the Committee agreed to continue to work cooperatively to reach agreement on these issues and assigned specific tasks to various Committee members and work group members. These assignments, once completed, will be reviewed by the EDSTAC, and to the extent agreement is reached, incorporated into a revised draft final report. The revised Draft Final Report will be the primary topic of discussion at the next plenary meeting. The following priority setting issues were considered by the EDSTAC at the February plenary meeting:
Scope of Chemicals Addressed
Although specifics had not been determined, the Committee agreed the scope of chemicals to be addressed in the screening and testing program should not be limited to only those under the purview of the EPA, and should include, for example, chemicals dealt with under the authority of the Food and Drug Administration. A Committee member was assigned to draft language, for insertion in Chapter 4, referencing the EDSTAC's decision to work beyond the scope of the statutes (Food Quality Protection Act (FQPA) and the Safe Drinking Water Act (SDWA) amendments).
High Throughput Pre-Screening (HTPS)
On the first day of the meeting, the EPA informed the Committee that a Request For Proposal (RFP) for the HTPS Demonstration Project had been sent out and EPA was awaiting response. A copy of the RFP was distributed to the Committee on the second day of the meeting. Please see Attachment I for a copy of the HTPS RFP. Further discussion concerning HTPS, revealed that the role of HTPS in the proposed Screening and Testing Program was not completely clear to everyone. The Committee agreed to assign certain Committee members the task of drafting language elaborating four distinct purposes for HTPS, to be included in the next draft of the final report. Additionally, the Committee agreed to revise the draft final report to ensure the report is consistent regarding the description of the types of assays to be conducted during the HTPS process.
The polymer discussion by the EDSTAC included comments by one member expressing concern about the differential treatment of "old" versus "new" polymers. Specifically, concern was raised about the current proposal to exclude old polymers from screening and testing. Another member raised the issue of what to do when components of a polymer are found to have significant potential as an endocrine disruptor and suggested that if a monomer/oligimer is determined to be an endocrine disruptor, the parent polymer should be considered an endocrine disruptor and sent directly to hazard assessment. Two Committee members were assigned to consider these two concerns and draft language to be inserted into the next version of the draft final report. Furthermore, the Committee decided to add "degradation assessment" to the polymer flow chart and text and also, to use the TSCA Inventory Update Rule (IUR) as a possible means to obtaining information on polymers in the future.
The primary topic of discussion regarding mixtures was the list of six categories of mixtures targeted to go through HTPS. The associated policy and technical issues and complexities related to the screening and testing of mixtures were also discussed. In order to address these issues, the Committee assigned two of its members to draft language re-prioritizing the list of six proposed mixture categories, and assigned three of its members to draft language elucidating the associated policy and technical issues related to screening and testing mixtures.
The Committee did not discuss the issue of the nominations process, but rather noted it was still a work in progress. Several Committee members will continue to work to develop language that further describes both the criteria and process to be used to evaluate nominations.
Endocrine Disruptor Priority Setting Database (EDPSD)
At the time of this meeting, the EDPSD was approximately fifty-percent complete. The PSWG agreed to review the list of identified data fields and ensure it reflects the most up-to-date view of the group regarding data fields to be included in the EDPSD. Additionally, the PSWG will cross-reference the recommended data fields against the data source matrices contained in Appendix G of the February draft final report.
"Sand Art" Proposal (Approaches To Setting Priorities for T1S and T2T)
A substantial portion of discussions regarding the Priority Setting Chapter involved the introduction of the PSWG's "sand art" proposal delineating an approach to the sorting and priority setting of chemicals in the screening and testing program. Following deliberations, the Committee agreed the PSWG would make revisions to Chapter 4 based on Committee discussions of the "sand art" proposal. At the next plenary meeting, after the incorporation of revisions explaining the proposal in further detail, EDSTAC will discuss this section of Chapter 4 at greater length. Please see Attachment J for an alternative proposal submitted by Rich Purdy, a PSWG member who was not in attendance.
VI. Chapter 5 - Screening and Testing
On the first day of the plenary meeting, the Committee spent approximately four hours discussing the key issues of Chapter 5, Screening and Testing, of the draft final report. Additional time was reserved the following morning for further discussions. Discussions began after Penny Fenner-Crisp, Chair of the Screening and Testing Work Group, provided an overview of Chapter 5. Please see Attachment K for copies of the overheads used during the presentation. In order to address issues still unresolved by the close of the two day plenary meeting, the Committee agreed to continue to work cooperatively to reach agreement on these issues and assigned specific tasks to several Committee members. These assignments, once completed, will be reviewed by the EDSTAC, and to the extent agreement is reached, incorporated into a revised draft of the final report. The revised Draft Final Report will be the primary topic of discussion at the next plenary meeting. The following screening and testing issues were considered by the EDSTAC at the February plenary meeting:
Tier 1 Screening (T1S)
The Committee agreed to recommend all the in vitro and in vivo assays identified in the draft Screening and Testing chapter. Likewise, the Committee reached agreement as to which alternative assays would be included in the EDSTAC's recommendations to EPA.
Bypassing Tier 1 Screening
The issue of bypassing T1S was raised in the evening of the first day of the meeting. The Committee spent a significant amount of time debating those instances, if any, in which T1S should be bypassed. Discussions continued the next morning and the EDSTAC recognized the interconnection among HTPS, alternative approaches to T1S and T2T, and low dose testing. The EDSTAC decided to redraft the Chapter 5 section on bypassing T1S in the context of the connected issues, and revisit the issue at the March plenary meeting.
The Committee specifically addressed the issue of "weight of evidence" during the evening session of the first day of the meeting while deliberating the issues of bypassing T1S and the need to do low dose testing. To address the issue, the EDSTAC asked a member to draft additional text for inclusion in the section. In addition, the Committee asked that the redraft include a more focused overview of the False Positive and Negative Results, reflecting the Committee's discussions.
Tier 2 Testing (T2T)
The Committee considered several issues in its discussions of T2T, including: 1) how T2 tests (i.e., mammalian and non-mammalian) will be chosen, 2) the method for determining the doses used during testing, 3) recommended additional endpoints in the mammalian two-gen test, and 4) criteria for the type of mammalian (i.e., two-gen or alternative) tests applied. The EDSTAC agreed parts of the T2T section needed revision and asked various EDSTAC members to draft language reflecting the T2T discussions.
Low Dose Testing
Although the Committee made progress toward reaching agreement on the issue of low dose testing, the issue remained unresolved at the close of the plenary meeting. As discussed in earlier sections, the issue was viewed as tied closely to a number of other issues (e.g., HTPS, bypassing T1S). On the morning of the second day, some tentative agreements were reached about these interconnections (e.g., conduct estrogen, androgen, and thyroid transactional activity assays on bench or HTPS), however, specific language was not agreed upon at that time. The facilitation team and EPA staff agreed to try and capture these discussions.
Please note, two additional documents were handed out during discussions of Chapter 5. See Attachment L for a description of "endocrine function" and Attachment M for a copy of "Endocrine Disruption: An Overview of the Issue."
VII. Chapter 6 - Communications and Outreach
In the afternoon of the second day of the plenary meeting, the EDSTAC discussed Chapter 6, Communications and Outreach, of the draft final report. Discussions began after Douglas Crawford-Brown, a member of the Communication and Outreach Work Group, provided an overview of Chapter 6. Please see Attachment N for copies of the overheads used during the presentation. The discussion was brief because the Communication and Outreach Work Group had to delay completing its recommendations until certain decisions involving priority setting and screening and testing were made by the Committee (e.g. identification of decision nodes). The Communications and Outreach Chapter will be discussed in greater length at the next plenary meeting.
VIII. Other Aspects of the Washington, D.C. Plenary
Approval of the Orlando Plenary Meeting Summary
Each member of the EDSTAC was provided with a copy of the Orlando meeting summary prior to the Washington, D.C. plenary meeting. The Committee approved the summary after incorporating one revision. Once approved, copies of the final meeting summary were made available to interested members of the public.
Next Steps for the EDSTAC
As noted above, the EDSTAC will meet again on March 17-18 in Baltimore, Maryland, at which time the Committee will review changes to the report since the February plenary, and will further revise the report as necessary. The draft final report must be ready for the SAB/SAP consultation process by April 3; the consultation meeting will take place May 5-6. The results of the SAB/SAP consultation process will be made available to the EDSTAC before the final plenary session which will be held June 17-18, in Washington, D.C. The final EDSTAC Report is to be completed and submitted to EPA by July 3rd.
1 Please note that attachments will be available
via the Web site or through the EPA Docket.