Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Endocrine Disruptors Screening and Testing Advisory
April 29 - May 1, 1997 Baltimore, Maryland
Final Meeting Summary
On April 29, 30, and May 1, the third plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in Baltimore, Maryland. Please refer to Attachment A for a list of Committee members in attendance.
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 Communication & Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG)).
The objectives for the Baltimore plenary were to: (1) provide clarification on the EDSTAC's charge; (2) to approve the Houston plenary meeting summary; (3) seek consensus on the draft Conceptual Framework (CF) document and flow chart; and (4) provide guidance and clarification to each of the three work groups on their tasks and directions until the next plenary meeting.
II. Opening Comments and Clarification of the EDSTAC Charge
Dr. Lynn Goldman, the Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) for the U.S. Environmental Protection Agency (EPA), and the EDSTAC Chair, welcomed the Committee members to the meeting, thanked them for their attendance, and extended her appreciation to all work group members for their efforts since the Houston plenary.
Dr. Goldman stated her desire for the EDSTAC to gain a sense of closure on issues raised by her letter to the Committee members (sent to them prior to the Baltimore plenary and attached hereto as Attachment B) regarding the charge and direction of the EDSTAC. In discussing the letter, Dr. Goldman addressed several specific issues including the scope and timing of the EDSTAC deliberations, the connection between screening and testing and risk assessments, and validation issues.
With regard to scope and timing, Dr. Goldman acknowledged that Congress, in its passage of the Food Quality Protection Act (FQPA) and the Safe Drinking Water Act (SDWA), has established the minimum scope of the EDSTAC's deliberations. However, she noted that the Committee has already decided that the scope of the strategy needs to be somewhat broader than only focusing on estrogenic effects to include androgenic and thyroid-related hormonal effects as well. Furthermore, EPA and, consequently, the EDSTAC, are required by these statutes to propose and implement an endocrine disruptor screening and testing program within a specified period of time. Recognizing the tightness of the time constraints on the EDSTAC, Dr. Goldman emphasized that the primary charge to the Committee is to develop consensus recommendations on an endocrine disruptor screening and testing strategy that has scientific integrity, flexibility, and regulatory utility, in a timeframe that allows the Agency to meet the mandate set by Congress.
Elaborating on the need for the screening and testing strategy to have regulatory utility, Dr. Goldman noted that the current draft of the Conceptual Framework places the EDSTAC's multi-tiered approach to screening and testing into the larger risk assessment framework. Specifically, it shows that the results of screening and testing will have value and utility for the hazard assessment component of the risk assessment process. While she acknowledged that some on the Committee have concerns about the connection being made in the draft between screening and testing and hazard assessments, Dr. Goldman commented that the risk assessment framework is imbedded in the statutes which underlie much of the Agency's work and regulations in this area and, therefore cannot be ignored. She also acknowledged that risk assessments are only one of a number of possible decision-making tools and criteria that will be used as the basis of any possible future regulation of endocrine disruptors.
With respect to validation issues, Dr. Goldman noted that the term is used differently in scientific disciplines, and is therefore not clearly defined or consistently understood across disciplines. She noted, however, that the term "validated testing systems" was used by Congress in the FQPA and SDWA provisions on endocrine disruptor screening and testing. To this end, she echoed the substance of her letter to the Committee, which addressed validation by stating that the Committee should not limit itself to only identifying screens and tests that are already widely used. However, any new methods identified by the Committee should be relevant to the endpoint of concern, be amenable to standardization and widespread use, and have a history of reliable performance in several laboratories. With respect to novel or innovative screening and testing methodologies that have not yet been validated, Dr. Goldman noted that EPA is interested in looking at methods beyond those of current use, and that the Agency would like the Committee to help identify methods which might prove useful in the future, as well as methods available for current use. In addition, she stated that she would like the Committee to address the issue of how to ensure validation can occur for new testing methods in a timely fashion.
In conclusion, Dr. Goldman stressed that EPA needs the Committee to develop a screening and testing program for endocrine disruptors to help protect public health and the environment. She noted that EPA has recently released a paper produced by the Agency's Science Policy Council entitled Special Report on Environmental Endocrine Disruption: An Effects Assessment and Analysis. She emphasized that this paper represents a snapshot of EPA's thinking on the current state of the science on endocrine disruption. The document is neither a policy statement on the subject nor is it a final position on the state of the science on endocrine disruption.
In responding to Dr. Goldman's comments, a number of Committee members suggested that the Conceptual Framework document should remain neutral on the connection between screening and testing and risk assessment, while still making it clear that the testing phase will address the need for dose- response information. Others stated that it would be confusing to totally ignore the connection between screening and testing and risk assessment and that it was important for the document clearly state the relationship between screening and testing and the risk assessment process. Dr. Goldman stated that while she did not wish for the EDSTAC to become engaged in a debate about the value and utility or risk assessments, she agreed that when the Committee focused on the draft CF later in the meeting, it should take a more neutral approach that would make it clear that the screening and testing strategy should have utility to a wide variety of decision-making needs and processes, including but not limited to the hazard assessment component of the risk assessment process. She noted that there is a difference between recognizing the connection between screening and testing and risk assessment and endorsing the connection.
III. Approval of Meeting Summary of February 5-6, 1997, Plenary Meeting
The re-drafted February 5-6 Houston plenary meeting summary, distributed to the Committee via Federal Express on April 25, was approved by the Committee without further changes.
IV. Draft Conceptual Framework (CF) Document and Flow Chart
[Note to the reader: Three versions of the draft CF (will be) attached to this document. Each version represents a different draft, that can be distinguished by the date of the draft-- 4/25/97(Attachment C), 4/30/97 (Attachment D), and 5/15/97(Attachment E). The 4/25/97 draft was distributed to the Committee as part of the preparatory materials for the Baltimore plenary. The 4/30/97 draft was developed on the night between the two days of the plenary meeting based on the discussion that took place during the first day. The 5/15/97 draft represents the most current working draft of the CF. It reflects the discussions of the Baltimore plenary as described below. Please note that the 5/15/97 draft is available through the EDSTAC Web site http://www.epa.gov/ scipoly/oscpendo/index.htm>. These three versions are attached hereto to allow the reader to track the specific textual changes, should you desire to do so.]
Mr. Timothy Mealey, Associate Director of The Keystone P's Science and Public Policy Program, began the discussion of the CF by explaining that the 4/25/97 draft CF, distributed in the April 25 mailing to Committee members, represented a document amended by staff of The Keystone P and EPA after the last Principles Work Group (PWG) meeting, and that the PWG had neither seen nor approved the changes. As such, the document was to be viewed as a draft for full Committee review which owed much to the dedication and hard work of the PWG, but not as a formal product of that work group. Mr. Mealey acknowledged that substantive changes had been made to the PWG's draft of the CF, and that these changes (and the risk implicit in making them) were made due to the facilitator's view that seeking consensus of the full committee on the CF merited such a decision. Pursuant to Committee feedback with respect to this decision, the facilitators agreed that any similar actions in the future would be characterized by more explicit attribution of edits and suggested changes.
Section I. Introduction
At the request of members of the Committee, a sentence was added to the first paragraph of the Introduction stating that all draft recommendations contained in the document are premised on the principle of scientific validity.
Section II. Definition of Key Terms
Committee members discussed the issue of the definition of an "endocrine disruptor" as reliant to a great degree on the notion of adverse effect, as well as on the earlier discussion of the risk assessment paradigm. Four definition options of "endocrine disruptor" were included in the 4/25/97 draft CF; most of the distinctions among these options revolved around the degree to which adverse effects are implemented into the definitions.
It was emphasized that the option characterized as the OECD definition was, more accurately, a definition developed during the European Workshop on the Importance of Endocrine Disruptors on Human Health and Wildlife also known as the Weybridge Workshop (RPT. #17549 by The Environment Climate Programme of DG XII European Commission) and is not one that has been officially adopted by the OECD.
Discussion surrounding the definition options focused on: the inclusion of the word "adverse" and the consequent difficulties in defining the exact meaning of the word; the desire for international harmonization of the definition of "endocrine disruptor" for facilitating linkages among international business, legal, and public policy arenas; the inclusion of endocrine disrupting effects on organismic progeny and populations; the need to strike a balance between an overly broad definition of "endocrine disruptor" and one that would limit the Committee's abilities; and the recognition that any definition developed would be revisited both during the EDSTAC process by the Committee itself and well after its completion by the outside community.
After discussion of the different options, it was suggested that none of the four options included in the draft CF contained a satisfactory definition, and that a new definition should be developed. Through a process of proposing a "strawman" option, the following definition of "endocrine disruptor" was tentatively agreed upon by the Committee:
"An endocrine disruptor is an exogenous substance that changes endocrine function and causes adverse effects at the level of the organism, its progeny, and/or (sub)populations of organisms."
The Committee had agreed to use the definition of "weight of the evidence" that is used in the "Science and Judgment" Report of the National Academy of Science. However, in reviewing this report there is no single concise definition of this concept and, to the extent that there was language that explained the concept, it was very much tied to risk characterization, rather then hazard assessment. Consequently, a bracketed indication was inserted into the CF text to indicate that a definition of this term will be inserted.
Section III. Purpose and Context
Mr. Mealey reviewed the changes made to Section III of the draft CF--Purpose and Context for Endocrine Disruptor Screening and Testing--explaining its evolution from a paragraph addressing risk assessment to the broader statement regarding the context for the EDSTAC's deliberations which was now before the Committee. He briefly described the scope and content of each paragraph of the draft CF before opening the discussion to comments from Committee members. What follows is a brief description of the concerns raised and changes made to the draft.
The first and second paragraph in the 4/25/97 draft included language that attempted to be a concise statement of the nature and scope of the endocrine disruption problem, and the state of the science regarding endocrine disruption. Following a discussion whereby several Committee members expressed concern about the factual statements in this paragraph. Language was proposed and considered in the 4/30/97 draft that described the evidence of adverse effects in humans, laboratory and farm animals, and wildlife from high and low doses of certain chemical substances and mixtures. This language was changed to clarify the state of knowledge about high dose exposure versus low dose exposure and was then deleted from the CF pursuant to Committee members' requests. Dr. Goldman proposed that these paragraphs be redrafted using information developed for her Congressional testimony on TSCA screening and testing and other factual information that has already been developed about the problem of endocrine disruption. Subsequently, the Committee agreed to revisit, at a later date, the need for contextual language to be inserted after the Committee has received a briefing from the National Research Council (NRC) when it completes its review of the nature and scope of the endocrine disruption problem in September. Thus, it was agreed that these paragraphs be deleted from the draft for the time being.
Section III of the CF now begins with reference to the SDWA and FQPA statutes as mandating a screening and testing program addressing endocrine disrupting chemical substances and mixtures. A reference was added to the CF to describe the intention of the Committee to create such a screening and testing program that could be used by a number of agencies, not just by EPA, that are charged with implementing a broad array of statutes related to the protection of human health and the environment.
Changes were made to the CF to reflect the broader scope of protection of human health and the environment rather than just to inform risk management and risk reduction decisions and actions. Members agreed to eliminate the word paradigm from the CF document and to make specific reference to the NAS risk assessment framework as one aspect of the context within which the EDSTAC screening and testing conceptual framework will be implemented. Within the context of the human health risk assessment framework, Dr. Goldman clarified the uses of data from the EDSTAC screening and testing program will be in the hazard identification and dose- response assessment components. While exposure data was recognized as being valuable, she noted that the screening and testing strategy will not be designed to provide information about the levels of exposure.
One Committee member proposed language that would state in "plain English" what is meant by such terms as risk assessment, hazard assessment, hazard identification, and does-response assessment. It was agreed that this language should be used to define these terms in the definition section (Section II) of the CF. It was also proposed that this language be used to replace all references to the use of such terms as risk assessment, hazard assessment, hazard identification, and does-response assessment. This proposal was not accepted.
Language was added in response to concerns that were raised regarding the parity between the human and ecological realms, and to clarify that the ecological risk assessment framework will include consideration not only of organisms and populations, but of effects on communities and ecosystems, as well.
Section IV. Overview of the EDSTAC Conceptual Framework
Paul De Morgan of The Keystone P, reviewed the changes that were made to Section IV of the CF, noting specifically the need to clarify what is meant by the term of "weight of evidence" as used in the document. He also pointed out that the term "prescreening" which describes the first activity of the framework, had been replaced with the term "priority setting."
During the discussion concerning "weight of evidence," several members suggested that the consideration of a "weight of evidence" approach is critical to the different steps of the screening and testing program, and that it should be pursued. A question was raised regarding the ability to actually accomplish such an evaluation for each of the studies that will be undertaken in the course of screening and testing. Mr. De Morgan suggested that the STWG and PSWG would address this issue in their deliberations, and that the work groups would present options to the full group for discussion at a later date.
Dr. Goldman stated that the term "weight of evidence" is viewed within the Agency as a process of comprehensive evaluation of multiple sources of data, and that it falls somewhere between the scientific and policy processes. A suggestion was made to put the definition of weight of evidence in Section II of the CF. Committee members agreed to do so, using the definition contained in the NAS "Science and "Judgment" Report. [Please note that the 5/15/97 draft does not yet include a definition of the term "weight of the evidence" because, upon review of the NAS "Science and Judgment" Report, although the term was used throughout the Report, there was not a single concise definition contained therein.]
Section V. Scope of the EDSTAC Conceptual Framework
This section was modified to clarify the scope of the hormonal effects that the screening and testing program will address, including: language reflecting EPA's consideration of a single test for multiple hormone interactions; cutting across multiple species; consideration of long-term or delayed effects; and allowance for other categories of hormone receptors that may arise in the future given new developments in endocrinology. In addition, text was added to Section V regarding the types of hormone effects to be included in the screening and testing program.
Section VI. General Principles to Guide the Development of the Endocrine Disruptor Screening and Testing Program
Committee members agreed to modify the text of this section to add a caution against the alteration of tests and assays that might compromise the ability of existing toxicity assays to address other endpoints. In addition, a statement was added describing the need to examine existing screening and testing data for physiological changes in low dose groups, as well as in high dose groups.
Section VII. The EDSTAC Conceptual Framework
Priority Setting -- Obtain and Analyze Existing Information to Set Priorities
Some EDSTAC members expressed concern with the option set forth in the 4/25/97 draft at the first decision node of the flow chart to obtain further information, commenting that the option seems to establish an ongoing information gathering loop. The point was made that the box labeled "Obtain additional information" assumes that the job of obtaining adequate information was not doe properly in the first instance. Based on these concerns, the Committee agreed to change the top box of the flowchart to read "Obtain and Analyze Existing Information" rather than just "Analyze Existing Information" and to eliminate the separate box labeled "Obtain additional information." Additional corresponding changes were made to both the text and the flowchart. With these changes, however, several Committee members offered the caveat that a lack of information is not an adequate reason to do nothing.
A discussion regarding the examples that are present in the opening paragraph of this section ensued, with some members voicing support for deletion and some for maintaining them. One member of the Principles Work Group suggested that the examples were originally inserted to reveal the thinking that went into the priority setting phase and to provide guidance to the Priority Setting Work Group. Now that the PSWG is in place, however, he suggested, and the Committee agreed, that it would be appropriate to delete them until that work group can come back to the Committee with examples that should be included in the final report.
Tier 1 Screening Subsection
Several Members felt that "weight of evidence" should not contravene positive Tier 1 screening results indicating potential endocrine disruption, and language contrary to this perspective from earlier drafts was deleted. It was noted that this issue represented an area of overlap between the work of the STWG, which will design the testing and interpretation strategy, and the PSWG, which will design a strategy for evaluating and prioritizing existing information about the potential for endocrine disruption.
Tier 2 Testing Subsection
Committee members requested that the CF, when finalized, explain, in "plain English," the difference between false positive or "Type I" and false negative or "Type II" errors. Dr. Goldman advised the Committee that EPA staff would need to do a thorough reading of the CF in order to make the language both consistent throughout the document and intelligible to the general public. Therefore, she urged the Committee to spend its time raising substantive issues of import. The facilitators also noted that one of the tasks of the Communication and Outreach Work Group (COWG) will be to review all EDSTAC materials before they are finalized to ensure that they are understandable to the general public.
One member of the Committee requested and it was agreed that the CF make reference to the potential use and modification of current tests presently being used to study other endpoints. Members of the EDSTAC also requested and it was agreed that language should be inserted to make it clear that Tier 2 testing consider the effects of endocrine disruptors on progeny.
Regarding the language in the CF regarding the interpretation of Tier 2 testing, four options were developed by EDSTAC members as potential choices. Some Committee members were uncertain as to the Committee's ability to guide interpretation of tests without specific knowledge of what the tests would be. Other members expressed concern over the interpretation of the language during the peer review process. Based on the discussions that took place at this point of the meeting, the EDSTAC identified, but did not yet agree upon, four possible options for language to be used at this juncture in the text of the CF. The language in the 5/15/97 draft reads as follows:
Interpretation of results from Tier 2 testing should reflect current scientific judgment, including considerations such as "weight-of-evidence" and consistency of the dataset. In interpreting Tier 2 testing results, any change in endocrine function should be ...
OPTION 1: ...considered valid until further information provides a basis for rejecting this conclusion.
OPTION 2: ...further examined until it can be shown that it is not adverse.
OPTION 3: ...considered potentially adverse until shown otherwise.
OPTION 4: delete this sentence altogether.
Draft Conceptual Framework Flow Chart
As per instructions from the Committee, the language in the first and third bullets of the box labeled "Obtain and Analyze Existing Information" was revised to eliminate any use of examples and to make sure it is clear that toxic effects includes human and ecological. Also per requests by Committee members, a footnote was added to the box labeled "Stop S&T Unless..." to include the four possible means to restart screening or testing.
Some members of the Committee pointed out areas of inconsistent verbiage between the flow chart and the text. Mr. Mealey offered assurance that issues of consistency would be addressed in the next revision.
V. EDSTAC Coordination Group
The Committee agreed that future efforts of the work groups would benefit from an increased level of coordination. Toward this end, the facilitators agreed to initiate a process, as necessary, to address the need for coordination through a subset of the Committee members. Further information about this coordination group will be available at the next plenary.
VI. Discussion and Comments Regarding the EDSTAC Process
Toward the end of the plenary meeting, a period of time was set aside for a discussion and feedback to EPA and The Keystone P about the EDSTAC process. Dr. Goldman and the facilitators encouraged the Committee members to be candid with their comments, and asked for feedback on three aspects of the EDSTAC process in particular:
1. reactions to the way in which the 4/25/97 draft was produced and distributed between the last Principles Work Group meeting and the Baltimore plenary;
2. feedback on the pace and content of plenary discussions, and in particular on the process of discussing and/or addressing specific textual passages within the documents; and
3. comments on the availability of documents to both the pubic and the Committee in advance of meetings, particularly in light of the ground rule established by the Committee stating that documents under development would not be disseminated to the public until those documents were ready to be discussed by the full Committee.
With respect to the first issue, Committee members expressed their understanding of this process, and several EDSTAC members expressed their appreciation for the opportunity to review the CF prior to the plenary, adding that they felt the opportunity to provide comment had been valuable. Others noted that they did not receive the draft in time to review it before the meeting. It was requested that, if conditions warrant this type of approach in the future, the appropriate work group should be notified that the document would be revised, and that any changes made to the draft should be more clearly attributed for accurate characterization and clarification.
Some members of the Principles Work Group expressed frustration and confusion at the time spent as a work group to reach consensus on a document that was then revised and presented to the full Committee in a new form. Dr. Goldman noted that, in the future, work groups may not have time to come to consensus by the time a document needs to go to the plenary but it was hoped that the work groups would at least present clearly framed options for consideration by the Committee. However, she noted that the process of shepherding a document from the work group to the plenary will need to be managed with greater communication and sensitivity. Mr. Mealey added that the breadth of response from the other work groups after the Principles Work Group met in mid-March had been unexpected, He stated that it would have been ideal to reconvene the PWG before the Baltimore meeting. As this was not possible, it was decided to develop and present a revised draft that addressed the concerns that had been raised in order to focus the discussion at the Baltimore plenary. He noted that emphasis on the development of a consensus would be on the EDSTAC itself rather than the work groups.
Regarding the second issue of the pace and content of the plenary discussions, many Committee members requested that future discussions focus on substantive issues, and that the efforts to rework the precise text of documents stay in the domain of interested subgroups of the Committee, sidebar conversations, and/or the work groups. Furthermore, Committee members noted that the EDSTAC needed to be aware of the potential public perceptions created in spending a great deal of plenary time discussing the specific textual changes that might need to be made to EDSTAC documents.
Committee members expressed their desire for The Keystone P and EPA to develop a detailed schedule for the remainder of the EDSTAC process due to the great amount of work remaining to be completed in a relatively short period of time. Doing this, they felt, would designate defined deadlines and deliverables for Committee and/or work group review, thereby eliminating similar situations as that of the CF in the future and allowing appropriate and timely debate in both the work groups and in the plenary. A few members of the Committee recommended that EPA approach Congress for an extension of the EDSTAC's timeframe.
The Keystone P and EPA, therefore, agreed to devise a clear and detailed schedule of meeting dates and deadlines for use by the work groups and the Committee, with the understanding that once this schedule was agreed upon by the EDSTAC and/or work group members, the responsibility would then lie with the Committee members to meet those deadlines.
Several Committee members requested that increased clarity be given by EPA regarding the consensus objective of the EDSTAC. In particular, it was asked how firm EPA's desire was that the Committee operate on a consensus basis, what process would be invoked should consensus not be reached, and what would happen to the minority opinion in the case of dissent. In response to these questions, it was noted that Dr. Goldman would communicate her thoughts on behalf of EPA to the Committee members before the July plenary. In addition, it was requested that tighter facilitation of the Committee be implemented to determine instances where consensus is not the paramount goal and disagreement might be footnoted, or when an issue needs to be deliberated until consensus is reached.
Work Group Issues
Some Committee members expressed frustration related to the work groups, commenting that it was problematic and inefficient to need to bring non-Committee work group members "up to speed" on the EDSTAC's deliberations during valuable work group meeting time. It was requested that non-Committee work group members be kept better apprised of the EDSTAC's decisions and reasoning prior to work group meetings, and that work group members be reminded that it is inappropriate to revisit the Committee's decisions in the work groups.
Members of the Committee also raised concerns regarding work group attendance by non-Committee work group members. It was suggested that if non-Committee work group members could not consistently attend the work group meetings and stay updated on the Committee's work, these individuals should remove themselves from the work group either by their own volition or by encouragement for reasons of work group efficiency and effectiveness.
Congressional Briefings Regarding the EDSTAC
Some Committee members raised concerns related to a lack of awareness of the existence and activities of the EDSTAC among members of Congress, adding that endocrine disruptor-related legislation under discussion on Capitol Hill (e.g., an effort related to the Clean Water Act) may be either redundant or uninformed without increased awareness about the EDSTAC. Dr. Goldman agreed with this concern, noting that she is in the process of preparing to brief Capitol Hill staff and that she may call upon members of the Committee to help provide help with this and/or future briefings and progress reports on the EDSTAC.
VII. Communications & Outreach Work (COWG) Group Issues
Comments on the draft EDSTAC Charge as Drafted by the COWG
Judy O'Brien, the lead facilitator for the COWG, and Drs. Christopher Borgert and Peter de Fur, the co- chairs of the COWG, asked the Committee for feedback on a draft document describing the EDSTAC's charge which was developed by the work group (Attachment F). Committee members voiced general support for the document, and noted, in particular, that the last paragraph of the document was beneficially descriptive. It was suggested that the document make explicit the Committee's intention to look at both human and ecological effects of endocrine disruptors, as well as the Committee's intent to grapple with issues related to the prioritization of chemical substances and mixtures. Dr. Borgert thanked the Committee for the feedback, adding that the work group would rework the text of the document according to the Committee's recommendations so that it might be ready for public distribution.
Public Outreach by the COWG on Behalf of the EDSTAC
Members of the COWG sought guidance from the EDSTAC regarding the work group's role and responsibilities in initiating public outreach on behalf of the Committee. Dr. Goldman added that, in establishing the EDSTAC, there had been a great deal of interest from other stakeholder groups, and that the EDSTAC should determine the degree to which the COWG should be communicating information to those groups. In addition, Committee members pointed out that the COWG's charge held two types of communication objectives: (1) information targeted at specific individuals and groups, and (2) information developed for broad, general disbursement.
Dr. Goldman noted that the job of the work group is to both perform communication and outreach regarding the work of the EDSTAC as well as to make recommendations to EPA on future communication and outreach efforts (e.g., suggestions of outreach EPA should engage in for the screening and testing phases; explanatory "one-liners" for endocrine disruptor screens and tests similar to those EPA developed for toxicology tests; etc.).
VIII. Comments Regarding the Upcoming Great Lakes Symposium
Gary Timm of EPA gave an update regarding the upcoming Great Lakes Symposium on Endocrine Disruptors. The Symposium is being designed by Region V EPA as a one-day workshop dovetailing with the July EDSTAC plenary in Chicago, and is expected to draw a large audience, with possible effects on the size of public attendance and the volume of public comment at the EDSTAC plenary.
Committee members offered concerns with respect to the Symposium, that it might be viewed by the public as a template for holding future symposia in conjunction with EDSTAC meetings. Several members of the Committee felt this situation, should it arise, would put increased pressure on EDSTAC members to participate and/or speak in these meetings due to the public perception their absence might create. They also expressed concern regarding the increased time and financial pressures additional meetings might create. Several Committee members urged that meetings such as the Symposium not be held at the same time or location as EDSTAC meetings.
Dr. Goldman commented that situations such as the Symposium will pose challenges for the Committee with respect to communication and the interface between such meetings with the deliberations of the EDSTAC. Dr. Goldman noted that the Symposium will not be focused on screening and testing as the EDSTAC is, but rather on the general issues related to endocrine disruption. She added that EPA will need to exercise caution in future scheduling and characterization of such symposia and similar meetings so as not to interfere with or confuse the EDSTAC process.
Members of the Committee recognized that the EDSTAC cannot determine when and where EPA or other groups will hold their meetings. However, it was strongly affirmed that any Committee member's decision to attend such events, as well as that member's role at such meetings, should not be viewed as indicative or representative of an EDSTAC stance or position.
IX. Clarification of the Organization for Economic Coordination and Development (OECD) Process Related to Endocrine Disruptors
Dr. Goldman commented briefly on the status of the OECD process, noting that the survey of all the OECD countries has been completed, and that the OECD staff are compiling the responses. The OECD plans to develop a process for endocrine disruptor testing, and has agreed with EPA that there should be an exchange of products, as appropriate, at every stage when the respective groups are comfortable with such a sharing.
Dr. Goldman pointed out the joint United States/OECD history of harmonization with respect to testing guidelines, and noted that endocrine disruptors presented an opportunity to formulate testing guidelines before either party had created their own regimen. She commented that the next meeting of the OECD Chemicals Group was slated to be held in mid-June in Paris. Although endocrine disruptors represent a relatively small part of the group's focus at this meeting, she felt it would offer a good opportunity for EPA to give the group a sense of where the EDSTAC's work stands. In addition, Dr. Goldman noted that the United Kingdom is taking the lead role in the OECD efforts related to this issue, and that the EDSTAC may, at some point, take part in a meeting of the UK representatives and/or invite them to participate in an EDSTAC meeting.
X. Timeline, Next Plenary, and Closing Comments
Committee members agreed to reserve the dates of October 1-15 in their calendars pending the selection of exact dates for the October plenary meeting, tentatively slated to take place in the New York City metropolitan area.
Prior to the October plenary, probably in mid-September, members of the EDSTAC will be briefed by members of the NRC on its findings. The forum for this briefing will most likely consist of a conference call, where EDSTAC members will have the opportunity to listen to the briefing without being required to be physically present. Members of the EDSTAC will be given copies of the NRC report prior to the meeting to aid their preparation.
Dr. Goldman closed the meeting by thanking the Committee members for their patience and hard work during the previous one and one-half days. Dr. Goldman recognized the occasional frustration involved in a consensus-oriented science and policy process, especially from a group of individuals who have never worked together. She noted, though, that the Committee was in fact making progress, and urged the EDSTAC members to continue working diligently and conscientiously toward the final goal.
XI. Public Comment
Following a brief public reception hosted by the EDSTAC and attended by several members of the Committee on the first day of the plenary meeting, members of the public were invited to offer comments related to the scope and charge of the EDSTAC. The public comment session lasted longer than two hours, and allowed time for more than forty individuals to provide comment to Committee members, nearly all of whom were present. Due to the number of individuals seeking to provide public comment, all those who signed up to speak to the EDSTAC were requested to keep their comments to no more than four minutes in length. While this request may have caused frustration on behalf of some individuals, the intended and effected result was to allow all persons wishing to provide comment the opportunity to do so. Written comments submitted by members of the public may be found in the public docket (Docket ID: EPA-HQ-OPPTS-42189; phone 202-260-7099). This meeting summary attempts to capture the essence of the comments made by members of the public to the EDSTAC during the public comment session.
Thomas Hobbins, MD, from Physicians for Social Responsibility, commented that one of the most important recommendations offered by his organization is that Congress needs to provide a higher level of funding for endocrine disruption research. Dr. Hobbins related anecdotally the potential for paradigmatic shifts in thinking related to perception and actual awareness of health problems and risks. He urged the Committee to look at zero tolerance as a guide post rather than acceptable thresholds for risk.
Keith Bowers, of ICF, Inc., offered comments concerning international institutions working on issues of endocrine disruption. Mr. Bowers commented that the endocrine disruptor-related work being done by agencies and organizations such as the United Nations Environmental Programme and the OECD is being conducted in conjunction with their work on persistent organic pollutants. He stated that it was important for the EDSTAC to know how its work differs conceptually from the OECD's work, and that the Committee should look at non-persistent organic pollutant types of chemicals.
Gail LeMaire, Ph.D., of the Endometriosis Association, stated that there are currently millions of American women and girls with endometriosis, and expressed frustration at the lack of support for women with the disease, as well as the lack of information and research on the disease to date. Dr. LeMaire requested that more research be conducted on the relationship of chemicals such as dioxin, PCBs, and TCCD and their effects on the body. She added that studies should not simply examine instances of adverse effects, but should be proactive before such effects are manifested in the body. Dr. LeMaire concluded by stating that progesterone is noticeably missing from the EDSTAC's scope.
Anneke Davis, from the Maryland Conservation Council commented on the public information process of the EDSTAC. Recognizing that the Committee is under tremendous pressure to produce their deliverables, she stated that testing is going to take a lot of time and money, as well as public support. In order to accomplish this and to garner public support for adequate funding of the implementation of the EDSTAC's recommendations, Ms. Davis encouraged the Committee to keep groups of citizens concerned about endocrine disruption issues, such as the Maryland Conservation Council, informed. Furthermore, Ms. Davis encouraged the EDSTAC to draft its final report in a manner that will be intelligible to and usable by the general public. Finally, she urged that the Committee not forget that the effects of endocrine disruptors on ecological systems can have a tremendous impact on humans as well.
John Holtzman, of the Chemical Manufacturers Association noted his appreciation of the Committee's emphasis on insisting upon a scientific approach to its deliberations and deliverables. He noted that the EDSTAC's work will benefit the large number of studies currently being conducted in the field of endocrine disruption.
Carolyn Burridge, of the Maryland Chemical Industry Council complimented the members of the EDSTAC on their progress, and noted the timeliness of the Committee's work given the attention endocrine disruption is getting in state and national legislatures. However, she expressed concern that the state of the science on endocrine disruption is not yet sufficiently advanced to allow the formulation of sound public policy related to the subject. She encouraged the EDSTAC to emphasize the need for solid science and facts in its work, and to appropriately apply its limited resources toward this end.
Susan Gilson, from FMC Corporation, expressed support for the work of the EDSTAC, and encouraged the Committee to develop recommendations useful to professionals in fields affected by endocrine disruption, referencing her position as an industrial hygienist as an example of such fields. In addition, she noted interest in the work of the STWG in gauging dose responses, as well as other tools the work group employs.
John Casana, an environmental engineer, stressed his desire for the EDSTAC to use a scientific approach to quantifying risk and decision making in its work; to make a conscious decision as to what degree of uncertainty is acceptable in its recommendations; and, if there is greater uncertainty than appropriate, to devise a way to get to an acceptable level of uncertainty for a defensible position for future generations.
Grace Ziem, MD, Ph.D., requested that the EDSTAC seek testimony from physicians who are treating humans suffering from problems related to endocrine disruption when making recommendations for screening and testing. Dr. Ziem encouraged the Committee members to be sensitive to frustrations that can occur in the interface of academics and physicians, and asked that the Committee allow as much flexibility as possible in its recommendations for physicians to treat their patients according to their own judgment.
Linda Roberts, an employee of Chevron, requested that, whenever possible, the public have access to documents discussed at the plenary meetings in advance of such meetings to allow for appropriate comment and understanding of the issues. She expressed appreciation for Dr. Goldman's comments with respect to validation and encouraged the Committee to develop clear criteria for interpreting the results from screens and tests. In addition, she noted that, as data from screens and tests are collected, it would be useful to check this data against known endocrine disruptors to see how predictive the testing was. Ms. Roberts also requested the Committee to be sensitive to the issues of dose selection, and to hold more discussion with respect to the issue of zero tolerance.
Ajax Eastman, a former member of the Maryland Conservation Council, expressed concern about the development, production, and release of potential endocrine disrupting chemicals during the time it takes for the EDSTAC to reach consensus on a screening and testing program for EPA. He questioned whether a science or policy measure existed to slow or stop the introduction of such new chemicals until the Committee's recommendations are developed. Mr. Eastman also expressed concern that the CF would allow issues such as risk assessment and cost/benefit analysis to put greater priority on economic matters than human and ecological health.
Pat Lane noted great concern about the health consequences of the incineration of medical and municipal wastes. Ms. Lane expressed appreciation for the publicly open and flexible process being used by the EDSTAC in developing its recommendations. In addition, she commented that terms such as "risk assessment" and "parts-per-trillion" are perhaps not clearly or fully understood by the general public, and that such terminology takes on international implications when used in reference to chemicals used around the world. Furthermore, Ms. Lane noted that the public's perception of risk is a critical element in effective communication and protection, and asked the Committee to use any influence it had to encourage medical facilities to sort their waste and reduce the incineration of PCBs.
Lisa Carlson and Kirstin Smith, both medical students at Johns Hopkins University and members of the student chapter of Physicians for Social Responsibility, presented a joint statement and expressed both concern that only two systems--the gonadol and thyroidal systems--were mentioned in the Committee's scope, as well as hope that the Committee would expand its scope beyond estrogen-, anti-estrogen-, androgen-, anti-androgen-, and thyroid-related effects. Ms. Smith read a statement from the student chapter of Physicians for Social Responsibility which called for: (1) larger studies on humans and animals looking at chemical effects and synergies; (2) the burden of proof to be placed on manufacturers to prove the safety of chemicals before marketing them; (3) the use of small doses in testing for endocrine disruption; (4) restrictions on medical waste incinerators and annual monitoring by EPA of waste from every incinerator for levels of mercury and dioxin; and (5) aggressive education of the public by EPA on endocrine disruption.
Phyllis Glazer and Sherre Holmer, of Mothers Organized to Stop Environmental Sins (MOSES), detailed the story of Winona, Texas, where a well was driven through the local aquifer for the injection of hazardous waste into the ground, which resulted in contamination of the aquifer. They commented that, in most cases, those affected by endocrine disruption lack political power, and urged that any screening and testing program should make use of anecdotal information from affected persons who live or have lived within two miles of facilities which store, produce, or dispose of hazardous waste. Furthermore, Ms. Glazer and Ms. Holmer requested that the screening and testing program developed by the Committee take into account the synergistic effects of multiple chemicals, due to their view that the regulation of exposure to single chemicals is a matter of regulatory convenience. They recommended that the screening and testing program focus on: the most vulnerable life stages; both human health and the environment; and the transference of chemicals through bioaccumulation and human relationships (e.g., breast feeding). In addition, they recommended that: information about the potential harm of any substance be released from the Committee to the public at the earliest opportunity; the Committee place emphasis on the certainty of safety. They noted that the endocrinological effects do not necessarily follow a linear relationship, and that current levels of acceptable risk burden populations of minorities. Finally, they urged the EDSTAC to practice good science without allowing an uneven balance of representation on the Committee. In accord with this, they recommended that the Committee membership be restructured to decrease the number of agency and industry representatives.
Albert Donnay, executive director of MCS Referral and Resources, addressed the definition of "endocrine disruptor" as discussed by the Committee. Mr. Donnay commented that the inclusion of the notion of "adverse" in the definition overlooks the fact that there are many endocrine disruptors that may produce beneficial or therapeutic effects, and that effects of endocrine disruptors may vary by individual. He encouraged the Committee to remind the public that such beneficial endocrine disruptors do exist. In addition, he asked the Committee to not only include the young and developing in recommended field studies, but to also include elderly animals. Mr. Donnay also encouraged the Committee to consider its definition reference to exogenous substance, stating that light can have an effect on hormones (e.g., diurnal cycles). Finally, he asked that the EDSTAC clarify their definition inclusion of "(sub)populations" to identify what the smallest subpopulation that needed to be considered was.
Gwen Dubois, MD, of Physicians for Social Responsibility, stated that the consideration of groups and classes of chemicals rather than of individual chemicals in the screening and testing program was very sensible. She urged the Committee to not be reticent to recommend action on information of harmful endocrine disruption to ban certain chemicals. In addition, Dr. Dubois expressed hope that the Committee's recommendations would address exposure to multiple chemicals, and asked the Committee to consider the hazards of medical waste.
Raymond Yang, a professor of Toxicology at Colorado State University, applauded the endurance of the EDSTAC members through the course of difficult deliberations. He expressed his view that the figure regarding the number of chemicals released into the environment used by the Committee was low, and encouraged the Committee to give serious consideration to the issue of mixtures in all of its deliberations, products, and recommendations.
Bruce Baird Struminger, a student at Johns Hopkins University Medical School, expressed concern regarding the way that EPA formed the EDSTAC. He stated his view that the Committee lacked a clear sense of consensus on the definition of "endocrine disruptor" and noted that, while simplicity is good where appropriate, the emphasis in the definition should be on accuracy. Mr. Struminger stated that the issue of endocrine disruption is a complex one, and that a simple definition would not help protect the public health. He urged that scope be enlarged to include additional hormones, and expressed his feeling that policy on endocrine disruption is getting ahead of the clinical science on the issue. He expressed dissatisfaction with the level of education on endocrinology in medical schools, as well as the lack of communication about the issue of endocrine disruption in endocrine journals. He asked the Committee to take a precautionary stance in its recommendations and, given the growing and irreversible bioaccumulation levels of dioxins and PCBs, to place the onus on industries to prove their products do not compromise human health.
Audrey R. McMahon, from the Learning Disabilities Association, stated that maternal thyroid dysfunction is a very serious endocrine disruption issue. She further stated that EPA research has clearly related PCBs to diminished thyroid function and subsequent effects on humans, including embryonic development. Ms. McMahon expressed her view that developmental disabilities are epidemic in the United States, and added that she hoped the Committee's recommendations would help this situation.
Mimi Cooper, of the League of Women Voters in Baltimore, expressed her hope that chlorines and the burning of dioxins would be affected by the Committee's work and would eventually be brought under control.
Yataka Aoki, from Johns Hopkins University Public Health School, stated that it is difficult for members of the general public to understand what Types I and II errors are, and asked the Committee to use commonly familiar language in its recommendations and final report.
Erica Wexler, a science teacher from South Baltimore and a member of the Community Advisory Panel, commented that it was important for the EDSTAC to follow a scientific process and take all the advice and views into account as it proceeds with its tasks. She added that the Committee should identify the best screens and tests, validate them, and implement their use.
Greg Merrill, from the Chlorine Chemistry Council, noted a threefold increase in state legislation that make reference to endocrine disruption, and that those who were responsible for creating many of the regulations and laws, particularly at the state level, are looking to the EDSTAC for guidance. He stated that it was important that the foundations EDSTAC establishes and the principles adopted be based on sound science to ensure confidence in their implementation.
Davis Baltz, of Commonweal, described journal articles about gender maturation and exposure to certain chemicals. He stated that, as reflected by research in the popular press; evidence of endocrine disruption is increasing. Mr. Baltz expressed hope that the Committee would draw the conclusion to increase research and prevent exposure. He stated that members of the public have a right to know about the EDSTAC's activities, and that plenaries should continue to be conducted across the country to allow input from different geographical areas.
Ann Mulligan, National Coordinator for The DES Cancer Network, stated that DES-affected persons represent one of the few populations known to be affected by endocrine disruption. She urged the Committee to construct a new paradigm for endocrine disruption, and to adopt zero risk and precautionary principles. Ms. Mulligan described generational effects of DES, adding that DES is still being given to women in other countries and the affected population, therefore, is a global one. She commented that traditional risk assessment failed those exposed and needs to be revisited, noting that another chemical, AZT, currently being prescribed to pregnant women shows DES-like effects.
Alyce Ortizar, of the Well Mind Association of Greater Washington, detailed cancer rates and breast cancer incidence stating that she was troubled by the fact that companies that have caused endocrine disruption seem to be benefiting from treating endocrine disruption. She urged the adoption of zero tolerance beliefs, and the shifting of the burden of proof onto industry.
Carolyn S. Van Pelt, of DuPont and the American Crop Protection Association, applauded the Committee for its process and for the work performed thus far.
Daniel Pontious, from the Maryland Public Interest Research Group, stated that the information shared with the public is only as good as the testing that is done to generate that information. He expressed his appreciation that the Committee would be looking at multiple chemical exposures, and encouraged the use of caution and scrutiny in looking at low-dose toxicity of some chemicals.
Keary Cope, a student at Johns Hopkins University, suggested the consideration of certain metabolites in the Committee's work.
Alan Noe, of the American Crop Protection Association, noted that the large number of public commenters indicated a high level of interest in issues related to endocrine disruption. He commented on the role and benefits of pesticides in the American agricultural sector, and discouraged the use of the precautionary principle. He also urged that science "drive" the EDSTAC process.
Lara Shane, of Responsible Industry for a Sound Environment, expressed her belief that the EDSTAC process is a great one to bring people from the different sides of the spectrum to come together in productive discussion and action, and offered the Committee her wholehearted support.
Valerie Jewitt, from the American Crop Protection Association, commented that her family had been impacted by the incidence of breast cancer, and said she supported getting all affected parties involved in the EDSTAC process. She encouraged the use of sound science in effecting the parties' mutual goal of making the environment safer for all life, and added that she looked forward to when this type of process is commonplace in decision making.
Charles Cangerni, of Reliance Fire Protection, discussed the role of small business in the United States, noting that they do not generally have the same employment and financial resources as large companies. Mr. Cangerni urged the Committee to keep small businesses in mind when recommending screening and testing techniques.
Melissa Sheridan, a member of the Endometriosis Association, stated that she suffers from the disease, and told the Committee that the EDSTAC's work is vitally important and very appreciated.
Gail McPherson, an American Agri-woman and farmer, expressed great concern regarding her feeling that the general public was characterizing the agricultural sector as polluting and causing disease. She urged the public and the EDSTAC to remember the role of the agricultural sector in the development of the United States.
David Fisk, a medical student at Johns Hopkins University and member of the student chapter of Physicians for Social Responsibility, stated that endocrine disruption was a major topic of discussion at a recent national conference in Chicago. He urged that the burden of proof rest on chemical manufacturers and incinerator operators.
Polly Walker, MD, encouraged the adoption of zero exposure and precautionary principles and a new type of risk assessment. She stated that the long lasting and irreversible effects of endocrine disruption are unconscionable. Dr. Walker further stated that unless the real levels of potential harm are put into the equation of risk assessment, new technologies will not be developed to address them. She encouraged the Committee to consider the synergistic and additive effects of chemicals in endocrine disruption.
Victor Perez, a medical student at Johns Hopkins University and a member of a south Baltimore community, stated that his community receives disproportionate effects from hazardous waste. He noted that amphibians tend to be the first type of organisms to be noticeably affected by environmental changes due to their breeding patterns and aquatic life. Similarly, he stated that inner-city and urban populations have emerged as somewhat of an indicator species for humankind, especially in reference to endocrine disruption. He encouraged the Committee to seriously consider such populations in its deliberations.
XII. Response to Public Comment
Judy O'Brien, Associate of The Keystone P, thanked the members of the public for their comments and asked Committee members if they had any comments, clarifications, or questions related to the public comment.
With respect to Dr. Ziem's comments, one Committee member noted that the continued need to integrate the work of the EDSTAC with practitioners is one that has been reiterated by Committee members themselves throughout the EDSTAC process. In addition, it was noted that the EDSTAC is not charged with developing clinical tests to assess endocrinological wellness, but rather experimental toxicology related to endocrine disruption.
Regarding the interface between science and public policy, one Committee member noted the difficulties attendant in banning or regulating chemicals already on the market. With respect to the Alar scare, another Committee member noted that the scientist presented the Alar information correctly, but the media blew the information out of proportion. Due to this unpredictability, the Committee member urged the EDSTAC, and the COWG in particular, to try to anticipate potential public relations/perception problems to the greatest extent possible.
With respect to the EDSTAC's scope, Dr. Goldman commented that the Committee is not responsible for setting standards or for advising EPA on how to set them. Nor, she added, is the Committee responsible for medical waste incineration issues. Dr. Goldman noted, in the convening phase, many Committee members advocated for taking as comprehensive a strategy as possible to address the widest possible scope of hormones. However, given the time pressures of accomplishing the tasks and mandated deliverables, certain hormones were necessarily selected as a starting point for the Committee's scope. The EDSTAC's recommendations will, however, provide a general framework for EPA to use as new information comes forward in the application of screening and testing programs for a variety of hormonal endpoints and mechanisms.
Regarding public comments about research, Dr. Goldman noted that the EDSTAC can make recommendations concerning research and studies to be done, but that the Committee would not be performing any research or studies itself. In response to comments regarding regulated agency membership on the Committee, Dr. Goldman noted that the Agencies that generate waste are not part of the EDSTAC, but that many agencies represented on the Committee are indeed regulators.
One Committee member replied to comments regarding the EDSTAC's scope and industry onus and burden of proof, noting that the industry representatives on the Committee are sincerely concerned that everything that is produced in their industry is safe for humans and the environment. He added that, with respect to scope, the hormonal areas identified as foci for the Committee's work are those where the Committee members believe the EDSTAC has the greatest chance of making solid decisions and recommendations given the deadlines and the current state of the science.
Another Committee member addressed Dr. Yang's comments regarding the consideration of mixtures stating that, while there may not yet seem to be a great deal of discussion on the subject at the plenary level, much work on mixtures was taking place at the work group level, and would eventually be brought before the full Committee.
Another Committee member pointed out that there is, indeed, representation on the EDSTAC by physicians who are treating patients with endocrinological disorders.
Dr. Goldman thanked the public for their thoughts, and expressed her appreciation of the public's attention and patience in observation of the involved, and sometimes intricate, discussions of the EDSTAC. One Committee member urged members of the public to look to their own communities, not the Committee, to find the solutions to community problems. Dr. Goldman echoed these sentiments, adding that she recognized the value of and need for inter-community communication and encouraged communities affected by endocrine disruption and hazardous waste to begin to engage each other in dialogue.
After the public comment period, several EDSTAC members expressed their recognition of the troubling health and environmental consequences of endocrine disruptors, but urged the public to recognize that the charge of the EDSTAC is to develop a screening and testing program for endocrine disruptors. Committee members encouraged future public comment on thoughts and ideas specifically related to the development of an effective, strategic, and efficient screening and testing program, rather than testimony related to the effects and perils of diseases and endocrine disruption. Public comment opportunities at the Chicago plenary and future meetings may, therefore, be designed to facilitate this type of discourse.