Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Endocrine Disruptor Screening and Testing Advisory
July 15 - 16, 1997
On July 15 and 16, 1997, the fourth plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in Chicago, Illinois. 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)). 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.
The objectives for the Chicago plenary were to: 1) confirm the consensus goal of the EDSTAC; 2) provide feedback and guidance to each of the three work groups on their accomplishments made thus far, and direction on how to proceed in future efforts; and 3) to provide information on the status and direction of activities by the Organisation for Economic Co-operation and Development (OECD) related to endocrine disruption issues.
II. Opening Comments and Confirmation of the Consensus Goal
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 Baltimore plenary.
Dr. Goldman stated that the EDSTAC had been designed from the very beginning to establish a process that might reach consensus. The EPA, she noted, chose to address the statutory mandate for a screening and testing program through the mechanism of a Federal Advisory Committee rather than through interest group consultation specifically for the purpose of bringing together diverse stakeholders to advise the Agency through an interactive, consensus-oriented process. Dr. Goldman added that she remains personally involved and committed to the goal of reaching consensus in the development of the screening and testing program, as well as in seeking consensus to assist implementation at the time of regulation.
Dr. Goldman recognized that the work of the EDSTAC lies at the nexus of science and policy, and the inherent complexities of such an effort. However, she encouraged the Committee members to remain resolved in their commitment toward the consensus process. She praised the Committee's demonstration of dignity and respect in their deliberations, and urged that future meetings and interactions continue to be characterized by the highest level of integrity. In addition, Dr. Goldman reminded EDSTAC members that they agreed in the Committee ground rules to not characterize others' opinions to the media or public.
When a consensus is achieved by the Committee, EPA and The Keystone Center will put such an agreement in language that accurately communicates the decisions, and the Committee may use the document to communicate with the media at the end of the process.
In responding to Dr. Goldman's comments, a number of Committee members expressed concerns regarding two possibilities--first, that certain "non-aligned" parties might contend the EDSTAC may not be as interest balanced as possible, and second, that members of the EDSTAC who have not been able to attend previous meetings be encouraged to have more of a presence so that their expertise would be incorporated into the EDSTAC's final product.
To address the first concern, a suggestion was made that a more internal-oriented peer review process precede the SAB/SAP review to insure that the EDSTAC's product represented the informed perspective of all parties possible. Tim Mealey, facilitator from The Keystone Center, noted this suggestion would receive serious consideration. Dr. Goldman stated that, with respect to the second concern, the convening of meetings during the summer months often conflicts with many schedules, and that Committee members' absence should not be perceived as a lack of desire to participate. She said EPA and The Keystone Center have shared this concern, and the scheduling of meetings further in advance should help address this.
III. Presentation and Request for Feedback on PSWG Activities
The PSWG received some important feedback from the plenary which helped to clarify the direction they need to go to resolve many key issues. On the other hand, it is clear from the feedback received that there is still much work to be done and several significant questions that remain unanswered.
The PSWG presented an update on its activities and sought feedback on three primary issues: 1) whether the six information categories (3 effects and 3 exposure) identified by the work group were the right categories to be focusing on; 2) the proposed use of molecular weight, as well as other possible criteria, for going to the Stop Box; and 3) the options for "how far to go" in terms of the degree of complexity to the approach for setting priorities for Tier 1 Screening (T1S). See Attachment B for a copy of the overhead slides used by the PSWG during its presentation.
SIX INFORMATION CATEGORIES
Nancy Kim, PSWG co-chairperson, explained to the plenary that the PSWG had identified six categories of information that would be the focus of the sorting and priority setting phase including 3 effects-related categories and 3 exposure-related categories. See Attachment C for information regarding the strengths, limitations, and guiding principles for the six information categories.
In general, the Committee accepted these six categories as being adequate to cover the types of information that should be used to "obtain and analyze existing information" for the purpose of sorting and priority setting for endocrine disruptor (ED) screening and testing. Under the effects heading, the Committee did recommend that the category of information the work group had labeled "toxicology and metabolism" should be relabeled toxicology and pharmaco-kinetic effects. The reason for this change was to make it clear that this category of information was broader than just toxicology and metabolism. The other two effects categories of epidemiology and field studies, and structure-activity models remained unchanged. And, under the exposure heading it still includes production and use data, monitoring data, and fate and transport data and models.
The Committee also provided feedback on some of the specific strengths, limitations, and guiding principles under each of these information categories. These more specific changes are not enumerated here. Rather, the specific changes suggested will be incorporated into the PSWG's working draft.
In summary, the Committee accepted the approach the PSWG is taking to focus on these two general categories of effects and exposure-related information, with three specific categories of information under each. The acceptance of this six-part categorization of information will undoubtedly help to focus the work group's efforts and, as discussed below, to sort through the feedback from the EDSTAC on the options for "how far to go" with the approach to priority setting for T1S.
MOLECULAR ATTRIBUTES, INCLUDING MOLECULAR WEIGHT, AS SORTING CRITERIA TO GET TO THE STOP BOX
John Walker was the next presenter on behalf of the PSWG. John focused on: 1) the general concept of using molecular attributes as the basis of sorting level criteria to "go to the Stop Box;" 2) a specific proposal for using molecular weight of 1000 atomic mass units; and 3) the possible use of other criteria such as octanol-water partition coefficient (Kow) and/or molecular cross sectional area. See Attachment D for a copy of the overhead slides used by the John Walker during his presentation.
In general, the Committee appeared to be receptive to the overall concept of using appropriate molecular attributes as the basis for sorting level criteria that will be used to place chemical substances into the Stop Box. However, this general acceptance of the concept will ultimately depend on the specifics of what attributes the PSWG recommends for consideration. In that regard, the Committee was much more responsive to the molecular weight criterion than to either the octanol-water partition coefficient or the cross sectional area. What follows is a list of the concerns that need to be addressed in further advancing the use of 1000 atomic mass units as a sorting criterion, followed by a brief discussion of the feedback given on the other two criteria.
Molecular Weight (MW)
Concerns regarding the MW criterion included:
- MW seems to focus on migration/absorption through pores, while chemical substances and mixtures (CSM) sometimes migrate through the tight junctions between cells which sometimes breakdown (e.g., in the lungs, especially when inflamed by reaction to the CSM, a CSM may induce an ED reaction within the lung; macrophage engulfment may occur; and endocrine disruption effects could potentially move to the lymphatic system);
- Reactive polymers should not be included under this criterion; need to focus on non-reactive or neutral organic polymers;
- The need to consider higher absorption rates for infants versus adults, as well as all possible absorption routes, when determining whether 1000 atomic mass units is the appropriate number;
- The need to not only say that this criterion does not include monomers and breakdown products of polymers, but to generate specific recommendations that make it clear how the monomers and breakdown products of polymers will be identified and included in screening and testing, even though the polymers that are their precursors will not; and
- The need to fully reference relevant scientific literature that can be used to strengthen the rational for using MW as a criterion for going to the Stop Box.
Once the concerns outlined above are fully accounted for, and once the PSWG has made a determination of what the actual MW number should be (i.e., 1000 atomic mass units, or some other number), the PSWG should find a way to determine what the practical implications are in terms of the number of chemical substances that meet this criterion.
Other Possible Sorting Criteria
As noted above, the Committee's reaction to the other two possible sorting criteria -- octanol-water partition coefficient and molecular cross sectional area -- was less enthusiastic. In general, Committee members suggested that these two criteria might be used to help set priorities for T1S but not as the basis for placing CSM in the Stop Box.
The possibility was raised about trying to use these two, or perhaps additional molecular attribute criteria, in combination with molecular weight, as the basis for placing CSM in the Stop Box. Although it appeared that the Committee might be receptive to this, it was also clear that should the PSWG recommend such an approach, it needs to be very well thought out and scientifically defensible.
Before concluding the discussion of using molecular attributes as the basis for placing CSM in the Stop Box, it was suggested that there is a need for further clarification of what it means to place CSM in the Stop Box. In particular, it was suggested that the four criteria listed as "Stop S&T Unless" outlined in the EDSTAC Conceptual Framework need further elaboration and clarification.
Finally, several PSWG and Committee members stressed the practical importance of the need to continue to pursue a Committee consensus on a scientifically defensible specific molecular attribute or set of molecular attributes that can be used to justify placing CSM in the stop box. They noted that without such a criteria the universe of CSM to be tested will be extremely large.
OPTIONS FOR "HOW FAR TO GO" WITH THE APPROACH TO T1S PRIORITY SETTING
Tom Osimitz presented the options the PSWG had identified for how far to go with the approach to T1S priority setting. At a minimum, the PSWG was recommending that, once the guiding principles for the six information categories are finalized, they be used to guide priority setting for T1S. Going beyond this minimalist approach, the PSWG identified and presented six distinct options of increasing complexity including:
- Six separate priority lists by information category;
- Two priority lists (one integrating the effects-related information categories and one integrating the exposure-related information categories);
- Qualitative integration of information into the nine categories inherent in the 3x3 matrix, based on the determination of whether the CSM is high priority (H), low priority (L), or no data (ND) for effects and exposure;
- Rank order the nine combinations of effects and exposure based on the H, L, ND determinations;
- Priority lists within each of the nine combinations; or
- Single rank ordered list spanning all nine combinations.
In providing feedback, several Committee members seemed to suggest that options 1 and 5 would not be very helpful. Therefore, the Committee's discussions primarily focused on options 2, 3, 4 and 6. Furthermore, there seemed to be a recognition that options 2, 3 and 4 were highly interrelated. In other words, once the effort is made to separately integrate all effects and all exposure related information into two separate priority lists based on a determination of H, L or ND for effects and exposure (option 2), one has essentially already made the determinations that would be necessary to place CSM into one of the nine possible combinations in the 3x3 matrix (option 3). Taking the next step to rank order the nine possible combinations (option 4) would then require some value judgments about the relative importance of the nine possible combinations (i.e., H/H, H/L, L/H, H/ND, ND/H, L/L, L/ND, ND/L, ND/ND).
It was recognized that option 6 would require more effort than options 2, 3, or 4. It was also clarified that the information that would be used as the basis for the determinations that are necessary to move from options 2, 3, and 4 and, if selected, on to option 6 would not be lost but would be passed forward from the sorting and priority setting phase to the screening and testing phases.
Clarification was given that the terms High (H) and Low (L) referred to high and low priority for screening and testing rather than high and low suspicion or concern of endocrine disruption. However, it was also recognized that the nature of what was being analyzed under the effects category differs from what is being analyzed under the exposure category. For example, one Committee member suggested that the nine possible combinations should be "validated" after they have been used for a while to determine if they are truly predictive of whether the CSM is really an endocrine disruptor. It was pointed out that such a validation was only really relevant for the effects side, since the exposure side has nothing to do per se with whether a CSM is an endocrine disruptor. Rather it focuses on whether there should be a high or low priority for screening and testing based on a combination of information and value judgments about production volumes, uses, monitoring data, environmental fate and transport considerations, etc. Several Committee members raised concerns about the strong likelihood that a very large number of chemicals in the TSCA inventory will end up in the "no data" category for the effects-related information. It was clarified that what was really meant was "inadequate data" since all chemicals in the TSCA inventory, for example, will at least have data on such things as LD50. However, there was a clear consensus on the Committee that LD50 data was inadequate for purposes of priority setting. Additional concerns were raised about the use of structure-activity relationship (SAR) models as the principal means of dealing with the problem of inadequate effects data.
SOME NEW IDEAS AND IMMEDIATE NEXT STEPS
Later in the meeting, the possible use of robotics to efficiently conduct a large number of in vitro receptor binding screening assays was suggested by a Committee member as a means of addressing the problem of having little to no effects data that can be used to set priorities for screening and testing (as well as the apparent reluctance of many to rely upon the use of SARs to address this problem). This Committee member further suggested that EPA might consider taking responsibility for conducting such assays in a centralized fashion. Although EPA representatives did not seem to be too receptive to the idea of EPA actually being the entity to conduct such screens, the concept of moving forward with this approach on a voluntary basis seems to be picking up some momentum following the Chicago plenary.
Specifically, some members of the TSCA regulated industry may consider voluntarily stepping forward to conduct in vitro receptor binding screening assays on some specified set of chemicals. There may be some receptivity to this idea, understanding that: 1) such assays only focus on two of the three hormones of concern (whether thyroid-oriented high throughput assays are available is not yet clear); 2) they only address one mechanism of action (receptor binding); and 3) the results of these assays would not be the only information that would ultimately be used in sorting and priority setting (i.e., other effects data and exposure data would still need to be considered).
IV. Presentation and Request for Feedback on STWG Activities
At the Chicago plenary meeting, members of the STWG presented their progress, since the Baltimore meeting, on developing a Tier One Screening (T1S) battery, and thinking about the Tier Two Testing (T2T) phase. Four specific areas the STWG identified for feedback from the EDSTAC were: 1) T1S Design Criteria; 2) Tailored Approach to T1S; 3) Assays Under Consideration for the T1S Battery; and 4) Questions to Address in Further Developing the T1S Battery. See Attachment F for a copy of the overhead slides used by the STWG during its presentation.
Regarding the T1S Design Criteria, EDSTAC members indicated the criteria proposed by the STWG are consistent with the CF and agreed with the idea of using the five proposed criteria in assessing the acceptability of possible approaches to T1S. Some specific changes to the language were suggested, and these were mainly semantical. In addition, Committee members suggested a couple issues for the STWG to consider in finalizing the criteria. The idea of including validation as an additional criterion was raised and the ability of the battery to assess the various physical and chemical properties of the chemical substances or mixture being considered was also proposed. Another recommendation was that the STWG develop a general reasoning for including each of these criteria. Finally, the Committee asked that, when a T1S battery is proposed, the STWG develop an "assessment" of the battery by identifying the strengths and weaknesses as they relate to the criteria.
In general, Committee members expressed support for a "tailored" or "flexible" approach to T1S as a valid way to consider proceeding, recognizing that the concept needs a fair amount of expansion and elucidation before they could agree that it is, indeed, the best way to proceed. However, a number of concerns were raised regarding the difficulty of implementing such a potentially confusing program. Some EDSTAC members suggested STWG continue to consider the application of an entire battery to all chemical substances and mixtures. Additional discussion focused on the need to balance the ability to move a high volume of chemicals through T1S and the desire to be certain the chemicals are safe before placing them in the "Stop S&T Unless..." Box.
Specific concerns raised included:
- different combinations of screens would provide a non-uniform set of information which may, therefore, be more difficult to interpret consistently;
- the process would be too slow if EPA were the "gatekeeper". If EPA were not the "gatekeeper," then there was a lack of clarity about who would make the decisions about which screens to use;
- assuming that all T1S assays would need to be completed before going to the "Stop" box and the goal is to gather as much information as possible before proceeding to T2T, it was unclear why the entire T1S battery would not be conducted; and
- elements of "subjectivity" would need to be scrutinized because they potentially allow for "ways out" of the process that may not be consistent with precautionary approaches to screening and testing.
Regarding the assays under consideration for the T1S battery, EDSTAC members expressed concern that the STWG not omit invertebrates without consulting more scientists with expertise in this field. Committee members noted that the list of endpoints presented by the STWG did not include an assay that would expose a fetus to observe in utero effects, and that inclusion of such an assay or assays was vital. Discussion, however, revolved around the issue of whether to include these endpoints in T1S or in T2T. No conclusions were reached, but this issue will need to be explicitly addressed in the final design of the screening and testing program. The Committee also recommended that the work group address the issue of what dose concentrations to use in T1S and T2T in the course of its continuing discussions related to standardization.
As per the work group's general direction, the EDSTAC indicated that the questions identified by the STWG as questions needing to be addressed in further developing the T1S battery were appropriate questions to be considering.
The STWG held a conference call on July 22 to discuss issues that arose during the Chicago plenary and to strategize plans for its upcoming activities. The STWG will meet on August 12 and 13, in Washington, D.C., and again on September 9, 10, and 11, in Keystone, CO. As indicated above, this meeting will include an opportunity to discuss overlap issues with the PSWG.
V. Presentation and Request for Feedback on COWG Activities
The COWG presented an update of its activities to the Committee on the second day of the plenary meeting. The purpose for the COWG agenda item was to provide the Committee with a brief summary of the work group activities to date, and to receive feedback from the Committee on the two specific tasks of the work group which were outlined in the memo that was distributed to the full Committee prior to the Chicago plenary. Those activities included the EPA Outreach Mailing and the Focus Group idea. Following a brief summation of work group tasks and activities, the Committee was asked to comment on the EPA Outreach mailing. Very little discussion occurred on this, and the Committee agreed that it would be a valuable activity to undertake. Therefore, the work group and EPA will continue to move forward on this activity. They anticipate sending the mailing out by the end of August in order to have results back in time to report to the Committee at the October plenary.
The focus group concept was the second task discussed by the Committee, and the work group received quite a bit of feedback on this idea. Several issues of concern were raised by Committee members, and the basic conclusion was that the COWG should attempt to gather additional information about the need for such meetings prior to moving forward with their organization. Some of the concerns raised included:
- Resource constraints--EPA is unable to provide support for such meetings; attendees would therefore have to pay their own way. Several Committee members were concerned with this, particularly environmental justice representatives and those in rural areas who would be precluded from attending due to their inability to pay.
- The need for such a meeting--many members suggested that we do a needs
assessment for holding focus group meetings prior to inviting people
to attend. The point was made that the purpose of the meetings themselves
was, in part, to do such a needs assessment; but it was also suggested
that this might not be the best way to accomplish such a goal.
In lieu of immediately going forward with the focus group invitations, Committee members provided suggestions regarding outreach to groups not represented on the full Committee:
- Talk with some leaders in these fields through Committee members (such as Jane Reese-Coulbourn for disease-specific groups, Florence Robinson for Environmental Justice, and Chris Borgert for "downstream" industries) to get a better sense of what these groups would like to hear and what kind of Committee interaction would be valuable for them.
- Ask recipients of the outreach memo, or some other type of mailing, if such a focus group meeting would be useful. Would it be more helpful to get materials from the Committee for distribution to their constituencies?
- Ask leaders of these groups how they communicate with their members.
- Provide teleconferencing or a written exchange of questions and answers.
- Explore ways the EPA regional offices could be utilized in this regard.
The work group is currently working on a questionnaire to address the Committee's concerns and will be included in the packet of materials for the outreach mailing.
ADDITIONAL SUGGESTIONS RELEVANT TO THE COWG'S ACTIVITIES
- It was requested by some members of the Committee that the COWG pull together a standard package of materials (i.e., slides) about the EDSTAC and its progress that could be used for speaking engagements and the like. However, in discussing this further, it was determined that due to the dynamic nature of the EDSTAC process and the work involved, it would be more efficient to provide the Committee with some basic materials that would afford guidance on the type of information that is appropriate for their use when speaking about the EDSTAC. In this regard, Committee members agreed to make use of the Description of the EDSTAC charge, which was approved in Baltimore, along with additional materials to be provided by Keystone. Finally, in order to combat a concern raised which led to the suggestion to use "standard materials," members agreed that the need for such materials may not be as urgent if people reiterated their pledge to agree to the ground rules by speaking only for themselves, not the EDSTAC, and by not characterizing others' comments.
- Develop a mechanism for informing citizens about the outcomes and actions of the EDSTAC's recommendations after the Committee has dissolved.
- Ensure continued use of the Web site as a means of communicating.
VI. Presentation on OECD Endocrine Disruptor-Related Issues
Herman KoČter , manager of the Test Guidelines Programme for the OECD's International Program on Chemical Safety, and Principal Administrator of the Environmental Health and Safety Division at the OECD, presented the EDSTAC with an overview of the OECD's deliberations and screening and testing program related to endocrine disruptors. Mr. KoČter emphasized the importance of considering international harmonization issues in the EDSTAC's work, as well as the value of conducting deliberations in cognizance of the regulatory implementation and assessment contexts.
International coordination of efforts on endocrine disruptor-related issues will likely become increasingly important, given the globalization of commerce and information exchange. Prime issues for such coordination, Committee members pointed out, include: the establishment of an international inventory of chemicals; the coordination of scientific assessment; the compilation and harmonization of definitions; the coordination of an international research strategy; the harmonization of screening and testing guidelines; and the facilitation of education and information exchange on endocrine disruptor-related issues.
Mr. KoČter expressed his belief that the Committee's decision to develop a screening and testing program in light of the concept of risk assessment, but not in the specific context of the current risk assessment framework, represented an artificial and potentially hurtful separation. Mr. KoČter also commented that the work of the EDSTAC was being conducted in a very theoretical realm, and that more grounded discussions would be vital to developing an effective screening and testing program. He noted that assessment, or value judgments, would likely have to take place at many different points of the program produced by the EDSTAC, and encourage the Committee to keep this in mind during its deliberations. Furthermore, he observed that he did not care for the concept of a Stop Box, adding that he felt the best claim that can be made for public health is to say that there is very low concern.
One major concern expressed by Mr. KoČter centered on the issue of patenting. Noting that it is a big issue globally and internationally; he stated that the OECD will never adopt a screening or testing guideline based on a patented test, feeling that doing so would be restrictive. He encouraged the EDSTAC, and especially the STWG, to keep this in mind during the development of the screening and testing program. However, he added that he has had discussions with the EPA and with the Occupational Safety and Health Agency on the patent issue, and recognized that there is a difference of opinion within agencies. One option suggested, apparently, entails the potential for an Agency to purchase a patent if it is deemed the best or only test appropriate for the task.
VII. Discussion and Comments Regarding the EDSTAC Process
Dr. Goldman and Mr. Mealey commented on the positive dynamic of discussions at the Chicago plenary, noting that the credit for the progress and tone of the meeting owed much to the substantial work group efforts since Baltimore. Mr. Mealey commented that Keystone staff, with help from EPA, was working hard to appropriately address the facilitation of science and policy issues in the forum of the Committee. Recognizing the sensitive and honest nature of some discussions, Mr. Mealey urged the Committee to make a redoubled effort to be aware of the fact that issues of criticism be raised in a sensitive fashion.
In reacting to several EDSTAC members' questions and comments about interactions with public audiences and the press, Mr. Mealey reiterated that Committee members have agreed to refrain from characterizing others' views, and he urged the Committee to respect this ground rule. Some EDSTAC members requested the production of a common set of slides or other presentation products that could be used to assist them in speaking from a common platform in discussing the state of EDSTAC deliberations. Mr. Mealey noted that the EDSTAC process is presently, and will continue to be, a very dynamic one, and that such a set of materials would likely become quickly outdated and confusing. Therefore, he stated that The Keystone Center will make a greater effort to produce public-oriented memoranda after plenary meetings, or as needed, so that Committee members may use the documents as distributable and educational resources for the purpose of communicating information about the EDSTAC to interested members of the public.
VIII. Timeline, Next Plenary, and Closing Comments
The following schedule of upcoming meetings of the EDSTAC and its work groups is provided to enable Committee members, non-Committee work group members, and interested parties to remain aware of the overall EDSTAC schedule. Although work group meetings are not open to public observation, much of the work group deliberations will be made explicitly evident at the plenary meetings.
Upcoming meetings of the EDSTAC and its work groups include, but are not limited to, the following:
August 5 & 6
August 12 & 13
September 9, 10, & 11
|PSWG & STWG||
October 7 & 8
New York, NY
COWG, PSWG, & STWG
New York, NY
November 13 & 14
December 2 & 3
February 2 & 3
It is possible that the National Academy of Sciences may provide a briefing to the EDSTAC on its analysis and survey of endocrine disruptor-related literature. Furthermore, Mr. Mealey noted that it is likely the Committee and work groups will be working from a "single text document" by October, and that a first draft of final report in front of Committee should optimally be before the EDSTAC by December. Concurrent with this time frame, EPA is setting up the peer review process, which should take place in the March-April time frame. This peer review will entail a 90-day process with a public comment period.
IX. Public Comment
Following the Committee's deliberations 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 over 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.
Patricia Speth, a concerned citizen who comes from a family of farmers, expressed concern that the agricultural industry may be adversely impacted by endocrine disruptors, prior to gaining additional information about their effects. She expressed her support for the EDSTAC process and suggested that the approach this problem should be deliberate and practical and urged that solutions not be based on emotionalism or "junk science."
Joe DiGangi, of Greenpeace in Chicago and formerly a corporate scientist, spoke to the issue of risk assessment. He urged the Committee to reopen the risk assessment discussion within the Committee's deliberations because he feels as though the Committee has an obligation to show to the public there is a disparity of views on this issue. He also would like to see industry take on the burden of proof to demonstrate the safety of new chemicals.
Brett Hulsey, of the Sierra Club, mentioned his role on the FACA for water monitoring and expressed concern about the fish people consume today and the lack of knowledge about fishing advisories that exists and the potential for harm because of that lack of knowledge. He supports due diligence for companies, particularly to handle the high costs associated with cleaning up polluted areas. Finally, he urged the Committee to be conservative and make screens as extensive as possible that go beyond adverse affect.
Mark Richie, of the Institute for Agriculture and Trade Policy, an organization that is concerned about pollution and health concerns, particularly due to airborne chemicals, which may render products produced in an organic manner polluted, suggested that multiple layers of impacts are of great concern, as is the eroding market niche for organic products due to this pollution. He cautioned the Committee to take the precaution that is necessary to protect public health, but to also remember that decisions are being made to protect other industries as well.
Ellen Kauffman, of the Endometriosis Association in Chicago, stated that she was there representing women with endometriosis and related information about the disease and some concerns of those women who have it. She indicated that studies have shown that a transfer of toxins can occur in-utero and during breast feeding, and the hormonal effects in children of mothers with the disease are increasingly being realized. Ms. Kauffman related that there are 5 1/2 million cases of endometriosis today and is estimated to occur in 10% of women of reproductive age. Endometriosis is affecting women at younger and younger ages with greater severity--the costs of this disease are high.
Davis Baltz, of Commonweal, Inc., spoke directly about the screening and testing program, suggesting that chemicals in the Stop Box should undergo a random sampling process in order to ensure they have not been placed there erroneously. He also suggested breast milk should be tested. Regarding Production and Use data, he supported breaking these out into two separate categories because use information is quite different that production information. Mr. Baltz expressed his support for the public's right to know about these issues every step of the way, which includes a comprehensive educational effort.
Rob Christie, Director of Public Affairs for FMC Corporation, expressed concern both personally and professionally about the work of the EDSTAC. He related his opinion that any direction the Committee takes with public policy in this area should be based on sound science and he urged the Committee to remain focused on their tasks, in order to reach the deadlines ahead of them.
Jackie Hunt Christensen, of Health Care Without Harm, asked the Committee to do the following: 1) recommend to EPA that chemicals such as dioxins be phased out immediately, rather than go to tier 2 testing; 2) testing of chemicals used in medical products should be reviewed, as well as products produced by health care facilities; and 3) make it a priority that chemicals that cross the placenta or are present in breast milk should be tested.
Lynn Fahey McGrath, manager of risk assessment for Hoechst Corporation, a multinational chemical company, said there is a clear need for chemical products to pose a minimal risk to consumers and the environment. She urged against the publication of premature results and their effects (e.g., poor deselection choices), noting that in Europe, positive results from a screen can result in deselection. Her experience working in Europe has broadened her perspective on these issues, and she encourages the Committee to incorporate greater coordination there. She also encouraged the Screening and Testing Work Group to reevaluate baseline data and, at a minimum, allow flexibility for data required in other countries.
Jack Weinberg of Greenpeace discussed some of the policy implications of the decisions EDSTAC has already made. He noted that the concept of endocrine disruption used at the Wingspread Conference was broader than that used by the EDSTAC and very useful because it captured a range of mechanisms that operated at very minute concentrations. Mr. Weinberg recognized that, for pragmatic reasons, the EDSTAC limited the scope of its efforts to three hormonal systems, but asked the Committee to make clear to the public that the extent of endocrine disruption was not circumscribed nor fully addressed by consideration of the three hormones in the EDSTAC's scope. Linda Roberts, of Chevron, directed her comments to the Priority Setting Work Group. She indicated that Chevron has had some experience with SAR models and, in terms of their utility and use, she suggested that the accuracy of SAR output is a function of the degrees of structural similarity between the untested chemicals and the tested chemicals. Regarding Option 3 of the PSWG's presentation, she urged the work group to clarify what is meant by High, Low, and No Data, especially in terms of production and use. For the No Data option, she supported using the term "inadequate information". Regarding the Stop Box, Ms. Roberts suggested that there is not much of a distinction between 20,000 and 40,000 chemicals, because many will not be tested in our lifetime. She urged the Committee to evaluate the chemicals they do want to test and design the program to incorporate them. Regarding the STWG activities, Ms. Roberts encouraged the use of validation in the biological variability of the process. She suggested it would be helpful, for example, to know how reproducible the endpoints are, how many animals are needed, and whether the results are reproducible in good lab. Finally, regarding dose response, she asked for guidance from the STWG on the sizes of doses it thinks is appropriate, particularly for the high and low doses.
Joanna Hoelscher, Director of the Illinois office of Citizens for a Better Environment, thanked the Committee for holding a meeting in Chicago and for the opportunity to comment. She urged the EDSTAC to not lose sight of the broader mission of protecting public health and the environment in both the short term and the long term, and therefore encouraged the use of the "precautionary principle". Ms. Hoelscher then made specific comments directed toward PSWG and COWG. To the PSWG, she said the CF must take into account the fact that there are already significant amounts of information in the literature on chemicals already known to be endocrine disruptors, and there should be a mechanism to fast track these in order to eliminate exposure. She also stated that traditional risk assessment methodologies are inadequate to protect public health, which should be included in the CF. Finally, she suggested prioritization be given to certain chemicals based on bioavailability and persistence. To the COWG, she requested that scientific uncertainty not be considered tantamount to an assumption of no danger.
Michael Murry of the National Wildlife Federation directed his comments to the PSWG as follows. First, he suggested the uncertainty that exists with SARs has to be an issue when looking at toxicological effects. Second, regarding the log Kow, he suggests that increasing the Kow means increasing the bioaccumulation of chemicals and there is no reason why there should be an upper limit on Kows. Third, Mr. Murray suggested that there are two potential sources of breakdown products from plants--monomers and dymers--and the only way to control discharge of them is to control discharge of their parent compounds. Finally, regarding exposure data, he encouraged evaluation in a precautionary way because 2000 new chemicals are introduced each year and some processes are still behind and testing old chemicals that were banned 20 years ago.
Sarah Janssen, a medical student who is a member of Physicians for Social Responsibility, raised several concerns regarding potential endocrine disruptors. Specifically, she is concerned about toxic releases from a local toxic waste incinerator as well as about endocrine disruptors in the air, water, and ground. A main concern lies with her future potential patients and the ramifications of these chemicals being emitted into the environment. Ms. Janssen commended the Committee for its intention to screen and test mixtures and encouraged them to look at low doses. She also urged for an increase in federal funding for the development of more sensitive assays.
Mark Holmer, of the Chemical Industry Council of Illinois, provided some general comments to the Committee. He stressed the importance of remaining objective when examining such issues and urged that sound science be applied. He praised EPA for reaching outside of its own employees to create the Committee and for assembling such a diverse group. Finally, he urged that science lead EPA to whatever regulatory path they take.
Ed Gunderson, chairman of regulatory affairs for the Chemical Industry Council of Illinois, suggested any policies developed be based on sound science, be technically realistic, and serve to protect the public health and the environment. He urged that protocols for the Screening and Testing program provide conclusive data demonstrating beyond any doubt that an adverse effect could result from a realistic exposure route. Mr. Gunderson also encouraged the use of a scientific, dosage-risk-based approach to developing the program.
Lynn Lawson, with the Multiple Chemical Sensitivities: Health and Environment, described health effects she presently experiences due to chemical sensitivity and lifestyle changes she has made to limit exposures to such chemicals. Many of the chemicals indicated in personal blood tests, she asserted, appear on lists of suspected endocrine disruptors. Ms. Lawson asked the EDSTAC to: 1) address the endocrine disrupting potential of mixtures first in their screening and testing program; 2) consider new chemicals guilty until proven innocent; 3) "sunset" chemicals known, or likely, to be endocrine disruptors, noting her feeling that any threshold for such chemicals is too high.
Marjorie Fischer, of the League of Women Voters, stated that chemicals in the environment should not impinge public health, especially the health of children. She added that the current position of the League of Women Voters on pesticides is that exposures to people should be reduced and that nontoxic alternatives to these pesticides should be used. Ms. Fischer noted that many suspected endocrine disruptors would appear to be pesticides and would, therefore, seem to be of interest to the League due to its interests, stances, and publications. She expressed appreciation of the inclusive definition of endocrine disruptors tentatively being used by the Committee, and urged that zero tolerance parameters be imposed on endocrine disrupting chemicals, especially in light of effects caused by fetal exposure to such chemicals.
Cecile Sastre, from the Endometriosis Association, asked the EDSTAC to remember the real effects diseases attributed to endocrine disruptors are having on humans. She described symptoms and illnesses related to the disease of endometriosis, and noted that evidence indicates certain chemicals are responsible for endometriosis and a myriad of other diseases. Ms. Sastre told the Committee she is personally afflicted by endometriosis, and described the effects the disease has had on her life, including severe chemical sensitivities, difficulties finding employment due to the hazards of workplaces, as well as other lifestyle complications. She urged the EDSTAC to set zero tolerance standards, and to consider the synergistic actions of chemicals.
Dr. George Raab, former chair of the Species Survival Unit of the Chicago Zoological Society, commented on the synergies of chemical compounds affecting species. In particular, he sought to report recent information on the phenomenon of declining amphibian populations in several parts of the world. Although, he admitted, the ultimate causal effects and factors to which these declines may be attributed have not yet been satisfactorily identified, he noted that some declines indicate there might be endocrine disruption or distortion effects at work, especially in parts of Central America. Dr. Raab urged the financing of studies on these declines and effects on the broadest scale possible.
Jim Houston, with the International Joint Commission's Canadian Section in Ottawa, reflected on the interface between efforts directed toward endocrine disruptors in his country and in the United States. He noted that the earlier Canadians are involved in similar activities and are informed by the United States on its efforts, the more efficiently the problem may be addressed.
Charlie Cray, of Greenpeace, stated that the fact that the Committee is focusing on developing a screening and testing program should not delay current federal or state actions to phase out products proven to cause endocrine disrupting effects. He noted there was a need to support policies on endocrine disruptors even when uncertainties exist. Mr. Cray described current European studies indicating the timeliness of phasing out the use and production of certain chemicals. Particularly addressing the endocrine disrupting potential of chemicals in medical products, Mr. Cray noted that allegedly safe alternatives are available and urged their use. He encouraged the Committee to talk about releases and exposures of potentially endocrine disrupting chemicals from common products into waste water and other media.
Chuck Elkins, an environmental consultant, commented that the Committee's T1S design sounded fairly sophisticated and seemed consistent with the current state of the science and with similar efforts. However, he expressed caution that a decision to use either one or a very small number of decision makers to decide what testing would be done in a tailored approach could prove to be a bottleneck in the screening and testing process. Mr. Elkins asked that the Committee pay particular attention to communications issues in the sorting and prioritization process, as these stages of the program could be misunderstood by both the public and decision makers.
Mary Beth Doyle, from the Ecology Center of Ann Arbor, thanked the Committee for conducting a meeting in the Great Lakes region, and for the Committee's hard work. She encouraged the Committee to adopt the "precautionary principle" in its program, and to insure chemicals are tested thoroughly before being released into the environment. With respect to hormone disruptors, she noted the inclusion of the word "adverse" in the working definition concerned her, and urged the EDSTAC to develop a broader definition. In addition, Ms. Doyle expressed concern with the Stop Box, noting her feeling that the scientific tools currently available to screen and test for endocrine disruptors are too crude to send a chemical substances or mixtures definitively to the Stop Box. Rather, she requested that such chemical substances or mixtures be assigned to a low priority group. Furthermore, Ms. Doyle suggested that the EDSTAC "groundtruth" chemicals sent to the Stop Box to ensure the accuracy of the screening and testing program. She also said that community concern over a chemical substances or mixtures should be sufficient to pull a chemical out of the Stop Box for re-entry into the screening and testing program.
Penny Richards, the Learning Disabilities Association of Illinois, Inc., expressed concern about the impact of agricultural chemicals on the lifestyle and health of humans, and especially on her developmentally disabled child. Specifically, Ms. Richards noted concern regarding hormonal disruption due to fetal exposure, and urged the EDSTAC to promote and protect children's health. She urged the Committee to adopt the "precautionary principle," adding that chemicals should not have a "civil right" of being considered innocent or harmless until proven guilty. She stated that no permission had been given by any human for a chemical body burden.
David De Rosa, from Greenpeace in Chicago, expressed his concern caused by the recognition that, due to realistic constraints, all chemicals cannot be tested for endocrine disruption. Therefore, he noted, he hoped that scientists would be able to learn from the EDSTAC's screening and testing program how to make educated guesses about classes of chemicals, and that scientists would apply that knowledge in anticipating any effect, not just adverse effects. Mr. De Rosa stated that the screening and testing program should look at chemical substances or mixtures, as well as their breakdown products, with which people come into contact on a daily basis. He encouraged the prioritization process to use production volume figures, and requested that any chemical proven to be an endocrine disruptor be banned.
Bill Holland, of Illinois Public Interest Research Group, stated his concern about the potential hazards of minute doses of endocrine disrupting chemicals, noting that damage from exposure may not be apparent until much later in an organism's development process. He stated that his organization urged the adoption of both the "precautionary principle" and zero exposure tolerances. Mr. Holland added that industry should be responsible for showing that their chemicals are safe before approval, use, and release into the environment. Furthermore, he requested EPA make significant and easily understandable efforts to educate the public on endocrine disruption issues, chemicals being tested, and the endocrine disruptor screening and testing process.
Angel Cohoon, also of Greenpeace, offered great concern regarding the effects of endocrine disruptors on early stages of development, especially due to fetal exposure from chemical substances or mixtures present in pregnant mothers. She urged the Committee to consider using the "precautionary principle" and to immediately phase out any chemical proven to be an endocrine disruptor. Despite economic and practical difficulties, Ms. Cohoon expressed confidence that scientific ability existed to eliminate proven endocrine disruptors.
Barbara Alexander Malarky, of the Waste Handlers Network, praised Illinois EPA's efforts on hormone disruption publications to date. She urged that the Committee's prioritization process place significant emphasis on the cumulative and synergistic effects of endocrine disruptors, and that it not look at chemicals in isolation. Ms. Malarky expressed concern regarding the effects of waste incinerators, especially from the disposal of dioxin and cows, due to the potential for interaction of airborne endocrine disrupting chemicals.
Tracy Easthope, from the Ecology Center of Ann Arbor, recommended to the Committee that all proceedings of the International Joint Commission and their science advisory board be included as part of the official proceedings of the Committee. She noted that persistence is an important criteria to consider in the screening and testing program, and that testing should be sensitive sentinel species as an "early warning system" in order to avoid economic and human health/environmental costs. In addition, she questioned the scientific ability to send a chemical definitively to the Stop Box as indicated in the Conceptual Framework. Ms. Easthope encouraged the Committee to look at research indicating that the timing of exposure has significant implications for endocrine disrupting effects, including synergies and seasonal variations, due to the fact that toxicity differs depending on stage of development and health of the organism at the time of exposure (e.g., fetal exposure from mother's body burden). She expressed concern about: limitations on exposure detection due to the state of the science; the Committee's working definition of an "endocrine disruptor"; and the potential for a lack of clarity about screening and testing results (e.g., whether or not a chemical substances or mixtures is an endocrine disruptor if results of T1S or T2T are mixed). Finally, Ms. Easthope emphasized the importance of risk assessment considerations in the Committee's development of a screening and testing program, as well as the need to constantly reevaluate the effectiveness of whatever tools are designed to address the endocrine disruptor issue.
XII. Response to Public Comment
Dr. Goldman noted that while the Committee is not yet, as a whole, in agreement on the role of risk assessment and its use in regulating chemicals, discussion on the subject had not at any point been constrained or inhibited. She asked members of the public to remember that this, in addition to other issues, are still at a level of tentative agreement, and not to characterize all of the EDSTAC's deliberations as firmly agreed upon.
In response to one commenter's request that the EDSTAC look at the international context and regulatory practices in the European Union as it proceeds in its deliberations, Dr. Goldman indicated this was an issue for the STWG to consider. However, she cautioned that some testing data used by European authorities might not be available for the EDSTAC's screening and testing program due to confidential business information constraints and to differences in evaluation methods.
With respect to international harmonization and coordination issues, Dr. Goldman reminded the Committee and members of the public, that EPA and the EDSTAC have begun to cooperate with other international organizations on endocrine disruption issues. Specifically, interaction is currently underway with the OECD, with one of EPA's specific goals being the structuring of the Committee's work to make its efforts available to the OECD, and vice versa.
She also highlighted recent and ongoing international coordination efforts with the Summit of Eight, where an environmental agenda was put together for protecting children on an international level, including the consideration of endocrine disruption. In addition, the United States is involved in the International Program for Chemical Safety, an international effort that will involve the coordination and collaboration of research on matters of chemical safety and endocrine disruption.
With respect to comments regarding the Committee's tentative definition of an "endocrine disruptor" and its decision to focus its efforts on a defined set of endpoints related to estrogen-, androgen-, and thyroid-related effects, Dr. Goldman agreed with one commenter that the Committee should take care to recognize that these hormones did not constitute the full extent of potential endocrine disruption. In addition, she noted that, while the EDSTAC will focus on the three specified hormonal systems, the Committee plans to develop broader guiding principles for a broader application of the screening and testing program to consider endocrine disruptors in general.
With respect to the issue of screening and testing mixtures, one EDSTAC member noted that the issue is being taken very seriously, and is presently being addressed by the PSWG. Although a specific formula for addressing mixtures in the sorting, priority setting, screening, and testing processes has not yet been developed, it was indicated that more information would likely be available on the issue in upcoming plenary meetings.
Several Committee members expressed their appreciation of the public comments, noting in particular the scientific and policy-related sophistication of the remarks. Committee members, in response to some of the public remarks, noted their recognition of the multiple and sensitive issues tied to communication, and reiterated their intention to give this aspect of the screening and testing program great attention.