Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Endocrine Disruptor Screening and Testing Advisory Committee
December 2-3, 1997
Meeting Summary(1) I. Background
On December 2 and 3, 1997, the sixth plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in Orlando, Florida. Please refer to Attachment A for a list of Committee members in attendance.
The sixth plenary meeting consisted of one and one-half days of full Committee meetings, providing an opportunity for each of the work groups -- the Communications and Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG) -- to provide a status report on their deliberations and discuss draft recommendations ready for the EDSTAC consideration. The meeting also included an opportunity for public comment on the evening of the first day. The afternoon of the second day was devoted to work group meetings.
During the first EDSTAC plenary meeting, held in San Francisco in December, 1996, the Committee approved a set of ground rules for the operation of the EDSTAC's deliberations and activities, reached agreement on the EDSTAC's goals and objectives, as well as on the scope of the EDSTAC's focus and activities, and began discussions of the Committee's principles and work groups. During the second EDSTAC plenary, held in Houston in February, 1997, the Committee conducted a series of educational tutorials on scientific issues related to endocrine disruption, discussed a set of principles, tentative definitions, and a conceptual framework to guide its efforts, and defined membership issues related to the three primary work groups (the Communications and Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG)). At the third EDSTAC plenary meeting, convened in Baltimore in April, 1997, the Committee gained clarification on the EDSTAC's charge, provided sufficient guidance to have a tentative consensus on the draft Conceptual Framework (CF) document and flow chart, and provided each of the work groups with direction and guidance. At the fourth EDSTAC plenary, held in Chicago in July, 1997, the Committee confirmed the consensus goal of the EDSTAC, provided feedback and guidance to each of the three work groups on their accomplishments and direction on how to proceed in future efforts, and gained information on the status and direction of activities by the Organisation for Economic Cooperation and Development (OECD) related to endocrine disruption issues. The fifth plenary session of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) was held in New York, NY, on October 7 and 8. The meeting was well attended, and the Committee made significant progress in many areas. Most notably, each of the work groups received guidance and constructive feedback from the full Committee on the direction and substance of their efforts.
The EDSTAC will meet again in Washington, D.C., on February 3 and 4, 1998. The meeting will be held at The Madison Hotel located at 15th and M Streets N.W. The phone number to The Madison is 202-862-1600 and the fax number is 202-785-1255. Please note that, as a previous plenary and public comment period was held in the Washington area, there will be no public comment period at the February plenary. The meeting is, however, still open for public observation.
II. Overview of the Orlando Plenary Meeting
The Orlando plenary furthered the Committee's efforts toward achieving a consensus on recommendations to EPA regarding an endocrine disruptor screening and testing program. Below you will find information about the major points discussed at the plenary meeting. In some cases, brief summaries of some of the discussions and next steps resulting from the work group meetings on December 3 are included.
[Note to reader: This memo is intended to provide you with a brief summary of the discussions that took place at the plenary. We have not included copies of the documents that were distributed in advance of the meeting and were the basis of the discussions that took place at the meeting. These documents will, however, be included as attachments in the official summary of the meeting that will be posted to the EDSTAC Web Site,
III. Screening and Testing Work Group (STWG)
On the morning of December 2, Earl Gray and George Daston presented the STWG approach to Tier 1 Screening (T1S). All EDSTAC members received copies of the Second Interim Report of the STWG prior to the meeting. Please see Attachment B for a copy of this report. Given the length of the presentation, the EDSTAC decided to discuss issues related to T1S before hearing subsequent presentations. After these discussions, and just prior to lunch, George gave an overview of the group's approach to Tier 2 Testing (T2T). After lunch, the EDSTAC discussed issues related to T2T and then Chris Borgert gave a presentation on standardization and validation. Copies of slides used in the STWG presentation are included in Attachment C.
In general, the EDSTAC complimented the STWG on the amount of work and effort put into the Second Interim Report, but Committee members had many comments and suggestions for consideration by the work group, a number of which have been discussed by the STWG. Members of the EDSTAC, in addition, did make some specific requests of the STWG as they move forward on some of the more difficult issues. In addition, given the time left for the EDSTAC to reach agreement on a draft final report, some EDSTAC members indicated they would offer additional comments, and in some cases specific language, for consideration between the plenary meeting and subsequent STWG meetings.
Comments and Suggestions Regarding T1S
T1S Battery Options
EDSTAC members spent most of their time discussing the three T1S battery options. The following working draft language was presented, but not agreed to for the reasons discussed below, near the end of the meeting:
EDSTAC recommends use of "Option 1" as a reference T1S battery, providing the component assays are properly validated prior to their inclusion. Assays identified as alternatives in "Options 2" and "3", the intact adult male and the pubertal male rodent in vivo assays (and the related placental aromatase in vitro assay) will be validated concurrently. EDSTAC anticipates the alternative assays, if validated, [may] be utilized to [modify or supplement] the Option 1 reference battery to improve sensitivity and the ability to detect endocrine disrupting substances [while reducing redundancies, time, and resource requirements]. In addition, other assays, identified as research priorities (such as an invertebrate bioassay) consistent with the T1S criteria, should be developed and validated. If properly validated these assays may be utilized to further modify or supplement the Option 1 reference battery.
While all EDSTAC members were comfortable moving forward with "Option 1" as the reference battery, it was apparent that more thorough rationale (along with the in-depth protocols) for including "Options 2" and "3" are needed before the entire group will be comfortable recommending all assays move into the standardization and validation phase of the program. These more comprehensive rationale/protocols would need to clarify what kinds and numbers of chemicals have gone through the specific assays. The idea of having the Science Advisory Board/Science Advisory Panel (SAB/SAP) consider all three options during their review, before the EDSTAC makes a final decision, was also raised.
Weight of Evidence Approach
Though the EDSTAC members did not spend as much time on this section of the Interim Report, they did indicate a number of concerns with the existing language. While, there seemed to be some support for general principles (though the existing ones need to focus more on screening) other members indicated they would like to see more specific principles. In addition, some members requested the STWG develop a few examples of how the weight of evidence approach would apply in individual cases. In particular, consideration needed to be given to when a chemical would not go to T2T even if positive results occurred in T1S. One Committee member questioned why an assay would be included in the battery in the first place if the results of that assay were so unimportant that they could be potentially disregarded.
The EDSTAC did not spend any time talking about the details of this section, though one member did express some concerns. Gary Timm, of EPA, who wrote the first draft of the section, agreed to discuss these concerns with the EDSTAC member and relay his findings to the STWG.
Other General Comments and Issues Raised
During their deliberations EDSTAC members raised a few additional questions which need to be addressed in the final version of the STWG Report, including:
- In general, what is the rationale for current dose selection in T1S? More specifically, why are such high doses used in the assays?
- What is the relationship between in vitro and in vivo assays?
- What is the difference, including relative sensitivity, of subcutaneous (sc) and intraperitoneal (ip) routes of administration?
- Has food been considered as a route of uptake for chemicals with low water solubility in nonmammalian assays?
Finally, given the EDSTAC's direction, the STWG has not included an in utero developmental assay in T1S for a variety of reasons. However, the Committee felt that text should be included in the EDSTAC's Final Report of the consideration given the issue by the STWG. Lovell Jones agreed to write some language, based on the language in the STWG's First Interim Report, to address this concern.
Comments and Suggestions Regarding T2T
Given the amount of time taken discussing the T1S options, EDSTAC members did not get to discuss the T2T section in as much detail. However, once again, a number of comments and specific suggestions were made.
Guidance for Selecting Tier 2 Tests
EDSTAC members did not spend much time addressing this issue, however, it seemed as though they recognized the need to base decisions around the selection and design of Tier 2 tests on existing biological effects and exposure information. The STWG, it was noted, may need to expand upon this section in the final version of the report.
Comprehensive Versus Less Comprehensive Study Design
Again, not much time was spent discussing this issue. The major point raised was the need for the STWG to further develop the circumstances under which less comprehensive study designs for mammalian and nonmammalian tests would be utilized. In addition, a specific example or examples of a less comprehensive study design needs to be developed for the next version of the Final Report.
Of all the T2T issues, dose considerations received the most discussion. A number of EDSTAC members expressed concern that the issue had not been developed further and indicated they would like to see more expansion on the possible options, laid out at the end of the section, to address the questions raised by the existing controversy over low doses. These EDSTAC members indicated they would be developing some additional comments/possible language for the STWG to consider in developing their section of the Final Report.
Initial Approach to Standardization and Validation of the T1S and T2T Program
EDSTAC members gave some advice on how to continue developing the standardization and validation section of the Final Report. Specific suggestions included making the distinctions between the "categories", with regard to the level of standardization, validation, or methods development required, more explicit and giving them more specificity. When an EDSTAC member asked whether the STWG planned on developing specific guidelines for the validation of screens and tests, Penny Fenner-Crisp noted those guidelines exist in the ICVAM Report which will likely be utilized in structuring the validation program.
Some EDSTAC members felt consideration of Category IV Assays (Further Research, Development, Validation, and Standardization), because of the importance of some of the ideas subsumed within it, needed to be recognized earlier in the document. Work group members are working on developing language that refers to this section and could be incorporated into the document earlier.
During the discussion of implementation of a validation program, questions were raised regarding identification of a set of chemicals to be used as the "test materials" in validating each assay. As you know, five criteria were laid out in the Second Interim Report, and, at the meeting, EPA agreed to develop such a set of chemicals as part of the validation program, based on these criteria and additional criteria developed by the STWG. The set of chemicals will be disseminated to EDSTAC members for discussion. In addition, EPA indicated an effort to determine the specific information necessary to validate each of the T1S assays is underway and will hopefully be in place as part of the final version of the STWG report.
At the end of the discussion, it was noted that validation is being addressed by not only the STWG, but also the PSWG and the High Throughput Pre-Screening (HTPS) Task Group, and these efforts need to be consolidated in the final report. Please see Attachment D for a copy of a discussion paper on an HTPS demonstration/validation proposal.
IV. Priority Setting Work Group (PSWG)
The PSWG presented to, and received feedback from, the Committee on four issues.
These included: how to handle mixtures in the screening and testing program; how to address polymers in the program; the proposed Conceptual Framework flow chart revised to reflect recent developments in the work group's deliberations; and, an update on the development of the Endocrine Disruptor Priority Setting Database (EDPSD).
The PSWG distributed a Mixtures paper, drafted by Tom Osimitz with work group input, to the full Committee on Tuesday. Please refer to Attachment E for a copy of this paper. The PSWG received positive feedback and commendations for the paper, which was discussed on Wednesday, and which described the work group's proposal for screening and testing mixtures for endocrine disrupting potential. It was seen as a thorough and fair handling of a complex and somewhat intractable problem. The endocrine disruptor issue, in general, was also seen as a good opportunity to try to get more attention paid to the mixture issue. There were three major issues raised in response to the paper:
- Dr. Goldman indicated that there may be some legal questions that her staff will try to address in the coming weeks about the Agency's authority to require screening and testing of mixtures containing both "owned" and "orphaned" chemicals.
- Recognition of the connection between the recommendation to include mixtures in both the demonstration of the feasibility of the HTPS and T1S validation and a broader set of feasibility demonstration and validation issues.
- The importance of including recommendations about EPA needing to be prepared to do something if a mixture, such as a source of community drinking water, is found to be an endocrine disruptor.
At the plenary meeting, the work group gave only a very brief update on the work being done to resolve issues related to the handling of polymers in the screening and testing program. The work group then spent time after the completion of the plenary discussing a draft paper produced by Tom Osimitz. The results of this discussion are outlined below.
Revised Flow Chart/EDSTAC Timelines/Handling of Pesticides
During the afternoon of the first day of the plenary, the Committee discussed the so-called "optimistic" and "pessimistic" timelines for EPA implementation of the endocrine disruptor screening and testing program (EDSTP). Please see Attachment F for a copy of these timelines. During the discussion of the PSWG's proposed changes to the flow chart, it was acknowledged that these timelines have significant implications that had not yet been incorporated into the flow chart. Specifically, the so-called "parallel track" approach to Phase I of the program (i.e., conducting T1S concurrent with HTPS) was no longer seen as possible, in light of the projected time it will take to complete standardization and validation of T1S under both scenarios. Thus, it was agreed that the flow chart needed to be revised to show a more sequential approach, whereby the HTPS step would be completed in advance of the first opportunity for putting chemicals through T1S.
One implication of this understanding for the PSWG is that the first opportunity that EPA will have to make priority setting decisions will occur after the completion of the HTPS step in the process. In other words, the priority setting system that the PSWG is creating should assume that the information that will be generated during HTPS will be available to decision makers and should therefore be accounted for in the design of the priority setting system/process. Although the full Committee was admittedly just hearing this information for the first time, no one expressed any major concerns with these implications. Later in the meeting, the steps EPA is planning to take in the short-term to demonstrate the feasibility of the HTPS were described and no one expressed any major concerns with these efforts either. Thus, it appears that the PSWG will need to quickly try to grapple with these changes and focus on developing a set of recommendations that assume HTPS will be a part of the program and will be completed and available prior to the need for EPA to make final decisions on what will be the first set of chemicals and mixtures to be subjected to T1S.
The modifications to the flow chart presented by the PSWG at the meeting included changes the PSWG felt would better reflect: a) the possibility of a chemical being permitted to bypass T1S and go directly to T2T; and b) the handling of polymers.
As to the first point, the PSWG felt it was helpful to distinguish between the possibility of a chemical being permitted to bypass T1S and go directly to T2T and the need to set priorities for T1S during Phase I of the program. In the previous version of the flow chart these two decisions appeared to be interconnected.
In discussing this issue, Penny Fenner-Crisp indicated she felt it was appropriate to separate pesticides from industrial chemicals for priority setting purposes with or without the possibility of a T1S bypass. The reasons she stated for doing so included the fact that there is a much more detailed and comprehensive set of information available on pesticides, especially use and effects information, than there is for industrial chemicals. In addition, the pesticide reregistration process is driving the way the Agency is determining priorities for screening and testing pesticides, and this was not likely to change even in the face of recommendations from the EDSTAC that may not have considered the importance of the reregistration process. At least one Committee member expressed concerns about the possibility pesticides might be allowed to "bypass" T1S. She reminded the Committee that another member of the Committee, who is also a member of the STWG, had previously expressed similar concerns. The Committee did not spend much time discussing the implications of Penny's comments, however, the work group did spend some time discussing them at its follow-up meeting. The results of this discussion are outlined below.
With regard to the revisions to the flow chart related to the handling of polymers, the PSWG recommended a change that simply makes the flow chart consistent with the discussion that took place in New York. Specifically, the PSWG is in agreement that even in the case where a polymer is excluded from consideration for screening and testing, this exclusion would be a temporary "hold" pending the screening and testing of its monomers. As it turns out, even this change is contingent upon the options for how to handle polymers which were discussed at the follow-up PSWG meeting, and described below.
Discussion of the EDPSD
In addition to the mixtures issue, much of the plenary time devoted to PSWG focused on a presentation and discussion of the proposed use of the EDPSD. Please refer to Attachment G for a copy of the slides used during this presentation. The PSWG presented three alternatives:
- Abandon the effort to develop a database tool.
- Continue with the effort to develop a database tool but only go so far as to scope out the type of data that should be considered for inclusion, and the type of effort that may need to be expended to complete work on the EDPSD. Do not expect to have the time or resources available within the EDSTAC process to make use of the completed database tool to select from among alternative approaches to priority setting. EPA could then continue work on the database tool and use it sometime in the future during implementation of the priority setting process.
- Make adjustments to the EDSTAC process to allow not only for scoping the type of data and level of effort that would be necessary for completing work on the EDPSD, but to complete work on the database and use it to select from among alternative approaches to priority setting within the EDSTAC process.
- By and large, the presentation on the EDPSD was well received. Committee members seemed to readily understand the utility of such a tool to assist in the application and utilization of a complex set of data to the task of setting priorities for ED screening and testing. The major expressions of concern mirrored those expressed in the past by PSWG members regarding the need to ensure the quality and reliability of any data that might be used in the EDPSD, especially with regard to effects-related information and databases.
- It was apparent to all that the choice between the three alternatives was really a choice for EPA to make. When pressed to indicate clearly which of these options she preferred, Dr. Goldman stated that she preferred "two plus." This response was discussed by PSWG members who were in attendance at the end of the follow-up meeting. The interpretation of the group to the "two plus" response is described below.
- The PSWG agreed that the correct interpretation of the "two plus" response was that Dr.. Goldman and the plenary were positively inclined toward further development and utilization of the EDPSD. In other words, the option of abandoning the effort to further develop the tool was explicitly rejected. However, beyond this point, the PSWG agreed that Dr. Goldman supported and even encouraged the PSWG to try to answer certain questions with respect to the further development of the EDPSD, including:
- What are the goals or purposes that would be served by the EDPSD (e.g., as a tool to achieve consensus on an approach or on a narrow set of options for priority setting, transparency, etc.);
- What ground rules might the PSWG recommend for how to use the tool to address concerns that it not be used to simply confirm or bring about a priori assumptions about what the results of the priority setting step should be;
- The possibility of using a tiered approach to the use of Toxline, Medline, and other effects-related databases that would require QA/QC if they are to be of use;
- The scope of work and time it would take to complete the EDPSD, including the specific data sources and databases to be included; and
- Steps that could be taken to ensure the upkeep and maintenance QA/QC of the tool.
The work group also agreed on the need to incorporate into the overall set of recommendations being developed for the EDSTAC, a recommendation to use the EDPSD, but not to presume the EDPSD would be developed and be made available for use by the EDSTAC within the confines of the EDSTAC process. Dr. Goldman expressed a strong indication that she would not like to change the overall schedule for producing the draft EDSTAC report for peer review, or for concluding the EDSTAC process immediately following a final plenary in mid-June 1998.
V. Communications and Outreach Work Group (COWG)
The COWG used the memorandum distributed prior to the plenary meeting, as a focus for their presentation. Please see Attachment H for a copy of this memorandum. Described below are the main elements Committee members indicated they would like to see addressed further, as well as some additional points discussed in the work group meeting held immediately following the plenary.
The work group's materials were presented by its co-chairs, Chris Borgert, who reviewed the material in the memo and identified issues for discussion, and Peter de Fur, who presented specific areas where feedback from the Committee was requested. It was also noted that the results of the surveys from the September, 1997, EPA Outreach mailing were being compiled and would be presented to the group at a later date for their information. Please see Attachment I for a copy of the slides used during the presentation.
What is the EDSTAC and how did it operate?
The Committee suggested it would be valuable to include a basic description of the EDSTAC process, including purpose and goals for the Committee, an overview of each work group and scope of work, the number of plenary meetings, and the range of public commenters at each. The one-page document developed by the COWG, along with additional language from the convening report if necessary, will be used to provide this description.
What are endocrine disruptors?
The Committee felt the recommendation about education should not be as comprehensive as that proposed by the COWG. Instead, they suggested EPA undertake an outreach and education effort about the issue of endocrine disruptors only to the extent necessary to ensure the public understands the screening and testing program. In other words, a broad, comprehensive education program about the issue of endocrine disruption (similar to EPA's efforts regarding issues such as lead or radon, for example) was thought to be beyond the scope of the EDSTAC recommendations. However, when educating the public about the screening and testing program, members did see the need to provide context for that information. This could be accomplished through brochures or other information, such as the description of endocrine disruption included in the EPA outreach mailing.
Concept of a Tracking System and Central Repository of results
The Committee seemed to agree with the development of a system for tracking chemicals within the screening and testing program. Discussed further by the work group was the need to include, as a part of the tracking system, information accessible by the public, regarding the results of screens and tests (also referred to as the Central Repository).
Reaching out to targeted audiences
The EDSTAC would like to see specific audiences targeted for outreach efforts including: farm workers, other workers in general, unions, patient groups, pediatric groups, environmental justice organizations, downstream industries, and small business. Several EDSTAC members suggested using brochures and booklets to explain the screening and testing program and, as necessary, the issue of endocrine disruptors. In addition, active communication could take place at the various decision nodes of the flow chart (as previously identified by the work group), denoting significant decisions the public may be interested in learning about.
Explanation of the screening and testing program and headings for the results of each of the decision nodes
The EDSTAC would like to see an explanation of each of the flow chart boxes. In addition, they suggested creating titles or headings for the information/lists developed once chemicals have gone through each step in the process. This information could be used for the type of outreach described in number 4. It could also be used by EPA when requests are received for updates about the program.
The Committee recognized that such status reports should be understandable by all and should explain what it means and does not mean to be at a particular step in the program. The COWG has worked on developing descriptions of such lists, referred to as "boilerplates." Such descriptions are not yet complete, as the information needed to draft them is contingent on many of the decisions being made by the other two work groups.
Principles of Communication
The work group would like to provide EPA with some general principles for communication to ensure clear and concise messages are presented to the public.
Dr. Goldman agreed Committee members should participate in various briefings to, for example, the SAB/SAP or Congressional staff, particularly of those members who crafted the legislation leading to the creation of the EDSTAC. She also suggested the group develop language of what to say when the report is released at various stages and begin to think about who, from the Committee, should be involved in such briefings. Such a recommendation will likely be forwarded to the Committee prior to the next Plenary meeting.
Draft Commitment of EDSTAC Members
A document entitled, "Draft Commitment of EDSTAC Members," was presented to the group, though it was recognized the piece is a work in progress and not a consensus document of the entire work group. This document, which assumes a consensus outcome, attempts to recognize the commitment made by members of the EDSTAC to apply a consensus approach to the development of the screening and testing program, and to carry on this commitment throughout the implementation phases of the Program. In addition, it advocates a process by which members of the EDSTAC and their organizations and constituencies agree to give the screening and testing program an opportunity to succeed before suggesting any changes or modifications. A prominent reason for developing such a commitment is the unprecedented nature of the approach to screening and testing being developed by the Committee. Many believe this type of commitment will help ensure the Program is successfully implemented.
The Committee was asked to briefly review this document at the time of the meeting, but not discuss it in any detail at that time. Rather, they were asked to bring it back to their organizations and consider whether or not they could sign off on an agreement of this nature, if consensus is, in fact, reached. Please see Attachment J for a copy of this draft document.
VI. Other Aspects of the Orlando Plenary
Approval of the New York Plenary Meeting Summary
Due to time constraints prior to the Orlando plenary, Committee members did not receive copies of the draft New York meeting summary before the December meeting. However, copies of the draft summary were given to each EDSTAC member at the opening of the first day of the plenary, and Committee members approved the summary on the morning of the second day. At this point, copies of the meeting summary were made available to interested members of the public in attendance.
Nominations Task Group
The Nominations Task Group reported on its progress since the New York plenary. The group held a conference call prior to the Orlando meeting, during which the members of the task group identified five foundational principles. The task group presented these principles to the Committee for discussion, noting they were not yet ready to offer any formal recommendations to the plenary.
The five foundational principles were:
- A process that allows impacted citizens and communities to nominate chemicals for endocrine disruptor screening and testing should be incorporated into the EDSTAC's recommendations. As explained below, this process would run parallel to, but would be separate and distinct from, the main priority setting steps of the EDSTP.
- The nominations process should allow for both an early opportunity to submit nominations, including the possibility of nominating chemicals for "Phase I" screening, and an opportunity to react to the lists of chemicals that EPA will at some point be formally proposing for T1S during Phase I and for T1S during subsequent phases of the EDSTP.
- The nominations process should utilize a different set of exposure-related criteria than will be used for the core priority setting steps of the EDSTP. The question of whether the effects-related criteria should remain the same as those that will be used in the core priority setting steps of the EDSTP is yet to be answered. The exposure-related criteria for the nominations process should be designed to allow for chemicals that may not have high exposures on a national scale, but do have high exposures on community scale, to be eligible to receive a priority for T1S.
- For each phase of the EDSTP, a predetermined percentage of the total number of chemicals that will be subjected to T1S should be set aside for chemicals that received nominations but are not selected through the main priority setting process. For each phase, these nominated chemicals would be evaluated against the specialized criteria referred to above. Priorities for the nominated chemicals would be established in accordance with these specialized criteria rather than attempting to integrate the prioritization of the nominated chemicals with the chemicals that were selected through the main priority setting process.
- It should be permissible to submit nominations without data or evidence as it relates to the specialized criteria. However, the submission of data and evidence related to the specialized criteria will be encouraged.
Committee members acknowledged the good work of the task group, as well as the importance of including a nominations process in the screening and testing program, and offered feedback on recommended modifications. For example, the Committee asked the task group to address the question of whether nominated chemicals would be subjected to the same criteria as all other chemicals for the purposes of priority setting. In addition, members of the EDSTAC asked the task group to clarify that the nominations process would extend not just to chemicals, but to mixtures as well. Committee members also asked the group to think about whether it would recommend a certain percentage of nominated chemicals and mixtures be subjected to the screening and testing program in each phase.
Alternative Flow Chart Presentation
A Committee member, Tim Kubiak, presented a flow chart he had drafted as an alternative to the Conceptual Framework flow chart. A copy of this flow chart is included as Attachment K. Mr. Kubiak asked the EDSTAC for feedback on this proposed alternative, inquiring as to whether other Committee members felt it more clearly depicted the framework of the EDSTAC's deliberations and the screening and testing program.
Committee members acknowledged some aspects of Mr. Kubiak's flow chart as being helpful. For example, they referenced the fact that, while the EDSTAC had chosen to limit its scope of investigation to estrogen, androgen, and thyroid mediated events, the realm of endocrine disruption was really much broader.
EDSTAC members thanked Mr. Kubiak for his suggestion, and recommended that the alternative flow chart not be used, but that the significant elements of it be reiterated in the text of the Conceptual Framework document.
VII. Public Comment
On the evening of the first day of the EDSTAC plenary meeting, time was set aside for the public to provide comment to Committee members. Approximately twenty individuals, representing diverse interests, spoke during the public comment session. 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.
Ellen Bregg, of the Coalition to Stop Children's Exposures to Pesticides, urged the EPA to allow independent laboratories to perform testing in addition to that done by the EPA. She expressed concern about the use of pesticides in urban areas and the effects of low dose exposures to malathion and pesticides. Ms. Bregg said she would like to see more educational information about pesticides. She stated she wants to know which chemicals will be addressed by the screening and testing program, whether chemical effects will be looked at individually or cumulatively, and whether there will be a focus on the effects at the developmental stage. Ms. Bregg added she would like to see press releases providing updates on the Committee's progress.
Greg Koontz, Regulatory Affairs Manager for the Chemical Producers and Distributors Association, emphasized the burden of the screening and testing program needs to be commensurate with the gravity of the adverse effects caused by endocrine mediated toxicity. He indicated chemicals with health, safety, or other benefits should not be sacrificed through regulatory overkill, and the demands of an endocrine screening and testing program should be flexible to reflect the seriousness of the threat as demonstrated by science. Such a program, Mr. Koontz stressed, should be efficient and cost-effective. He expressed support for further research into potential endocrine disruptor effects from low doses but opposes a test program including low dose testing unless the need for it is substantiated by good science, and then only if the hypothesis applies generally to chemicals and not just exceptional cases. He expressed concern with the testing program possibly increasing overall risks to public health by reducing the availability of certain chemicals or by scaring the public into not using particular products (for example, mosquito-control chemicals, the use of which aids in preventing cases of viral equine encephalitis.) Mr. Koontz suggested using a nomination approach, whereby chemicals would proceed through the normal priority setting process. Mr. Koontz finished by saying the EPA, if needed, should ask Congress for more time to implement a sensible approach.
Chuck Elkins, an environmental consultant with Jellinek, Schwartz, & Connolly, Inc., presented five ideas. First, the success of EDSTAC will not be based upon how many chemicals are screened, rather on whether the information coming out of the program is useful. Second, while chemicals are in the program they are highly vulnerable as a full data set is not available until the chemical in question gets to the end of the program. Third, each stage of the program needs to be clearly defined (e.g., what is screening). Fourth, only EDSTAC has the credibility to make recommendations and, in so doing, they need to write their words carefully, work on principles, and avoid using lists. Fifth, too many chemicals should not be forced into the program at the beginning as the system will break down if chemicals do not get through the program quickly.
John Brennan, a high school biology teacher from Orlando, Florida, discussed his concerns about the influence of the media regarding the level of attention the issue of endocrine disruption receives. He commented that although some sensationalism pushes the issue, which can be beneficial, it is important to take a reasoned approach and consider all sides. As an example, Mr. Brennan pointed out both the benefits (e.g. possible safeguard against lyme disease) and detriments (e.g. health risks from exposure) of applying insecticide to a child. He encouraged the Committee to keep an open, scientific mind about the issue of endocrine disruption and not let the press influence its decisions.
Nancy Stephens, Executive Director of the Florida Manufacturing and Chemical Council, emphasized the need for the Committee to balance the importance of chemical use with the safety issues associated with such use. She requested the Committee not be persuaded by political and emotional agendas, but rather address the issue of endocrine disruption on a scientific basis. Ms. Stephens suggested the Committee provide EPA with a "tool box" with which the Agency can evaluate chemicals.
Suzanne Spencer, representing the Northeast Florida Chapter of the Sierra Club, stated there is an urgent need to develop a screening and testing program to detect endocrine disruption in humans, fish, and wildlife. She brought a letter from Maurice Coman, Chair to the Northeast Florida Group, Sierra Club, discussing the link between dioxin and related chemicals to cancer and reproductive, immunological, and developmental dysfunction. Ms. Spencer also brought correspondence from the Food and Drug Administration involving consumer exposure to dioxin through food sources. She noted the need to do significantly more research concerning the health effects of environmental hazards on children, and added the threat to children will persist until this happens.
Davis Baltz, of Commonweal and member of the EDSTAC Communications and Outreach Work Group, reminded the Committee that over the past year it has heard from a broad cross-section of Americans concerned about the implications of endocrine disruption, including the following: Sierra Club; Endometriosis Association; cancer survivors; learning disability networks; consumers; environmental justice representatives; mothers; pregnant women; farmers; ranchers; gardeners; unions; small business; environmental consultants; veterinarians; the League of Women Voters; and, individual citizens. Mr. Baltz noted a common theme to be concern for children and added, it should be remembered, that as adults, we impose risks on our children without their consent. He reminded the Committee of its agreement regarding the definition of 'screening' as "the application of assays to detect the potential for endocrine disrupting properties of chemical substances and mixtures." Mr. Baltz emphasized that, for the promotion of children's healthy development, the EDSTAC must include a means for establishing developmental endpoints for low doses at the 'screening' phase.
Betty Mekdeci, Director of the Association of Birth Defect Children Inc. (ABDC), indicated the greatest examples of how exposure to herbicides increases the likelihood that a child will suffer from a disability or birth defect, are the children of Vietnam veterans. She spoke of an analysis, performed by ABDC and the New Jersey Agent Orange Commission, which identified disabilities in 800 children of Vietnam veterans compared to 400 children of non-Vietnam veterans and noted further evidence suggested the effects could be transgenerational. Ms. Mekdeci said the types of problems included; chronic skin disorders, benign tumors/cysts, cancers, emotional/behavioral problems, chronic fatigue, tooth problems, and others. Ms. Mekdeci expressed concern with the lack of accurate exposure data on herbicides.
Andy LaVigne, Executive Director of the Florida Fertilizer and Agrichemical Association, stated extensive testing is performed on agricultural chemicals and pesticides before these products are used. He said no scientist will give a determination of zero risk regarding the use of a specific chemical because there are so many variables potentially impacting the effects related to use. Mr. LaVigne said claims of pesticides not being well tested before registration and release for public use, and claims they are not specifically tested for estrogenic activity, are not true. He noted EPA requires each pesticide be thoroughly tested for its potential to cause adverse effects, including hormone disruption. Mr. LaVigne requested the Committee not use a "paparazzi science" approach but rather develop a screening program based on the best available scientific data.
Pam Williams, of the Endo Association, indicated that dioxins are one of the most toxic compounds known to man and are linked to endometriosis and other health problems. Ms. Williams said ninety percent of human dioxin exposure is from meat and dairy products because the animals from which these products originate, are exposed to dioxins via pesticides, herbicides, plastics incineration (PVC), and pulp and paper production processes. Ms. Williams urged the Committee to consider the following questions: how much is too much; can the current levels of dioxins already present be reduced; are there other ways to do what we are doing; and, what effect will these changes have on the future of humanity?
Keith Branly, Vice President of Research and Development of Micro Flo, a small pesticide formulating business, stated the need for the burdens to equal the benefits which result from pesticide regulation. He noted many small businesses are impacted by toxicity testing and the demands of a screening and testing program need to be viable and cost effective. Mr. Branly added testing and screening requirements should not deprive the public of the use of products with clear health benefits. Regarding the issue of low-dose testing raised in T2T, he said he feels it is not cost-effective and is premature until a low-dose testing hypothesis is accepted by the scientific community.
Katie Holmes, an aquatic toxicologist with BASF Corporation, requested the Committee verify the practicality, not just the theory behind, the studies it recommends be used to analyze potential endocrine disruptors. Ms. Holmes encouraged the EDSTAC to consult with individuals who run relevant studies daily, and are aware of the scientific and practical issues associated with the tests. She expressed particular concern regarding the mysid life-cycle, fish life-cycle, and avian reproduction studies being considered by the Committee.
Jeannie Economos, of the Farmworkers of Florida, expressed concern about farmworker exposure to pesticides and related health effects. She stated chemicals are being screened on an individual basis when, in fact, people are exposed to all kinds of chemicals over time and therefore, the cumulative effects associated with chemical exposure should be considered. Ms. Economos commented on the high incidence of miscarriage among farmworkers and said she wants to see studies performed on this particular sector in order to evaluate the long-term effects of chemical exposure.
Lukner Millen, speaking on behalf of farmworkers, indicated there are still many instances where pesticides are being used in the vicinity of workers. He told a story of a female farmworker who was working in the fields when she broke out in a rash all over her body and was unable to identify the pesticides to which she had been exposed. Mr. Millen commented that exposure problems persist and he wants the persons responsible for exposing farmworkers to pesticides (e.g., spraying the fields while workers are present) to be held accountable for their actions. He closed by saying he is counting on the Committee to act to change this situation.
Joy Cummings, a Florida rancher and farmer, explained she was a chemicals sales representative until she realized the harmful effects associated with chemical exposure. After moving to her farm she found her community was contaminated. Ms. Cummings remarked that people are eating fish contaminated with dioxins, female fish are taking on male sexual characteristics (as are some female humans in the community), and there is a high rate of children with learning disabilities as well as a high rate of leukemia. She stated she worked on a dioxin FACA and is still worried about the dioxins which she believes are probably caused from chlorine. Her message to industry was to stop dumping poisons and to stop using chlorine.
Linda Young, Southeast coordinator of the Clean Water Network, stated she was also speaking on behalf of Margaret Williams of the Citizens for Toxic Exposure, a group located in southern Florida which evolved due to concern about citizens' health. She emphasized the public health must not go unprotected because of scientific uncertainties and encouraged the application of the precautionary principle. Ms. Young also noted the need to assess the effects of chemicals on the most vulnerable populations, including the fetus.
Lisa Doig, of the Farmworkers Association of Florida, Inc., stated she strongly suspects a direct relationship between exposure to pesticides and worker outbreaks of rashes, welts, bumps on the body, birth defects, and miscarriages. She commented on cases where women farmworkers experienced rashes, believed to be caused by chemical exposure, and then subsequently had miscarriages. Ms. Doig suggested an in-depth study into the cause and effect relationship of pesticides and public health threats, and making available to the public the results.
Estaban Caro Jr., a farmworker, stated that as a common worker he is exposed to a number of different pesticides and suffers from itching and swelling skin. He said the farmworkers are aware of their exposure to such chemicals on a daily basis. With the help of organizations like the Farmworkers Association, Mr. Caro explained, workers have been better able to get needed information about how to protect themselves from pesticide exposure and how to get treatment once exposure occurs. He expressed concern about how the exposure will affect him and other workers in the long run and asked the Committee to do whatever possible to make the farmworkers' lives a little better.
VIII. Response to Public Comment
Dr. Lynn Goldman thanked the public for their comments and reminded them of the Committee's scope. She indicated that EPA has heard concerns expressed about farmworkers and fern nursery staff exposures and indicated more attention needs to be focused in this area. Dr. Goldman noted the need for the Committee to understand the extent of exposure possible and to understand that laws and regulations do not always work as they should.
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