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Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC)

Plenary Meeting
October 7-8, 1997
LaQuardia Marriott, New York, New York
Meeting Summary*

I. Background

On October 7 and 8, 1997, the fifth plenary meeting of the EDSTAC, chartered under the Federal Advisory Committee Act (FACA), was convened in New York, New York. 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 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 sixth plenary meeting in Orlando meeting will consist of one and-a-half day plenary meeting that will be open to public on December 2 and 3. Each of the three work groups will provide a status report on their deliberations and discuss draft recommendations that are ready for the consideration of the EDSTAC. The meeting will start at 9:00 a.m. and go until 5:30 p.m. on December 2. After a dinner break there will be an opportunity for public comment from 7:00 p.m. until 9:00 p.m. on the evening of December 2. The meeting will reconvene at 8:30 a.m. and adjourn by noon on December 3. The afternoon of the second day will be devoted work group meetings.

Following the Orlando plenary, the EDSTAC will meet again in Washington, D.C. on February 2-3, 1998. The meeting will be held at The Madison Hotel located at 15th and M Streets N.W. in Washington, DC. The phone number to The Madison is 202-862-1600 and the fax is 202-785-1255.

II. Apologies for Temporary Delay

Unfortunately, the EDSTAC facilitation team had to temporarily halt its facilitation and other support activities for the EDSTAC for most of the past month, pending approval of a modification to the existing support contract. This was due to an unexpected delay in contracting paperwork that got caught up in the change over in the federal fiscal year. This resulted in a temporary delay in our ability to continue to meet the needs of the EDSTAC in the manner to which both the Committee and the public have grown accustomed. We have appreciated your patience during the course of this delay and we are happy to report that we can now resume our normal activities in support of the EDSTAC.

III. Overview of the New York Plenary Meeting

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 -- the Communications and Outreach Work Group (COWG), the Priority Setting Work Group (PSWG), and the Screening and Testing Work Group (STWG) -- received guidance and constructive feedback from the full Committee on the direction and substance of their efforts.

The New York plenary enabled the Committee to make substantial progress towards its goal of achieving a consensus on recommendations to EPA on 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 October 9 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, the address for which is http://www.epa.gov/scipoly/oscpendo/index.htm

IV. Priority Setting Work Group (PSWG)

At the New York plenary meeting, members of the PSWG presented issues, options, and recommendations developed by the work group since the Chicago plenary. The main objectives of the PSWG presentation were to offer information and seek feedback on: a) the proposed additions to the conceptual framework for the screening and testing program; b) the eleven criteria for priority setting for chemicals; c) the use and interpretation of High Throughput Pre-Screening; and d) the handling of certain classes of polymers in the screening and testing program. Please see Attachment B for a copy of slides developed by the PSWG for its presentation.

Discussion of Additions to the Conceptual Framework

Tom Osimitz provided members of the EDSTAC with an overview of the PSWG's proposed modifications to the conceptual framework. He highlighted the use of the eleven criteria (effects-related, exposure-related, and statutorily driven), and asked the Committee for feedback on the development of cutoff points for certain criteria and how to use the criteria in the priority setting process, given the value-laden nature of prioritization.

In general, Committee members expressed support for the incorporation of a time dimension into the conceptual framework and for the use of a parallel track approach during Phase I (i.e., concurrent screening and testing of priority chemicals with systematic priority setting for the remainder of the chemicals). However, some Committee members expressed concern that the overall process not be made inefficient or overly complicated with these changes. Recognizing this concern, work group members expressed the view that the parallel track approach was developed to ensure that chemicals of immediate concern could be subjected to screening and testing during Phase I while more information was gathered on chemicals for which there is currently little or no effects-related data. It was acknowledged that although this may make the program more complicated to implement during Phase I, work group members expressed the view that the benefits achieved from the use of a parallel track approach outweigh these costs. The plenary agreed with this view and directed the work group to continue to pursue refinements in the parallel track approach for Phase I.

Members of the EDSTAC questioned who would be responsible for conducting the priority setting process. In response, it was noted that EPA would be responsible for conducting the prioritization phase due to the centralized nature of the process. This differs from the screening and testing phase, during which the "owner" of a chemical would be responsible for conducting the screening and testing.

Discussion of Eleven Criteria for Prioritizing Chemical for Screening and Testing

In discussing the criteria, Committee members raised particular issues they felt needed to be addressed in the criteria. Specifically, it was recommended that PSWG's criterion #4, "Production volume" be modified to include chemical use. Several EDSTAC members indicated that the production and use criterion should account for both international production volume and exports.

Committee members asked the PSWG to consider how to account for degradation products in the criteria. One response that was given was that such chemicals may be captured by biomonitoring criteria. It was also noted that the nomination process, although still under development, might offer an avenue by which degradation products could enter into the sorting and priority setting process. In any case, the work group needs to explicitly discuss this issue.

The Committee reaffirmed the need for the PSWG to develop recommendations aimed at ensuring information gathered in the priority setting process would not be lost, but rather retained and communicated to appropriate parties during the course of implementing the screening and testing phase of the program.

Committee members expressed concern that the criteria not devolve into a rote checklist or be used in some other way to obscure the important decisions being made during the priority setting stage of the program. Committee members further encouraged the PSWG to clarify what types of information or data would be subsumed under each criteria (e.g., bioaccumulation would be subsumed under criteria #5 -- fate and transport).

The Committee discussed whether or not the PSWG should take steps to apply the eleven criteria to such an extent that the EDSTAC could ultimately recommend to EPA a list of chemicals that meet these criteria, and therefore should be considered as a priority for Phase I screening and testing.

It was explained that some of the criteria are not very meaningful unless potential cutoff points are also identified (e.g., production volume). It was pointed out that the identification of potential cutoff points would allow the work group to determine the number of chemicals that are above or below the cutoff. The work group could thereby gain a better understanding of the potential implications of different cutoff points regarding the number of chemicals that might be considered as a priority for Phase I screening and testing. Such cutoffs, in addition, would enable the work group to perform sensitivity analyses and analyze different "what if" scenarios to better understand the interrelationships between the different criteria, as well as the utility and implications of each criterion.

A number of concerns were raised about whether the PSWG should develop a single list of chemicals that could be considered a priority for Phase I screening and testing. One concern was that there was a potential for misuse and negative market impacts on chemicals that would be included on such a list. Because of this, it was suggested that the PSWG and the EDSTAC should not develop or recommend such a list until such time as EPA is ready to actually begin implementing the screening and testing portion of the program. Another concern was that in the view of some Committee members, the recommendation of such a list goes beyond the original charge to the Committee. These Committee members expressed the view that the EDSTAC should limit their recommendations to a set of criteria and a process for implementing or making use of the criteria and stay away from the recommendation of a list of chemicals that meet the criteria. Other Committee members expressed the view that even if the EDSTAC chooses not to recommend a list, people outside of the EDSTAC will use the criteria (and particularly the cutoff points for the criteria) to generate such a list. Therefore, it would be better for the EDSTAC to address the issue of proper communication of the purpose and intent of such a list as part of its deliberations and output rather than leaving it to chance.

The Committee agreed that the PSWG should not take steps to apply the eleven criteria to the point that it will recommend a list of chemicals that meet the criteria at the next plenary. Rather, the PSWG was requested to continue to refine the criteria and, where applicable, potential cutoff points, so different scenarios can be presented to the December plenary. In developing and presenting these scenarios, if possible, the PSWG was directed to include an analysis of the number of chemicals that might meet the criteria and different cutoff points, but not to present a list or set of lists for consideration. Furthermore, it was decided that the question of whether the EDSTAC should ultimately develop recommendations that would include a list of chemicals that EPA should consider as a priority for Phase I screening and testing would be taken up again in December.

Discussion of the Incorporation of High Throughput Pre-Screening (HTPS) into the EDSTAC Conceptual Framework

Angelina Duggan presented the HTPS concept to the EDSTAC, focusing on its use and role in the priority setting phase of the screening and testing program. She emphasized that the incorporation of the use of HTPS into Phase I of the program was primarily intended for the purpose of generating information on the potential for endocrine disruption activity that would not otherwise be available in the absence of the use of HTPS. She noted that such information would be incorporated with exposure and any other effects-related information to complete the task of priority setting.

She also noted that the types of assays that would be conducted during the HTPS step (i.e., either receptor binding and/or transcriptional activation assays) would not serve as a complete substitute for Tier 1 Screening (T1S). However, they could potentially serve as substitute for only the in vitro portion of the T1S battery, pending the outcome of the deliberations of the Screening and Testing Work Group (STWG). Some Committee members expressed the view that transcriptional activation assays should be used in the HTPS process, and receptor binding assays should be kept in T1S for the purposes of competitive binding analyses.

It was readily acknowledged that HTPS would only serve as one element in the information gathering and priority setting process and would be viewed in light of its limitations. These limitations include the limited information regarding mode and mechanism of action that is generated by the types of assays that can be run using HTPS technology.

Committee members asked what the implications of negative HTPS results might be with regard to the priority setting function of this information. HTPS task group members stated that, while positive results in HTPS might increase the priority of a given chemical, negative results would not translate into a lower priority, and would certainly not be used to place a chemical in the "hold box" (i.e., stop further consideration of screening and testing). Some Committee members pointed out that raising the priority of one chemical will presumably lower the priority of another chemical. The point was also made that the PSWG's proposal to collapse the previously proposed three-by-three priority setting matrix into a two-by-two matrix would not, therefore, be possible for chemicals with negative HTPS results, as those results would still be the functional equivalent of having no data.

Notwithstanding these concerns, the reaction of many Committee members to the HTPS proposal was generally positive. However, there was no consensus reached about its adoption or incorporation into the EDSTAC Conceptual Framework. The HTPS task group was charged to continue the work on developing this concept, including a scheme for what assays should be included in the HTPS and how the HTPS step should be conducted in relation to both the priority setting and screening and testing phases of the program. In so doing, the task group was asked to develop a concise list of pros, cons, and options relating to the proposed use of HTPS.

Discussion of the Chemical Nominations Process

The Committee discussed the possible incorporation of a nomination process into the EDSTAC conceptual framework to allow for public nominations of chemicals that should be screened for endocrine disruption. The PSWG noted that it had not yet developed this idea to the point of being ready to recommend it for consideration by the plenary.

One point of view expressed about the possible use of a nomination process was that any chemicals that are nominated should be evaluated against the same criteria that all chemicals are evaluated against. In other words, these Committee members stated that nominations not serve as "trump cards" that would result in the nominated chemicals being prioritized above other chemicals simply due to their status as having been nominated. Other Committee members expressed the view that the reason for having a nomination process is that the generic criteria might not be sufficient for addressing the unique concerns of impacted communities. Some examples cited included instances where the exposure level was acute but below the universal threshold of the criteria, or where effects or exposure data was anecdotal rather than empirical.

No conclusions were reached about whether to recommend a nomination process and, if so, what type of nomination process should be recommended. A task group drawn from the membership of the PSWG and COWG will continue to explore this concept.

Discussion of the Handling of Polymers in the Screening and Testing Program

Ted Schettler presented the PSWG's thoughts on the handling of polymers in the screening and testing program. He noted that the work group had hoped to present a definitive proposal but had abandoned the use of an exclusionary criteria based on molecular weight due to concerns about intestinal absorption in infants and wildlife prior to the period of intestinal closure. He added that PSWG recognizes that leachable monomers and degradation products need to be explicitly addressed in the screening and testing program, and that the fate of a polymer needed to be bound to the screening and testing results of their monomers and degradation products. The PSWG, therefore, felt it might be valuable to look at polymers in classes and ask whether their biological activity has been examined before temporarily placing the in the "hold box." To address concerns of the Committee, it was clarified that "additives" would be subjected to the screening and testing program, as would monomers and degradation products, just like all other chemicals. No conclusions where reached in the plenary about how to handle polymers.

Next Steps

Members of the PSWG will be developing a more comprehensive discussion paper and proposal for how to handle polymers in the screening and testing program. This paper will include a thorough discussion of the factual basis for the proposal, and outline issues of concern that have been considered (e.g., additives; neonatal exposure; discussion of/complications of degradation products and leachable monomers, etc.). The paper will also address issues such as:

The work group will also continue its course of developing a database tool that can be used to evaluate the data that will come in for each criterion, and that will allow the EDSTAC to consider different scenarios for prioritizing chemicals given a set of parameters. The PSWG will prepare a document to explain how the database tool was developed and how EPA can use it to assist in sorting and prioritizing chemicals for screening and testing. The document will also outline why the PSWG developed the tool as it did and what information the database provides. Furthermore, the work group will provide recommendations for how EPA ought to further develop the tool for maximum efficiency. The PSWG will continue to gather information and data on each of the eleven criteria for use in prioritizing chemicals for screening and testing. This data will be used to enhance the database tool described above.

Finally, the PSWG is continuing to work on a proposal for addressing mixtures in the prioritization process, and will coordinate efforts on a chemical nominations process with the Communications and Outreach Work Group described below.

Issues Still Needing to be Addressed in Future PSWG Deliberations

The following issues arose during the course of the October 9 PSWG meeting, but were not resolved:

V. Screening and Testing Work Group (STWG)

All EDSTAC members received copies of the STWG Draft Interim Report prior to the meeting. Please see Attachment C for a copy of the Interim Report. On Tuesday afternoon, Dr. Earl Gray, of EPA, presented the STWG efforts up until this time. EDSTAC members commented on the value of the presentation and felt it did a nice job of incorporating the current recommendations as well as the science behind them. At the conclusion of the presentation, Dr. Gray offered three possible "batteries," that he indicated were his own ideas, which gave the EDSTAC members a sense of how the assay types the work group had recommended could be mixed and matched.

Please see Attachment D for a copy of Dr. Gray's slides.

After the presentation, EDSTAC members were asked to try moving through the Interim Report in a methodical fashion, but to also ask general questions as necessary.

The issues they discussed fell into the following six categories:

General Comments

Some in the group expressed concern with the battery size, even though they recognized all the assays listed in the Interim Report were not intended to be included in the eventual battery, and the potential for such a large number of assays to result in bottlenecks. However, the need to ensure a level of certainty was also recognized. In giving advice to the STWG, some EDSTAC members encouraged a less duplicative, more simple T1S battery that enables relatively "automatic" decisions on whether or not to move to T2T. By less duplicative, the sense of the EDSTAC seemed to be that, given the goal of identifying potential endocrine disruptors in T1S, including a broad range of taxa in T1S was not necessary unless the specific assay added something important or could more effectively address an endpoint. However, as is noted a few sections below, the group did stress the importance of including a broad taxonomic range in T2T. An overriding point, throughout the deliberations, was the need for the program to incorporate the flexibility to deal with the results of research and future scientific advances as they emerge.

In discussing the number of assays to be included, Douglas Crawford-Brown presented a one-page graph related to the relationship between the number of assays and the likelihood of a false positive result. STWG members, who had discussed the issue briefly before, appreciated the document and indicated it could be helpful in their final decisions. In addition, it was suggested a similar graph, related to false negatives, might also be helpful.

Bypassing T1S

The question of whether or not specific compounds should be allowed to bypass T1S was raised. Some people indicated there may be times, besides statutorily-driven ones, when companies wish to move a compound directly to T2T. Others felt information, otherwise obtained during T1S, would therefore be unavailable for T2T development. Some suggested that T2T could be designed to make sure more information was obtained depending on the number of assays completed in T1S. At the end of the discussion, Dr. Lynn Goldman asked the STWG members to flesh out the pros and cons regarding bypassing T1S when making final recommendations.

Inclusion of an In Utero Developmental Assay in T1S

While the Interim Report raised the possibility of including an in utero developmental assay, no decisions were made prior to the meeting. Many EDSTAC members raised this issue on the first day and discussed it in further detail on the morning of the second day. Concerns were raised that, if a developmental assay were not included in T1S, some potential endocrine disruptors might be missed. However, others indicated that inclusion of such an assay is not necessary as there is no proof that it adds value beyond those already included in the T1S, while also meeting other criteria agreed to by the EDSTAC such as time needed to perform.

At the end of the discussion all the EDSTAC members in attendance agreed that, given the current knowledge of in utero developmental assays, one does not need to be included in T1S. In addition, the group agreed that development of an in vivo assay that could be included, practically, in T1S should be a very high research priority. (One suggested assay currently being researched is an in vivo for embryonic tissues.) Everyone also agreed that in utero (and in ovo) developmental tests should be included in T2T. Dr. Goldman asked the group to lay out pros and cons of not including an in utero developmental assay in their eventual T1S recommendations. A number of EDSTAC members also suggested that non-mammalian assays be further explored to address developmental issues in T1S.

Inclusion of the Hypothalmus-Pituitary-Gonadal (HPG) Axis in T1S

During the presentation, Earl identified the HPG axis as one endpoint that could be "added" into the battery when looking for estrogen, androgen, and thyroid effects. Some EDSTAC members indicated they felt HPG was a part of the original mandate and should be incorporated in the battery. Everyone agreed an argument for inclusion of the HPG axis could easily be made and encouraged the STWG to include it in their final T1S recommendations.

Identifying Research Priorities

Throughout the deliberations, EDSTAC and STWG members identified issues they felt might need more research before being included in the STWG recommendations. Some examples included: a) development of an in utero / in ovo assay for T1S to address developmental concerns; b) questioning whether and, if so, when and under what circumstances the initial focus on estrogen, androgen, and thyroid might need to be expanded; and c) standardizing/validating some of the mammalian and non-mammalian assays still under consideration to address how they apply to endocrine disruption.

Defining T2T

Many EDSTAC members remarked on the need to have a better sense of the work group's thoughts on T2T before fully assessing T1S. It was suggested that people are currently trying to put everything in T1S and will continue to do so until T2T is better defined. At that time, EDSTAC will be able to discuss them while seeing the bigger picture of the entire screening and testing program. One suggestion for the STWG members in developing T2T, and the EDSTAC members in reviewing the recommendations, was to re-read the Conceptual Framework document developed by the EDSTAC in May, 1997.

Specific suggestions, related to earlier T1S discussions, covered: first, making sure to incorporate in utero (and other taxa) developmental tests; second, including a broad range of taxa, paying serious attention to oviparous organisms and others that have unique maternal transmission mechanisms; and, third, addressing the concerns related to low dose effects and the subsequent need to incorporate a wider range of doses in testing protocols.

VI. Communications and Outreach Work Group (COWG)

The Communications and Outreach Work Group (COWG) presented an update to the Committee on the second day of the plenary. Co-chairs Chris Borgert and Peter de Fur reviewed the work group's progress to date and verified some of the communications issues heard during the course of the public comment period and the Committee's discussions the previous day. As was indicated by the number of times the issue of communication arose throughout the course of the plenary meeting, the importance of such issues to this process is becoming more clear to Committee members. With each passing meeting, it has also become increasingly apparent that the work of this group is going to be more intense and more time-consuming in next few months.

Some of the communication issues raised during the public comment period include the following. The COWG reviewed these issues during their discussions in New York.

It was also noted that the Committee heard the public's interpretation or version of some events and discussions in the scientific community. This observation should serve as a reminder to EDSTAC members that their work is read by others and how communication occurs is critical to the process and outcome of the Committee.

Issues raised during EDSTAC discussions, including those that were raised during the COWG update portion of the agenda include:

  1. The Committee and the COWG should make recommendations to EPA regarding their communications to the public about the results of this process, including, but not limited to information about the report; the list of chemicals for T1S priority; and what to say about endocrine disrupting chemicals.

  2. The COWG should work with the PSWG to craft a means of defining and establishing the nominations process.

  3. Develop recommendations to EPA on communicating the criteria by which HTPS will take place. This includes helping to define the concept of HTPS and the meaning of its results and its use for chemicals.

  4. Work on proposal for development of a central repository or data base for results of the screening and testing program.

  5. Explanation and clarification of the use and purpose of lists--what do they mean, what don't they mean?
  6. Explore the communications implications of a company that bypasses the screening step and goes directly to testing.

  7. Clearly explain the use and limitations of different assays as well as what a battery of assays means, including the meaning of false positives and false negatives.

  8. Look at vehicles of communication other than the EPA Web site, so as not to exclude those without access to the Internet.

  9. Explore concept of developing an agreement for Committee members to subscribe to the principles regarding communication and use of information generated by the screening and testing program. This idea recognizes the fact that there is a lot of inherent power collectively at the table, which, if agreements were reached, could be used to assist in preventing misuse of information.

As mentioned above, the COWG discussed these issues during the course of their work group meeting following the Plenary. Out of those discussions, several assignments were given that would further expand on the above issues as well as others. The group views the results of such assignments as the first step toward development of recommendations to be included in the communications chapter of the final EDSTAC report.

VII. Other Aspects of the New Plenary

Nominations Task Group

As discussed at the New York plenary, a Nominations Task Force (NTG) is being formed to discuss the viability of a chemical nominations process being included in the ED screening and testing program to allow members of the public an opportunity to nominate chemicals as a priority for Phase I screening and testing and/or to be included in the parallel track of systematic priority setting. This task group will be exploring whether and how to incorporate a "nominations process" into the EDSTAC Conceptual Framework. The NTG is comprised of members of the Priority Setting and Communications and Outreach Work Groups.

Update on Activities of the Organisation for Economic Cooperation and Development (OECD)

Mr. Herman Koëter, Principal Administrator for the Environmental Health and Safety Division in OECD's Environment Directorate, provided the EDSTAC with an update on OECD activities relating to endocrine disruptors. The OECD circulated a review paper among its member countries which outlined different options for an endocrine disruptor screening and testing program. The OECD is in the process of receiving comments from those countries on this paper, and is considering a three-step process in its screening and testing which include screening; sub-chronic testing; and chronic testing. The OECD will conduct meetings in December, 1997, to discuss the development and validation of tests for its endocrine disruptor screening and testing program. The OECD's website http://www.oecd.org/home/ Exit Disclaimer contains information about their work in the field of endocrine disruption.

VIII. 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 approximately twenty-five individuals to provide comment to Committee members, nearly all of whom were present. 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.

Frank Stoppenbach, a resident of the Hudson Valley, noted that he was concerned about the presence of PCBs in his community and about the impacts on small communities of chemical exposures. He encouraged the consideration of fetal and developmental exposures in the EDSTAC screening and testing program. Furthermore, Mr. Stoppenbach encouraged that data regarding endocrine disruptors generated by the screening and testing program be made as publicly accessible as possible. He expressed concern, as well, about the use of SLAP suits in his community.

Greg Koontz, director of regulatory affairs for the Chemical Producers and Distributors Association, described benefits of the products supported by his organization. He encouraged support for efficient, cost effective responses to environmental problems commensurate with the problems they are meant to address. He noted concern about the impact of regulatory actions on small businesses, as well as cost impacts from such regulation. Mr. Koontz questioned the scope of the endocrine disruption issue, as well as the accuracy and ability of assays to detect designated endpoints. He encouraged the Committee to clarify the definitional and utilization issues of false positives and negatives, and urged a balanced approach to risk assessment.

Ralph Magin, a research and development scientist with the Albermarle Corporation, expressed his support for toxicity testing requirements that afford increased public health protection. He noted the broad array of assays under consideration, and encouraged the Committee to be pragmatic in its selection process. He also noted that toxicity screening and testing is a decision-oriented process and should be characterized by relevant and reliable endpoints and methods, upon which clear interpretations of results can be made. Mr. Magin stated that those who review and interpret the testing results will not likely be research scientists, and that opportunities to clarify ambiguities will not be forthcoming once the EDSTAC process is concluded. He questioned the present potential scope of screens under consideration by the STWG, and encouraged the group to be pragmatic and to use validated assays in the screening and testing tiers to ensure, among other things, that resources are not expended to study chemicals of little concern.

Laura Whatley, with American Cyanamid Company, recognized the need to know about endocrine disrupting chemicals, and recommended the development of a deliberate, practical approach to do so, in order to save time and resources. She furthermore encouraged the Committee to base its recommendations on sound, verifiable science so that future policy would be based on that sound science.

Geri Barish, president of the Long Island Breast Cancer Coalition and a member of One in Nine, a breast cancer support and advocacy group, noted concern about the growing chemical use of developing countries and the breast cancer rates in these countries. She offered DDT use in India as an example of this, and noted the lack of public access to politicians, scientists, and education regardless of culture.

Ed Sabo, New York coordinator for the Chlorine Chemistry Council, stated his support for the EDSTAC process, noting that the endocrine disruptor issue is a complex subject with limited scientific information on which to base public policy. He commented that the goal of achieving consensus on a screening and testing program requires staying focused, and urged the Committee not to lose focus by wanting to develop a list of endocrine disruptors. He indicated that such development was not a part of the EDSTAC's mission. Mr. Sabo expressed his feeling that chemicals entering the screening and testing program through the nominations process should undergo screening through the same criteria as all other chemicals. Finally he stated that diligence will ensure that laws and regulations will be based on sound science.

Linda Roberts, of Chevron Research and Technology Company, commented that in utero tests should be included in the screening and testing program as definitive testing. In addition, she noted that definitive testing should more thoroughly characterize toxicity, and that in utero assays would be a benefit in doing this. Ms. Roberts indicated her preference that laboratories expend resources on such testing rather than on screens.

Mary Dauden, with the Coalition Organized to Protect the Environment, stated that the first and foremost role of government is the protection and quality of human health. She expressed support for the use of in utero developmental assays examine responses in populations at greatest risk, from pre-natal fetuses to infants to the elderly. She said that fetuses are exposed to many chemicals which can cause cancer and mental disabilities.

Walter Schroeder, of the Nassau/Suffolk Landscape Gardeners Association, Inc., on Long Island, said that the EDSTAC was doing a great job for the most part. He noted awareness of breast cancer incidences in his community, but indicated that the determination of pesticides as causative factors in breast cancer is not clear cut. Mr. Schroeder cited the retraction of the Tulane study and Steve Safe's article as examples of the continuing debate over the effects of endocrine disruptors, and encouraged the Committee to act prudently.

Diana Hinchcliff, executive director of the New York State Chemical Alliance, indicated her support of the EDSTAC process and her hope that the Committee's goal will be accomplished in an objective manner. Ms. Hinchcliff cited the public's likely misinterpretation of lists and past examples of misuse or misunderstanding of lists as reasons to avoid developing lists of chemicals or to deliberate at length on the use of chemicals. Rather, she suggested the Committee create an endocrine disruptor screening and testing program based on the best available science to determine which chemicals have endocrine disruption potential, and to do so carefully, expeditiously, and judiciously, bearing in mind issues related to implementation.

Hamdy Balba, with Uniroyal Chemical Company, referenced the adverse effects of many endocrine disruptors in urging the Committee to use an analytical and methodological approach in creating its screening and testing program. He suggested the establishment of a database for all documented and suspected industrial and natural chemicals with endocrinological properties. Mr. Balba encouraged the development of a reliable assay for confirming endocrinological activities to assist the regulatory agencies in prioritizing chemicals for screening and testing and protecting public health and the environment. Finally, he advised the Committee to be aware of possible antagonistic, synergistic effects of chemicals.

Joe Gregella, executive director of the Long Island Farm Bureau, noted that farmers are extremely concerned, as are commercial applicators, of any potential impacts of pesticides. He stated that he hoped the EDSTAC could help instill public confidence in the government by reintroducing sound science to policy. Mr. Gregella urged that science dictate the decisions made by the EDSTAC. He acknowledged the emotional aspects of the debate over the endocrine disruption issue and urged for the development of studies that can be verified and validated by peer reviews and reproducibility. Furthermore, he noted that public policy needs to balance many variables, including economic and social concerns, but he hoped it would do so guided by sound science.

Jim Lamb, a toxicologist with Jelnecks, Schwartz, and Connelly, commented that the design of the entire system needs to be built with primary objective of being able to do a risk assessment on adverse effects on the endocrine system, noting his belief that the "adverse" qualifier was critical. Mr. Lamb also stated that in utero testing is critical to the endocrine disruption argument, but urged that it be conducted in the testing tier, not in the screening tier. He stated his support for a bypass option for chemicals to go straight from prioritization to testing, contingent upon the design of a comprehensive testing tier.

Davis Baltz, with Commonweal, asked whether degradation products and metabolites be captured by the assay battery of the screening tier of the screening and testing program, and expressed concern regarding the perceived difficulty of moving a chemical out of the "Hold" box. He questioned the ability of the Committee to focus testing on the hypothalmus-pituitary-gonadol (HPG) axis, given the rapidly emerging and developing state of the science related to endocrine disruption. Regarding the screening battery, Mr. Baltz commented that the battery needed to maintain flexibility to address issues not anticipated by the Committee. He also noted his belief that the addition of an invertebrate assay to the screening and testing program was critical to support EPA's goal of protecting the environment. Mr. Baltz noted that the issue of how to address commonly found mixtures had not yet been agreed upon by the EDSTAC, and indicated his concern about the chemical body burden issue. He asked how new chemicals would be handled by the screening and testing program, urging that they be handled more stringently and that they be screened and tested right away. Commenting on the nominations process, Mr. Baltz indicated his support for the concept of giving the public a process to offer input into the screening and testing program, and noted his belief that a separate set of criteria should be established to gauge the merits of the chemical nominations.

Marian Feinberg, of the South Bronx Clean Air Coalition, referenced concern regarding childhood cancer incidences and prenatal sensitivity in requesting that screening and testing tiers agreed upon by the Committee capture the broadest possible mechanisms. Ms. Feinberg asserted that inner-city communities are being heavily impacted by endocrine disruptor-related illnesses, and urged that the roots of transmission (e.g., ingestion, inhalation) of such diseases be examined. She also commented on an alleged lack of union representation on the Committee and in the audience, as well as a lack of representation by impacted community representatives. She encouraged the Committee and the COWG to develop publicly accessible and intelligible language in presenting the EDSTAC's deliberations and recommendations.

Jim Moore, executive director of the New York Coalition for Alternatives to Pesticides, encouraged the EDSTAC to adopt the precautionary principle. He indicated his desire for the onus to be on manufacturers to prove the safety of chemicals, or to offer compelling reasons for bringing products to market that transcend doubt. He cited DES, DDT, and thalidomide as examples of science policy failures that did not determine safety prior to release, and noted that science should not dominate public policy but that it should be a part of policy making. He commented that the Committee's definition of "adverse" effects is too narrow given the lack of knowledge in the field, and stated that the EDSTAC's top priority should be a true understanding of the true mechanisms of endocrine disruption. Mr. Moore stated his desire for a greater emphasis on research into endocrine disruption issues.

Christian Klossner, with the New York Public Interest Research Group, noted his concern regarding the increasing use of pesticides in this country and their effects on endocrine systems. With respect to priority setting, he stated his belief that the prioritization criteria should be: chemicals that are implicated by current toxicological or endocrinological data; chemicals that bioaccumulate or are persistent; likelihood of exposure; consumer products; and child exposure. He indicated that he felt pesticides fit all of these categories and should, therefore, be of priority for the endocrine disruptor program. Regarding screening and testing, he requested that the Committee include assays and tests designed to encompass developmental and fetal life stages. Mr. Klossner indicated his support for the EDSTAC's careful consideration of conventional risk assessment, and encouraged the Committee to examine chemical synergies. He asked that the onus of proof of chemical safety lie with the chemicals' producers.

Wanda Cohen asked the Committee about timeframes, required resources, and risk management issues related to the screening and testing program. In addition, she questioned how new information would be integrated into the process, and whether endocrine effects beyond estrogen, androgen, and thyroid would be addressed. She also asked about the development of the chemical nominations process and public accessibility of information coming out of the screening and testing program. Ms. Cohen commented that she was unsure how multisystem effects such as multineurological effects, degradation products, intermediates, and metabolites would be accounted for in the priority setting criteria. She asked about additional legislative authorities that might be applicable to the EDSTAC's work, such as the Clean Air Act. Ms. Cohen questioned how the process of updating databases of information would take place and how the databases would be kept useful and accessible to the public. She also commented that exposure is not necessarily equivalent to effect.

Bill Sanock, with the Cornell Cooperative Extension, commented that he works closely with breast cancer groups, as well as pesticide users, and noted that those who use pesticides have great concern about their safety and support the Committee's work to provide more information. He stated the need to use good, practical science in the process, and asked how the EDSTAC would communicate results and recommendations of the screening and testing program to the public. He encouraged the Committee to approach risk assessment and exposure issues using common sense and practical research.

Judith Helfund, with the DES Cancer Network, stated that Long Island has the highest rate of DES exposure in the country, and indicated the region's required attention on related issues. She offered a very detailed account of personal physical problems due to DES exposure as a youth, and urged the Committee to adopt the precautionary principle to avoid future incidences similar to her own. In addition, Ms. Helfund asserted that transgenerational impact of DES exposure and endocrine disruption was a reality, and should be considered as the effects would be manifested long after exposure. She stated that information is needed to make informed decisions and to give consent to exposure.

Minna Barrett, professor of environmental psychology at the State University of New York, stated that her mother had died of thyroid and breast cancer. She encouraged the Committee to include lifespan scrutiny and mechanisms (especially with respect to fetal exposure), synergistic chemical reactions (including low dose exposure and inert synergies) health implications for endocrine sensitive cancers and other diseases, and synchronicity, bioaccumulative, and persistent considerations in the endocrine disruptor screening and testing program. She encouraged the EDSTAC to include an analysis of developmental endpoints in the screening and testing tiers to catch effects of chemicals to which neonatal children are often exposed. Ms. Barrett stated her perception that many of the endocrine disruptor issues had been perpetuated by the economy, and indicated her sense that industry is suspect. She commented that low risk allowances are not acceptable, and that only no risk situations would be acceptable.

IX. Response to Public Comment

Lynn Goldman thanked the public for their comments, noting that they reflected the serious challenge to the Committee and EPA to protect human health and the environment, and to do so in ways that are effective, cost effective, and practical. She stated that she expected a mutually beneficial outcome for both economic development and environmental protection if the EDSTAC was successful in reaching its goals. With respect to public access to information, Dr. Goldman commented that efforts have been made to develop an endocrine disruptor Web site and to keep it updated.

With respect to the retraction of the Tulane study, Dr. Goldman indicated her belief that the portrayal of the situation surrounding the retraction had been inaccurate. She noted that, while that particular study had been withdrawn because it cannot be reproduced, other studies exist in the literature supporting the synergy of endocrine disrupting chemicals. Furthermore, she commented that the legislation that started the EDSTAC process was introduced several months prior to the publication of the Tulane study.

Dr. Goldman commented on the obvious thoughtful preparation by commenters, and recognized their efforts. She reiterated that the EDSTAC process has been a science-based process from the very outset, and that it would continue to be so. In response to some comments, she noted that EPA is engaged in activities to address the rising rates of childhood cancer.

One Committee member responded to Mr. Baltz' concern with respect to the handling of mixtures by noting that the subject was being addressed by the PSWG and that the issues of identification, prioritization, and technical aspects of how to screen and test mixtures still needed to be discussed.

Dr. Goldman, in response to public comments about the inclusion of an in utero assay in the screening and testing program, commented that there is no debate in the Committee about whether it should be part of the process, but rather where in the process it should be included (i.e., T1S or T2T). With respect to prenatal detection of childhood cancer, she commented that while the concern is valid, it is not within the scope of the EDSTAC but that other EPA offices are addressing the issue. Regarding public comments about missing or inappropriate Committee representation, she stated that not all EDSTAC members were present at the New York meeting, but that the EDSTAC did have union representation and environmental justice representation, and that membership on the Committee from industry was important and vital for consensus. Dr. Goldman noted that environmental protection has often been done in an adversarial manner with industry, but that the EDSTAC represents a coming together around a common interest and in good will.

Some members of the public commented critically about the location of the New York plenary as being inconvenient and inaccessible by mass transportation. Dr. Goldman acknowledged these criticisms and offered an explanation of why the meeting had to be held in the determined location. However, she indicated that future meetings would try to address the public's concerns.

Committee members summarized for the public some of the COWG's efforts, and the work group's goals of making all Committee communication palatable, understandable, and clear for the public. It was also noted that a survey had been widely distributed by EPA on communications issues related to the EDSTAC, and that copies of the survey were available for those who desired to complete the forms. Members of the COWG expressed interest in hearing from the public how to efficiently and effectively communicate with and to the public, and encourage members of the public to assist COWG by offering suggestions.

David Parkinson, a Committee member, referenced his years of working with steelworkers and other union groups, noting that he, indeed, did lend a union perspective to the EDSTAC, counter to public statements to the contrary. He noted his current affiliation with occupational and environmental health clinics in the New York area, funded partly by state, and his desire to work with environmental groups in the area to design something they can do for themselves to test and monitor health concerns. In addition, Mr. Parkinson indicated the willingness of the clinics to assist patients who are sick and need evaluation given an environmental problem even without health insurance.

One Committee member thanked the public for their comments, and acknowledged her appreciation as a scientist for the calls from observers for policy based on sound science. In addition, she acknowledged the need to balance science with other factors to create sound public policy. She noted that repeatability and peer review are of great importance to the EDSTAC, and her appreciation for the public's encouragement of the adoption of the precautionary principle.

EDSTAC members indicated their support for a public nominations process, in recognition of the importance that the public have a continuing role in the endocrine disruptor screening and testing process. Members of the Committee noted their intention to scrutinize similar programs already in place at other organizations or agencies in the design of the EDSTAC's process.

Industry representatives on the EDSTAC encouraged the public to overcome their mistrust of the sector by focusing on the Committee's product, and by remembering that many scientists working with industry have spent a great deal of time training to learn about the issues without malintent. It was stated that public input is very important to the EDSTAC process, and that industry representation is present because industry has a responsibility, as a stakeholder, to be involved in the consensus-building process.

1. Please note that attachments will be available via the Web site or through the EPA Docket

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