· 52 wanted to receive information via the EDSTAC Web Site · 3 wanted to receive information via the EPA Public Docket · 91 wanted to receive information via e mail transmissions · 3 wanted to receive information via an electronic bulletin board · 3 wanted to receive information via speakers · 58 wanted to receive information via facsimile ( fax) transmissions · 115 wanted to receive information via the U. S. mail · 10 wanted to receive information via attendance at public plenary meetings · 9 wanted to receive information via existing EPA communication sources · 21 wanted to receive information via public conferences/ workshops · Other:  1 wanted to receive information at local meetings EDSTAC Final Report Chapter Six Appendices August 1998 Appendix U Compilation of Public Comment to the EDSTAC Table of Contents I. October 31  November 1, 1996   Washington, D. C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. December 12 13, 1996   San Francisco, California . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 III. February 5 6, 1997   Houston, Texas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 IV. April 29  May 1, 1997   Baltimore, Maryland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 V. July 15 16, 1997   Chicago, Illinois . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 VI. October 7 8, 1997   New York, New York . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 VII. December 2 3, 1997   Orlando, Florida . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Response to Public Comment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 EDSTAC Final Report Chapter Six Appendices August 1998 1 U  I. October 31  November 1, 1996   Washington, D. C. 1 2 3 Two opportunities were given at this meeting for the members of the public observing the 4 proceedings to comment on all aspects of the formation of the EDSTAC. 5 6 October 31, 1996 7 8 Lynn Bradley, Director, Environmental Health, Association of State and Territorial Public Health 9 Laboratory Directors, indicated that her organization has members interested in human monitoring 10 and the related issues of how you deal with exposure. She recommended that EPA start thinking 11 about addressing the human exposure concerns concurrently with the efforts to design a screening 12 and testing program. 13 14 Chris Wilkinson of the Technology Sciences Group, Inc. related that, as a scientist, he is appalled 15 with this process because law is mandating science and therefore science is under the gun. He also 16 expressed concern about the perceived confusion surrounding the scope of the Committee. His 17 advice was that since the law says EPA has to do one thing, develop a screen for estrogenicity, the 18 Committee should deal with the law and then do the other tasks as time permits. The Committee's 19 work could be utilized as a model for future efforts. He also suggested a set of steps the 20 Committee should take: first, identify substances that have to go into a screen; second, complete 21 the screens ( a simple process that will raise flags); third, complete actual testing ( dose response 22 issues); and fourth, bring in exposure because EPA will be doing a risk assessment. 23 24 Elizabeth Onon, who was not present at the meeting, asked that her comments be read into the 25 record. Gary Timm of EPA read the letter. She asked the Committee to address the potential link 26 between endocrine disrupters and the growing body of scientific knowledge regarding porphyria as 27 relate to chemical disabilities. She further indicated that the nominees did not represent the victims 28 of endocrine disrupters. 29 30 Stuart Cagen, Shell Chemical Company, indicated his support for the concept of what the 31 Committee should produce. He suggested that the process has to include validation, 32 interpretation, and an understanding of what EPA does with the results. 33 34 Steve Schraeder, National Institute for Occupational Safety and Health ( NIOSH), expressed 35 concern about the Committee only considering estrogens, especially as we now recognize that 36 many of the effects we originally thought to be estrogens are actually anti estrogens and anti 37 androgens. He suggested that the time is right for the Committee to go broader. 38 EDSTAC Final Report Chapter Six Appendices August 1998 2 U  Mary Dadden, President, Long Island Breast Cancer Study, relayed her disappointment in how the 1 information regarding the meeting was communicated. She requested that, in the future, notice be 2 given at least four to six weeks in advance. In addition, she indicated her desire to see the 3 discussions recognize the truly dangerous nature of chemicals and pesticides in the environment 4 and their effects on humans. She suggested that the Committee consider opening at least two seats 5 to consumer advocates who are not involved from a scientific perspective but can bring the 6 concerns of the general public. 7 8 In response, the facilitator/ convenor indicated that efforts to provide more notice will be made. He 9 also indicated that the National Breast Cancer Coalition had offered to assist in coordinating 10 efforts to involve disease specific consumer interests in addition to breast cancer groups. One 11 nominee added that the addition of consumer advocates to the Navy Breast Cancer Study had been 12 very helpful and that this Committee should consider their inclusion. The idea of a 13 communications work group, where concerns around the possibility of the public misunderstanding 14 the results of screens and tests could be addressed, was raised. Another nominee added that the 15 Committee seemed to be missing a representative of the people affected most by these chemicals 16 and pesticides. The idea of moving the EDSTAC meetings around the country was raised as one 17 way to include a wide range of perspectives and interests including consumer advocates. In 18 addition, using the Internet to disseminate information was proposed, though its ability to 19 disseminate information to a wide range of individuals was also recognized. 20 21 Alan Robeson raised the issue of testing mixtures. He indicated that a lot of people are concerned 22 about pesticide runoff from agricultural lands and the combinations of pesticides. He 23 recommended that, if the Committee moves its meetings around the country, they should go to a 24 midwest city such as Chicago, Kansas City, or Des Moines in the spring. 25 26 John Berlau of Consumer Alert asked that the Committee consider consumer's interest, but added 27 that there are different definitions of what constitute " consumer interests." He asked that the 28 Committee look at the benefits of these substances as well as the negatives and said that consumers 29 do not benefit from regulations developed without good science. 30 31 Miranda Henning, ChemRisk, suggested that, given the exposure issues as well as the fact that the 32 information might be used in risk assessments, the Committee should involve a risk assessor. 33 34 Eric Juzenas, Health Policy Analyst, American Public Health Association, suggested that the 35 Committee's environmental justice representation should be enhanced by adding some additional 36 participants. 37 38 Rick Hind, Greenpeace, stressed that the Committee should keep in mind the issue of public 39 disclosure and participants should volunteer information regarding their financial backing and/ or 40 EDSTAC Final Report Chapter Six Appendices August 1998 3 U  interests as they relate to endocrine disrupter screening and testing if people want the process to be 1 truly transparent. Relating to scope he said that the Committee should focus on looking at this 2 through the lens of existing FIFRA and TSCA regulations. In addition, he felt that the Committee 3 should not get caught looking at chemicals one by one. 4 5 Charlie Cray, Greenpeace, wanted the Committee to look at persistent organic pollutants. He also 6 added that the Committee should incorporate, from an environmental justice perspective, some of 7 the folks who represent the people who suffer as a result of the migration of these substances to 8 the colder regions of the world ( e. g., Alaska). He indicated that the public wants a list of products 9 they should not buy and labeling that explains what is in a product. Other countries that have 10 approached these issues, ( e. g., Denmark) may be a useful source of information. If EPA is not 11 going to develop these lists, he asked, who will? 12 13 Nelsa Ford asked whether all future meetings were going to be public now? EPA indicated that all 14 EDSTAC meetings will be public, however, whether all work group meetings will be public 15 remains to be determined. 16 17 November 1, 1996 18 19 Maurice Zeeman, OPPTS, EPA, raised the issue of the Committee balancing ecological and human 20 health issues because so much uncertainty exists regarding human health effects whereas we are 21 more certain about ecological effects. 22 23 John McCarthy, American Crop Protection Association, commended the Committee nominees, 24 EPA, and Keystone on their efforts. He raised three points: first, focus equally on human and 25 ecological effects; second, look at all possible hormonal effect endpoints raised during the 26 deliberations in parallel, while recognizing the statutory importance of specific ones; and third, the 27 Committee should get on with the task at hand without getting too bureaucratic and use the 28 Science Integration and Coordination work group in the future if necessary. 29 30 Layla Patarsi, Center for Food Quality, Food and Drug Administration, explained that food 31 additives comprise a set of chemicals not currently regulated under TSCA or FIFRA, and asked 32 that the Committee consider them in their deliberations. 33 34 Robert Fisher, National Council of the Paper Industry for Air and Stream Improvement, talked 35 about the structure of the Committee and recommended that the group consider looking at how 36 the EPA structured a process dealing with the Gulf of Mexico where many similar issues were 37 addressed. They used a tiered process and included issue committees, a technical steering 38 committee, and a management committee/ policy review board. He also added that the meetings of 39 the working groups should be open to the public for observation for two reasons, first, the private 40 EDSTAC Final Report Chapter Six Appendices August 1998 4 U  sector is often involved in research relevant to the issues being discussed, and second, the private 1 sector is often involved in the decision making process and needs to know about the findings 2 coming out of these efforts. 3 4 Bill Kelley, the Institute for Regulatory Policy, recommended the nominees develop a list of what 5 can be done between the organizational meeting and the December meeting before leaving. He 6 also raised serious misgivings regarding the name endocrine " disrupters" and suggested changing it 7 to " disruption" or " effects" as the Committee is talking about a hazard screening process rather 8 than risk assessment. 9 10 Elizabeth Reeves, requested the Committee consider using cell culture testing rather than animal 11 tests. She added that the Committee should remember the ultimate stakeholder is the American 12 citizen and the ecological issues should not be overlooked. 13 14 Mary Ann Dodden, expressed support for the evolution toward a broader definition of endocrine 15 disrupters than just hormone disruption. If the definition says " only affect the hormone system," 16 she felt, the Committee will not examine the immune, reproductive, growth and neuro systems. 17 She also stated that the Committee needs to recognize that other issues may be added to their 18 discussions as their understanding of science evolves. 19 20 Elsa Ford, asked the Committee to commit to follow up testing of past use and new use chemicals 21 as pertains to endocrine disruption. Coordinated documentation, she added, is important in these 22 types of efforts. Finally, she said that the public needs to know about the cumulative effects of 23 chemicals and pesticides in the real world and asked the Committee not to focus only on single 24 ones. 25 26 Patricia Fail, Research Triangle Institute, told the Committee nominees she had been working 27 mainly on FIFRA issues for the past 10 15 years. After listening to the need for various screens 28 and tests during the past two days, she indicated that the Committee needs to take already existing 29 data ( from FIFRA companies) and validate the tests that exist and see if the chemicals that test 30 positive are actually endocrine disrupters. 31 32 John Hines, an independent consultant, told the nominees that they need to address what 33 product( s) they expect as a result of this effort. He also indicated that the discussions on 34 prioritization of what issues to address were good. Regarding membership, he added, the 35 Committee nominations seem to be carefully structured and will result in a fairly large Committee, 36 so do not add too many more people. 37 38 II. December 12 13, 1996   San Francisco, California 39 EDSTAC Final Report Chapter Six Appendices August 1998 5 U  1 2 Lewell D. Brenneman, MD, Ph. D., expressed his point of view that few toxins in the environment 3 are tested for cancer and hormone disruption. He outlined two approaches for dealing with 4 manufactured chemicals such as carcinogens acceptable risk and public health, and expressed 5 concern about the fact that it is usually the consumer, rather than the producer, that has the burden 6 of proving chemical toxicity. Dr. Brenneman urged the EDSTAC to develop long term and 7 generational testing approaches to endocrine disruption. 8 9 Joan Reiss, Project Coordinator of the Bay Area Breast Cancer Study, urged the Committee to 10 develop outreach activities beyond their present scope, using several and varied means of 11 communication. Ms. Reiss encouraged the Committee to be bold, swift, and innovative with its 12 activities. She also stressed that small doses of chemicals can have an additive effect, and she 13 urged the Committee to consider this when looking at screening and testing. Ms. Reiss went on to 14 request that the Committee identify key geographical areas and criteria to start studying endocrine 15 disruption; that new chemicals should be kept off the market until proven not harmful to humans 16 and animals; that acceptable dose standards be shifted from levels for adult males to those 17 acceptable for a newborn infant; and that synergistic effects of chemicals be analyzed. 18 19 Cindy Dyer of the U. S. Department of Agriculture, Food Safety and Inspection Service, 20 commented that brominated flame retardants, which bioaccumulate, and are widely used in 21 shipping cartons, are a prevalent class of chemical which needs to be scrutinized. Dr. Dyer stated 22 her view that there is currently too much concentration on dioxin and PCBs in the scientific 23 community, and that brominated compounds, as opposed to chlorinated compounds, deserve 24 closer investigation. Dr. Dyer also urged the Committee to utilize exposure hazard database 25 information. 26 27 Judy Brady, a member of the Cancer Prevention Coalition and the Women's Cancer Resource 28 Center, urged the Committee to look at the safety of breast milk as it relates to endocrine 29 disruption. 30 31 Keith Bowers, of the IFS Kaiser Consulting Group, Global Environmental Issues Unit for Eastern 32 Europe and the former Soviet Union, made the suggestion that the EDSTAC consider identifying 33 and reviewing data developed in other countries that might help or provide insight and fill data 34 gaps in its own and other domestic efforts related to endocrine disruption. Mr. Bowers stated that 35 issues such as endocrine disruption are transborder issues, and that societies all across the globe 36 are concerned and working on the same matters. 37 38 Sandra Marquart, of the West Coast office of Mothers and Others for a Livable Planet, asked the 39 Committee to consider the following priorities for testing: pesticides, plastics, solvents, and other 40 EDSTAC Final Report Chapter Six Appendices August 1998 6 U  products of major daily use. Ms. Marquart stressed her belief that this is an international issue, 1 heavily influenced by trade patterns. She also encouraged the Committee to adjust its risk 2 considerations from levels acceptable for adult males to finding the levels for the most susceptible 3 organisms ( e. g., infants), and to address issues of synergism and threshold levels. Ms. Marquart 4 asked the EDSTAC to develop the most practical tests to find the greatest number of chemicals 5 given its budgetary constraints. She urged EPA not to wait for final endpoints to be determined, 6 but rather to take action and to extend public outreach to consumers at the first sign of possible 7 problems with chemicals. Ms. Marquart further urged the Committee to hold future meetings as 8 close to mass transit systems as possible. 9 10 Leslie Meister, of the Silicon Valley Toxics Coalition in San Jose, stressed the synergistic effects of 11 chemicals in Silicon Valley laborers' and consumers' bloodstreams. Ms. Meister urged the 12 Committee to use the " precautionary principle" in its decision making processes. She stated that 13 issues of importance in the screening process include the determination of exposure thresholds for 14 different populations ( e. g., workers or children or in utero infants), and the identification of 15 endpoints. 16 17 Davis Baltz, of Commonweal, asked the EDSTAC to look at the synergistic effects of chemicals. 18 He suggested that, in order to streamline the EDSTAC's process, the Committee consider classes 19 of chemicals as a whole when it is determined that several individual chemical members of that 20 class pose problems. Mr. Baltz also stated that the validation of screens should provide 21 information that is both useful and predictive, allowing EPA to enact policies and draft legislation 22 that reduce exposure to hazardous chemicals. He, too, encouraged the Committee to adopt the 23 use of a " precautionary principle." 24 25 Robert Gould, Associate Pathologist at the Santa Theresa Community Hospital in San Jose and a 26 member of Physicians for Social Responsibility, urged the Committee to act promptly and to create 27 a timetable for developing appropriate methodologies. Dr. Gould stated that screening and testing 28 must be a part of an ongoing process of communication, and that the EDSTAC process should be 29 completely open and transparent, including activities of the work groups. He asked the Committee 30 to address estrogenic compounds; thyroid, androgenic, anti estrogenic, and anti androgenic 31 effects; and additive and synergistic effects. Dr. Gould suggested EPA regulate whole classes of 32 chemicals, and to use a " precautionary principle" as its guiding mechanism. He recommended that 33 measures of high sensitivity and low specificity be used; that both wildlife and human health 34 effects be considered; that background levels in humans should be taken into account; and that the 35 EDSTAC study entire populations and communities. 36 37 Ritchie Fraley, a scientist at SRI International, stated that while receptivity measurement is cost 38 effective and efficient, adherence to receptor mediated tests could miss particular mechanistic 39 indications. Dr. Fraley indicated that technologies such as accelerator mass spectrometry might 40 EDSTAC Final Report Chapter Six Appendices August 1998 7 U  prove helpful in the Committee's work. She also asked how testing would be funded, and who 1 would conduct the tests. 2 3 Jane Williams, of California Communities Against Toxics, stated that California is an industrialized 4 state, subject to a wide range of impacts including dioxin contamination and effects from military 5 facilities. She requested that the Committee address human health and ecological effects, as well 6 as synergistic impacts. Ms. William expressed concern that a lack of connection to the policy 7 making arena would render the process ineffective. She asked the Committee to consider the task 8 of implementation in the course of developing its recommendations and develop recommendations 9 in such a way that all producers and communities could understand and use them. 10 11 Please refer to Attachment F for textual statements provided by Dr. Brenneman, Ms. Reiss, Dr. 12 Dyer, Mr. Baltz, and Dr. Gould. 13 14 Response to Public Comment 15 16 The EDSTAC chair thanked the public for its comments and perspectives, adding that the degree 17 of the quality of the comments at this meeting were exceptionally intelligent and helpful. Dr. 18 Goldman explained that there would be four more meetings during this fiscal year in different parts 19 of the country, and that EPA hopes to improve its outreach efforts and will coordinate a 20 communications and outreach work group to assist in this effort. 21 22 Dr. Goldman stated that the endocrine disruption screening and testing process came about as part 23 of legislation on drinking water standards and pesticides. She emphasized that the matter of real 24 importance in the process is to do the necessary work using the best available science, and to do so 25 in a framework that will help make policy decisions to help public health and the environment. Dr. 26 Goldman clarified that the language in the standard in the new pesticide legislation is " a reasonable 27 certainty of no harm." She stated that the EDSTAC will take into account a multiplicity of 28 exposures, and that other processes are also under way to advise and inform the agency in this 29 matter. 30 31 Regarding the process of the advisory Committee, Dr. Goldman stated that all decisions made by 32 the Committee will be made in the full Committee in open session, and that much will be brought 33 to the Committee by work groups and individual scientists. 34 35 Dr. Goldman recognized that Toxics Release Inventory ( TRI) matters are not of peripheral 36 concern for her. She stated her belief in the need to link domestic efforts with international 37 activities, and highlighted the fact that the Office of Economic Cooperation and Development 38 ( OECD), which has been working on issues related to the testing of chemicals, recently decided to 39 EDSTAC Final Report Chapter Six Appendices August 1998 8 U  address endocrine disruption issues. She also offered other examples of international efforts 1 related to chemical pollutants, endocrine disruption, and persistent organic pollutants, and that the 2 United States is presently working with Europe and Canada on long range transport, global policy 3 on populations, and the planning of a meeting at the United Nations Environmental Programme 4 ( UNEP) in January to discuss coordination of research. 5 6 III. February 5 6, 1997   Houston, Texas 7 8 9 Due to changes in the schedule, some members of the public were able to provide comments prior 10 to Dr. Goldman's departure during the afternoon of the first day of the Houston plenary meeting. 11 A period of two hours was also devoted to public comments later in the evening of the first day, 12 during which nearly the entire Committee was present. A total of nineteen members of the public 13 offered comments, twelve of whom also submitted written comments which can be found in the 14 EPA Docket. This meeting summary attempts to capture the essence of the comments made by 15 the public to the EDSTAC during both of those sessions. In addition, some members of the public 16 who were not present at the meeting sent written comments to The Keystone Center. While these 17 are not summarized below, they are also available through the Docket. 18 19 Sue Pope, a member of Downwinders At Risk and an advisory board member of the American 20 Lung Association of Texas, expressed great concern over human health and ecological problems in 21 her community seemingly attributable to endocrine disruption. In particular, Ms. Pope chronicled 22 health problems of her family and livestock alleged to stem from hazardous waste incineration at a 23 cement kiln in her area. Ms. Pope entered into the Docket a video which included a television 24 show about hazardous waste related problems in her town, Winona, Texas. This segment is 25 entitled " Winona Residents Demand Justice for their Children" and is available through the EPA 26 Docket. 27 28 LaNell Anderson, a citizen from Channelview, Texas, detailed health problems in her community 29 and family as a result of the effects of dioxin releases along the Houston Ship Channel. Ms. 30 Anderson asked that the Committee make explicit its goals and expected steps for the 31 implementation of its recommendations, and that State authorities be involved in the EDSTAC as 32 appropriate. She asserted that the EDSTAC process merited close public scrutiny and monitoring, 33 as its effects will have national impacts. Ms. Anderson encouraged full, impartial, firm, and 34 informed participation by each of the Committee members in the EDSTAC process. 35 36 Brandt Mannchen commented on the composition of the Committee and encouraged awareness 37 that no specific interest in the Committee have the ability to unduly influence the process. He said 38 EDSTAC Final Report Chapter Six Appendices August 1998 9 U  that he felt the Committee was not broad enough in its composition, especially with respect to 1 community based group representation, specific health problem/ developmental effects group 2 representation, and minority representation. Mr. Mannchen encouraged the EDSTAC to develop a 3 screening and testing program that would be flexible enough to accommodate chemical synergies, 4 additive effects, and new information as it becomes available. 5 6 Chavel Lopez, a member of the Southwest Public Workers Union in San Antonio, Texas, 7 commented on the health problems surrounding areas adjacent to Kelly Air Force Base due to fuel 8 and toxic chemical storage and toxic chemical dumping. Mr. Lopez, a member of a group of 9 approximately 500 concerned citizens in Bear and Medina counties, raised concerns regarding 10 contamination of the Edwards Aquifer. He also urged that the Committee include more 11 representation of people of color. 12 13 LaNell Anderson read a statement written by Ms. Phyllis Glazer, President of Mothers Organized 14 to Stop Environmental Sins ( MOSES), which raised concerns about the effects of a hazardous 15 waste incineration facility near the town of Winona, and expressed dissatisfaction with the 16 requirements of State agencies in requiring testing for dioxins. In addition, Ms. Glazer's statement 17 offered concern about the effects of other hazardous waste sites shipping waste to the incinerator 18 for disposal and/ or storage. 19 20 Jane Elioseff, of the Galveston Houston Association for Smog Prevention ( GHASP), an 21 organization devoted to improving the air quality of the Galveston Houston area, noted that the 22 Galveston Houston area is a severe ozone non attainment area with high levels of nitrogen oxide. 23 She stated that this represented a large air quality problem for a suburban area. Ms. Elioseff said 24 that GHASP, which receives funding from the W. Alton Jones Foundation to pursue its work, has 25 determined that endocrine disruption is connected to air pollution and has just published a report 26 on air quality in Houston, called " Danger in the Air," which she made available for the Docket. 27 28 Yolanda Johnson, a member of the Southwest Public Workers Union in San Antonio, Texas, 29 expressed great concern with the generational effects of environmental contamination and 30 endocrine disruption. Both she and her husband have experienced health problems, as have most 31 members of their family raised near the fuel and chemical storage and disposal sites at Kelly Air 32 Force Base. Ms. Johnson thanked the Committee for its work, and urged the EDSTAC to 33 encourage greater communication and disclosure with respect to endocrine disrupting hazards. 34 35 Susan Pitman, Network Coordinator of The Chemical Connection, A Public Health Network of 36 Texans Sensitive to Chemicals, commented that the Committee ought to consider chemically 37 sensitive persons and vulnerable populations in screening and testing for endocrine disruptors, 38 rather than using healthy adult males as its benchmark. 39 40 EDSTAC Final Report Chapter Six Appendices August 1998 10 U  Dominga Adams, a member of the Southwest Public Workers Union in San Antonio, Texas, 1 detailed numerous ailments experienced by both herself and her husband, as well as by their 2 children and grandchildren. Ms. Adams expressed doubt that her family's health problems were 3 genetic, and indicated she felt they were caused by chemicals from Kelly Air Force Base. She also 4 encouraged thorough governmental communication with the public in instances where health risks 5 may or do exist. 6 7 Suzanne Martine Rohrer, of The Endometriosis Association, explained that she was diagnosed 8 with endometriosis, discussed the effects of the disease, and outlined the consequent challenges in 9 her life due to the disease. She urged the Committee to work diligently and asked that dioxin 10 receive particular scrutiny, since high level exposure to dioxin has been associated with increased 11 incidents of endometriosis. 12 13 Kim Phillips, former environmental chairman for the Texas PTA, said that she was grateful for and 14 supportive of the Committee's work, and asked that children, rather than adult males, be used as 15 guides for exposure effects. Ms. Phillips cautioned the EDSTAC that consensus processes can 16 prove difficult, but that they are worth the effort. She outlined some of her organization's 17 principal concerns with respect to endocrine disruptors, and urged the Committee to consider the 18 synergistic effects of chemicals and to err on the side of caution. 19 20 Raul Villar, a retired welder from Kelly Air Force Base, commented on his family's health 21 problems since living near Kelly Air Force Base, and expressed anger that the contamination of the 22 area around his home had not been made publicly known prior to his purchase of the lot. 23 24 David Casen, of Save Whitewright and Tri Counties ( SWAT), said he was concerned about 25 dioxins in his community, and deeply cynical about the consensus process of the EDSTAC. Mr. 26 Casen stated that he feared the Committee's decisions would be made based on political 27 considerations. He also expressed his concern caused by having representatives from chemical 28 production companies on the Committee. Mr. Casen asked the EDSTAC to use mechanistic 29 findings as suggestive but not limiting factors in screening and testing, and that the Committee 30 adopt the " precautionary principle." 31 32 Virginia Castillo, a citizen residing near Kelly Air Force Base, asked that someone look into the 33 causes of numerous health problems in the community adjacent to the Base. 34 35 Davis Baltz, a Research Associate with Commonweal, outlined eleven points. These points 36 covered: using caution to determine when an effect was " adverse;" the importance of the 37 EDSTAC's Principles Work Group, its charge, and its composition; deferral of chemicals in the 38 screening and testing process; the importance of recognizing new information on endocrine 39 disruption and chemical effects; the need for " a new paradigm" with respect to timing and 40 EDSTAC Final Report Chapter Six Appendices August 1998 11 U  exposure information; a re evaluation of quantitative risk assessment; the encouragement of the 1 use of the " precautionary principle;" the need for EPA to identify and allocate material resources 2 to permit full participation and expression of all points of view within work groups; his desire to 3 have a defined schedule of meeting dates for the duration of the EDSTAC process; the need for 4 encouraging public education and comment on matters related to endocrine disruption from other 5 countries; the importance of studying sex steroid and thyroid related effects; and, the need for 6 screening, testing, and evaluating endocrine disruptors to become an ongoing responsibility of 7 EPA. 8 9 Neil Carman, Ph. D., of the Sierra Club and formerly of the Texas Air Quality Board, presented 10 comments from people near a site in Jacksonville, Arkansas, which expressed doubts about the 11 fairness of health studies by the EPA and the Agency for Toxic Substances and Disease Registry. 12 Mr. Carman also said he had little faith in the regulatory process. He urged the EDSTAC to look 13 at synergistic effects of chemicals and to use the " precautionary principle." 14 15 Winifred Hamilton, Ph. D., of GHASP, stated that she felt most affected communities are not 16 represented adequately in decisionmaking processes related to endocrine disruption. She said it 17 was difficult to buy a non contaminated house in Houston due to the prevalence of chlordane. Dr. 18 Hamilton urged the Committee to remain focused on health concerns, and offered caution that 19 consensus processes not be misused. She continued by outlining principles she felt were 20 important, including shifting the focus of acceptable levels of endocrine disruptors to protecting 21 the most vulnerable populations ( e. g., children and conceptuses in utero). 22 23 Judy Starns, a citizen from Channelview, Texas, outlined the impacts of contamination in her 24 community, and expressed concern that her community has not been able to have a fair health 25 study conducted. 26 27 Karla Lamb, a citizen from Channelview, Texas, outlined personal health problems since moving to 28 Houston in 1975. She expressed anger and frustration at the deleterious effects chemical exposure 29 has had on her health, and urged the Committee to help others in similar situations. 30 31 Response to Public Comment 32 33 Dr. Fenner Crisp thanked the members of the public for their comments. She stated that due to 34 the mandate under which the EDSTAC was operating, the scope of the Committee's deliberations 35 would likely have to start by focusing on the sex steroids, but that such a focus was not indicative 36 of the EPA's research priorities. 37 38 EDSTAC Final Report Chapter Six Appendices August 1998 12 U  Regarding the public request for a document detailing the state of the science related to endocrine 1 disruption, Dr. Fenner Crisp stated that the EPA has been working on such a document for one 2 and one half years. The document is currently undergoing review by EPA's Science Policy 3 Council, and should be available on the World Wide Web and in hard copy through conventional 4 avenues shortly. 5 6 Referring to public comments on the EDSTAC process and concerns with respect to consensus 7 processes in general, the facilitator stated that comments on the Committee's process, even critical 8 ones, are very welcome. With respect to the availability of information, he said that he hoped the 9 use of the World Wide Web site would help meet the needs of the public, and added that the pace 10 of the EDSTAC would hopefully decrease, thereby allowing members of the public an easier 11 opportunity to track its deliberations. 12 13 Members of the Committee spoke to the concerns citizens raised about having representatives 14 from chemical producing industries sitting on the EDSTAC. Some members firmly stated that 15 there was, in no manner, a conflict of interest. In fact, Committee members pointed out, it is only 16 in places like the EDSTAC that representatives of all interested parties can speak and share 17 commonalties as humans, and that a level of trust in the commonality of commitment would have 18 to evolve. 19 20 Committee members also cautioned members of the public against putting all their hope in the 21 EDSTAC as the solution to endocrine disruption or, more generally, to environmental 22 contamination. They stated that the EDSTAC is only one part of a process to improve the 23 situation, and that the limitations of science alone would likely present very real constraints to the 24 effectiveness of the Committee. 25 26 IV. April 29  May 1, 1997   Baltimore, Maryland 27 28 29 Following a brief public reception hosted by the EDSTAC and attended by several members of the 30 Committee on the first day of the plenary meeting, members of the public were invited to offer 31 comments related to the scope and charge of the EDSTAC. The public comment session lasted 32 longer than two hours, and allowed time for more than forty individuals to provide comment to 33 Committee members, nearly all of whom were present. Due to the number of individuals seeking 34 to provide public comment, all those who signed up to speak to the EDSTAC were requested to 35 keep their comments to no more than four minutes in length. While this request may have caused 36 frustration on behalf of some individuals, the intended and effected result was to allow all persons 37 wishing to provide comment the opportunity to do so. Written comments submitted by members 38 EDSTAC Final Report Chapter Six Appendices August 1998 13 U  of the public may be found in the public docket ( Docket Number OPPTS 42189; phone 202 260 1 7099). This meeting summary attempts to capture the essence of the comments made by members 2 of the public to the EDSTAC during the public comment session. 3 4 Thomas Hobbins, MD, from Physicians for Social Responsibility, commented that one of the most 5 important recommendations offered by his organization is that Congress needs to provide a higher 6 level of funding for endocrine disruption research. Dr. Hobbins related anecdotally the potential 7 for paradigmatic shifts in thinking related to perception and actual awareness of health problems 8 and risks. He urged the Committee to look at zero tolerance as a guide post rather than acceptable 9 thresholds for risk. 10 11 Keith Bowers, of ICF, Inc., offered comments concerning international institutions working on 12 issues of endocrine disruption. Mr. Bowers commented that the endocrine disruptor related work 13 being done by agencies and organizations such as the United Nations Environmental Programme 14 and the OECD is being conducted in conjunction with their work on persistent organic pollutants. 15 He stated that it was important for the EDSTAC to know how its work differs conceptually from 16 the OECD's work, and that the Committee should look at non persistent organic pollutant types of 17 chemicals. 18 19 Gail LeMaire, Ph. D., of the Endometriosis Association, stated that there are currently millions of 20 American women and girls with endometriosis, and expressed frustration at the lack of support for 21 women with the disease, as well as the lack of information and research on the disease to date. Dr. 22 LeMaire requested that more research be conducted on the relationship of chemicals such as 23 dioxin, PCBs, and TCCD and their effects on the body. She added that studies should not simply 24 examine instances of adverse effects, but should be proactive before such effects are manifested in 25 the body. Dr. LeMaire concluded by stating that progesterone is noticeably missing from the 26 EDSTAC's scope. 27 28 Anneke Davis, from the Maryland Conservation Council commented on the public information 29 process of the EDSTAC. Recognizing that the Committee is under tremendous pressure to 30 produce their deliverables, she stated that testing is going to take a lot of time and money, as well 31 as public support. In order to accomplish this and to garner public support for adequate funding of 32 the implementation of the EDSTAC's recommendations, Ms. Davis encouraged the Committee to 33 keep groups of citizens concerned about endocrine disruption issues, such as the Maryland 34 Conservation Council, informed. Furthermore, Ms. Davis encouraged the EDSTAC to draft its 35 final report in a manner that will be intelligible to and usable by the general public. Finally, she 36 urged that the Committee not forget that the effects of endocrine disruptors on ecological systems 37 can have a tremendous impact on humans as well. 38 39 EDSTAC Final Report Chapter Six Appendices August 1998 14 U  John Holtzman, of the Chemical Manufacturers Association noted his appreciation of the 1 Committee's emphasis on insisting upon a scientific approach to its deliberations and deliverables. 2 He noted that the EDSTAC's work will benefit the large number of studies currently being 3 conducted in the field of endocrine disruption. 4 5 Carolyn Burridge, of the Maryland Chemical Industry Council complimented the members of the 6 EDSTAC on their progress, and noted the timeliness of the Committee's work given the attention 7 endocrine disruption is getting in state and national legislatures. However, she expressed concern 8 that the state of the science on endocrine disruption is not yet sufficiently advanced to allow the 9 formulation of sound public policy related to the subject. She encouraged the EDSTAC to 10 emphasize the need for solid science and facts in its work, and to appropriately apply its limited 11 resources toward this end. 12 13 Susan Gilson, from FMC Corporation, expressed support for the work of the EDSTAC, and 14 encouraged the Committee to develop recommendations useful to professionals in fields affected 15 by endocrine disruption, referencing her position as an industrial hygienist as an example of such 16 fields. In addition, she noted interest in the work of the STWG in gauging dose responses, as well 17 as other tools the work group employs. 18 19 John Casana, an environmental engineer, stressed his desire for the EDSTAC to use a scientific 20 approach to quantifying risk and decision making in its work; to make a conscious decision as to 21 what degree of uncertainty is acceptable in its recommendations; and, if there is greater uncertainty 22 than appropriate, to devise a way to get to an acceptable level of uncertainty for a defensible 23 position for future generations. 24 25 Grace Ziem, MD, Ph. D., requested that the EDSTAC seek testimony from physicians who are 26 treating humans suffering from problems related to endocrine disruption when making 27 recommendations for screening and testing. Dr. Ziem encouraged the Committee members to be 28 sensitive to frustrations that can occur in the interface of academics and physicians, and asked that 29 the Committee allow as much flexibility as possible in its recommendations for physicians to treat 30 their patients according to their own judgment. 31 32 Linda Roberts, an employee of Chevron, requested that, whenever possible, the public have access 33 to documents discussed at the plenary meetings in advance of such meetings to allow for 34 appropriate comment and understanding of the issues. She expressed appreciation for 35 Dr. Goldman's comments with respect to validation and encouraged the Committee to develop 36 clear criteria for interpreting the results from screens and tests. In addition, she noted that, as data 37 from screens and tests are collected, it would be useful to check this data against known endocrine 38 disruptors to see how predictive the testing was. Ms. Roberts also requested the Committee to be 39 EDSTAC Final Report Chapter Six Appendices August 1998 15 U  sensitive to the issues of dose selection, and to hold more discussion with respect to the issue of 1 zero tolerance. 2 3 Ajax Eastman, a former member of the Maryland Conservation Council, expressed concern about 4 the development, production, and release of potential endocrine disrupting chemicals during the 5 time it takes for the EDSTAC to reach consensus on a screening and testing program for EPA. He 6 questioned whether a science or policy measure existed to slow or stop the introduction of such 7 new chemicals until the Committee's recommendations are developed. Mr. Eastman also 8 expressed concern that the CF would allow issues such as risk assessment and cost/ benefit analysis 9 to put greater priority on economic matters than human and ecological health. 10 11 Pat Lane noted great concern about the health consequences of the incineration of medical and 12 municipal wastes. Ms. Lane expressed appreciation for the publicly open and flexible process 13 being used by the EDSTAC in developing its recommendations. In addition, she commented that 14 terms such as " risk assessment" and " parts per trillion" are perhaps not clearly or fully understood 15 by the general public, and that such terminology takes on international implications when used in 16 reference to chemicals used around the world. Furthermore, Ms. Lane noted that the public's 17 perception of risk is a critical element in effective communication and protection, and asked the 18 Committee to use any influence it had to encourage medical facilities to sort their waste and reduce 19 the incineration of PCBs. 20 21 Lisa Carlson and Kirstin Smith, both medical students at Johns Hopkins University and members of 22 the student chapter of Physicians for Social Responsibility, presented a joint statement and 23 expressed both concern that only two systems the gonadol and thyroidal systems were 24 mentioned in the Committee's scope, as well as hope that the Committee would expand its scope 25 beyond estrogen, anti estrogen, androgen, anti androgen, and thyroid related effects. Ms. 26 Smith read a statement from the student chapter of Physicians for Social Responsibility which 27 called for: ( 1) larger studies on humans and animals looking at chemical effects and synergies; ( 2) 28 the burden of proof to be placed on manufacturers to prove the safety of chemicals before 29 marketing them; ( 3) the use of small doses in testing for endocrine disruption; ( 4) restrictions on 30 medical waste incinerators and annual monitoring by EPA of waste from every incinerator for 31 levels of mercury and dioxin; and ( 5) aggressive education of the public by EPA on endocrine 32 disruption. 33 34 Phyllis Glazer and Sherre Holmer, of Mothers Organized to Stop Environmental Sins ( MOSES), 35 detailed the story of Winona, Texas, where a well was driven through the local aquifer for the 36 injection of hazardous waste into the ground, which resulted in contamination of the aquifer. They 37 commented that, in most cases, those affected by endocrine disruption lack political power, and 38 urged that any screening and testing program should make use of anecdotal information from 39 affected persons who live or have lived within two miles of facilities which store, produce, or 40 EDSTAC Final Report Chapter Six Appendices August 1998 16 U  dispose of hazardous waste. Furthermore, Ms. Glazer and Ms. Holmer requested that the 1 screening and testing program developed by the Committee take into account the synergistic 2 effects of multiple chemicals, due to their view that the regulation of exposure to single chemicals 3 is a matter of regulatory convenience. They recommended that the screening and testing program 4 focus on: the most vulnerable life stages; both human health and the environment; and the 5 transference of chemicals through bioaccumulation and human relationships ( e. g., breast feeding). 6 In addition, they recommended that: information about the potential harm of any substance be 7 released from the Committee to the public at the earliest opportunity; the Committee place 8 emphasis on the certainty of safety. They noted that the endocrinological effects do not necessarily 9 follow a linear relationship, and that current levels of acceptable risk burden populations of 10 minorities. Finally, they urged the EDSTAC to practice good science without allowing an uneven 11 balance of representation on the Committee. In accord with this, they recommended that the 12 Committee membership be restructured to decrease the number of agency and industry 13 representatives. 14 15 Albert Donnay, executive director of MCS Referral and Resources, addressed the definition of 16 " endocrine disruptor" as discussed by the Committee. Mr. Donnay commented that the inclusion 17 of the notion of " adverse" in the definition overlooks the fact that there are many endocrine 18 disruptors that may produce beneficial or therapeutic effects, and that effects of endocrine 19 disruptors may vary by individual. He encouraged the Committee to remind the public that such 20 beneficial endocrine disruptors do exist. In addition, he asked the Committee to not only include 21 the young and developing in recommended field studies, but to also include elderly animals. Mr. 22 Donnay also encouraged the Committee to consider its definition reference to exogenous 23 substance, stating that light can have an effect on hormones ( e. g., diurnal cycles). Finally, he asked 24 that the EDSTAC clarify their definition inclusion of "( sub) populations" to identify what the 25 smallest subpopulation that needed to be considered was. 26 27 Gwen Dubois, MD, of Physicians for Social Responsibility, stated that the consideration of groups 28 and classes of chemicals rather than of individual chemicals in the screening and testing program 29 was very sensible. She urged the Committee to not be reticent to recommend action on 30 information of harmful endocrine disruption to ban certain chemicals. In addition, Dr. Dubois 31 expressed hope that the Committee's recommendations would address exposure to multiple 32 chemicals, and asked the Committee to consider the hazards of medical waste. 33 34 Raymond Yang, a professor of Toxicology at Colorado State University, applauded the endurance 35 of the EDSTAC members through the course of difficult deliberations. He expressed his view that 36 the figure regarding the number of chemicals released into the environment used by the Committee 37 was low, and encouraged the Committee to give serious consideration to the issue of mixtures in 38 all of its deliberations, products, and recommendations. 39 40 EDSTAC Final Report Chapter Six Appendices August 1998 17 U  Bruce Baird Struminger, a student at Johns Hopkins University Medical School, expressed concern 1 regarding the way that EPA formed the EDSTAC. He stated his view that the Committee lacked a 2 clear sense of consensus on the definition of " endocrine disruptor" and noted that, while simplicity 3 is good where appropriate, the emphasis in the definition should be on accuracy. Mr. Struminger 4 stated that the issue of endocrine disruption is a complex one, and that a simple definition would 5 not help protect the public health. He urged that scope be enlarged to include additional 6 hormones, and expressed his feeling that policy on endocrine disruption is getting ahead of the 7 clinical science on the issue. He expressed dissatisfaction with the level of education on 8 endocrinology in medical schools, as well as the lack of communication about the issue of 9 endocrine disruption in endocrine journals. He asked the Committee to take a precautionary 10 stance in its recommendations and, given the growing and irreversible bioaccumulation levels of 11 dioxins and PCBs, to place the onus on industries to prove their products do not compromise 12 human health. 13 14 Audrey R. McMahon, from the Learning Disabilities Association, stated that maternal thyroid 15 dysfunction is a very serious endocrine disruption issue. She further stated that EPA research has 16 clearly related PCBs to diminished thyroid function and subsequent effects on humans, including 17 embryonic development. Ms. McMahon expressed her view that developmental disabilities are 18 epidemic in the United States, and added that she hoped the Committee's recommendations would 19 help this situation. 20 21 Mimi Cooper, of the League of Women Voters in Baltimore, expressed her hope that chlorines and 22 the burning of dioxins would be affected by the Committee's work and would eventually be 23 brought under control. 24 25 Yataka Aoki, from Johns Hopkins University Public Health School, stated that it is difficult for 26 members of the general public to understand what Types I and II errors are, and asked the 27 Committee to use commonly familiar language in its recommendations and final report. 28 29 Erica Wexler, a science teacher from South Baltimore and a member of the Community Advisory 30 Panel, commented that it was important for the EDSTAC to follow a scientific process and take all 31 the advice and views into account as it proceeds with its tasks. She added that the Committee 32 should identify the best screens and tests, validate them, and implement their use. 33 34 Greg Merrill, from the Chlorine Chemistry Council, noted a threefold increase in state legislation 35 that make reference to endocrine disruption, and that those who were responsible for creating 36 many of the regulations and laws, particularly at the state level, are looking to the EDSTAC for 37 guidance. He stated that it was important that the foundations EDSTAC establishes and the 38 principles adopted be based on sound science to ensure confidence in their implementation. 39 40 EDSTAC Final Report Chapter Six Appendices August 1998 18 U  Davis Baltz, of Commonweal, described journal articles about gender maturation and exposure to 1 certain chemicals. He stated that, as reflected by research in the popular press; evidence of 2 endocrine disruption is increasing. Mr. Baltz expressed hope that the Committee would draw the 3 conclusion to increase research and prevent exposure. He stated that members of the public have a 4 right to know about the EDSTAC's activities, and that plenaries should continue to be conducted 5 across the country to allow input from different geographical areas. 6 7 Ann Mulligan, National Coordinator for The DES Cancer Network, stated that DES affected 8 persons represent one of the few populations known to be affected by endocrine disruption. She 9 urged the Committee to construct a new paradigm for endocrine disruption, and to adopt zero risk 10 and precautionary principles. Ms. Mulligan described generational effects of DES, adding that 11 DES is still being given to women in other countries and the affected population, therefore, is a 12 global one. She commented that traditional risk assessment failed those exposed and needs to be 13 revisited, noting that another chemical, AZT, currently being prescribed to pregnant women 14 shows DES like effects. 15 16 Alyce Ortizar, of the Well Mind Association of Greater Washington, detailed cancer rates and 17 breast cancer incidence stating that she was troubled by the fact that companies that have caused 18 endocrine disruption seem to be benefiting from treating endocrine disruption. She urged the 19 adoption of zero tolerance beliefs, and the shifting of the burden of proof onto industry. 20 21 Carolyn S. Van Pelt, of DuPont and the American Crop Protection Association, applauded the 22 Committee for its process and for the work performed thus far. 23 24 Daniel Pontious, from the Maryland Public Interest Research Group, stated that the information 25 shared with the public is only as good as the testing that is done to generate that information. He 26 expressed his appreciation that the Committee would be looking at multiple chemical exposures, 27 and encouraged the use of caution and scrutiny in looking at low dose toxicity of some chemicals. 28 29 Keary Cope, a student at Johns Hopkins University, suggested the consideration of certain 30 metabolites in the Committee's work. 31 32 Alan Noe, of the American Crop Protection Association, noted that the large number of public 33 commenters indicated a high level of interest in issues related to endocrine disruption. He 34 commented on the role and benefits of pesticides in the American agricultural sector, and 35 discouraged the use of the precautionary principle. He also urged that science " drive" the 36 EDSTAC process. 37 38 EDSTAC Final Report Chapter Six Appendices August 1998 19 U  Lara Shane, of Responsible Industry for a Sound Environment, expressed her belief that the 1 EDSTAC process is a great one to bring people from the different sides of the spectrum to come 2 together in productive discussion and action, and offered the Committee her wholehearted support. 3 4 Valerie Jewitt, from the American Crop Protection Association, commented that her family had 5 been impacted by the incidence of breast cancer, and said she supported getting all affected parties 6 involved in the EDSTAC process. She encouraged the use of sound science in effecting the 7 parties' mutual goal of making the environment safer for all life, and added that she looked 8 forward to when this type of process is commonplace in decision making. 9 10 Charles Cangerni, of Reliance Fire Protection, discussed the role of small business in the United 11 States, noting that they do not generally have the same employment and financial resources as 12 large companies. Mr. Cangerni urged the Committee to keep small businesses in mind when 13 recommending screening and testing techniques. 14 15 Melissa Sheridan, a member of the Endometriosis Association, stated that she suffers from the 16 disease, and told the Committee that the EDSTAC's work is vitally important and very 17 appreciated. 18 19 Gail McPherson, an American Agri woman and farmer, expressed great concern regarding her 20 feeling that the general public was characterizing the agricultural sector as polluting and causing 21 disease. She urged the public and the EDSTAC to remember the role of the agricultural sector in 22 the development of the United States. 23 24 David Fisk, a medical student at Johns Hopkins University and member of the student chapter of 25 Physicians for Social Responsibility, stated that endocrine disruption was a major topic of 26 discussion at a recent national conference in Chicago. He urged that the burden of proof rest on 27 chemical manufacturers and incinerator operators. 28 29 Polly Walker, MD, encouraged the adoption of zero exposure and precautionary principles and a 30 new type of risk assessment. She stated that the long lasting and irreversible effects of endocrine 31 disruption are unconscionable. Dr. Walker further stated that unless the real levels of potential 32 harm are put into the equation of risk assessment, new technologies will not be developed to 33 address them. She encouraged the Committee to consider the synergistic and additive effects of 34 chemicals in endocrine disruption. 35 36 Victor Perez, a medical student at Johns Hopkins University and a member of a south Baltimore 37 community, stated that his community receives disproportionate effects from hazardous waste. He 38 noted that amphibians tend to be the first type of organisms to be noticeably affected by 39 environmental changes due to their breeding patterns and aquatic life. Similarly, he stated that 40 EDSTAC Final Report Chapter Six Appendices August 1998 20 U  inner city and urban populations have emerged as somewhat of an indicator species for humankind, 1 especially in reference to endocrine disruption. He encouraged the Committee to seriously 2 consider such populations in its deliberations. 3 4 Response to Public Comment 5 6 Judy O'Brien, Associate of The Keystone Center, thanked the members of the public for their 7 comments and asked Committee members if they had any comments, clarifications, or questions 8 related to the public comment. 9 10 With respect to Dr. Ziem's comments, one Committee member noted that the continued need to 11 integrate the work of the EDSTAC with practitioners is one that has been reiterated by Committee 12 members themselves throughout the EDSTAC process. In addition, it was noted that the 13 EDSTAC is not charged with developing clinical tests to assess endocrinological wellness, but 14 rather experimental toxicology related to endocrine disruption. 15 16 Regarding the interface between science and public policy, one Committee member noted the 17 difficulties attendant in banning or regulating chemicals already on the market. With respect to the 18 Alar scare, another Committee member noted that the scientist presented the Alar information 19 correctly, but the media blew the information out of proportion. Due to this unpredictability, the 20 Committee member urged the EDSTAC, and the COWG in particular, to try to anticipate potential 21 public relations/ perception problems to the greatest extent possible. 22 23 With respect to the EDSTAC's scope, Dr. Goldman commented that the Committee is not 24 responsible for setting standards or for advising EPA on how to set them. Nor, she added, is the 25 Committee responsible for medical waste incineration issues. Dr. Goldman noted, in the convening 26 phase, many Committee members advocated for taking as comprehensive a strategy as possible to 27 address the widest possible scope of hormones. However, given the time pressures of 28 accomplishing the tasks and mandated deliverables, certain hormones were necessarily selected as 29 a starting point for the Committee's scope. The EDSTAC's recommendations will, however, 30 provide a general framework for EPA to use as new information comes forward in the application 31 of screening and testing programs for a variety of hormonal endpoints and mechanisms. 32 33 Regarding public comments about research, Dr. Goldman noted that the EDSTAC can make 34 recommendations concerning research and studies to be done, but that the Committee would not 35 be performing any research or studies itself. In response to comments regarding regulated agency 36 membership on the Committee, Dr. Goldman noted that the Agencies that generate waste are not 37 part of the EDSTAC, but that many agencies represented on the Committee are indeed regulators. 38 39 EDSTAC Final Report Chapter Six Appendices August 1998 21 U  One Committee member replied to comments regarding the EDSTAC's scope and industry onus 1 and burden of proof, noting that the industry representatives on the Committee are sincerely 2 concerned that everything that is produced in their industry is safe for humans and the 3 environment. He added that, with respect to scope, the hormonal areas identified as foci for the 4 Committee's work are those where the Committee members believe the EDSTAC has the greatest 5 chance of making solid decisions and recommendations given the deadlines and the current state of 6 the science. 7 8 Another Committee member addressed Dr. Yang's comments regarding the consideration of 9 mixtures stating that, while there may not yet seem to be a great deal of discussion on the subject 10 at the plenary level, much work on mixtures was taking place at the work group level, and would 11 eventually be brought before the full Committee. 12 13 Another Committee member pointed out that there is, indeed, representation on the EDSTAC by 14 physicians who are treating patients with endocrinological disorders. 15 16 Dr. Goldman thanked the public for their thoughts, and expressed her appreciation of the public's 17 attention and patience in observation of the involved, and sometimes intricate, discussions of the 18 EDSTAC. One Committee member urged members of the public to look to their own 19 communities, not the Committee, to find the solutions to community problems. Dr. Goldman 20 echoed these sentiments, adding that she recognized the value of and need for inter community 21 communication and encouraged communities affected by endocrine disruption and hazardous 22 waste to begin to engage each other in dialogue. 23 24 After the public comment period, several EDSTAC members expressed their recognition of the 25 troubling health and environmental consequences of endocrine disruptors, but urged the public to 26 recognize that the charge of the EDSTAC is to develop a screening and testing program for 27 endocrine disruptors. Committee members encouraged future public comment on thoughts and 28 ideas specifically related to the development of an effective, strategic, and efficient screening and 29 testing program, rather than testimony related to the effects and perils of diseases and endocrine 30 disruption. Public comment opportunities at the Chicago plenary and future meetings may, 31 therefore, be designed to facilitate this type of discourse. 32 33 V. July 15 16, 1997   Chicago, Illinois 34 35 36 Following the Committee's deliberations on the first day of the plenary meeting, members of the 37 public were invited to offer comments related to the scope and charge of the EDSTAC. The 38 EDSTAC Final Report Chapter Six Appendices August 1998 22 U  public comment session lasted over two hours, and allowed time for more than forty individuals to 1 provide comment to Committee members, nearly all of whom were present. Due to the number of 2 individuals seeking to provide public comment, all those who signed up to speak to the EDSTAC 3 were requested to keep their comments to no more than four minutes in length. While this request 4 may have caused frustration on behalf of some individuals, the intended and effected result was to 5 allow all persons wishing to provide comment the opportunity to do so. Written comments 6 submitted by members of the public may be found in the public docket ( Docket Number OPPTS 7 42189; phone 202 260 7099). This meeting summary attempts to capture the essence of the 8 comments made by members of the public to the EDSTAC during the public comment session. 9 10 Patricia Speth, a concerned citizen who comes from a family of farmers, expressed concern that 11 the agricultural industry may be adversely impacted by endocrine disruptors, prior to gaining 12 additional information about their effects. She expressed her support for the EDSTAC process 13 and suggested that the approach this problem should be deliberate and practical and urged that 14 solutions not be based on emotionalism or " junk science." 15 16 Joe DiGangi, of Greenpeace in Chicago and formerly a corporate scientist, spoke to the issue of 17 risk assessment. He urged the Committee to reopen the risk assessment discussion within the 18 Committee's deliberations because he feels as though the Committee has an obligation to show to 19 the public there is a disparity of views on this issue. He also would like to see industry take on the 20 burden of proof to demonstrate the safety of new chemicals. 21 22 Brett Hulsey, of the Sierra Club, mentioned his role on the FACA for water monitoring and 23 expressed concern about the fish people consume today and the lack of knowledge about fishing 24 advisories that exists and the potential for harm because of that lack of knowledge. He supports 25 due diligence for companies, particularly to handle the high costs associated with cleaning up 26 polluted areas. Finally, he urged the Committee to be conservative and make screens as extensive 27 as possible that go beyond adverse affect. 28 29 Mark Richie, of the Institute for Agriculture and Trade Policy, an organization that is concerned 30 about pollution and health concerns, particularly due to airborne chemicals, which may render 31 products produced in an organic manner polluted, suggested that multiple layers of impacts are of 32 great concern, as is the eroding market niche for organic products due to this pollution. He 33 cautioned the Committee to take the precaution that is necessary to protect public health, but to 34 also remember that decisions are being made to protect other industries as well. 35 36 Ellen Kauffman, of the Endometriosis Association in Chicago, stated that she was there 37 representing women with endometriosis and related information about the disease and some 38 concerns of those women who have it. She indicated that studies have shown that a transfer of 39 toxins can occur in utero and during breast feeding, and the hormonal effects in children of 40 EDSTAC Final Report Chapter Six Appendices August 1998 23 U  mothers with the disease are increasingly being realized. Ms. Kauffman related that there are 5 1/ 2 1 million cases of endometriosis today and is estimated to occur in 10% of women of reproductive 2 age. Endometriosis is affecting women at younger and younger ages with greater severity the 3 costs of this disease are high. 4 5 Davis Baltz, of Commonweal, Inc., spoke directly about the screening and testing program, 6 suggesting that chemicals in the Stop Box should undergo a random sampling process in order to 7 ensure they have not been placed there erroneously. He also suggested breast milk should be 8 tested. Regarding Production and Use data, he supported breaking these out into two separate 9 categories because use information is quite different that production information. Mr. Baltz 10 expressed his support for the public's right to know about these issues every step of the way, 11 which includes a comprehensive educational effort. 12 13 Rob Christie, Director of Public Affairs for FMC Corporation, expressed concern both personally 14 and professionally about the work of the EDSTAC. He related his opinion that any direction the 15 Committee takes with public policy in this area should be based on sound science and he urged the 16 Committee to remain focused on their tasks, in order to reach the deadlines ahead of them. 17 18 Jackie Hunt Christensen, of Health Care Without Harm, asked the Committee to do the following: 19 1) recommend to EPA that chemicals such as dioxins be phased out immediately, rather than go to 20 tier 2 testing; 2) testing of chemicals used in medical products should be reviewed, as well as 21 products produced by health care facilities; and 3) make it a priority that chemicals that cross the 22 placenta or are present in breast milk should be tested. 23 24 Lynn Fahey McGrath, manager of risk assessment for Hoechst Corporation, a multinational 25 chemical company, said there is a clear need for chemical products to pose a minimal risk to 26 consumers and the environment. She urged against the publication of premature results and their 27 effects ( e. g., poor deselection choices), noting that in Europe, positive results from a screen can 28 result in deselection. Her experience working in Europe has broadened her perspective on these 29 issues, and she encourages the Committee to incorporate greater coordination there. She also 30 encouraged the Screening and Testing Work Group to reevaluate baseline data and, at a minimum, 31 allow flexibility for data required in other countries. 32 33 Jack Weinberg of Greenpeace discussed some of the policy implications of the decisions EDSTAC 34 has already made. He noted that the concept of endocrine disruption used at the Wingspread 35 Conference was broader than that used by the EDSTAC and very useful because it captured a 36 range of mechanisms that operated at very minute concentrations. Mr. Weinberg recognized that, 37 for pragmatic reasons, the EDSTAC limited the scope of its efforts to three hormonal systems, but 38 asked the Committee to make clear to the public that the extent of endocrine disruption was not 39 circumscribed nor fully addressed by consideration of the three hormones in the EDSTAC's scope. 40 EDSTAC Final Report Chapter Six Appendices August 1998 24 U  1 Linda Roberts, of Chevron, directed her comments to the Priority Setting Work Group. She 2 indicated that Chevron has had some experience with SAR models and, in terms of their utility and 3 use, she suggested that the accuracy of SAR output is a function of the degrees of structural 4 similarity between the untested chemicals and the tested chemicals. Regarding Option 3 of the 5 PSWG's presentation, she urged the work group to clarify what is meant by High, Low, and No 6 Data, especially in terms of production and use. For the No Data option, she supported using the 7 term " inadequate information". Regarding the Stop Box, Ms. Roberts suggested that there is not 8 much of a distinction between 20,000 and 40,000 chemicals, because many will not be tested in 9 our lifetime. She urged the Committee to evaluate the chemicals they do want to test and design 10 the program to incorporate them. Regarding the STWG activities, Ms. Roberts encouraged the 11 use of validation in the biological variability of the process. She suggested it would be helpful, for 12 example, to know how reproducible the endpoints are, how many animals are needed, and whether 13 the results are reproducible in good lab. Finally, regarding dose response, she asked for guidance 14 from the STWG on the sizes of doses it thinks is appropriate, particularly for the high and low 15 doses. 16 17 Joanna Hoelscher, Director of the Illinois office of Citizens for a Better Environment, thanked the 18 Committee for holding a meeting in Chicago and for the opportunity to comment. She urged the 19 EDSTAC to not lose sight of the broader mission of protecting public health and the environment 20 in both the short term and the long term, and therefore encouraged the use of the " precautionary 21 principle". Ms. Hoelscher then made specific comments directed toward PSWG and COWG. To 22 the PSWG, she said the CF must take into account the fact that there are already significant 23 amounts of information in the literature on chemicals already known to be endocrine disruptors, 24 and there should be a mechanism to fast track these in order to eliminate exposure. She also stated 25 that traditional risk assessment methodologies are inadequate to protect public health, which 26 should be included in the CF. Finally, she suggested prioritization be given to certain chemicals 27 based on bioavailability and persistence. To the COWG, she requested that scientific uncertainty 28 not be considered tantamount to an assumption of no danger. 29 30 Michael Murry of the National Wildlife Federation directed his comments to the PSWG as follows. 31 First, he suggested the uncertainty that exists with SARs has to be an issue when looking at 32 toxicological effects. Second, regarding the log K ow, he suggests that increasing the K ow means 33 increasing the bioaccumulation of chemicals and there is no reason why there should be an upper 34 limit on K ow s. Third, Mr. Murray suggested that there are two potential sources of breakdown 35 products from plants monomers and dymers and the only way to control discharge of them is to 36 control discharge of their parent compounds. Finally, regarding exposure data, he encouraged 37 evaluation in a precautionary way because 2000 new chemicals are introduced each year and some 38 processes are still behind and testing old chemicals that were banned 20 years ago. 39 40 EDSTAC Final Report Chapter Six Appendices August 1998 25 U  Sarah Janssen, a medical student who is a member of Physicians for Social Responsibility, raised 1 several concerns regarding potential endocrine disruptors. Specifically, she is concerned about 2 toxic releases from a local toxic waste incinerator as well as about endocrine disruptors in the air, 3 water, and ground. A main concern lies with her future potential patients and the ramifications of 4 these chemicals being emitted into the environment. Ms. Janssen commended the Committee for 5 its intention to screen and test mixtures and encouraged them to look at low doses. She also urged 6 for an increase in federal funding for the development of more sensitive assays. 7 8 Mark Holmer, of the Chemical Industry Council of Illinois, provided some general comments to 9 the Committee. He stressed the importance of remaining objective when examining such issues 10 and urged that sound science be applied. He praised EPA for reaching outside of its own 11 employees to create the Committee and for assembling such a diverse group. Finally, he urged that 12 science lead EPA to whatever regulatory path they take. 13 14 Ed Gunderson, chairman of regulatory affairs for the Chemical Industry Council of Illinois, 15 suggested any policies developed be based on sound science, be technically realistic, and serve to 16 protect the public health and the environment. He urged that protocols for the Screening and 17 Testing program provide conclusive data demonstrating beyond any doubt that an adverse effect 18 could result from a realistic exposure route. Mr. Gunderson also encouraged the use of a 19 scientific, dosage risk based approach to developing the program. 20 21 Lynn Lawson, with the Multiple Chemical Sensitivities: Health and Environment, described health 22 effects she presently experiences due to chemical sensitivity and lifestyle changes she has made to 23 limit exposures to such chemicals. Many of the chemicals indicated in personal blood tests, she 24 asserted, appear on lists of suspected endocrine disruptors. Ms. Lawson asked the EDSTAC to: 25 1) address the endocrine disrupting potential of mixtures first in their screening and testing 26 program; 2) consider new chemicals guilty until proven innocent; 3) " sunset" chemicals known, or 27 likely, to be endocrine disruptors, noting her feeling that any threshold for such chemicals is too 28 high. 29 30 Marjorie Fischer, of the League of Women Voters, stated that chemicals in the environment should 31 not impinge public health, especially the health of children. She added that the current position of 32 the League of Women Voters on pesticides is that exposures to people should be reduced and that 33 nontoxic alternatives to these pesticides should be used. Ms. Fischer noted that many suspected 34 endocrine disruptors would appear to be pesticides and would, therefore, seem to be of interest to 35 the League due to its interests, stances, and publications. She expressed appreciation of the 36 inclusive definition of endocrine disruptors tentatively being used by the Committee, and urged that 37 zero tolerance parameters be imposed on endocrine disrupting chemicals, especially in light of 38 effects caused by fetal exposure to such chemicals. 39 40 EDSTAC Final Report Chapter Six Appendices August 1998 26 U  Cecile Sastre, from the Endometriosis Association, asked the EDSTAC to remember the real 1 effects diseases attributed to endocrine disruptors are having on humans. She described symptoms 2 and illnesses related to the disease of endometriosis, and noted that evidence indicates certain 3 chemicals are responsible for endometriosis and a myriad of other diseases. Ms. Sastre told the 4 Committee she is personally afflicted by endometriosis, and described the effects the disease has 5 had on her life, including severe chemical sensitivities, difficulties finding employment due to the 6 hazards of workplaces, as well as other lifestyle complications. She urged the EDSTAC to set 7 zero tolerance standards, and to consider the synergistic actions of chemicals. 8 9 Dr. George Raab, former chair of the Species Survival Unit of the Chicago Zoological Society, 10 commented on the synergies of chemical compounds affecting species. In particular, he sought to 11 report recent information on the phenomenon of declining amphibian populations in several parts 12 of the world. Although, he admitted, the ultimate causal effects and factors to which these 13 declines may be attributed have not yet been satisfactorily identified, he noted that some declines 14 indicate there might be endocrine disruption or distortion effects at work, especially in parts of 15 Central America. Dr. Raab urged the financing of studies on these declines and effects on the 16 broadest scale possible. 17 18 Jim Houston, with the International Joint Commission's Canadian Section in Ottawa, reflected on 19 the interface between efforts directed toward endocrine disruptors in his country and in the United 20 States. He noted that the earlier Canadians are involved in similar activities and are informed by 21 the United States on its efforts, the more efficiently the problem may be addressed. 22 23 Charlie Cray, of Greenpeace, stated that the fact that the Committee is focusing on developing a 24 screening and testing program should not delay current federal or state actions to phase out 25 products proven to cause endocrine disrupting effects. He noted there was a need to support 26 policies on endocrine disruptors even when uncertainties exist. Mr. Cray described current 27 European studies indicating the timeliness of phasing out the use and production of certain 28 chemicals. Particularly addressing the endocrine disrupting potential of chemicals in medical 29 products, Mr. Cray noted that allegedly safe alternatives are available and urged their use. He 30 encouraged the Committee to talk about releases and exposures of potentially endocrine disrupting 31 chemicals from common products into waste water and other media. 32 33 Chuck Elkins, an environmental consultant, commented that the Committee's T1S design sounded 34 fairly sophisticated and seemed consistent with the current state of the science and with similar 35 efforts. However, he expressed caution that a decision to use either one or a very small number of 36 decision makers to decide what testing would be done in a tailored approach could prove to be a 37 bottleneck in the screening and testing process. Mr. Elkins asked that the Committee pay 38 particular attention to communications issues in the sorting and prioritization process, as these 39 stages of the program could be misunderstood by both the public and decision makers. 40 EDSTAC Final Report Chapter Six Appendices August 1998 27 U  Mary Beth Doyle, from the Ecology Center of Ann Arbor, thanked the Committee for conducting 1 a meeting in the Great Lakes region, and for the Committee's hard work. She encouraged the 2 Committee to adopt the " precautionary principle" in its program, and to insure chemicals are tested 3 thoroughly before being released into the environment. With respect to hormone disruptors, she 4 noted the inclusion of the word " adverse" in the working definition concerned her, and urged the 5 EDSTAC to develop a broader definition. In addition, Ms. Doyle expressed concern with the Stop 6 Box, noting her feeling that the scientific tools currently available to screen and test for endocrine 7 disruptors are too crude to send a chemical substances or mixtures definitively to the Stop Box. 8 Rather, she requested that such chemical substances or mixtures be assigned to a low priority 9 group. Furthermore, Ms. Doyle suggested that the EDSTAC " groundtruth" chemicals sent to the 10 Stop Box to ensure the accuracy of the screening and testing program. She also said that 11 community concern over a chemical substances or mixtures should be sufficient to pull a chemical 12 out of the Stop Box for re entry into the screening and testing program. 13 14 Penny Richards, the Learning Disabilities Association of Illinois, Inc., expressed concern about the 15 impact of agricultural chemicals on the lifestyle and health of humans, and especially on her 16 developmentally disabled child. Specifically, Ms. Richards noted concern regarding hormonal 17 disruption due to fetal exposure, and urged the EDSTAC to promote and protect children's health. 18 She urged the Committee to adopt the " precautionary principle," adding that chemicals should not 19 have a " civil right" of being considered innocent or harmless until proven guilty. She stated that no 20 permission had been given by any human for a chemical body burden. 21 22 David De Rosa, from Greenpeace in Chicago, expressed his concern caused by the recognition 23 that, due to realistic constraints, all chemicals cannot be tested for endocrine disruption. 24 Therefore, he noted, he hoped that scientists would be able to learn from the EDSTAC's screening 25 and testing program how to make educated guesses about classes of chemicals, and that scientists 26 would apply that knowledge in anticipating any effect, not just adverse effects. Mr. De Rosa 27 stated that the screening and testing program should look at chemical substances or mixtures, as 28 well as their breakdown products, with which people come into contact on a daily basis. He 29 encouraged the prioritization process to use production volume figures, and requested that any 30 chemical proven to be an endocrine disruptor be banned. 31 32 Bill Holland, of Illinois Public Interest Research Group, stated his concern about the potential 33 hazards of minute doses of endocrine disrupting chemicals, noting that damage from exposure may 34 not be apparent until much later in an organism's development process. He stated that his 35 organization urged the adoption of both the " precautionary principle" and zero exposure 36 tolerances. Mr. Holland added that industry should be responsible for showing that their chemicals 37 are safe before approval, use, and release into the environment. Furthermore, he requested EPA 38 make significant and easily understandable efforts to educate the public on endocrine disruption 39 issues, chemicals being tested, and the endocrine disruptor screening and testing process. 40 EDSTAC Final Report Chapter Six Appendices August 1998 28 U  Angel Cohoon, also of Greenpeace, offered great concern regarding the effects of endocrine 1 disruptors on early stages of development, especially due to fetal exposure from chemical 2 substances or mixtures present in pregnant mothers. She urged the Committee to consider using 3 the " precautionary principle" and to immediately phase out any chemical proven to be an endocrine 4 disruptor. Despite economic and practical difficulties, Ms. Cohoon expressed confidence that 5 scientific ability existed to eliminate proven endocrine disruptors. 6 7 Barbara Alexander Malarky, of the Waste Handlers Network, praised Illinois EPA's efforts on 8 hormone disruption publications to date. She urged that the Committee's prioritization process 9 place significant emphasis on the cumulative and synergistic effects of endocrine disruptors, and 10 that it not look at chemicals in isolation. Ms. Malarky expressed concern regarding the effects of 11 waste incinerators, especially from the disposal of dioxin and cows, due to the potential for 12 interaction of airborne endocrine disrupting chemicals. 13 14 Tracy Easthope, from the Ecology Center of Ann Arbor, recommended to the Committee that all 15 proceedings of the International Joint Commission and their science advisory board be included as 16 part of the official proceedings of the Committee. She noted that persistence is an important 17 criteria to consider in the screening and testing program, and that testing should be sensitive 18 sentinel species as an " early warning system" in order to avoid economic and human 19 health/ environmental costs. In addition, she questioned the scientific ability to send a chemical 20 definitively to the Stop Box as indicated in the Conceptual Framework. Ms. Easthope encouraged 21 the Committee to look at research indicating that the timing of exposure has significant 22 implications for endocrine disrupting effects, including synergies and seasonal variations, due to 23 the fact that toxicity differs depending on stage of development and health of the organism at the 24 time of exposure ( e. g., fetal exposure from mother's body burden). She expressed concern about: 25 limitations on exposure detection due to the state of the science; the Committee's working 26 definition of an " endocrine disruptor"; and the potential for a lack of clarity about screening and 27 testing results ( e. g., whether or not a chemical substances or mixtures is an endocrine disruptor if 28 results of T1S or T2T are mixed). Finally, Ms. Easthope emphasized the importance of risk 29 assessment considerations in the Committee's development of a screening and testing program, as 30 well as the need to constantly reevaluate the effectiveness of whatever tools are designed to 31 address the endocrine disruptor issue. 32 33 Response to Public Comment 34 35 Dr. Goldman noted that while the Committee is not yet, as a whole, in agreement on the role of 36 risk assessment and its use in regulating chemicals, discussion on the subject had not at any point 37 been constrained or inhibited. She asked members of the public to remember that this, in addition 38 EDSTAC Final Report Chapter Six Appendices August 1998 29 U  to other issues, are still at a level of tentative agreement, and not to characterize all of the 1 EDSTAC's deliberations as firmly agreed upon. 2 3 In response to one commenter's request that the EDSTAC look at the international context and 4 regulatory practices in the European Union as it proceeds in its deliberations, Dr. Goldman 5 indicated this was an issue for the STWG to consider. However, she cautioned that some testing 6 data used by European authorities might not be available for the EDSTAC's screening and testing 7 program due to confidential business information constraints and to differences in evaluation 8 methods. 9 10 With respect to international harmonization and coordination issues, Dr. Goldman reminded the 11 Committee and members of the public, that EPA and the EDSTAC have begun to cooperate with 12 other international organizations on endocrine disruption issues. Specifically, interaction is 13 currently underway with the OECD, with one of EPA's specific goals being the structuring of the 14 Committee's work to make its efforts available to the OECD, and vice versa. 15 16 She also highlighted recent and ongoing international coordination efforts with the Summit of 17 Eight, where an environmental agenda was put together for protecting children on an international 18 level, including the consideration of endocrine disruption. In addition, the United States is 19 involved in the International Program for Chemical Safety, an international effort that will involve 20 the coordination and collaboration of research on matters of chemical safety and endocrine 21 disruption. 22 23 With respect to comments regarding the Committee's tentative definition of an " endocrine 24 disruptor" and its decision to focus its efforts on a defined set of endpoints related to estrogen, 25 androgen, and thyroid related effects, Dr. Goldman agreed with one commenter that the 26 Committee should take care to recognize that these hormones did not constitute the full extent of 27 potential endocrine disruption. In addition, she noted that, while the EDSTAC will focus on the 28 three specified hormonal systems, the Committee plans to develop broader guiding principles for a 29 broader application of the screening and testing program to consider endocrine disruptors in 30 general. 31 32 With respect to the issue of screening and testing mixtures, one EDSTAC member noted that the 33 issue is being taken very seriously, and is presently being addressed by the PSWG. Although a 34 specific formula for addressing mixtures in the sorting, priority setting, screening, and testing 35 processes has not yet been developed, it was indicated that more information would likely be 36 available on the issue in upcoming plenary meetings. 37 38 Several Committee members expressed their appreciation of the public comments, noting in 39 particular the scientific and policy related sophistication of the remarks. Committee members, in 40 EDSTAC Final Report Chapter Six Appendices August 1998 30 U  response to some of the public remarks, noted their recognition of the multiple and sensitive issues 1 tied to communication, and reiterated their intention to give this aspect of the screening and testing 2 program great attention. 3 4 VI. October 7 8, 1997   New York, New York 5 6 7 Following the Committee's deliberations on the first day of the plenary meeting, members of the 8 public were invited to offer comments related to the scope and charge of the EDSTAC. The 9 public comment session lasted over two hours, and allowed time for approximately twenty five 10 individuals to provide comment to Committee members, nearly all of whom were present. Written 11 comments submitted by members of the public may be found in the public docket ( Docket 12 Number OPPTS 42189; phone 202 260 7099). This meeting summary attempts to capture the 13 essence of the comments made by members of the public to the EDSTAC during the public 14 comment session. 15 16 Frank Stoppenbach, a resident of the Hudson Valley, noted that he was concerned about the 17 presence of PCBs in his community and about the impacts on small communities of chemical 18 exposures. He encouraged the consideration of fetal and developmental exposures in the 19 EDSTAC screening and testing program. Furthermore, Mr. Stoppenbach encouraged that data 20 regarding endocrine disruptors generated by the screening and testing program be made as publicly 21 accessible as possible. He expressed concern, as well, about the use of SLAP suits in his 22 community. 23 24 Greg Koontz, director of regulatory affairs for the Chemical Producers and Distributors 25 Association, described benefits of the products supported by his organization. He encouraged 26 support for efficient, cost effective responses to environmental problems commensurate with the 27 problems they are meant to address. He noted concern about the impact of regulatory actions on 28 small businesses, as well as cost impacts from such regulation. Mr. Koontz questioned the scope 29 of the endocrine disruption issue, as well as the accuracy and ability of assays to detect designated 30 endpoints. He encouraged the Committee to clarify the definitional and utilization issues of false 31 positives and negatives, and urged a balanced approach to risk assessment. 32 33 Ralph Magin, a research and development scientist with the Albermarle Corporation, expressed his 34 support for toxicity testing requirements that afford increased public health protection. He noted 35 the broad array of assays under consideration, and encouraged the Committee to be pragmatic in 36 its selection process. He also noted that toxicity screening and testing is a decision oriented 37 process and should be characterized by relevant and reliable endpoints and methods, upon which 38 EDSTAC Final Report Chapter Six Appendices August 1998 31 U  clear interpretations of results can be made. Mr. Magin stated that those who review and interpret 1 the testing results will not likely be research scientists, and that opportunities to clarify ambiguities 2 will not be forthcoming once the EDSTAC process is concluded. He questioned the present 3 potential scope of screens under consideration by the STWG, and encouraged the group to be 4 pragmatic and to use validated assays in the screening and testing tiers to ensure, among other 5 things, that resources are not expended to study chemicals of little concern. 6 7 Laura Whatley, with American Cyanamid Company, recognized the need to know about endocrine 8 disrupting chemicals, and recommended the development of a deliberate, practical approach to do 9 so, in order to save time and resources. She furthermore encouraged the Committee to base its 10 recommendations on sound, verifiable science so that future policy would be based on that sound 11 science. 12 13 Geri Barish, president of the Long Island Breast Cancer Coalition and a member of One in Nine, a 14 breast cancer support and advocacy group, noted concern about the growing chemical use of 15 developing countries and the breast cancer rates in these countries. She offered DDT use in India 16 as an example of this, and noted the lack of public access to politicians, scientists, and education 17 regardless of culture. 18 19 Ed Sabo, New York coordinator for the Chlorine Chemistry Council, stated his support for the 20 EDSTAC process, noting that the endocrine disruptor issue is a complex subject with limited 21 scientific information on which to base public policy. He commented that the goal of achieving 22 consensus on a screening and testing program requires staying focused, and urged the Committee 23 not to lose focus by wanting to develop a list of endocrine disruptors. He indicated that such 24 development was not a part of the EDSTAC's mission. Mr. Sabo expressed his feeling that 25 chemicals entering the screening and testing program through the nominations process should 26 undergo screening through the same criteria as all other chemicals. Finally he stated that diligence 27 will ensure that laws and regulations will be based on sound science. 28 29 Linda Roberts, of Chevron Research and Technology Company, commented that in utero tests 30 should be included in the screening and testing program as definitive testing. In addition, she 31 noted that definitive testing should more thoroughly characterize toxicity, and that in utero assays 32 would be a benefit in doing this. Ms. Roberts indicated her preference that laboratories expend 33 resources on such testing rather than on screens. 34 35 Mary Dauden, with the Coalition Organized to Protect the Environment, stated that the first and 36 foremost role of government is the protection and quality of human health. She expressed support 37 for the use of in utero developmental assays examine responses in populations at greatest risk, 38 from pre natal fetuses to infants to the elderly. She said that fetuses are exposed to many 39 chemicals which can cause cancer and mental disabilities. 40 EDSTAC Final Report Chapter Six Appendices August 1998 32 U  Walter Schroeder, of the Nassau/ Suffolk Landscape Gardeners Association, Inc., on Long Island, 1 said that the EDSTAC was doing a great job for the most part. He noted awareness of breast 2 cancer incidences in his community, but indicated that the determination of pesticides as causative 3 factors in breast cancer is not clear cut. Mr. Schroeder cited the retraction of the Tulane study and 4 Steve Safe's article as examples of the continuing debate over the effects of endocrine disruptors, 5 and encouraged the Committee to act prudently. 6 7 Diana Hinchcliff, executive director of the New York State Chemical Alliance, indicated her 8 support of the EDSTAC process and her hope that the Committee's goal will be accomplished in 9 an objective manner. Ms. Hinchcliff cited the public's likely misinterpretation of lists and past 10 examples of misuse or misunderstanding of lists as reasons to avoid developing lists of chemicals 11 or to deliberate at length on the use of chemicals. Rather, she suggested the Committee create an 12 endocrine disruptor screening and testing program based on the best available science to determine 13 which chemicals have endocrine disruption potential, and to do so carefully, expeditiously, and 14 judiciously, bearing in mind issues related to implementation. 15 16 Hamdy Balba, with Uniroyal Chemical Company, referenced the adverse effects of many endocrine 17 disruptors in urging the Committee to use an analytical and methodological approach in creating its 18 screening and testing program. He suggested the establishment of a database for all documented 19 and suspected industrial and natural chemicals with endocrinological properties. Mr. Balba 20 encouraged the development of a reliable assay for confirming endocrinological activities to assist 21 the regulatory agencies in prioritizing chemicals for screening and testing and protecting public 22 health and the environment. Finally, he advised the Committee to be aware of possible 23 antagonistic, synergistic effects of chemicals. 24 25 Joe Gregella, executive director of the Long Island Farm Bureau, noted that farmers are extremely 26 concerned, as are commercial applicators, of any potential impacts of pesticides. He stated that he 27 hoped the EDSTAC could help instill public confidence in the government by reintroducing sound 28 science to policy. Mr. Gregella urged that science dictate the decisions made by the EDSTAC. He 29 acknowledged the emotional aspects of the debate over the endocrine disruption issue and urged 30 for the development of studies that can be verified and validated by peer reviews and 31 reproducibility. Furthermore, he noted that public policy needs to balance many variables, 32 including economic and social concerns, but he hoped it would do so guided by sound science. 33 34 Jim Lamb, a toxicologist with Jelnecks, Schwartz, and Connelly, commented that the design of the 35 entire system needs to be built with primary objective of being able to do a risk assessment on 36 adverse effects on the endocrine system, noting his belief that the " adverse" qualifier was critical. 37 Mr. Lamb also stated that in utero testing is critical to the endocrine disruption argument, but 38 urged that it be conducted in the testing tier, not in the screening tier. He stated his support for a 39 EDSTAC Final Report Chapter Six Appendices August 1998 33 U  bypass option for chemicals to go straight from prioritization to testing, contingent upon the design 1 of a comprehensive testing tier. 2 3 Davis Baltz, with Commonweal, asked whether degradation products and metabolites be captured 4 by the assay battery of the screening tier of the screening and testing program, and expressed 5 concern regarding the perceived difficulty of moving a chemical out of the " Hold" box. He 6 questioned the ability of the Committee to focus testing on the hypothalamus pituitary gonadol 7 ( HPG) axis, given the rapidly emerging and developing state of the science related to endocrine 8 disruption. Regarding the screening battery, Mr. Baltz commented that the battery needed to 9 maintain flexibility to address issues not anticipated by the Committee. He also noted his belief 10 that the addition of an invertebrate assay to the screening and testing program was critical to 11 support EPA's goal of protecting the environment. Mr. Baltz noted that the issue of how to 12 address commonly found mixtures had not yet been agreed upon by the EDSTAC, and indicated 13 his concern about the chemical body burden issue. He asked how new chemicals would be handled 14 by the screening and testing program, urging that they be handled more stringently and that they be 15 screened and tested right away. Commenting on the nominations process, Mr. Baltz indicated his 16 support for the concept of giving the public a process to offer input into the screening and testing 17 program, and noted his belief that a separate set of criteria should be established to gauge the 18 merits of the chemical nominations. 19 20 Marian Feinberg, of the South Bronx Clean Air Coalition, referenced concern regarding childhood 21 cancer incidences and prenatal sensitivity in requesting that screening and testing tiers agreed upon 22 by the Committee capture the broadest possible mechanisms. Ms. Feinberg asserted that inner city 23 communities are being heavily impacted by endocrine disruptor related illnesses, and urged that the 24 roots of transmission ( e. g., ingestion, inhalation) of such diseases be examined. She also 25 commented on an alleged lack of union representation on the Committee and in the audience, as 26 well as a lack of representation by impacted community representatives. She encouraged the 27 Committee and the COWG to develop publicly accessible and intelligible language in presenting 28 the EDSTAC's deliberations and recommendations. 29 30 Jim Moore, executive director of the New York Coalition for Alternatives to Pesticides, 31 encouraged the EDSTAC to adopt the precautionary principle. He indicated his desire for the 32 onus to be on manufacturers to prove the safety of chemicals, or to offer compelling reasons for 33 bringing products to market that transcend doubt. He cited DES, DDT, and thalidomide as 34 examples of science policy failures that did not determine safety prior to release, and noted that 35 science should not dominate public policy but that it should be a part of policy making. He 36 commented that the Committee's definition of 37 " adverse" effects is too narrow given the lack of knowledge in the field, and stated that the 38 EDSTAC's top priority should be a true understanding of the true mechanisms of endocrine 39 EDSTAC Final Report Chapter Six Appendices August 1998 34 U  disruption. Mr. Moore stated his desire for a greater emphasis on research into endocrine 1 disruption issues. 2 3 Christian Klossner, with the New York Public Interest Research Group, noted his concern 4 regarding the increasing use of pesticides in this country and their effects on endocrine systems. 5 With respect to priority setting, he stated his belief that the prioritization criteria should be: 6 chemicals that are implicated by current toxicological or endocrinological data; chemicals that 7 bioaccumulate or are persistent; likelihood of exposure; consumer products; and child exposure. 8 He indicated that he felt pesticides fit all of these categories and should, therefore, be of priority 9 for the endocrine disruptor program. Regarding screening and testing, he requested that the 10 Committee include assays and tests designed to encompass developmental and fetal life stages. 11 Mr. Klossner indicated his support for the EDSTAC's careful consideration of conventional risk 12 assessment, and encouraged the Committee to examine chemical synergies. He asked that the 13 onus of proof of chemical safety lie with the chemicals' producers. 14 15 Wanda Cohen asked the Committee about timeframes, required resources, and risk management 16 issues related to the screening and testing program. In addition, she questioned how new 17 information would be integrated into the process, and whether endocrine effects beyond estrogen, 18 androgen, and thyroid would be addressed. She also asked about the development of the chemical 19 nominations process and public accessibility of information coming out of the screening and testing 20 program. Ms. Cohen commented that she was unsure how multisystem effects such as 21 multineurological effects, degradation products, intermediates, and metabolites would be 22 accounted for in the priority setting criteria. She asked about additional legislative authorities that 23 might be applicable to the EDSTAC's work, such as the Clean Air Act. Ms. Cohen questioned 24 how the process of updating databases of information would take place and how the databases 25 would be kept useful and accessible to the public. She also commented that exposure is not 26 necessarily equivalent to effect. 27 28 Bill Sanock, with the Cornell Cooperative Extension, commented that he works closely with breast 29 cancer groups, as well as pesticide users, and noted that those who use pesticides have great 30 concern about their safety and support the Committee's work to provide more information. He 31 stated the need to use good, practical science in the process, and asked how the EDSTAC would 32 communicate results and recommendations of the screening and testing program to the public. He 33 encouraged the Committee to approach risk assessment and exposure issues using common sense 34 and practical research. 35 36 Judith Helfund, with the DES Cancer Network, stated that Long Island has the highest rate of 37 DES exposure in the country, and indicated the region's required attention on related issues. She 38 offered a very detailed account of personal physical problems due to DES exposure as a youth, and 39 urged the Committee to adopt the precautionary principle to avoid future incidences similar to her 40 EDSTAC Final Report Chapter Six Appendices August 1998 35 U  own. In addition, Ms. Helfund asserted that transgenerational impact of DES exposure and 1 endocrine disruption was a reality, and should be considered as the effects would be manifested 2 long after exposure. She stated that information is needed to make informed decisions and to give 3 consent to exposure. 4 5 Minna Barrett, professor of environmental psychology at the State University of New York, stated 6 that her mother had died of thyroid and breast cancer. She encouraged the Committee to include 7 lifespan scrutiny and mechanisms ( especially with respect to fetal exposure), synergistic chemical 8 reactions ( including low dose exposure and inert synergies) health implications for endocrine 9 sensitive cancers and other diseases, and synchronicity, bioaccumulative, and persistent 10 considerations in the endocrine disruptor screening and testing program. She encouraged the 11 EDSTAC to include an analysis of developmental endpoints in the screening and testing tiers to 12 catch effects of chemicals to which neonatal children are often exposed. Ms. Barrett stated her 13 perception that many of the endocrine disruptor issues had been perpetuated by the economy, and 14 indicated her sense that industry is suspect. She commented that low risk allowances are not 15 acceptable, and that only no risk situations would be acceptable. 16 17 Response to Public Comment 18 19 Lynn Goldman thanked the public for their comments, noting that they reflected the serious 20 challenge to the Committee and EPA to protect human health and the environment, and to do so in 21 ways that are effective, cost effective, and practical. She stated that she expected a mutually 22 beneficial outcome for both economic development and environmental protection if the EDSTAC 23 was successful in reaching its goals. With respect to public access to information, Dr. Goldman 24 commented that efforts have been made to develop an endocrine disruptor Web site and to keep it 25 updated. 26 27 With respect to the retraction of the Tulane study, Dr. Goldman indicated her belief that the 28 portrayal of the situation surrounding the retraction had been inaccurate. She noted that, while 29 that particular study had been withdrawn because it cannot be reproduced, other studies exist in 30 the literature supporting the synergy of endocrine disrupting chemicals. Furthermore, she 31 commented that the legislation that started the EDSTAC process was introduced several months 32 prior to the publication of the Tulane study. 33 34 Dr. Goldman commented on the obvious thoughtful preparation by commenters, and recognized 35 their efforts. She reiterated that the EDSTAC process has been a science based process from the 36 very outset, and that it would continue to be so. In response to some comments, she noted that 37 EPA is engaged in activities to address the rising rates of childhood cancer. 38 39 EDSTAC Final Report Chapter Six Appendices August 1998 36 U  One Committee member responded to Mr. Baltz' concern with respect to the handling of mixtures 1 by noting that the subject was being addressed by the PSWG and that the issues of identification, 2 prioritization, and technical aspects of how to screen and test mixtures still needed to be discussed. 3 4 Dr. Goldman, in response to public comments about the inclusion of an in utero assay in the 5 screening and testing program, commented that there is no debate in the Committee about whether 6 it should be part of the process, but rather where in the process it should be included ( i. e., T1S or 7 T2T). With respect to prenatal detection of childhood cancer, she commented that while the 8 concern is valid, it is not within the scope of the EDSTAC but that other EPA offices are 9 addressing the issue. Regarding public comments about missing or inappropriate Committee 10 representation, she stated that not all EDSTAC members were present at the New York meeting, 11 but that the EDSTAC did have union representation and environmental justice representation, and 12 that membership on the Committee from industry was important and vital for consensus. Dr. 13 Goldman noted that environmental protection has often been done in an adversarial manner with 14 industry, but that the EDSTAC represents a coming together around a common interest and in 15 good will. 16 17 Some members of the public commented critically about the location of the New York plenary as 18 being inconvenient and inaccessible by mass transportation. Dr. Goldman acknowledged these 19 criticisms and offered an explanation of why the meeting had to be held in the determined location. 20 However, she indicated that future meetings would try to address the public's concerns. 21 22 Committee members summarized for the public some of the COWG's efforts, and the work 23 group's goals of making all Committee communication palatable, understandable, and clear for the 24 public. It was also noted that a survey had been widely distributed by EPA on communications 25 issues related to the EDSTAC, and that copies of the survey were available for those who desired 26 to complete the forms. Members of the COWG expressed interest in hearing from the public how 27 to efficiently and effectively communicate with and to the public, and encourage members of the 28 public to assist COWG by offering suggestions. 29 30 David Parkinson, a Committee member, referenced his years of working with steelworkers and 31 other union groups, noting that he, indeed, did lend a union perspective to the EDSTAC, counter 32 to public statements to the contrary. He noted his current affiliation with occupational and 33 environmental health clinics in the New York area, funded partly by state, and his desire to work 34 with environmental groups in the area to design something they can do for themselves to test and 35 monitor health concerns. In addition, Mr. Parkinson indicated the willingness of the clinics to 36 assist patients who are sick and need evaluation given an environmental problem even without 37 health insurance. 38 39 EDSTAC Final Report Chapter Six Appendices August 1998 37 U  One Committee member thanked the public for their comments, and acknowledged her 1 appreciation as a scientist for the calls from observers for policy based on sound science. In 2 addition, she acknowledged the need to balance science with other factors to create sound public 3 policy. She noted that repeatability and peer review are of great importance to the EDSTAC, and 4 her appreciation for the public's encouragement of the adoption of the precautionary principle. 5 6 EDSTAC members indicated their support for a public nominations process, in recognition of the 7 importance that the public have a continuing role in the endocrine disruptor screening and testing 8 process. Members of the Committee noted their intention to scrutinize similar programs already in 9 place at other organizations or agencies in the design of the EDSTAC's process. 10 11 Industry representatives on the EDSTAC encouraged the public to overcome their mistrust of the 12 sector by focusing on the Committee's product, and by remembering that many scientists working 13 with industry have spent a great deal of time training to learn about the issues without malintent. It 14 was stated that public input is very important to the EDSTAC process, and that industry 15 representation is present because industry has a responsibility, as a stakeholder, to be involved in 16 the consensus building process. 17 18 19 20 VII. December 2 3, 1997   Orlando, Florida 21 22 23 Ellen Bregg, of the Coalition to Stop Children's Exposures to Pesticides, urged the EPA to allow 24 independent laboratories to perform testing in addition to that done by the EPA. She expressed 25 concern about the use of pesticides in urban areas and the effects of low dose exposures to 26 malathion and pesticides. Ms. Bregg said she would like to see more educational information 27 about pesticides. She stated she wants to know which chemicals will be addressed by the 28 screening and testing program, whether chemical effects will be looked at individually or 29 cumulatively, and whether there will be a focus on the effects at the developmental stage. Ms. 30 Bregg added she would like to see press releases providing updates on the Committee's progress. 31 32 Greg Koontz, Regulatory Affairs Manager for the Chemical Producers and Distributors 33 Association, emphasized the burden of the screening and testing program needs to be 34 commensurate with the gravity of the adverse effects caused by endocrine mediated toxicity. He 35 indicated chemicals with health, safety, or other benefits should not be sacrificed through 36 regulatory overkill, and the demands of an endocrine screening and testing program should be 37 flexible to reflect the seriousness of the threat as demonstrated by science. Such a program, Mr. 38 EDSTAC Final Report Chapter Six Appendices August 1998 38 U  Koontz stressed, should be efficient and cost effective. He expressed support for further research 1 into potential endocrine disruptor effects from low doses but opposes a test program including low 2 dose testing unless the need for it is substantiated by good science, and then only if the hypothesis 3 applies generally to chemicals and not just exceptional cases. He expressed concern with the 4 testing program possibly increasing overall risks to public health by reducing the availability of 5 certain chemicals or by scaring the public into not using particular products ( for example, 6 mosquito control chemicals, the use of which aids in preventing cases of viral equine encephalitis.) 7 Mr. Koontz suggested using a nomination approach, whereby chemicals would proceed through 8 the normal priority setting process. Mr. Koontz finished by saying the EPA, if needed, should ask 9 Congress for more time to implement a sensible approach. 10 11 Chuck Elkins, an environmental consultant with Jellinek, Schwartz, & Connolly, Inc., presented 12 five ideas. First, the success of EDSTAC will not be based upon how many chemicals are 13 screened, rather on whether the information coming out of the program is useful. Second, while 14 chemicals are in the program they are highly vulnerable as a full data set is not available until the 15 chemical in question gets to the end of the program. Third, each stage of the program needs to be 16 clearly defined ( e. g., what is screening). Fourth, only EDSTAC has the credibility to make 17 recommendations and, in so doing, they need to write their words carefully, work on principles, 18 and avoid using lists. Fifth, too many chemicals should not be forced into the program at the 19 beginning as the system will break down if chemicals do not get through the program quickly. 20 21 John Brennan, a high school biology teacher from Orlando, Florida, discussed his concerns about 22 the influence of the media regarding the level of attention the issue of endocrine disruption 23 receives. He commented that although some sensationalism pushes the issue, which can be 24 beneficial, it is important to take a reasoned approach and consider all sides. As an example, Mr. 25 Brennan pointed out both the benefits ( e. g. possible safeguard against lime disease) and detriments 26 ( e. g. health risks from exposure) of applying insecticide to a child. He encouraged the Committee 27 to keep an open, scientific mind about the issue of endocrine disruption and not let the press 28 influence its decisions. 29 30 Nancy Stephens, Executive Director of the Florida Manufacturing and Chemical Council, 31 emphasized the need for the Committee to balance the importance of chemical use with the safety 32 issues associated with such use. She requested the Committee not be persuaded by political and 33 emotional agendas, but rather address the issue of endocrine disruption on a scientific basis. Ms. 34 Stephens suggested the Committee provide EPA with a " tool box" with which the Agency can 35 evaluate chemicals. 36 37 Suzanne Spencer, representing the Northeast Florida Chapter of the Sierra Club, stated there is an 38 urgent need to develop a screening and testing program to detect endocrine disruption in humans, 39 fish, and wildlife. She brought a letter from Maurice Coman, Chair to the Northeast Florida 40 EDSTAC Final Report Chapter Six Appendices August 1998 39 U  Group, Sierra Club, discussing the link between dioxin and related chemicals to cancer and 1 reproductive, immunological, and developmental dysfunction. Ms. Spencer also brought 2 correspondence from the Food and Drug Administration involving consumer exposure to dioxin 3 through food sources. She noted the need to do significantly more research concerning the health 4 effects of environmental hazards on children, and added the threat to children will persist until this 5 happens. 6 7 Davis Baltz, of Commonweal and member of the EDSTAC Communications and Outreach Work 8 Group, reminded the Committee that over the past year it has heard from a broad cross section of 9 Americans concerned about the implications of endocrine disruption, including the following: 10 Sierra Club; Endometriosis Association; cancer survivors; learning disability networks; consumers; 11 environmental justice representatives; mothers; pregnant women; farmers; ranchers; gardeners; 12 unions; small business; environmental consultants; veterinarians; the League of Women Voters; 13 and, individual citizens. Mr. Baltz noted a common theme to be concern for children and added, it 14 should be remembered, that as adults, we impose risks on our children without their consent. He 15 reminded the Committee of its agreement regarding the definition of ` screening' as " the application 16 of assays to detect the potential for endocrine disrupting properties of chemical substances and 17 mixtures." Mr. Baltz emphasized that, for the promotion of children's healthy development, the 18 EDSTAC must include a means for establishing developmental endpoints for low doses at the 19 ` screening' phase. 20 21 Betty Mekdeci, Director of the Association of Birth Defect Children Inc. ( ABDC), indicated the 22 greatest examples of how exposure to herbicides increases the likelihood that a child will suffer 23 from a disability or birth defect, are the children of Vietnam veterans. She spoke of an analysis, 24 performed by ABDC and the New Jersey Agent Orange Commission, which identified disabilities 25 in 800 children of Vietnam veterans compared to 400 children of non Vietnam veterans and noted 26 further evidence suggested the effects could be transgenerational. Ms. Mekdeci said the types of 27 problems included; chronic skin disorders, benign tumors/ cysts, cancers, emotional/ behavioral 28 problems, chronic fatigue, tooth problems, and others. Ms. Mekdeci expressed concern with the 29 lack of accurate exposure data on herbicides. 30 31 Andy LaVigne, Executive Director of the Florida Fertilizer and Agrichemical Association, stated 32 extensive testing is performed on agricultural chemicals and pesticides before these products are 33 used. He said no scientist will give a determination of zero risk regarding the use of a specific 34 chemical because there are so many variables potentially impacting the effects related to use. Mr. 35 LaVigne said claims of pesticides not being well tested before registration and release for public 36 use, and claims they are not specifically tested for estrogenic activity, are not true. He noted EPA 37 requires each pesticide be thoroughly tested for its potential to cause adverse effects, including 38 hormone disruption. Mr. LaVigne requested the Committee not use a " paparazzi science" 39 approach but rather develop a screening program based on the best available scientific data. 40 EDSTAC Final Report Chapter Six Appendices August 1998 40 U  Pam Williams, of the Endo Association, indicated that dioxins are one of the most toxic 1 compounds known to man and are linked to endometriosis and other health problems. Ms. 2 Williams said ninety percent of human dioxin exposure is from meat and dairy products because 3 the animals from which these products originate, are exposed to dioxins via pesticides, herbicides, 4 plastics incineration ( PVC), and pulp and paper production processes. Ms. Williams urged the 5 Committee to consider the following questions: how much is too much; can the current levels of 6 dioxins already present be reduced; are there other ways to do what we are doing; and, what effect 7 will these changes have on the future of humanity? 8 9 Keith Branly, Vice President of Research and Development of Micro Flo, a small pesticide 10 formulating business, stated the need for the burdens to equal the benefits which result from 11 pesticide regulation. He noted many small businesses are impacted by toxicity testing and the 12 demands of a screening and testing program need to be viable and cost effective. Mr. Branly 13 added testing and screening requirements should not deprive the public of the use of products with 14 clear health benefits. Regarding the issue of low dose testing raised in T2T, he said he feels it is 15 not cost effective and is premature until a low dose testing hypothesis is accepted by the scientific 16 community. 17 18 Katie Holmes, an aquatic toxicologist, requested the Committee verify the practicality, not just the 19 theory behind, the studies it recommends be used to analyze potential endocrine disruptors. Ms. 20 Holmes encouraged the EDSTAC to consult with individuals who run relevant studies dial, and are 21 aware of the scientific and practical issues associated with the tests. She expressed particular 22 concern regarding the mysid life cycle, fish life cycle, and avian reproduction studies being 23 considered by the Committee. 24 25 Jeannie Economos, of the Farmworkers of Florida, expressed concern about farmworker exposure 26 to pesticides and related health effects. She stated chemicals are being screened on an individual 27 basis when, in fact, people are exposed to all kinds of chemicals over time and therefore, the 28 cumulative effects associated with chemical exposure should be considered. Ms. Economos 29 commented on the high incidence of miscarriage among farmworkers and said she wants to see 30 studies performed on this particular sector in order to evaluate the long term effects of chemical 31 exposure. 32 33 Lukner Millen, speaking on behalf of farmworkers, indicated there are still many instances where 34 pesticides are being used in the vicinity of workers. He told a story of a female farmworker who 35 was working in the fields when she broke out in a rash all over her body and was unable to identify 36 the pesticides to which she had been exposed. Mr. Millen commented that exposure problems 37 persist and he wants the persons responsible for exposing farmworkers to pesticides ( e. g., spraying 38 the fields while workers are present) to be held accountable for their actions. He closed by saying 39 he is counting on the Committee to act to change this situation. 40 EDSTAC Final Report Chapter Six Appendices August 1998 41 U  1 Joy Cummings, a Florida rancher and farmer, explained she was a chemicals sales representative 2 unti