>ACTION ALERT > >TO: Individuals and organizations concerned about protecting > children from environmental toxicants > >FROM: Children's Environmental Health Network > >RE: Upcoming Federal action on endocrine disruptors: > Opportunity for public comment > >DATE: February 9, 1999 > > >Summary: Individuals and organizations interested in protecting children >from environmental hazards can submit comments to EPA about its proposed >program to identify substances that affect hormone systems, called >endocrine disruptors or EDs. > >Background information on EDs and comments drafted by the Network follow. > >Comments are needed on this proposal because it includes some facets that >are not adequately protective of children, some aspects that require >clarification, some positive proposals that are controversial and need >support, and several areas where the agency has specifically requested >comment and is more open to input. > >Time Frame for Action: EPA is accepting comments until February 26, 1999. > >Actions needed: Please consider submitting comments from your >organization and/or as an individual. Background materials and sample >comments follow; adapt and add information about your interest and >concerns in this issue. Mail comments (preferably in triplicate) to: > >OPPT Document Control Officer (7407) >Office of Pollution Prevention and Toxics >Environmental Protection Agency >401 M St., SW., Room G-099, East Tower >Washington, DC 20460 >ATTN: docket control number OPPTS-42208 > >Comments can also be submitted as an ASCII file by e-mail to: >or on disks in Wordperfect 5.1/6.1 or ASCII file >format. All comments must be identified by the docket control number >OPPTS-42208. > >If possible, please e-mail a copy of your comments to or >fax to 703-685-0427. If you have questions or comments, please call >703-486-1664. > >Thank you. > > >Federal Register Notice: The EPA proposal was printed in the December >28, 1998, Federal Register (Volume 63, Number 248), pages 71541-71568. >It can also be accessed at: > >http://www.epa.gov/fedrgstr/EPA-PEST/1998/December/Day-28/p34298.htm > >Background: In 1996, Congress required the EPA to develop tests to be >used to identify which substances are endocrine disruptors (EDs), >synthetic and natural chemicals that change hormonal activity in living >things. Examples of EDs include polychlorinated biphenyls (PCBs), >dioxins, and some pesticides (such as DDT). The Environmental Protection >Agency (EPA) is now accepting comments about its proposed testing >protocol. > >EDs may be responsible, at least in part, for reproductive problems in >both women (e.g., endometriosis, the increasingly early onset of puberty >in young girls), and men (falling sperm counts, congenital birth defects >of the reproductive organ) and for increases in the frequency of certain >kinds of cancer (breast, prostate, and testicular). These chemicals have >also been linked to developmental deficiencies and learning disabilities >in children, though the mechanisms in these deficits may not be endocrine >disruption. > >EDs are found primarily in food, in polluted drinking water, and most >recently in some plastics which are leaching component parts. EDs can >persist in the environment and many accumulate in the of animals and >humans such as the brain and liver. Traces of many of these chemicals >can be found in animals and humans in all parts of the world. > >The Network is concerned about EDs because of the extreme vulnerability >of the developing hormonal systems in the fetus, the infant and the >child. Today, more than 70,000 chemicals are allowed for use in the U.S.; >for the vast majority of them, little is known about their health effects >on children. An appropriate screening and testing program will be the >first step in identifying substances that are EDs. This knowledge will >shape policies and standards relating to the release, use, and disposal >of EDs and thus, how well we protect children from exposure to EDs. An >inadequate testing protocol may mean that EDs are not appropriately >recognized or regulated as such, leading to inadequate protection of >children. > > >************************* > >ENDOCRINE DISRUPTOR SCREENING & TESTING >COMMENT TOPICS IDENTIFIED BY THE CHILDREN'S ENVIRONMENTAL HEALTH NETWORK > >OPPT Document Control Officer (7407) >Office of Pollution Prevention and Toxics >Environmental Protection Agency >401 M St., SW., Room G-099, East Tower >Washington, DC 20460 > >ATTN: docket control number OPPTS-42208 > > >The key issue in evaluating EPA's proposed Endocrine Disruptor Screening >Program is how confident we can be that every substance that has a >hormonal effect in humans will be identified. This task is especially >important in protecting children from endocrine disruptors (EDs) > >Children are at particularly high risk from exposure to EDs due to the >extreme vulnerability of the developing hormonal systems in the fetus, >the infant and the child. The full range of endocrine-disrupting >substances in our environment and their potency is unknown. > >Some components of the EPA's proposal are adequate for the task; however, >other aspects will not provide the confidence we seek that all >hormonally-active chemicals will be identified. Thus, this proposal must >be modified. > >Expeditious Action and Adequate Resources: The agency faces many >challenges in instituting an effective testing program on time and within >its limited resources. To assure that this program progresses without >delays, the agency must make securing the resources needed for this >program a high priority. Otherwise, key steps, such as standardizing and >validating the proposed assays, will be delayed. > >Definitions: The EPA proposal implies that substances will be identified >as endocrine disruptors only if they are shown to have an adverse effect, >as opposed to being shown to have any hormonal effect. An "adverse" >effect can be a difficult, subjective, time-consuming and controversial >label to apply. If proof of an adverse effect is required, chemicals that >are endocrine disruptors may not be labeled as such. > >The EPA must clarify this proposal to reflect that every chemical with >any hormonal effect is identified as an endocrine disruptor. To do >otherwise would be to gravely compromise the effectiveness of this >testing program and to provide misleading information. > >Look for estrogen, androgen, and thyroid hormone effects: In its >proposal, the agency indicates that its tests would look for androgen and >thyroid hormone effects as well as estrogenic effects, and asks if this >wider scope is appropriate. > >The answer to this question is a strong yes. It is vital that the scope >of the tests in the Endocrine Disruptor Screening Program include more >than estrogenic effects, since endocrine disruption can occur in the >androgen and thyroid hormone systems as well as the estrogen hormone >system. EPA should be commended for seeking to assure that its screening >and testing program look for effects on all of these hormone systems. >The agency should resist any efforts to narrow the focus of this >screening and testing program. > >Adequacy of Testing: The EPA is to be commended for recognizing that >new tests and assays will have to be created to assure that all potential >hormonal impacts are reviewed. However, some serious gaps exist. Tests >must provide more information about behavioral and subtle effects. The >absence of an assay that looks at crucial development stages, when an >organism is particularly vulnerable, is a critical gap. The agency must >place a high priority on the creation of such an assay and its inclusion >as one of the mandatory tests. No chemical can be deemed as "completed >testing" until it has gone through such an assay. > >Additionally, since the EPA is recommending substantial improvements to >the protocols of existing tests in recognition that these older tests >were not adequate for getting information on hormone disruption, tests >conducted under old protocols should not be considered as complying with >this program. Chemicals that have gone through earlier versions of a test >must be required to fill the information gaps between the earlier and the >improved test protocols. > >Low-Dose Testing: Some scientists are concerned that relying on a >single-dose level might miss effects that emerge at very low doses, >giving false negative results. The agency's proposal is not clear on how >it will respond to these concerns. The EPA should move quickly in >researching and resolving these concerns so that low-dose screening and >testing becomes an integral part of its program. The agency should >propose and seek comment on a plan and schedule for initiating and >completing a low-dose testing program. If low-dose levels are not >adequately built into the screening tier, the program will be deeply >flawed. > >Substantial Population: In question 17 of this notice, the agency asks >how to define the term 'substantial population' as a specific group to >take into account when it is estimating human exposures to toxicants. > >The agency should consider each of the following categories of children >as a "substantial population" to be considered: the fetus, the infant, >the toddler, the child, and the adolescent. The exposure patterns and >diets of each of these groups varies greatly within the population of >"children" depending upon their stage of development, as does the impact >of exposure to an endocrine disruptor. As the agency notes, "there is >little doubt that small disturbances in endocrine function, especially >during certain highly sensitive stages of the life cycle. . . can lead to >profound and lasting effects." Arguably, a child in one of these "highly >sensitive stages" may be more profoundly affected than someone who is >older and the impact may be more severe and would be more likely to be >life-long. Due to the increased risk of life-long impact, each of these >groups is a "substantial population" due to their differing and unique >susceptibilities. > >Exemptions From the Screening Program: In question two of this notice, >EPA asks if classes of chemicals exist that should be exempted from this >testing program. Given that no method of predicting the hormonal effect >of chemicals yet exists, the agency has no basis for exempting chemicals >from the Endocrine Disruptor Screening Program. If, in the future, the >agency considers providing exemptions to a class of chemicals, the agency >should institute such exemptions through the rule-making process to allow >for adequate public discussion and review. > >Bypassing Tests: Just as the agency has insufficient information to >assure that classes of chemicals can be safely exempted from the testing >program, it has little information to assure that chemicals can bypass >screens or tests without risking the loss of relevant information. > >In conclusion: > >The definition of "endocrine disruptor" should include any substance that >has an effect on hormonal systems. > >Once an adequate testing protocol has been identified, the agency should >move forward expeditiously and with all possible resources to validate >this protocol. > >The agency has little evidence indicating that any chemicals should be >exempted from testing or allowed to bypass certain tests and thus any >exemptions or "by-pass conditions" should be very narrowly drawn. > >The agency should modify this proposal to assure that the Endocrine >Disruptor Screening Program is a complete and adequate program that will >generate a very low false negative rate. ---------------------------------------------------------------------- To get off the CONS-EQST-HORMONE-MIMICS list, send an email message to: [email protected] with the message text (not subject): SIGNOFF CONS-EQST-HORMONE-MIMICS
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