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>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
>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
>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:
>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
>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
>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
>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
>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
>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.

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