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April 2005
In Support of Child-Safe U.S. Chemical Policies:
Statement of Principles
Children are our future. We must place our policies and actions in the context
of their impact on the health and well-being of present and future generations.
The vast majority of industrial chemicals lack basic publicly-available data on
potential health and environmental impacts to assure that they are child-safe.
Although many chemicals in commerce are likely to be safe, known toxic
substances are used in everyday products and released into our environment. In
the absence of knowledge about the risks to children, current laws allow
children to be exposed to chemicals with completely unknown toxicity.
After many years with very little progress on child-safety of chemicals in the
U.S., we now are at a moment when unique opportunities have surfaced. There is
much strong opposition to reform that can best be countered with an emphasis on
making chemicals child-safe.
Health is defined (by the WHO) as a “state of complete physical, mental and
social well-being, and not merely the absence of disease or infirmity.” It
follows that health risks to children include functional impairments, such as
behavior and learning ability. They include adverse impacts on well-being across
a lifetime that result from exposures in utero and in childhood. Protecting
children requires not only the consideration of the fetus, infant, child and
adolescent, but also the reproductive health of the child’s parents.
Clear, sound science underlies the principles of children’s environmental
health. A solid consensus exists in the scientific community for these concepts
and as additional scientific knowledge in this field expands, it continues to
reinforce this foundation.
These principles and knowledge need to be applied to U.S. chemicals policies,
which are outdated and are not protective of children and their health.
We agree that:
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Children and health are to be the focus of chemicals policy:
children are our future and we need to assign a high value to preserving their
potential health and productivity. The protection of children and other
vulnerable populations (such as workers, the elderly, the genetically
susceptible, or the immunocompromised) should be the basis by which chemical
regulatory decisions are made.
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Chemicals policies should be action-oriented and employ
approaches that are sufficiently conservative to provide assurances that we are
acting cautiously to protect our children. Waiting for certain evidence of harm
means that a generation or more of children would be placed unnecessarily at
risk of life-long, irreversible damage.
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Chemical risk assessments should specifically
consider children and how their behavior, environment and diet differ from those
of adults, and how these differences result in different exposure patterns.
Chemicals to which children are (or may be) exposed should be evaluated
specifically with regards to hazards unique to early life stages of exposure,
such as developmental neurotoxicity, immunotoxicity and endocrine toxicity as
well as teratogenicity and early life carcinogenesis. Chemical assessments need
to account for risks of aggregate exposures to a chemical from multiple sources
as well as cumulative exposures to chemicals with the same mode of action and
from chemical mixtures. The National Academy of Sciences (NAS), when reviewing
Federal pesticide regulatory policy, said “In the absence of data to the
contrary, there should be a presumption of greater toxicity to infants and
children.”
On research:
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Adequate resources must be dedicated for research and
development of safer alternatives, as well as rewarding innovation and promoting
existing safer alternatives.
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Scientifically-valid research designed to reduce, refine or
replace the need for laboratory animals should be encouraged. When research
involving laboratory animals is necessary, research animals must be used in a
responsible manner.
On responsibility and transparency:
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Those who manufacture, process, or otherwise use in commerce,
chemicals should be held responsible for the burden of fully assessing
children’s potential exposures to the chemical and the potential health effects
for children. The government should exert strong quality control and oversight
on all scientific activities that are used to support safety assessments for
chemicals. Transparency for the public of the methods used, data sources, source
of funds for studies, study authors, etc., is required. Chemicals policies
should prevent exposure to any chemical for which adequate information on
potential health risks to children is not publicly available.
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Chemical regulation needs to be informed by biomonitoring of
chemical exposures across the lifespan, especially including women of
childbearing age and young children. Chemicals policies should support tools to
interpret and understand the biomonitoring data being generated and to make such
information available to the public. Stringent government oversight and
guidelines for quality of biomonitoring are necessary. Biomonitoring data can
serve as a trigger for focus on a chemical but should not be the only trigger
for requiring more information or limiting use.
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All chemical risk assessment and biomonitoring data and
interpretive materials should be easily understandable by the public and should
be widely available, through the Internet and other venues.
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Because chemicals have impacts on the health of children, health
care providers must play an integral role in risk communication for individuals
and communities and therefore must receive relevant education and training.
On global interrelationships:
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Because many persistent chemicals, metals, and chemicals in
commerce have global or regional impacts on the health of children, chemical
regulation needs to occur in the context of cooperation on international efforts
to protect health including by ratification of the Stockholm convention on POPs,
the Rotterdam convention on PIC, as well as cooperation on future efforts such
as the Globally Harmonized System and efforts to reduce risks from lead and
mercury.
Requirements For “Child Safe” Chemicals Legislation
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Clear requirements and regulatory authority that EPA place a
high priority on protecting children's health (as defined above) and on
protecting other vulnerable subpopulations.
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A strong safety standard, such as a “reasonable
certainty of no harm” as defined under FFDCA.
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Health protection of children is the basis for chemical
regulatory decisions.
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No exposure to chemicals that do not meet core information
requirements.
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The burden of proof is shifted; industry is to demonstrate
safety of a chemical by supplying required data (as described below).
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A process with deadlines and commitment to timeliness, and
mechanisms for ensuring that protective measures are adopted by default if
action is not taken on a timely basis.
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Rewards for generation of information about chemicals and
exposures through more rapid approvals (and penalties for failing to provide
information, such as losing market access).
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Support and rewards for research, development and innovation,
and for safer substitutes through exemptions and more rapid approvals for much
safer substitutes.
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An additional safety margin for children, pregnant women, the
fetus, nursing women, and women of child-bearing age, to assure a “mother’s
right to a healthy child.”
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Recognition of and protection for children most at risk,
including children of lower socioeconomic status, children of racial and ethnic
minority status, children with special health care needs, and children whose
parents have occupational exposure to chemicals.
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EPA to establish protocols for data collection, hazard and
exposure assessments that explicitly consider children and their most sensitive
and vulnerable health effects. Such protocols re-assessed routinely and strictly
enforced by the EPA.
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Consideration of multiple and synergistic effects of different
chemicals, of chemicals with multiple pathways of exposure, and of chemical
mixtures.
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Require generation of biomonitoring data and methods for
interpreting and understanding biomonitoring data; biomonitoring must be
scientifically standardized and collected under guidelines established by EPA.
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Approval of a chemical is not a permanent decision for a
chemical. “Approved” chemicals go through a review process on a regular basis,
with more frequent review of more hazardous materials. The review process to be
re-assessed routinely to take into account new science.
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A transition process that prioritizes review and approval of
existing chemicals. Priority is to be given to “the worst first” -- after
consideration of children’s exposures, biomonitoring data, developmental
neurotoxicity, disparate impacts on certain populations, intrinsic properties
(such as bioaccumulative or environmental persistence), use patterns, and
production volume.
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Strong enforcement provisions including routine inspections and
random audits of facilities and laboratories.
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Strong citizen suit and petition provisions, and clear deadlines
for action written into the law.
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Routine EPA review and monitoring of the facilities conducting
the studies (such as regular inspections and randomized data audits with severe
penalties), to be funded by fees on industry, and transparency about who is
funding and conducting studies submitted.
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Right to know about biomonitoring and other health related
chemical information (other than confidential business information). Begin with
the presumption that information is not “confidential business information”
(CBI) unless proven otherwise. Health and environmental information cannot be
declared CBI.
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Strengthen participation by state (and sometimes local)
government and sharing of CBI with states; no preemption of stricter state laws.
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Strengthen role of other Federal agencies including NIEHS, NTP,
and CDC, in biomonitoring and in assessment of hazards of chemicals.
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Management of chemicals in commerce internationally In this
regard, the U.S. should be a leader and a good partner in international efforts
for sound management of chemicals, including:
Ratifying the Stockholm Convention on Persistent Organic Pollutants (POPs)
Ratifying the Rotterdam Convention on Prior Informed Consent (PIC)
Signed:
Children’s Environmental Health Network
American Public Health Association
Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN)
Environmental and Energy Study Institute
Healthy Schools Network, Inc.
Learning Disabilities Association of America
FOR MORE INFORMATION: 202-543-4033
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