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July 2005
S. 1391: The Kid Safe Chemicals
Act
ANALYSIS BY THE CHILDREN’S ENVIRONMENTAL HEALTH
NETWORK
S. 1391, introduced by Sens. Frank Lautenberg (D-NJ) and
James Jeffords (I-VT) and other Senators, would better protect children from
harmful chemical exposures by updating and strengthening the Toxic Substances
Control Act.
Policy and Goals: The bill would set as U.S. policy “paramount
national goal(s)” of promoting children’s health, recognizing children’s unique
vulnerabilities to toxicants, and minimizing toxic substances in the
environment. The bill sets the goal of eliminating “the exposure of all
children, workers, consumers, and sensitive subgroups to harmful chemicals
distributed in commerce by 2020.”
Priority Chemical List: In order to address the worst chemicals
first, a list of priority will be developed. EPA will have 18 months to develop
the first priority list of at least the first 300 chemicals, and those chemicals
must be assessed for safety by 2010. The list must be updated annually. Criteria
for prioritizing chemicals would include a chemical’s known or suspected
reproductive, immunological, carcinogenic, and other toxigenic characteristics,
as well as its presence in humans, in food, or in drinking water, with the
exception of those substances “naturally present.” The agency must assess all
chemicals on the priority list at least once every 15 years.
Safety Standard: For the first time, chemical substances will have
to meet a safety standard, “a reasonable certainty that no harm,” in order to be
distributed in commerce. The safety standard must account for the aggregate
toxic exposures “of a fetus, infant, child, worker or member of other sensitive
subgroup.” To account for children’s unique vulnerabilities, an additional
ten-fold safety factor is to be applied to levels set for adults. Within three
years of placing a substance on the priority list (above), EPA must determine if
the manufacturer has established that the substance meets the safety standard.
If the agency doesn’t meet the deadline, the manufacturer must issue a public
notice that the safety determination is pending. If the agency does not act
within two more years, the substance will be prohibited from being “distributed
in commerce.”
Restricting Chemicals: Chemicals that do not meet the safety
standard, or that miss the five-year deadline, or for which the manufacturer did
not meet the information and other requirements of the law, cannot be
distributed in commerce. EPA can exempt chemicals from this restriction. The
President may also exempt a specific use of a chemical “in the paramount
interest of national security” or if unavailability would “cause significant
disruption” of the nation’s economy and no feasible alternative is available.
Individuals who are harmed by exposure to an exempted substance can sue the
chemical’s manufacturer or user.
Certification: Within one year of the Act’s enactment, chemical
manufacturers must certify to the EPA that a chemical meets the safety standard,
or that they do not have sufficient information to determine if the chemical
substance meets the standard. They must also provide to EPA, all information
they possess on the substance’s effects, exposure, and production volume .
Information: EPA has the authority to request a wide range of
information on a substance (such as human health effects and biological fate and
transport) and to use this information in making its safety determination on the
substance. Information on each substance is to be updated at least every three
years by the manufacturer. Laboratories that develop data used to determine
whether or not a chemical meets the safety submitted would be subject to random
inspections.
A standardized, public database is to be created for sharing information related
to chemical toxicity, use and exposure.
Confidential Business Information (CBI): The existing definition
of CBI is narrowed, so that human health effects of a chemical cannot be defined
as CBI.
Safer Alternatives: EPA will create a program encouraging safer
alternatives to existing chemicals. Possible incentives could include expedited
review of new substances and a special designation for safer alternatives.
Biomonitoring: Manufacturers of high-volume chemicals (more than
one million pounds per year), and of chemicals to which people are exposed and
which are of concern to the agency (for example, a chemical that bioaccumulates)
would be required to conduct biomonitoring studies on those chemicals once every
three years and make their method for detecting the substance or its metabolites
in humans publicly available. The EPA would establish a standard for conducting
biomonitoring tests.
Interagency Board: The EPA is to establish an Interagency Science
Advisory Board on Children’s Health and Toxic Substances, working with the
National Institute of Environmental Health Sciences, the Centers for Disease
Control and Prevention, the National Toxicology Program, the National Cancer
Institute, the National Tribal Science Council, and children’s health research
centers. The Board is to provide independent and expert advice to the EPA.
Green Chemistry Research: The bill directs the creation of at
least four green chemistry and technology research and clearinghouse centers,
funded at $40 million in FY 2006 and $30 million annually in FY 2007-2010.
International Cooperation: Working with other Federal agencies,
the EPA is to support international efforts to develop harmonized protocols and
databases regarding chemical information, testing and safer alternatives.
Alternatives to Animal Testing: The bill encourages minimizing the
use of animal testing of chemical substances. Every other year, the EPA is to
publish a list of acceptable alternative testing methods. The bill authorizes $5
million for this research.
Positive features of S. 1391:
1. The bill sets standards that are more protective of human health, and
specifically takes children’s unique vulnerabilities and susceptibilities into
account.
2. The paradigm under which chemicals are regulated will be changed to place the
burden on manufacturers to demonstrate ac chemical’s safety, rather than on the
government to prove harmful effects. Chemicals that fail to meet the safety
standard will be banned or restricted.
3. The priority list of chemicals will help to assure that a safety
determination will be made first for those substances of greatest concern .
4. Extensive information about a chemical’s human health and environmental
effects will be generated and made available to the public. The use of
“confidential business information” would be considerably reduced
5. Biomonitoring information will also increase and guidelines for such testing
will be developed.
6. Safer alternatives will be strongly encouraged.
7. Alternatives to animal testing will be encouraged.
Concerns about S. 1391:
1. The deadlines in the bill will be challenging for EPA to meet and will call
for substantial resources.
2. The exemptions in the bill allowing chemicals, or a specific use of a
chemical, could be a large loophole, failing to halt the use of risky
substances.
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