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.