The American Chemistry Council and its members support Congress’ effort to modernize our nation’s chemical management system. Such a system should place protecting the public health as its highest priority, and should include strict government oversight. It should also preserve America’s role as the world’s leading innovator and employer in the creation of safe and environmentally sound technologies and products of the business of chemistry.
The current chemical management law, the Toxic Substances Control Act (TSCA), is more than 30 years old. It should be modernized to keep pace with advances in science and technology. Moreover, the law must provide the Environmental Protection Agency with the resources and the authority to do its job effectively.
We have previously offered general concepts on which to base a modern chemical management system. This document expands upon those concepts and begins to provide more detail, which we hope will be useful to policy makers. We will continue to refine the details of our principles for modernizing TSCA and are committed to working with all stakeholders toward enactment of effective legislation.
1. Chemicals should be safe for their intended use.
Ensuring chemical safety is a shared responsibility of industry and EPA.
Industry should have the responsibility for providing sufficient information for EPA to make timely decisions about safety.
EPA should have the responsibility for making safe use determinations for high priority chemicals, focusing on their most significant uses and exposures.
Safe use determinations should integrate hazard, use, and exposure information, and incorporate appropriate safety factors.
Consideration of the benefits of chemicals being evaluated, the cost of methods to control their risks, and the benefits and costs of alternatives should be part of EPA’s risk management decision-making, but should not be part of its safe use determinations.
Other agencies, such as FDA and CPSC, should continue to make safety decisions for products within their own jurisdictions.
2. EPA should systematically prioritize chemicals for purposes of safe use determinations.
Government and industry resources should be focused on chemicals of highest concern.
The priorities should reflect considerations such as the volume of a chemical in commerce; its uses, including whether it is formulated in products for children; its detection in biomonitoring programs; its persistent or bioaccumulative properties; and the adequacy of available information.
3. EPA should act expeditiously and efficiently in making safe use determinations.
Since a chemical may have a variety of uses, resulting in different exposure potentials, EPA should consider the various uses and focus on those resulting in the most significant exposures.
EPA should complete safe use determinations within set timeframes.
4. Companies that manufacture, import, process, distribute, or use chemicals should be required to provide EPA with relevant information to the extent necessary for EPA to make safe use determinations.
Companies throughout the chain of commerce should be responsible for providing necessary hazard, use, and exposure information.
EPA should be authorized to require companies, as appropriate, to generate relevant new data and information to the extent reasonably necessary to make safe use determinations without having to prove risk as a prerequisite or engaging in protracted rulemaking.
Testing of chemicals should progress to more complex and expensive tests through a tiered approach as needed to identify hazards and exposures of specific concern.
To minimize animal testing, existing data should be considered prior to new testing, and validated alternatives to animal testing should be used wherever feasible.
Existing data and information should be leveraged in EPA’s safe use determinations, including data and information from other mandatory and voluntary programs such as REACH and the U.S. High Production Volume challenge.
5. Potential risks faced by children should be an important factor in safe use determinations.
Safe use determinations should consider the effects of a chemical on children and their exposure to the chemical.
Safe use determinations should consider whether an extra margin of safety is needed to protect children.
6. EPA should be empowered to impose a range of controls to ensure that chemicals are safe for their intended use.
The controls could range from actions such as labeling, handling instructions, exposure limits and engineering controls to use restrictions and product bans.
The controls should be appropriate for managing the risk, taking into account alternatives, benefits, costs, and uncertainty.
7. Companies and EPA should work together to enhance public access to chemical health and safety information.
EPA should make chemical hazard, use, and exposure information available to the public in electronic databases.
Other governments should have access to confidential information submitted under TSCA, subject to appropriate and reliable protections.
Companies claiming confidentiality in information submittals should have to justify those claims on a periodic basis.
Reasonable protections for confidential as well as proprietary information should be provided.
8. EPA should rely on scientifically valid data and information, regardless of its source, including data and information reflecting modern advances in science and technology.
EPA should establish transparent and scientifically sound criteria for evaluating all of the information on which it makes decisions to ensure that it is valid, using a framework that addresses the strengths and limitations of the study design, the reliability of the test methods, and the quality of the data.
EPA should encourage use of good laboratory practices, peer review, standardized protocols, and other methods to ensure scientific quality.
9. EPA should have the staff, resources, and regulatory tools it needs to ensure the safety of chemicals.
EPA’s budget for TSCA activities should be commensurate with its chemical management responsibilities.
10. A modernized TSCA should encourage technological innovation and a globally competitive industry in the United States.
A new chemical management system should preserve and enhance the jobs and innovative products and technologies contributed by the business of American chemistry.
Implementation of TSCA should encourage product and technology innovation by providing industry certainty about the use of chemicals.