Reauthorization of TSCA and Proposed Regulatory Changes
During 2010, the U.S. Environmental Protection Agency ("EPA") is expected to make a strong push in support of reauthorizing and substantially amending the Toxic Substances Control Act ("TSCA"). Since its adoption in 1976, TSCA has remained largely unchanged. However, EPA has announced that one of its key priorities for this year is to press Congress to modernize and strengthen the tools available under TSCA to enable EPA to regulate more effectively the broad array of chemicals that are used in commerce. In connection with this effort, EPA has issued a series of principles to guide the legislative process. These principles include the following concepts:
- Chemicals need to be reviewed against safety standards that are based on sound science and reflect risk based criteria protective of human health and the environment.
- Manufacturers must be required to provide sufficient hazard exposure and use data for chemicals that they make to support a determination by EPA that the chemicals are safe and do not endanger public health (including relevant subpopulations such as children) or the environment.
- EPA must be vested with authority to obtain information regarding chemical use and exposure from downstream processors and users of chemicals. EPA must have clear authority to take risk management actions when chemicals do not meet safety standards, taking into account considerations such as children’s health, economic costs, social benefits and equity concerns.
- EPA must be authorized to set priorities for conducting safety reviews on existing chemicals and impose clear, enforceable and practicable deadlines on both itself and industry for completion of such reviews.
- The design of safer and more sustainable chemicals, processes and products must be encouraged with the objective of producing chemicals that pose lower risks, are more energy efficient and are more sustainable.
- Standards for substantiating claims of confidential business information ("CBI") to protect information that is disclosed to EPA must be made stricter, including eliminating CBI protection for information and data relevant to health and safety.
- A sustained source of funding for implementing the TSCA program must be developed.
An overhaul of TSCA is obviously a step that requires Congressional action. While EPA may press for new legislation, EPA cannot control what Congress decides to do and when Congress may take action. Consequently, EPA is simultaneously taking steps on its own through aggressive implementation of the existing TSCA program to advance certain of the objectives that it has articulated for legislative reforms.
For example, in a notice published in the Federal Register on January 21, 2010, EPA announced a new policy for reviewing CBI claims in the context of submissions under Section 8(e) of TSCA. (Section 8(e) of TSCA requires those who manufacture, process or distribute in commerce a chemical substances or mixture to immediately inform EPA if they obtain information which reasonably supports the conclusion that the chemical or mixture presents a substantial risk of injury to health or the environment.) Under EPA's new policy, where a health and safety study submitted under Section 8(e) of TSCA involves a chemical identity that is already listed on the public portion of the TSCA Chemical Substances Inventory, the chemical identity generally cannot be protected as CBI. In general, this policy appears to be designed to eliminate the ability of a regulated entity to claim as CBI information regarding a chemical identity where a health and safety study has been submitted and the chemical identity is already listed in the public portion of the TSCA Chemical Substances Inventory. In EPA's view, the new policy will make more health and safety information available to the public. EPA has indicated that this new policy is part of a broader effort to increase transparency and provide additional information to the public. Similarly, on December 30, 2009, EPA issued action plans for phthalates, perfluorinated chemicals, polybrominated diphenyl ethers, and short-chain chlorinated paraffins. These action plans summarize available hazard, exposure, and use information for the chemicals that they cover; describe the risks that each chemical may present; and identify the specific steps that EPA is taking to address those concerns. EPA has indicated that it expects to have issued a total of 12 action plans for various classes of chemicals by the end of 2010.
Along with the action plans described above, EPA is moving forward with risk management actions involving a number of chemicals, including lead, mercury, formaldehyde, polychlorinated biphenyls ("PCBs"), glymes, and certain carbon nanotubes. These actions include strengthening regulations governing lead paint work practices standards for renovation and remodeling, banning the use of lead weights in tires, banning the use of mercury in various types of switches, relays and other devices, reevaluating use authorizations for PCBs (discussed in more detail below), and regulating two types of carbon nanotube chemical structures.
Engineered nanoscale materials pose particular challenges because they may be comprised of chemicals that are included in the TSCA inventory but behave very differently than those chemicals. Accordingly, one of the key issues that EPA expects to address in 2010 under TSCA is when an engineered nanoscale material should be considered to be a new chemical for purposes of TSCA. In addition, EPA is developing regulations to require regulated entities to report data on existing uses, production volumes, specific physical properties, chemical and structural characteristics, methods of manufacture and processing, exposure and release information, and available health and safety information pertaining to nanoscale materials.
Finally, EPA has indicated that it intends to reexamine various use authorizations for PCBs with the aim of narrowing or eliminating such authorizations. Pursuant to TSCA, the manufacture of PCBs was banned as of January 1, 1979. However, because PCBs were widely being used as of that date, EPA promulgated regulations allowing PCBs to continue to be used for certain purposes (such as in dielectric fluid in electrical equipment) provided that certain conditions were satisfied. These regulations have affected a broad spectrum of the regulated community. EPA is now signaling that it intends to terminate such use authorizations. In certain instances, such a step will have significant impacts on those entities that continue to rely on the PCB use authorizations. An advanced notice of proposed rulemaking is expected to be issued in early 2010 presenting EPA's approach for phasing out use authorizations for PCBs.