Under the Toxic Substances Control Act (TSCA) as well as the Pollution Prevention Act (PPA), (see www.epa.gov/opptintr/existingchemicals/pubs/basicinfo.html) USEPA has statutory authority to address pollution prevention, risk assessment, hazard and exposure assessment and characterization, and risk management for chemical substances in commercial use. Specifically, TSCA directs EPA to:
- Maintain the Chemical Substances Inventory, which is a list of existing chemicals in commerce. (Chemicals not already listed on the TSCA Inventory are considered "new chemicals" under TSCA and must go through a review process before they can be added to the Inventory and become "existing chemicals."
- Require testing of chemical substances where necessary to evaluate potential human health or environmental hazards.
- Regulate (including restricting or banning) the manufacture, importation, processing, distribution, use, and/or disposal of any chemical substance that presents an unreasonable risk of injury to human health or the environment.
- Coordinate certain actions on chemical substances under TSCA with actions taken under other federal laws, including those administered by other federal agencies as well as other laws administered by EPA. If risk on a chemical substance is already managed effectively under a different statute, regulation under TSCA generally is not used.
As outlined by EPA (www.epa.gov/opptintr/existingchemicals/pubs/enhanchems.html), on September 29, 2009, Lisa Jackson, EPA Administrator, announced that EPA is putting in place a comprehensive approach to enhance the Agency’s current chemicals management program under TSCA. This approach includes the following activities:
- New regulatory risk management actions.
- Development of Chemical Action Plans.
- Submittal of information.
- Increased public access to information about chemicals.
- Identification of Priority Chemicals for review and assessment.
The purpose of this blog article is to discuss in further detail EPA’s proposed actions with regard to Item 5 above. On September 7, 2011, EPA hosted a webinar to obtain public input regarding its new approach, a two-step process, to identify priority chemicals for review and assessment under TSCA. Step 1 would consist of the identification of an initial group of chemicals (estimated to be in the “several hundreds” by EPA during the webinar) based on specific data sources and Chemical Action Plan priority factors, which are:
- Chemicals identified as potentially of concern for children’s health (e.g., chemicals with reproductive or developmental effects).
- Chemicals identified as persistent, bioaccumulative, and toxic (PBT).
- Chemicals identified as probable or know carcinogens.
- Chemicals used in children’s products.
- Chemicals used in consumer products.
- Chemicals detected in biomonitoring programs.
EPA states (www.epa.gov/opptintr/existingchemicals/pubs/chempridiscguide.html) that “chemicals meeting one or more of these Action Plan prioritization factors would become part of the initial group of specialty chemicals for review.” Under Step 1, EPA proposes to use a broad range of domestic and international data sources to identify chemicals for further review. Some of these data sources include:
- Integrated Risk Information System (IRIS).
- TRI PBT Rule.
- Great Lakes Binational Toxics Strategy Canadian Categorization.
- Chemicals proposed to UNECE LRTAP POPs and Stockholm Convention on POPs.
- Voluntary Children’s Chemical Evaluation Program.
- California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986).
- Washington State Children’s Safe Products Act.
- Danish Consumer Products Studies.
Under Step 2, EPA would refine the group of specialty chemicals identified using a broader range of data sources to further analyze and select specific chemicals for further assessment. EPA identifies the following types of exposure data source categories that will be used:
- Uses.
- Environmental releases.
- General human exposures, including indoor air contaminants.
- Worker exposures.
- Environmental exposures.
- National Library of Medicine Databases.
- TSCA Test Submission Database (TSCATS).
- USEPA:
- Office of Pesticide Programs
- Ambient Water Quality Criteria Documents
- Drinking Water Standards Health Effects Support Documents
- ECOTOX database
- IPCS Concise International Chemical Assessment Documents (CICADS)
As summarized by Lynn L. Bergeson in the November and December 2011 editions of Pollution Engineering (see Legal Outlook, pages 10 and 11 respectively), as commercial and industrial users of existing chemical compounds in the U.S. consider the implications of EPA’s proposed new approach to identifying priority chemicals for review and assessment under TSCA, the following issues should be considered:
- A potentially large list of chemicals (estimated by EPA to be in the “several hundreds”) will initially be generated for review.
- The process to be used by EPA to select which chemicals will be evaluated is not clear.
- EPA states it will consider “risk-based prioritization factors” in Step 1. However, how EPA will integrate “risk-based prioritization factors” into the process is also not clear.
Finally, as with other revisions to TSCA proposed by EPA over the last several years, there could be potentially important impacts on the commercial and industrial use of chemicals in the U.S. One such impact could ultimately be the development of a “chemicals of concern” list under Step 1, with the potentially adverse impacts associated with the development of such a list by EPA. Furthermore, under TSCA, it should be noted that EPA has the statutory authority to regulate (including restricting or banning) the manufacture, importation, processing, distribution, use, and/or disposal of any chemical substance that presents an unreasonable risk of injury to human health or the environment. Therefore, continued monitoring of EPA’s proposed revisions to TSCA is recommended as EPA moves the process forward.
This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here.
Energy and Environment Monitor