EPA Issues Eleventh Hour "Action Plans" for Classes of Chemicals
On December 30, 2009, the Environmental Protection Agency (EPA) announced "action plans" under the Toxic Substances Control Act (TSCA) for certain chemicals, including certain phthalates, short-chain chlorinated paraffins, polybrominated diphenyl ethers (PBDEs), and perfluorinated chemicals, asserting that these chemicals "have raised a range of health and environmental concerns." (The agency's announcement is available here ).
After an earlier promise to release the first action plans in December 2009, EPA fulfilled its commitment on December 30. If EPA stays on schedule another set of action plans would be expected in March. The next chemicals slated for action plans include benzidine dyes and pigments, and bisphenol A. EPA plans to add phthalates and PBDEs to its newly-established "Chemicals of Concern" list. This listing process may lead to regulations requiring significant risk reduction measures intended to protect human health and the environment. Once a substance is listed, companies may provide EPA with information demonstrating that the chemical does not pose an unreasonable risk. "Chemicals of concern" has become a buzz phrase in recent months, as the concept of prioritization has taken center stage. In EPA's Essential Principles for Reform of Chemicals Management Legislation, issued in September 2009, the Agency stated that TSCA reform would be necessary for the agency to effectively target chemicals of concern. (See here.)
During a Congressional hearing in November 2009, Steve Owens, Assistant Administrator for EPA's Office of Prevention, Pesticides, and Toxic Substances, made clear that EPA is pursuing regulatory prioritization of chemicals based on their presence in human blood, whether they are PBTs, their toxicity, and their production volume. The action plans released last week are evidence that EPA is proceeding without delay with prioritization. The action plans should not be interpreted as a sign that the Agency intends to ease its insistence for TSCA reform. As noted in its announcement, EPA believes that TSCA is "both outdated and in need of reform" and will continue to seek "comprehensive reform … that ensures a full assessment of the safety of chemicals on the market today and effective actions to reduce risks where chemicals do not meet the safety standard."
In the announcement EPA Administrator Jackson also emphasized the importance of chemical safety for children, which may be an indicator that the Agency will join the push for introduction of a 2010 version of the Kid Safe Chemicals Act (KSCA). Although it is unclear whether a legislative TSCA reform proposal will directly mirror the versions of KSCA introduced in 2005 and 2008, industry generally is expecting a TSCA reform bill in 2010. Prioritization is gaining attention on the state level as well. In early December, 13 states jointly released the States' Principles on Reform of the Toxic Substances Control Act, available here.
One of the highlighted reform principles is to prioritize chemicals of concern and regulate the perceived most problematic chemicals in commerce. New York signed on to the multi-state reform proposal but is also pursuing its own prioritization initiative. Recently, a state advisory council known as the Interagency Committee on Sustainability and Green Procurement proposed creation of a "Chemical Avoidance List." The current draft of the list identifies approximately 95 "priority toxic chemical substances" that would be phased out when cost-effective safer alternatives are identified. The list currently includes two substances for which EPA has already established action plans (PBDEs and perfluorinated compounds), and one substance for which an action plan is forthcoming (Bisphenol A). Establishing a "Chemical Avoidance List" would implement Governor David Paterson's 2008 Executive Order No. 4, Establishing a State Green Procurement and Agency Sustainability Program, which directs the Committee to reduce or eliminate the health and environmental risks from the use or release of toxic substances.
Summary of Four Chemical Action Plans
In the action plan for each chemical, EPA summarizes certain hazard, exposure, and use information on the chemical; discusses risks presented by the chemical; and sets forth actions to address the agency's concerns. Below is a brief summary of EPA's findings and actions the Agency intends to take to manage risks posed by each chemical. The complete action plans are available at here.
Long-Chain Perfluorinated Chemicals
Long-chain perfluorinated chemicals (PFCs) are used in a variety of industrial and consumer applications to impart nonstick, stain-resistant, fire-resistant or surfactant properties. PFCs comprise both perfluoroalkyl sulfonates (PFAS) and perfluoroalkyl carboxylates (PFAC). The PFAS category includes perfluorohexane sulfonic acid, higher homologues and their salts and precursors, and the PFAC category includes perfluorooctanoic acid (commonly called C8), higher homologues and their salts and precursors. EPA is concerned about long-chain PFCs because EPA believes that they are "bioaccumulative in wildlife and humans," "persistent in the environment," and "toxic to laboratory animals and wildlife." Although EPA acknowledges that significant adverse effects have not been discovered in the general human population, EPA notes that significant adverse effects have been identified in laboratory animals and wildlife. EPA believes that continued exposure could increase body burdens to levels that would result in adverse outcomes, given the long half-life of these PFCs. EPA plans to take the following actions on long-chain PFCs:
- Initiate rulemaking under TSCA section 6 in 2012, which may lead to a ban or restrictions on the manufacture, import, processing and use of PFCs.
- Consider rulemaking under TSCA section 6 on the PFAS sub-category that could address articles containing PFAS and expand the 2010/2015 PFOA Stewardship Program.
- Evaluate the potential for disproportionate impact of long-chain PFCs on developing fetus, children and other vulnerable sub-populations.
Polybrominated Diphenyl Ethers
Polybrominated diphenyl ethers (PBDEs) are used as flame-retardants in a wide range of applications. Each commercial version is a mixture composed of several PBDE congeners. EPA is concerned that certain PBDE congeners are persistent, bioaccumulative and toxic (PBT) to both humans and the environment. Although the U.S. phased out the manufacture and import of penta- and octaBDE in 2004, the component congeners of these substances are being detected in humans and the environment. A potential source is the breakdown of decabromodiphenyl ether (decaBDE), one type of PBDE, which was included in EPA's Voluntary Children's Chemical Evaluation Program. EPA intends this action plan to reinforce the recently announced voluntary phase-out of decaBDE. As the result of negotiations with EPA, the two U.S. producers of decaBDE, Albemarle Corporation and Chemtura Corporation, and the largest U.S. importer, ICL Industrial Products, Inc., have committed to end production, importation, and sales of decaBDE for most uses in the U.S. by December 31, 2012, and to end all uses by the end of 2013. For more information on the phase-out agreement, please see here. For PBDEs, EPA proposes to take the following actions:
- Initiate rulemaking under TSCA section 5(b)(4) to add commercial PBDE mixtures and/or their congeners Chemicals of Concern List, with the goal of proposing a rule in late 2010.
- Initiate rulemaking under TSCA section 5 to establish a significant new use rule (SNUR) requiring notification to EPA prior to manufacture or import of articles containing pentaBDE or octaBDE. EPA aims to propose the SNUR in August of 2010.
- Initiating rulemaking under TSCA section 4 on the previously announced test rule for decaBDE, and initiate rulemaking under TSCA section 5 to establish a SNUR for decaBDE. The SNUR and test rule are slated for proposal in 2010.
Phthalates are used as plasticizers to increase the flexibility, transparency, durability and longevity of plastics. EPA's action plan on phthalates applies to eight types of phthalates: dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), butyl benzyl phthalate (BBP), di-n-pentyl phthalate (DnPP), di(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP). According to EPA, phthalates pose the greatest risk to the development of the male reproductive system. EPA proposes to take the following actions to manage phthalates:
- Initiate rulemaking under TSCA section 5(b)(4) to add the eight phthalates to the Chemicals of Concern List. EPA aims to propose a rule in 2010.
- Two of the eight phthalates are currently on the list of toxic chemicals under section 21 of the Emergency Planning and Community Right-to-Know Act (EPCRA). EPA plans to initiate rulemaking in late 2010 to add the other six phthalates to this list of toxic chemicals.
- Consider initiating rulemaking under TSCA section 6 to limit or ban the eight phthalates. EPA will continue to work with the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA) to complete a comprehensive review of phthalates.
- Pursue rulemaking in 2010 or 2011 under TSCA section 5(a)(2) to require notification to EPA before manufacture or processing of DnPP for a significant new use.
- Complete by 2012 a Design for the Environment and Green Chemistry alternatives assessment to encourage industry to move away from phthalates.
Short-Chain Chlorinated Paraffins (SCCPs) and Other Chlorinated Paraffins
- Short-chain chlorinated paraffins (SCCPs) are used as a component of lubricants and coolants in metalworking applications and as both a secondary plasticizer and flame retardant in plastics. According to EPA, SCCPs are persistent, bioaccumulative in wildlife and humans, transported globally in the environment, and toxic to aquatic organisms at low concentrations. For SCCPs, EPA plans to take the following actions:
- Consider rulemaking under TSCA section 6 to ban or restrict the manufacture, import, processing or distribution in commerce, export, and use of SCCPs
- Require submission of premanufacture notices (PMNs) for SCCPs, medium-chained chlorinated paraffins (MCCPs), and long-chained chlorinated paraffins (LCCPs) that are not on the TSCA Inventory.
- Initiate action under TSCA section 5 to address risks posed by SCCPs, and potentially risks associated with MCCPs and LCCPs.
- For more information on legislative and regulatory efforts to reform the Toxic Substances Control Act, please visit Keller and Heckman's TSCA Reform Center at www.tsca-reform.com.