On August 18, EPA posted action plans for benzidine dyes, nonylphenol and nonylphenol ethoxylates, and hexabromocyclododecane. The chemicals at issue are “existing,” meaning that they are currently included on the inventory established under the Toxic Substances Control Act (TSCA) and therefore may be lawfully manufactured, processed, and used in the United States, subject to whatever restrictions or other requirements the Agency imposes. According to EPA, these chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively. Restrictions or further conditions on their use could therefore have significant economic implications for certain stakeholders.
The action plans summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify the specific steps EPA is contemplating to address those concerns. According to the plans, the Agency is contemplating a range of actions under TSCA as well as listings under the Toxic Release Inventory (TRI) established pursuant to Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). As it undertakes the proposed actions, EPA will provide opportunities for public and stakeholder comment and involvement.
The action plans are a further demonstration of EPA’s commitment to using its existing legal authorities to regulate chemicals that may pose a risk to human health and the environment. Until new legislation amending TSCA is enacted, readers should anticipate EPA’s creative and robust use of its existing authorities to implement the Administration’s chemicals management policies.
More information, including copies of the action plans, is available here. A summary of the plans is provided below.
This action plan addresses 48 dyes derived from benzidine and its congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine.
According to EPA, Benzidine and its congeners are important precursors in the synthesis of dyes. Some of these dyes have the potential to metabolize to aromatic amines that are considered to be carcinogenic. Benzidine and dyes metabolized to benzidine are classified as known human carcinogens, and Benzidine’s congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine and dyes metabolized to the latter two congeners have all been classified as “reasonably anticipated to be human carcinogens.”
The dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. According to the Agency, they have the potential to be leached from textiles, such as clothing, that are in prolonged contact with human skin. They are also used as reagents and biological stains in laboratories, are used in the food industries, and have more recent uses in laser, liquid crystal displays, ink-jet printers, and electro-optical devices. Because the dyes have the potential to metabolize to carcinogenic amines both in and on the human body, EPA is concerned about the potential risk from exposure, including exposure of children, from using products containing benzidine and congener-based dyes.
On the basis of existing information, EPA has concluded that the following actions would be warranted:
1. Initiate rulemaking to add four benzidine-based dyes to an existing TSCA section 5(a)(2)significant new use rule (SNUR) for benzidine-based substances at 40 CFR 721.1660. (A SNUR requires manufacturers who intend to use a chemical for the identified significant new use to submit an application, known as a Significant New Use Notice (SNUN), to the Agency for review at least 90 days prior to beginning that activity. The Agency’s review of the SNUN provides an opportunity to take other regulatory action if appropriate.)
2. Initiate rulemaking to establish a new TSCA section 5(a)(2)SNUR for benzidine congener-based dyes, including 44 specific such dyes.
3. Consider proposing to eliminate the article exemption applied to SNURs to address potential concerns for exposure to these dyes on imported finished textiles.
4. Consider initiating action under TSCA section 6, if EPA learns that these dyes are present in imported finished textiles.
5. Consider additional regulatory action, if EPA determines that there are other ongoing uses for these dyes and needs to obtain information necessary to determine whether those uses present concerns which need to be addressed.
Nonylphenol and Nonylphenol Ethoxylates
This action plan addresses Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs). NP and NPEs are produced in large volumes, with uses that lead to widespread release to the aquatic environment.
NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms. NP has also been shown to exhibit estrogenic properties in in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs.
NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products. Many of these, such as laundry detergents, are “down-the-drain” applications. Some others, such as dust-control agents and deicers, lead to direct release to the environment. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP.
According to the Agency, NP and NPEs have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents.
EPA is initiating both voluntary and regulatory actions to manage potential risks from NP and NPEs. EPA intends to:
1. Support and encourage the ongoing voluntary phase-out of NPEs in industrial laundry detergents, as agreed to by the Textile Rental Services Association of America (TRSA). The phase out, which has already begun, is being coordinated with EPA’s DfE Safer Detergents Stewardship Initiative (SDSI)program and would end the use of NPEs in industrial laundry detergents by 2013 for liquid detergents and 2014 for powder detergents. In addition, EPA intends to encourage the manufacturers of all NPE-containing direct-release products (e.g., firefighting gels and foams, dust-control agents and deicers) to move to NPE-free formulations. EPA will develop an alternatives analysis and encourage the elimination of NPE in other industries that discharge NPEs to water, such as the pulp and paper processing and textile processing sectors, where safer alternatives may be available.
2. Initiate rulemaking to simultaneously propose a SNUR under TSCA section 5(a)and a test rule for NP and NPEs under TSCA section 4. The SNUR would designate use of NPEs in detergents and cleaning products as a significant new use, which would require submission of a SNUN at least 90 days before beginning that use. The proposed test rule would require development of the information necessary to determine the effects that NPEs and NP may have on human health or the environment.
3. Consider initiating rulemaking under TSCA section 5(b)(4)to add NP and NPEs to the Concern List of chemicals that present or may present an unreasonable risk of injury to health or the environment.
4. Initiate rulemaking to add NP and NPEs to the Toxics Release Inventory (TRI) established under EPCRA, which would require facilities to report releases of these chemicals to the environment.
This action plan addresses EPA’s review of hexabromocyclododecane (HBCD), a category of brominated flame retardants. HBCD is used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products.
According to EPA, people may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment. HBCD is supposedly found world-wide in the environment and wildlife. EPA claims that HBCD is found in human breast milk, adipose tissue, and blood. It supposedly bioaccumulates in living organisms and biomagnifies in the food chain, and it is persistent in the environment and is transported long distances.
The action plan finds that HBCD is highly toxic to aquatic organisms. It also presents human health concerns based on animal test results indicating potential reproductive, developmental and neurological effects.
EPA intends to initiate the following actions to manage the risk that may be presented by HBCD.
1. Consider initiating rulemaking under TSCA section 5(b)(4)to add HBCD to the Concern List of chemicals which present or may present an unreasonable risk of injury to health or the environment. EPA intends to publish this notice of proposed rulemaking by the end of 2011.
2. Initiate rulemaking under TSCA section 5(a)(2) to designate manufacture or processing of HBCD for use as a flame retardant in consumer textiles as a significant new use. This would require manufacturers and processors to file a SNUN 90 days before manufacturing or processing HBCD for this use. The SNUR also would be proposed to apply to imports of consumer textiles articles containing HBCD.
3. Consider initiating rulemaking under TSCA section 6(a)to regulate HBCD. A section 6(a) action could take the form of a comprehensive ban on the manufacturing, processing, distribution in commerce and use of a chemical substance, or a more targeted regulation to address specific activities. The extent of the rule for HBCD would be determined during the rulemaking process.
4. Initiate rulemaking in 2011 to add HBCD to the Toxics Release Inventory (TRI). Listing on TRI will require manufacturers or importers to provide environmental release information.
5. Conduct a Design for the Environment (DfE)alternatives assessment of HBCD. The information developed may be used to encourage industry to move away from HBCD instead of, in addition to, or as part of any regulatory action taken under TSCA. The alternatives assessment would build upon existing knowledge and would consider various exposed populations, including sensitive human subpopulations, as well as environmental exposure. The work will begin in 2011, with completion expected in 2013.
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Follow the Green Chemistry Law Report for future updates on EPA’s contemplated actions for these chemicals.