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August 18, 2010

EPA Announces Action Plans for Chemicals Used in Dyes, Flame Retardants, and Industrial Detergents

The ACTA Group

On August 18, 2010, the U.S. Environmental Protection Agency (EPA) announced action plans for benzidine dyes, hexabromocyclododecane (HBCD), and nonylphenol (NP) and nonylphenol ethoxylates (NPE). According to EPA, the chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively. The action plans identify a range of actions EPA is considering under the Toxic Substances Control Act (TSCA), as well as listing under the Toxics Release Inventory (TRI). More information is available online.

Benzidine Dyes

EPA’s action plan addresses 48 dyes derived from benzidine and its congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine. EPA states that it is concerned about the dyes because some of them “have the potential to metabolize to aromatic amines that are considered to be carcinogenic.” Benzidine-based and congener-based dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. According to EPA, these dyes have the potential to be leached from textiles, such as clothing, that are in prolonged contact with human skin. The dyes 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. EPA also reviewed benzidine congener-based pigments, but determined that the presence of the pigments in such consumer products as printing inks, paints, plastics, and textiles was unlikely to present an exposure concern because the pigments are not bioavailable and are not absorbed into the body.

On the basis of existing information, EPA believes 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 C.F.R. Section 721.1660;
  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; and
  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 that need to be addressed.

More information is available online.


HBCD is a category of brominated flame retardants, and is used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products. People may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment. According to EPA, it is concerned about HBCD because it is found world-wide in the environment and wildlife. It is also found in human breast milk, adipose tissue, and blood. It bioaccumulates in living organisms and biomagnifies in the food chain. It appears to be persistent in the environment and to be transported long distances. EPA states that HBCD is highly toxic to aquatic organisms, and presents human health concerns based on animal test results indicating potential reproductive, developmental, and neurological effects. At the same time, EPA acknowledges uncertainty regarding the availability of substitutes for HBCD’s use in polystyrene foam although there appear to be substitutes for its use as a flame retardant in other applications. A point that EPA neglects to mention is that HBCD was identified in 2008 as a high priority in the now discontinued Chemical Assessment and Management Program (ChAMP) (see online).

EPA intends to initiate the following actions:

  1. Consider initiating rulemaking under TSCA Section 5(b)(4) to add HBCD to the list of chemicals of concern that 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 notify EPA before manufacturing or processing HBCD for this use. The SNUR also would be proposed to apply to imports of consumer textiles articles containing HBCD. EPA has evidence to suggest that the use of HBCD in textiles may be limited to specialty commercial applications, and that general consumer textile use may be so limited it would be appropriate for SNUR regulation. If information shows this assumption to be incorrect, EPA will consider initiating rulemaking under TSCA Section 6(a) to address general consumer textile use.
  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 TRI. Listing on TRI will require manufacturers or importers to provide environmental release information.
  5. Conduct a 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.

More information is available online.

NP and NPEs

According to EPA, it is concerned about NP and NPEs, both of which are produced in large volumes with the latter having uses that reportedly lead to widespread release to the aquatic environment. EPA states:

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.

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 intended to manage potential risks from NP and NPEs:

  1. Support and encourage the ongoing voluntary phase-out of NPEs in industrial laundry detergents. In discussions with EPA, the Textile Rental Services Association of America (TRSA) agreed to expedite a phase-out of NPEs in industrial laundry detergents. The phase out, which has already begun, is being coordinated with EPA’s Design for the Environment (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. DfE also intends to expand the scope of SDSI, and encourage those industries to make commitments under SDSI. For detergent uses, the DfE-sponsored CleanGredients database offers a source of ready alternatives that EPA states are functionally equivalent to NPEs based on performance characteristics and safer because they meet the DfE criteria for safer surfactants.
  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 proposed SNUR would designate use of NPEs in detergents and cleaning products a significant new use, which would require submission of a significant new use notice (SNUN) to EPA at least 90 days before beginning that use. This gives EPA the opportunity to take other regulatory action if appropriate. The proposed test rule would require development of the information necessary to determine the effects that NPEs and NP have on human health or the environment. EPA issued an advance notice of proposed rulemaking (ANPRM) for NP and NPEs on June 17, 2009. EPA intends to evaluate how releases and exposures are mitigated through the phase-out action, however, and would finalize any proposed testing actions accordingly.
  3. Consider initiating rulemaking in late 2011 under TSCA Section 5(b)(4) to add NP and NPEs to the list of chemicals of concern that present or may present an unreasonable risk of injury to health or the environment.
  4. Initiate rulemaking in late 2011 to add NP and NPEs to the TRI, which would require facilities to report releases of these chemicals to the environment.

More information is available online.