The U.S. Environmental Protection Agency (EPA) published a notice on April 4, 2014, announcing that it issued a testing consent order that incorporates an enforceable consent agreement (ECA) for octamethylcyclotetrasiloxane (D4), a chemical intermediate and component of personal care products. 79 Fed. Reg. 18822. There are two big take away messages here. First, that EPA issued a testing order at all under Toxic Substances Control Act (TSCA) Section 4 is big news as none has been issued in a while. Second, this is not your standard Section 4 order, for the reasons discussed below. The ECA may well serve as a template for other similar ECAs, and stakeholders may wish to read on to understand what is new and different about this ECA.
According to EPA, D4 is a high production volume chemical (100-500 million pounds per year), is highly persistent in sediment, exhibits high bioaccumulation potential, is a potential reproductive toxicant, exhibits aquatic toxicity, is present in biomonitoring (blood, breast milk, and aquatic species), and is used in consumer products, including soaps and detergents, adhesives and sealants, and polishes and sanitation products. EPA most recently expressed concern with D4 on June 1, 2012, when EPA added D4 and 17 other chemicals to the list of chemicals for assessment in 2013 and 2014 under EPA's Work Plan Chemicals program (see online). EPA's interest in D4 goes way back, however, almost 30 years to November 1984 when EPA's Interagency Testing Committee (ITC) recommended what was then referred to as octamethylcyclotetrasiloxane (OMCTS) be considered for chemical fate and environmental effects testing. In 1985, EPA issued a proposed TSCA test rule requiring OMCTS manufacturers to conduct certain chemical fate and environmental effects testing. 50 Fed. Reg. 45l23 (Oct. 30, 1985). A final rule announcing an ECA was issued four years later on January 10, 1989. 54 Fed. Reg. 818.
Key Testing Parameters
As reported in several trade press accounts, the negotiations relating to the new ECA were protracted and difficult. Under the ECA, EPA will require testing for D4's presence in several environmental media. The testing program will be conducted over a one-year period. EPA will use the information obtained through the ECA in conjunction with other available data to assess exposures and risks due to environmental releases from D4. As a result of the ECA, exporters of D4, including persons who do not sign the ECA, are subject to TSCA export notification requirements.
According to the Federal Register notice, Dow Corning Corporation, Evonik Corporation, Momentive Performance Materials USA Inc., Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation agreed to certain environmental testing that EPA will use to characterize sources and pathways of release of D4 to the environment and resulting exposures of aquatic and sediment dwelling organisms to D4. The ECA requires testing for the presence of D4 around specified wastewater treatment plants (WWTP) at the method detection limits specified in the ECA. The notice states that environmental testing will be conducted at direct discharge sites. Direct discharge sites are D4 manufacturing and/or processing sites that discharge process wastewater into the environment after on-site wastewater treatment. Environmental testing will be conducted at WWTPs serving indirect discharge sites. Indirect discharge sites are D4 processing sites, including product formulation sites, that discharge process wastewater to off-site WWTPs. The notice states that primarily non-industrial WWTPs receive less than 15 percent of wastewater from industrial facilities and, preferably, no wastewater from D4 manufacturing or processing (including product formulation) sites. Environmental testing will be conducted at WWTPs serving primarily non-industrial wastewater treatment sites. Reportedly, the number of monitoring sites was a key stumbling block during the negotiations.
Following completion of the required environmental testing, the signatory companies must submit a final report to EPA. EPA states that it intends to release the final report to the public. EPA will use the test data to develop D4 environmental exposure and risk assessments. EPA notes that other federal agencies, including the Agency for Toxic Substances and Disease Registry (ATSDR), the Consumer Product Safety Commission (CPSC), and the U.S. Food and Drug Administration (FDA), could use the data in assessing chemical risks and in taking appropriate actions within their programs.
Interesting Aspects of the ECA
As of April 4, 2014, the effective date of the ECA and the order that incorporates the ECA under TSCA Section 4, any of the signatory companies or any other person who exports or intends to export any D4 that is the subject of the ECA and order that incorporates the ECA, in any form, are subject to the export notification requirements of TSCA Section 12(b). Section 12(b) requires any person who exports or intends to export to a foreign country a chemical substance or mixture for which the submission of data is required under TSCA Section 4 to submit a notification of the export or intended export to EPA. Typically, EPA provides a 30-day period before export notification is required. Not so here.
Interestingly also, the Federal Register notes that as of the effective date of the order (April 4, 2014), "any of the Companies, as well as any other person, who exports or intends to export any D4 that is the subject of this ECA and Order that incorporates the ECA, in any form, are subject to the export notification requirements of TSCA section 12(b)" (emphasis added). While the meaning of "in any form" is less than clear in the Federal Register notice and the point is not explained in the ECA text, 40 C.F.R. § 707.60(b) states that "[n]o notice of export will be required for articles...unless" EPA "so requires in the context of individual section 5, 6, or 7 actions." Thus, despite the lack of clarity, the export notification requirement, absent additional EPA action, does not extend to articles containing D4.
Substantively, the testing requirements under the ECA are unique. This ECA represents one of the few attempts to generate exposure test data pertinent to a substance. Another example is the ECA on refractory ceramic fibers (40 C.F.R. § 799.5000), which issued in 1993 and included exposure monitoring testing. As noted, testing is to be conducted on samples collected at four direct discharge locations and five indirect discharge locations that include D4 processors, including product formulators.
Finally, this is the first ECA to issue since EPA changed its approach in 2010 to developing ECAs to include discrete timelines for negotiation. For more information on the new Section 4 process, see online. The fact that the revised negotiation approach was successful and given the need for and difficulties in otherwise obtaining exposure test data, this approach with D4 could serve as a template for future ECAs intended to assess chemical exposures.
The ECA is available online. The Federal Register notice is available online.
International Conference on Chemical Policy (ICCP) 2014,
April 22-24, 2014, Seoul, South Korea
The Korea Chemical Management Association's annual chemical policy conference is expected to draw record attendance due to the global interest in The Act on the Registration and Evaluation of Chemicals (K-REACH) as the January 1, 2015, effective date approaches. Leslie S. MacDougall will give a presentation on the similarities and differences between K-REACH and U.S. chemical assessment and management.
Webinar: EU Biocidal Products Regulation (BPR):
What it Means for Industry and How it Compares to U.S. Regulation,
April 30, 2014, 1:00 p.m. - 2:30 p.m.
The webinar, presented by Bloomberg BNA and featuring Andrew R. Bourne, Lisa R. Burchi, and Lara A. Hall, will focus on existing industry norms and explore how current standard practices will be affected by the new developments in EU biocides regulation. The current trends in the EU biocides regulatory landscape will be compared to the U.S. system (the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)), and the time and practical steps necessary to bring a product to market in the U.S. and EU will be contrasted. 1.5 hours of CPE or CLE credit.