Green Chemistry Updates

GREEN CHEMISTRY DEVELOPMENTS

California Prepares For Release of Final “Safer Consumer Product Alternatives” Regulations: The 15-day comment period regarding the California Department of Toxic Substances Control (CDTSC) November 16, 2010, release of revisions to its “Safer Consumer Product Alternatives” (SCPA) regulations ended on December 3, 2010. The SCPA regulations pertain to the identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and regulatory responses for selected alternatives. CDTSC appears on track, as required under the 2008 law (A.B. 1879), to adopt regulations to address chemicals and chemical ingredients in consumer products by January 1, 2011.

If the revised SCPA regulations are adopted as is the focus of CDTSC’s efforts for the first five years will be limited to three categories of consumer goods “Priority Products.” Specifically, the revised SCPA regulations would initially limit the types of consumer products that could be classified as “Priority Products” to: (1) children’s products; (2) personal care products; and (3) household cleaning products. After five years (i.e., after January 1, 2016), CDTSC would not be required to limit the scope of Priority Products to these three types of consumer products. It should be noted that there are some exemptions for certain products (e.g., food, pharmaceuticals, medical devices) that will continue to apply. In addition, CDTSC removed all references to nanotechnology and nanomaterials in the revised proposed SCPA regulations.

One of the initial responsibilities of CDTSC would be the creation of a list of “Chemicals of Concern,” which is required to be completed by December 31, 2011, and then the creation of a list of “Priority Products,” which is required to be completed by December 31, 2012. The SCPA regulations provide that in preparing the initial list of Chemicals of Concern, CDTSC “shall only consider chemicals that are one or more of the following”:

  • Chemicals that are carcinogens or reproductive toxins, or both.
     
  • Chemicals that are listed as Category 1A or 1B mutagens in Annex VI to Regulation (EC) No. 1272/2008 of the European Parliament and the Council.
     
  • Chemicals that have been determined by EPA to be persistent bioaccumulative toxic chemicals (although this criteria does not apply to any list of Chemicals of Concern issued after the initial list).

The proposed revised SCPA regulations also provide the criteria by which CDTSC shall determine those chemicals “of highest priority.” The regulations provide that CDTSC “shall seek to identify and give priority to those chemicals that pose the greatest threat of adverse public health and environmental impacts, are most prevalently distributed in commerce and contained in products used by consumers, and for which there is the greatest potential for consumers or environmental receptors to be exposed to the chemicals in quantities that can result in adverse public health or environmental impacts.”

CDTSC is required under the proposed revised SCPA regulations to make its initial proposed Chemicals of Concern list available on CDTSC’s website for public review and comment and hold “one or more public workshops to provide an opportunity for the public to comment orally on the proposed list,” before a final list is issued.

To assist CDTSC, the proposed revised SCPA regulations set forth a procedure under which CDTSC could request data or other information concerning chemicals and products. The type of information that could be requested includes:

  • Chemical and product data and information specified in Section 69302.3 (Chemicals of Concern Prioritization) and 69303.3 (Priority Products Prioritization);
     
  • Available and applicable chemical identification and description information;
     
  • Information describing the types, categories, and classes of products that contain Chemicals of Concern;
     
  • Information on intentionally-added chemicals and chemical ingredients in specified products, and quantities of the chemical in the entire product or component;
     
  • Market presence information;
     
  • Description of end-of-life management program(s) for a product, if any; and
     
  • Standard analytical chemical protocols, if available, for the detection and measurement of a chemical in products and in environmental and biological media.

Although CDTSC attempted to clarify and scale back the types and amount of information that parties could be required to submit as part of the information-gathering process that feeds into the identification and prioritization processes for chemicals and products, companies may still face significant burdens and confidentiality protection issues if required to provide the information described above.

The revised regulations and documents added to the rulemaking file are available online.

NANOTECHNOLOGY

EPA Posts Interim Technical Guidance For Assessing Exposure To Nanomaterials: EPA has posted a June 17, 2010, document entitled “Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials.” According to the Interim Guidance, EPA prepared it “to serve as a guide when developing screening level exposure and environmental fate and transport assessments for nanomaterials,” such as those submitted under the TSCA New Chemicals Program. The Interim Guidance is applicable for neat nanomaterials (i.e., powdered or particulate forms), as opposed to nanoscale particles embedded within composites. At this time, according to the Interim Guidance, EPA does not have models or methods capable of predicting the fate of, or exposure to, nanoscale particulates in the environment. This fact, combined with the limited data for nanomaterials, means that there is uncertainty in estimating removal efficiencies, degradation half-lives, partitioning, and transport of nanomaterials. To address the uncertainty, EPA recommends using a conservative bounding “what if” scenario, which assumes that nanomaterials are not removed during wastewater treatment or incineration (i.e., 0 percent removal efficiency), are persistent (i.e., P3), are highly bioaccumulative (i.e., B3), and are highly mobile in groundwater unless measured data are available that proves otherwise. EPA describes this conservative approach as “prudent at this time given the limited available data and lack of historical knowledge regarding the behavior of nanomaterials in the environment.” The Interim Guidance is available online.

Australian Government Reviews Notification Process For Industrial Nanomaterials: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) recently announced new administrative processes for the notification and assessment of industrial nanomaterials that are considered new chemicals, which will be of interest to companies introducing nanomaterials as new chemicals in Australia. NICNAS is the governmental, industrial chemical notification system in Australia and is responsible for the management of the Australian Inventory of Chemical Substances. After convening consultations between November 2009 and February 2010, NICNAS is now introducing new administrative processes for notifying and assessing industrial nanomaterials that are considered new chemicals under Part 3 of the Industrial Chemicals Notification and Assessment Act 1989. The information was published in the Australian government’s October 5, 2010, Chemical Gazette, which can be viewed online. A more detailed memorandum is available online.

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