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California Targets Nanometal Oxides, Nanosilver, and Zerovalent Iron in Possible Second Mandatory Data Call-In for Nanomaterials

Beveridge & Diamond, P.C., June 18, 2009

The California Department of Toxic Substances Control (“DTSC”) has announced its intention to request information and data for “reactive nanometal oxides” and other nanomaterials.  The original announcement, on April 14, 2009, identified nanoscale aluminum oxide, silicon dioxide, titanium dioxide, and zinc oxide as examples of possible nanometal oxides to be reviewed.  A recent update added nanoscale silver, nano zerovalent iron, and cerium oxide.  If DTSC undertakes a formal, mandatory data call-in, it would be the second call-in for nanomaterials under California’s Chemical Information Call-In law, A.B. 289, California Health and Safety Code, Chapter 699, sections 57018-57020.  In January 2009, DTSC issued its first call-in for carbon nanotubes (“CNTs”). 

Through the proposed data call-in, DTSC intends to expand its current knowledge of “analytical test methods, fate and transport in the environment, and other relevant information” for the nanomaterials selected.  DTSC will issue the request to “manufacturers,” defined to include businesses located in California that produce these materials or import them for sale in California. One concern is that while A.B. 289 limits the law’s scope to “manufacturers,” in the previous data call-in DTSC asserted that it also applied to “companies outside California who may export carbon nanotubes into the State.”  The definitions for key terms such as “manufacturer” and “chemical” are sufficiently broad to enable the Agency to require the participation of consumer product companies.  After DTSC issues the request, companies subject to the call-in will have one year to respond to DTSC with the required information, including generating any data that DTSC requires.

A data call-in for these materials could have significant implications for industry.  For example, it may be the first step in a process that leads to state regulation of these nanomaterials.  Responding to the data call-in and generating the necessary data and other information may well be resource-intensive and costly.  In addition, the statute places a substantial burden on companies attempting to protect their confidential business information (“CBI”).  If DTSC receives a request for the public release of CBI, it will notify the company of the request and the company must obtain a declaratory judgment or preliminary injunction from a California court within 30 days of the Agency’s notice to avoid public release. 

The Agency’s proposal also raises a number of important science policy issues for industry consideration and input.  For example, DTSC will need to define the nanoscale with minimal ambiguity so that companies know whether their materials are included in the program. The call-in would benefit from guidance on the amount and type of material characterization data that should be available before hazard data for a particular material are considered sufficiently reliable.  Companies also may want to provide input on the endpoints that may be the most relevant for the different nanomaterials under consideration.  These and related issues could have important implications for the DTSC program and the future regulation of nanomaterials in California.  They also could affect the regulation of nanomaterials in other jurisdictions that may model their programs on California’s. 

Manufacturers of the targeted nanomaterials, as well as manufacturers of products containing them, may wish to submit comments on DTSC’s proposal.  Although DTSC has not set a deadline for receiving comments, industry stakeholders should consider submitting comments in the near future to help shape the program that the Agency is currently contemplating.

Key documents can be found at http://www.dtsc.ca.gov/
TechnologyDevelopment/Nanotechnology/index.cfm
.  

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For more information, please contact Laura Duncan at (415) 262-4003 (lduncan@bdlaw.com), Mark Duvall at (202) 789-6090 (mduvall@bdlaw.com), or Phil Moffat at (202) 789-6027 (pmoffat@bdlaw.com). 

This alert was prepared with the assistance of Alexandra Wyatt.

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