Public comments regarding California’s Green Chemistry Draft Regulation for Safer Consumer Products were due last week.  My comment /letter on the nanotechnology provisions contained in the draft regulation is set forth below.  Additionally, you can find a copy of the draft regulation here.


July 15, 2010

Heather Jones, MS 22A
California Department of Toxic Substances Control
Office of Legislation & Regulatory Policy
P.O Box 806
Sacramento, CA 95812
Re: Comments regarding draft regulation: Safer Consumer Product Alternatives, Chapter 53 of Division 4.5 of Title 22, California Code of Regulations

Dear Ms. Jones:

Please accept this letter as my personal comments regarding the nanotechnology-related provisions of the above-referenced draft regulation. Many thanks in advance for your consideration of my brief thoughts.

As a general matter, I believe chemical regulations should be drafted to provide the State with all of the power it needs to effectively do its job without unfairly maligning any chemical substance, either directly or by implication. It is a delicate balance that this draft regulation obviously attempts to achieve. I hope that my specific comments further assist in this regard.

Definition of “Chemical:” I do not believe that Part 3 of the definition of “Chemical” on Page 5 of the draft regulation is necessary. As you know, that provision provides an alternative definition of “Chemical” as: “Materials or substances manufactured or engineered at the nanoscale, which contains nanostructures, or is considered to be a nanomaterial.” Simply put, the first two parts of the definition of “Chemical” in their current form are more than broad enough to capture all nanoscale chemical substances. There is no need to single them out in a separate provision. Doing so implies some type of special skepticism or worry which is not necessary to accomplish the purpose or objectives of the draft regulation.

Definition of “Importer:” The definition of “Importer” on Page 7 of the draft regulation should contain a phrase acknowledging that “Importers” are entities physically located or operating in California. Businesses located outside of the State which ship products into the State are covered by the definition of “Make available for use in California” on Page 8. This distinction is important because some out-of-state manufacturers/distributors of carbon nanotubes were considered “importers” under the CDTSC’s January 2009 carbon nanotube data call-in. This issue should be remedied in the proposed regulation.

Definitions of “Nanomaterial,” “Nanoscale,” and “Nanostructure”: The definitions of these three terms on Page 8 of the draft regulation are only necessary if Part 3 of the definition of “Chemical” on Page 5 is retained. Consistent with my above recommendation, I respectfully suggest that they be eliminated along with Part 3 of the definition of “Chemical” which incorporates them by reference. However, in the event these terms are retained, the State should strongly consider changing the definition of “Nanoscale” to follow commonly accepted definitions used throughout the world which rely on a size range of 1 to 100 nanometers. Any deviation from this traditional definition should be thoroughly explained and justified by the State.

If the State is concerned that some companies might claim they are exempt from the regulation because the materials they manufacture are larger than 100 nm and thus are not truly “nanoscale,” the definitions of “Chemical” provided in Parts 1 and 2 on Page 5 are still broad enough to capture these companies’ materials. Additionally, the term “approximately” could be inserted in the definition of “Nanoscale” which would provide CDTSC the latitude it needs to review companies seeking to invoke any arbitrary size limitation. Further, the definitions of “Nanomaterial” and “Nanostructure” on Page 8 of the draft regulation could be amended to include materials made or sold by any company representing that it or its products are “nano,” or nanoenabled, etc. This would further prevent undue reliance on a technical size limitation.

Finally, the terms “nanomaterial,” “nanoscale,” and “nanostructure” are currently the subject of draft technical specifications being prepared by the International Organization for Standardization (ISO) which has 163 country participants. If technical definitions are included in California’s regulation, I believe ISO’s definitions are the best place to start. I am sure that ISO would be happy to provide the State with current drafts of the relevant technical specifications upon request.
Thank you again for taking the time to consider my thoughts. I would be happy to discuss the draft regulation with you or anyone else at any time.

Very truly yours,

John C. Monica, Jr.