Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

California's Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins.  Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009. 

In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked.  We cover each material below.

CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions. 

CDTSC plans to issue all of these new data call ins sometime before the end of the year.  Stay tuned . . .

Nano Silver

Proposed Questions:  What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?

Preliminary Recipients:  Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.

Nano Zero Valent Iron

Proposed Questions:  What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its lifecycle? How do you sample, measure, and monitor quality? Performance? How do you detect, measure, and monitor releases from facility operations? How do you measure and monitor fate and transport after useful life?

Preliminary Recipients:  American Elements, AMEC Geomatrix, hepure Technologies, OnMaterials, Quantum Sphere, Stanford Materials, Sun Innovations.

Nano Titanium Dioxide

Proposed Questions: What machines and methods do you use to analyze your materials? What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? What is the toxicity when your material is directly contacted with human skin? What is the weathering, liberation rate of your material into the environment? Impacts? What is you actual production amount this year?

Preliminary Recipients:  DuPont, BASF, Evonik, Ishihara, Altair nano, Huntsman, Kronos, Kemira, Kon Corp., Tronox, Nanocompsix, Nano-oxide, Green millenium, MK nano, Advanced Nano, NanoCo, Pilkington.

Nano Zinc Oxide

Proposed Questions:  Describe .specifically the nanostructure, functionalities, and properties (physical, chemical, and biological) of nano zinc oxide material that is produced in the facility.  Describe the in-house instrument and analytical methods you use to determin the presence of nano zinc oxide in the workplace and environment. Describe the chemical information provided by external vendors relative to nano zinc oxide nanostructure, functionalities, and properties.  Describe the instrumentation and analytical methods used by external laboratories that provided the above chemical information.

Preliminary Recipients:  UC San Diego, UC Berkeley, USC, Ferity Zinc Oxide Inc., APF Laboratories, Atomate Corporation, Stanford Materials, Alpha Enivornmental, Nanophase technologies, Sokang nano, Antaria Corporation, Ocean Nano Tech, LaamScience, Advanced nanotechnology, NanoGate, Inframat Advanced Materials, Reade Advanced Materials, KIA, Nanjing Hi Tech Nano Material Co., ltd., Nanozinc Oxide South Africa, NanoMaterials Technology, UmiCore Group, Horsehead Corporation.

Nano Cerium Oxide

Proposed Questions:  What machines and methods do you use to analyze your materials?  What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? Do you know reactions when your material is released into aquatic environment? Do you know reactions when your material is released into air? What is you actual production amount this year?

Preliminary Recipients:  Saint-Gobain, Evonik, Meliorum Tech., Inframat Advanced materials, Antaria, HEFA Rare Earth Canada, Nanocerox, Nyacol, Energenics, MTI Corporation.

Quantum Dots

Proposed Questions:  What are the chemical compositions (purity, concentration, and chemical make-up) of your product's core and shell structures (including organic and inorganic attachments)? Specify its size, hydrodynamic diameter (HD), and surface area.  What analytical detection methods do you use to determine its presence in the workplace and environment? What are the surface properties (surface reactivity, groups, charge) and solubility in water and other solvents? What is the stability of your product in different environments (variable pH, temp, pressure, O2, UV light, water, etc.)? Does it aggregate in aquatic media?

Preliminary Recipients:  Nanosys/QD Soleil, Bloo Solar, Life Technologies, Stio, Quantum Dot Corporation, Chemicon International, Zymera, Invisage Technologies, University of California schools, Intelligent Optical Systems, Kovlo, NanoGram, Philips Lumileds Lighting Co., Toshiba America Electronics Components, Samsung Semiconductor, SEMI, Ultratech, Shrink Nanotechnologies.

 

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In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".

This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j) and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

The language affecting SWCNTs is the same.

Following receipt of a notice to file adverse comments, EPA withdrew the SNURs affecting MWCNTs and SWCNTs on  08/21/2009. A proposed final rule was published in the Federal Register on 11/06/2009. This proposed rule retained the language of the original direct rule while also adding new language regarding the release of the MWCNTs and SWCNTs into water. The added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

Again, the language for SWCNTs was the same.

After receiving and reviewing comments submitted by the public about the proposed rule, EPA added more new language clarifying that the requirements of the rule didnot apply after the substances had been cured, incorporated or embedded into a polymer matrix that had been cured or is a solid that will not undergo anymore chemical processing.  Again, the added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting--(1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the chemical substance after it has been completely
reacted (cured); incorporated or embedded into a polymer matrix that
itself has been reacted (cured); or embedded in a permanent solid
polymer form that is not intended to undergo further processing except
for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tightfitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this chemical substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

EPA has issued these final SNURs to achieve four objectives:

EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
    EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
    EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
    EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
 

In the review of the comments received in response to the proposed final rule, EPA specifies that these SNURs apply only to "the specific CNTs that were the subject of PMNs P-08-177 P-08-328. . . . EPA acknowledges that CNTs made by different manufacturers and processes may be considered different substances for purposes of reporting new chemical substances under TSCA. EPA will make this determination on a case-by-case basis." Other comments filed focused on what the commenters contend is the near impossibility of achieving 100% filtration of CNTs from the waste streams produced by manufacturing or processing of these substances and discharged into U.S. waters.

This rule comes into effect on 10/18/2010. To read the comments submitted and supporting materials, please go here.

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Cal. DTSC and UCLA Present -- Nanotechnology VI Symposium: ‘Progress in Protection’

This one-day workshop, on Wednesday, October 13, is sponsored by the California Department of Toxic Substance Control and UCLA. Leading scientists will discuss the latest strategies in protecting workers in the research, development and manufacturing of nanomaterials, and define further research and developmental needs relating to occupational safety and health.

Nanotechnology is an expanding field that has the potential to create many new materials and products with a huge range of applications. It is already being used in cell phones, stain-resistant clothes, cosmetics, disease detection and in medicine. Business projections suggest that nanotechnology could be a $1 trillion industry in the US by 2015.

Registration for this free conference and webcast is required. 

The program presenters are leaders in university research, manufacturing and industry. They include:

WHO

Maziar Movassaghi, Acting Director, California Department of Toxic Substance Control

Andre Nel, M.D., Ph.D., Chief, Division of NanoMedicine, California NanoSystmes Institute; Director, UC Center for Environmental Implications of Nanotechnology

Mark Methner, Ph.D., CIH, Team Leader NIOSH Nanotechnology Field Research Team

Hilary Godwin, Ph.D. Professor, UCLA School of Public Health - Environmental Health Sciences; Education Director, UC Center for Environmental Implications of Nanotechnology

WHEN

Wednesday, October 13, from 9 a.m. to 5 p.m.

WHERE

UCLA California Nano Systems Institute. 570 Westwood Plaza, Building 114. Los Angeles CA 90095. Parking available on the UCLA campus $10. For more information contact: Teresa Lara, UCLA Luskin Center, tlara@publicaffairs.ucla.edu (310) 267-5435 or Charlotte Fadipe, DTSC, Cfadipe@dtsc.ca.gov (916) 956-2838.
 

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In an article in the September issue of Nature ("Nanotechnology: Small wonders"), Corie Lok reviews the beginnings and accomplishments of the National Nanotechnology Initiative (NNI) over the last ten years.

The article attributes the creation of the NNI to four factors:

- A booming US economy, particularly in the high tech sector

- Support from the Clinton administration as it entered its last year in office

- Developments within the then emerging science of nanotechnology that caught the public's attention

- Visionary scientists and engineers who could clearly and in terms everyone could understand communicate what this new field of science was about and how it would benefit everyone. The late Dr. Richard Smalley and Mihail Roco are noted by Ms. Lok for their work in getting NNI started.

NNI's success in creating research centers and legitimizing nanotech in the eyes of the general public, leading  to a flow of venture capital to start-up companies that planned to commercialize the results of nanotech research, is offset by what Lok and others consider its biggest flaw, a lack of focus on the possible adverse effects of nanomaterials on the environment and human health. NNI is now beginning to fund research in these areas.

As the article notes, NNI deserves a great deal of the credit for nurturing nanotechnology over the past decade. But as nanotech has begun to mature, expectations of returns on the investments of both public and private capital in the form of practical and commercial applications and products have risen. In many ways, nanotech and nanoindustries are still at a beginning stage and applications of nanotech in such fields as medicine are still being developed and explored.

NNI faces an uncertain future, with bills that would reauthorize and continue funding for NNI, such as HR 554, the "National Nanotechnology Initiative Amendments Act", passed in the House in February 2009  and HR 5116, the "America COMPETES Reauthorization Act", passed in the House in June 2010 awaiting action in the Senate. S. 1482, the Senate version of the "National Nanotechnology Initiatives Amendment Act" - despite the same title, they are not companion bills - remains stuck in the Senate Committee on Commerce, Science and Transportation.  As Congress returns from the August recess, these bills may be brought up for debate before Congress adjourns so members may run for re-election.  It is also possible that the bills may be brought up for debate in a "lame-duck" session following the elections.

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