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White House Issues Nanotechnology EHS Policy Statement

One June 9, the President’s Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."

The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach.  While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have. 

Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks.  Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.

 …

University of California, San Francisco Publishes Nanotechnology Regulatory Policy Recommendations

The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California’s Office of Environmental Health Hazard Assessment  (OEHA).  The document is designed to provide the State with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.  We previously provided our comments on the May 2010 draft of this document here.  A year later, many of our same concerns still apply to the final document.

The new document makes a range of recommendations, which are set forth below:

Recommendations to address health risks from nanomaterials for OEHHA that can be achieved under the existing regulatory structure:

1. Develop a definition of nanomaterials that can be used to identify them.

2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial.

3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.

4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products.

5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring.

6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media.…

Request for Public Comment on Draft NNI Strategy for Nanotechnology Related Environmental, Health and Safety Research

On 01/13/2011, the Office of Science and Technology Policy published a notice in the Federal Register extending the time for filing comments for the Draft NNI Strategy for Nanotechnology Related Environmental, Health and Safety Research to 01/21/2011. The 2011 Draft Strategy is designed to replace and update  the 2008 Strategy and is the product of a series of stakeholder workshops, responses to a request for information published in the Federal Register on 07/06/2010 and comments filed online in response to questions posted on the NNI Strategic Portal.

The Draft Strategy, dated 12/06/2010, notes NNI’s EHS "Research Strategy provides guidance to the federal agencies as they develop their agency specified nanotechnology EHS research priorities implementation plans, and timelines." Added to that guidance

. . . is the inclusion of ethical, legal and societal implications (ESLI) of EHS research. . . .How nanotechnology research and applications are introduced into society, how transparent decisions are; how sensitive and responsible policies are to the needs and perceptions of the full range of stakeholders; and how ethical, legal and social issues are address will determine public trust and the future of innovation driven by nanotechnology.

Chapter 1 of the draft is introductory. Chapter 2 discusses the need to develop "A Comprehensive Measurement Infrastructure Consisting of a Suite of Complementary Tools", defined here as protocols, standards (reference materials), instruments, models and Data (further defined as "benchmark data that have been measured using validated protocols and reference materials  . . . or other well-characterized test materials . . .for …

EPA Releases SNURS Affecting Multi-Walled and Single-Walled Carbon Nanotubes

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.  …

Massachusetts Issues Nano-EHS Guidance Document

This article originally appeared on the National Nanomanufacturing Network’s InterNano website on August 25, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Massachusetts’ Office of Technical Assistance and Technology (OTA) recently released its “OTA Technology Guidance Document: Nanotechnology – Considerations for Safe Development” which has been in development for the past couple of years. The document begins by noting the tremendous positive influence nanotechnology is predicted to have in the fields of biomedical devices, electronics, clean energy, and materials engineering, while at the same time acknowledging that “there are indications of potential harm from certain exposures and release of engineered nanoparticles.” OTA also believes that there “is little uncertainty” regarding available means to prevent potential workplace exposure to nanoscale materials. Simply put, despite unknown EHS risks, there is more than adequate knowledge to control potential exposure in OTA’s view.

The end of the report contains a bibliography of existing resources covering state-of-the-art workplace good practices for nanoscale materials. The bibliography includes the “usual suspect” documents and websites published by NIOSH, ICON, German government, British Standards Institute, ED/DuPont, NanoSafe, and ASTM. From these primary sources, OTA distills a basic set of good practices for entities working with nanoscale materials in Massachusetts.

First, establish a risk reduction plan for facilities working with nanoscale materials. Such a plan should have two levels. First, it should attempt to protect against direct and immediate worker exposure. Second, it should also attempt to protect against possible releases during transport, use, and disposal after the …

Wisconsin Legislature to Study Potential Regulation of Nanomaterials

Following California’s lead, Wisconsin’s legislature recently formed a special committee to study the potential regulation of nanomaterials from an environmental, health, and safety perspective.   Our readers will be interested in the committee’s membership and focus:

Special Committee on Nanotechnology Chair: Rep. Chuck Benedict Vice Chair: Sen. Mark Miller Legislative Council Staff: Mary Matthias, Pam Shannon, and Larry Konopacki Member List

The Special Committee is directed to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee shall consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements. The Special Committee shall also develop strategies to facilitate the development of nanotechnology to create and retain jobs in Wisconsin, including ways in which government can help nanotechnology researchers, small firms, and start-ups address potential risks and meet regulatory requirements.  

You can find prior articles about Wisconsin’s prior efforts here and here.  The committee’s first meeting appears to be scheduled for September 2010.…

National Nanotechnology Coordination Office Announces a Public Meeting

Today’s Federal Register carries a notice of a public meeting on Tuesday March 30th and Wednesday March 31st 2010 to be held at the Holiday Inn Rosslyn-Key Bridge in Arlington Virginia .

The meeting will be a workshop designed "to provide an open forum to discuss the state-of-the-art of the science related to environmental, health, and safety aspects of nanomaterials in two areas: Risk Management Methods and Ethical, Legal, and Societal Implications (ELSI) of Nanotechnology."

Registration is required to attend the workshop and information on how to register is available in the notice. Anyone wishing to present 3-5 minutes of public comments also needs to register. Written or electronic comments must be submitted via e-mail at capstone@nnco.nano.gov until April 30, 2010. Written comments can also be mailed to Capstone Workshop, c/o NNCO, 4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230.  

Those unable to attend the workshop in person can view the main sessions via webcast. The draft agenda for the workshop is below. Among the invited speakers and guest is John Monica, a partner in Porter Wright’s DC office. Further information about the workshop is available on the National Nanotechnology Initiative website.

Schedule and Agenda

Draft Agenda (2/25/10):

Tuesday, March 30

7:30 a.m. Registration and Continental Breakfast

8:30 a.m. Morning Introductory Session: -Welcome

-Opening Remarks

– Highlights from previous workshops

– Introduction to Risk Management Methods: Gary Marchant, Arizona State University Greg Lowry, Carnegie Mellon University

– Introduction to Ethical, Legal, and Societal Implications of Nanotechnology …

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Nanotechnology Law & Business just published our new article on the EPA’s recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

Nanotechnology Health and Safety Forum — June 8 – 9, 2009

The Nanotechnology Health and Safety Forum which is being sponsored by Battelle, Porter Wright, University of Washington, University of Oregon, Oregon State University, and several others is taking place on June 8 – 9, 2009 at the Edgewater Hotel in Seattle, Washington.

Keynote speakers include: Dr. Leroy Hood, Co-Founder of the Institute for Systems Biology; Dr. Kenneth Dawson, Director of the Centre for BioNano Interactions; Dr. Justin Teeguarden Senior Research Scientist at Pacific Northwest National Laboratory and recent co-author of the NRC’s assessment of the NNI’s EHS research strategy; Dr. Vladimir Murashov from NIOSH; Dr. Saber Hussain from the Air Force Research Laboratory; former U.S. Congressman George Nethercutt; and Dr. Robert Tanguay from Oregon State University.

The program has 4 units:  Framing the Unknown; nanoEHS Perspective; Insurance, Nanotechnology, and Risk; and Nanotechnology: The Next Ten Years.

I will be speaking on the Insurance, Nanotechnology, and Risk panel on the second day of the conference along with Steve Knutson from Zurich North America; Walter Andrews from Hunton & Williams; and William E. Barr from Chubb Insurance.

You can sign up for the conference here.  Hope to see you there.…

EPA Issues Significant New Use Rules for Two Nanomaterials

This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.…

Environmental Law Alert

AUTHORED BY MICHAEL HEINTZ

Nanomaterials are becoming an increasing part of everyday life. Even now, man-made materials that measure one ten-thousandth the diameter of a human hair are found in products from computer chips and pesticides to stain-resistant fabrics and shampoo. As such, the U.S. Environmental Protection Agency is beginning to study the scientific properties of engineered nanomaterials to determine whether they should be regulated under the environmental statutes.

The cross-governmental National Nanotechnology Initiative, a partnership among several governmental agencies focused on research and sharing information about nanomaterials, states that to be nanotechnology, three factors must be met. The technology must 1) involve “an understanding and control of matter at dimensions of roughly 1 to 100 nanometers” (a nanometer is one-billionth of a meter); 2) “encompass nanoscale science, engineering, and technology”; and 3) involve “imaging, measuring, modeling and manipulating matter at this length scale.” Nanomaterials, thus, are purposefully engineered materials that measure between 1 and 100 nanometers. Interest is increasing in nanomaterials because their physical properties are governed by the laws of quantum mechanics, which produces “dramatic changes in [their] mechanical, optical, chemical, and electronic properties.” …

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