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

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.

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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.

7. As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT).

8. Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.

9. Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed.

10. Integrate nanomaterials into current efforts to modernize toxicity testing.

11. Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity.

12. Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and NGOs.

13. Continue to include opportunities for public input and comment during decision-making processes.
 

Recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA.

1. Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products.

2. Require reporting of properties that can identify nanomaterials that are persistent,bioaccumulative, and toxic (PBT). Phase out uses consistent with approaches for other PBTs.

3. Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential.

4. Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products.

5. Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials

6. Require sufficient toxicological testing—preferably pre-market and also post-market as necessary—to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants.

7. Implement a labeling system that requires labeling of products that contain nanomaterials.
 

8. Increase funding and support for targeted, nano-specific research to fill data gaps.
 

9. Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.
 

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Presenting what looks to be a very interesting line-up of top-rate speakers, the American Bar Association's Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation, and Right-to-Know Committee) is presenting a webinar on January 27, 2011:

Nano Governance: The Current State of Federal, State, and International Regulation

Here is a summary of the webinar from ABA's online announcement:

States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. Companies globally are continuing to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. Nano Governance: The Current State of Federal, State, and International Regulation will address these issues in a half-day program. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. Attendees will gain insight into potential public health and environmental impacts and the approaches various government agencies and industrial stakeholders are pursuing to address these issues while also promoting nanotechnology. The program is open to attorneys and other professionals with chemical regulatory compliance practices.

Educational Objectives:

• Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
• Understand Potential Public Health and Environmental Impacts and the approaches various government agencies are pursuing to promote nanotechnology while also addressing potential public health and environmental risks
• Appreciate complexities of addressing potential risks with existing governance tools and strategies while also embracing new approaches to accommodate evolving technologies

I hope to attend by telephone and encourage any interested readers to do the same.  It should be a great conference.

 

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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 nanoscale materials leave the manufacturing facility.

Second, evaluate potential worker exposure to nanoscale materials during the manufacturing process and then implement a hierarchy of exposure controls, including: substituting source materials with non-nano substances where appropriate, implementing engineering controls, using administrative controls, and requiring the use of personal protective equipment. This is all standard NIOSH-fare drawn from NIOSH’s excellent “Approaches to Safe Nanotechnology: Managing the Risks and Safety Concerns Associated with Engineered Nanoparticles.” OTA’s guidance document, however, does a good job of drawing out the most important “nuggets” of information from the NIOSH document in a few short pages.

Third, analyze whether unintentional release of nanoscale materials may occur with consumer use or disposal of the product. Along these lines, OTA recommends companies consider: labeling products as already suggested by BSI and the EU, warning potentially affected downstream users and others regarding potential EHS risks through the use of the Material Safety Data Sheets and other written warnings, complying with existing environmental laws such as the Toxic Substances Control Act, conducting an open and transparent risk and hazard testing regime for the product throughout its complete lifecycle, and recognizing that proactive prevention of EHS concerns is required for successful commercialization of nanotechnology.

In the end, OTA’s document is a helpful quick reference guide, but it does not cover any new ground or delve deeply into its existing source material. Businesses involved in nanomanufacturing should still consult the underlying source material cited in the document, as well as EHS and legal experts as necessary. Massachusetts should be commended, however, for putting out this basic guidance document and attempting to proactively address these issues.
 

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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.

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This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an initial nano-regulatory step, the paper recommends excluding “new” nanoscale materials not already on the Inventory from regulatory low volume exemptions, “thereby shifting a post-market audit activity to a pre-market assessment (i.e. new nanomaterials to be assessed under permit or certification categories prior to commercialization).” The suggestion is not unduly punitive, and a similar approach is already in use by the US EPA.

Additionally, the paper recommends modifying the Research and Development exemption for “new” chemical substances to require annual reporting of nanoscale materials produced in quantities exceeding 100 grams per year. While the paper could benefit from some explanation of why this specific threshold was selected, the idea of providing basic information on nanoscale materials used in sufficient quantities for research and development is not onerous.

The main rationale for these modifications is that the “uncertainty surrounding the hazards, exposure, and risk assessment methodologies . . . means that the determination of ‘no unreasonable risk’ or ‘non-hazardous’, both of which are prerequisites to a range of exemptions, is not expected to be straightforward,” and the accompanying need for a case-by-case approach to the responsible development of nanoscale chemical substances.

Regarding “existing” nanoscale chemical substances, the paper recommends that the Australian Government consider following up on their somewhat disappointing voluntary data call-ins under the NICNAS scheme (held in 2006 and 2008) with a study on “the feasibility of a mandatory notification and assessment program.” Such a program would be designed to establish a database of “existing” nanoscale chemicals in use in Australia and increase public confidence in regulatory oversight efforts. U.S. EPA is also considering a mandatory data call-in for nanoscale materials, while California has already issued a mandatory data call-in for carbon nanotubes and is targeting several additional nanoscale materials.

Australia’s DHA’s recommendations are well-balanced. Business and commercialization needs are recognized even though human and environmental, health, and safety regulatory needs are given priority. However, the paper largely ignores the most difficult topic in this space—whether nanoscale versions of “existing” chemicals already on the Australian Inventory of Chemical Substances should be considered “new” chemical substances for regulatory purposes, as suggested by Ludlow, Bowman, and Hodge in their review of Australia’s regulatory framework for nanotechnology, thus triggering pre-market approval requirements prior to commercialization. This issue has been argued back and forth in the US, the EU and other jurisdictions for quite some time, and it is unlikely that Australia will be able to avoid similar strong debate. It is perhaps the biggest issue facing regulators seeking to modify Australia’s industrial chemical legislative framework to fully cover both “new” and “existing” nanoscale materials.

Beyond the substantive regulatory changes noted above, the paper does an excellent job of explaining what “industrial nanomaterials” are, their current regulatory status in Australia, and national and international regulatory activities for nanoscale materials. Moreover, the paper is written in sharp, clear language. It provides lots of key questions for stakeholders to consider when thinking about these issues, as well as surveys and questionnaires encouraging feedback and input. The Australian Government is also sponsoring public consultation activities in most of the country’s larger metropolitan areas to explains the paper to stakeholders first-hand and to solicit additional input.

References

National Industrial Chemical Notification and Assessment Scheme (Department of Health and Aging, Australian Government). Proposal for Regulatory Reform of Industrial Nanomaterials. Public Discussion Paper. November 2009. Available from NICNAS. http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp

Ludlow K, Bowman DM, and Hodge GA. 2007. A Reveiw of Possible Impacts of Nanotechnology on Australia'a Regulatory Framework. Monash Centre for Regulatory Studies, Monash University, Melbourn.
 

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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.

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Nanotechnology Law Report -- Spring 2009

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Battelle Memorial Institute, the University of Washington, and the University of Oregon are co-sponsoring the international Nanotechnology Health and Safety Forum (NHSF) in Seattle, Washington on June 8 - 9, 2009.  The NHSF is coinciding with the first world-wide meeting of the International Organization for Standardization (ISO) TC 229 -- Nanotechnologies being held in the United States, and will take place at the Bell Harbor International Conference Center.

Topics covered at the NHSF will include:

• The EHS Progress Report: today's status and tomorrow's next steps
• International Standards: developing a timeline & milestones
• Navigating Regulations: encouraging dialogue between Europe, Asia, and the U.S.
• Safety Guidelines: state of the science and recommended occupational safety guidelines for working with nanomaterials
• Managing Risk: the insurance industry perspective
• What's New: current activities of innovative nano-manufacturers

I have been invited to speak on the insurance/managing risk panel along with speakers from Riddell Williams, Hunton & Williams, Zurich North America, and Chubb Insurance:

The availability of insurance for entities using nanotechnology is critical to the further development and application of nanomaterials in industry. Yet the widening use of nanotechnology (while toxicology remains to be determined) is a central concern for the global insurance industry. Insurance, Nanotechnology, and Risk addresses the prospects for managing nano risk through the perspectives of a Silicon Valley loss control specialist, a major international underwriter, and liability / coverage counsel.

This should be a great conference with an international focus; plus Seattle in June is going to be a lot of fun. Hope to see you there.

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Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy. 

Please be sure to visit the journal to see the rest of this issue's articles:

• Grading of Fullerene Nanotubes for Composite Applications
• Next Generation Carbon Fiber
• Patenting Graphene: Opportunities and Challenges
• Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
• Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
• The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
• A Nano-Mesothelioma False Alarm
• Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
• French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
• The Validity of European Nanotechnology Patents in Germany
• Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
• Top Ten Ways Nanotech Will Impact Cleantech
• Updates

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This Article Was Authored and Contributed by the American National Standards Intititute

This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.

In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO). 

ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.

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As reported by AzoNano.com, the EPA recently announced the award of two grants, collectively worth $600,000, to researchers at Oregon State University to study the human health impacts of nanomaterials.  The pair of studies look like the first step toward nanotechnology regulation.  According to the AzoNano article, the first study is a survey of common manufactured nanomaterials to understand their interaction with biological processes.  The second study looks specifically at how manufactured nanomaterials may "damage or kill cells:"

Dr. Alan Bakalinsky is studying the relationship between specific characteristics of nanoparticles, like shape and structure, and their effects on cells. The work is expected to lead to the development of safety guidelines for industrial and environmental exposure to nanomaterials. "We're trying to identify specific structures in manufactured nanoparticles that might cause damage to cells," said Bakalinsky. "If we can determine which shapes and structures are most dangerous to cell function, it should be possible to design the materials to avoid those shapes and minimize the risk of damage."

Both Oregon State researchers, Drs. Bakalinsky and Tanguay, look to be relatively new to the nanotechnology field.  Bakalinsky is a food science researcher and Tanguay is a molecular toxicologist. 

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By Tim Cahill:

On February 20, 2007, the Investor Environmental Health Network ("IEHN") issued a report entitled "Beneath the Skin: Hidden Liabilities, Market Risk and Drivers of Change in the Cosmetics and Personal Care Products Industry." IEHN represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products. The IEHN's report warns that nanotechnologies represent one of the significant health risks in the cosmetics industry and that investors in this industry must be aware that sweeping changes are likely to occur in this market. The report describes the Food and Drug Administration's ("FDA") current oversight of cosmetics as a "a porous and ill-defined regulatory framework" and cites to the fact that "cosmetics are generally exempt from pre-market review" as a major limitation in the FDA's ability to regulate cosmetics. As a result, the report recommends that cosmetics manufacturers take independent steps to monitor the safety of their products in order to avoid potential liability and gain a competitive advantage by increasing their brand trust.

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