Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On May 20, 2006, the U.S. Environmental Protection Agency (EPA) stated that it would like to initiate discussions regarding testing of nanoscale materials under the in-depth portion of the Nanoscale Materials Stewardship Program (NMSP). Under the NMSP, companies that manufacture, import, process, or use nanoscale materials for commercial purposes voluntarily submit data to EPA and also participate in the development of additional data. To date, EPA has received three submissions for nanoscale materials under the basic program. EPA has also received commitments from ten additional companies to submit data on nanoscale materials under the basic program. Thus far, no one has signed up to participate in the in-depth portion of the NMSP, however. EPA encourages anyone interested in starting this dialogue to contact it.

Submissions under the NMSP basic program include:

• Dupont;
• Office ZPI; and
• One additional confidential submission.

Ten additional companies have committed to submit information under the NMSP basic program:

• BASF Corporation;
• Bayer Material Science;
• Dow Chemical;
• Evonik/Degussa;
• General Electric;
• Nanocyl North America;
• Nanophase Technologies Corporation;
• PPG Industries;
• Sasol North America; and
• Strem Chemicals.

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The U.S. Environmental Protection Agency’s (EPA) May 5, 2008, Unified Agenda includes an item regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On January 28, 2008, EPA announced the NMSP. According to the Unified Agenda notice, EPA intends to publish in March 2009 an interim evaluation of the NMSP, and a final evaluation of the NMSP, “including next steps,” in April 2010.

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On May 1, 2008, the International Center for Technology Assessment (ICTA), together with 13 other consumer, health, and environmental groups, filed a petition with the U.S. Environmental Protection Agency (EPA) demanding that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and that it take additional actions under FIFRA and other environmental statutes concerning, consumer products containing nanoscale silver. ICTA also released an inventory of the nano silver-containing consumer products referenced in the petition.

The petition contends that nano silver is “the most commonly used nanomaterial in consumer products and the fastest growing sector of nanomaterial commercialization,” and that most companies “market their nano-silver products [by] putting emphasis on the nano-silver ingredient, touting its antimicrobial and antibacterial qualities . . . .” The petition states that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” In support of the petition, the ICTA-led coalition pointed to, inter alia, EPA Region 9’s recent FIFRA enforcement settlement with a California company, IOGEAR, that had been making antimicrobial claims for the nano silver coating on computer accessories it was marketing.

The petition requests that EPA take the following actions:

• Clarify that nano silver and products containing it are pesticides requiring registration under FIFRA;
• Classify nanomaterial pesticides such as nano silver as new pesticides [i.e., new active ingredients] that require new registrations, with nano-specific toxicity testing and risk assessment;
• Assess the potential human health and environmental risks of nano silver under FIFRA, the Food Quality Protection Act, the Endangered Species Act, and the National Environmental Policy Act;
• Take immediate action, including the issuance of Stop Sale, Use, or Removal Orders, to halt the sale of nano silver products with unapproved antimicrobial claims;
• Fully apply all FIFRA regulations in the event EPA registers any nano silver products; and
• Utilize its FIFRA authority to further review the potential human health and environmental impacts of nano silver, including undertaking either a classification review or a Special Review, amending the FIFRA regulations to require as part of a registration application the submission of nanomaterial and/or nano silver-specific data, undertaking a registration review of existing bulk silver registrations, regulating nano silver pesticide devices, and establishing a tolerance for nano silver under the Federal Food, Drug, and Cosmetic Act.

The coalition requests that EPA respond to the petition “within a reasonable time.”

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On April 18, 2008, The American Chemical Society Science & the Congress Project, The Society of Toxicology, and The Society for Risk Analysis sponsored a Congressional briefing entitled “Nanotechnology 102: Understanding Congress’ Role.” Panelists included Kristen Kulinowski, Director of the International Council on Nanotechnology (ICON); J. Clarence (Terry) Davies, Senior Advisor, Woodrow Wilson Center Project on Emerging Nanotechnologies (PEN); James Cooper, Vice President of Petrochemicals, National Petrochemical and Refiners Association; and Charles Auer, Director, Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA).

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On April 9, 2008, the Project on Emerging Nanotechnologies (PEN) released a report entitled Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology. According to the report, because of the slow pace of federal action to regulate development of nanotechnology, “there is ‘room at the bottom’ for state and local governments to move forward in pursuing regulatory and other oversight options.” Research for the report identified a number of states with laws promoting the nanotechnology industry or other initiatives encouraging research and development on nanotechnology applications. The report states that each of the 50 states is “home to at least one company, university, government laboratory, or other type of organization working with nanomaterials.”

The report discusses possible options for states and localities to oversee the environmental, health, and worker safety impacts of nanotechnology. According to the report, the following existing state authorities and experiences could be applied to nanotech oversight:

• Air: At least 15 state agencies have adopted stringent air quality laws or regulations to fill a gap in federal standards, and at least 29 local air agencies are authorized to adopt more stringent air quality controls;
• Waste: Several states have imposed standards for regulating metals in waste that are not covered by U.S. Environmental Protection Agency (EPA) regulations;
• Water: State laws often offer substantial flexibility for regulating and controlling water discharges that may contain pollutants;
• Labeling: States are free to adopt their own product labeling requirements, similar to those provided for toxic chemicals by California’s Proposition 65; and
• Worker Safety: The Occupational Health and Safety Administration (OSHA) has approved plans for 21 states that enable them to adopt federal safety standards for workers in private industry.

The report identifies California, Michigan, Massachusetts, New York, and New Jersey as “the states that appear most able to launch initiatives for overseeing safe and responsible development of nanotechnology.” 

The report identifies the following four scenarios for potential action by states or localities to fill gaps in federal oversight and thereby initiate their own oversight of nanotechnology’s health, safety, and environmental impacts:

1. Localities could require disclosure of potential health, safety, or environmental hazards;
2. States or localities may choose to adopt standards that are expert-driven, such as the nanotechnology workplace standards being developed by ASTM International, the International Organization for Standardization, or other standards bodies;
3. Stakeholders -- such as state or local regulators in other programs, consumers, workers, and even nearby businesses -- may play an important role in nanotechnology oversight when they exert pressure on states to control or prevent releases of nanomaterials; or
4. One or more states may choose to collaborate to establish joint regional standards or approaches for overseeing the safe development of nanotechnology.

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On February 29, 2008, the U.S. Environmental Protection Agency (EPA) announced a March 17-18, 2008, public meeting “to discuss opportunities for industry-government partnerships to foster greater public awareness of the environmental attributes of household and institutional consumer products and help make consumers aware of efforts on the part of consumer product manufacturers to improve the environmental performance of their products and production facilities.” According to EPA, the primary purpose of the initial meeting, which has received little notice to date, is “to establish a dialog among government, industry, and public stakeholders leading to formation of a Consumer Products Environmental Partnerships Working Group.” EPA states that, once formed, the Working Group will identify and develop possible partnership approaches such as product labeling, consumer education programs, environmental information websites, product stewardship programs, and manufacturer recognition programs. It describes the increased use of nanomaterials in consumer products as “an emerging issue.” To attend the meeting, which will be held in Research Triangle Park, North Carolina, EPA asks for the submission of name and affiliation by e-mail or telephone to Mr. Bruce Moore, EPA, Office of Air Quality Planning and Standards, at (919) 541-5460 no later than March 13, 2008.

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On February 13, 2008, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft report entitled Draft Nanomaterial Research Strategy (NRS), which is intended to guide EPA’s Office of Research and Development in nanomaterial research.  Versar, Inc., an EPA contractor for external peer review, will convene a panel of experts and organize and conduct an independent expert external peer meeting on April 11, 2008, to review EPA’s draft NRS. Comments on EPA’s draft NRS are due March 14, 2008. Members of the public may register to attend the April 11, 2008, peer review meeting as observers. In addition, there will be time in the afternoon for attendees to give oral comments or provide written comments at the meeting.

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In today’s Federal Register, the U.S. Environmental Protection Agency (EPA) published a notice describing the design and format of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP) for nanoscale materials under the Toxic Substances Control Act (TSCA). EPA intends the NMSP “to complement and support its new and existing chemical efforts on nanoscale materials” under TSCA. Participants may participate in a basic program by submitting existing data, or may participate in an in-depth program to test engineered nanoscale materials. EPA intends to publish a summarized interim report approximately one year after the initiation of the NMSP, which will be based on data reported during the first six months of the basic program. EPA will then develop a more detailed report reflecting its evaluation of the NMSP approximately two years after initiation of the NMSP.

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In a December 3, 2007, letter, to the Secretaries of Wisconsin’s Department of Natural Resources (DNR), Department of Health and Family Services (DHFS), and Department of Agriculture, Trade, and Consumer Protection (DATCP), Wisconsin State Representative Terese Berceau (D) asks for their assistance in creating a policy “to address potential environmental problems associated with the emerging field of nanotechnology.” Berceau refers to the ordinance adopted by Berkeley, California, and the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program (NMSP), and proposes a reporting system and creation of a registry in Wisconsin “including addressing areas that are simply not yet fully defined in an emerging and growing technological field.” Berceau states that whether the registry is created by rule or legislation “is best determined with the guidance of the regulatory agencies dealing with similar issues today -- in public health, environmental protection, and consumer protection.”

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The U.S. Environmental Protection Agency’s (EPA) December 10, 2007, Unified Agenda includes a notice regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On July 12, 2007, EPA announced the availability of an NMSP concept paper, a proposed information collection request (ICR), and a paper that describes determining the TSCA Inventory status of nanoscale materials. According to the Unified Agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents.

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On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.”

The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:

• Purpose:  Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
• Current Understanding:  The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications.  As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
• Information Development:  Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment.  To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
• Risk Assessment and Risk Management:  The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation.  As experience is gained, these approaches can be refined.  The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
• International:  Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation.  The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community.  The federal government should also promote access to information across the international community.  These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
• Regulatory Path Forward:  In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
  • Regulation should focus where need exists and where scientific information supports action (e.g., targeted to specific groups and classes of materials instead of a “one-size-fits-all” approach);
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
  • Where possible, regulatory approaches should enable rather than hinder innovation;
  • Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
  • Benefits of regulation should justify their costs;
  • Regulations should be developed in an open and transparent manner; and
  • Regulations and guidance should consider established requirements and guidance such as the following:
    • Executive Order (EO) 12866 -- Regulatory Planning and Review (Oct. 4, 1993);
    • Information Quality Act and Information Quality Guidelines: OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002);
    • National Technology Transfer and Advancement Act of 1995;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (Feb. 10, 1998);
    • OMB Final Information Quality Bulletin for Peer Review (Dec. 16, 2004);
    • OMB Final Bulletin for Agency Good Guidance Practices (Jan. 18, 2007); and
    • OMB/OSTP Memorandum:  Updated Principles for Risk Analysis (Sept. 19, 2007).

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As part of the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ (OPP) ongoing Nanotechnology Task Force Work, we understand that OPP is seriously considering revising the pesticide registration application form to require particle size information for both active ingredients and any inerts.

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Last week, the U.S. Environmental Protection Agency (EPA) placed in the docket a report summarizing remarks and public comments made during the August 2, 2007, meeting on the Nanoscale Materials Stewardship Program (NMSP). The purpose of the meeting was to discuss and receive comments on the development of the voluntary NMSP. The intent of the report is to provide an overview of the discussion that occurred. It does not analyze or evaluate any portion of the discussions. EPA structured the meeting agenda to allow formal comments from eight, pre-registered stakeholders, and allocated time in the afternoon to allow additional stakeholders who requested time to speak to make public comments.  The meeting concluded with a question and answer session focusing on key issues that were specifically identified by EPA.  The meeting brought together 124 participants, including stakeholders in academia, non-governmental organizations (NGO), government, industry, professional organizations, the press, international entities, and the general public.  Meeting minutes were not prepared and a transcript was not recorded.

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On August 2, 2007, the U.S. Environmental Protection Agency (EPA) convened a public meeting on the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). The meeting, which EPA had announced in a July 12, 2007, Federal Register notice, was well attended, with approximately 100 people in attendance. After introductory remarks by several EPA officials, various organizations presented their views on the NMSP and the associated draft documents made available by EPA on July 12, 2007. Among those offering comments were the American Chemistry Council (ACC) Nanotechnology Panel, Environmental Defense (ED), Consumers Union, the NanoBusiness Alliance, the International Council on Nanotechnology, and Dr. J. Clarence Davies of the Project on Emerging Nanotechnologies (PEN).

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The Council of State and Territorial Epidemiologists (CSTE) recently issued a position statement on nanotechnology risks. The CSTE statement observes that the “health, safety and environmental effects of nanomaterials are poorly understood,” and that “our limited knowledge of [nanotechnology’s] potential harm is cause for concern.” Among other things, CSTE calls: for increased funding for research on the environmental, health, and safety impacts of nanotechnology; for the Food and Drug Administration (FDA) to require content-labeling on products containing nanoparticles that are aerosolized or applied to the skin; and for the U.S. Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) to issue standards for the protection of workers, the public, and the environment against known or suspected harmful effects of nanoparticles.

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On June 9, 2007, the U.S. Environmental Protection Agency (EPA) signed three Federal Register notices related to the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA) (appended). EPA intends to publish the notices in the July 12, 2007, Federal Register. The first notice announces a public meeting on August 2, 2007, to receive comments on the development of the voluntary NMSP. The second notice announces the availability of two draft documents for public review and comment: (1) “Concept Paper for the Nanoscale Materials Stewardship Program under TSCA” (Concept Paper); and (2) “TSCA Inventory Status of Nanoscale Substances -- General Approach” (TSCA Inventory Paper). The third notice solicits public comments on specific aspects of the proposed information collection request (ICR) for the voluntary NMSP. According to EPA, the purpose of the August 2, 2007, public meeting, which will occur during the comment period on the draft documents, is to further discussion and development of the NMSP. Registration for the meeting will be open until July 30, 2007, but is not necessary to attend the meeting. Registration will be available through the NMSP website at http://www.epa.gov/oppt/nano. Requests to make oral comments at the meeting are due July 30, 2007.

Draft Documents

The TSCA Inventory Paper describes EPA’s current thinking regarding whether a nanoscale material is a “new” or “existing” chemical substance under TSCA. The Concept Paper describes EPA’s general approach, issues, and considerations for the NMSP, and is intended to serve as a starting point for continuing work with stakeholders on the detailed design of the NMSP. Comments will be due 60 days after EPA publishes the notice of availability in the Federal Register, which EPA expects to occur on July 12, 2007.

EPA states that it developed the concept paper to outline its initial thinking about the NMSP.  EPA will be working collaboratively with other federal agencies and stakeholders to further develop and implement the NMSP.  Although dependent on the outcome of this development process, EPA envisions that the components of the NMSP could include:

• Assembling existing data and information from manufacturers and processors of existing chemical nanoscale materials;
• Encouraging the development of test data needed to provide a firmer scientific foundation for future work and regulatory/policy decisions; and
• Identifying and encouraging use of a basic set of risk management practices in developing and commercializing nanoscale materials.

The concept paper outlines proposed ideas for reporting on nanoscale materials in commerce, developing data on representative nanoscale materials, and identifying risk management practices.  According to EPA, it describes who may wish to participate, the reporting expectations for participants, what the program could entail, and what EPA intends to do with the data generated from the program.  It also describes the potential benefits of participation.

EPA will use the data from the NMSP to gain an understanding of which nanoscale materials are produced, in what quantities, how they are used, and the data that is available for such materials.  EPA scientists will use data collected through the NMSP, where appropriate, to aid in determining how and whether certain nanoscale materials or categories of nanoscale materials may present risks to human health and the environment.

While EPA is seeking comment on all aspects of the NMSP and the TSCA Inventory Paper, EPA states that it “is especially interested in comments on the following items”:

1. Whether the data elements that have been identified in the NMSP are appropriate for nanoscale materials.
2. Timing and phasing of submissions under the NMSP basic and in-depth programs and whether approaches for tiering data submissions are appropriate.
3. Who would participate in NMSP and how to encourage participation, especially from small- and medium-sized enterprises.
4. What criteria to use for the NMSP program evaluation and views on the timing and nature of any reports EPA may issue.
5. How to engage industry and other stakeholders in the NMSP in-depth program and approaches for generating test data.
6. The processes and roles for EPA, participants, and other stakeholders during development and evaluation of data for the in-depth program.
7. Possible approaches for identification and use of alternative sources of data, to minimize the burden of information collection associated with the NMSP.
8. Uses for the data submitted to EPA under the NMSP.
9. Issues relevant to scope, definitions, and descriptions.
10. The suitability of the approach for determining the TSCA Inventory status of nanoscale materials discussed in the TSCA Inventory Paper.
11. Whether, in combination, the TSCA Inventory Paper and the NMSP Concept Paper are sufficiently clear in how EPA plans to address nanoscale materials that are new or existing chemicals under TSCA and the NMSP and, if needed, an indication of areas where further clarification may be warranted.

Draft ICR

The draft ICR covers the information collection-related activities related to NMSP and the estimated paperwork burdens associated with those activities. EPA is soliciting public comments on specific aspects of the proposed information collection for the voluntary NMSP.  Comments on the draft ICR are due 60 days after it is published in the Federal Register, which EPA expects to occur on July 12, 2007.

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On June 22, 2007, the U.S. Environmental Protection Agency (EPA) announced the award of two research grants totaling almost $600,000 to scientists at Oregon State University, who will evaluate whether some engineered nanomaterials adversely affect human health. Under the first research grant, scientists will review a variety of commonly manufactured nanomaterials to determine their potential interactions with biological processes; if the researchers find nanomaterials that produce adverse human health effects, they will seek to identify the potential cellular and genetic targets of those nanomaterials and group the nanomaterials by composition and effects. The second research grant will focus on how engineered nanomaterials can damage or kill cells, and is expected to lead to the development of occupational and environmental exposure guidelines.

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In the July 2, 2007, Federal Register, the U.S. Environmental Protection Agency (EPA) published a notice regarding its conference entitled “Pollution Prevention through Nanotechnology,” which will be held on September 25-26, 2007, in Arlington, Virginia. EPA intends the conference to provide a forum to exchange ideas and information on using nanotechnology to develop new ways to prevent pollution. Lynn L. Bergeson is on the Steering Committee for the conference. Representatives from industry, academia, non-governmental organizations, and government are invited to focus on current practices and potential research areas in nanotechnology that incorporate the concept of pollution prevention in three major areas:

• Products: Less toxic, less polluting, and wear-resistant.
• Processes: More efficient and waste-reducing.
• Energy and Resource Efficiency: Processes and products that use less energy and fewer raw materials because of greater efficiency.

Registration is open until September 14, 2007, but is not required to attend the conference.

According to EPA, the conference will feature discussions of nanotechnology life-cycle considerations and the responsible development of nanotechnology. EPA provided the following questions, which will be addressed by conference participants. EPA intends the questions to focus presentations and discussions at the conference, and states that answers to these questions could help guide subsequent work in pollution prevention through nanotechnology.

1.         Which nanotechnologies show the greatest promise for preventing pollution?

Considerations:

• This question should be viewed through the lens of life-cycle thinking to minimize the possibility of unintended consequences.
• Which pollution prevention applications are the most likely to find real-world applications?
• What barriers exist to the adoption of nanotechnology-enabled pollution prevention applications?

2.         What are the most promising areas of research on pollution prevention applications of nanotechnologies?

Considerations:

• Which research areas could improve our understanding of the full life-cycle of nanomaterials?
• How can the beneficial properties of engineered products of nanotechnology, such as increased surface activity, greater conductivity, improved strength-weight ratio, altered optical properties (changes in color or opacity), and flame retardancy be used to improve materials and products and reduce the production of pollutants at their source?

3.         What recommendations do conference participants have for promoting and encouraging pollution prevention in the development and application of nanotechnology?

Considerations:

• What actions could be taken, and by whom?
• What mechanisms, programs, or associations could promote the research, development, and adoption of such applications?
• What role can EPA programs play?

The July 2, 2007, Federal Register notice includes a call for posters. EPA encourages submissions “in the area of nanotechnology products, nanotechnology processes, or nanotechnology energy/resource efficiency,” and “[p]osters with a focus on safer chemistries through use of nanotechnology are especially encouraged.” Because of space constraints, EPA will accept only a limited number of posters in each area. Poster applications are due July 31, 2007.

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On April 24, 2007, the Kojo Nnamdi Show, a news magazine program on National Public Radio (NPR), aired a program entitled “New Approaches to Nanotechnology.” The program featured: David Rejeski, Director, Project on Emerging Nanotechnologies (PEN), Woodrow Wilson International Center for Scholars/Pew Charitable Trusts; Rick Weiss, Science and Medicine Reporter, The Washington Post; Jeffrey Schloss, Co-Chair, Trans-National Institutes of Health (NIH) Nano Taskforce, NIH; and Nora Savage, Environmental Engineer, Office of Research and Development (ORD), U.S. Environmental Protection Agency (EPA).

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On May 23, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled EPA and Nanotechnology: Oversight for the 21st Century, which identifies actions that should be taken to establish an oversight system. The report focuses in particular on the U.S. Environmental Protection Agency (EPA), which it describes as “a key agency in any oversight effort because of its numerous regulatory authorities and its mission to protect the environment and human health.” According to the report, a review of existing EPA authorities reveals a number of weaknesses. In particular, the report states that the Toxic Substances Control Act (TSCA), “which is the only law potentially capable of providing general oversight for nanotechnology, is extremely deficient in many respects and needs to be amended.” Moving beyond TSCA, the report states further that “virtually every authority that EPA has at its disposal has weaknesses in terms of nanotechnology oversight.” The report discusses tools that will need to be combined in an oversight system, including information tools, voluntary efforts, economic tools, and liability. The report also discusses the role of state and local governments, and public participation, and outlines nine different examples of the ways the tools could be used. The report concludes with an action agenda containing more than 25 actions necessary to improve the oversight of nanotechnologies.

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At the 2007 GlobalChem Conference in Baltimore, Maryland, Lynn L. Bergeson presented slides on “Nanotechnology:  What’s New.”  Bergeson & Campbell, P.C. co-sponsored this important conference.

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In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

To determine the extent to which federal agencies have undertaken EHS research and how they are prioritizing and managing this research, the Committee and Caucus ask GAO to:

•  Review the extent to which NNI-related resources have been devoted to study the EHS risks of nanomaterials;
• Identify the key areas of research for which this EHS funding has been used;
• Determine what processes the Nanotechnology Environmental and Health Implications Working Group uses to prioritize and coordinate these various EHS research efforts; and
• Review and identify any EHS-related research and regulatory activities, independent of the NNI, that EPA, FDA, CPCS, and OSHA have undertaken, the amount of funding made available for these efforts, and the extent to which information about these efforts has been communicated to the Working Group to ensure that they are considered in the overall research planning processes for the NNI.

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