EPA Awards Grant to Study the Life Cycle of Nanomaterials

The U.S. Environmental Protection Agency (EPA) has awarded a $5 million, four-year grant to investigators led by Arizona State University to study the life cycle of nanomaterials. According to EPA’s description of the award, the project involves an interdisciplinary team of chemists, toxicologists, scientists, engineers, and social scientists to evaluate the trade-offs between intended function of nanomaterials in products and risks to humans and the environment across their life cycle from creation, through use and disposal. The description states that researchers will evaluate four product lines expected to have variable nanomaterial release rates (i.e., dispersed in liquids used in industrial manufacturing (e.g., polishing agents), dispersed in products (e.g., foods), embedded in composite polymers (e.g., thermoplastics, membranes for water filtration), and coated on the surfaces of flexible polymeric materials (e.g., textiles) using four high-volume nanomaterials (titanium dioxide, silicon dioxide, nanosilver, and multi-wall carbon nanotubes) that exhibit properties unique from each other and properties similar to other emerging nanomaterials.  The description states that the results are expected to:

  1. Reduce uncertainty in risks from nano-enabled products for the public, manufacturing communities, and regulatory agencies;
  2. Provide the framework for existing and future nano-enabled product designs that preserve commercial value while minimizing adverse environmental health and safety effects;
  3. Train a diverse group of undergraduate, graduate, and post-doctoral scientists to work as a network and produce integrated research products; and
  4. Educate the public on the importance of the life cycle perspective for maximizing the benefits of nano-enabled products.

EPA Stops Sale of Unregistered Food Containers Containing Nanosilver

On March 31, 2014, the U.S. Environmental Protection Agency (EPA) announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA’s press release, the company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain nanosilver as an active ingredient, and the company markets other products as containing nanosilver, which the company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states:

During a November 13, 2013 EPA inspection of the company’s facility in Englewood, New Jersey, a Pathway representative acknowledged that the company sold plastic products containing nano silver. The label for the Kinetic Go Green Premium food storage container stated that the product contained nano silver technology and that the nano-sized particles of silver helped to reduce the growth of bacteria and mold, allowing foods to stay fresh up to three times longer. In addition, the company’s product description touted the benefits of nano silver in its products and the company’s website contained several claims that describe how the nano silver particles destroy, kill or reduce the growth of mold, fungus and bacteria.

EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Wal-Mart, and other large retailers directing them not to sell these products.

NNI Publishes Supplement to President's 2015 Budget

On March 25, 2014, the National Nanotechnology Initiative (NNI) published a supplement to President Obama’s 2015 budget request submitted to Congress on March 4, 2014.  The supplement provides a description of the activities underway in 2013 and 2014 and planned for 2015 by the federal government agencies participating in the NNI, primarily from a programmatic and budgetary perspective.  NNI states that it is based on the NNI Strategic Plan and reports actual investments for 2013, estimated investments for 2014, and requested investments for 2015 by Program Component Area (PCA). NNI states that the President’s 2015 budget provides over $1.5 billion for NNI, “reflect[ing] nanotechnology’s potential to significantly improve our fundamental understanding and control of matter at the nanoscale and to translate that knowledge into solutions for critical national issues.” According to NNI, the investments in 2013 and 2014 and proposed for 2015 “continue the emphasis on accelerating the transition from basic R&D to innovations that support national priorities, while maintaining a strong base of foundational research, to provide a pipeline for future nanotechnology-based innovations.”

America Competes Reauthorization Act Would Reauthorize NNI

On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs.  The bill would reauthorize the National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in the development of new technologies and products based on breakthroughs in our understanding of materials at the atomic and molecular level.” Under the bill, the National Nanotechnology Coordination Office (NNCO) would develop and maintain a public database of projects funded under at least the environmental, health, and safety (EHS) program component area, or any successor program component area. The database would include a description of each project, its source of funding by agency, and its funding history. The bill states that the National Nanotechnology Program will include research on: (1) the development of instrumentation and tools required for the rapid characterization of nanoscale materials and for monitoring of nanoscale manufacturing processes; and (2) approaches and techniques for scaling the synthesis of new nanoscale materials to achieve industrial-level production rates. On March 6, 2014, the bill was referred to the House Committee on Science, Space, and Technology and to the Committee on Education and Workforce. On March 11, 2014, the bill was referred to the Science, Space, and Technology Subcommittee on Research and Technology.

NSF Announces Availability of Market Report on Emerging Nanotechnology

On February 25, 2014, the National Science Foundation (NSF) announced the results of an NSF and National Nanotechnology Coordination Office (NNCO)-funded independent study that identifies more than $1 trillion in global revenue from nano-enabled products in 2013. NSF states that, to help quantify the global growth in nanotechnology research and development, Lux Research released a new report on global spending for emerging nanotechnology and the next generation of nano-enabled products. According to NSF, the findings “help illustrate the long-term impact investments in fundamental science and engineering research under an innovative initiative can have on the global marketplace.” NSF states:

The survey shows global funding for emerging nanotechnology has increased by 40-to-45 percent per year for the last three years.  It shows that revenue from nano-enabled products grew worldwide from $339 billion in 2010 to $731 billion in 2012 and to more than $1 trillion in 2013.  Revenue from the United States alone was $110 billion, $236 billion and $318 billion those same years, respectively.

NNCO Releases 2014 NNI Strategic Plan

On February 28, 2014, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2014 National Nanotechnology Initiative (NNI) Strategic Plan.  The NNI Strategic Plan represents the consensus of the participating agencies as to the high-level goals and priorities of the NNI and specific objectives for at least the next three years.  It is intended to provide an integrated, interagency approach informing the nanotechnology-specific strategic plans of NNI agencies.  The Strategic Plan describes the four overarching goals of the NNI, the major program component areas (PCAs) used to track the categories of investments needed to ensure the success of the NNI, and the near-term objectives that provide concrete steps toward collectively achieving the NNI vision and goals.  The Strategic Plan also describes collaborative interagency activities, including Nanotechnology Signature Initiatives (NSIs), which serve as a model of specifically targeted and closely coordinated interagency, cross-sector collaboration designed to accelerate innovation in areas of national priority.  The first three NSIs, launched in 2010, are focused on solar energy, sustainable manufacturing, and next-generation electronics.  In 2012, two additional NSIs on informatics and sensors were introduced. The goals of the NNI are to:

  • Advance a world-class nanotechnology research and development program;
  • Foster the transfer of new technologies into products for commercial and public benefit;
  • Develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and
  • Support responsible development of nanotechnology.

EPA Promulgates Final SNURs for Multi-Walled Carbon Nanotubes and Infused Carbon Nanostructures

On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order. The consent order requires the use of personal protective equipment (PPE); no domestic manufacture; import of the substances at a cumulative, aggregate volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies; and no use of the substances resulting in surface water releases. The SNUR designates as a “significant new use” the absence of these protective measures. The direct final rule also includes a SNUR for infused carbon nanostructures (generic). According to EPA, no significant inhalation exposures are expected when the PMN substance is manufactured according to the process identified in the PMN, to incorporate the PMN substance into pellets. Therefore, EPA states, it has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. The direct final rule is effective on April 14, 2014. Written adverse or critical comments, or notice of intent to submit such, are due March 14, 2014.

Lynn L. Bergeson Participates in Congressionally-Requested Forum on Nanomanufacturing, Which Is Summarized in New GAO Report

On February 7, 2014, the U.S. Government Accountability Office (GAO) released a report entitled Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health, which provides highlights from a Congressionally-requested forum on specific issues in nanotechnology manufacturing that was held July 23-24, 2013. The House Committee on Science, Space, and Technology asked the GAO and the National Academies to convene the forum and elicit the views of a group of leading experts, including Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. The report summarizes forum discussions in the following areas:

  • The future of nanomanufacturing, as viewed by forum participants;
  • U.S. investments in nanotechnology research and development (R&D) and current challenges to U.S. competitiveness in nanomanufacturing;
  • Ways to enhance U.S. competitiveness; and
  • Issues in addressing the environmental, health, and safety (EHS) implications of nanomanufacturing.

The report states that forum participants identified gaps and challenges in four key areas where they believe future action is needed:  (1) international data on R&D investment; (2) international standards; (3) U.S. competitiveness; and (4) EHS issues. The report includes profiles of four nanomanufacturing industries: “Nanotechnology and the Future of the Semiconductor Industry”; “Nanotechnology and the Future of Battery-Powered Vehicles”; “Nanotechnology and the Future of Nano-Based Concrete”; and “Nanotechnology and the Future of Nanotherapeutics in Medicine.”

Journal of Nanoparticle Research Publishes Article Describing Occupational Safety and Health Criteria for Responsible Development of Nanotechnology

On December 7, 2013, the Journal of Nanoparticle Research published online an article entitled “Occupational safety and health criteria for responsible development of nanotechnology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), describe five criterion actions that they believe should be practiced by decision-makers to ensure the responsible development of nanotechnology: “(1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers’ exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits.”  According to the authors, because of the current “unknowns and concerns about nanomaterials,” “it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments.” The article notes: “The findings and conclusions of this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health.”

NIOSH Publishes Nanotechnology Research and Guidance Strategic Plan

On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and commercialization of engineered nanomaterials.” NIOSH states that, for fiscal years 2013-2016, it will continue to fill information and knowledge gaps addressing the five NIOSH Nanotechnology Research Center (NTRC) strategic goals:

  1. Increase understanding of new hazards and related health risks to nanomaterial workers;
  2. Expand understanding of the initial hazard findings of engineered nanomaterials;
  3. Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches;
  4. Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies; and
  5. Assess and promote national and international adherence with risk management guidance.

To address these strategic goals and promote the responsible development of engineered nanomaterials, NIOSH states that the strategic plan will expand research activities in ten critical areas:  toxicity and internal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk assessment; engineering controls and personal protective equipment (PPE); fire and explosion safety; recommendations and guidance; global collaborations; and applications.

USDA Announces Public-Private Partnership to Advance Commercial Potential of Cellulosic Nanomaterial from Wood

On December 11, 2013, the U.S. Department of Agriculture (USDA) announced a three-year public-private partnership intended to advance rapidly “the development of the first U.S. commercial facility producing cellulosic nanomaterial, a wood fiber broken down to the nanoscale.” The partnership is between the U.S. Endowment for Forestry and Communities (Endowment) and the U.S. Forest Service. According to USDA, potential applications include ballistic glass replacements, body armor, auto and aerospace structural materials, flexible electronic circuits, and solar panels. The partnership seeks to overcome technical barriers to large-scale wood-based nanotechnology processing, while filling gaps in the science and technology that are needed for commercialization. The new venture will:

  • Emphasize the potential of wood- based nanotechnology for the economy and the environment;
  • Overcome technical barriers to commercialization of wood- based nanotechnology;
  • Demonstrate commitment to creating high paying jobs in rural America through value- added manufacturing and high value products; and
  • Showcase the commitment of USDA and the Forest Service to innovation.

The partnership is currently seeking additional public and private sector funding.

Draft NNI Strategic Plan Released for Public Comment

On November 19, 2013, the National Science and Technology Council, Committee on Technology, and Subcommittee on Nanoscale Science, Engineering, and Technology requested public comments on the draft 2014 National Nanotechnology Initiative Strategic Plan. The Strategic Plan provides the framework within which each National Nanotechnology Initiative (NNI) agency will carry out its nanotechnology programs and is intended to sustain coordination of interagency activities. The Strategic Plan includes the following goals: (1) advance a world-class nanotechnology research and development program; (2) foster the transfer of new technologies into products for commercial and public benefit; (3) develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and (4) support responsible development of nanotechnology. According to the draft Strategic Plan, “success will be measured by continual and substantive progress toward the four goals.” The program component areas were revised to represent better the current state of nanotechnology, improving their alignment with the goals and objectives of the Strategic Plan. Objectives in the draft Strategic Plan were revised to reflect advances in nanotechnology and evolving stakeholder needs. Sub-objectives were assigned to each objective to improve consistency among the goals. NNI requests comments of approximately one page or less in length (4,000 characters). According to the November 19, 2013, Federal Register notice, comments are due December 17, 2013. The NNI website states that comments are due December 18, 2013, however.

NIOSH Issues New Recommendations to Control Worker Exposure to Engineered Nanomaterials

On November 8, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes, which identifies and describes strategies for the engineering control of worker exposure during the production or use of engineered nanomaterials. NIOSH notes that there are currently more than 1,000 nanomaterial-containing consumer products available, including “makeup, sunscreen, food storage products, appliances, clothing, electronics, computers, sporting goods, and coatings.” According to the report, hazards involved in manufacturing and processing nanomaterials “should be managed as part of a comprehensive occupational safety, health, and environmental management plan.” NIOSH states: “Engineering controls are favored over administrative controls and personal protective equipment for lowering worker exposures, because they are designed to remove the hazard at the source, before it comes into contact with the worker.” The report includes specific conclusions and recommendations on the following topics: general; control banding; hierarchy of controls; engineering controls; administrative controls; and personal protective equipment.

Court Vacates and Remands EPA's Conditional Registration of HeiQ's Nanosilver Products

On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part the Natural Resources Defense Council’s (NRDC) petition for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20) nanosilver products. The court held that “substantial evidence” supported EPA’s decision to use the characteristics of toddlers rather than infants in determining whether AGS-20 placed consumers at risk. The court vacated EPA’s decision “insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20.” The court stated: “Our decision to grant the petition and vacate the decision in part is based solely on the fact that EPA’s own rule states that there is a risk concern requiring mitigation when the calculated MOE is less than or equal to 1,000 and, under these circumstances, the actual MOE equals 1,000. This holding does not affect any portion of EPA’s decision where the calculated MOE is greater than 1,000.” Finally, the court held that “substantial evidence supported the EPA’s decision not to consider additional sources of exposure to nanosilver other than AGS-20 in concluding that the product would not have adverse effects on consumers.”

FDA Finds Current Regulatory Review Processes Protect Public from Risks of Nanomaterials

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. According to the item, “[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials.” CDER conducted a series of risk assessment and risk management exercises concerning drugs that contain nanomaterials to determine if its current regulatory processes are adequate to identify any potential risks and reduce those risks. CDER states that these exercises “determined that our current regulatory review processes indeed can adequately protect the public from potential risks associated with the use of nanomaterials in drug products.” CDER also identified areas that could benefit from improvement, including “increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials.”  FDA will present the findings of these exercises at the January 14-15, 2014, workshop on “Nanomaterial Drug Products:  Current Experience and Management of Potential Risks.”

EPA Releases Final Comprehensive Environmental Assessment Applied to MWCNTs in Flame-Retardant Coatings in Upholstery Textiles

The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments. The final report presents a case study of multiwalled carbon nanotubes (MWCNT) used in flame-retardant coatings applied to upholstery textiles. EPA states that the case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product life cycle, environmental transport and fate, exposure-dose in receptors (i.e., humans, ecological populations, and the environment), and potential impacts in these receptors. EPA notes that the final report “is not a health, risk, or exposure assessment and as such does not draw conclusions about potential risks, or present an exhaustive review of the literature.” Instead, according to EPA, it presents the research priorities identified by experts to aid research planning. EPA states that the outcomes of these research efforts may subsequently inform long-term MWCNT assessments.

Nickel Nanoparticles Nominated for Listing in Report on Carcinogens

On September 20, 2013, the National Toxicology Program (NTP) published a Federal Register notice requesting information on 20 substances, mixtures, and exposure circumstances, including nickel nanoparticles, nominated for possible review for future editions of the Report on Carcinogens (RoC). NTP seeks information concerning:  (1) data on current production, use patterns, and human exposure; (2) information about published, ongoing, or planned studies related to evaluating carcinogenicity; (3) scientific issues important for assessing carcinogenicity of the substance; and (4) names of scientists with expertise or knowledge about the substance. The 12th RoC lists nickel compounds as “known to be human carcinogens.” Metallic nickel is listed as “reasonably anticipated to be a human carcinogen.” Information on nickel nanoparticles is due October 18, 2013.

NNI Posts Report on Symposium on Assessing the Economic Impact of Nanotechnology

The National Nanotechnology Initiative (NNI) has posted a report on its March 2012 international “Symposium on Assessing the Economic Impact of Nanotechnology.” NNI held the symposium in conjunction with the Organization for Economic Cooperation and Development (OECD), and the American Association for the Advancement of Science (AAAS) hosted it. Participants included scientists, engineers, policy analysts, private investors, technology leaders, and the general public from both OECD and emerging economies.  Participants reported on initiatives for assessing the impact of nanotechnology and other technological fields.  There was a consensus that more pilot initiatives and trials are needed to gain experience and knowledge and to aid in the development of good practices or guidelines for impact assessment.  The report states that the data obtained would facilitate efforts to develop robust international documentary standards, which are critical to the broad commercialization and adoption of nanotechnology. According to the report, participants drew attention to the need to obtain information about impact without greatly increasing the burden on respondents.  The report notes that the symposium emphasized the importance of measuring the full range of nanotechnology’s impacts, addressing risks, costs, and benefits.  Impact analyses need to be on a sound footing in order to be undertaken on a global scale and comparable, the report states, and internationally agreed upon definitions of nanotechnology are needed. The participants concluded that nanotechnology “is sufficiently mature to justify the collecting of data to support the performance of economic impact assessments.” The report provides the reasoning behind the conclusion and identifies potential challenges involved.

NRC Releases Report on Advancing Research Agenda for EHS Aspects of Nanomaterials

On September 12, 2013, the National Research Council (NRC) released a report entitled Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked the NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). The Committee to Develop a Research Strategy for EHS Aspects of ENMs was formed and released a report in January 2012, A Research Strategy for the Environmental, Health, and Safety Aspects of Engineered Nanomaterials. That report developed a research plan with short- and long-term priorities and estimated resources needed to implement the research plan. In the 2013 report, the Committee assesses the trajectory of research progress on the basis of indicators identified in its first report. According to the report, while some progress has been made in advancing the research agenda on the EHS aspects of ENMs, little work has been done to implement an integrated research strategy throughout the federal government. The Committee reiterates a conclusion from the first report, that accountability for implementing a research strategy “is hampered by the absence of an entity with sufficient management and budgetary authority to direct research efforts governmentwide.” The Committee “maintains that [the National Nanotechnology Initiative (NNI)] would benefit from a clearer separation of authority and accountability for its environmental, health, and safety research enterprise in relation to its mandate to promote nanotechnology development and commercialization.” The report suggests “progress could be accelerated if a single agency with sufficient management and budgetary authority was designated to direct” EHS research efforts and ensure implementation of a coordinated plan among the federal agencies that make up the NNI.

CRS Prepares Report on National Nanotechnology Initiative

The Congressional Research Service (CRS) prepared an August 9, 2013, report entitled The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues. According to the report, from fiscal year (FY) 2001 through FY 2013, the federal government invested approximately $17.9 billion in nanoscale science, engineering, and technology through the U.S. National Nanotechnology Initiative (NNI). President Obama has requested $1.7 billion in NNI funding for FY 2014. While the 109th, 110th, and 111th Congresses considered legislation reauthorizing the NNI, none of the bills passed. The report recommends that if the 113th Congress considers legislation reauthorizing the NNI, it may wish to consider “budget authorization levels for the covered agencies; [research and development] funding levels, priorities, and balance across the program component areas; administration and management of the NNI; translation of research results and early-stage technology into commercially viable applications; environmental, health, and safety issues; ethical, legal, and societal implications; education and training for the nanotechnology workforce; metrology, standards, and nomenclature; public understanding; and international dimensions.” The report states that “[c]onsideration may also be given to the establishment of an independent review panel and to coordination of the timing for the [National Nanotechnology Advisory Panel] assessment, the [National Research Council] assessment, and the [Nanoscale Science, Engineering and Technology] Subcommittee’s strategic plan for the NNI.”

EPA Announces Proposed Decision to Register Nanosilver Pesticide Product

On August 27, 2013, the U.S. Environmental Protection Agency (EPA) announced its proposed decision to register “Nanosilva,” a nanosilver-containing antimicrobial pesticide product. According to EPA, Nanosilva is a silver-based product “used as a non-food-contact preservative to protect plastics and textiles (e.g., in household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories) from odor and stain causing bacteria, fungi, mold and mildew.” EPA states that it evaluated exposure to nanosilver from Nanosilva “using data showing that plastics and textiles treated with the product released, at most, exceedingly small amounts of silver.” EPA also reviewed other information submitted by the applicant and used data from the scientific literature to evaluate the hazard of nanosilver. Based on its evaluation, EPA determined that Nanosilva “will not cause unreasonable adverse effects on people, including children, or the environment.” As a condition of registration, EPA is requiring the company to generate additional data. Comments on the proposed decision are due September 26, 2013. More information, including the Proposed Decision Memo, is available in the online docket.

EPA Promulgates SNURs for Two Carbon Nanotube Substances

On August 7, 2013, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) through a direct final rule for 53 chemical substances that were the subject of premanufacture notices (PMN), including two PMN substances whose reported chemical names include the term “carbon nanotube” (CNT). Seven of the chemical substances, including the CNT substances, are subject to consent orders under Section 5(e) of the Toxic Substances Control Act. Persons who intend to manufacture or process any of the 53 chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The SNURs are effective October 7, 2013. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due September 6, 2013. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, it will withdraw the relevant SNUR(s) before the effective date.

NNI Will Hold Workshop on Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology

The National Nanotechnology Initiative (NNI) will hold a September 10-11, 2013, workshop concerning “Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology.” NNI is holding the workshop to facilitate stakeholder discussion of key elements needed to assess, manage, and communicate potential risks associated with use of nanomaterials and nanotechnology-enabled products, including:

  • Understanding of the state of practice for the consideration of risk used by industry, academia, and the general public;
  • Analysis of the role of comparative risk assessment in these evaluations, including decision analysis tools and gap analysis tools;
  • Identification, through case study presentations, of stakeholder values and risk perceptions that inform their decision making, and the potential integration of these values and perceptions into a practical framework for risk communication;
  • Current risk management practices in the emerging technology communities; and
  • Determination of steps to improve the linkage of risk assessment to risk management and risk communication.

The workshop will include three roundtable discussions on:  the perspectives and needs of (1) small businesses and (2) large enterprises, both pertaining to the responsible development of nanotechnology, as well as a roundtable on (3) public risk perception and communication. NNI invites interested members of the general public and NNI stakeholders, including representatives from academia, industry, small business, non-governmental organizations, and government to attend. Registration is free and on a first-come, first-served basis. The main sessions will be webcast.

EPA Regulatory Agenda Includes Notice Concerning Nanoscale Materials

On July 3, 2013, the U.S. Environmental Protection Agency (EPA) posted its 2013 Regulatory Agenda, which includes the following item concerning nanoscale materials:

Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials.  Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity.  The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment.  In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.  The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in August 2013.

EPA Promulgates Final SNURs for 17 Chemical Substances, Including Certain Carbon Nanotubes

On June 26, 2013, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN), including for certain carbon nanotubes. The SNURs require persons who intend to manufacture or process any of these 17 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The final rule includes EPA’s response to comments. EPA encourages any manufacturers or processors who intend to conduct testing or submit a significant new use notification (SNUN) to contact EPA prior to commencing testing to avoid duplicative testing, to identify alternative testing, and to discuss protocols and testing strategies. A commenter suggested that EPA provide mandatory nano-specific ingredient and warning labeling requirements. In response, EPA states that the SNURs and consent orders that are the basis for the SNURs do not require nano-specific labeling or warnings because: “(1) the basis for the consent orders and SNURs is not that they are nanomaterials per se, but rather is based on their specific properties and potential risks, and (2) companies that manufacture, process, and use chemical substances that are carbon nanotubes and fullerenes already clearly identify those chemical substances as nanomaterials.” The proposed SNURs would allow the submission of data in support of a new chemical exposure limit (NCEL) under 40 C.F.R. Section 721.30. EPA notes that, because of the uncertainty surrounding the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of 1 microgram per cubic meter (µg/m3), it “will not adopt the NIOSH REL as a NCEL at this time because EPA cannot determine that at the REL the potential exposures may not present an unreasonable risk.” EPA states that it will consider the final NIOSH REL, or other alternative exposure controls for carbon nanotubes, if a submission requesting such is made under 40 C.F.R. Section 721.30. EPA states that, despite uncertainties cited by a commenter, it “believes that its assessment and risk management of nanomaterials, although sometimes hampered by a lack of submitted data, is adequate to identify and prevent potential unreasonable risks to human health or the environment from manufacturing processing, and using nanomaterials including risks to workers.” The final rule will be effective on August 26, 2013.

NNI Posts FAQs for Small and Medium Businesses

The National Nanotechnology Initiative (NNI) posted frequently asked questions (FAQ) for small and medium business and industry. According to NNI, the FAQs provide answers to some of the most common questions from the nanotechnology business community. The FAQs provide links to sites where a nanotechnology start-up company can obtain information about government funding opportunities; resources intended to help a small company focusing on research and development of nanotechnology-enabled products or services; and ways for a small nanotechnology business to protect intellectual property. The FAQs list U.S. government regulatory agencies that play a role in nanotechnology commercialization; links for information on meetings or workshops related to nanotechnology; ways for small nanotechnology companies to find out what the federal government is interested in buying; and a link to the Department of Commerce Bureau of Industry and Security, which is charged with the development, implementation, and interpretation “of U.S. export control policy for dual-use commodities, software, and technology.” The FAQs state that the Bureau maintains a webpage “devoted to guidance on how to comply with export control laws and regulations.”

NIOSH Announces Public Meeting and Opportunity for Public Comment on Proposed Survey

On June 19, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing a public meeting and opportunity for comment on a proposed NIOSH survey. The primary purpose of the survey is to evaluate the use of NIOSH guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.  The proposed survey will examine the extent to which NIOSH and other guidelines are implemented and the barriers to using the guidelines. According to NIOSH, information collected from the survey will be useful in future revisions of the guidelines.  Registration to attend the July 31, 2013, meeting is due July 17, 2013, and will be accepted on a first come, first served basis. Public comments on the proposed survey are due September 15, 2013.  A draft questionnaire is available in the docket.

NNCO Will Hold Public Workshop Regarding Updating the NNI Strategic Plan

The National Nanotechnology Coordination Office (NNCO) will hold a workshop on June 11-12, 2013, to obtain input from stakeholders regarding the goals and objectives of an updated National Nanotechnology Initiative (NNI) Strategic Plan, which is currently under development and scheduled for completion by December 2013. Participants will be invited to suggest additions to and provide feedback on wording and emphasis areas in the NNI goals, the objectives that support these goals, and the Nanotechnology Signature Initiatives. Comments will also be solicited on the relationship between these topics and the revised Program Component Areas, which will be presented at the workshop.  NNCO invites representatives of the U.S. research community, industry, non-governmental organizations, and interested members of the general public to offer suggestions to the U.S. government interagency group that is drafting the new plan, which is an update of the 2011 NNI Strategic Plan.  The workshop will be webcast.

NNI Publishes Report on RSL Initiatives in Nanotechnology

On May 17, 2013, the National Nanotechnology Initiative (NNI) published a report on regional, state, and local (RSL) initiatives in nanotechnology. The report is the result of a workshop, convened May 1-2, 2012, and sponsored by the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council and the Oregon Nanoscience and Microtechnologies Institute. The goal of the workshop was to improve the outcomes of nanotechnology research, education, and business activities undertaken to advance nanotechnology. The report states that the strategy for achieving this goal is “to exploit synergies between the various initiatives, promote sharing of information and resources, and develop ongoing mechanisms for relevant interactions.” The report is not intended to be a consensus document. It states that one theme rose to the top, however: “The continuing global economic downturn after 2008 and the demise of many previously sold RSL initiatives since the third NNI RSL workshop in 2009 gave a strong sense of urgency to the participants’ requests for more Federal attention to and matching financial support of the various regional, state, and local initiatives in nanotechnology.” The report includes recommendations in the following categories: commercialization; collaboration; policy; workforce; support for RSL initiatives; and RSL roadmapping. It also includes a “’Next Steps’ category to capture activities that can be begun immediately to keep interested parties in touch with one another.”

EPA Promulgates SNUR for Functionalized Multi-Walled Carbon Nanotubes

On May 9, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a significant new use rule (SNUR) for premanufacture notice (PMN) substance P-12-44, which is identified as “functionalized multi-walled carbon nanotubes.” According to the Federal Register notice, “[t]he PMN states that the generic (non-confidential) use of the substance is as an additive for rubber and batteries.” EPA states that it determined that “use of the substance other than as described in the PMN; manufacturing, processing, or use in a powder form; or any use of the substance resulting in surface water releases may cause serious health effects or significant adverse environmental effects.” EPA believes the results of the following tests would help characterize the health and environmental effects of the PMN substance: (1) A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to three months, bronchoalveolar lavage fluid analysis, particle size distribution information and other toxicologically relevant properties, data on histopathology of pulmonary and ex-pulmonary organs/tissues (cardiovascular, central nervous system, liver, kidney, etc.), pulmonary deposition (lung burden), clearance half-life (biopersistence) and translocation of the test material, and a determination of cardiovascular toxicity; (2) analysis by Scanning Transmission Electron Microscopy, Transmission Electron Microscopy, or Scanning Electron Microscopy of number of walls (range and average), tube ends (open, capped, circular, other), tube width/diameter (measure inner and outer diameters or range), tube length (range) including a description of any deformities found in the tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional groups found on the tubes (include the method of determination); and (4) particle size determined by count not by weight or volume (preferably using Scanning Transmission Electron Microscopy). The rule is effective on July 8, 2013.

Lynn L. Bergeson Will Participate in DOD Webinar

On May 15, 2013, Lynn L. Bergeson will participate in a U.S. Department of Defense (DOD) webinar on “Sustainable Chemicals and Materials for Defense Forum.” Bergeson will provide an overview of the U.S. Environmental Protection Agency’s (EPA) proposed significant new use rules for carbon nanomaterials and biobased chemicals/new chemical exposure limits. The webinar is open to interested stakeholders, who should contact Joey Skoloda for more information.

EPA Applies Life-Cycle Assessment to Nanoscale Technology

On April 30, 2013, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) announced the availability of the final report entitled Application of Life-Cycle Assessment to Nanoscale Technology: Lithium-ion Batteries for Electric Vehicles. The life-cycle assessment (LCA) was conducted by the DfE/Office of Research and Development (ORD) Li-ion Batteries and Nanotechnology Partnership. The Partnership conducted a screening-level LCA of currently manufactured lithium-ion (Li-ion) battery technologies for electric vehicles, and a next generation battery component that uses single-walled carbon nanotube technology. EPA states that the study demonstrates how the life-cycle impacts of an emerging technology and novel application of nanomaterials (i.e., the single-walled carbon nanotube technology anode) can be assessed before the technology is mature, and provides a benchmark for future LCAs of this technology. The final report’s key results and conclusions state: “In addition, the SWCNT nanotechnology applications assessed show promise for improving the energy density and ultimate performance of the Li-ion batteries in vehicles. However, the energy needed to produce these anodes in these early stages of development is significant (i.e., may outweigh potential energy efficiency benefits in the use stage). Over time, if researchers focus on reducing the energy intensity of the manufacturing process before commercialization, the overall environmental profile of the technology has the potential to improve dramatically.”

USA Today Runs Article on New NIOSH Nanotech Safety Guidelines

An April 26, 2013, USA Today article entitled “CDC sets carbon nanotech safety guidelines” reports on the National Institute of Occupational Safety and Health (NIOSH) Current Intelligence Bulletin (CIB) 65, Occupational Exposure to Carbon Nanotubes and NanofibersThe article includes comments from Andrew Maynard, Chair of Environmental Health Sciences at the University of Michigan,  Todd Kuiken with the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars, and Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C. and a board member of the NanoBusiness Commercialization Association.

NIOSH CIB on Carbon Nanotubes and Nanofibers Includes Lower REL

On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m3) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 μg/m3 but that the analytic limit of quantification was 7 μg/m3.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 μg/m3. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed.

NRC Identifies Five High Priorities to Improve NNI

The National Research Council (NRC) announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:

  • Improve information gathering and communication at the project level;
  • Develop and implement interagency plans for focused areas;
  • Rework the NNI website to serve better the diversity of stakeholder groups;
  • Take advantage of new technologies for data collection and analysis; and
  • Identify, share, and implement best practices, especially relating to technology transfer and commercialization.

In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies.

TSCA Reform Legislation Would Regulate Special Substance Characteristic

On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform the Toxic Substances Control Act (TSCA) and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works Committee on a party-line vote in the 112th Congress. While the bill does not specifically mention nanomaterials, it defines “special substance characteristic”:

(A) IN GENERAL. -- The term ‘special substance characteristic’ means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.

(B) CONSIDERATIONS. -- In determining the existence of special substance characteristics, the Administrator may consider --

(i) size or size distribution;

(ii) shape and surface structure;

(iii) reactivity; and

(iv) any other properties that may significantly affect the risks posed.

It is now expected that Senator David Vitter (R-LA), ranking minority member of the Committee, will introduce his version of a TSCA reform bill, a possibility that has been discussed in the trade press for months. More information is available in Bergeson & Campbell, P.C.’s April 11, 2013, memorandum.

USDA Withdraws Final Rule Amending Guidelines for Designating Biobased Products for Federal Procurement

The U.S. Department of Agriculture (USDA) published a notice on April 8, 2013, withdrawing its April 1, 2013, final rule concerning the designation of product categories for federal procurement. According to the USDA, it is withdrawing the final rulemaking, which amended the guidelines for designating biobased products for federal procurement, because it published the final rule prematurely “due to an oversight in the development process.” The notice states that USDA’s Office of Procurement and Property Management “anticipates republishing the rulemaking in the coming months.”

USDA Amends Guidelines for Designating Biobased Products for Federal Procurement

In an April 1, 2013, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement. The amendments add eight sections to designate product categories within which biobased products will be afforded federal procurement preference: aircraft and boat cleaners; automotive care products; engine crankcase oil; gasoline fuel additives; metal cleaners and corrosion removers; microbial cleaning products; paint removers; and water turbine bearing oils. The amendments also add the proposed countertops subcategory to the existing composite panels product category. USDA also established minimum biobased contents for each of these product categories and subcategories. In addition, USDA is officially changing the term “item” to product category. The amendments will take effect on May 1, 2013.

House Committee Launches Bipartisan Review of Renewable Fuel Standard

This week, the House Energy and Commerce Committee released the first of five bipartisan white papers that explore important policy implications related to continued implementation of the Renewable Fuel Standard (RFS). The white papers are intended to solicit input and stimulate debate in several areas:  infrastructure, fuel compatibility, blending, economics, and environmental issues. Each paper will provide a detailed policy analysis on one area and then outline a series of questions intended to engage key stakeholders on that issue.

This first white paper, The Blend Wall and Fuel Compatibility Issues, focuses on one of the most pressing and complicated policy challenges facing proponents and opponents of biofuels. The paper recognizes a changed fuels refining environment from 2007, where fuel demand has fallen dramatically and 10 percent ethanol blends (the conventional ethanol blend percentage) are rapidly approaching saturation in the fuel pool. It discusses various aspects of mid-level ethanol blends (E15, E85), which have the ability to introduce higher volumes of biofuels than conventional blend levels. Some key questions posed at the end of the white paper for biofuels stakeholders relate to the feasibility of mid-level ethanol blends, the marketing and mis-fueling challenges to mid-level blends, the economics of the Blend Wall, and the intersection of new Corporate Average Fuel Economy (CAFE) vehicle standards and the RFS. The Committee asks stakeholders to respond to the first paper by April 5, 2013.

NIOSH Announces New Findings on Lung Tumor Formation in Laboratory Mice Exposed to Multi-Walled Carbon Nanotubes

On March 11, 2013, at the annual meeting of the Society of Toxicology, researchers from the National Institute for Occupational Safety and Health (NIOSH) reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes (MWCNT). According to NIOSH, the study was designed to investigate whether these tiny particles have potential to initiate or promote cancer. One group of laboratory mice was injected with a chemical that is a known cancer initiator, and another group of mice was injected with a saline solution as a control group. The mice then were exposed by inhalation either to air or to a concentration of MWCNT. According to NIOSH, mice receiving both the initiator chemical plus exposure to MWCNT were significantly more likely to develop tumors and have more tumors than mice receiving the initiator chemical alone. Additionally, mice exposed to MWCNT and to MWCNT plus the initiator chemical had larger tumors than the respective control groups. NIOSH concluded that the results indicate that MWCNT can increase the risk of cancer in mice exposed to a known carcinogen. NIOSH notes that the study does not suggest that MWCNTs alone cause cancer in mice.

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USDA Issues BioPreferred Program Notification

The United States Department of Agriculture (USDA) posted a notice on its website concerning the BioPreferred Program. According to USDA, due to the absence of funding in the Farm Bill extension legislation, USDA has suspended the processing of applications for voluntary certification of biobased products. USDA states that it “will continue limited activities related to the Federal procurement preference program, such as adding products to the BioPreferred catalog, as staff resources allow. All existing biobased product label certifications (900 'USDA Certified Biobased Products' as of December 31, 2012) are and will remain valid.” Since 2002, USDA has designated some 89 categories representing 9,000 biobased products, all of which qualify for federal sustainable procurement standards.

EPA Proposes SNURs for 37 Chemical Substances, Including 14 Nanomaterials

On February 25, 2013, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances that were the subject of premanufacture notices (PMN). EPA notes that the proposed SNURs include 14 PMN substances whose reported chemical names include the term “carbon nanotube” (CNT) or “carbon nanofibers.”  If issued in final, the SNURs would require persons who intend to manufacture, import, or process the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide it with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due April 26, 2013.

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Honda Reintroduces NANO Act

On January 23, 2013, Representative Mike Honda (D-CA) reintroduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R.394). Honda described the Act as a comprehensive bill intended to promote the development and responsible stewardship of nanotechnology in the U.S. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts convened by Honda and then-California State Controller Steve Westly during 2005. The bill includes recommendations from the Blue Ribbon Task Force for ways to promote the development and commercialization of nanotechnology; requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology; and includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. Honda introduced similar legislation in the 112th (H.R. 2749), 111th (H.R. 820), and 110th (H.R. 3235) Congresses. None of the bills made it out of subcommittee.

OSHA Publishes Fact Sheet on Working Safely with Nanomaterials

The Occupational Safety and Health Administration (OSHA) recently published a fact sheet entitled Working Safely with Nanomaterials. OSHA notes that workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion. OSHA intends the fact sheet to provide “basic information to workers and employers on the most current understanding of potential hazards associated with this rapidly-developing technology and highlight[] measures to control exposure to nanomaterials in the workplace.” According to the fact sheet, information and training provided to workers should include:

  • Identification of nanomaterials the employer uses and the processes in which they are used;
  • Results from any exposure assessments conducted at the work site;
  • Identification of engineering and administrative controls and personal protective equipment (PPE) to reduce exposure to nanomaterials;
  • The use and limitations of PPE; and
  • Emergency measures to take in the event of a nanomaterial spill or release.

OSHA states that there are few occupational exposure limits specific to nanomaterials. According to OSHA, because certain nanoparticles may be more hazardous than larger particles of the same substance, existing occupational exposure limits for a substance may not provide adequate protection from nanoparticles of the same substance. OSHA notes the following specific exposure limits:

  • OSHA recommends that worker exposure to respirable carbon nanotubes and carbon nanofibers not exceed 7.0 micrograms per cubic meter (μg/m3) as an 8-hour time-weighted average, based on the National Institute for Occupational Safety and Health (NIOSH) proposed Recommended Exposure Limit (REL); and
  • OSHA recommends that worker exposure to nanoscale particles of titanium dioxide (TiO2) not exceed NIOSH’s 0.3 milligrams per cubic meter (mg/m3) REL. By contrast, NIOSH’s REL for fine-sized TiO2 (particle size greater than 100 nm) is 2.4 mg/m3.

OSHA suggests that, because exposure limits for other nanomaterials do not exist yet, employers should minimize worker exposure by using the hazard control measures and best practices identified in the fact sheet and in the references noted.

EPA Announces Proposed 2013 Renewable Fuel Standards

The U.S. Environmental Protection Agency announced on January 31, 2013, the proposed 2013 percentage standards for four fuel categories that are part of the Renewable Fuel Standard Program. Once EPA publishes the proposed standards in the Federal Register, there will be a 45-day comment period. Under the Energy Independence and Security Act (EISA), the annual renewable fuel volume targets steadily increase to an overall level of 36 billion gallons in 2022. To meet this goal, EPA calculates a percentage-based standard, and, based on the standard, each refiner and importer determines the minimum volume of renewable fuel that it must ensure is used in its transportation fuel. The proposed 2013 overall volumes and standards are:

  • Biomass-based diesel (1.28 billion gallons; 1.12 percent);
  • Advanced biofuels (2.75 billion gallons; 1.60 percent);
  • Cellulosic biofuels (14 million gallons; 0.008 percent); and
  • Total renewable fuels (16.55 billion gallons; 9.63 percent).

EPA notes that, for 2013, it is proposing to implement EISA’s requirement to blend more than 1.35 billion gallons of renewable fuels over the amount mandated for 2012.

Court Vacates 2012 Cellulosic Biofuel Requirements

On January 25, 2013, the U.S. Court of Appeals for the District of Columbia Circuit vacated the U.S. Environmental Protection Agency’s (EPA) 2012 cellulosic biofuel requirements under the renewable fuel standard. American Petroleum Institute v. EPA, D.C. Cir., No. 12-1139. In its January 2012 final rule, EPA projected that 8.65 million gallons of cellulosic biofuel would be produced in 2012, and determined that a reduction in the volume of total advanced biofuels was unnecessary because other kinds of advanced biofuels could make up for the shortfall. The American Petroleum Institute (API) filed suit, challenging EPA’s 2012 projection for cellulosic biofuel and its refusal to reduce the volume of total advanced biofuels for 2012. While the court rejected API’s argument that EPA failed to justify its determination not to reduce the applicable advanced biofuels volume, the three-judge panel unanimously agreed that “because EPA’s methodology for making its cellulosic biofuel projection did not take neutral aim at accuracy, it was an unreasonable exercise of agency discretion.” The court vacated that aspect of the 2012 rule and remanded it to EPA. An EPA spokesperson stated that EPA is still reviewing the court’s decision.

Court Hears Oral Arguments in Case Challenging Conditional Registration of Nanosilver

Oral arguments were held on January 16, 2013, in the Natural Resources Defense Council’s (NRDC) case challenging the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20, a nanosilver product. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California). During oral arguments, EPA maintained that NRDC lacks standing to challenge the conditional registration. The judges appeared to reject EPA’s argument, suggesting that NRDC could prevail because of the low bar for establishing standing to challenge a rulemaking. The judges seemed less persuaded by NRDC’s argument that EPA erred in choosing three-year-olds rather than nine-month-olds as the most vulnerable subpopulation on which to base risk values. According to NRDC, EPA should have used infants, who are more likely to chew on textiles and could have higher exposures. EPA responded that EPA has a long-standing practice of using three-year-olds in risk assessments with similar exposure patterns to AGS-20, and that its use of three-year-olds was supported by leaching studies. NRDC further argued that EPA failed to consider the risk of aggregate exposures from other nanosilver products on the market. EPA responded that it applied uncertainty factors to account for data gaps and that HeiQ must submit more data to obtain a full registration.

NIOSH Seeks Comment for Updating Its 2013-2016 Nanotechnology Strategic Plan

On January 18, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice seeking comment on the types of hazard identification and risk management research to consider in updating its fiscal years 2013-2016 nanotechnology strategic plan. NIOSH states that it wants to “build on the accomplishments of ongoing research” to “develop strategic research goals and objectives for nanotechnology occupational safety and health research through 2016.” NIOSH previously identified ten critical research areas for nanotechnology research and communication: (1) toxicity and internal dose; (2) measurement methods; (3) exposure assessment; (4) epidemiology and surveillance; (5) risk assessment; (6) engineering controls and personal protective equipment; (7) fire and explosion safety; (8) recommendations and guidance; (9) global collaborations; and (10) applications. According to the notice, NIOSH is considering focusing the research goals on five key objectives: (1) increase understanding of new hazards and related health risks to nanomaterial workers; (2) expand understanding of the initial hazard findings on engineered nanomaterials; (3) support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches; (4) support epidemiologic studies for nanomaterial workers, including medical and exposure studies; and (5) assess and promote national adherence with risk management guidance. NIOSH requests public input to address the basis or rationale for priorities that NIOSH should give for studies of toxicity evaluation and/or workplace exposure characterization for engineered nanoparticles, and what rationale can be provided for recommending needs and types of technical and educational guidance materials. Comments are due March 19, 2013.

EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency (EPA) is scheduled to announce in the January 8, 2013, Federal Register the availability of its 2012 Regulatory Agenda. EPA’s Regulatory Agenda includes the following notice concerning nanoscale materials:

Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process nanoscale materials for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment. In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in July 2013.

EPA Amends Definition of Clean Cellulosic Biomass

On December 20, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a final rule setting forth EPA’s final decision on the issues for which it granted reconsideration pertaining to its March 21, 2011, final rule entitled “Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units.” The December 20, 2012, rule makes technical corrections to the March 21, 2011, final rule, including clarifying the definition of clean cellulosic biomass (revisions are in red):

 

Clean cellulosic biomass means those residuals that are akin to traditional cellulosic biomass, including, but not limited to: agricultural and forest-derived biomass (e.g., green wood, forest thinnings, clean and unadulterated bark, sawdust, trim, tree harvesting residuals from logging and sawmill materials, hogged fuel, wood pellets, untreated wood pallets); urban wood (e.g., tree trimmings, stumps, and related forest-derived biomass from urban settings); corn stover and other biomass crops used specifically for the production of cellulosic biofuels (e.g., energy cane, other fast growing grasses, byproducts of ethanol natural fermentation processes); bagasse and other crop residues (e.g., peanut shells, vines, orchard trees, hulls, seeds, spent grains, cotton byproducts, corn and peanut production residues, rice milling and grain elevator operation residues); wood collected from forest fire clearance activities, trees and clean wood found in disaster debris, clean biomass from land clearing operations, and clean construction and demolition wood.  These fuels are not secondary materials or solid wastes unless discarded.  Clean biomass is biomass that does not contain contaminants at concentrations not normally associated with virgin biomass materials.

The amended definition will be effective 60 days after publication in the Federal Register.

NIOSH to Publish Information and Comment Request for Silver Nanoparticles

The National Institute for Occupational Safety and Health (NIOSH) is scheduled to publish in the December 19, 2012, Federal Register a request for information and comment on silver nanoparticles. According to the notice, NIOSH has initiated an evaluation of the scientific data on silver nanoparticles “to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted.” NIOSH has identified a number of “relevant publications” on silver nanoparticles, and this listing will be available in Docket CDC-2012-0014, at http://www.regulations.gov, once the Federal Register notice is published. NIOSH requests additional information concerning:

  1. Published and unpublished reports and findings from in vitro and in vivo toxicity studies with silver nanoparticles;
  2. Information on possible health effects observed in workers exposed to silver nanoparticles;
  3. Information on workplaces and products in which silver nanoparticles can be found;
  4. Description of work tasks and scenarios with a potential for exposure;
  5. Information on measurement methods and workplace exposure data; and
  6. Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to silver nanoparticles occur.

Comments will be due 60 days after the notice is published in the Federal Register.

EPA and CPSC Collaborating on Nanomaterial Research

On December 11, 2012, the U.S. Environmental Protection Agency (EPA) and U.S. Consumer Product Safety Commission (CPSC) announced a research collaboration intended to assess potential impacts of nanomaterials on people’s health and the environment.  According to EPA’s press release, the research is part of a “larger international effort” that includes:

  • Identifying, characterizing and quantifying the origins of nanomaterials;
  • Studying biological processes affected by nanomaterials that could influence risk;
  • Determining how nanomaterials interact with complex systems in the human body and the environment;
  • Involving industry to develop sustainable manufacturing processes; and
  • Sharing knowledge through innovative online applications that allow for rapid feedback and accelerated research progress.

The press release states that CPSC will use the results of the research to inform:

  • Protocol development to assess the potential release of nanomaterials from consumer products;
  • Credible rules for consumer product testing to evaluate exposure; and
  • Determination of the potential public health impacts of nanomaterial used in consumer products.

 

EPA Determines Grain Sorghum Ethanol Qualifies as a Renewable Fuel

U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed on November 30, 2012, a supplemental rule associated with the Renewable Fuel Standard (RFS) Program. The final rule contains a lifecycle greenhouse gas (GHG) analysis for grain sorghum ethanol and a regulatory determination that grain sorghum ethanol qualifies as a renewable fuel under the RFS Program. According to the rule, EPA’s analysis indicates that ethanol made from grain sorghum at dry mill facilities that use natural gas for process energy meets the lifecycle GHG emissions reduction threshold of 20 percent compared to the baseline petroleum fuel it would replace, and therefore qualifies as renewable fuel.  The rule also includes EPA’s regulatory determination that grain sorghum ethanol produced at dry mill facilities, using specified forms of biogas for both process energy and most electricity production, has lifecycle GHG emission reductions of more than 50 percent compared to the baseline petroleum fuel it would replace, and that such grain sorghum ethanol qualifies as an advanced biofuel under the RFS Program. The rule will take effect when it is published in the Federal Register.

Regulatory Cooperation Council Holds Stakeholder Webinar on Nanotechnology Initiative

On November 28, 2012, the Canada-U.S. Regulatory Cooperation Council (RCC) held a webinar to discuss its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to information presented during the webinar, while the U.S. has received 137 notifications concerning nanomaterial substances, Canada has received only 16. While most of the nanomaterial substances notified in the U.S. were inorganic carbon, most of those notified in Canada were mixed metal oxides. During the webinar, both Canadian and U.S. spokespersons noted the difficulty in sharing information, due to confidential business information (CBI) claims. The RCC would like to be able to share information to inform better their regulatory programs and risk assessment/management approaches. This would include:

  • General Substance Information: Substance name, company, applications, volumes; and
  • Technical Substance Specific Information: Physchem properties, technical studies, and use pattern information.

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

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Lux Research Issues Report on the Demand for Bio-Based Materials

On November 20, 2012, Lux Research Inc. released a report entitled Bridging the Divide between Demands and Bio-Based Materials, in which the properties and commercial attractiveness of 38 applications and 21 conventional and bio-based polymers were assessed on 13 criteria, with three demand areas promising opportunity, according to Lux. Lux states that materials that fail to connect with end-user demands never reach the commercialization stage. Lux recommends that developers target large, addressable markets, among which the biggest are composites and coatings, industrial manufactured intermediates, and packaging. Lux notes that developers must offer bio-based alternatives at cost parity, offer more bio-based drop-in monomers, and continue to close performance gaps on temperature distortion and brittleness, as well as advance bio-based polymers beyond their reputation as merely “disposable.” Lux urges developers to meet or exceed expectations on cost and performance and be smart during roll-out. Kalib Kersh, a Lux analyst, stated that the U.S. Department of Agriculture (USDA) would expand the market for biobased chemicals if it fulfills its pledge to certify intermediates through its BioPreferred Program. During a recent conference held by the Society for the Commercial Development of Industrial Biotechnology, a USDA spokesperson stated that USDA intends to cover intermediates in its Program.

AFPM Seeks Review of 2013 Biomass-Based Diesel Fuel Requirement

The American Fuel & Petrochemical Manufacturers (AFPM) petitioned the U.S. Court of Appeals for the District of Columbia Circuit on November 21, 2012, for review of the U.S. Environmental Protection Agency’s (EPA) 2013 biomass-based diesel renewable fuel requirements. Under EPA’s September 27, 2012, final rule, EPA increased the volume of biomass-based diesel from 1.0 billion to 1.28 billion gallons for calendar year 2013. According to AFPM, a number of factors have surfaced since EPA issued the rule that could result in unintended consequences adversely impacting the domestic refining industry and U.S. consumers. AFPM states that the increase could reduce investment in advanced biofuels that compete with biodiesel and increase carbon emissions.  In addition, AFPM notes, the increase could negatively impact the price and supply of agricultural commodities, since additional biodiesel feedstocks, such as soybean oil, would be required under the rule.

Safe Nano Design Workshop Presentations Now Available

The presentations from the August 14-16, 2012, “Safe Nano Design: Molecule » Manufacturing » Market” workshop are now available. The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center held the workshop, during which participants provided input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop focused on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. A summary of all of the outcomes from each panel discussion is in development. Lynn L. Bergeson was on the Planning Committee for the workshop, and presented remarks.

EDF Creates Website on Emerging Chemical Testing Methods

Environmental Defense Fund (EDF) announced on November 12, 2012, the creation of a website intended to serve as a resource for understanding new chemical testing approaches. These approaches are typically less costly and time-consuming than animal-based tests. EDF notes that while the U.S. Environmental Protection Agency (EPA) has invested resources to create research programs to advance new types of chemical testing and assessment approaches, questions for users remain. EDF’s website includes the following resources:

  • Chemical Testing in the 21st Century:  A Primer -- An introduction to EPA’s Computational Toxicology (CompTox) research initiative and its component programs, such as ToxCast; a discussion of the opportunities and challenges of these new testing programs; and a discussion of issues and needs for greater engagement by the public interest community; and
  • Chemical Testing in the 21st Century:  Webinar Series -- Linked audio and video recordings of each of EDF’s three webinars (held in October) featuring EDF and EPA scientists exploring the basics of EPA’s new testing programs and the promises and challenges they present.

 

NIOSH Publishes Progress Report from Nanotechnology Research Center

On November 7, 2012, the National Institute for Occupational Safety and Health (NIOSH) Nanotechnology Research Center (NTRC) posted a document entitled Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004–2011. NIOSH established NTRC in 2004 to address occupational safety and health concerns associated with nanotechnology. The progress report summarizes program accomplishments from the inception of NTRC in 2004 through 2011. It includes an analysis of the progress made toward accomplishing the goals and objectives of the NIOSH Strategic Plan for Nanotechnology Research and toward addressing the goals and research needs identified in the National Nanotechnology Initiative (NNI) environmental, health, and safety (EHS) research strategy. The progress report states that NTRC “continues to support and promote the responsible development of nanotechnology through its ongoing research program and its contributions to the development of guidelines for hazard identification, exposure assessment, and risk characterization that can be used to develop and implement effective risk management practices.”

National Academies Releases Report on Sustainable Development of Algal Biofuels

On October 24, 2012, the National Academies released a report entitled Sustainable Development of Algal Biofuels, which was produced at the request of the U.S. Department of Energy (DOE). According to the report, biofuels made from algae could provide a domestic source of renewable fuel, but with current technologies, increasing production of algal biofuels to meet five percent of U.S. transportation fuel needs could “create unsustainable demands for energy, water, and nutrient resources.” While algal biofuels have the potential to improve the sustainability of the transportation sector, their potential is not yet realized and additional innovations requiring research and development are necessary to achieve the full potential. The report recommends that the environmental, economic, and social effects of algal biofuel production and use be compared with those of petroleum-based fuels and other fuel alternatives to determine whether algal biofuels contribute to improving sustainability. The report states that such comparison will be possible “only if thorough assessments of each step in the various pathways for algal biofuel production are conducted.”

Potassium Titanium Oxide SNUR Bans Manufacture of Particle Size Less Than 100 nm

On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.

EPA Announces RCC Nanotechnology Webinar and Requests Nominations for Case Studies

The Canada-U.S. Regulatory Cooperation Council (RCC) will hold a webinar on November 28, 2012, on its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to the U.S. Environmental Protection Agency (EPA), the purpose of the RCC’s nanotechnology initiative is to increase, where possible, regulatory transparency and coordination between the U.S. and Canada respecting nanomaterials. The Nanotechnology Work Plan includes specific objectives, deliverables, and milestones for tangible progress within the RCC’s two-year mandate. During the November 28, 2012, webinar, RCC will provide additional background information, as well as updates on ongoing activities under the Nanotechnology Work Plan. Stakeholders should confirm their webinar attendance no later than October 25, 2012.

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USDA Working to Increase Number of BioPreferred Products

Tom Vilsack, Secretary of Agriculture, spoke at the 2012 GreenGov Symposium on September 25, 2012. According to Vilsack, the United States Department of Agriculture (USDA) is working to support the manufacturing industry by increasing the number of biobased products approved for federal purchase. Currently, there are approximately 9,300 BioPreferred products, and USDA intends to make 18,000 BioPreferred products available. Under Executive Order 13,514, federal agencies are required to ensure that 95 percent of new contracts use biobased products when available. Under a February 21, 2012, Presidential Memorandum, the USDA is directed to increase the number of categories of biobased products available for purchase by 50 percent by February 21, 2013. There were 64 categories of biobased products available in February 2012, and Vilsack stated that USDA has increased the number of categories to 77, including lotions and moisturizers, leather, vinyl, rubber care products, and shaving products.

CDC Seeks Comment on Proposed NIOSH Exposure Assessment and Epidemiological Study of U.S. Workers

The Centers for Disease Control and Prevention (CDC) published a September 20, 2012, Federal Register notice seeking comment on a proposed National Institute for Occupational Safety and Health (NIOSH) exposure assessment and epidemiological study of U.S. workers exposed to carbon nanotubes (CNT) and carbon nanofibers (CNF). The notice states that the proposed research is a cross-sectional study of the current U.S. workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in two phases: (1) an industry-wide exposure assessment study to evaluate worker exposure and further develop and refine measurement methods for CNT and CNF; and (2) a cross-sectional study relating the best metrics of CNT and CNF exposure to markers of early pulmonary or cardiovascular health effects. The study will include a questionnaire given by NIOSH personnel as a computer-assisted personal interview, followed by medical examinations to evaluate pulmonary function and blood pressure, and collect sputum and blood. NIOSH will conduct statistical analyses to determine the nature of the relation between exposure to CNT and CNF and these biomarkers of early effect, considering potential confounding factors such as smoking, age, gender, and workplace coexposures, including non-engineered ultrafine particles. CDC invites comments on whether the proposed research is necessary for the proper performance of its functions, including whether the information shall have practical utility; the accuracy of its estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information. Written comments are due within 60 days of the notice.

NNCO Will Hold Webinar on Nano.gov Website

In a September 13, 2012, Federal Register notice, the Office of Science and Technology Policy (OSTP) announced that the National Nanotechnology Coordination Office (NNCO) will hold a webinar on September 20, 2012, to provide an open forum to answer questions and hear suggestions related to the National Nanotechnology Initiative’s (NNI) public website, which was redesigned in April 2011. According to the notice, NNCO is seeking public comment and recommendations on potential updates to, improvements on, and opportunities for public engagement through Nano.gov. The webinar will address the following questions:

  1. How is Nano.gov useful to you and your stakeholders/colleagues/peers?
  2. What do you like on Nano.gov? Which pages are most useful to you? Why?
  3. What would you like to see improved? Are there pages you do not understand? Confusing information? Poor layout? Difficult to use?
  4. Are there pages that you feel are missing from Nano.gov? What other types of pages would you like to see? What information would you like to find on Nano.gov that is not currently there?
  5. Are there similar websites that present information in a way that you find more useful, exciting, attractive, or user-friendly?

NRC Report on Science for Environmental Protection Examines Nanotechnology

On September 5, 2012, the National Research Council (NRC) released a pre-publication version of a report entitled Science for Environmental Protection:  The Road Ahead. The U.S. Environmental Protection Agency (EPA) asked NRC to assess EPA’s overall capabilities “to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities.” The report discusses nanotechnology as an example of using emerging science to address regulatory issues and support decision-making. The Committee states that, to have the capacity to address emerging tools, technologies, and challenges, EPA “will need to have enough internal expertise to identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions; determine what existing tools and strategies can be applied to answer those questions; determine the needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the science to make recommendations based on hazards, exposures, and monitoring.” According to the report, the example of engineered nanomaterials “illustrates some of the problems and pitfalls of current approaches to emerging technologies.” While EPA provided early funding regarding the use of nanotechnology in remediation, the report states that it missed the opportunity to support research addressing the environmental health and safety of nanomaterials, pollution prevention in the production of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay in early intervention include “insufficient federal agency leadership, emphasis, and policy regarding proactive rather than reactive approaches to safer design.” If EPA intends to promote and guide early intervention in the design and production of emerging chemicals, materials, and products, the report states, “it will need to commit to this effort beyond its regulatory role.”

EPA Publishes Final Nanomaterial Case Study For Nanoscale Silver in Disinfectant Spray

On August 1, 2012, the U.S. Environmental Protection Agency (EPA) posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states “is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials.” According to EPA, “[t]he complex properties of various nanomaterials make evaluating them in the abstract or with generalizations difficult if not impossible.” EPA notes that the case study does not represent a completed, or even preliminary, assessment of nanosilver. Instead, it and other similar case studies are intended to support research planning efforts for nanomaterials. The case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product lifecycle, transport, transformation and fate processes in environmental media, exposure-dose in receptors, and potential impacts in these receptors. If information is available, the case study also includes other direct and indirect ramifications of both primary and secondary substances or stressors associated with a nanomaterial. Through a structured collective judgment method, expert stakeholders used EPA’s draft case study to identify and prioritize research gaps that could inform future assessments and risk management efforts. Some of the research gaps pertain to nanosilver in disinfectant spray; others to nanosilver irrespective of its application, and still others to nanomaterials in general.

Amended Safe Chemicals Act Still Includes Special Substance Characteristics Provision

On July 25, 2012, the Senate Committee on the Environment and Public Works approved Senator Frank Lautenberg’s (D-NJ) amended Safe Chemicals Act of 2011 (S. 847) in a 10-8 partisan vote. While the bill does not explicitly mention nano, potentially relevant provisions remain in the amended text. These include the bill granting the Administrator the ability to determine that a variant of a chemical substance that exhibits one or more special substance characteristics either “is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics” or is a distinct chemical substance. In the event that a chemical substance exhibiting special substance characteristics is considered to be a variant that is a separate use, the manufacturer or processor will be required to satisfy conditions that are established by the Administrator. In the event that a chemical substance exhibiting special substance characteristics is considered to be a distinct chemical substance, and is not listed on the active inventory of chemicals manufactured or processed in the U.S., the manufacturer or processor would be required to submit data. This measure could have a significant impact on nanoscale chemical substances.

FDA Bill Signed by President Includes Nanotechnology Provision

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act” or other statutes administered by FDA. The Secretary may:

  1. Assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to FDA;
  2. In cooperation with other federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;
  3. Promote FDA programs and participate in collaborative efforts to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;
  4. Promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;
  5. Collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;
  6. Build scientific expertise on nanomaterials within FDA, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under the Act;
  7. Ensure ongoing training, as well as dissemination of new information within the FDA centers, and more broadly across FDA, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;
  8. Encourage FDA to participate in international and national consensus standards activities pertaining to nanomaterials; and
  9. Carry out other activities that the Secretary determines are necessary and consistent with the purposes described above.

 

EPA Extends Due Date for Comments on Nanosilver Registration Review

According to a July 10, 2012, memorandum added to the registration review docket for nanosilver, the Federal Register notice announcing the opening of the docket erroneously listed the comment period end date as August 19, 2012. The U.S. Environmental Protection Agency (EPA) memorandum states that the comment period has been extended to September 10, 2012, “to allow for a full 60-day comment period [that] is standard for registration review docket openings.”

NIOSH eNews Includes Nanotechnology Update

The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”:

  • A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help focus action to protect workers:
    • Review of the current evidence on the carcinogenic potential of carbon nanotubes (CNT), based on laboratory studies;
    • The role of physical and chemical properties related to cancer development;
    • CNT doses associated with changes to or damages in genes in laboratory animals and human tissue specimens;
    • Workplace exposures to CNT; and
    • Specific risk management actions needed to protect workers.
  • A study linking nanoparticle exposure to cellular responses associated with autoimmune risks. In laboratory studies, exposures to certain types of nanoparticles produced cellular changes that are associated with risks for disorders of the autoimmune system such as rheumatoid arthritis.
  • A recent paper highlighting the findings from an evaluation of the quality and completeness of information of nanomaterial safety data as it pertains to hazard identification, exposure controls, personal protective equipment, and toxicological information being communicated about the engineered nanomaterial. The study determined that the majority of the safety data sheets obtained in 2010-2011 provided insufficient data for communicating the potential hazards of engineered nanomaterials.
  • In a paper published in June, NIOSH researchers scrutinize the “oxidative stress paradigm,” a widely accepted scientific model for understanding the processes that in general are associated with cellular damage, to better understand the processes that can occur from reactions to nanoparticles. The answer to this question will have important ramifications for the development of strategies for mitigation of potential adverse effects of nanoparticles.
  • Recent findings indicating that improperly designed, maintained, or installed engineering controls may not be completely effective in controlling releases of nanomaterials into the workplace. Unprotected skin exposure to carbon nanofibers was noted in two instances and indicated the need for educating workers on the use of personal protective equipment.
  • A summary of emission data collected at four facilities that volunteered to serve as test sites. The measurements indicated that specific tasks can release engineered nanomaterials into the workplace atmosphere and that traditional controls such as ventilation can be used to limit exposure. Much research is still needed to understand the impact of nanotechnology on health, and to determine appropriate exposure monitoring and control strategies.

EPA Opens Registration Review Docket for Nanosilver

On July 6, 2012, the U.S. Environmental Protection Agency (EPA) announced the establishment of a registration review docket for nanosilver. EPA states that registration review is its “periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.” Registration review dockets include information intended to assist the public in understanding the types of information and issues that EPA may consider during the course of registration reviews. According to the preliminary work plan, EPA has information that there are silver-based pesticide products that were registered without the registrant disclosing to EPA the presence or characteristics of the nanosilver in their products. EPA sent a letter in August 2009 to each registrant with silver-based products requesting a statement as to whether their products contained any amount of silver in any form having a dimension that measures between 1 and approximately 100 nanometers. Four registrants responded that their products, which were registered using data for conventional silver, contain nanosilver. In the preliminary work plan, EPA states it is identifying several other products, registered using data for silver chloride, as potentially containing nanosilver. The registration review for nanosilver includes these products, as well as the two HeiQ nanosilver products conditionally registered in December 2011. According to the preliminary work plan, EPA believes that additional data are needed to determine whether the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for maintaining these registrations is met “due to nanosilver’s unique physical and chemical properties, and thus nanosilver’s potentially different health and safety properties as compared to silver.”

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EPA Nanomaterial Case Study Compares Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2012, the availability of an external review draft document entitled Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (EPA/600/R-12/043A). EPA states that the draft document “does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify what is known and unknown about MWCNT to support future assessment efforts.” On October 29, 2012, EPA will hold a public information exchange meeting to: (1) receive comments and questions on the draft document; and (2) provide information on the draft EPA nanomaterial case study and the workshop process that the draft document will be used in for identifying and prioritizing research gaps that could support future assessment and risk management efforts for MWCNT. Following the conclusion of the October 29 meeting, RTI International, an EPA contractor, will conduct a separate meeting on the “Nanomaterial Case Study Workshop Process: Identifying and Prioritizing Research for Multiwalled Carbon Nanotubes”' in the same location. EPA states that the workshop will be conducted independently by RTI International, with a set of invitee-only expert participants selected by RTI International, and will use a “structured decision science process” similar to the process used in previous workshops on nanoscale titanium dioxide in water treatment and in topical sunscreen and nanoscale silver in disinfectant spray. The RTI workshop will be open to public observers. Written comments on the draft document are due August 31, 2012. Registration for the public information exchange meeting will close on October 15, 2012. Space is limited, and reservations will be accepted on a first-come, first-served basis.

Registration Open for Workshop on Safe Nano Design

The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach.  The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop. Registration is open until July 13, 2012.

Recent Developments in NRDC's Case Concerning EPA's Conditional Registration of Nanosilver

On April 16, 2012, the Natural Resources Defense Council (NRDC) filed its brief in its lawsuit against the U.S. Environmental Protection Agency (EPA) concerning EPA’s conditional registration for HeiQ AGS-20, an end-use product containing nanosilver. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA, seeking to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles and prevent EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”

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NIOSH Releases Guidance on General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories

The National Institute for Occupational Safety and Health (NIOSH) has posted a document entitled General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories, which contains recommendations on engineering controls and safe practices for handling engineered nanomaterials in laboratories and some pilot scale operations. According to NIOSH, it designed the guidance “to be used in tandem with well-established practices and the laboratory’s chemical hygiene plan.” The guidance notes that experimental animal studies indicate that potentially adverse health effects may result from exposure to nanomaterials, and that the routes of exposure include inhalation, dermal exposure, and ingestion. The guidance concludes that “[t]he full range of occupational hygiene controls will be necessary to limit exposures to nanomaterials as a means to prevent adverse health outcomes in the research community.  Engineering and administrative controls can eliminate or minimize the amount of nanomaterials that will be present in workplace air or settled on surfaces.  Personal protective equipment can be used where other types of controls are not available or practical.”

Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account for advances in technology or the latest data, FACOSH asked its Emerging Issues Subcommittee to analyze federal agencies’ use of PELs. As part of its review, the Subcommittee identified other issues of interest, including dispersible engineered nanomaterials (DENM). A document entitled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies” includes the following text concerning DENMs:

  • OSHA defines nanomaterials as, “materials that have been purposefully manufactured, synthesized, or manipulated to have a size with at least one dimension in the range of approximately 1 to 100 nanometers and that exhibit unique properties determined by their size.”
  • Published scientific studies have indicated that at least some DENMs are biologically active, have produced toxicological reactions in the lungs of exposed experimental animals, and may readily penetrate intact human skin. While DENMs are truly an emerging issue and published results are not plentiful, scientists and federal agencies, such as NIOSH, continue to conduct research to understand fully the potential health effects of exposure.
  • Currently, both scientists and federal agencies agree that DENM toxicity depends heavily on the physical and chemical properties of the nanoparticles, such as particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity, and that these properties may differ substantially from those of the same material in macro-scale form.

U.S. Delegation May Present Nanotechnology Guidance at UN GHS Subcommittee Meeting

The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of Standards and Guidance, the paper would be presented under a work group examining the types of physical and chemical properties listed on safety data sheets (SDS). Landkrohn stated that a lack of data has impeded the work group’s ability to create a separate hazard class for nanomaterials.

EPA Releases Roadmap on Technology Innovation for Environmental and Economic Progress

On May 14, 2012, the U.S. Environmental Protection Agency (EPA) and the Department of Commerce announced efforts to launch an environmental technology initiative intended to help create American jobs in the growing environmental industry. EPA released a document entitled Technology Innovation for Environmental and Economic Progress: An EPA Roadmap, which states that EPA “will undertake policy, regulatory, financial, and voluntary actions, grounded in science, that will promote innovation along the entire continuum of technology development and deployment.” Specifically, according to the Roadmap, EPA “will advocate more cost-effective, innovative solutions that eliminate, or significantly reduce, adverse impacts to natural resources in a manner that promotes healthy, productive communities.” EPA states that its initial efforts will focus on four broad actions:

  1. Designing EPA policies, regulations, standards, permits, and procedures to leverage technology innovation;
  2. Catalyzing technology design, development, finance, commercialization, and adoption through partnerships with stakeholders;
  3. Stimulating cross-Agency consideration, development, commercialization, and adoption of breakthrough technologies; and
  4. Developing a new relationship with the investment community. EPA will take a number of steps to build relationships and improve communication.

NNI Agencies Announce New Nanotechnology Signature Initiative

On May 14, 2012, the agencies participating in the National Nanotechnology Initiative (NNI) announced the fourth Nanotechnology Signature Initiative, “Nanotechnology Knowledge Infrastructure:  Enabling National Leadership in Sustainable Design” (NKI). According to a press release issued by the National Nanotechnology Coordination Office (NNCO), this signature initiative will stimulate the development of models, simulation tools, and databases to enable the prediction of specific properties and characteristics of nanoscale materials.  This will then accelerate commercialization of nanotechnology innovations that maximize benefits to humans and the environment while minimizing risks. NKI identifies four areas that will benefit from focused attention:

  1. A diverse collaborative community of scientists, engineers, and technical staff to support research, development, and applications of nanotechnology to meet national challenges;
  2. An agile modeling network for multidisciplinary intellectual collaboration that effectively couples experimental basic research, modeling, and applications development;
  3. A sustainable cyber-toolbox to enable effective application of models and knowledge to nanomaterials design; and
  4. A robust digital nanotechnology data and information infrastructure to support effective data sharing, collaboration, and innovation across disciplines and applications.

CRS Publishes Nanotechnology Policy Primer

The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion.  Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead “may not be as large as it was for previous emerging technologies.” According to CRS, some research has raised concerns about the safety of nanoscale materials, and “[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation.”

EO on Promoting International Regulatory Cooperation Includes Emerging Technology

On May 1, 2012, President Barack Obama signed an Executive Order (EO) entitled “Promoting International Regulatory Cooperation,” which is intended to ensure that differing regulatory approaches taken by foreign governments do not unnecessarily limit the ability of American businesses to export and compete internationally. EO 13563, which Obama signed on January 18, 2011, states that the U.S. regulatory system must protect public health, welfare, safety, and the environment while promoting economic growth, innovation, competitiveness, and job creation. The May 1, 2012, EO calls for the Regulatory Working Group established by Executive Order 12866, and reaffirmed by EO 13563, to serve as a forum to discuss, coordinate, and develop a common understanding among agencies of U.S. government positions and priorities with respect to: international regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the federal government to support significant, cross-cutting international regulatory cooperation activities; and promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory approaches, as appropriate.

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Bill to Provide Tax Credits for Renewable Chemicals Introduced in the House

Representatives Bill Pascrell, Jr. (D-NJ) and Brian Bilbray (R-CA) introduced on April 26, 2012, the Qualifying Renewable Chemical Production Tax Credit Act of 2012 (H.R. 4953), which would amend the Internal Revenue Code to provide a credit for the production of renewable chemicals. The credit would be equal to $0.15 per pound of eligible content of renewable chemical produced during the taxable year. Eligible content would mean the biobased content percentage of the total mass of organic carbon in such chemical. Renewable chemical would mean any chemical produced in the U.S. from renewable biomass that is sold or used for the production of polymers, plastics, or formulated products, or as polymers, plastics, or formulated products, and is not sold or used for the production of any food, feed, or fuel. Chemicals would be excluded if the biobased content percentage is less than 25 percent; 10,000,000 pounds or more of such chemical was produced in 2000 from renewable biomass; the chemical is neither the product of nor reliant upon, biological conversion, thermal conversion, or a combination of biological and thermal conversion, of renewable biomass; or the chemical is composed of renewable chemicals that are eligible for a credit under the bill. The total number of credits under the program would be limited to $500,000,000, and no taxpayer may receive more than $25,000,000 in any taxable year. The program would end five years after the date of enactment of the bill. The bill was referred to the House Committee on Ways and Means.

PCAST Releases Fourth Assessment of the NNI

On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for fiscal year 2013 for 15 agencies with budgets dedicated to nanotechnology research and development (R&D).

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Obama Administration Releases National Bioeconomy Blueprint

On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of the Blueprint’s goals. These include initiatives to encourage federal procurement of an expanded range of biobased products; take better advantage of large pharmaceutical data sets to speed drug development; apply the latest genomics discoveries to identify quickly emerging microbial threats; and accelerate research on non-embryonic stem cells as possible treatments for blood-related and neurological diseases.

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Amended Federal Regulation Will Require Contractors to Report Purchase of Biobased Products

On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts.  According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products.  Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract.  DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.

FDA Releases Draft Guidance Documents on Nanomaterials

On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.” FDA states that the food draft guidance describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

  • Affect the identity of the food substance;
  • Affect the safety of the use of the food substance;
  • Affect the regulatory status of the use of the food substance; or
  • Warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

  • The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled; and
  • To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

FDA notes that both guidance documents encourage manufacturers to consult with it before taking their products to market. According to FDA, this consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status. Comments will be due 90 days after FDA announces their availability in the Federal Register.

 

USDA Amends Guidelines for Designating Biobased Products for Federal Procurement

In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packing and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.

B&C and Acta Will Hold an OSHA GHS Webinar

Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration's (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations' Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.

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EPA Promulgates SNUR for Infused Carbon Nanostructures

On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.

Dr. Robert Pohanka Appointed as Director of the NNCO

On March 20, 2012, the National Nanotechnology Coordination Office (NNCO) announced the appointment of Dr. Robert Pohanka as the Director of the NNCO. The NNCO provides technical and administrative support to the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee, serves as a central point of contact for federal nanotechnology research and development activities, and provides public outreach on behalf of the National Nanotechnology Initiative (NNI). Dr. Pohanka previously served as the Director of the Defense Venture Catalyst Initiative (DeVenCI), where he led and directed the strategy for finding private sector technologies, developed independently of the Department of Defense (DoD), and transitioned them to DoD Research, Development, and Acquisition. Prior to leading the DeVenCI program, Dr. Pohanka served as the Head of the Materials and Physical Sciences Department at the Office of Naval Research, where he was responsible for leading and directing the strategy for planning and executing a broad range of science and technology investments from basic physics and chemistry at the nanometer scale to engineering solutions for aircraft carriers.  During this period, Dr. Pohanka also served as Director for the Materials Science and Technology Division and as Director for the Ship, Hull, Mechanical, and Electrical Division.

NIOSH Sponsoring Workshop on Safe Nano Design

The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach.  The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop.

Presidential Memorandum Calls for Increased Federal Procurement of Biobased Products

President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from the United States Department of Agriculture (USDA), has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products.

EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency (EPA) announced in a February 13, 2012, Federal Register notice the availability of its Fall 2011 Regulatory Agenda. EPA’s Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in March 2012.
  • Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intends to publish an NPRM in March 2012.

 

EPA Administrator Jackson Will Tour UCLA Lab Receiving Funding for Nanotechnology

On February 17, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson will tour the Center for Environmental Implications of Nanotechnology (CEIN) at the University of California, Los Angeles. CEIN has been awarded a $24 million grant from EPA and the National Science Foundation, and is working to train the next generation of nano-scale scientists and engineers. According to EPA, CEIN is one of the nation’s only centers researching predictive toxicology of nanomaterials, and is developing a new approach to identify impacts and environmental hazards of nanomaterials before they become widely used in the environment. CEIN was established in September 2008 with the mission to ensure that nanotechnology is introduced in a responsible and environmentally compatible manner, thereby allowing the U.S. and international communities to leverage the benefits of nanotechnology for global economic and social benefit. CEIN is accomplishing this mission by developing a broad-based series of decision tools based on models of predictive toxicology and risk ranking premised on selected nanomaterial property-activity relationships that determine fate, transport, exposure, and biological injury mechanisms at cellular, tissue, organism, and population levels.

EPA Posts Summary of 2011 Nanomaterial Case Studies Workshop

On February 9, 2012, the U.S. Environmental Protection Agency (EPA) posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the National Center for Environmental Assessment (NCEA) to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials.  The basis of the workshop was the report Nanomaterial Case Study:  Nanoscale Silver in Disinfectant Spray.  According to the summary report, the outcomes of this and future workshops in the series -- prioritized information gaps and risk tradeoffs -- will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.

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EPA Extends Comment Period for Proposed SNURs

The U.S. Environmental Protection Agency (EPA) has announced that, in response to public comments, it will provide the public more time to comment on the December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states “the comment period is being reopened until 45 days following publication of the new notice (until approximately mid-March).”  Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW).  The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers.  These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the Occupational Safety and Health Administration (OSHA) standards as best practices.

This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.

 

International Symposium on Assessing the Economic Impact of Nanotechnology Will Be Held in March 2012

On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the “International Symposium on Assessing the Economic Impact of Nanotechnology.” The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. National Nanotechnology Initiative (NNI), organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically “the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts.” Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration will open February 10, 2012, and will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly.

NRDC Files Suit to Block EPA's Conditional Registration of Nanosilver

On January 26, 2012, the Natural Resources Defense Council (NRDC) filed a lawsuit in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Environmental Protection Agency (EPA) concerning its conditional registration of a pesticide product containing nanosilver as a new active ingredient for use as a preservative for textiles.  NRDC states that it seeks to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles. On December 1, 2011, EPA announced its conditional approval of HeiQ AGS-20.  As a condition of registration, EPA is requiring HeiQ to conduct a number of studies within four years, which EPA chose to allow time for protocol reviews prior to initiation of the studies, completion of the studies, and its review of the study results. NRDC states that it seeks to block EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”

NRC Publishes A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials

On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.

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Lynn L. Bergeson Will Participate in Webinar on the Greening of Consumer Products

Lynn L. Bergeson will participate in a February 7, 2012, Bloomberg BNA webinar entitled “The Greening of Consumer Products:  Legal, Regulatory, and Strategic Considerations.” Bloomberg BNA states that the webinar is intended to help users:

  • Identify the core concepts of green product development and the maturation of conventional environmental protection themes on which green product steward concepts rely;
  • Describe the diversity of legal and regulatory authorities, domestic and international, that are relevant to chemical, industrial, and consumer product manufacturers from a legal compliance perspective;
  • Analyze the role of private party standards and evolving concepts of product stewardship in product design and management;
  • Address the trends and emerging themes embedded in the commercial value chain that must be monitored to be competitive and successful;
  • Explore the challenges and value of green product marketing; and
  • Develop basic strategies for legal compliance and commercial success in green product marketing.

EPA OIG Concludes EPA Needs to Manage Nanomaterials More Effectively

On December 30, 2011, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs to Manage Nanomaterial Risks More Effectively. According to OIG, the purpose of its review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG states that it found “that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials.” According to OIG, although EPA has the statutory authority to regulate nanomaterials, it “currently lacks the environmental and human health exposure and toxicological data to do so effectively.” EPA proposed a policy, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), that would identify new pesticides being registered with nanoscale materials.  After “minimal industry participation” in EPA’s Nanoscale Materials Stewardship Program (NMSP), a voluntary data collection program, EPA has chosen to propose mandatory reporting rules for nanomaterials under FIFRA, and is developing proposed rules under the Toxic Substances Control Act (TSCA).

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Coalition Sues FDA Over Alleged Risks from Nanotechnology and Nanomaterials

A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011.  The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy. ICTA states that its lawsuit “demands” FDA respond to the coalition’s 2006 petition. The 2006 petition requested FDA take several actions, including requiring specific product labeling and health and safety testing; analyzing the environmental and health impacts of nanomaterials in products approved by FDA; and regulating sunscreens containing nanomaterials. In the December 21, 2011, complaint, the coalition states that, since 2006, “nanomaterial consumer products have continued to proliferate without oversight.” The coalition asks the court to order FDA to respond to its 2006 petition without further delay.

EPA Publishes Proposed SNURs for CNTs

The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.”  EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Comments are due January 27, 2012.

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NIOSH Science Blog Posts Entry Regarding Respiratory Protection for Workers Handling Engineered Nanoparticles

On December 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) posted an item on its Science Blog entitled “Respiratory Protection for Workers Handling Engineered Nanoparticles.” The purpose of the blog item is to provide an update on the science and rationale behind NIOSH’s recommendations for the use and selection of respirators against engineered nanoparticles. The article summarizes respirator performance research and respirator selection. Concerning next steps, NIOSH states that, while its research to date has been done in laboratory settings, using filtration test systems and manikins under aggressive test conditions, further research is needed in field settings and using human test subjects.  According to NIOSH, “[w]ell-designed studies on face seal leakage of nanoparticles, especially workplace protection factor (WPF) studies that validate assigned protection factor (APF) levels for respirators against nanoparticles will be important,” and such studies are already underway.

EPA Conditionally Registers Pesticide Product Containing Nanosilver As a New Active Ingredient

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles.  The final registration is not yet in the docket.  We believe, but cannot confirm, the final registration is largely similar to the draft proposed registration issued last year. As members of the nano community know well, this is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy.

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Congressional Nanotechnology Caucus Will Host Briefing on "Nanotech and Jobs"

On November 15, 2011, the Congressional Nanotechnology Caucus will host a briefing on the impact of nanotechnology on job creation. Topics to be addressed include the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers will include:

  • Robert D. “Skip” Rung, President and Executive Director, Oregon Nanoscience and Microtechnologies Institute;
  • Doug Jamison, Chief Executive Office, Harris & Harris; and
  • Hilary Flynn, Lux Research.

The briefing will begin at 3:00 p.m. in Room 385 of the Russell Senate Office Building. To RSVP, please contact Matt Bormet.

 

EPA Seeks Information Concerning Discharges of Nanosilver from Industrial Manufacturing

The U.S. Environmental Protection Agency (EPA) published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011.

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Nanotechnology Caucus Will Hold Briefing on Jobs and Nanotechnology

The Nanotechnology Caucus will hold a briefing on November 15, 2011, at 3:00 p.m. concerning jobs and nanotechnology. The briefing will focus on how targeted federal investments can lead to jobs down the road. More details will be forthcoming.

NCI Announces Public Private Industry Partnership Concerning Nanotechnology-Based Cancer Solutions

In an October 28, 2011, Federal Register notice, the National Cancer Institute’s (NCI) Alliance for Nanotechnology in Cancer announced the initiation of “Translation of Nanotechnology in Cancer” (TONIC), a public private industry partnership intended to promote translational research and development opportunities of nanotechnology-based cancer solutions. The notice states that an immediate consequence of this effort is the formation of a consortium involving government and pharmaceutical and biotechnology companies. The consortium will evaluate “promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients.” According to the notice, membership in the TONIC consortium will be limited to companies that: (1) have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval; and (2) are engaged in the development of nanotechnology-based formulations with application to imaging, diagnostics, and therapy.

EPA Posts Guidance to Facilitate Decisions for Sustainable Nanotechnology

The U.S. Environmental Protection Agency (EPA) posted a September 2011 guidance document entitled Guidance to Facilitate Decisions for Sustainable Nanotechnology, which was prepared by the National Risk Management Research Laboratory of the Office of Research and Development. EPA states that it developed the guidance to assist in assessing the sustainability of nanoproducts, and it is intended “to lay the groundwork for developing a decision-support framework through continual updates as research in this area progresses.”  The foundation of EPA’s approach, according to the guidance, is to consider existing standards and methods for environmental, economic, and social assessments using a life cycle perspective and offer guidance by relaying first-hand knowledge of applying assessment tools to nanotechnologies, whenever possible.  The guidance includes overviews of various assessment methodologies to help stakeholders make informed choices when selecting tools appropriate for their goals.  According to EPA, the key steps to be included in the evolving framework include:  characterizing a nanoproduct and identifying potential risks and impacts; identifying relevant stakeholders; defining the goal and scope of an assessment; assessing environmental, economic, and social impacts; evaluating sustainability criteria; developing and evaluating alternatives; and selecting and implementing a decision to support sustainability.  EPA will review and update the guidance as additional information becomes available.

NNI Releases 2011 EHS Research Strategy

On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human exposure assessment; (3) human health; (4) environment; (5) risk assessment and risk management methods; and (6) informatics and modeling. The Strategy also considers the ethical, legal, and societal implications (ELSI) of nanotechnology. NNI held a webinar on October 20, 2011, to announce the release of the Strategy, and Lynn L. Bergeson served on the panel. The Strategy, fact sheet, brochure, and webinar are available online.  NNI will post the panelist materials.

NNI Will Hold Webinar to Announce 2011 EHS Research Strategy

The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group, will serve as the moderator. Panelists will include:

  • Dr. Treye Thomas, NEHI Working Group Co-Chair;
  • Dr. Shaun Clancy, Evonik DeGussa Corporation;
  • Dr. Janet Carter, Occupational Safety and Health Administration (OSHA); and
  • Lynn L. Bergeson, Bergeson & Campbell, P.C.

The webinar will include a 20-minute question-and-answer segment following the presentations.

 

Nanotechnology Regulatory Science Act of 2011 Introduced in Senate

On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions.

Meeting of Nano Interests Held in Washington, D.C.

On September 22, 2011, during a meeting of nano interests in Washington, D.C., the following people spoke:

 

SNWG Releases Statement Concerning Nanosilver

The Silver Nanotechnology Working Group (SNWG) recently prepared a statement concerning nanosilver and its long history of safe and regulated use. SNWG notes the similarities between nanosilver and other antimicrobial silver materials available in the marketplace.  SNWG states that it “has interacted with the [U.S. Environmental Protection Agency (EPA)] in challenged exchanges on how best to regulate nanopesticides leading to a clear, reasonable, and responsible path for registration.” SNWG urges EPA and other agencies not to impose unwarranted barriers to emerging nanotechnology industries. Instead, SNWG asks that EPA and other agencies “nourish the benefits these can provide while screening finished products claiming pesticidal properties on a case by case basis for any environmental risk.” SNWG seeks “a sensible path forward for registering nanopesticides that is not burdensome for either the government or industry.”

FDA Regulatory Science Plan Addresses Nanomaterials and Nanotechnology

The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use these new scientific advances, FDA developed the Strategic Plan. According to the Strategic Plan, one of the ways FDA intends to support new approaches to improve product manufacturing and quality is by developing new analytical methods, including improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials in FDA-regulated products. The priority area entitled “Ensure FDA Readiness to Evaluate Innovative Emerging Technologies” includes the following statement regarding nanotechnology:

As medical products are being revolutionized by cutting-edge technologies like nanotechnology, it is more critical than ever for FDA to fully understand how nanomaterials are being used in these products.  FDA has established Nanotechnology Core Centers to provide critically needed equipment and technical staff to conduct product assessment and safety research in support of regulatory decision making.  These centers will facilitate investigations on the safety of products that use nanomaterials, establish methods to assess quality and effectiveness of products that use nanomaterials, and identify standards to be incorporated in the preclinical safety assessment of products that contain nanomaterials.

NANO Act Promotes Development and Responsible Stewardship of Nanotechnology

Representative Mike Honda (D-CA) re-introduced on August 1, 2011, the Nanotechnology Advancement and New Opportunities Act (NANO Act), which seeks to promote the development and responsible stewardship of nanotechnology in the U.S. According to Rep. Honda, the legislation is designed to maintain the U.S.’s leadership role in nanotechnology research by promoting the development and commercialization of the results. At the same time, the NANO Act addresses concerns raised about the potential health and safety risks associated with nanotechnology. It would require the National Nanotechnology Coordination Office (NNCO) to develop a report for Congress outlining a national nanotechnology development strategy after consulting with relevant federal agencies, including the U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health and Safety (NIEHS), and National Institute of Occupational Safety and Health (NIOSH) on nanotechnology’s potential risks. Through creation of research priorities for the federal government and industry that will help ensure development and responsible stewardship, the NANO Act looks to remove uncertainty about risk and future federal regulation -- resolving uncertainty as one of the major obstacles to commercialization. The NANO Act also includes provisions to create partnerships, raise awareness, and implement policies promoting nanotechnology, including public-private investment partnerships; grant programs supporting research and education; tax credits for investments, education, and training in nanotechnology; and directing the National Science Foundation (NSF) to partner with industry to encourage development of training to support nanotechnology manufacturing.

IATP Criticizes Development of Nanotechnology Products Without Regulatory Oversight

The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as “a small, but encouraging first step toward regulation.”

Comment Deadline Approaches for EPA's Policy on Nanoscale Materials in Pesticide Products

Comments on the U.S. Environmental Protection Agency’s (EPA) proposed policy on nanoscale materials in pesticide products are due August 17, 2011. EPA offers two approaches for obtaining the information EPA believes it needs concerning nanoscale materials in pesticide products. Under the first approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. EPA states that it would “prefer” to use this approach, despite industry’s concern over the use of the “adverse effects” reporting provision to obtain information. Under the second approach, EPA would use a data call-in (DCI) under FIFRA Section 3(c)(2)(B). EPA also proposes to apply an initial presumption that active and inert ingredients that are the nanoscale versions of non-nanoscale active and inert ingredients already present in registered pesticide products are potentially different from those conventionally sized counterparts. Registrants could rebut this initial presumption on a case-by-case basis.

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NNI Releases Reports from EHS Workshops

On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. According to NNI, the workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that “knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy.”

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EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency’s (EPA) July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011.
  • Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however.

EPA Extends Comment Period on Nanoscale Materials in Pesticide Products

The U.S. Environmental Protection Agency (EPA) is expected to publish a Federal Register notice on July 13, 2011, extending the comment period concerning possible approaches for obtaining information about what nanoscale materials are present in registered pesticide products until August 17, 2011. EPA states that it received requests from CropLife America, the Biocides Panel of the American Chemistry Council, the Chemical Producers & Distributors Association, and the International Center for Technology Assessment. The NanoBusiness Commercialization Association (NanoBCA) also requested a 90-day extension of the comment period, which was not granted.

Senate Subcommittee Will Hold Hearing on Nanotechnology Investment

Today Senator John D. Rockefeller IV (D-WV), Chair of the Senate Commerce Committee, announced that the Science and Space Subcommittee will hold a hearing on July 14, 2011, at 10:00 a.m. (EDT) on national nanotechnology investment. According to Rockefeller’s July 1, 2011, press release, as the Commerce Committee considers a reauthorization of the National Nanotechnology Initiative (NNI), the hearing will examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments.

Correction: "Nanotechnology 101" Will Be Held in Russell Senate Office Building

The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Russell Senate Office Building. Please note that the location has been corrected.

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Enviromental Protection Agency (EPA) published in the June 17, 2011, Federal Register a notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments are due July 18, 2011.

Nanotechnology Caucus Will Hold Lecture on June 22

The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Dirksen Senate Building. The agenda includes:

  • Opening Remarks: Vincent Caprio, Executive Director, NanoBusiness Commercialization Association;
  • Senator Ron Wyden (D-OR);
  • Sally Tinkle, Ph.D., Acting Director, National Nanotechnology Coordination Office, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology National Science and Technology Council;
  • Travis Earles, Ph.D. (Invited), Advanced Materials and Nanotechnology Initiatives, Lockheed Martin Corporation (formerly Assistant Director of Nanotechnology, White House Office of Science and Technology Policy);
  • Jim Hussey, CEO, NanoInk;
  • Frank Ignazzitto, Vice President, Government Business, QD Vision, Inc.;
  • Ajay Malshe (Invited), Co-Founder and Chief Technology Officer, NanoMech; and
  • Scott Livingston, Chairman and CEO, Livingston Securities.

To RSVP, please contact Vincent Caprio.

 

White House ETIPC Releases Policy Principles Concerning Regulation and Oversight of Nanotechnology and Nanomaterials

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that occur at the agency level. According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). OSTP states that the goals of all of these documents “are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.”

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register.

Congressional Nanotechnology Caucus Seeks Members

In a May 2011 letter, Representatives Ralph M. Hall (R-TX) and Eddie Bernice Johnson (D-TX) ask Congressional members to join the bipartisan and bicameral Congressional Nanotechnology Caucus. The Caucus was formed over ten years ago and is intended to inform legislators about nanotechnology issues, including the effect of nanotechnology on job creation and other economic benefits to the U.S. The National Nanotechnology Initiative (NNI), which was codified by Congress in 2003, coordinates the federal nanotechnology research and development of 25 federal agencies. Since enactment, the House has passed bills in the 110th (H.R. 5940) and 111th (H.R. 554 and H.R. 5116) Congresses to amend and reauthorize the NNI, but the Senate did not act in either Congress. Since fiscal year 2008, the NNI has received funding through annual appropriations bills. Nanotechnology stakeholders are urged to use this template letter to let their representatives and senators know of the importance of nanotechnology issues to their constituents and urge them to participate in the Caucus.

EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective June 6, 2011.

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ITA Seeks Comments Concerning Regulatory Cooperation between the U.S. and EU

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports.  Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to greater trade and investment between the U.S. and EU “are not tariffs or quotas, but rather differences in regulatory measures.” The ITA seeks public input to help identify divergences in regulatory measures in the transatlantic marketplace, “so that the U.S. Government can work cooperatively with the European Union to address them.” This notice offers an important opportunity to educate the ITA on subtle, yet significant trade impacts that are derivative of regulatory and/or competitive issues. ITA also seeks recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the U.S. and the EU. ITA asks that submitters be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. ITA states that it is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the U.S. and EU, “is a justifiable focus of enhanced regulatory cooperation.” Comments are due June 2, 2011.

House Subcommittee Holds Hearing on NNI Oversight

On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses included:

  • Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
  • Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
  • Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
  • Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
  • Mr. William Moffitt, President and Chief Executive Officer, Nanosphere, Inc.

The witnesses emphasized the need for Congress to reauthorize the National Nanotechnology Initiative (NNI) to ensure that the U.S. remains the global leader in nanotechnology. Other countries, such as Japan, China, and South Korea, have increased their investment in nanotechnology. Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his service as Director of the NNCO. Dr. Teague’s last day will be April 15, 2011.

 

NanoSafety Consortium Submits Proposed Testing Agreement to EPA

On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”

House Subcommittee Will Hold Hearing on Oversight of Nanotechnology

On April 14, 2011, the House Committee on Science, Space, and Technology Subcommittee on Research and Science Education will hold a hearing entitled “Nanotechnology:  Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses will include:

  • Dr. Clayton Teague, Director, National Nanotechnology Coordination Office;
  • Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
  • Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
  • Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
  • Mr. William Moffitt, President and CEO, Nanosphere, Inc.

 

NRC Includes Nanomaterials in Guidelines for Working with Hazardous Chemicals

On March 25, 2011, the National Research Council (NRC) announced the availability of a report entitled Prudent Practices in the Laboratory, which updates NRC’s guidelines on the safe use of hazardous chemicals. NRC last updated the guidelines in 1995, and the new edition includes new topics, including the handling of nanomaterials. The update sets out general guidelines for the management of nanomaterials. NRC developed the guidelines “from accepted chemical hygiene protocols for handling compounds of unknown toxicity.” The guidelines cover topics such as planning and assessing the hazards of nanomaterial work, information on grading the risk of working with different types of nanomaterial, and suggestions on ways to make sure the working environment is designed to protect laboratory personnel from exposure to nanoparticles.

Obama Administration Sets Forth Principles for Regulation and Oversight of Emerging Technologies

March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration’s principles for regulation and oversight of emerging technologies, including nanotechnology. The ETIPC Co-Chairs include John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy (OSTP); Cass R. Sunstein, Administrator, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB); and Islam A. Siddiqui, Chief Agricultural Negotiator, U.S. Trade Representative.

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NIOSH Requests Information to Update Its Nanotechnology Strategic Plan

On March 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) announced that it seeks comment on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. According to the Federal Register notice, NIOSH would like to build on the accomplishments of ongoing research to develop strategic research goals and objectives through 2015. Comments are due April 15, 2011.

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EPA Announces Nanotechnology Research Awards

On February 17, 2011, the U.S. Environmental Protection Agency (EPA) announced that it awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA states that, in collaboration with the United Kingdom's (UK) Natural Environment Research Council, it is leading this scientific research effort to understand better the potential risks to people’s health and the environment. The grants EPA awarded are intended to help researchers determine whether certain nanomaterials can leach out of products such as paints, plastics, and fabrics when they are used or disposed of and whether they could become toxic to people and the environment.  According to EPA, the U.S. Consumer Product  Safety Commission (CPSC) has also contributed $500,000 through a new research partnership between the two agencies.  Grant awards were made to three consortia consisting of researchers from the U.S. and the UK Each U.S. team of researchers received $2 million from EPA and CPSC, for a total of $6 million. Each UK team will also receive $2 million from the UK agencies, resulting in a grand total of $12 million to conduct the research.

President Obama Requests Additional Funding for NNI

Under the fiscal year (FY) 2012 budget request submitted by President Obama to Congress on February 14, 2011, funding for the National Nanotechnology Initiative (NNI) would increase by $201 million, to $2.1 billion. According to an Office of Science and Technology Policy (OSTP) fact sheet, agencies participating in the NNI have developed three signature initiatives in areas ready for advances through close and targeted program-level interagency collaboration: Nanoelectronics for 2020 and Beyond; Sustainable Manufacturing: Creating the Industries of the Future; and Nanotechnology for Solar Energy Collection and Conversion. Participating agencies will continue to support nanoscience and nanotechnology development through investigator-led research; multidisciplinary centers of excellence; education and training; and infrastructure and standards development. In addition, OSTP states, agencies will still maintain a focus on the responsible development of nanotechnology, with attention to potential human and environmental health impacts, as well as ethical, legal, and other societal issues. At a February 14, 2011, news briefing for reporters, OSTP Director John Holdren said budget reductions proposed by Republicans in Congress could be damaging if applied to federal research funding.

NNI Releases 2011 Strategic Plan

This week the National Nanotechnology Initiative (NNI) and the White House Office of Science and Technology Policy (OSTP) released the 2011 NNI Strategic Plan. According to NNI, the Plan retains the “overall vision,” four goals, and eight program component areas outlined in the previous edition of the Plan, which was released in December 2007. For the first time, the Plan includes specific objectives under each goal, outlining concrete steps that NNI member agencies will take toward collectively achieving the NNI vision and goals.  NNI member agencies will use the Plan to guide the coordination of their research, training programs, and resources. NNI states that the Plan incorporates a broad rage of stakeholder input obtained through NNI-sponsored workshops, a formal Request for Information published in the Federal Register, and the NNI Strategy Portal website.

Environmental Science & Technology Article Reviews History of Nanosilver and Policy Implications

On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History:  Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954.  The article states that 53 percent of the U.S. Environmental Protection Agency (EPA)-registered biocidal silver products likely contain nanosilver and most of the applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles.  The authors state: “The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term ‘nano.’”

EPA, EC, and OECD Officials Publish Article in Nature Nanotechnology

Nature Nanotechnology has posted a pre-publication version of an article entitled “Science Policy Considerations for Responsible Nanotechnology Decisions,” which is authored by regulatory officials of the U.S. Environmental Protection Agency (EPA), European Commission (EC), and the Organization for Economic Cooperation and Development (OECD). The authors offer their perspectives on possible approaches to maximizing the environmental benefits of nanotechnology and products that contain nanomaterials while minimizing the negative impacts. For the path forward, the regulators recommend that researchers and risk managers work together to develop approaches to limit exposure and identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. According to the regulators, industry “should contribute significantly to this work because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.” In recognition of the possibility to avoid risk before nanomaterials enter the environment, the regulators “support the application of a life cycle perspective and encourage the development of safer-by-design methods and approaches such as green chemistry for sustainable production of chemicals in ways that reduce environmental impact.”

America COMPETES Reauthorization Act Presented to President for Signature

On December 28, 2010, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010 (H.R. 5116) was presented to President Obama for signature. The bill, as unanimously passed by the Senate on December 17, 2010, does not include reauthorization of the National Nanotechnology Initiative (NNI). The House passed similar legislation on May 28, 2010, by a vote of 262-150. The House bill would have reauthorized the NNI. The Senate version, on the other hand, contains no reference to nanotechnology.

EPA Regulatory Agenda Includes Several Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
  • Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials.  According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
  • Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2).  The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.

EPA Claims Company Made Illegal Public Health Claims For Nano Silver Product

On December 15, 2010, the U.S. Environmental Protection Agency (EPA) announced that it fined Kinetic Solutions Inc., doing business as Rabbit Air, $82,400 for allegedly selling unregistered and misbranded pesticides and making unproven claims about their effectiveness. According to EPA, Kinetic Solutions Inc. made illegal public health claims for its air purifier branded “Nano Silver Pre Filter” and the filter’s ability to control over 650 types of bacteria, a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In addition, its air purifiers did not list a valid EPA Establishment Number on the packaging, a federal requirement that helps regulators keep track of where pesticides and devices are produced. EPA states that the violations were discovered through an online search and subsequent inspection by the California Department of Pesticide Regulation (CDPR). According to Kinetic Solutions Inc., the Nano Silver Pre Filter incorporates a substance called “nano silver” or “silver nano ions,” a substance or mixture of substances intended to prevent, destroy, repel, or mitigate bacteria and mold. Products that kill or repel bacteria or germs are considered pesticides, and must be registered with the EPA prior to distribution or sale. According to EPA, the Nano Silver Pre Filter is a pesticide and was not registered as such as required by federal law.

EPA OIG Will Focus on Nanomaterials in FY 2011

The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) posted its Fiscal Year 2011 Annual Plan, which identifies mandated and selected assignment topics continuing from fiscal year (FY) 2010 and scheduled to be started during FY 2011. According to the Annual Plan, carryover assignments from FY 2010 include EPA’s approach to nanomaterials. The Annual Plan includes no additional information regarding the assignment, which is not included in its FY 2010 Annual Plan.

EPA Will Hold Public Information Exchange on Nanomaterial Case Studies and Workshop on Nanoscale Silver

The U.S. Environmental Protection Agency (EPA) announced in a December 13, 2010, Federal Register notice that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials. Registration is required to attend the meeting, and EPA states that space is limited. Comments may be submitted in writing or made orally during the meeting. Written comments are due December 28, 2010. EPA intends to consider all such comments in evaluating whether or how to develop further case studies and workshops on nanomaterials. To date, EPA has published two Nanomaterial Case Studies -- Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen (Final), and Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft).

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Draft NNI EHS Research Strategy Available for Comment

The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy (Strategy). The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision.  It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision.  It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods) and evaluates the state of the science for each of these topics.  The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area.  The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.

NIOSH Seeks Comment on Draft CIB Concerning Occupational Exposure to Carbon Nanotubes and Nanofibers

The National Institute for Occupational Safety and Health (NIOSH) released a draft Current Intelligence Bulletin (CIB) entitled Occupational Exposure to Carbon Nanotubes and Nanofibers, which recommends that, until results from research studies can fully elucidate the physicochemical properties of carbon nanotubes (CNT) and carbon nanofibers (CNF) that define their inhalation toxicity, employers should take steps to minimize CNT and CNF exposures of all workers and implement an occupational health surveillance program that includes elements of hazard and medical surveillance.  The draft CIB includes more specific recommendations for employers and workers to minimize potential health risks associated with exposure to CNTs and CNFs. NIOSH will hold a public meeting on the draft CIB on February 3, 2011, in Cincinnati, Ohio. According to NIOSH, during the meeting, it will place special emphasis on:

  • Whether the hazard identification, risk estimation, and discussion of health effects for CNTs and CNFs are a reasonable reflection of the current understanding of the evidence in the scientific literature;
  • Workplaces and occupations where exposure to CNTs and CNFs occur;
  • Current strategies for controlling occupational exposure to CNTs and CNFs (e.g., engineering controls, work practices, personal protective equipment);
  • Current exposure measurement methods and challenges in measuring workplace exposures to CNTs and CNFs; and
  • Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

Notification of intent to intend the meeting is due to NIOSH on January 28, 2011. Comments on the draft CIB are due February 18, 2011.

 

NanoBusiness Alliance Interviews Lynn L. Bergeson

NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency’s (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of nanoscale materials; and the EPA’s Office of Pesticide Programs development of a policy under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will apply to nanopesticides. The NanoBusiness Alliance is an industry association founded to advance the emerging business of nanotechnology and microsystems for corporations, start-ups, researchers, universities, investors, and a host of other key stakeholders.  The Alliance’s mission is to create a collective voice for the emerging small-tech industry and develop a range of initiatives to support and strengthen the nanotechnology business community, through public policy efforts, events, research, and the creation of partnerships.

ICTA Petitions EPA to Investigate Nano-Copper Pesticides

On November 18, 2010, the International Center for Technology Assessment (ICTA) petitioned the U.S. Environmental Protection Agency (EPA) to investigate nano-copper pesticides. ICTA, which petitioned EPA in May 2008 to regulate nano-silver and other nano-pesticide products, singles out three registrations obtained by Osmose, Inc. for “micronized” copper carbonate. According to ICTA, “it does not appear that Osmose advised EPA when it applied for these three registrations that any of these products included intentionally produced nanoscale material, but, as explained below, it clearly knew this was the case.” The Office of Pesticide Programs (OPP) has stated that it intends to treat any pesticide products containing nanoscale materials as new products, and ICTA notes that “registrants were also on notice well before 2008 that OPP wanted any applicant requesting registration of a pesticide product containing a nanoscale active ingredient or inert ingredient to disclose that fact during the application process.” ICTA claims that Osmose used the formulator’s exemption to register its products, although it intentionally modified the structure of the purchased active ingredient to create nanoscale particles, which it neglected to tell EPA. ICTA requests that EPA “immediately investigate” the three products, and revoke the registrations, if EPA determines that Osmose registered the products on the basis of an invalid claim. ICTA also requests that EPA “thoroughly investigate other possible nanoscale copper products, which should include but not be limited to copper-based wood treatment products currently available on the market, as similar actions under FIFRA may be necessary.”

USDA ORACBA Risk Forum Discusses Moving Beyond Nanogeneralities

On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on “Moving Beyond Nanogeneralities -- Providing Focus to Nanopolicy Progress.” Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere, International Food Policy Research Institute. The speakers propose that the issues concerning nanotechnology and nanomaterials are so varied, broad, and controversial that they impeded the development of beneficial uses, even where the risks are negligible. The speakers suggest that, early in any discussion or in any risk assessment of nanomaterial uses, the problem selection and problem formulation are critical. If the selection and formulation are done well, regulators and stakeholders can make progress in risk assessment policy and risk management of specific uses of nanomaterials.

EPA Submits Proposed TSCA Section 8(a) Reporting Rule for Nanoscale Materials to OMB for Review

On November 22, 2010, the U.S. Environmental Protection Agency (EPA) submitted a proposed Toxic Substances Control Act (TSCA) Section 8(a) reporting rule to the Office of Management and Budget (OMB) for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require persons who manufacture nanoscale materials notify EPA of certain information including available use, production volume, methods of manufacture and processing, exposure and release information, and available toxicity data pertinent to existing nanoscale materials. EPA states that the proposed reporting of these activities will provide it with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

EPA Posts Interim Technical Guidance for Assessing Exposure to Nanomaterials

The U.S. Environmental Protection Agency (EPA) has posted a June 17, 2010, document entitled “Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials.” According to the Interim Guidance, EPA prepared it “to serve as a guide when developing screening level exposure and environmental fate and transport assessments for nanomaterials,” such as those submitted under the Toxic Substances Control Act (TSCA) New Chemicals Program.  The Interim Guidance is applicable for neat nanomaterials (i.e., powdered or particulate forms), as opposed to nanoscale particles embedded within composites.  At this time, according to the Interim Guidance, EPA does not have models or methods capable of predicting the fate of, or exposure to, nanoscale particulates in the environment.  This fact, combined with the limited data for nanomaterials, means that there is uncertainty in estimating removal efficiencies, degradation half-lives, partitioning, and transport of nanomaterials.  To address the uncertainty, EPA recommends using a conservative bounding “what if” scenario, which assumes that nanomaterials are not removed during wastewater treatment or incineration (i.e., 0 percent removal efficiency), are persistent (i.e., P3), are highly bioaccumulative (i.e., B3), and are highly mobile in groundwater unless measured data is available that proves otherwise.  EPA describes this conservative approach as “prudent at this time given the limited available data and lack of historical knowledge regarding the behavior of nanomaterials in the environment.”

NOSB Recommends Prohibiting Engineered Nanomaterials from Certified Organic Products

At the U.S. Department of Agriculture’s (USDA) National Organic Standards Board’s (NOSB) October 25-28, 2010, meeting, NOSB unanimously recommended that the USDA National Organic Program (NOP) prohibit engineered nanomaterials from certified organic products. NOSB considered a September 2, 2010, guidance document prepared by its Materials Committee concerning engineered nanomaterials in organic production, processing, and packaging. According to the Materials Committee, public comment “overwhelmingly agrees that nanotechnology in organic production and processing be prohibited at this time.” The Materials Committee notes, however, that “there is considerable debate and disagreement on what exactly nanotechnology is and what products of nanotechnology should be prohibited.”. The Materials Committee requested that the NOP allow NOSB to call for a symposium “to discuss the issues related to the human-engineered portion of this science,” which “would help to clarify these confusing issues, and serve to educate both the Board and the NOP on this topic.”

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NNI Draft Strategic Plan Available for Comment

The National Nanotechnology Initiative (NNI) draft Strategic Plan is available for comment until November 30, 2010. The Strategic Plan is the framework that underpins the work of the 25 NNI member agencies.  The Strategic Plan is intended to ensure that advances in nanotechnology research and development (R&D) and their applications to agency missions and the broader national interest continue. The purpose of the Strategic Plan is to facilitate achievement of the NNI vision by providing guidance for agency leaders, program managers, and the research community regarding planning and implementation of nanotechnology R&D investments and activities.

NIOSH Posts Impact Sheet Stating that Breathing Nanoparticles May Result in Damaging Health Effects

The National Institute for Occupational Safety and Health (NIOSH) has posted an October 2010 Impact Sheet entitled “NIOSH Research Methods Demonstrate that Breathing Nanoparticles May Result in Damaging Health Effects,” which reports the results of recently published research concerning the health effects of inhaling single-walled carbon nanotubes. According to the Impact Sheet, NIOSH scientists invented a way to suspend nanotubes in air, thus allowing for control of the concentration of particles, unlike previous studies, which dosed the mice through aspiration. NIOSH scientists placed the mice into a controlled environment where they would breathe the air containing the particles, and studied the effects of exposure after one, seven, and 28 days.  The Impact Sheet states that, although the effects were similar, the new results “demonstrated that carbon nanotubes were more potent when inhaled than when aspirated.”  According to NIOSH, “this research has shown early indications of serious health outcomes that may have longer term effects such as cancer, and therefore, ongoing research is important to more clearly understand the implications of exposure to carbon nanotubes.  This study and continued NIOSH research could soon help the development of occupational safety and health recommendations for carbon nanotubes that will protect the health of nanotechnology workers.”

NIH and FDA Will Fund Research on Nanoparticles

In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle:  Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.”

OPP Considering Labeling of Nanopesticides

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two previously unreported OPP regulatory activities. First, according to McLain, OPP intends to require that nanoproducts be labeled in the same way as other pesticide products. Ingredients would be listed as “nano-X,” and OPP would evaluate the claims on a case-by-case basis. Second, OPP apparently is considering issuing data call-ins to obtain information EPA may need to evaluate the registerability under FIFRA of nanoscale materials. Using its FIFRA data call-in authority is, of course, an option several industry groups have been urging in lieu of repurposing FIFRA Section 6(a)(2).

Plainly, OPP’s cryptic reference to FIFRA “nano labeling” requires far more explanation and some observers may find it disturbing. The presentation’s statement that “Nano-Products will be labeled the [sic] in the same way as other pesticide products” is, of course, ambiguous at best. Such an approach would lead to a number of important questions: What exactly is subject to labeling? Will the presence of any nanoscale material in a formulation trigger a nano label? How will confidentiality issues be addressed? The presentation raises other thorny issues, many of which appear to not have been publicly discussed.

NIOSH Announces Formal Partnership on Nanotechnology Research and Guidance

The National Institute for Occupational Safety and Health (NIOSH) announced on September 22, 2010, that it entered into a formal partnership with the National Science Foundation (NSF) Center for High-Rate Nanomanufacturing (CHN) that is intended to provide companies with practical research and guidance to promote occupational health and safety in nanotechnology. Through the new partnership, University of Massachusetts (UMass) Lowell, CHN, and NIOSH will “address safety issues so that discoveries can quickly turn into commercially available products.” NIOSH and UMass Lowell research teams will evaluate potential exposure to nanomaterials and recommend solutions at small- to medium-sized companies and research laboratories. NIOSH will publish best practices developed by UMass Lowell and CHN. UMass Lowell will host and NIOSH will co-sponsor the 5th International Symposium on Nanotechnology, Occupational, and Environmental Health on August 9-12, 2011, in Boston.

CDTSC and EPA Hold Public Workshop on State and Federal Nanomaterial Activities

On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA’s efforts related to CNTs. The candidate chemicals for CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions.

 

EPA Issues Final SNURs for Carbon Nanotubes

On September 17, 2010, the U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) for two chemical substances that were the subject of premanufacture notices (PMN). The two chemical substances are identified generically as multi-walled carbon nanotubes (MWCNT) (PMN P08177) and single-walled carbon nanotubes (SWCNT) (PMN P08328). Persons who intend to manufacture, import, or process either of these substances for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the SNURs are necessary because these chemical substances may be hazardous to human health and the environment. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule is effective October 18, 2010.

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CDTSC Reschedules Public Workshop on State and Federal Nanomaterial Activities

The California Department of Toxic Substances Control (CDTSC) has rescheduled its workshop on state and federal nanomaterial activities for September 22, 2010. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. The workshop is open to the public.

FDA Will Hold Public Workshop on Medical Devices and Nanotechnology

On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions. The workshop is open to the public, and the deadline for registration is September 15, 2010. Space availability permitting, on-site registration will be available on a first come first serve basis. Comments must be submitted by September 15, 2010, to be considered for the workshop discussion. All other comments are due October 22, 2010.

EPA And CDTSC Drafting MOU To Share Data

According to the California Department of Toxic Substances Control's (CDTSC) website, it is drafting a memorandum of understanding (MOU) with the U.S. Environmental Protection Agency (EPA) to facilitate information exchange, collaboration, and outline a working partnership on emerging chemicals, green chemistry, and materials management. Under the new MOU, EPA and CDTSC will:

1.  Establish chemical specific teams for priority chemicals of mutual interest;

     a.  Teams will develop specific goals, points of coordination, and focus areas.

2.  Share information on analytical methods, fate and transport, bioconcentration, toxicity, exposure, risk assessment, and similar topics relative to emerging chemicals;

3.  Share literature reviews, databases;

4.  Collaborate on identifying and prioritizing information and data gaps;

5.  Keep each other informed on workshops, symposia, web events, etc.;

6.  Share value-chain information (to the extent allowed by law):

     a.  Producers, importers;

     b.  Production volumes; and

     c.  Applications/intermediates/products.

7.  Explore ways to exchange information while protecting CBI; and

8.  Collaborate on research needs and funding. 

EPA Proposes Conditional Registration of Nanosilver Pesticide Product

On August 13, 2010, the U.S. Environmental Protection Agency (EPA) announced that it is proposing to register conditionally a pesticide product containing nanosilver as a new active ingredient for a period of four years. According to EPA, the antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product that is proposed for use as a preservative for textiles. As a condition of registration, EPA is proposing to require additional product chemistry, toxicology, exposure, and environmental data. EPA states that it will “evaluate these data as they are submitted during the period of the conditional registration to confirm the product will not cause unreasonable adverse effects to human health and the environment.” Under EPA’s new policy concerning public involvement in registration decisions, EPA is providing a 30-day opportunity for public comments on the proposed registration. Public comments will be accepted until September 11, 2010.

EPA Announces Availability of Nanomaterial Case Study for Nanoscale Silver in Disinfectant Spray

On August 13, 2010, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft document entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA intends to serve as part of a process to help identify and prioritize scientific and technical information that could be used in conducting comprehensive environmental assessments of selected nanomaterials. EPA states that the Case Study does not attempt to draw conclusions regarding potential environmental risks of nanoscale silver, but instead aims to identify what is known and unknown about nanoscale silver to support EPA’s future assessment efforts. EPA states that it is releasing the draft Case Study “solely for the purpose of pre-dissemination review under applicable information quality guidelines.” The draft Case Study “has not been formally disseminated by EPA,” and it “does not represent and should not be construed to represent any Agency policy or determination.” When preparing the final Case Study, EPA intends to consider any public comments received by September 27, 2010.

CDTSC Postpones Public Workshop on State and Federal Nanomaterial Activities

Due to California’s budget issues and resulting furlough for civil service employees, the California Department of Toxic Substances Control (CDTSC) has postponed its August 13, 2010, workshop on state and federal nanomaterial activities. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. CDTSC states that it will reschedule the workshop at a later date.

OMB Receives EPA Notice Concerning Pesticide Products Containing Nanoscale Materials

According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) regulations, that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product. On June 25, 2010, the U.S. Government Accountability Office (GAO) issued a report entitled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, which recommends, among other actions, that EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new. EPA responded that it agreed with GAO’s recommendation and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

NIEHS Begins Intramural NanoHealth Signature Program

 

The August 2010 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with the National Toxicology Program (NTP), labs in the NIEHS intramural program, and the U.S. Environmental Protection Agency (EPA) as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere.  The team will study the effects in cells tissue, animals, and human subjects. The research team will test the hypothesis that selected engineered nanomaterials induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:

  • Exposing human bronchial epithelia and alveolar macrophages -- native lungs cells donated by healthy volunteers -- to ENMs ex vivo to evaluate inflammation and cell toxicity;
  • Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
  • Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.

 

EPA Reopens Comment Period for Multi-Walled Carbon Nanotube SNUR

On July 28, 2010, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing that it is reopening the comment period for its February 3, 2010, proposed significant new use rule (SNUR) for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199).  According to the July 28, 2010, notice, a commenter noted that neither the proposed rule nor the docket contained specific carbon nanotube data or data supporting the nature of the dermal concern for carbon nanotubes. The commenter stated it was not possible to assess EPA’s evaluation and determination based on the current record. Another commenter noted that EPA’s subsequent reviews and concerns for carbon nanotubes have expanded, and that the proposed SNUR should reflect those updated data. EPA states that it has added additional explanation and references of its health and environmental concerns for carbon nanotubes to the public docket for consideration, and is reopening the comment period for 30 days. Comments are due August 27, 2010.

Safe Cosmetics Act Would Allow FDA to Require Labeling of Nanomaterials

On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would:

  1. Monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and
  2. Consider scale-specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.” The bill would also allow the FDA Secretary to require that:

  1. Minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than one dimension is 100 nanometers (nm) or smaller for not less than one percent of the ingredient particles in the cosmetic; and
  2. Other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

The bill was referred to the Committee on Energy and Commerce, as well as the Committee on Education and Labor.

 

OSTP Issues Request for Information on the NNI

On July 6, 2010, the White House Office of Science and Technology Policy (OSTP) published a Request for Information (RFI) on the National Nanotechnology Initiative (NNI). According to OSTP, the purpose of the RFI is to enhance the value of the NNI “by reaching out to the nanotechnology stakeholder community for specific input for the next NNI Strategic Plan to be published in December 2010.  The RFI refers to the NNI goals identified from the 2007 Strategic Plan as a starting point for questions covering themes such as research priorities, investment, coordination, partnerships, evaluation, and policy. OSTP states that it is interested in responses that address one or more of its questions, which are broadly categorized under goals and objectives; research priorities; investment; coordination and partnerships; evaluation; and policy, as related to the NNI.  Responses are due August 15, 2010.  OSTP states that submissions prior to the July 13-14, 2010, NNI Strategic Plan Stakeholder Workshop “may also inform dialogues” at the Workshop. OSTP intends to hold an “online public comment eventJuly 13-August 15, 2010, to solicit input on the NNI Strategic Plan.

GAO Report States That EPA Faces Challenges in Regulating Risk of Nanomaterials

According to a report released on June 25, 2010, by the U.S. Government Accountability Office (GAO), the U.S. Environmental Protection Agency (EPA) faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because EPA lacks the technology to monitor and characterize these materials, or the statutes include volume-based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials. In preparing its report, GAO identified examples of current and potential uses of nanomaterials; determined what is known about the potential human health and environmental risks from nanomaterials; assessed actions EPA has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so; and identified approaches that other selected national authorities and actions U.S. states have taken to address the potential risks associated with nanomaterials. GAO analyzed selected laws and regulations, reviewed information on EPA’s Nanoscale Materials Stewardship Program, and consulted with EPA officials and legal experts to obtain their perspectives on EPA’s authorities to regulate nanomaterials.

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PCAST Seeks Comment on Technology's Golden Triangle

The President’s Council of Advisors on Science and Technology (PCAST) seeks comment from stakeholders on how the federal government can best use its resources so three of the “newest and most promising technologies,” including nanotechnology, “provide the greatest economic benefits to society.” The President’s Innovation and Technology Advisory Committee (PITAC), which is part of PCAST, is soliciting information and ideas from stakeholders -- including the research community, the private sector, universities, national laboratories, state and local governments, foundations, and nonprofit organizations -- regarding the “Golden Triangle.” Each side of the Golden Triangle represents one of three areas of research that together are transforming the technology landscape today: information technology, biotechnology, and nanotechnology.

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House Bill Would Reauthorize NNI

On May 28, 2010, the House passed, by a vote of 262-150, the America COMPETES Reauthorization Act of 2010 (H.R. 5116), which would authorize funding for the National Nanotechnology Initiative (NNI), as well as the National Science Foundation (NSF), National Institute of Standards and Technology (NIST), and Department of Energy (DOE) Office of Science activities. The bill includes language from H.R. 554, the NNI Amendments Act of 2009, which the House passed in February 2009. H.R. 5116 would require NNI to work toward developing “standards related to methods and procedures for detecting, measuring, monitoring, sampling, and testing engineered nanoscale materials for environmental, health, and safety impacts.” The bill would fund research on “green nanotechnology” by creating research centers that would focus on methods and approaches to develop environmentally benign nanoscale products and nanoscale manufacturing processes; foster the transfer of the results of such research to industry; and provide for the education of scientists and engineers through interdisciplinary studies in the principles and techniques for the design and development of environmentally benign nanoscale products and processes. The bill would create a position, within the Office of Science and Technology Policy (OSTP), for a Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would ensure that a research plan for the environmental, health, and safety (EHS) research activities is developed, updated, and implemented.

FDA Posts MAPP on Reporting Format for Nanotechnology-Related Information

On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions.  According to the MAPP, this information “will be entered into a nanotechnology database under construction and ultimately be used to develop policy regarding these products.” Information to be collected includes whether the application contains nanomaterials; what type of nanomaterial is included in the product; whether the nanomaterial is a reformulation of a previously approved product; whether the nanomaterial is part of the drug substance or the drug product; whether the particle size was described in the application and what the reported particle size is; whether the techniques used to assess particle size are thoroughly described with respect to their adequacy; whether the nanomaterial is soluble or insoluble in an aqueous environment; and what other properties of the nanomaterial were measured and reported in the application, and how those properties were measured. The MAPP was effective June 3, 2010.

SNWG Concerned About EPA's Regulation of Nanoscale Pesticide Products

In a May 25, 2010, letter to the U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), the Silver Nanotechnology Working Group (SNWG) expressed its concern regarding the pending Office of Pesticide Programs (OPP) interpretation concerning the regulation of nanoscale pesticide products. In its letter, SNWG states that the new interpretation, which “includes an unsupported and arbitrary definition of ‘nanomaterial’ and ignores decades of historical safety data,” would be “a major and damaging change in policy.” SNWG lists the following concerns:

  • Institutionalize an arbitrary definition of nanotechnology;
  • Contradict the statutory language and purpose of Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA);
  • Improperly characterize nanosilver as a ‘new’ pesticide;
  • Stifle innovation without any benefit to human health and/or the environment; and
  • Promote a negative public perception regarding nanotechnology as a whole.

SNWG urges EPA to consider its concerns prior to releasing the pending policy.

 

PPDC Discusses Nanotechnology and Pesticides

On April 29, 2010, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP’s recent consultation with EPA’s Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take.

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TSCA Reform Bills Address Substance Characteristics

On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010 (S.3209), which is intended to address the “core failings” of the Toxic Substances Control Act (TSCA). Also on April 15, 2010, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, released a discussion draft of their TSCA reform legislation, the Toxics Chemicals Safety Act of 2010. While the bills do not explicitly address nanomaterials, both bills consider “characteristics” of chemical substances. The House bill defines “substance characteristic” as “with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including (A) chemical structure and composition; (B) size or size distribution; (C) shape; (D) surface structure; (E) reactivity; and (F) other characteristics and properties that may bear on toxicological properties.” The Senate bill defines “special substance characteristics” as such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider: (A) size or size distribution; (B) shape and surface structure; (C) reactivity; and (D) “any other properties that may significantly affect the risks posed.”  How these, and a wide range of other measures in the bills, play out will have a significant impact on new chemicals generally, and nanoscale chemical substances in particular.

NIOSH Announces Publication Of Research Paper On Biodegradation Of Carbon Nanotubes

The National Institute for Occupational Safety and Health (NIOSH) announced that laboratory studies, reported in a paper posted online by the journal Nature Nanotechnology on April 4, 2010, discovered that carbon nanotubes were biodegraded by an enzyme found in white blood cells, neutrophils.  According to NIOSH, the researchers demonstrated that, unlike carbon nanotubes that were not biodegraded in this way, the biodegraded nanotubes did not cause inflammation in the lungs of mice.  NIOSH states that the results are important for scientists in evaluating the biological effects of carbon nanotubes, particularly their fate and role in inflammation, and that more research would be needed for determining the applicability of the findings in assessing potential risk in occupational exposures.

EPA Awards $2 Million to Small Businesses to Develop Innovative Technologies

On April 5, 2010, the U.S. Environmental Protection Agency (EPA) announced that its Small Business Innovation Research (SBIR) Program awarded $2.38 million to 34 small businesses to develop “innovative, sustainable technologies to protect human health and the environment.” The awards focus on the following environmental research areas: increasing the efficiency of green building materials and systems; manufacturing innovation; prevention, monitoring, and control using nanotechnology; reducing greenhouse gases; new treatment technologies for drinking water; improving water infrastructure; reducing emissions from small air pollution sources and vehicles and biofuels production facilities; new approaches for cleaning up and monitoring hazardous waste sites; and new tools for homeland security systems. Examples of new technologies include NEI Corporation, which will develop a “self-healing nanocomposite to protect drinking water pipes from corrosion.” EPA is also requesting applications for the development of new environmental technologies. Applications are due May 11, 2010.

New OSTP Group Will Address Nanotechnology Issues

During the National Nanotechnology Initiative’s (NNI) March 30-31, 2010, conference regarding “Risk Management Methods & Ethical, Legal, and Societal Implications of Nanotechnology,” Tom Kalil, White House Office of Science and Technology Policy (OSTP), announced that the OSTP would create a new interagency group on emerging technologies, including nanotechnology. Kalil’s announcement is reported in an American Association for the Advancement of Science (AAAS) policy alert, which notes that OSTP intends the group to provide agencies a forum in which to discuss emerging policy issues.

EPA Chemical Enforcement Focuses on Nanoscale Materials Manufacturers

On March 30, 2010, Michael Bellot, Chief of the U.S. Environmental Protection Agency (EPA) Chemical Risk and Reporting Enforcement Branch, of the Office of Civil Enforcement, Waste and Chemical Enforcement Division, spoke at the Global Chemical Regulations Conference last week. Bellot described manufacturers of nanoscale materials as a “target-rich environment,” and stated that two-thirds of EPA’s 2009 chemical enforcement activity focused on nanoscale materials manufacturers. EPA did not go into detail on the scope of its enforcement activities, but suffice it to say entities that are engaged in nanoscale material manufacture and/or import should be mindful of this information.

EPA DfE Program Announces Lithium-ion Batteries and Nanotechnology Partnership

On March 4, 2010, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) Program announced a partnership led by the DfE Program and Office of Research and Development (ORD). The partnership is conducting a screening-level life-cycle assessment of currently manufactured lithium-ion battery technologies and a next generation battery component that uses single-wall carbon nanotube technology. According to the DfE Program, the partnership offers the opportunity to mitigate current and future impacts and risks by helping battery manufacturers and suppliers identify materials and/or processes associated with the greatest environmental impacts throughout the life cycle of their products, and identify areas that could benefit from increased energy efficiency.

FDA Responds to EWG's Letter Concerning Sunscreen Guidelines

In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen guidelines. In its March 2, 2010, response, FDA stated that most sunscreen products are currently marketed under an over-the-counter drug monograph entitled “Sunscreen Drug Products for Over-the-Counter Human Use.” According to the letter, FDA received over 3,000 comments in response to its August 2007 draft sunscreen guidelines. FDA concludes its response by stating:

Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public.

NanoBusiness Alliance Will Hold Ninth Annual Washington DC Roundtable

The NanoBusiness Alliance will hold its Ninth Annual Washington DC Roundtable on March 15-17, 2010, and it will begin with a networking dinner and reception. Legislative meetings are scheduled for March 16, 2010. On March 17, 2010, during the NanoBusiness Alliance Federal Roundtable, Charles Auer will moderate, and Lynn L. Bergeson will participate in, a panel on chemical and consumer product risk management policy and regulatory actions. The Roundtable is intended to stimulate dialogue between NanoBusiness Alliance members and federal agencies; provide members an opportunity to learn about the latest regulatory policy/impending regulatory actions and federal research initiatives; and familiarize NanoBusiness Alliance members with federal product approval authorities and processes and innovation strategies, with an emphasis on pending developments.

SNWG Responds to SAP Report on Nanosilver and Other Nanometal Oxide Pesticide Products

In a February 5, 2010, letter to the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, the Silver Nanotechnology Working Group (SNWG) provides its reactions to the recent Scientific Advisory Panel (SAP) report on nanosilver and other nanometal oxide pesticide products. In its letter, SNWG highlights a number of the statements and recommendations from the SAP report that it considers “highly relevant for the shaping of EPA policy towards nanosilver materials.” SNWG notes that nanosilver is not a new material; clarity is needed on EPA concept of nano; real-life conditions are essential for realistic risk assessment; EPA policy must allow for sustainable technology development; and SAP frequently confounded general “nano”-related issues and uncertainties with issues specific to nanosilver.

EPA SAP Releases Report on Nanosilver and Other Nanometal Pesticide Products

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products.  In addition to the general observations noted here, more information is available in our February 8, 2010, memorandum. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of “nanometal pesticide products.” Second, the Panel stated that existing models “are not appropriate” for use with silver nanomaterials and “will not accurately predict nanosilver exposure scenarios.” The Panel stated that it “strongly believe[s] that in addition to current data requirements under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)], additional assays which compared nanoscale and bulk materials would be most beneficial in addressing” differences in toxicokinetics and toxicodynamics for nanoscale materials. This conclusion alone poses formidable challenges for nanosilver pesticide applicants wishing to obtain registration status under FIFRA. Third, the Panel agreed that pesticide products should be tested on a “case-by-case basis,” EPA should use a meta-analysis on the products to understand better trends in life cycle analyses, and “close attention” should be given to products that claim a non-ionic mode of action as an antimicrobial agent. Fourth, the Panel outlined detailed research needs that EPA should consider. The outline will discourage even the most optimistic potential FIFRA registrant for a nanopesticide as the research needs are extensive and likely costly. The Panel also identified the “most useful short-term information needs,” of which stakeholders should be aware. Finally, the Panel stated that a “critical issue” that “must be clarified is the use of [the] terminology ‘nano’” and that for standardization, “the unique property for nanosilver should be established.”

EPA Proposes a Second SNUR for Multi-Walled Carbon Nanotubes

The U.S. Environmental Protection Agency (EPA) published on February 3, 2010, a proposed significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for multi-walled carbon nanotubes. The proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due March 5, 2010.

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NIOSH Announces Articles Addressing Nanomaterial Exposure Issues

On January 19, 2010, the National Institute for Occupational Safety and Health (NIOSH) announced three new peer-reviewed articles co-authored by NIOSH researchers. According to NIOSH, the articles report findings and conclusions from studies that examined issues related to potential occupational exposure to engineered nanomaterials. Two articles in the Journal of Occupational and Environmental Hygiene report on the design and application of the nanomaterial emission assessment technique, which was developed by the NIOSH nanotechnology field evaluation team. Part A describes the technique (Journal of Occupational and Environmental Hygiene, 7:127-132), while Part B discusses findings from use of the technique at 12 facilities. NIOSH states that the results summarized in Part B “demonstrated that the technique is useful in identifying and evaluating sources of nanomaterial emissions, and for evaluating engineering controls intended to minimize emissions and reduce exposures” (Journal of Occupational and Environmental Hygiene, 7:163-176). The third article, highlighted as a “featured research” paper in EHP, examines the potential for occupational exposure to engineered carbon-based nanomaterials in environmental laboratory studies. The article cautions that under some conditions, engineered nanomaterials can become airborne when mixed in solution by sonication.

EPA Extends Comment Period for Proposed CNT SNURs

On January 8, 2010, the U.S. Environmental Protection Agency (EPA) extended until February 8, 2010, the comment period for its November 6, 2009, proposed significant new use rules (SNUR) for multi-walled carbon nanotubes (CNT) and single-walled CNTs.  According to the January 8, 2010, notice, EPA received a request to extend the comment period.  On December 1, 2009, the U.S. World Trade Organization (WTO) Technical Barriers to Trade (TBT) Inquiry Point at the National Institute of Standards and Technology (NIST), on behalf of the European Economic Community (EEC) WTO TBT Enquiry Point, submitted a request to extend the comment period. According to the request, “the European Communities are currently reviewing the draft regulation,” and request that the comment deadline be extended. According to Charles Auer, formerly the Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and now affiliated with Bergeson & Campbell, P.C., this is the first request he is aware of from the EEC TBT Enquiry Point to OPPT. Auer noted that the EEC is not necessarily raising a trade concern, but may simply want to know the scope of the proposed regulation.

SNWG Presents Data on Silver and Nanotechnology to the SAP

The Silver Nanotechnology Working Group (SNWG) issued a press release regarding its presentation to the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) at its November 3-6, 2009, meeting. EPA asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have approached the Office of Pesticide Programs (OPP) seeking product registration. SNWG’s analysis included the key conclusions that nanosilver is not a new material and that EPA has “safely and successfully” regulated nanosilver products for decades.

NIOSH Updates Nanotechnology Research Reports

On November 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) released two nanotechnology publications. NOISH posted a document entitled Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The Report updates the February 2007 version, which described the progress of the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006. In the November 2009 Report, NIOSH describes program accomplishments achieved in 2007 and 2008. NIOSH states that the NTRC has, with limited resources, continued to make contributions to all the steps in the continuum from hazard identification to risk management. The second document, entitled Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps, updates the September 2005 Strategic Plan using knowledge gained from results of ongoing research as described in the 2007 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 update. NIOSH states that the Strategic Plan for the nanotechnology program is the roadmap it is using to advance knowledge about the implications and applications of nanomaterials.

EPA Proposes SNURs for Carbon Nanotubes

On November 6, 2009, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs are based on and consistent with the provisions in the underlying consent orders, and designate as a significant new use the absence of the protective measures required in the corresponding consent orders. Persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use would be required by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due December 7, 2009.

EPA Will Webcast SAP Meeting

The U.S. Environmental Protection Agency (EPA) has announced that it will stream its November 3-6, 2009, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting on the Internet. EPA has asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. OPP believes, based on its understanding of the scientific literature, that pesticides containing nanoscale materials may pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.

EPA Announces Research Strategy to Study Nanomaterials

On September 30, 2009, the U.S. Environmental Protection Agency (EPA) announced the availability of the Nanomaterial Research Strategy (Strategy), which EPA describes as its new research strategy to understand better how manufactured nanomaterials may harm human health and the environment.  The Strategy outlines what research EPA intends to support over the next several years to generate information about the safe use of nanotechnology and products that contain nanoscale materials.  The Strategy also includes research into ways nanotechnology can be used to clean up toxic chemicals in the environment.  In its announcement, EPA states that its role among federal agencies “is to determine the potential hazards of nanotechnology and develop approaches to reduce or minimize any risks identified.  As part of the strategy, researchers are investigating widely used nanomaterials, such as carbon nanotubes, which are used in vehicles, sports equipment and electronics; and titanium dioxide, which is used in paints, cosmetics and sunscreens.”

PEN Holds Meeting on Transatlantic Regulatory Cooperation

On September 23, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Technologies (PEN) hosted a meeting on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies.” The program is part of a collaborative research project involving experts from the London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and PEN. The project is funded by a grant from the European Commission to support pilot projects on “Transatlantic methods for handling global challenges.” The purpose of yesterday’s meeting was to discuss recommendations from the research effort that are part of a report released on September 10, 2009. The meeting was also intended to generate and examine new ideas to enable greater transatlantic convergence on nanotechnology oversight today and in the future.

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California DTSC Plans to Host Nano-Industry Symposium

 The California Department of Toxic Substances Control (DTSC) announced it will host the DTSC/California Nano-Industry Network Symposium, to be held November 16, 2009, in Sacramento, California. The Symposium, which is co-sponsored by the American Chemistry Council and Dupont, will use the DTSC’s nanotechnology data call-in as a backdrop. According to the preliminary agenda, the Symposium will feature two sessions. The first, entitled “Collaborative Efforts,” will discuss the key U.S. and international forums for collaboration on the health, safety, and environmental impacts of nanomaterials. The second session, “Company Engagement with Nanotechnology Safety,” will review examples of how companies can apply the evolving knowledge on nanomaterials safety to address systematically various areas of concern.

 

 

EPA Announces SAP Meeting Concerning Nanosilver

The U.S. Environmental Protection Agency (EPA) announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” Nominations of candidates to serve as ad hoc SAP members for this meeting are due September 30, 2009. The meeting will be open to the public. EPA asks that written comments be submitted by October 20, 2009, to allow for distribution to the SAP, and that requests for oral comments be made by October 27, 2009.  EPA also states that written comments and requests to make oral comments may be submitted until the date of the meeting, however.

EPA Announces Interagency Nanotechnology Implications Grantees Workshop

The U.S. Environmental Protection Agency (EPA) has announced the Interagency Nanotechnology Implications Grantees Workshop, which will feature presentations on recent research by EPA, the National Science Foundation (NSF), National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS), National Institute for Occupational Safety and Health (NIOSH), and Department of Energy (DOE) grant researchers.  According to EPA, the November 9-10, 2009, meeting “will encourage collaboration and cooperation among nanotechnology grantees sponsored by EPA, NSF, NIEHS, NIOSH and DOE and between other federal grantees and federal nanotechnology researchers.” The meeting is open to members of academia, government, nongovernmental organizations, industry, and the general public. Two agendas are available: (1) other nanomaterials; and (2) metals and carbon-based nanomaterials.

CPSC Holds Public Hearing on CPSC Agenda, Priorities, and Strategic Plan for FY 2011

On August 25, 2009, the United States Consumer Product Safety Commission (CPSC) held a public hearing to receive comments about its agenda and priorities for CPSC during fiscal year (FY) 2011, which begins October 1, 2010, and about its current strategic plan. CPSC invited participation by members of the public, and representatives from the Consumers Union, Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN), Thermo Fisher Scientific, National Association of State Fire Marshals, International Sleep Products Association, Kids in Danger, and American Apparel & Footwear Association testified. Don Mays, Consumers Union, and David Rejeski, PEN, addressed CPSC’s goals concerning nanomaterials.

EPA Withdraws Final SNURs for CNTs

Today’s Federal Register includes a notice from the U.S. Environmental Protection Agency (EPA) withdrawing the June 24, 2009, final significant new use rules (SNUR) for multi- and single-walled carbon nanotubes (CNT). EPA states that it published the final SNURs using direct final rulemaking procedures. Because EPA received a notice of intent to submit adverse comments on the rules, it is withdrawing the SNURs for CNTs. The Federal Register notice does not identify the commenter. The docket for the rulemaking includes a July 22, 2009, letter from WilmerHale stating that it intends to submit adverse comments on behalf of one or more clients. According to the notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.” The withdrawal is effective August 21, 2009.

NIOSH Invites Submission of Papers on Nanotechnology Exposure Assessments

 

According to its website, the National Institute for Occupational Safety and Health (NIOSH) has joined the International Journal of Occupational and Environmental Health in inviting submission of scientific papers for a special issue of the Journal. The special edition is provisionally entitled “Human and Environmental Exposure Assessment for Nanomaterials,” and will be edited by Vladimir Murashov, Ph.D., a special assistant to the NIOSH Director. Submissions are due January 15, 2010. More information about submission requirements can be found on the Journal’s website.

 

ECOS Wants to Participate in NSET Subcommittee Working Groups

In an August 7, 2009, letter to the White House Office of Science Technology and Policy (OSTP), the Environmental Council of the States (ECOS) expressed its interest in working with OSTP and other federal agencies regarding the “human health and ecological impacts and lifecycle consequences of intentional and unintentional releases of engineered nanoparticles into the environment.” According to ECOS, state environmental agencies want to participate in national efforts to develop best assessment and management practices. ECOS suggests that one option is for ECOS to join one or more of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee Working Groups within the National Nanotechnology Initiative (NNI) framework. ECOS asked OSTP for a meeting, “preferably this summer,” to obtain feedback on its key areas of interest and to discuss the best opportunities for its involvement in national efforts.

ITC Issues Priority Testing List Report

In a notice in the August 4, 2009, Federal Register, the Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) released its latest report to the Administrator. Under TSCA Section 4(e), the ITC is required ‘‘to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of rules for testing.” According to the report, “the ITC has no revisions to the TSCA section 4(e) Priority Testing List at this time.”

The report also describes the ITC’s emphasis during the reporting period (November 2008 to May 2009) on nanoscale materials and how best to regulate them. It summarizes the ITC’s recent reviews of the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program’s interim report and the National Institute for Occupational Safety and Health’s (NIOSH) nanotechnology guidelines. The report concludes by recommending data needs of ITC organizations be addressed and lists many of the data deficiencies.

EPA Clarifies Final CNT SNURs

On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

 

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.  The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

Article Advocates NIOSH-Led National Nanotechnology Partnership

The National Institute for Occupational Safety and Health (NIOSH) has posted a link to an article entitled “National Nanotechnology Partnership to Protect Workers,” which proposes the creation of a National Nanotechnology Partnership led by NIOSH. The article, posted online on July 7, 2009, by the Journal of Nanoparticle Research, suggests the partnership be a collaboration of government agencies, manufacturers, users, and others. The authors are John Howard, M.D. former NIOSH Director, and Vladimir Murashov, Ph.D., NIOSH.

NIOSH Announces Conference on Nanomaterials and Occupational Health and Safety

On July 15, 2009, the National Institute for Occupational Safety and Health (NIOSH) announced plans to hold a conference entitled “Nanomaterials and Worker Health:  Occupational Health Surveillance, Exposure Registries, and Epidemiological Research.” The conference is intended to identify gaps in information about potential occupational health effects of nanomaterials, as well as address questions related to occupational health and safety.

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FDA Spokesperson Says Regulatory Authority Is Sufficient to Address Nanotechnology

According to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to the FDA seeking acceptance of a nanotech food additive or coloring should address its “impact on identity and toxicity.” According to McCarthy, the idea of a Generally Regarded as Safe (GRAS) standard is not out of the question. Although a company “would have a hard time today” proving that a nanotechnology is generally recognized as safe, McCarthy thinks that “two years down the line, it could be a slam dunk; it could be very simple.

EPA Considering Test Rule For Multiwall CNTs

According to a notice in the U.S. Environmental Protection Agency's (EPA) May 11, 2009, Regulatory Agenda, a Toxic Substances Control Act (TSCA) Section 4(a) test rule “may be needed to determine the health effects” of multiwall carbon nanotubes (CNT). EPA states that the results of the tests that could be required under the rule could assist in understanding the health effects of the substance to manage/minimize any potential risk and exposure. Results could also help with establishing a correlation between the chemical/physical properties and health effects needed to protect the health of workers handling the substance. EPA has not determined when it will publish a notice of proposed rulemaking (NPRM).

PEN Report on Oversight of Next Generation Nanotechnology Recommends New Federal Agency

On April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence Davies, Ph.D., the agency would be primarily a scientific agency with a strong oversight component, in contrast to current federal agencies such as the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), which are primarily oversight bodies. Davies stated: “New thinking, new laws and new organizational forms are necessary.  Many of these changes will take a decade or more to accomplish, but there is an urgent need given the rapid pace of technological change to start thinking about them now.”

NIOSH Requests Data on CNTs

On April 8, 2009, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing that it “intends to evaluate the scientific data on carbon nanotubes (CNTs) and develop appropriate communication documents, such as an Alert and/or Current Intelligence Bulletin [CIB], which will convey the potential health risks and recommend measures for the safe handling of these materials.” CIBs are issued by NIOSH “to disseminate new scientific information about occupational hazards. A CIB may draw attention to a previously unrecognized hazard, report new data on a known hazard, or disseminate information on hazard control.”

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EPA Seeks Joint Applications from U.S. and UK Partners Regarding Nano Research

On March 31, 2009, the U.S. Environmental Protection Agency (EPA) announced the funding opportunity for its joint U.S. -- United Kingdom (UK) Research Program: Environmental Behavior, Bioavailability, and Effects of Manufactured Nanomaterials. EPA states that the outputs of the Program will be used to further scientific understanding of the fate, behavior, bioavailability, and effects of nanomaterials and risk management policy development. Two consortia, made up of UK and U.S. research institutions, will be selected for funding. EPA is seeking joint applications from U.S. and UK partners that:

  • Propose integrated model(s) of fate, behavior, bioavailability and effects for several important and representative nanomaterial classes over key environmental pathways using intrinsic material properties and life cycle analysis as a starting point for model development;
  • Validate and refine these model(s) through interdisciplinary research, addressing key assumptions and areas of uncertainty; and
  • Develop effective methods and tools to detect, assess, and monitor the presence of nanomaterials in biological and environmental samples.

NIOSH Publishes Approaches to Safe Nanotechnology

On March 30, 2009, the National Institute for Occupational Safety and Health (NIOSH) posted a document entitled Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials. The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. NIOSH released a draft version of the document for comment in October 2005, and then released a revised and updated version for additional comment in July 2006. According to NIOSH, the final version of this document “incorporates some of the latest results of NIOSH research, but it is only a starting point.” NIOSH states that the document serves a dual purpose: it is a summary of NIOSH’s current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops.

FDA Assessing Feasibility of Using Nanotechnology Test to Detect Anthrax Following a Bioterrorist Attack

On March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The europium nanoparticle-based immunoassay (ENIA) was able to detect the presence of a protein made by the anthrax bacteria known as protective antigen (PA). PA combines with another protein, lethal factor, to form anthrax lethal factor toxin, the protein that enters cells and causes toxic effects. FDA states that its researchers showed that ENIA is capable of detecting PA in quantities that are 100 times lower than current tests, such as the enzyme-linked immunosorbent assay (ELISA). The ENIA uses nanospheres covered with thousands of light-emitting atoms of europium that emit light, which acts as a signal that PA is present. The ENIA detected PA in 100 percent of samples of mouse plasma compared to 36.4 percent through ELISA. A report on the results of this study appears in the March issue of Clinical and Vaccine Immunology.

FDA Announces Nanotechnology Collaboration

On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that could mitigate the risks associated with nanoengineered products. FDA states that all outcomes “will be placed in the public domain for the benefit of all stakeholders.” The ANH member institutions include Baylor College of Medicine; the University of Texas’ M.D. Anderson Cancer Center; Rice University; the University of Houston; the University of Texas Health Science Center at Houston; Texas A & M Health Science Center; the University of Texas Medical Branch at Galveston; and the Methodist Hospital Research Institute.

NIOSH Issues Update Regarding Paper on Issues in Developing Worker Epidemiological Studies Related to Engineered Nanoparticles

According to a February 27, 2009, National Institute for Occupational Safety and Health (NIOSH) Update entitled “Issues in Developing Worker Epidemiological Studies Related to Engineered Nanoparticles Are Discussed in Paper,” NIOSH scientists and a colleague from Emory University have prepared a paper concerning issues that researchers will need to consider in designing sound epidemiological studies of workers who may be exposed to engineered nanoparticles in the manufacturing and commercial use of nanomaterials.  According to the authors, even though the fundamental principles of epidemiology can be applied to engineered nanoparticles, researchers will face challenges typically not encountered in studies involving traditional materials. These challenges relate to the unique characteristics and properties of engineered nanomaterials, the relative newness of nanotechnology, and the fact that nanotechnology is not an industry in itself, but a process that may involve different industry sectors and occupational groups. The factors that would influence the design of an epidemiological study include:

  • Heterogeneity (the chemical and physical diversity of engineered nanoparticles);
  • Temporal factors (the challenge that nanotechnology, generally, has not been in use for the length of time it may take for some diseases to become apparent);
  • Disease endpoints (determining what diseases or symptoms to look for on the basis of limited research evidence);
  • Exposure characterization (determining what to measure and how to measure it); and
  • Study population (finding a group of workers for a study who have been exposed to the same type of engineered nanoparticle at levels high enough and for a long enough time to provide scientifically reliable and comparable results).

The paper will be published by the Journal of Occupational and Environmental Medicine.

 

FDA Panel States FDA Wants More Information before Issuing Guidance

During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the companies might not be submitting products due to “uncertainty over excessive burden from regulation.”  He described FDA’s role as “an encouraging gatekeeper,” and urged companies to submit their products and test results. Deputy Director Douglas Throckmorton, FDA Center for Drug Evaluation and Research (CDER), stated:  “We are at work understanding what we have at hand, developing a full inventory of nanoscale products before we get into the guidance business.  But I will say this, we know much less than we need to on the effect of nanoscale materials on manufacturing.” Norman Alderson, FDA Associate Commissioner for Science, described the challenges of nano-engineered materials, including the lack of: standards and reference materials; toxicological and biocompatibility data for most products; and standardized physical and chemical characterization procedures.

NNCO Responds to NRC Report on Nanotechnology Research Strategy

On February 13, 2009, the National Nanotechnology Coordination Office (NNCO) released a statement regarding the National Research Council’s (NRC) December 10, 2008, report regarding its review of the National Nanotechnology Initiative (NNI) Strategy for Nanotechnology-Related Environmental, Health, and Safety (EHS) Research.  According to the statement, NNI member agencies noted the report’s “substantial and important recommendations for further progress on EHS research,” and “look forward to working with the NRC on achieving the vital and shared goals of clearly, proactively assessing the potential benefits and risks that may be associated with specific nanomaterials in specific applications.”  NNCO notes that it “do[es] not believe that the NRC evaluation recognized the breadth and depth of the NNI commitment to EHS research. . . .  Furthermore, the report drew a number of conclusions with which the NNI member agencies respectfully disagree.” NNCO provided detailed comments to the NRC in a January 5, 2009, letter. On February 24-25, 2009, NNCO held a workshop regarding the science related to EHS aspects of engineered nanoscale materials in the area of human and environmental exposure assessment, one of the five EHS research categories identified in the Strategy for Nanotechnology-Related Environmental, Health, and Safety Research.

NIOSH Offers Interim Guidance For Worker Medical Screening, Hazard Surveillance Pertaining To Engineered Nanoparticles

On February 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of “Current Intelligence Bulletin 60: Interim Guidance for the Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles.” NIOSH offers the following recommendations for workplaces where workers may be exposed to engineered nanoparticles in the course of their work:

  • Take prudent measures to control exposures to engineered nanoparticles;
  • Conduct hazard surveillance as the basis for implementing controls; and
  • Continue use of established medical surveillance approaches.

According to NIOSH, its recommendations respond to ongoing interest by employers and other stakeholders in having authoritative occupational safety and health guidance in the manufacturing and industrial use of engineered nanomaterials. NIOSH states that its recommendations also reflect its ongoing leadership in providing such interim scientific guidance as research progresses for determining whether engineered nanomaterials pose risks for adverse occupational health effects.

 

NANO Act Introduced in Congress

On February 3, 2009, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R. 820), which is intended to ensure the development and responsible stewardship of nanotechnology. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital convened by Honda and then-California State Controller Steve Westly during 2005.

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PEN Report Faults FDA Regulation of Nanotechnology-Based Dietary Supplements

On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of information, lack of resources and the agency’s lack of statutory authority in certain critical areas.” The authors note that, under current law, supplement manufacturers must disclose only limited information about their products, and the information available is the result of manufacturers promoting their use of nanotechnology when marketing their products. PEN states that, according to its inventory of federal environmental, health, and safety research on nanotechnology, the U.S. government provides less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

NNI Reauthorization Legislation Introduced In House Committee

On January 15, 2009, Representative Bart Gordon (D-TN), Chair of the House Science Committee, introduced the National Nanotechnology Initiative (NNI) Amendments Act of 2009 (H.R. 554). The bill is identical to H.R. 5940, which passed the House in the previous Congress with a 407-6 vote. The legislation would reauthorize the multi-agency research program that Congress established in 2003 through the 21st Century Nanotechnology Research and Development Act of 2003 (Pub. Law 108-153). Under the Act, federal agencies would be required to develop a research plan and implementation strategy that specifies near- and long-term goals, sets milestones and time frames for meeting near-term goals, clarifies agencies’ roles in implementing the plan, and allocates sufficient resources to accomplish those goals. The bill would authorize funding for research in areas of national need, such as research to develop renewable energy and batteries that could store energy more efficiently, and would direct agencies to take steps to help private companies commercialize nanotechnology applications.

NGOs Call for Obama Administration to Establish Moratorium on Pesticidal Nanotechnology

According to a draft January 7, 2009, document, non-governmental organizations (NGO) such as Beyond Pesticides and the Pesticide Action Network for North America recommend that the Obama Administration take a number of immediate actions within its first 100 days, including establishing a moratorium on pesticidal nanotechnology. The NGOs call for the suspension of the registration of nanoproducts with pesticidal properties, and the removal of untested products from the market.  The NGOs urge the Obama Administration to direct the U.S. Environmental Protection Agency (EPA) to develop a clear testing protocol that identifies the full range of potential adverse health and environmental effects of nanoproducts with pesticidal properties. The NGOs cite the 60-day comment period on the International Center for Technology Assessment (ICTA) petition as an acknowledgment by EPA of “the critical need for in-depth review of products utilizing nanotechnology pesticides.” ICTA petitioned EPA in May 2008 to regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

EPA Publishes NMSP Interim Report

On January 12, 2009, the U.S. Environmental Protection Agency (EPA) released
its interim report on 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. Under the Basic Program, EPA
invited participants to voluntarily report available information on the engineered nanoscale
materials they manufacture, import, process, or use. As of December 8, 2008, 29 companies or
associations submitted information to EPA covering 123 nanoscale materials and a further seven
companies have outstanding commitments to the Basic Program. Under the In-Depth Program,
EPA invited participants to work on a plan for the development of data on representative
nanoscale materials over a longer time frame. As of December 8, 2008, four companies have
agreed to participate. EPA states that, based on the current interim results, “the NMSP can be
considered successful.” EPA notes that a number of the environmental health and safety data
gaps still exist, however, and “EPA is considering how to best use testing and information
gathering authorities under the Toxic Substances Control Act [(TSCA)] to help address those
gaps.”

EPA Announces Receipt of CNT PMNs

In a January 5, 2009, Federal Register notice, the U.S. Environmental Protection Agency (EPA) announces receipt of several premanufacture notices (PMN) concerning multi-walled carbon nanotubes (CNT). Under Section 5 of the Toxic Substances Control Act (TSCA), EPA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. According to the notice, EPA received the CNT PMNs on September 17, 2008, and the projected end date was December 15, 2008. The submitter name is claimed as confidential business information (CBI). Comments on the PMNs are due February 4, 2009.

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EPA Announces Receipt of Fullerene PMNs

In a December 12, 2008, Federal Register notice, the U.S. Environmental Protection Agency (EPA) announces receipt of several premanufacture notices (PMN) from Nano-C, Inc. concerning fullerenes. Under Section 5 of the Toxic Substances Control Act (TSCA), EPA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. According to the notice, EPA received the fullerene PMNs on November 5, 2008, and the projected end date is February 2, 2009.  Comments on the PMNs are due January 12, 2009.

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EPA Announces Joint Research Partnership with UK Agencies Regarding the Behavior and Effects of Nanomaterials in the Environment

On December 29, 2008, the U.S. Environmental Protection Agency (EPA) announced that it is in the process of finalizing a major joint research effort with a number of United Kingdom (UK) agencies that is intended to develop and validate predictive tools and similar conceptual models that predict exposure, bioavailability, and effects of manufactured nanomaterials in the environment. The UK agencies include the Natural Environment Research Council, Engineering and Physical Sciences Research Council, Department for Environment, Food, and Rural Affairs, and Environment Agency.  According to EPA, the research partnership will include a joint call issued by all organizations involved and will incorporate a common review and evaluation process.  EPA states: “The intent is to form consortia of both UK and US investigators using combined but independent national funding arrangements.” EPA expects the solicitations to be issued in February 2009.

EPA Regulatory Agenda Includes Item on Nanoscale Materials Stewardship Program

According to a notice in the U.S. Environmental Protection Agency’s (EPA) November 24, 2008, Regulatory Agenda, EPA intends to publish an interim evaluation in March 2009 of the Nanoscale Materials Stewardship Program (NMSP), and a final evaluation of the NMSP, including next steps, in April 2010. The NMSP 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.

EPA Requests Comments on Petition to Regulate Silver Nanoparticles under FIFRA

On November 19, 2008, the U.S. Environmental Protection Agency (EPA) announced the availability for review and comment of a petition requesting EPA regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to the notice, EPA “has determined that the petition raises issues that potentially affect private and public sector stakeholders.” The International Center for Technology Assessment (ICTA) and 13 other consumer, health, and environmental groups filed the petition. Comments are due January 20, 2009.

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Consumers Union Petitions FDA to Require Safety Assessment on the Use of Nanoparticles

On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm that use of certain nanoparticles is widespread in mineral-based sunscreens, and that company representatives are making erroneous assertions about these particles in their products.” Consumers Union purchased sunscreens that contain titanium dioxide and/or zinc oxide, focusing on products that, according to company representatives, do not contain nanoparticles. According to the Consumer Reports article, Consumers Union found that four of the five companies’ statements about their products, asserting that they did not contain nanoparticles, were incorrect.

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EPA Posts TSCA 8(e) Submission for Carbon Nano Tubes

Last week, the U.S. Environmental Protection Agency posted a submission made by BASF Chemical Company under Section 8(e) of the Toxic Substances Control Act (TSCA), which requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. In its July 8, 2008, submission, BASF submitted the results of a subchronic inhalation study in rats, reporting that the no observed effect concentration is below 0.1 mg/m3. In a September 9, 2008, letter, EPA’s Office of Pollution Prevention and Toxics (OPPT) states that it conducts preliminary screens of all Section 8(e) submissions and routinely requests additional information from submitters to complete these preliminary screens or to evaluate submissions further. OPPT requested the complete report from BASF.

EPA Will Publish Notice Regarding TSCA Inventory Status of Carbon Nanotubes

According to the Office of the Federal Register, tomorrow the U.S. Environmental Protection Agency (EPA) will publish a notice regarding the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNT). EPA states that it “generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.” As a result, many CNTs may therefore be new chemicals under TSCA Section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA Section 5 where required under 40 C.F.R. Part 720 or Part 723. To determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import under 40 C.F.R. Section 720.25.  According to the notice, some time after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA Section 5 requirements for CNTs.

EPA Issues Consent Order for Multiwalled Carbon Nanotubes

The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN).

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NIOSH Posts Update Regarding Nanotechnology Research

In an October 2, 2008, Update entitled “NIOSH Nanotechnology Research News Notes:  New Papers on PPE, Toxicity; New Partnerships, Award,” the National Institute for Occupational Safety and Health (NIOSH) describes two new peer-reviewed papers, two new international partnerships, and a professional award.

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