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We are pleased to announce that NanoBusiness Alliance (NbA) has selected Lynn L. Bergeson as one of its “Most Influential Nanotechnology Leaders from 2010.” The NbA is the industry association for the emerging nanotechnology industry. Through its extensive network of leading start-ups, Fortune 500 companies, research institutions, non-governmental organizations, and public-private partnerships, the NbA shapes nanotechnology policy and helps accelerate the responsible commercialization of...

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...

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

On December 21, 2010, the California Department of Toxic Substances Control (CDTSC) issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. According to CDTSC, Health and Safety Code Section 57018(a)(4) defines a “manufacturer” as a “person who produces a chemical in this state or imports a chemical...

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...

Bergeson & Campbell, P.C. (B&C) is pleased to announce that it attended the first day of the “Nanotechnology Innovation Summit,” which celebrated the tenth anniversary of the National Nanotechnology Initiative (NNI), to meet with many of our clients who showcased their products. The Summit was held December 8-10, 2010, at the Gaylord National Convention Center outside Washington, D.C. The Summit provided attendees an opportunity to meet with key federal government leaders and...

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....

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...

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...

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...

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...

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...

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...

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...

On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. Of particular note, CDTSC has removed all references to nanotechnology and nanomaterials in the proposed regulations, which previously defined nanomaterials and included “physical, chemical, or quantum properties specific to nanomaterials” on the list of prioritization factors that CDTSC would consider in...

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...

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,...

On November 4, 2010, the Project on Emerging Nanotechnologies (PEN) released a report entitled Voluntary Initiatives, Regulation, and Nanotechnology Oversight: Charting a Path, which reviews a number of voluntary options available for the oversight of nanotechnology products and processes. The report classifies the various types of voluntary initiatives and the partnerships that underlie them, and assesses the factors that are most likely to contribute to program success. The thesis of the...

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...

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...

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...

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...

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...

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...

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...

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...

The California Office of Environmental Health Hazard Assessment (OEHHA) has released for comment a pre-regulatory draft regulation regarding the specification of hazard traits, environmental and toxicological end-points, and other relevant data that are to be included in California’s Toxics Information Clearinghouse. The California Department of Toxic Substances Control (CDTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products...

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...

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;...

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...

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...

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...

The Massachusetts Office of Technical Assistance (MOTA) will post this week a Technology Guidance Document entitled “Nanotechnology — Considerations for Safe Development,” which includes recommendations intended to enhance the safety of nanotechnology.  According to MOTA, it is providing the Guidance for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment — it will...

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...

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...

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...

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: Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it...

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...

On July 1, 2010, the NanoBusiness Alliance issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.” The NanoBusiness Alliance is committed to working with governments and nanomaterials stakeholders to manage the sustainable development and use of nanomaterials in a responsible way. The Position Statement states: As an...

We are pleased to announce the release of the final white paper from the October 8-9, 2009, summit entitled “Environmentally Responsible Development of Nanotechnology,” which was held by The Research Triangle Environmental Health Collaborative. The charge for summit attendees was to explore issues regarding potential risk across nano-enabled product lifecycles, with the goal of generating a set of recommendations for North Carolina businesses regarding how to address such...

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...

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...

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...

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...

On April 22, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) announced that, on May 5, 2010, the University of California at San Francisco’s (UCSF) Program on Reproductive Health will hear comments from an expert panel and the public on a draft UCSF document entitled “A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California.” The draft document includes a number of recommendations for...

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...

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...

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...

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;...