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.

American Academy of Dermatology Annual Meeting Includes Presentation on Nanotechnology in Cosmetic Products

During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products, and perfumes.  Nanoparticles used in sunscreens increase protection and coverage on the skin, while being less visible than microparticles. In anti-aging products, nanotechnology may allow active ingredients to penetrate the top layer of the skin. Researchers are currently exploring nanoparticle treatments of conditions such as melanoma.  Dr. Nasir noted, however, that dermatologists are concerned about the potential health risks posed by nanotechnology, and “anxiously await” the Food and Drug Administration’s review of the safety of nanoparticles.

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.

Wisconsin Legislature Considers Nanotechnology Registry

In a December 16, 2009, letter, three members of the Wisconsin Assembly requested that a Legislative Council study be conducted on the feasibility of creating a nanotechnology registry and the development of subsequent legislation to monitor the use, manufacture, and disposal of nanomaterials in Wisconsin. The letter, signed by State Representatives Terese Berceau (D), Chuck Benedict (D), and Penny Bernard Schaber (D), notes that entities manufacturing or using nanomaterials in Wisconsin are not required by state or federal regulation to identify materials they are using, how they transport and dispose of them, or where such work is taking place. According to the letter, data gaps present “serious concerns” to first responders and public agencies responsible for addressing health consequences or releases into air or water. The letter states: “The development of a registry in partnership with science, business, and the public sector -- and which enhances the economic development of our state -- is our ultimate goal.”

NIOSH Announces Conference on Nanomaterials and Worker Health

The National Institute for Occupational Safety and Health (NIOSH) announced that it will hold a conference entitled “Nanomaterials and Worker Health:  Medical Surveillance, Exposure Registries, and Epidemiologic Research,” on July 21-23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado. According to NIOSH, the goal of the conference is to identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers.  The conference will include invited and submitted papers, breakout sessions to allow for small group discussions, and poster presentation.

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.

PEN Releases findNano

On November 10, 2009, the Project on Emerging Nanotechnologies (PEN) released findNano, an application for Apple’s iPhone and iPod Touch that is intended to let users determine whether consumer products are nanotechnology-enabled. According to PEN, the application allows users to browse an inventory of more than 1,000 nanotechnology-enabled consumer products, from sporting goods to food products and electronics to toys, using the iPhone and iPod Touch.  Using the built-in camera, iPhone users can even submit new nanotech products to be included in future inventory updates.

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.

Lynn L. Bergeson Chairs Panel at Conference on "Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"

The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S., which is funded by a grant from the European Commission. Their research findings on issues of transatlantic regulatory cooperation were published in a report during the conference. The conference was intended to bring together regulatory experts from the United States (U.S.) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. The materials released at the conference include a briefing paper entitled Regulating Nanomaterials:  A Transatlantic Agenda, and the report entitled Securing the Promise of Nanotechnologies:  Towards Transatlantic Regulatory Cooperation.

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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.

Lynn L. Bergeson Will Speak at Conference on "Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson will be speaking at the September 10-11, 2009, international conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. The London School of Economics, Chatham House, the Environmental Law Institute, and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have spent the past year examining issues of transatlantic regulatory cooperation. During the conference, their research findings will be published in a major report, which is scheduled to be released on September 10, 2009. The conference is intended to bring together regulatory experts from the United States (US) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future.

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PEN Consumer Product Inventory Includes over 1,000 Items

Yesterday the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) announced that its inventory of nanotechnology-enabled consumer products includes over 1,000 items. When PEN began the inventory in March 2006, it included 212 products. According to PEN, health and fitness items represent 60 percent of the products listed. More products are based on nanoscale silver than any other nanomaterial, with 259 products (26 percent of the inventory) using silver nanoparticles. The inventory includes products from over 24 countries, including the U.S., China, Canada, and Germany. The inventory includes products that have been identified by their manufacturer or a credible source as being nanotechnology-based. PEN states that this update identifies products that were previously sold, but which may no longer be available. PEN encourages users to submit new and updated information.

PEN Releases Map Showing Nanotechnology-Related Activities in the U.S.

On August 18, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released data showing that more than 1,200 companies, universities, government laboratories, and other organizations are involved in nanotechnology research, development, and commercialization. According to PEN, this is a 50 percent increase from the 800 organizations it identified two years ago. The data are part of PEN’s interactive map displaying the growing “Nano Metro” landscape, powered by Google Maps®. PEN’s accompanying analysis ranks cities and states by numbers of companies, academic and government research centers, and organizations and technology focus by sector.

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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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IEHN Examines Regulatory Loopholes

On June 16, 2009, the Investor Environmental Health Network (IEHN) released a report entitled Bridging the Credibility Gap:  Eight Corporate Liability Accounting Loopholes that Regulators Must Close, which discusses the effect of undisclosed potential and pending liabilities on investors. The report identifies eight regulatory loopholes that businesses could use to hide future liabilities from an investor’s risk assessment. Two case studies for asbestos and nanomaterials are used to assess the effectiveness of current disclosure requirements and recommend improvements.

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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.

CDTSC Will Hold Nanotech III Symposium

On March 19, 2009, the California Department of Toxic Substances Control (CDTSC) will hold a full-day nanotechnology symposium on nanomaterials regulation from a variety of perspectives. According to CDTSC, the symposium will focus on the regulatory aspects of nanotechnology, the role of the U.S. Environmental Protection Agency (EPA), and CDTSC’s chemical information call-in program including nanoscale materials. CDTSC states that federal interest in nanomaterial regulation and California’s efforts “provide a great opportunity for fostering technological advances that recognize environmental and public health concerns. The goal is to create a partnership where we can enhance research where needed and promote sustainable processes as well as applications.” Registration is required. The symposium will also be available via web cast.

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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.

CDTSC Issues Data Call-In for Carbon Nanotubes

In a January 22, 2009, letter, the California Department of Toxic Substances Control (CDTSC) announced that it is requiring the submission of data “regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes” (CNT). CDTSC states that the term “manufacturers” includes persons and businesses that produce CNTs in California or import CNTs into California for sale.  According to the letter, CDTSC is using its authority under California Health and Safety Code, Chapter 699, Sections 57018-57020. Section 57019(d)(2) requires that the data requested be provided within one year of the date of the letter.

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.

EHP-in-Press Posts Article Regarding C60 Fullerenes and SWCNTs

On November 12, 2008, EHP-in-Press posted an article entitled “Oxidatively Damaged DNA in Rats Exposed by Oral Gavage to C60 Fullerenes and Single-walled Carbon Nanotubes.” According to the article, C60 fullerenes and single-walled carbon nanotubes (SWCNT) are expected to be used in medicine and consumer products with potential human exposure. The objective was to determine whether the hazardous effects of these particles involve oxidative stress with generation of oxidatively damaged DNA that might be the initiating event in the development of cancer. The authors concluded that oral exposure to low doses of C60 fullerenes and SWCNTs is associated with elevated levels of 8-oxo-7,8-dihydro-2’-deoxyguanosine in the liver and lung, “which is likely to be caused by a direct genotoxic ability rather than an inhibition of the DNA repair system.” EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

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

Poll Finds Many Americans Unaware of Emerging Technologies

On September 30, 2008, the Project on Emerging Nanotechnologies (PEN) released the results of a poll regarding nanotechnology and synthetic biology. According to PEN, almost half of U.S. adults have heard nothing about nanotechnology, and nearly nine in 10 Americans say they have heard only a little or nothing at all about synthetic biology. PEN states that, based on the poll results, “the level of U.S. public awareness about nanotechnology has not changed measurably since 2004,” when PEN sponsored the first poll on the topic. In synthetic biology, advanced science and engineering are used to construct or re-design living organisms so that they can carry out specific functions. PEN predicts that this emerging technology will likely develop rapidly in the coming years. According to PEN, the first synthetic biology “blockbuster” drug is anticipated to hit the market in the near future -- an affordable treatment for the 500 million people in the world suffering from malaria.

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Insurance Company Will Exclude Nanotubes And Nanotechnology From Coverage

Beginning November 15, 2008, the Continental Western Insurance Group will no longer cover bodily injury, property damage, or personal and advertising injury from “nanotubes or nanotechnology in any form.” The company said its intent was to “remove coverage for the, as of yet, unknown and unknowable risks created by the products and processes that involve nanotubes.” According to the company, “reports have raised concerns regarding health risks from workers that may be inhaling carbon nanotubes during the manufacture of certain products. The carbon nanotubes resemble asbestos fibers in appearance, raising the concern that they may cause illness similar to that linked to asbestos.” The company concluded that it would not be prudent “to knowingly provide coverage for risks that are, as of yet, unknown and unquantifiable. We are all too aware of what happened to companies involved in asbestos-related exposures in the past, and see this as a very similar issue. By excluding coverage for bodily injury and property damage specifically caused by nanotubes and nanotechnology, we can continue to provide coverage for other exposures in the multitude of companies and products using nanotechnology now and in the future.” According to the notice to policyholders, the exclusion would apply to situations including “the use of, consumption of, ingestion of, inhalation of, absorption of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology.”

EPA Announces Centers for the Environmental Implications of Nanotechnology

On September 18, 2008, the U.S. Environmental Protection Agency (EPA) announced that, to ensure nanotechnology is developed in a responsible manner, the National Science Foundation (NSF) and EPA awarded $38 million to establish two Centers for the Environmental Implications of Nanotechnology (CEIN).  EPA contributed $5 million to the overall award, which is the largest award for nanotechnology research in its history.  The CEINs will conduct research on the possible environmental, health, and safety impacts of nanomaterials, using very different approaches than previous studies. Led by the University of California at Los Angeles (UCLA) and Duke University, the CEINs will study how nanomaterials interact with the environment and human health, and are intended to result in better risk assessment and mitigation strategies to be used in the commercial development of nanotechnology.  Each CEIN will work as a network, connected to multiple research organizations, industry, and government agencies, and will emphasize interdisciplinary research and education.

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EPA Will Host Nanotechnology Conference in Chicago

On September 18, 2008, the U.S. Environmental Protection Agency (EPA) announced that EPA Region 5 will host the 2008 International Environmental Nanotechnology Conference: Applications and Implications, October 7-9, 2008, in Chicago, Illinois. According to EPA, researchers from Asia, Australia, and Europe will join U.S. scientists and government officials to discuss nanotechnology applications for environmental cleanup, pollution control, and the implications of releasing engineered nanoparticles into the environment. Partner agencies represented at the conference include the Agency for Toxic Substances and Disease Registry (ATSDR), National Institute of Environmental Health Sciences (NIEHS), National Science Foundation (NSF), U.S. Army, U.S. Navy, U.S. Department of Energy (DOE), and University of Illinois at Chicago’s Great Lakes Centers for Occupational and Environmental Safety and Health.

FDA Nanotechnology Meeting

The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and dietary supplements.  In general, the meeting yielded no new information pertinent to FDA’s nanotechnology plans or policies.

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EPA to Seek Public Comment on ICTA Petition on Nanoscale Silver Products

Recent press reports have indicated, and an attorney with the International Center for Technology Assessment (ICTA) has confirmed, that the U.S. Environmental Protection Agency (EPA) contacted ICTA last week and informed the organization that it (EPA) intends to seek public comment on the nanoscale silver petition filed by ICTA and 13 other consumer, health, and environmental groups on May 1, 2008. The petition demanded, inter alia, that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act consumer products containing nanoscale silver. The petitioners requested that EPA respond to the petition “within a reasonable time.”

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PEN Releases Report on the Consumer Products Safety Commission and Nanotechnology

 On August 21, 2008, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars released its latest nanotechnology report, The Consumer Products Safety Commission and Nanotechnology, written by Dr. E. Marla Felcher. Dr. Felcher states that “[a] rapid increase in both the number and complexity of [nanotechnology-enabled consumer] products places significant responsibility on [the U.S. Consumer Product Safety Commission (CPSC)] to take the lead in regulating this new technology, but the agency is not in a position to do so.” After providing a brief history of the CPSC, Dr. Felcher asserts that the agency “has never lived up to its expectations,” and highlights five weaknesses in CPSC’s oversight capacity as exemplifying why CPSC is unable “to oversee the safety of complex, high-tech products made using nanotechnology”:

  1. Its data collection system is not nano ready;
  2. It has limited ability to inform the public about health hazards associated with nanotechnology products;
  3. It has limited ability to ensure that recalled products are removed from store shelves;
  4. It lacks sufficient enforcement personnel to identify manufacturers that fail to report nanotechnology product hazards; and
  5. It does not have sufficient authority to promulgate mandatory safety standards for nanotechnology products.

 

 

Federal Agencies Will Hold Workshop on Enabling Standards for Nanomaterial Characterization

The National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization.  According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to biological systems, to that of internationally accepted standards to accelerate research, development, risk identification, regulation, and widespread public adoption of nanotechnology. The workshop is intended to address this need on several fronts. Workshop sponsors and contributors include:  ASTM International; Food and Drug Administration (FDA); Nanotechnology Characterization Laboratory (NCL) at NCI-Frederick; National Cancer Institute (NCI); National Institute for Occupational Safety and Health (NIOSH); NIST; National Institute of Environmental Health Sciences (NIEHS); and Oregon Nanoscience and Microtechnologies Institute (ONAMI).  The workshop is limited to 100 attendees.

FDA Announces Public Meeting on Nanoscale Materials

In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the development of agency guidances.” Written comments in response to the Federal Register notice must be received by FDA no later than October 24, 2008.

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City of Cambridge Adopts Recommendations for a Municipal Health and Safety Policy on Nanomaterials

On July 28, 2008, the City Council of Cambridge, Massachusetts voted to accept a set of recommendations for a municipal health and safety policy on nanomaterials. The recommendations were set forth in a report prepared by the Cambridge Public Health Department (CPHD) and the Cambridge Nanomaterials Advisory Committee (CNAC). Cambridge now becomes the second city in the United States -- Berkeley, California is the other -- to have taken municipal action on nanomaterials. Continue Reading...

CRC Press Publishes Nanotechnology and the Environment

We are pleased to announce that CRC Press has published Nanotechnology and the Environment, which Lynn L. Bergeson co-authored. Nanotechnology and the Environment includes a general explanation of nanomaterials, their properties, and their uses; describes the processes used to manufacture nanoscale materials; furnishes information on the analysis of nanomaterials in the environment and their fate and transport, including the effects of wastewater treatment on nanomaterials; discusses possible risks to human health and the environment; and describes developing regulations to manage those risks. Continue Reading...

OPP Posts Page on Nanotechology and Pesticides

On July 22, 2008, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) posted a web page entitled “Pesticide Issues in the Works:  Nanotechnology, the Science of Small.” The web page states: “[The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and EPA’s implementing regulations provide an effective framework for regulating pesticide products that are a product of nanotechnology or that contain nanoscale materials.” According to the page, “EPA is currently examining potential hazard, exposure, policy, regulatory, and international issues that may be associated with pesticides that are a product of nanotechnology or that contain nanoscale materials.” While EPA has met with several companies “to discuss requirements for some specific nanoscale materials being considered for use as pesticides,” EPA has not yet received a formal registration application. EPA “strongly recommends” that companies contact the pesticide registration Ombudsmen “to arrange a pre-application conference as early as possible in the development of any pesticide that would be a product of nanotechnology or that would contain nanoscale material.”

EPA Prepared to Issue TSCA Section 8 Rule to Obtain Data

On July 22, 2008, Jim Willis stated that the U.S. Environmental Protection Agency (EPA) is prepared to issue a rule under Section 8 of the Toxic Substances Control Act (TSCA) to obtain data regarding nanoscale materials. Under the Nanoscale Materials Stewardship Program (NMSP) Basic Program, EPA asked companies to report data voluntarily on the engineered nanoscale materials they manufacture, import, process, or use. As of July 22, 2008, manufacturers of approximately 60 nanoscale materials had responded to EPA that they would participate in the NMSP. Willis stated that he hoped more companies would participate, so that data on about 100 nanoscale materials would be provided. The deadline for submissions under the Basic Program is July 28, 2008. Continue Reading...

Bill to Reauthorize NNI Introduced in Senate

On July 17, 2007, Senators Daniel K. Inouye (D-HI), Chair of the Commerce, Science, and Transportation Committee, John Kerry (D-MA), Olympia Snowe (R-ME), Ted Stevens (R-AK), Mark Pryor (D-AR) and Gordon Smith (R-OR) introduced the National Nanotechnology Initiative Amendments Act of 2008. The bill would reauthorize the National Nanotechnology Initiative (NNI) and amend aspects of the program to prioritize better research and development activities. Continue Reading...

PEN and GMA Review Regulatory Process for Nanomaterials in Food Packaging

On June 25, 2008, the Project on Emerging Nanotechnologies (PEN) and the Grocery Manufacturers Association (GMA) released a report entitled Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues, which concludes that engineered nanoscale materials use in food packaging materials raise new safety evaluation challenges for regulators and industry. The report uses hypothetical food packaging applications to examine how the regulatory process would apply to nanotech food packaging materials and to identify issues that should be addressed to ensure the process works effectively. According to the report, the unique focus of its dialogue among experts and stakeholders from government, industry, and the public interest community was “upstream” -- on products that have not yet been commercialized, but which contain features of products that would likely move from development into the marketplace.

Lynn L. Bergeson Will Participate in NSTI Nanotech 2008 Conference

We are pleased to announce that Lynn L. Bergeson will be speaking on June 2, 2008, at the Nano Science and Technology Institute (NSTI) Nanotech 2008 conference, which will run from June 1-5, 2008. She will be participating in a session on the U.S. Environmental Protection Agency’s Nanoscale Materials Stewardship Program. In addition, she is a co-presenter of the poster entitled “Nanomaterials down the drain: perception and reality.”

NIOSH Blog Asks Whether Carbon Nanotubes Should Be Handled Like Asbestos

On May 20, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted an entry on its science blog entitled “Nanotechnology: Should carbon nanotubes be handled in the workplace like asbestos?” The entry was prompted by the release of two recent reports contributing to the carbon nanotube/asbestos fiber comparison debate. The entry asks what the implications are to the risk assessment and risk management of carbon nanotubes in U.S. workplaces, and states:

However, questions have been raised about using these research findings for risk assessment analysis in the light of study limitations such as use of model animals, artificial administration methods, and sometimes extremely high doses, which are not representative of those exposures usually present in the workplace environment.  Such limitations are not unusual for pioneering scientific studies.  They simply mean that at this stage of the research, gaps remain that need to be closed by further study before quantitative risk assessment can be conducted.
Continue Reading...

EPA Seeks Participants for In-Depth Portion of NMSP

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

EHP-in-Press Posts Article Regarding Effects of Single-Wall Carbon Nanotubes

On May 16, 2008, EHP-in-Press posted an article entitled “Raw Single-Wall Carbon Nanotubes Induce Oxidative Stress and Activate MAPKs, AP-1, NF-κB, and Akt in Normal and Malignant Human Mesothelial Cells.” According to the article, the unique physicochemical and mechanical properties of single-wall carbon nanotubes have many potential new applications in medicine and industrial uses. The article states that exposure to single-wall carbon nanotubes induced generation of reactive oxygen species, increased cell death, enhanced DNA damage, H2AX phosphorylation, and activated poly(ADP-ribose) polymerase, activator protein-1, nuclear factor kappa B, protein p38, and protein serine-threonine kinase in a dose-dependent manner.  The article concludes that the cellular and molecular findings reported suggest that single-wall carbon nanotubes “can cause potentially adverse cellular responses in mesothelial cells through activation of molecular signaling associated with oxidative stress, which is of sufficient significance to warrant in vivo animal exposure studies.” EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

EPA Unified Agenda Includes Item on Nanoscale Materials Stewardship Program

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

ICTA-Led Coalition Petitions for FIFRA Regulation of Nanoscale Silver Products

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

GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research

On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research. Continue Reading...

Senate Committee Will Hold NNI Reauthorization Hearing

On April 24, 2008, the Senate Committee on Commerce, Science, and Transportation will hold a hearing entitled “National Nanotechnology Initiative: Charting the Course for Reauthorization.” The National Nanotechnology Initiative (NNI) currently receives approximately $1.5 billion. The hearing will examine the five-year period since the NNI was initially authorized in 2003 and explore issues the Committee should consider for the next reauthorization.  

Witnesses scheduled to speak at the hearing include:

  • Panel 1
  • The Honorable Richard M. Russell
    Associate Director and Deputy Director for Technology
    Executive Office of the President 
  • Mr. Robert A. Robinson
    Managing Director, Natural Resources and Environment Team
    U.S. Government Accountability Office
  • Panel 2
  • Mr. Matthew M. Nordan
    President
    Lux Research Incorporated 
  • Mr. David Rejeski
    Director, Foresight and Governance Project and Project on Emerging Nanotechnologies
    Woodrow Wilson Center  
  • Dr. P. Lee Ferguson
    Assistant Professor, Department of Chemistry and Biochemistry
    University of South Carolina 
  • Dr. Anita Goel
    Nanobiosym Incorporated
  • Dr. Jim Heath
    Director
    NSB Cancer Center

Congressional Briefing Held on Nanotechnology

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

PEN Report Finds States Could Prompt Federal Action Regarding Nanotechnology

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

EHP Includes Nanoparticles Correspendence and Article Regarding Nanotubes

The April 1, 2008, issue of Environmental Health Perspectives (EHP) includes correspondence regarding a 2007 EHP article concerning the aggregation and toxicology of titanium dioxide nanoparticles, as well as the authors’ response. The issue also includes an article entitled “Ecological Uptake and Depuration of Carbon Nanotubes by Lumbriculus variegatus.” The authors synthesized radioactively labeled nanotubes using a novel methane chemical vapor deposition procedure. According to the authors, the results suggest that purified carbon nanotubes do not readily absorb into organism tissues.

SVTC Calls for Increased Regulation of Nanomaterials

On April 2, 2008, the Silicon Valley Toxics Coalition (SVTC) released a report entitled Regulating Emerging Technologies in Silicon Valley and Beyond: Lessons Learned from 1981 Chemical Spills in the Electronics Industry and Implications for Regulating Nanotechnology.  According to SVTC, the emergence of nanotechnology is similar to the electronics industry in the early 1980s, when new manufacturing processes ultimately resulted in groundwater pollution throughout Santa Clara County. The report provides a case study of the regulatory landscape in Santa Clara County and traces the “clear and alarming parallels” to current regulations for nanotechnology. SVTC outlines recommendations for policy reform, based on closing existing gaps in data, technology, and safety. The report includes a set of sample questions that SVTC intends for communities to use to gather information about the use and safety of nanomaterials and processes in nearby facilities. Continue Reading...

NIOSH Seeks Participants for Field Research and for Metal Oxides Study

On March 25, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted fact sheets regarding several initiatives for which it seeks participants. NIOSH states that the initiatives are fully funded by NIOSH, and there is no monetary cost to the participant.  The first two fact sheets concern NIOSH’s Nanotechnology Field Research Team, which is available to conduct site visits at facilities involved in the research, manufacture, or use of various types of nanomaterials. The third fact sheet describes NIOSH’s metal oxide particle exposure assessment study, for which NIOSH seeks manufacturers and end-users of fine and ultrafine metal oxides. Continue Reading...

NSF-Funded Television Series to Air in April 2008

Nanotechnology: The Power of Small,” the first major television series to examine the implications of advances in nanotechnology, will begin airing on local public broadcasting stations in April 2008. The series is funded by the National Science Foundation (NSF) and the presenting station and grantee for the series is Oregon Public Broadcasting. In the episodes, award-winning National Public Radio correspondent John Hockenberry asks policymakers, scientists, journalists, and community leaders questions concerning nanotechnology’s potential to impact people’s privacy and security, health, and environment. Featured experts include Harvard University researcher George M. Whitesides, Project on Emerging Nanotechnologies (PEN) chief scientist Andrew Maynard, and author Joel Garreau, among others. Continue Reading...

CNSI Will Hold Legislative Summit on Nanotechnology

On April 25, 2008, the California Nanosystems Institute (CNSI) will hold a conference entitled “The Future of Nanotechnology: A Legislative Summit.” The conference sponsors include California Assembly Member Mike Feuer (AD 42-D), Office of the Vice Chancellor for Research (OVCR), State Government Relations (SGR), and CNSI. Panelists include Lenny Rome, Ph.D.; Andre Nel, Ph.D., MD; John Froines, Ph.D.; Hilary Godwin, Ph.D.; Tim Malloy, JD; and Jeffrey Wong. CNSI describes the conference as “the first step for stakeholders from industry, government, research institutes and environmental groups to discuss responsible ways to regulate nanotechnology without stifling progress.”

DuPont and ED Will Hold Nano Risk Management Training Workshops

DuPont and Environmental Defense (ED) will hold two interactive workshops on nano risk management. The workshops are intended to give participants the tools they need to:

  • Understand (and explain to others) why nano-specific risk management is necessary;
  • Assemble and leverage the internal and external resources to implement nano-specific risk management; and
  • Begin implementing nano-specific risk management in an efficient and effective manner.

The workshops will include:

  • Interactive discussions of how to implement nano-specific risk management;
  • Case studies of nano-specific risk management in use by companies and governments; and
  • Sources of additional help for companies adopting these approaches.

The first workshop will be held April 2, 2008, at the Sustainable Packaging Coalition in San Francisco, California. A second workshop will be held April 8, 2008, at the Toxics Use Reduction Institute in Boston, Massachusetts.

PTO Will Hold Nanotechnology Customer Partnership Meeting in April 2008

The U.S. Patent and Trademark Office (PTO) will hold a Nanotechnology Customer Partnership meeting on April 22, 2008. According to PTO, it intends the Partnership to provide a forum to share ideas, experiences, and insights between individual users and PTO. PTO states that it does not intend to use the Partnership to arrive at a group consensus.  Individual opinions are sought from varying participants, and the meetings are intended to be informal in nature.  Due to space limitations, PTO asks attendees to RSVP by e-mail or telephone to Jill Warden at (571) 272-1267 to confirm attendance.  If it becomes necessary to restrict the number of attendees, PTO will do so on a first come, first served basis.

FOE Releases Report on Nanotechnology in Food and Agriculture

A recent report released by Friends of the Earth (FOE) calls for a moratorium “on the further commercial release of food products, food packaging, food contact materials and agrochemicals that contain manufactured nanomaterials until nanotechnology-specific safety laws are established and the public is involved in decision making.” The report, entitled Out of the Laboratory and on to Our Plates:  Nanotechnology in Food & Agriculture, lists 104 commercially available foods, nutritional supplements, food contact materials, and agricultural chemicals identified by FOE that contain manufactured nanomaterials.  According to FOE, due to the “reluctance of food manufacturers to discuss their use of nanotechnology,” this list likely “represents only a small fraction of commercially available products that contain nanomaterials.” FOE states that many more nanofood products are in development, and many of the world’s largest food companies are exploring nanotechnology for food processing and packaging.  Many of the world’s largest agrochemicals and seed companies also have active nanotechnology research and development programs. FOE claims that regulations in the U.S., Europe, and Australia fail to address nanomaterials and calls for nano-specific food regulation to ensure food safety.

NIOSH Seeks Comment on Strategic Plan for Nanotechnology Research

Last week the National Institute for Occupational Safety and Health (NIOSH) requested comments on its Strategic Plan for NIOSH Nanotechnology Research and Guidance:  Filling the Knowledge Gaps (Strategic Plan).  NIOSH intends the Strategic Plan “to provide a tool for coordinating nanotechnology research across the Institute and to provide a guide for enhancing the development of new research efforts that will respond to the challenges of working with a new technology.” According to NIOSH, the Strategic Plan “represents a cohesive, multidimensional, and timely research agenda for addressing knowledge gaps concerning possible worker exposures to nanomaterials, the health risks from such exposure, and development of control technology and prevention measures.” Comments are due June 1, 2008. Continue Reading...

EPA Will Hold Meeting on Industry-Government Partnerships

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

NIOSH Publishes "Safe Nanotechnology in the Workplace"

On February 29, 2008, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a brochure entitled “Safe Nanotechnology in the Workplace: An Introduction for Employers, Managers, and Safety and Health Professionals.” The brochure addresses the following questions: whether nanoparticles are hazardous to workers; how workers can be exposed; whether nanoparticles can be measured; and whether worker exposures can be controlled. The brochure states that little information is available about the hazards of nanoparticles in the workplace, and that NIOSH is conducting research to determine whether they pose a health threat to exposed workers. According to the brochure, workers may be exposed by three routes: inhalation (the most common); ingestion; and skin. Traditional industrial hygiene sampling methods can be used to measure airborne nanoparticles, and scientists are developing more sensitive and specific sampling techniques. The brochure states that worker exposures can be controlled with engineering controls, respirators, and training.

PEN Brief Reviews Applicability of TRI to Nanomaterials

On February 26, 2008, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars released a brief entitled Application of the Toxics Release Inventory to Nanomaterials, which examines whether the Emergency Planning and Community-Right to-Know Act (EPCRA) and the Toxics Release Inventory (TRI) could be applied to nanomaterials. According to the brief, although several organizations have analyzed whether specific environmental laws could be used to regulate nanomaterials, none has examined EPCRA or TRI in any detail. Under TRI, the owners and operators of certain facilities are required annually to complete a toxic chemical release form for each listed toxic chemical manufactured, processed, or otherwise used in a certain quantity in the preceding year. The brief discusses how the following requirements may apply to nanomaterials: facilities; toxic chemicals; threshold amounts; and information reported.

NSET Releases Strategy for Nanotechnology-Related EHS Research

On February 14, 2008, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology released a final document entitled Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, which describes the National Nanotechnology Initiative’s (NNI) strategy for addressing priority research on the environment, health, and safety (EHS) aspects of nanomaterials. The NNI EHS Strategy assigns priority to research and information needs identified by the NSET Subcommittee. NNI released an interim version of the EHS Strategy in August 2007, entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment. NNI incorporated public comments in preparing the final EHS Strategy. The Nanotechnology Environmental and Health Implications (NEHI) Working Group developed the EHS Strategy “to accelerate progress in research to protect public health and the environment, and to fill gaps in, and -- with the growing level of effort worldwide -- to avoid unnecessary duplication of, such research.”

EPA Releases Draft Nanomaterial Research Strategy

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

CRS Report Reviews Possible Risk Management Approaches for Congress to Consider

According to a January 22, 2008, Congressional Research Service (CRS) report entitled Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, questions about the need for, and ideal form of, nanotechnology regulations are “exceedingly difficult” to address, given the current state of scientific understanding. CRS considered challenges faced by scientists, entrepreneurs, and agency officials involved in the National Nanotechnology Program as they work to define the characteristics of nanomaterials; the environmental, human health, and safety (EHS) risks they might pose; and how any potential risks should be addressed. The report states that challenges include the wide variety of nanomaterials and applications; lack of basic information about their properties; lack of conventions for naming, measuring, and identifying nanomaterials; the proprietary nature of some critical information; the need to prioritize federal resource needs; and a possible lack of clear statutory authority or appropriate regulatory framework to anticipate or respond to any identified risks. CRS states that, should Congress choose to intervene, it might choose any of several approaches: increasing funding for workshops in standardization or other research relevant to identifying and possibly ameliorating any EHS concerns associated with nanomaterials; changing the allocation of research money among agencies or the interagency research management structure; adopting a national or international research strategy; or enacting legislation that authorizes, mandates, or constrains agency actions to require information collection or to restrict production, sale, use, or disposal of nanomaterials.

EPA Announces Voluntary NMSP

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

Good Governance: Evolution of the Nanoscale Materials Stewardship Program

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson published an article appearing in the Winter 2007 issue of Nanotechnology Law & Business. The article discusses the U.S. Environmental Protection Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and related issues.

Wisconsin Representative Requests Assistance in Creating Registry

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

TSCA and Engineered Nanoscale Substances

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson and Ira Dassa published an article appearing in the Fall 2007 issue of Sustainable Development Law and Policy. The article discusses several issues in connection with the application of the Toxic Substances Control Act (TSCA) to engineered nanoscale materials.

NNI Releases Strategic Plan

On January 2, 2008, the National Nanotechnology Initiative (NNI) released its Strategic Plan, which describes NNI’s investment strategy and the program component areas called for by the 21st Century Nanotechnology Research and Development Act of 2003. Under the Act, NNI must update its Strategic Plan every three years, and this plan updates and replaces the December 2004 plan. The Strategic Plan outlines the goals and priorities of NNI and describes approaches for achieving them. NNI states that the Plan supports “leading edge research, sustains the extensive infrastructure of facilities, seeks to facilitate technology transfer, and addresses environmental, health, and societal concerns.”

NIOSH Summarizes Recent International Activities

On December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research:

  • On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to establish a NIOSH-led project to: (1) exchange information on measuring and controlling exposures to nanomaterials; and (2) develop suggestions for further steps by the Working Party.
  • At a December 4-7, 2007, meeting, a project group of the International Organization for Standardization (ISO) Technical Committee 229 voted to approve a draft report of safety and health practices in occupational settings relevant to nanotechnology. The draft report was based on NIOSH’s interim document entitled Approaches to Safe Nanotechnology, and was developed with NIOSH leadership and participation on the project group. 
  • On December 2, 2007, NIOSH participated in a meeting of the World Health Organization’s (WHO) Global Network of Collaborating Centres in Occupational Health, focusing on nanotechnology. The objective of the meeting was to determine how the WHO collaboration can develop and support research and cooperation in preventing exposure to potentially hazardous engineered nanoparticles. NIOSH is collaborating on five communication and networking projects with various WHO centers.

EPA Unified Agenda Includes Item on Nanoscale Materials Stewardship Program

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

PEN Hosts a Seminar on Nanotechnology and the Media

On December 18, 2007, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted a seminar, Nanotechnology & the Media: The Inside Story, to mark the release of a new PEN study on mass media coverage of nanotechnology risks. Conducted by Professor Sharon M. Friedman and Brenda P. Egolf of Lehigh University, the study identified a sizable increase in 2006 over previous years in the number of stories appearing in American and British newspapers and wire services on nanotechnology risks. The study also showed a surge in the number of articles addressing government regulation of nano and a simultaneous decrease in media reports focused on scientific issues (e.g., nano-related study/research results).

FDLI and PEN Will Cosponsor First Annual Conference on Nanotechnology Law, Regulation, and Policy

The Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include:

  • How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force Report?
  • How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech issues in the workplace?
  • Is Congress ready to act on nanotechnology if federal regulators don’t?
  • What first and second generation nanotechnology products are already on the market, and what’s to come?
  • Do Europe and Asia approach nanotechnology safety and oversight differently than the United States?
  • When it comes to nanotechnology, should size make a regulatory difference?

Draft CIB on Medical Screening of Workers Potentially Exposed to Nanoparticles Available for Comment

On December 12, 2007, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of the draft Current Intelligence Bulletin (CIB) entitled “Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.” NIOSH will hold a public meeting on the draft CIB on January 30, 2008. The meeting will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Because the meeting room accommodates only 80 people, NIOSH must receive notification of intent to attend the meeting no later than January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify NIOSH no later than January 11, 2008. NIOSH will give priority for attendance to those providing oral comments. NIOSH will then accommodate other requests to attend the meeting on a first-come basis. Comments on the draft CIB are due February 15, 2008. Continue Reading...

Environmental Defense Suggests Potential Model for Restructuring NNI

On November 19, 2007, Environmental Defense (ED) issued a press release that states that the National Nanotechnology Initiative (NNI) is not effectively addressing the potential risks of nanotechnology, and that a potential model for resolving the conflict between NNI’s dual charges to both promote and oversee the technology could be drawn from the Atomic Energy Commission (AEC). Like the NNI, the AEC, first established in 1946, was tasked with both encouraging the development and use of nuclear power and regulating its safety. Concerns about this dual charge led Congress to abolish the AEC in 1975, and to assign its risk research and oversight functions to a new entity, the Nuclear Regulatory Commission. In the press release, ED suggests that an entity within NNI, “either newly formed or significantly elevated in status,” could be given independent budgetary and management authority, responsibility, accountability, and resources to develop and direct the overall federal nanomaterial risk research strategy.

Congressional Nanotechnology Caucus Holds Briefing

On November 19, 2007, the Congressional Nanotechnology Caucus held a briefing on “Nanotechnology and Environment, Health & Safety Issues.” The panel of speakers included Vicki Colvin, Ph.D., Professor of Chemistry and Chemical Engineering, Center for Biological and Environmental Nanotechnology, Rice University; Andrew Maynard, Ph.D., Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars; and Pat Casano, Counsel for Environmental, Legislative, and Regulatory Affairs, General Electric. The panel discussed the environmental, health, and safety (EH&S) implications of nanotechnology.

Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight

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

Pesticide Registration Applications Could Include Particle Size Information

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

EHP Publishes Research Article and Meeting Report on Nanomaterials

The November 1, 2007, issue of Environmental Health Perspectives (EHP) includes a research article and meeting report concerning nanomaterials. The research article, entitled “Nanosize Titanium Dioxide Stimulates Reactive Oxygen Species in Brain Microglia and Damages Neurons in Vitro,” describes the in vitro neurotoxicity of P25, a commercially available titanium dioxide nanomaterial. According to the study, P25 appears to be non-toxic to isolated N27 neurons, but stimulates BV2 microglia to produce reactive oxygen species and damages oxidative stress-sensitive neurons in cultures of brain striatum. The meeting report, entitled “Meeting Report: Hazard Assessment for Nanoparticles -- Report from an Interdisciplinary Workshop,” presents the findings from a nanotoxicology workshop held on April 6-7, 2006, at the Woodrow Wilson International Center for Scholars. Meeting attendees addressed two questions: what information is needed to understand the human health impact of engineered nanoparticles, and how this information is best obtained. Continue Reading...

House Subcommittee Holds Hearing on Relationship Between Environmental and Health Policy and Nanotechnology

On October 31, 2007, the House Committee on Science and Technology’s Research and Science Education Subcommittee held a hearing on the relationship between environmental and health policy and nanotechnology. The Subcommittee examined how the U.S. can stay at the forefront of scientific research and development, while at the same time establishing priorities and a detailed plan for research on the potential environmental and health risks of engineered nanomaterials. The Science and Technology Committee held two previous hearings on this issue -- one in 2005 and another in 2006 -- with the objective of reviewing the importance of risk research for achieving the potential benefits of nanotechnology and the efforts of the interagency National Nanotechnology Initiative (NNI) to put in place a research strategy. Progress in developing the research strategy has been slow, however. The hearing explored the status of the planning efforts and received suggestions from outside witnesses on ways to improve the process. Continue Reading...

Nanomaterials Included on ATSDR List of Proposed Substances for Toxicological Profile Development

On October 25, 2007, the Agency for Toxic Substances and Disease Registry (ATSDR) requested nominations from a list of proposed substances that it will evaluate for toxicological profile development. The list of proposed substances includes nanomaterials. According to the notice, ATSDR will evaluate all data and information associated with the nominated substances and will determine the final list of substances to be chosen for toxicological profile development. Comments are due November 26, 2007.

NTP Board Will Review Proposed Research and Testing of Nanoscale Gold

On October 17, 2007, the National Toxicology Program (NTP) announced that the Board of Scientific Counselors (BSC) will meet on December 6, 2007. The notice states that the preliminary agenda topics include review of NTP study nominations and proposed research and testing activities for several substances, including nanoscale gold. Written comments are due November 21, 2007. The deadline for pre-registration is November 29, 2007. NTP will post when available a copy of the preliminary agenda, committee roster, draft NTP research concepts, and any additional information on the NTP website. The meeting will be videocast through the Internet.

EPA Provides Summary of August 2007 NMSP Meeting

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

Internet Dialogue on Nanotechnology Focuses on Consumers

On October 23-24, 2007, the Project on Emerging Technologies (PEN), in collaboration with Consumers Union -- publisher of Consumer Reports magazine and Consumer Reports Online -- will host an online conversation about nanotechnology and consumer products. The event, ConsumersTalkNano, is intended to provide an easily accessible venue for the public to discuss information and share thoughts about the usage and potential benefits and risks of consumer products made with nanomaterials. The dialogue will explore key issues surrounding the ways that the American public, researchers, policymakers, scientific experts, and the media learn about and respond to nanotechnology consumer products. Participants in the dialogue will be able to ask questions of expert panelists, examine the use of nanotechnology in consumer products, discuss who is responsible for oversight, and communicate on needed future actions. PEN plans to use the information gained from the event to inform policymakers about how consumers perceive the use of nanotechnology in products that they can buy in the stores or over the Internet and what consumers think about related risks, benefits, and uncertainties. The ConsumersTalkNano website will host videos, podcasts, and links to information about nanotechnology. Individuals interested in participating in the dialogue should register to receive updates and further details about the dialogue.

California Hosts Symposium on Potential Hazards of Nanoparticles in the Environment

On October 3, 2007, the California Department for Toxic Substances Control (DTSC) held a symposium on the potential hazards of nanoparticles in the environment. According to DTSC, exploring environmentally safe processes in nanotechnology manufacturing is a component of the California Green Chemistry Initiative.  Under the Initiative, a multi-agency state team is exploring a different approach to environmental protection -- transitioning away from managing toxic chemicals at the end of the life-cycle, to reducing or eliminating their use altogether.  DTSC states that this new approach is similar to measures adopted by the European Union (EU) and the Canadian government to encourage greater manufacturer responsibility. Continue Reading...

Poll Gauges Public Knowledge of Nanotechnology

The Project on Emerging Nanotechnologies (PEN) has released the findings of a national survey that indicates Americans’ awareness of nanotechnology remains low.  The fact that only 6 percent of Americans say they have “heard a lot” about nanotechnology is surprising, given that approximately $50 billion worth of nano-goods were on the market in 2006 -- a number that is growing quickly. Specific survey questions examined opinions on the safety of our food system, as well as the use of nanotechnology in food packaging and products. Continue Reading...

NNI Releases Brochure Entitled "Big Things from a Tiny World"

The National Nanotechnology Initiative (NNI) recently released a brochure entitled “Big Things from a Tiny World.” The brochure is intended for general readers rather than scientists, and describes what nanotechnology is, what nanotechnology-related products are available now, and the potential contributions of nanotechnology to address issues such as clean, renewable energy, clean water, and medical devices and drugs. The brochure also describes potential technological impacts and the research that is under way to identify those impacts.

ACGIH Will Present Webinar on Nanotechnology Health and Safety

The American Conference of Governmental Industrial Hygienists (ACGIH) will hold a webinar entitled “Nanotechnology Health and Safety: Case Studies in the Occupational Setting” on December 4, 2007. The webinar will discuss the uncertainties associated with the hazards and potential risks of working with engineered nanoparticles; describe ways to help manage exposure to engineered nanoparticles; and illustrate how occupational health and safety controls, both engineering and administrative, can be implemented to manage better worker health and safety.  Additionally, the webinar will present case studies that will highlight how select organizations that use engineered nanoparticles in production facilities (metal oxide and metal alloy), as well as research laboratories, are addressing the safety and health issues behind this new technology. Continue Reading...

Environmental Health Perspectives Publishes Study Regarding Pharmacokinetics of Quantum Dots

The September 1, 2007, issue of Environmental Health Perspectives includes an article entitled “Persistent Tissue Kinetics and Redistribution of Nanoparticles, Quantum Dot 705, in Mice: ICP-MS Quantitative Assessment.”  The purpose of the study was to assess the tissue disposition and pharmacokinetics of quantum dots (QD705) in mice.  According to the article, the plasma half-life of QD705 in mice was short (18.5 hours), but analyses revealed QD705 persisted and even continued to increase in the spleen, liver, and kidney 28 days following an intravenous dose.  Considerable time-dependent redistribution from body mass to liver and kidney was apparent between 1 and 28 days post-dosing.  The recoveries at both time points were near 100%; all QD705s reside in the body.  Neither fecal nor urinary excretion of QD705 was detected appreciably in 28 days post-dosing.  Fluorescence microscopy demonstrated deposition of QD705 in the liver, spleen, and kidneys.

Nanoparticle Flow Processing Consortium Files Notifications with DOJ and FTC

On August 27, 2007, the Antitrust Division of the Department of Justice (DOJ) published a notice in the Federal Register announcing that, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. Sections 4301 et seq., the Nanoparticle Flow Processing Consortium has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission (FTC) disclosing (1) the identities of the parties to the venture and (2) the nature and objectives of the venture. The notice states that the Consortium filed the notifications for the purpose of invoking the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: 3M Company, St. Paul, Minnesota; The Proctor & Gamble Company, Cincinnati, Ohio; Corning Incorporated, Corning, New York; BASF Aktiengesellschaft, Ludwigshafen, Germany; and Imperial Chemical Industries PLC, London, United Kingdom. The general area of the Consortium’s planned activity is to: (1) develop, test, and validate computer-simulation technologies of near-term application that can improve the quality and reduce the cost of nanoparticle suspension/dispersion manufacture (including suspension stability and processibility); (2) transfer the technology developed under the Research and Development Program in a manner that offers the Consortium members opportunities for commercial advantage; and (3) develop methodologies and aptitude for modeling and simulation of multiscale phenomena intrinsic to the stability and dynamics of dense, nanoparticle suspensions.

FDA Releases Proposed Rule Regarding Sunscreens

Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register. Continue Reading...

CDTSC Will Hold Symposium on Potential Hazards of Nanomaterials in the Environment

The California Department of Toxic Substances Control (CDTSC) will hold a symposium entitled “Nanotechnology Symposium II:  Potential Hazards of Nanomaterials in the Environment” on October 3, 2007. The draft agenda includes the following topics: 

  • Chemical Properties and Commercial/Industrial Applications of Nanotechnology;
  • Physico-Chemical Characterization of Nanoparticles and Its Relation to Their Bio-Interactions;
  • Potential Ecotoxicity of Nanoparticles Released to the Environment;
  • Nanomaterial Human Health Risks and Risk Assessment; and
  • One Proactive Approach to Responsible Nanotechnology Development:  The DuPont -- Environmental Defense NanoRisk Framework.

President's Council on Bioethics Will Discuss Ethical Issues Associated with Nanotechnology

On August 14, 2007, the Department of Health and Human Services (DHHS) published a Federal Register notice announcing the 30th meeting of the President’s Council on Bioethics. The agenda items listed in the notice include “continue the exploratory phase of a potential inquiry into ethical issues associated with nanotechnology with expert presentations and Council discussions.” The meeting will be September 6-7, 2007.

EHS Research Priorities Released for Comment

On August 16, 2007, the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007. Continue Reading...

EHP-in-Press Reports Study on Neurotoxicity of P25 Nanomaterial

On August 3, 2007, EHP-in-Press posted an article entitled “Nanosize Titanium Dioxide Stimulates Reactive Oxygen Species in Brain Microglia and Damages Neurons, In Vitro.” The article describes the in vitro neurotoxicity of P25, a commercially available titanium dioxide nanomaterial. According to the study, P25 appears to be non-toxic to isolated N27 neurons, but stimulates BV2 microglia to produce reactive oxygen species and damages oxidative stress-sensitive neurons in cultures of brain striatum. EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

NIOSH Posts MSDSs for Nanomaterials in NIL

The National Institute for Occupational Safety and Health (NIOSH) has posted several material safety data sheets (MSDS) for nanomaterials in its Nanoparticle Information Library (NIL). The goal of the NIL is to help occupational health professionals, industrial users, worker groups, and researchers organize and share information on nanomaterials, including their health and safety-associated properties.  To view the MSDSs, enter msds in the search field.

International Coalition Urges Nano-Specific Regulations

On July 31, 2007, an international coalition of consumer, public health, environmental, and labor organizations issued the Principles for the Oversight of Nanotechnologies and Nanomaterials and called for strong, comprehensive oversight of the new technology and its products. According to the coalition, the manufacture of products using technology has “exploded in recent years,” while “evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards.” Continue Reading...

EPA Holds Public Meeting on the NMSP

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

Nanotechnology Bill Introduced in House

On July 31, 2007, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (HR 3235), which is 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 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. Continue Reading...

FDA Nanotechnology Task Force Issues Report

On July 25, 2007, the Food and Drug Administration (FDA) Nanotechnology Task Force issued its report, which addresses regulatory and scientific issues and offers recommendations for each. The Task Force intends its report to outline ways for FDA to enhance its knowledge of nanotechnology to support its oversight for products using such technology, and to inform interested stakeholders what information may be needed to support the marketing of FDA-regulated products that use nanoscale materials. The Task Force recommends FDA consider developing specific guidance for manufacturers and researchers, including guidance to clarify what information should be provided to FDA about products and when the use of nanoscale materials may change the regulatory status of particular products. In its press release announcing the availability of the Task Force report, FDA states that, as with other FDA guidance, “draft guidance documents would be made available for public comment prior to being finalized.” The Task Force also recommends that FDA work to assess data needs to better regulate nanotechnology products; develop in-house expertise; ensure consideration of relevant new information on nanotechnology as it becomes available; and evaluate the adequacy of current testing approaches to assess safety, effectiveness, and quality of nanoscale materials.

Council of State and Territorial Epidemiologists Issues Statement on the Occupational and Environmental Risks of Nanotechnology

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

EPA Will Hold NMSP Public Meeting and Releases Draft Documents

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

EPA Awards Almost $600,000 to Oregon State University Nanotechnology Researchers

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

EPA Will Hold Conference on "Pollution Prevention through Nanotechnology"

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

  • Products: Less toxic, less polluting, and wear-resistant.
  • Processes: More efficient and waste-reducing.
  • Energy and Resource Efficiency: Processes and products that use less energy and fewer raw materials because of greater efficiency.
Registration is open until September 14, 2007, but is not required to attend the conference. Continue Reading...

Final Nano Risk Framework Released

On June 21, 2007, Environmental Defense (ED) and DuPont, who commenced a partnership on nanotechnology in September 2005, released the final Nano Risk Framework, which establishes “a systematic and disciplined process for identifying, managing, and reducing potential environmental, health, and safety risks of engineered nanomaterials across all stages of a product’s ‘lifecycle.’” The Framework is aimed primarily at organizations, both private and public, that are actively working with nanomaterials and developing associated products and applications. ED and DuPont believe that “adoption of the Frameworkcan promote responsible development of nanotechnology products, facilitate public acceptance, and support the formulation of a practical model for reasonable government policy on nanotechnology safety.”

NTP Board of Scientific Counselors Reviews Nomination of Nanoscale Silver for Testing

At its June 22, 2007, meeting, the National Toxicology Program’s (NTP) Board of Scientific Counselors (BSC) reviewed nominations of several substances for testing, including nanoscale silver. The Food and Drug Administration nominated nanoscale silver for toxicological studies “based on (a) increasing widespread use in drug, food and cosmetic products, and (b) the general lack of data on the toxicology and pharmacokinetics of these materials.” Comments on the testing nomination were submitted by the People for the Ethical Treatment of Animals (PETA) and the Physicians Committee for Responsible Medicine (PCRM); the Nano Testing Consortium; and the Silver Institute.

Nano-Bio Interaction Workshop Materials Available

The International Council on Nanotechnology (ICON) held a workshop entitled “Towards Predicting Nano-Bio Interactions” on June 5-7, 2007. The plenary presentations and meeting information are now online.

EHP-in-Press Publishes Study Regarding Pharmacokinetics of Quantum Dots

EHP-in-Press published an article entitled “Persistent Tissue Kinetics and Redistribution of Nanoparticles, Quantum Dot 705, in Mice: ICP-MS Quantitative Assessment.” The purpose of the study was to assess the tissue disposition and pharmacokinetics of quantum dots (QD705) in mice. According to the article, the plasma half-life of QD705 in mice was short (18.5 hours), but analyses revealed QD705 persisted and even continued to increase in the spleen, liver, and kidney 28 days following an intravenous dose. Considerable time-dependent redistribution from body mass to liver and kidney was apparent between 1 and 28 days post-dosing. The recoveries at both time points were near 100%; all QD705s reside in the body. Neither fecal nor urinary excretion of QD705 was detected appreciably in 28 days post-dosing. Fluorescence microscopy demonstrated deposition of QD705 in the liver, spleen, and kidneys. EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

FDA Announces New Advisory Committee to Address Risk Communication

On June 4, 2007, the Food and Drug Administration (FDA) announced a new advisory committee intended to counsel FDA on how to strengthen the communication of risks and benefits of FDA-regulated products to the public. The Risk Communication Advisory Committee will:

  • Help FDA better understand the communication needs and priorities of the general public;
  • Advise FDA on the development of strategic plans to communicate product risks and benefits; and
  • Make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

Congressional Nanotechnology Caucus Will Host Nanotechnology and Energy Events

On June 18, 2007, the Congressional Nanotechnology Caucus will host a briefing on Nanotechnology Applications for Renewable Energy. On July 16, 2007, the Caucus will host a briefing on Nanotechnology Applications for Energy Conservation. Each event will begin at 2 p.m. (EDT). The purpose of the Congressional Nanotechnology Caucus is to promote nanotechnology, educate policy makers about this emerging area, and facilitate communications between industrial and academic researchers and the Hill.

NPR Program Discusses New Approaches to Nanotechnology

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

July Issue of Consumer Reports Includes Article on Nanotechnology

The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.

PEN Report Recommends TSCA Amendments

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

NRDC Report Claims U.S. Has Failed to Protect Citizens from Nanomaterials

On May 15, 2007, the Natural Resources Defense Council (NRDC) issued a report entitled Nanotechnology’s Invisible Threat: Small Science, Big Consequences, which claims that the U.S. government has failed “to use its authority to protect citizens from the potentially dangerous effects of nano-scale chemistry.” Continue Reading...

U.S. - European Union Integration on Nanotechnology

At the 2007 U.S.-European Union (EU) Summit in Washington, D.C. late last month, President Bush and European Union (EU) leaders signed an economic integration agreement, the Framework for Advancing Transatlantic Economic Integration Between the United States of America and the European Union.

Continue Reading...

New NSF-Funded Study on Silver Nanoparticles

Two researchers at the University of Missouri -- Columbia’s College of Engineering have received an $84,000 grant from the National Science Foundation (NSF) to study the potential effects of silver nanoparticles on wastewater treatment systems. According to a university press release, Baolin Deng, an associate professor of civil and environmental engineering, and Zhiqiang Hu, an assistant professor of civil and environmental engineering, “will determine how silver nanoparticles interact with bacteria that are used for wastewater treatment.” Already present in a wide range of consumer products, silver nanoparticles enter the wastewater stream when people who have used silver nanoparticle-enhanced products (e.g., cosmetics, bandages) wash themselves. The study is expected to be completed by June 2008.

ED Will Hold Webcast on REACH, TSCA, and CEPA Best Practices

Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA). Continue Reading...

City of Berkeley Issues Manufactured Nanoscale Material Reporting Guidance

The Toxics Management Division (TMD) in the City of Berkeley’s Planning and Development Department has issued guidance on the nanoparticle municipal ordinance that the Berkeley City Council adopted on December 12, 2006. Under the ordinance, facilities that manufacture or use “manufactured nanoparticles” must submit to the TMD “a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.” The term “manufactured nanoparticles” is defined to mean particles “with one axis less than 100 nanometers in length.” The TMD guidance makes clear that facility reports covering the period June 1, 2007 -- June 2, 2008, are due by June 1, 2007, and must include, among other things, toxicological and ecological information about the nanoscale material and information about the potential exposure pathways and likelihood of exposure via those pathways.

Regulatory Agenda Includes Nanoscale Materials Stewardship Program

On April 30, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its latest Semiannual Regulatory Agenda, which serves to update the public on regulations and major policies currently under development by EPA.  One of the entries in the Toxic Substances Control Act (TSCA ) portion of the agenda is entitled "Nanoscale Materials Under TSCA" and addresses the forthcoming Nanoscale Materials Stewardship Program (NMSP), the design of which EPA publicly announced in October 2006.  The agenda entry estimates that drafts of various documents -- "a document that describes the specific elements of the voluntary [NMSP]," "an updated document that describes the approach to nanoscale materials under TSCA and a paper that describes determining the inventory status of nanoscale materials" -- will be made available sometime this month.  While we recognize that the Regulatory Agenda is often quite inaccurate in terms of forecasting, we did not want this brief update to go overlooked.  The NMSP documents are currently undergoing inter-agency review.

EPA Requests Stakeholders to Resubscribe to E-Mail Notification List

On April 16, 2007, the U.S. Environmental Protection Agency (EPA) announced that, due to a technical problem, it is unable to verify receipt of contact information from anyone who subscribed to the e-mail notification list on the Office of Pollution Prevention and Toxics (OPPT) Nanotechnology web page from October 18 to November 1, 2006, and again from January 18 to January 23, 2007.  According to EPA, it has corrected the problem and is now compiling a list of stakeholders to contact as the Nanoscale Materials Stewardship Program moves forward.  EPA requests that anyone who subscribed to the e-mail notification during these periods do so again.

Joint Economic Committee of Congress Releases a New Study on Nanotechnology

In mid-March 2007, Representative Jim Saxton (R-NJ), the ranking minority member of the Joint Economic Committee (JEC), released a new Congressional study on nanotechnology. On balance an extremely positive report, the JEC Study “discusses the range of sciences currently covered by nanotechnology,” describes “what nanotechnology is and how it relates to previous scientific advances,” as well as “the most likely future development of different technologies in a variety of fields,” and includes a review of the federal government’s current nanotechnology policy. Importantly also, the report urges three changes pertinent to the use of nanotechnology in products: product labeling; disclosure to FDA of safety testing and publication of any adverse results; and enhanced public education in the area of nanotechnology.

ICON Launches Nanotechnology Journal

The International Council on Nanotechnology (ICON) and Rice University’s Center for Biological and Environmental Nanotechnology (CBEN) announced on March 22, 2007, they have launched a monthly online journal that contains citations and links to articles on the environment and health impacts of nanotechnology. The ICON and CBEN coalition launched the first online database of nanomaterial scientific findings in August 2005, but the new journal -- The Virtual Journal of Nanotechnology Environment, Health & Safety (VJ-Nano EHS) -- “has taken the concept one step further,” the coalition said. The virtual journal organizes the information contained in the existing database into a reader-friendly monthly journal format. New features include a rotating guest editorship and a series of papers on topics of interest taken from the database. Contents of the journal are searchable. In the future, the coalition said, the journal will include a section on the most cited nanotechnology environment, health, and safety papers.

Lynn L. Bergeson Presents What's New in Nanotechnology

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

PEN Releases LCA Report

On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts. Continue Reading...

Senate Requests GAO Review of NNI

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

NIOSH Reports Progress Made in Protecting Workers from Nanomaterials

In February 2007, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled Progress Toward Safe Nanotechnology in the Workplace, which summarizes the progress made by the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006.  According to NIOSH, by redirecting existing resources, NTRC developed a research program that has made progress towards hazard identification and characterization, exposure assessment, risk assessment, and risk management. Continue Reading...