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

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.

The proposed rule provides the following basis for action:

The PMN states that the substance will be used as an additive/filler for polymer composites and support media for industrial catalysts. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance. For the uses described in the PMN, worker inhalation and dermal exposures are minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of gloves and protective clothing, where there is a potential for dermal exposure; use of the substance without a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with an N100 cartridge, where there is a potential for inhalation exposure; or use other than as described in the PMN, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at 721.170(b)(3)(ii).

The proposed SNUR would apply only to the multi-walled carbon nanotubes described in premanufacture notice (PMN) P08-199. According to EPA, in the past, some stakeholders have asked whether these types of SNURs apply to all variants of carbon nanotubes. EPA states: “This is not the case.” The chemical name listed in the proposed SNUR is “multi-walled carbon nanotubes (generic),” and the CAS Number is “not available.” On November 6, 2009, EPA published a proposed SNUR for the multi-walled carbon nanotubes described in PMN P08-177.

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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.

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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.

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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.

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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.

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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.”

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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.

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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.

Lynn L. Bergeson moderated a panel concerning chemicals regulation and nanomaterials, and Steve Owens, Assistant Administrator for Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency (EPA), was one of the panelists. According to Owens, EPA is considering proposing new reporting requirements for manufacturers of nanomaterials. Owens described the Nanoscale Materials Stewardship Program, which EPA intended to encourage submission and development of information, including risk management practices for nanoscale materials, “less than a resounding success.” The reporting requirements would help EPA collect more environmental, health, and safety data regarding nanomaterials.

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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.

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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.

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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.

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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).

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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.”

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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.

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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.

Speakers include:

• Assembly Member Mike Feuer, 42nd District
• Kristan Markey, EPA Nanoscale Materials Stewardship Program (NMSP)
• Richard Denison, Ph.D., Environmental Defense Fund (ED)
• Professor Timothy Malloy, UCLA
• Mark Bünger, Lux Research
• Mary Beth Miller, Unidym, Inc.
• Sheila Davis, Silicon Valley Toxics Coalition
• Eric M.V. Hoek, Ph.D., UCLA

 

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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).

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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.”

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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.

The notice includes the following information:

Case No.	Use	Chemical
P-08-0733	(G) (1) A reinforcement for composites: Open, non-dispersive use; (2) A conductive additive for composites: Open, non-dispersive use; (3) A conductive additive for batteries: Contained use	(G) A multi-walled CNT
P-08-0734	(G) (1) A reinforcement for composites: Open, non-dispersive use; (2) A conductive additive for composites: Open, non-dispersive use; (3) A conductive additive for batteries: Contained use	(G) A multi-walled CNT

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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.

 

The notice includes the following information:

Case No.	Use	Chemical
P-09-0054	(S) (1) Compound for use in organic electronic devices.  (2) Compound used to improve the mechanical properties of rubbers, plastics, and lubricants.  (3) Compound for use as an additive to increase the conductivity of materials.	(S) [5,6]fullerene-C60-ih
P-09-0055	(S) (1) Compound for use in organic electronic devices. (2) Compound used to improve the mechanical properties of rubbers, plastics, and lubricants. (3) Compound for use as an additive to increase the conductivity of materials.	(S) [5,6]fullerene-C70-d5h(6)
P-09-0056	(S) (1) Compound for use in organic electronic devices. (2) Compound used to improve the mechanical properties of rubbers, plastics, and lubricants. (3) Compound for use as an additive to increase the conductivity of materials.	(S) [5,6]fullerene-C84-d2
P-09-0057	(S) (1) Compound for use in organic electronic devices. (2) Compound used to improve the mechanical properties of rubbers, plastics, and lubricants. (3) Compound for use as an additive to increase the conductivity of materials.	(S) [5,6]fullerene-C84-d2d

 

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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.

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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.

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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.

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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.

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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).

EDF obtained a redacted copy of the consent order, and provides the following summary of the requirements:

• Conduct a 90-day inhalation toxicity test in rats;
• Supply EPA with a one-gram sample of its MWCNTs and its Material Safety Data Sheet;
• Submit certain characterization data within six months after commencing full manufacture;
• Require its workers to wear protective gloves and clothing shown to be impermeable and National Institute for Occupational Safety and Health (NIOSH)-approved respirators;
• Use the substance only for a particular use, claimed confidential but generically identified as a “property modifier” in electronics and polymer composites; and
• Provide the nanomaterial only to entities that agree to the same use restrictions and worker protection conditions.

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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.

According to EPA, the UCLA CEIN will develop a predictive scientific model to study the environmental and health effects of different types of nanomaterials and human health faster than can be done by traditional animal toxicity testing.  The model to be developed will consider: which nanomaterials are most likely to come into contact with the environment, which animals/plants can act as early sentinels of environmental changes, and high throughput methods to screen many chemicals quickly.

At Duke University’s CEIN, researchers plan to study the potential environmental and biological effects on a wide range of nanomaterials -- from natural to man-made, using a novel outdoor laboratory approach.  In the coming year, the research team will develop 32 tightly controlled and monitored ecosystems in Duke Forest in Durham, N.C.  Known as “mesocosms,” these living laboratories provide areas where researchers can add nanoparticles and study the resulting interactions and effects on plants, fish, bacteria, and other elements.

 

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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.

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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.”

According to the ICTA attorney, EPA is preparing a Federal Register notice that will invite public comments on the ICTA Petition. It is not yet known how long the comment period will be or when the notice will be published in the Federal Register. The EPA Office of Pesticide Programs’ recently posted webpage on nanotechnology does not make any mention of the impending notice.

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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.”

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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.

EPA invites companies that manufacture, import, process, or use nanoscale materials for commercial purposes to join the NMSP, including those who:

• Manufacture or import engineered nanoscale materials;
• Physically or chemically modify or process an engineered nanoscale material;
• Physically or chemically modify or process a non-nanoscale material to create an engineered nanoscale material; or
• Use engineered nanoscale materials in the manufacture of a product.

EPA also invites others, including researchers who develop or study engineered nanoscale materials, to participate. Any participation in the NMSP is voluntary.

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

Submissions under the NMSP basic program include:

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

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

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

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

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

The petition requests that EPA take the following actions:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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