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

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

EPA Announces RCC Nanotechnology Webinar and Requests Nominations for Case Studies

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

Under the Nanotechnology Work Plan, there is a pilot project to examine Canadian and U.S. risk assessment and risk management practices and approaches through an evaluation of case studies for specific nanomaterials. EPA states that Canada and the U.S. are considering a number of materials for the case studies and would welcome suggestions from stakeholders. Proposals of nanomaterials for consideration are due October 25, 2012, and must include:

  • Chemical name of the nanomaterial;
  • Whether the nanomaterial has been notified to/reviewed by either jurisdiction;
  • Commercial applications of the nanomaterial;
  • Information on exposure and environmental fate of the nanomaterial;
  • A complete list of available test data on the nanomaterial and related analogs, including environmental and human toxicity studies; and
  • Acknowledgment that, for the purposes of this exercise, both Canada and the U.S. will be able to exchange information freely, including confidential business information (CBI).

 

NRC Report on Science for Environmental Protection Examines Nanotechnology

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

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

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

EPA Extends Due Date for Comments on Nanosilver Registration Review

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

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

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

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

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

In its April 16, 2012, brief, NRDC argues that EPA’s decision that HeiQ AGS-20 will not cause unreasonable adverse effects on human health was not supported by substantial evidence. According to NRDC, in calculating the risks to human health, “EPA failed to evaluate the risks to infants, even though they have an especially high likelihood of exposure to AGS-20 because they are more likely than other age groups to chew on textiles coated with it.” NRDC states that had EPA properly taken infants into account, application of its own risk criteria “would have shown that AGS-20 poses unacceptable risks, and thus may have ‘unreasonable adverse effects.’” NRDC further argues that EPA likewise failed to consider the risk of aggregate exposures from other nanosilver on the market. Had it done so, NRDC states, EPA’s analysis would have shown that registering AGS-20 creates unacceptable risks. NRDC concludes that, because EPA’s finding of no “unreasonable adverse effects” rested on “significantly understated risk assessments,” its decision is not supported by substantial evidence and must be vacated.

On April 23, 2012, the International Center for Technology Assessment, Center for Food Safety, Friends of the Earth, Beyond Pesticides, Center for Environmental Health, and Institute for Agriculture and Trade Policy filed a motion for leave to file a brief as amici curiae in support of NRDC. According to the motion, counsel for amici contacted the parties seeking their consent. NRDC consented, while EPA and Intervenor, HeiQ Materials AG, took no position.

The amici argue that, as stakeholders whose organizational and membership interests will be harmed by the conditional release of HeiQ AGS-20 nanosilver pesticide products, as well as by the regulatory precedent EPA’s action “sets more broadly” for U.S. oversight of nanotechnology, nanomaterials, and nanosilver pesticides, they have “a strong interest in presenting their concerns regarding the conditional registration of HeiQ, as well as offering the Court the broader ‘nano-world’ perspective surrounding this specific approval action.” According to amici, because EPA ignored “the hundreds of other nano-silver pesticide products also available,” these products will create significant aggregate exposures for which it did not account. Finally, the amici state, “EPA already has a blueprint and legal impetus for responsible oversight of these nano-silver pesticide products including AGS-20, in the form of a 2008, still-unanswered legal petition submitted to the agency by these same Amici.”

On June 14, 2012, EPA filed its answering brief, arguing that NRDC lacks standing to challenge EPA’s decision because NRDC has not demonstrated that it or its members face an injury that is “actual or imminent,” rather than “conjectural or hypothetical.” EPA states that, on the merits, its determination that HeiQ AGS-20 will not cause unreasonable adverse effects to consumers “is reasonable and supported by substantial evidence in the record.” According to EPA, it “conservatively estimated potential consumer exposure to nanosilver from HeiQ AGS-20, assuming, among other things, that 35% of the silver contained in an AGS-20 treated textile that is chewed or worn could be ingested or absorbed as nanosilver, and that a three-year-old child could be exposed to a new textile daily for six months.” Despite data gaps concerning HeiQ AGS-20, EPA determined it had sufficient evidence to conclude “that even a three-year-old chewing and wearing a new AGS-20 treated textile every day for six months could potentially be exposed to no more than 1/1000th of the quantity of nanosilver which did not cause any adverse health effects in relevant scientific studies.” Given the low risk, EPA states that it reasonably concluded that HeiQ AGS-20 will not cause unreasonable adverse effects to consumers, and its risk assessment “warrants substantial deference from the Court.”

Amici briefs supporting EPA’s position are due 14 days after June 14, 2012 or June 28, 2012.

EPA Promulgates SNUR for Infused Carbon Nanostructures

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

EPA Posts Summary of 2011 Nanomaterial Case Studies Workshop

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

The goal of this workshop was to prioritize responses to the question of what research or information is most needed to conduct a comprehensive environmental assessment of nanoscale silver used in disinfectant spray? The workshop used the nominal group technique (NGT) as the collective judgment tool to facilitate the discussion and prioritization of information needs among the group of diverse participants. The summary report lists prioritized research questions within the following research themes:

1.         Analytical Methods (120 points, 19 votes);

2.         Exposure and Susceptibility (120 points, 17 votes);

3.         Physical and Chemical Toxicity (115 points, 16 votes);

4.        Kinetics and Dissolution (98 points, 15 votes);

5.         Surface Characteristics (81 points, 14 votes);

6.         Sources and Release (76 points, 15 votes);

7.         Mechanisms of Nanoscale Silver Toxicity (72 points, 11 votes);

8.         Test Methods -- Mammals/Humans (67 points, 11 votes);

9.         Ecotoxicity Test Methods (59 points, 10 votes);

10.       Is New Nano Unique? (59 points, 10 votes);

11.       Biological Effects (56 points, 10 votes);

12.       Ecological Effects Required for Risk Assessment (43 points, 9 votes);

12.       Communication, Engagement, and Education (43 points, 9 votes);

14.       Fate and Transport of Nano-Ag (39 points, 12 votes);

14.       Adequacy of Current Data (39 points, 6 votes);

16.       Dissolution (36 points, 9 votes);

17.       Information from Manufacturers (35 points, 10 votes);

17.       Adaptive Tolerance/Resistance (35 points, 8 votes);

19.       Metrics (33 points, 7 votes);

20.       Kinetics II (22 points, 5 votes);

21.       Benefits (9 points, 5 votes);

22.       Incentivize Research for Comprehensive Environmental Assessment (CEA) (8 points, 1 vote); and

23.       CEA Framework (1 point, 1 vote).

EPA Extends Comment Period for Proposed SNURs

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

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

 

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

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

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

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

To help guide research, the Committee noted the following four research categories, which it states should be addressed within five years:

  • Identify and quantify the nanomaterials being released and the populations and environments being exposed;
  • Understand processes that affect both potential hazards and exposure;
  • Examine nanomaterial interactions in complex systems ranging from subcellular to ecosystems; and
  • Support an adaptive research and knowledge infrastructure for accelerating progress and providing rapid feedback to advance research.

The Committee acknowledged a gap between funding and the level of activity required to support its strategy. The Committee concluded that any reduction in the current funding level of approximately $120 million per year over the next five years for health and environmental risk research by federal agencies would be a setback to nanomaterials risk research. Moreover, according to the Committee, additional “modest resources” from public, private, and international initiatives are needed in critical areas -- informatics, nanomaterial characterization, benchmarking nanomaterials, characterization of sources, and development of networks for supporting collaborative research -- to derive maximum strategic value from the research investments.

The Committee states that implementation of the strategy should also include the integration of domestic and international participants involved in nanotechnology-related research, including the National Nanotechnology Initiative (NNI), federal agencies, the private sector, non-governmental organizations, and the academic community. The Committee noted that the current structure of the NNI, which has no top-down budgetary or management authority to direct nanotechnology-related EHS research, hinders its accountability for effective implementation. In addition, according to the Committee, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. The Committee concluded that, to carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential.

 

EPA OIG Concludes EPA Needs to Manage Nanomaterials More Effectively

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

According to OIG, even if mandatory reporting rules are approved, the effectiveness of EPA’s management of nanomaterials remains in question for the following reasons:

  • Program offices do not have a formal process to coordinate the dissemination and utilization of the potentially mandated information;
  • EPA is not communicating an overall message to external stakeholders regarding policy changes and the risks of nanomaterials;
  • EPA proposes to regulate nanomaterials as chemicals and its success in managing nanomaterials will be linked to the existing limitations of those applicable statutes; and
  • EPA’s management of nanomaterials is limited by lack of risk information and reliance on industry-submitted data.

OIG states that if EPA does not improve its internal processes and develop a clear and consistent stakeholder communication process, it will not be able to assure that it is effectively managing nanomaterial risks. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop a process to assure effective dissemination and coordination of nanomaterial information across relevant program offices.  The OIG report states that EPA “agreed with our recommendation and provided a corrective action plan with milestone dates.” By January 31, 2012, the report states, EPA will convene a workgroup “consisting of representatives from all relevant offices to begin development of process.” By July 31, 2012, EPA will “[c]omplete draft document outlining process.”

EPA Publishes Proposed SNURs for CNTs

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

EPA notes that, since confidentiality claims preclude a more detailed description of the identity of the CNTs, if an intended manufacturer, importer, or processor of CNTs is unsure of whether its CNTs are subject to the proposed SNURs, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at 40 C.F.R. § 721.11. EPA states that it is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.”

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

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

As a condition of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration, EPA is requiring additional data to confirm its assessment that HeiQ AGS-20 will not cause unreasonable adverse effects on human health or the environment. EPA proposed on August 13, 2010, that it would conditionally register HeiQ AGS-20, which EPA stated is intended for use as a preservative in textile products, including those made from natural and synthetic fibers and which are used to manufacture indoor use articles such as sheets, blankets, towels, napkins, outerwear, sportswear, sleepwear, undergarments, socks and hosiery, and outdoor use articles such as sailcloth, tarps, tents, and awnings. EPA proposed to grant a four-year conditional registration under Section 3(c)(7)(C) of FIFRA. More information is available in our August 26, 2011, memorandum.

Comments submitted on EPA’s proposed conditional registration are available in the online docket. At this time, responses to these comments, as well as EPA’s Decision Document, have not yet been posted, but are expected shortly. EPA will also submit to the online docket a description of the additional studies and timeline when the data must be submitted.

EPA Seeks Information Concerning Discharges of Nanosilver from Industrial Manufacturing

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

EPA is soliciting data on the manufacture, use, and environmental release of silver materials, including nanosilver. EPA requests information on:

  • Raw silver products, such as colloidal nanosilver;
  • Intermediates such as polymers or fibers embedded with silver, nanosilver, or silver compounds; and
  • End products, such as silver-embedded textile and plastic products, or appliances with nanosilver coated surfaces.

 

EPA Posts Guidance to Facilitate Decisions for Sustainable Nanotechnology

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

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

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

 

SNWG Releases Statement Concerning Nanosilver

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

NANO Act Promotes Development and Responsible Stewardship of Nanotechnology

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

IATP Criticizes Development of Nanotechnology Products Without Regulatory Oversight

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

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

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

At least one non-governmental organization, Friends of the Earth, has created an online petition that urges EPA to consider nanoscale active and inert ingredients in pesticides as new, and to use the FIFRA Section 6(a)(2) method to obtain information. With the comment deadline fast approaching, and the potential complexity, legal vulnerability, and burdens presented by the different options, it is critically important for potentially affected entities to consider carefully the issues and approaches discussed and offer strong and compelling comment of a caliber comparable to the quality and thoughtfulness of EPA’s notice.

EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials

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

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

EPA Extends Comment Period on Nanoscale Materials in Pesticide Products

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

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

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

EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes

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

EPA issued a proposed SNUR on February 3, 2010, and then on July 28, 2010, it reopened the comment period for 30 days to address public comment and add information to the docket. In the May 6, 2011, Federal Register notice, EPA states that, in response to comments on the basis for the proposed SNUR, EPA developed a revised summary document entitled “Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes,” which specifies EPA’s current hazard concerns as supported by available information and data. According to the May 6, 2011, notice, EPA considered comments on the proposed SNUR, and the final SNUR:

  • Retains the proposed workplace protection and specific use provisions as significant new uses;
  • Adds exclusions from applicability of the SNUR uses identified as ongoing; and
  • Identifies those forms of the subject PMN substance that are exempt from the provisions of the SNUR. These exemptions apply to quantities of the PMN substance:
    • After they have been completely reacted (cured);
    • Incorporated or embedded into a polymer matrix that itself has been reacted (cured); or
    • Embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

NanoSafety Consortium Submits Proposed Testing Agreement to EPA

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

EPA Announces Nanotechnology Research Awards

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

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

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

EPA Regulatory Agenda Includes Several Notices Concerning Nanoscale Materials

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

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

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

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

EPA OIG Will Focus on Nanomaterials in FY 2011

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

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

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

Immediately following the public information exchange meeting, ICF International (ICF), an EPA contractor, will conduct a separate meeting, the ICF International Nanomaterial Case Studies Workshop:  Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Silver, in the same location. According to the Federal Register notice, the workshop will be conducted with a selected set of invite-only participants in a structured decision science process known as Nominal Group Technique (NGT). The workshop will use the EPA document Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft) as a starting point for identifying and prioritizing possible research directions related to nanoscale silver. EPA expects the ICF workshop to conclude by 1:00 p.m. (EST) on Friday, January 7, 2011. Although funded by EPA, the ICF workshop is being conducted independently of EPA so as to comply with provisions of the Federal Advisory Committee Act (FACA). The ICF workshop will be open to public observers.

NanoBusiness Alliance Interviews Lynn L. Bergeson

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

ICTA Petitions EPA to Investigate Nano-Copper Pesticides

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

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

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

EPA Posts Interim Technical Guidance for Assessing Exposure to Nanomaterials

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

EPA Issues Final SNURs for Carbon Nanotubes

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

EPA issued direct final SNURs on these two substances on June 24, 2009. EPA withdrew the notices on August 21, 2009, after receiving notices of intent to submit adverse comments on the SNURs. EPA issued proposed SNURs on November 6, 2009. In response to comments on the applicability of the SNURs for these chemicals, EPA has included clarifying language for those forms of the subject PMN substances that are exempt from the provisions of the SNURs.  These exemptions apply to quantities of the PMN substances: after they have been completely reacted (cured); incorporated or embedded into a polymer matrix that itself has been reacted (cured); or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing. In response to comments on the basis for the SNURs, EPA developed revised human health effects and environmental effects summaries for carbon nanotubes (CNT).

CDTSC Reschedules Public Workshop on State and Federal Nanomaterial Activities

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

EPA And CDTSC Drafting MOU To Share Data

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

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

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

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

3.  Share literature reviews, databases;

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

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

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

     a.  Producers, importers;

     b.  Production volumes; and

     c.  Applications/intermediates/products.

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

8.  Collaborate on research needs and funding. 

EPA Proposes Conditional Registration of Nanosilver Pesticide Product

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

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

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

CDTSC Postpones Public Workshop on State and Federal Nanomaterial Activities

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

OMB Receives EPA Notice Concerning Pesticide Products Containing Nanoscale Materials

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

NIEHS Begins Intramural NanoHealth Signature Program

 

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

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

 

EPA Reopens Comment Period for Multi-Walled Carbon Nanotube SNUR

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

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

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

GAO’s report includes the following recommendations, all of which are “in process.” EPA’s responses are from its May 4, 2010, letter responding to GAO’s recommendations. The letter is included in GAO’s report.

  • The Administrator of EPA should complete its plan to issue a significant new use rule (SNUR) for nanomaterials.

EPA response: EPA agrees. EPA will continue to issue SNURs for nanoscale materials that are new chemical substances on a case-by-case basis, as appropriate, and intends to propose a SNUR for nanoscale materials that are existing chemical substances by December 2010.

  • The Administrator of EPA should modify Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.

EPA response: EPA agrees and intends to clarify that, as part of the application for registration, applicants for pesticide registrations which contain nanomaterial ingredients need to specifically identify those ingredients.

  • The Administrator of EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

EPA response: EPA agrees and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

  • The Administrator of EPA should make greater use of the Agency’s authorities to gather information under existing environmental statutes. Specifically, EPA should complete its plan to use data gathering and testing authorities under the Toxic Substances Control Act (TSCA) to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies.

EPA response: EPA agrees and intends to propose a Section 8(a) information-gathering rule as described in the recommendation and also intends to propose a Section 4 test rule.

  • The Administrator of EPA should make greater use of the Agency’s authorities to gather information under existing environmental statutes. Specifically, EPA should use information-gathering provisions of the Clean Water Act (CWA) to collect information about potential discharges containing nanomaterials.

EPA response: EPA agrees that collecting information about discharges is a critical component of understanding potential environmental risks. EPA’s Office of Research and Development, and others, is conducting research to determine whether nanomaterials may enter the water in forms and levels of concern, as well as how to detect and monitor nanomaterials in effluents and aquatic systems. Once we have these capabilities, EPA will consider whether new reporting requirements should be applied to companies who may be discharging nanomaterials into the environment, including under the CWA.

  • The Administrator of EPA should consider revising the Inventory Update Rule (IUR) under TSCA so that it will capture information on the production and use of nanomaterials and so that the Agency will receive periodic updates on this material.

EPA response: EPA agrees and will consider proposing periodic reporting under the IUR for nanoscale materials.

 

SNWG Concerned About EPA's Regulation of Nanoscale Pesticide Products

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

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

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

 

PPDC Discusses Nanotechnology and Pesticides

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

OPP’s working definition of nanomaterial is:

An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

Although nanomaterials occur naturally and can be produced unintentionally, Jordan noted that OPP’s working definition includes the phrase “intentionally produced,” and that those are the ones OPP intends to address.

To obtain more data on hazard and exposure from nanosilver and other nanometal pesticide products, OPP is in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of regulations under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and propose a new policy in June 2010. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material.

Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment’s (ICTA) May 2008 petition. In its petition, ICTA urged EPA to regulate nanosilver products as pesticides, and asked EPA to take action on an estimated 600 unregistered nanosilver products marketed in the U.S.

Jordan noted the following activities in other EPA offices:

  • Office of Research and Development (ORD) developing a Draft Case Study on nanosilver (expected in 2010); and
  • Office of Pollution Prevention and Toxics (OPPT) developing the following rules under the Toxic Substances Control Act (TSCA):
  • Significant New Use Rule (SNUR) -- Intended to address nanoforms of existing chemicals;
  • Section 8(a) Rule -- Would obtain existing data on current nanomaterials; and
  • Section 4 Test Rule -- Likely at the end of 2010.

 

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

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

EPA DfE Program Announces Lithium-ion Batteries and Nanotechnology Partnership

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

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.

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.

EPA Extends Comment Period for Proposed CNT SNURs

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

SNWG Presents Data on Silver and Nanotechnology to the SAP

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

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.”

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.

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.

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.

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.

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 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.”

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.

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.

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

 

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.

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

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.

 

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

 

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

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

EPA Regulatory Agenda Includes Item on Nanoscale Materials Stewardship Program

According to a notice in the U.S. Environmental Protection Agency’s (EPA) November 24, 2008, Regulatory Agenda, EPA intends to publish an interim evaluation in March 2009 of the Nanoscale Materials Stewardship Program (NMSP), and a final evaluation of the NMSP, including next steps, in April 2010. The NMSP is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment.

EPA 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).

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.

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.

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.

 

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.

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.”

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.

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.

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.

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.

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.

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.

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.”

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.”

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.

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.

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.

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.”

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.

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).

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.

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.”

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.