Nanotechnology Law Blog

Health Canada Adopts Interim Policy Statement on Health Canada's Working Definition for Nanomaterials

Lynn L. Bergeson — Mon, 08 Mar 2010 17:30:43 -0500

On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary.

NanoBusiness Alliance Will Hold Ninth Annual Washington DC Roundtable

Lynn L. Bergeson — Tue, 02 Mar 2010 17:12:53 -0500

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

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

Lynn L. Bergeson — Wed, 10 Feb 2010 16:04:20 -0500

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

Lynn L. Bergeson — Tue, 09 Feb 2010 17:27:31 -0500

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

Lynn L. Bergeson — Fri, 05 Feb 2010 15:25:12 -0500

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.

NIOSH Announces Articles Addressing Nanomaterial Exposure Issues

Lynn L. Bergeson — Thu, 28 Jan 2010 18:21:04 -0500

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

House of Lords Committee Releases Report on Nanotechnologies and Food

Lynn L. Bergeson — Thu, 14 Jan 2010 19:25:29 -0500

On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

EPA Extends Comment Period for Proposed CNT SNURs

Lynn L. Bergeson — Wed, 13 Jan 2010 20:32:04 -0500

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

Wisconsin Legislature Considers Nanotechnology Registry

Lynn L. Bergeson — Tue, 29 Dec 2009 16:40:35 -0500

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

Bayer Material Sciences Announces OEL for Baytubes

Lynn L. Bergeson — Mon, 28 Dec 2009 17:19:14 -0500

Last month, Bayer Material Science (BMS) announced that it derived an occupational exposure limit (OEL) of 0.05 milligrams per cubic meter (mg/m³) for Baytubes, BMS multi-wall carbon nanotubes. According to BMS, “[t]he latest results of sub-chronic inhalation studies support the conclusion that Baytubes act like poorly soluble particles.” BMS derived the OEL based on previous single and recent repeated inhalation studies. BMS states: “All relevant information are now included in the updated Safety Data Sheet and will further ensure that our customers work safely with our Baytubes.”

NIOSH Announces Conference on Nanomaterials and Worker Health

Lynn L. Bergeson — Fri, 18 Dec 2009 10:21:58 -0500

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

SNWG Presents Data on Silver and Nanotechnology to the SAP

Lynn L. Bergeson — Fri, 11 Dec 2009 17:55:03 -0500

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

NIOSH Updates Nanotechnology Research Reports

Lynn L. Bergeson — Thu, 26 Nov 2009 00:47:58 -0500

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

EC Opens Public Consultation on the Nanotech Research Code of Conduct

Lynn L. Bergeson — Mon, 23 Nov 2009 17:12:12 -0500

On November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.

Australia Releases Proposal Intended To Strengthen Nanomaterial Regulation

Lynn L. Bergeson — Tue, 17 Nov 2009 18:29:31 -0500

On November 9, 2009, Australia announced the availability of a public discussion paper proposing to strengthen regulation of industrial nanomaterials used in Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which includes representatives from industry, the community, and research sectors. Major regulatory reforms would include: refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. The discussion paper contains a questionnaire and survey intended to encourage written submissions. Comments are due December 23, 2009.

PEN Releases findNano

Lynn L. Bergeson — Mon, 16 Nov 2009 18:27:45 -0500

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

EC Adopts 2007-2009 Nanotechnology Implementation Report

Lynn L. Bergeson — Thu, 12 Nov 2009 18:28:30 -0500

On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”

EPA Proposes SNURs for Carbon Nanotubes

Lynn L. Bergeson — Mon, 09 Nov 2009 18:25:32 -0500

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.

EHP-in-Press Article Evaluates Silver Nanoparticle Toxicity

Lynn L. Bergeson — Tue, 03 Nov 2009 11:04:13 -0500

On October 23, 2009, EHP-in-Press posted an article entitled “Evaluation of Silver Nanoparticle Toxicity in vivo Skin and in vitro Keratinocytes,” which assesses the potential cytotoxicity of silver nanoparticles in human epidermal keratinocytes, and their inflammatory and penetrating potential into porcine skin in vivo. According to the article, silver nanoparticles are non-toxic when dosed in washed silver nanoparticle solutions or carbon-coated. The authors conclude that their study “provides a better understanding [of silver nanoparticles] safety in vitro as well as in vivo and a basis for occupational and risk assessment.” EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

EPA Will Webcast SAP Meeting

Lynn L. Bergeson — Mon, 02 Nov 2009 10:07:35 -0500

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.