Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EPA Conditionally Registers Nanosilver Pesticide Product

Posted in Federal, Legal/Regulatory Issues, United States

On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.”  This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications.  According to EPA, the product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew.  Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories. EPA based its decision “on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature.”  EPA states that these data show that treated plastics and textiles release “exceedingly small amounts of silver.”  Based on this evaluation, EPA “determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products.”  EPA notes that it is requiring the company “to generate additional data to refine the Agency’s exposure estimates.”  According to EPA, it will post a response to comments received on its 2013 proposed registration decision document, as well as the current decision document, in the rulemaking docket.

Nano Community Members Can Benefit from Membership in the Sustainable Nanotechnology Organization

Posted in Legal/Regulatory Issues, United States

Membership in the Sustainable Nanotechnology Organization (SNO) offers a number of benefits to members of the nano community. As a member of the Governing Board, I strongly recommend that you consider joining and become part of the SNO family.

SNO’s purpose is to provide a professional society forum to advance knowledge in all aspects of sustainable nanotechnology, including both applications and implications. SNO is comprised of individuals and institutions that are engaged in:

  • Research and development of sustainable nanotechnology;
  • Implications of nanotechnology for environment, health, and safety (EHS);
  • Advances in nanoscience, methods, protocols, and metrology;
  • Education and understanding of sustainable nanotechnology; and
  • Applications of nanotechnology for sustainability.

As SNO is a non-profit, membership fees are tax-deductible. New membership fees will be good for the November 8-10, 2015, conference, to be held in Portland, Oregon. Technical sessions will be held concerning sustainable nanotechnology in industrial systems; food systems; governance systems; water systems; material use and waste management systems; “natural” ecosystems; social systems; energy systems; health systems; transportation systems; urban systems; and information technology systems.

NNCO Will Hold SME Webinar on May 20

Posted in Federal, United States

The National Nanotechnology Coordination Office (NNCO) will hold its next webinar focusing on the experiences, successes, and challenges for small- and medium-sized enterprises (SME) working in nanotechnology and on issues of interest to the business community on May 20, 2015, from 2:00-3:00 p.m. (EDT).  The webinar will include the following speakers:

  •  Ajay P. Malshe, Founder, Executive Vice President, and Chief Technical Officer of NanoMech. NanoMech has developed patented platform nanotechnology innovations in machining and manufacturing, lubrication and energy, adaptive chemistries for advanced textile coatings, metal surface coatings, biomedical implant coatings, and strategic military applications; and
  •  Matthew Putnam, Chief Executive Officer of Nanotronics Imaging. Nanotronics Imaging uses a convergence in computational processing, automation, and artificial intelligence algorithms to image and analyze materials at the nanoscale for development of new semiconductors, medical devices, regenerative organs, and photovoltaics.

The speakers will provide an overview of their experiences, successes, and challenges in the nanotechnology SME space.  This will be followed by a question and answer segment with members of the public.  Questions for the panel can be submitted to webinar@nnco.nano.gov through the end of the webinar.  Registration will be limited to 200 on a first-come, first-served basis.  A webcast will be posted afterwards.

EPA Direct Final Rule Includes SNURs for Several Biobased Chemicals

Posted in Biobased Products, Federal, Legal/Regulatory Issues, United States

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 25 chemical substances that were the subject of premanufacture notices (PMN).  The SNURs require persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.  The rule will be effective July 7, 2015.

The draft final rule includes SNURs for several biobased chemicals.  The SNURs for fatty acids, satd. and unsatd alkyl-, esters with polyol (generic) (PMN Number P-13-139) and fatty acids reaction products with polyethylenepolyamine and naphthenic acids (generic) (PMN Numbers P-14-616 and P-14-617) limit uses of those substances to those in the PMNs, but that aquatic toxicity testing could demonstrate lower hazard and obviate the need for the SNUR.  A SNUR for 1,2,3-propanetriol, homopolymer, dodecanoate (PMN Number P-14-395), which could be a biobased chemical, limits “use of the substance that results in releases to surface waters exceeding 18 ppb.”  Again, aquatic toxicity testing could demonstrate lower hazard and lead to a higher concentration limit or obviate the need for the SNUR.  These SNURs demonstrate what we have stated many times, namely that biobased chemicals are “renewable,” but not necessarily non-toxic.  Esters are a category that triggers concerns according to EPA’s New Chemicals Program Chemical Categories report, so regulations to limit releases of these substances to water should not be a surprise.  When submitting PMNs to EPA for new biobased chemicals, companies should keep in mind that robust pollution prevention statements can offset possible concerns by putting the new biobased substance in a risk context with incumbent technologies that it may replace.  EPA can make a reduced risk determination and forgo regulation if it has sufficient information to substantiate the relative risk of the new substance and the incumbent it will displace.

EPA Will Hold Public Meeting on Proposed Rule on Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, Uncategorized, United States

The U.S. Environmental Protection Agency (EPA) published a notice in the May 8, 2015, Federal Register announcing a public meeting on June 11, 2015, to discuss EPA’s April 6, 2015, proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. This is a very important opportunity for stakeholders to offer comments on a rulemaking that has important implications for the nano community. EPA intends the public meeting to provide an opportunity for further discussion of the proposed requirements and the meeting is intended to facilitate comments on all aspects of that proposed rule, especially comments on specific issues as identified in the proposed rule:

  1. Identifying the chemical substances that would be subject to reporting;
  2. Distinguishing between nanoscale forms of a reportable chemical substance;
  3. Reporting discrete forms at least 135 days before commencement of manufacture or processing;
  4. Considerations for EPA’s economic analysis;
  5. Electronic reporting; and
  6. Consideration of potential future rulemaking regarding periodic reporting.

The meeting will be held on June 11, 2015, from 9:00 a.m. to 4:00 p.m., at the East William Jefferson Clinton Building, Room 1153, 1201 Constitution Avenue, NW, Washington, D.C. Requests to participate in the meeting must be received by June 1, 2015.

Wilson Center’s Synthetic Biology Project Announces Product and Application Inventory

Posted in United States

The Wilson Center’s Synthetic Biology Project announced on April 29, 2015, a first-of-its-kind inventory to track products and applications using the emerging technology of synthetic biology.  The inventory is intended to provide the public the best available look at the many manufacturer-identified synbio-based products and the companies that produce them.  The Synthetic Biology Project notes that because synthetic biology is a rapidly changing technology platform, the data represented in the inventory may not represent the most current developments in any particular product category, company, or market status designation.  The Synthetic Biology Project states that by crowdsourcing expertise, its goal is to create a “living” inventory for the exchange of accurate information on synbio-enabled products and applications.  Registered users are encouraged to submit relevant data pertaining to synthetic biology applications, their function, properties, and producer(s).  Registered users can update current product information, upload supporting scientific studies, and add new products, as well.

NIOSH Announces Publication of Paper from Industrywide Study on Carbon Nanotube and Nanofiber Exposure

Posted in Federal, Occupational Health and Safety Issues, Research, United States

On April 27, 2015, the National Institute for Occupational Safety and Health (NIOSH) announced publication of “Carbon Nanotube and Nanofiber Exposure Assessments: An Analysis of 14 Site Visits” in Annals of Occupational Hygiene.  The paper is the second report from NIOSH’s Industrywide Study.  According to NIOSH, the findings illustrate which tasks have the highest exposures, trends in exposure, nature and character of materials involved, effectiveness of controls when used, and continued refinement of the methods used to evaluate exposure of this high-priority class of nanomaterials.  NIOSH visited 14 sites to assess exposures to carbon nanotubes (CNT) (13 sites) and carbon nanofibers (CNF) (one site).  According to the abstract, overall, elemental carbon personal breathing zone and area time-weighted average samples were below the NIOSH recommended exposure limit (REL) of one microgram per cubic meter (µg/m3) elemental carbon as a respirable mass (96 percent were less than one µg/m3 at the respirable size fraction), while 30 percent of the inhalable personal breathing zone elemental carbon samples were found to be greater than one µg/m3.  The abstract states:  “Until more information is known about health effects associated with larger agglomerates, it seems prudent to assess worker exposure to airborne CNT and CNF materials by monitoring [elemental carbon] at both the respirable and inhalable size fractions.  Concurrent [transmission electron microscopy] samples should be collected to confirm the presence of CNT and CNF.”

USDA Announces $3.8 Million Awarded in Grants for Nano Research

Posted in Federal, Research, United States

The U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA) announced on April 27, 2015, that it awarded more than $3.8 million in grants “focused on using nanotechnology to find solutions to societal challenges such as food security, nutrition, food safety, and environmental protection.”  The grants were made through NIFA’s Agriculture and Food Research Initiative (AFRI), which is authorized by the 2014 Farm Bill.  According to USDA’s press release, past projects include a Cornell University and Rensselaer Polytechnic Institute venture that led to the development of a new nanotechnology that could prevent bacteria from sticking to medical equipment and food processing machinery, and a Harvard School of Public Health project investigating the effectiveness of a chemical-free, nanotechnology-based method for the inactivation of pathogenic and spoilage microorganisms on the surface of fruits and vegetables.  The press release lists the following fiscal year 2014 projects:

  •  The University of Georgia, Athens, Georgia, $496,192;
  •  University of Iowa, Iowa City, Iowa, $496,180;
  •  University of Kentucky Research Foundation, Lexington, Kentucky, $450,000;
  •  University of Massachusetts, Amherst, Massachusetts, $444,200;
  •  North Dakota State University, Fargo, North Dakota, $149,714;
  •  Rutgers University, New Brunswick, New Jersey, $450,000;
  •  Pennsylvania State University, University Park, Pennsylvania, $447,788;
  •  West Virginia University, Morgantown, West Virginia, $496,168; and
  •  University of Wisconsin-Madison, Madison, Wisconsin, $450,100.

ECETOC Nano Task Force Proposes Decision-Making Framework for the Grouping and Testing of Nanomaterials

Posted in International, Research

The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Nano Task Force published an article in Regulatory Toxicology and Pharmacology entitled “A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping).” The DF4nanoGrouping consists of three tiers to assign nanomaterials to four main groups, to perform sub-grouping within the main groups, and to determine and refine specific information needs. According to the abstract, the DF4nanoGrouping covers all relevant aspects of a nanomaterial’s life cycle and biological pathways. Use (including manufacture), release, and route of exposure are applied as qualifiers within the DF4nanoGrouping to determine if, e.g., nanomaterials cannot be released from a product matrix, which may justify the waiving of testing. The four main groups encompass: (1) soluble nanomaterials; (2) biopersistent high aspect ratio nanomaterials; (3) passive nanomaterials; and (4) active nanomaterials. The abstract states that the DF4nanoGrouping aims to group nanomaterials by their specific mode-of-action, resulting in an apical toxic effect that is eventually directed by a nanomaterial’s intrinsic properties. Since the exact correlation of intrinsic material properties and apical toxic effect is not yet established, however, the abstract states that the DF4nanoGrouping uses the functionality of nanomaterials for grouping rather than relying on intrinsic material properties alone. The abstract describes the DF4nanoGrouping as a hazard and risk assessment tool that applies modern toxicology and contributes to the sustainable development of nanotechnological products. It ensures that no studies are performed that do not provide crucial data and, therefore, saves animals and resources.

NNI Publishes Outcomes of the 2015 EU-U.S.: Bridging NanoEHS Research Efforts Joint Workshop

Posted in EU Member State

The National Nanotechnology Initiative (NNI) published on March 23, 2015, the outcomes of the March 12-13, 2015, joint workshop held by the U.S. and the European Union (EU), “Bridging NanoEHS Research Efforts.”  The workshop was intended to promote and deepen the collaboration on nanotechnology environmental, health, and safety (nanoEHS) research.  Workshop participants reviewed progress toward U.S.-EU Communities of Research (COR) goals and objectives, shared best practices, and identified areas for cross-COR collaboration.  To address new challenges, the CORs were realigned and expanded with the addition of a COR on nanotechnology characterization.  The seven CORs now address:

  • Characterization;
  • Databases and Computational Modeling;
  • Exposure through Product Life;
  • Ecotoxicity;
  • Human Toxicity;
  • Risk Assessment; and
  • Risk Management and Control.

According to the workshop outcomes, the CORs support the shared goal of responsible nanotechnology development as outlined in the U.S. NNI Environmental, Health, and Safety Research Strategy, and the research strategy of the EU NanoSafety Cluster.  The CORs directly address several priorities described in these documents, including the creation of a comprehensive nanoEHS knowledge base and international cooperation on the development of best practices and consensus standards.