Nanotechnology
The Organization for Economic Cooperation and Development (OECD) issued a June 9, 2015, press release entitled "OECD chemical studies show way forward for nanomaterial safety."
On June 5, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 22 chemical substances that were the subject of premanufacture notices (PMN), including graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN Number P-14-763).
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."
Membership in the Sustainable Nanotechnology Organization (SNO) offers a number of benefits to members of the nano community. SNO's purpose is to provide a professional society forum to advance knowledge in all aspects of sustainable nanotechnology, including both applications and implications.
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.
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)."
On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission.
On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale.
The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register.
On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs). The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.
On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA). See http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2 According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify "significant new activities."
The Federal Office of Public Health (FOPH) announced on December 17, 2014, that the Federal Council decided to continue the action plan for synthetic nanomaterials until 2019. See http://www.bag.admin.ch/nanotechnologie/12167/?lang=en The objectives of the action plan include:
- Development of regulatory framework conditions for the responsible handling of synthetic nanomaterials;
- Creation of scientific and methodical conditions aimed at identifying and preventing potential harmful effects of synthetic nanomaterials on health and the environment;
- Promotion of the public dialogue about opportunities and risks of nanotechnology; and
- Better utilization of existing tools for the development and rollout of sustainable nanotechnology applications.
Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes. See http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=4BCC7425-1 Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures.
“On November 24, 2014, the European Parliament (EP) Committee on Environment, Public Health and Food Safety (ENVI) considered draft legislation concerning novel foods. See http://www.europarl.europa.eu/news/en/news-room/content/20141125IPR80424/html/Novel-foods-MEPs-call-for-moratorium-on-nano-foods-and-labelling-of-cloned-meat. The Committee amended the draft legislation, proposing a moratorium on the use of nanomaterials in food based on the precautionary principle. The Committee approved the amended draft legislation by a vote of 57-4, with two abstentions. EP Member James Nicholson (ECR, UK), who is steering the legislation through the EP, stated that he was not completely satisfied with the vote. ”
The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). See http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2014)536293. The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor vehicles.
The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled "Realizing the Promise of Carbon Nanotubes -- Challenges, Opportunities and the Pathway to Commercialization" on September 15, 2014. See http://nano.gov/2014CNTTechInterchange The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and Space Administration (NASA). According to the notice, the objectives of the meeting are to identify, discuss, and report the technical barriers preventing the production of carbon nanotube-based materials with electrical and mechanical properties approaching theoretical values, and to explore ways to overcome these barriers.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. See http://apvma.gov.au/node/11191 APVMA states that it "has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products." APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines.
Nano product registries in Europe are the newest twist to satiating the public’s relentless “right to know.” Nominally intended to prevent hazards, facilitate monitoring, and promote consumer choice, nano product registries also risk stigmatizing nano products, diverting limited government and private resources, and potentially creating commercial barriers to a promising technology. This article in the American Bar Association’s Natural Resources & Environment magazine focuses on efforts of multiple European countries that are presently at varying stages of establishing product registries to keep track of nanomaterials and the products that contain them. After outlining the stated purposes of these registries and explaining how they operate, the article explores whether they are achieving their stated goals or inadvertently inviting unintended consequences.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively.
On March 19, 2014, the U.S. Environmental Protection Agency (EPA) issued an administrative order to Pathway Investment Corp. (Pathway) of Englewood, New Jersey, to stop the sale of plastic food storage containers that are not registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to a press release issued on March 31, 2014, by EPA concerning the stop sale order, the Company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain “nanosilver” as an active ingredient, and the Company markets other products as containing nanosilver, which the Company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Walmart, and other large retailers directing them not to sell these food storage containers. This enforcement action put nanosilver in the public spotlight, and not in a good way. This article summarizes recent regulatory developments pertinent to nanosilver, and discusses the recent EPA enforcement action to explain what the case means, and what it does not mean.
On May 23, 2014, the U.S. Environmental Protection Agency (EPA) posted its 2014 Regulatory Agenda, which still includes RIN 2070-AJ54, "Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule." See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=2070-AJ54.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-557-3800 • 202-557-3836 (fax) | lawbc.com
Contact • Twitter
Privacy Policy | Terms of Use | Cookie Policy | Attorney Advertising | Trademarks
©2023 Bergeson & Campbell, P.C.
All Rights Reserved.