The U.S. Environmental Protection Agency (EPA) has extended the comment period on its April 6, 2015, proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. Comments will now be due August 5, 2015. EPA will publish a Federal Register notice announcing the extension during the week of June 29, 2015. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. EPA also proposes to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. On June 11, 2015, EPA held a public meeting to discuss the proposed rule. More information regarding the meeting is available in Bergeson & Campbell, P.C.’s June 24, 2015, memorandum, EPA Holds Public Meeting on TSCA Section 8(a) Proposed Rule.
On May 26, 2015, Sustainable Nanotechnologies (SUN) began a survey on risk management of nanotechnology. A key objective of SUN is to build the SUN Decision Support System to facilitate safe and sustainable nanomanufacturing and risk management. It will integrate tools for ecological and human health risk assessment, lifecycle assessment, economic assessment, and social impact assessment within a sustainability assessment framework. SUN seeks responses from personnel of companies involved in nanotechnology-related activities who are familiar with the risk management practices.
Taking Nanotechnological Remediation Processes from Lab Scale to End User Applications for the Restoration of a Clean Environment (NanoRem) is a research project funded through the European Commission (EC) FP7. On May 6, 2015, NanoRem issued a press release announcing that no significant toxicological effects were found on soil or water organisms when ecotoxicological tests were undertaken for a range of nanoparticles that could be used for remediation projects:
- NanoFer 25S, made from nanoscale zero-valent iron, used for the remediation of chlorinated hydrocarbons in the large scale flume pilot experiment, and at Spolchemie I, Czech Republic;
- Carbo-Iron, a composite made from activated carbon and zero-valent iron, to be used for the remediation of chlorinated hydrocarbons in the large-scale flume pilot experiment, and at Balassagyarmat, Hungary;
- Fe-Oxide, nanoscale goethite, used for the remediation of toluene in the large-scale container pilot experiment, and at Spolchemie II, Czech Republic;
- Fe-Zeolites, aluminosilicate containing an iron catalyst, used in lab-scale remediation studies; and
- Bionanomagnetite, with and without five percent Pd, nanomagnetite produced by bacteria, used in lab-scale remediation studies.
Ecotoxicity testing will continue for any new nanoparticles or formulations developed as the NanoRem project progresses.
On June 17, 2015, the Office of Science and Technology Policy (OSTP) published a request for information (RFI) seeking suggestions for “Nanotechnology-Inspired Grand Challenges for the Next Decade.” The Federal Register notice states: “A Nanotechnology-Inspired Grand Challenge should be an ambitious but achievable goal that harnesses nanoscience, nanotechnology, and innovation to solve important national or global problems and has the potential to capture the public’s imagination.” According to OSTP, the challenge should “inspire different sectors to invest resources to achieve the ambitious goal and stimulate a network of activities that will drive scientific ideas towards commercial products while catalyzing new discoveries.” An effective grand challenge has the following characteristics:
- A measurable end-point that is highly ambitious but achievable;
- Requires advances in fundamental scientific knowledge, tools, and infrastructure for successful completion;
- Has clear intermediate milestones (measurable and valuable in their own right) that will be achieved en route to the final goals;
- Drives the need for collaboration between multiple disciplines, some of which do not normally interact, causing multiple organizations to come together to collaborate and to share resources and information to solve the challenge;
- Spans efforts from discovery and fundamental science to engineering demonstration and commercialization; i.e., catalyzes the transition of technologies from laboratory to market;
- Is too big to be undertaken by one or even a few organizations;
- Is exciting enough to motivate decision makers to provide funding and resources and multiple organizations to collaborate, share resources, and information to solve the challenge; and
- Captures the imagination of the public, thereby facilitating strong support for the resources required to achieve the goals.
The RFI includes examples developed by the National Nanotechnology Initiative (NNI) agencies, working with the National Nanotechnology Coordination Office and OSTP. By 2025, the nanotechnology research and development (R&D) community is challenged to:
- Increase the five-year survival rates by 50 percent for the most difficult to treat cancers;
- Create devices no bigger than a grain of rice that can sense, compute, and communicate without wires or maintenance for ten years, enabling an “internet of things” revolution;
- Create computer chips that are 100 times faster yet consume less power;
- Manufacture atomically-precise materials with fifty times the strength of aluminum at half the weight and the same cost;
- Reduce the cost of turning sea water into drinkable water by a factor of four; and
- Determine the environmental, health, and safety characteristics of a nanomaterial in a month.
- OSTP seeks input from nanotechnology stakeholders, including researchers in academia and industry, non-governmental organizations (NGO), scientific and professional societies, and all other interested members of the public. Responses are due July 16, 2015.
The European Chemicals Agency (ECHA) issued a June 9, 2015, press release reminding registrants to consider the Organization for Economic Cooperation and Development’s (OECD) dissemination of hazard information on the following nanomaterials, and to update their dossiers accordingly:
- Cerium oxide;
- Fullerenes (C60);
- Gold nanoparticles;
- Multi-walled carbon nanotubes;
- Silicon dioxide;
- Silver nanoparticles;
- Single-walled carbon nanotubes;
- Titanium dioxide (NM100-NM105); and
- Zinc oxide.
ECHA “encourages registrants of these substances to carefully assess the new data. When relevant, they should take this information into account and update their registration dossiers accordingly to ensure the safe use of their substances.”
On June 10, 2015, the U.S. Environmental Protection Agency (EPA) issued proposed significant new use rules (SNUR) for 30 chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (generic) (PMN Number P-13-793). On October 27, 2014, EPA promulgated a SNUR for this PMN substance through a direct final rule. EPA withdrew the SNUR on December 23, 2014, after receiving notice of intent to submit adverse comments. According to the June 10, 2015, Federal Register notice, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk to human health or the environment. The notice states:
EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects.
EPA notes that a notice of intent to comment adversely has been submitted. EPA “awaits the adverse comment during the open comment period.” Comments on the proposed SNUR are due July 10, 2015.
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). This substance is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order that includes the following requirements:
- Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a National Institute of Occupational Safety and Health (NIOSH)-certified respirator (where there is a potential for inhalation exposure).
- Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the material safety data sheet (MSDS).
- Manufacturing, processing, or use of the PMN substance only as described in the consent order.
- No use of the PMN substance using an application method that generates a vapor, mist, or aerosol.
- Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substances specified in the consent order.
- No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States.
The SNUR designates as a significant new use the absence of these protective measures. EPA states that it determined that the results of certain particle size distribution and material characterization testing would be needed for the PMN substance. According to EPA, the company has agreed to submit the full chemical characterization testing described in the testing section of the consent order within the timeframes identified in the order. Depending on the results of the characterization testing, additional toxicity testing may be required at a confidential aggregate manufacture volume, as detailed in the consent order. The June 5, 2015, rule will take effect on August 4, 2015.
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.” The press release states:
- Today the OECD marked the end of a seven-year experimental testing program, investigating 11 commercially viable nanomaterials across over 110 different chemical tests;
- The results were coordinated from across 11 countries with tests and data generated from dozens of government agencies, universities, research institutions, and businesses; and
- Over 780 studies on the specific properties of nanomaterials were undertaken to fill in the gaps of our understanding of nanomaterials.
The 11 nanomaterials tested include cerium oxide; dendrimers; fullerenes (C60); gold nanoparticles; multi-walled carbon nanotubes; nanoclays; silicon dioxide; silver nanoparticles; single-walled carbon nanotubes; titanium dioxide (NM100-NM105); and zinc oxide. OECD states: “The tests showed that the standard test guidelines used for normal chemical substances are in the most part suitable for use on nanomaterials. Changes to the Test Guidelines to better understand the intrinsic properties of nanomaterials are now providing a clear framework for OECD countries to move forward in the examination of nanomaterials.” According to OECD, its testing program “gives member governments confidence that the use of the OECD test guidelines to determine the impact that nanomaterials may have on the environment or human health are suitable in the most part.” OECD states that it will now focus on how the test guidelines can be better adapted “to make sure that the intrinsic properties of nanomaterials are fully accounted for.”
The National Institute for Occupational Safety and Health (NIOSH) announced that in a paper published May 7, 2015, online ahead of print in the Journal of Occupational and Environmental Hygiene, “NIOSH authors Vladimir Murashov and John Howard highlight occupational risk mitigation practices for nano-enabled medical products throughout their life cycle for major health care workplace settings.” The manuscript highlights occupational risk mitigation practices for nano-enabled medical products throughout their life cycle for all major workplace settings, including: (1) medical research laboratories; (2) pharmaceutical manufacturing facilities; (3) clinical dispensing pharmacies; (4) health care delivery facilities; (5) home health care; (6) health care support; and (7) medical waste management. It further identifies critical research needs for ensuring worker protection in the health care industry.
The Consumer Product Safety Commission (CPSC) is sponsoring a July 7-8, 2015, workshop, co-sponsored by the National Nanotechnology Initiative (NNI), entitled “Quantifying Exposure to Engineered Nanomaterials from Manufactured Products — Addressing Environmental, Health, and Safety Implications.” This is a technical workshop to determine the state of the science and the tools and methods available to characterize and quantify exposure to engineered nanomaterials from consumer products. The U.S. federal regulatory agencies participating in the NNI have put forth a risk-based regulatory agenda regarding engineered nanomaterials. Because risk is calculated based on both hazard and exposure, this approach requires exposure data. A main goal of this approach is to bridge toxicology with exposure science. Registration is on a first-come, first-served basis and will be limited to 120 people.