On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency’s (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit. The Natural Resources Defense Council (NRDC) filed a petition (Case Number 15-72308), as well as the Center for Food Safety (CFS) and International Center for Technology Assessment (ICTA) (Case Number 15-72312). Both suits ask the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” NRDC challenged EPA’s first conditional registration of a nanosilver product, which it granted to HeiQ in 2011. On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part NRDC’s petition for review of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20). The court held that “substantial evidence” supported EPA’s decision to use the characteristics of toddlers rather than infants in determining whether AGS-20 placed consumers at risk. The court vacated EPA’s decision “insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20.”
On July 16, 2015, the European Chemicals Agency (ECHA) announced the following appeals in which the keywords include nanoforms:
- J.M. Huber Finland Oy, Case A-011-2015;
- RHODIA OPERATIONS SAS, Case A-010-2015;
- IQESIL SA, Case A-009-2015; and
- Evonik Degussa GmbH, Case A-008-2015.
The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation. ECHA requested that each appellant submit the following information:
- Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
- Composition of the substance (Annex VI, 2.3); and
- Description of the analytical methods used (Annex VI, 2.3.7).
In each case, the appellant contends that ECHA breached the principle of legal certainty by requesting information related to undefined terms, such as “forms,” “grades,” and “nanoforms.” Each appellant asks the Board of Appeal to annul the contested decision in so far as it requests the appellant to submit information as identified in the appeal.
The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. The notice also applies to any person who, during the 2014 calendar year, imported a total quantity greater than 100 kg of a substance set out in Schedule 1, at any concentration, whether alone, in a mixture, or in a product. The notice does not apply to a substance in Schedule 1, whether alone, in a mixture, or in a product, that:
(a) Is in transit through Canada;
(b) Is naturally occurring;
(c) Is incidentally produced;
(d) Is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported in 2014 pursuant to a permit issued under those Regulations;
(e) Is, or is contained in, a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act where that pest control product is registered under the Pest Control Products Act;
(f) Is, or is contained in, a fertilizer or supplement within the meaning of section 2 of the Fertilizers Act where that fertilizer or supplement is registered under the Fertilizers Act;
(g) Is, or is contained in, a feed within the meaning of section 2 of the Feeds Act where that feed is registered under the Feeds Act; or
(h) Is mixed with, or attached to, a seed within the meaning of section 2 of the Seeds Act where that seed is registered under the Seeds Act.
Information to be provided includes:
- The basis on which the substance identified was determined to be in nanoscale form by indicating “research & development sources,” “technical data,” “information available from patents,” “marketing claim,” “assumption,” or “other (specify)”;
- The total quantity of the substance manufactured or imported;
- The consumer and commercial codes that apply to the known or anticipated final substance, mixture, or product containing the substance;
- For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in commercial activities;
- For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in consumer activities;
- For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use by or for children 14 years of age or younger; and
- The study title(s) of any unpublished or published data or studies on the substance with regard to physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, release, or disposal of the substance from the final mixture or product.
Any person who provides information in response to this notice may submit a written request that the information or part of it be treated as confidential. Responses are due February 23, 2016.
The European Commission (EC) Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial. The report is the last in a series of three, and provides scientific support to the EC in its review of the definition used to identify materials for which special provisions might apply (e.g., for ingredient labeling or safety assessment). According to JRC, as the definition should be broadly applicable in different regulatory sectors, “the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental and manufactured nanomaterials. Furthermore, size as the sole defining property of a nanoparticle, as well as the range of 1 nm to 100 nm as definition of the nanoscale should be maintained.” JRC notes that several issues seem to deserve attention in terms of clarification of the definition and/or provision of additional implementation guidance, however, including:
- The terms “particle,” “particles size,” “external dimension,” and “constituent particles.”
- Consequences of the possibility of varying the current 50 percent threshold for the particle number fraction (if more than half of the particles have one or more external dimensions between one nanometer (nm) and 100 nm, the material is a nanomaterial). Variable thresholds may allow regulators to address specific concerns in certain application areas, but may also confuse customers and lead to an inconsistent classification of the same material based on the field of application.
- Ambiguity on the role of the volume-specific surface area (VSSA). The potential use of VSSA should be clarified and ambiguities arising from the current wording should be eliminated.
- The methods to prove that a material is not a nanomaterial. The definition makes it very difficult to prove that a material is not a nanomaterial. This issue could be resolved by adding an additional criterion.
- The list of explicitly included materials (fullerenes, graphene flakes, and single wall carbon nanotubes even with one or more external dimensions below one nm). This list does not include non-carbon based materials with a structure similar to carbon nanotubes. A modification (or removal) of the current list could avoid inconsistencies.
- A clearer wording in the definition could prevent the misunderstanding that products containing nanoparticles become nanomaterials themselves.
According to JRC, many of the issues addressed in the report can be clarified by developing new or improved guidance. JRC notes that relying only on guidance documents for essential parts of the definition may lead to unintended differences in the implementation and decision making, however. Therefore, the report identifies and discusses possibilities to introduce more clarity in the definition itself. JRC states that it will continue to support the review process of the definition and its implementation in European Union legislation.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) published on July 6, 2015, the final report entitled Nanotechnologies for pesticides and veterinary medicines: regulatory considerations. According to the report, its objective is to highlight the regulatory issues that need to be considered when bringing agricultural or veterinary (agvet) chemical products of nanotechnology to the Australian market. The report addresses relevant aspects of nanotechnology including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The report states: “Every attempt has been made to ensure the information on this rapidly-evolving field was current at the time of writing. The report represents a first attempt to offer a blueprint on the regulatory considerations applicable to nanotechnology in Australian agriculture and animal husbandry.” According to the report, the general consensus is that, for the foreseeable future, existing regulatory frameworks developed for macroscale chemicals will be used to regulate nanomaterials. Over time, the report states, the framework will evolve as new information highlighting limitations in the current risk assessment paradigm becomes available. APVMA intends to use the report to develop a final regulatory approach for nanotechnology products, including:
- Building capability and expertise so new products can be evaluated effectively;
- Analyzing the data requirements;
- Enhancing the existing regulatory framework if required as knowledge evolves; and
- Continuing to engage with the international scientific community so that the latest research is being considered.
The Organization for Economic Cooperation and Development (OECD) has issued the following publications in its Series on the Safety of Manufactured Nanomaterials:
- No. 55 — Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates at Workplaces: The primary goal of this publication is to describe a reliable formal methodology for conducting consistent exposure related measurements and assessments of aerosols containing engineered nano-objects and their agglomerates and aggregates in workplace operations. This publication presents a harmonized tiered approach that is “systematic, consistent, practical, and flexible for conducting field-based, real-time workplace release and exposure measurement and assessment” to airborne nano-objects and their agglomerates and aggregates and off-line analyses of measurement samples.
- No. 56 — Analysis of the Survey on Available Methods and Models for Assessing Exposure to Manufactured Nanomaterials: The OECD Working Party for Manufactured Nanomaterials (WPMN) Steering Group 8 agreed to conduct an informal survey as an initial step in compiling information regarding methods and models for assessing exposure to manufactured nanomaterials. The results were intended to develop an inventory of available methods and models used to assess human and environmental exposure to manufactured nanomaterials. The survey gathered information on a variety of types of methods and models, including those used to set priorities, screen nanomaterials, develop detailed assessments of exposure, and other types of methods or models.
- No. 57 — Guidance Manual Towards the Integration of Risk Assessment into Life Cycle Assessment of Nano-Enabled Applications: Based on the conclusions of a 2011 workshop on “Environmentally Sustainable Use of Manufactured Nanomaterials,” the OECD WPMN Steering Group 9 Project on the Environmentally Sustainable Use of Manufactured Nanomaterials developed this guidance manual intended to support decision making in various situations; including research, innovation, product development, scaling-up of production, marketing, and end-of-life, as well as regulatory decisions. This publication aims to incorporate knowledge of risk analyses of the environmental impact in life cycle assessment studies as decision-making tools during both upstream (research and development) and downstream (industrialization, usage, re-use, end-of-life management: recycling, recovery, destruction) phases of a nanostructured product.
On July 7, 2015, the American Chemical Society (ACS) will hold a webinar to address the White House’s recently announced Nanotechnology-Inspired Grand Challenges for the Next Decade. The webinar will feature ACS Nano Editor-in-Chief Paul Weiss and the White House Office of Science and Technology Policy’s Lloyd Whitman. The webinar is free, and registration is open to the general public.
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.