On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.” When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release. Petitioners disputed these facts. While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.” According to the court, EPA cites no evidence in the record to support its assumption that current users of conventional-silver pesticides will switch to NSPW (“the substitution assumption”), but contends that it will occur as a “logical matter.” The court states that the lack of evidence supporting the substitution assumption is problematic in light of EPA’s other unsupported assumption, that there will be no new products. The court notes that EPA assumes current users of conventional-silver pesticides will switch to NSPW because of its benefits, but that these same benefits will not prompt manufacturers to incorporate NSPW into new products. EPA could have proved these assumptions, but without evidence in the record to support the assumptions, the court states that it “cannot find that the EPA’s public-interest finding is supported by substantial evidence as required by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence. The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners. More information will be available in Bergeson & Campbell, P.C.’s forthcoming memorandum.
On April 26, 2017, France’s National Research and Safety Institute (INRS) published a press release announcing the availability of an English summary of a foresight study conducted in 2014 on the development of nanomaterials by 2030 and the consequences on safety and health in small businesses in France. Four scenarios were envisioned:
(1) Strong and successful commitment from both state and industry: massive development;
- Economy driven by innovation;
- Strong state involvement;
- Marked interest by companies;
- Controlled health and environment risks;
- An enthusiastic society;
- Massive, global development; and
- Suitable prevention means are generally set up in companies but there is a residual risk of transient exposure or accidents in poorly controlled work situations and difficulties for the ageing population to adapt to the pace of change;
(2) Informed rejection by society: development in a few strategic sectors:
- An economic and political debacle;
- Destruction of the industrial fabric;
- Distrust of innovation by society;
- Uncertain health and environment risks; and
- Slow development, confined to a few strategic sectors deemed priorities;
(3) Industry in the driving seat: development in growth sectors only:
- A morose economic situation;
- Very limited political support;
- A certain disinterest by society;
- Health and environment risks not assessed;
- Development heavily supported by manufacturers, but rationalized and targeted at growth sectors; and
- Prevention of occupational risks is strictly handled by companies and is mainly oriented towards preserving the means of production. The response, mostly insurance-focused, is based on compensation and not on prevention;
(4) Sustained regional will: development based on local skills:
- A strong and prosperous Europe of the regions;
- Massive support in certain regions;
- A peaceful and indifferent society;
- Health and environment risks poorly studied and therefore not anticipated;
- Development based on local skills: creation of clusters of excellence; and
- Occupational risks are generally managed by local structures located within clusters of competitiveness. These regional entities apply the rules decided at European level, based on co-management between employer associations and employee unions.
According to INRS, the possible future outcomes “should lead to a better apprehension of the risks associated with these promising materials.” The foresight study is one of three exercises that INRS has conducted to date. In 2017, INRS intends to begin a fourth exercise that will address the circular economy and its consequences on occupational safety and health.
Germany’s Federal Institute for Occupational Safety and Health (BAuA) has published the final report for the project “Methodology for the Identification of Granular Biopersistent Particles (GBP) at Workplaces.” The final report states that the category includes respirable granular biopersistent particles without known significant specific toxicity. This category comprises various materials such as minerals, metals, metal oxides, or polymers that show a negligible solubility in lung fluids (extracellular lung lining fluid, intracellular lysosomal fluid). The abstract states:
Module 1: In vivo study — Analysis of the bronchoalveolar lavage fluid (BALF) following intratracheal instillation
The analysis of the inflammatory potency of 6 GBP candidates included μ-TiO2 “Bayertitan T”, nano-TiO2 P25, μ-Eu2O3, μ-BaSO4, μ-ZrO2 and nano-SiO2, each at a low (0.5 μl per rat) and high (1.5 μl) volumetric dose. In the differential cell count, μ-TiO2 did not induce statistically significant polymorphonuclear neutrophil (PMN) levels on day 3 post-treatment in the low dose group. The GBP requirement of a very low inflammogenicity was confirmed. PMN levels of approx. 12% in the high dose group indicated a bolus effect. μ-BaSO4 showed a behavior similar to μ-TiO2. In contrast, nano-TiO2 P25, μ-Eu2O3, μ-ZrO2 and nano-SiO2 did not meet this GBP criterion.
Module 1: In vivo study — Chemical analysis of the lung burdens
On day 3, an average retention of approx. 70% as compared to the administered total dose was detected; approx. 1/3 of the dose is eliminated from lungs by rapid clearance mechanisms (coughing, ciliae-mediated processes, etc). The clearance half-time showed a value close to the physiological rat lung clearance of approx. 60 days in the μ-TiO2 “Bayertitan T” low dose group. In the high dose group a doubled half-time was observed (overload effect). In the μ-BaSO4 and amorphous silica groups, smaller values in the range of 25-40 days were calculated indicating an additional dissolution effect. In the μ-Eu2O3 and μ-ZrO2 groups increased half-times, i.e. 4- to 5-fold and 2- to 4-fold, respectively, were calculated indicating a clear surface chemistry-related contribution to the toxic and clearance-retardative outcome.
At μ-TiO2 “Bayertitan T” and nano-TiO2 P25 very low ionic moieties regarding the total lung burden were detected (≤0.1weight-% in the 0.5 μl doses), the other dusts showed higher (0.2-0.7 weight-%) or very high (30 weight-%; Eu2O3) moieties.
Module 2: In vitro assays
The plasmid scission (PSA) and the cytotoxicity assay towards THP-1 cells indicated effects matching to the in vivo results in the Eu2O3 dust group. Overall, in vitro assays under investigation did not mirror the in vivo results with statistically significant power.
Module 3: Acellular solubility of test materials
On the basis of the acellular solubility results in artificial lung fluids a threshold value of ≤ 1 mg/l could be agreed on to define the category of “low soluble particles.”
The inhalation exposure pathway will show lower effects as compared to intratracheal instillation as no bolus effects will occur. Therefore, the final setting of maximum tolerable clearance t1/2 and PMN levels to define the GBP category should await the outcome of the inhalation validation study.
The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA published two new guidance documents:
- Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment (IR&CSA) (quantitative structure-activity relationships (QSAR) and grouping of chemicals): The appendix advises registrants on how to justify the use of hazard data between nanoforms (and non-nanoforms) and within groups of nanoforms of the same substance; and
- How to prepare registration dossiers that cover nanoforms — best practices: The document provides recommendations for distinguishing between different nanoforms of a substance, and how to report information on nanoforms consistently in the dossiers. ECHA states it originally intended this to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing it as an advisory best practice document. More information on the Board of Appeal decision is available in our March 6, 2017, blog item.
In addition, ECHA published updates to three of its existing guidances on nanomaterials — the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance). ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. ECHA notes that the scope of the updates covers human health and environment related endpoints and incorporates new developments in the scientific understanding of hazard/risk assessment of nanomaterials. It also takes account of ECHA’s experience from compliance checks and substance evaluation.
The International Agency for Research on Cancer (IARC) announced on May 19, 2017, publication of Volume 111 of the IARC Monographs, Some Nanomaterials and Some Fibres. The Monograph contains evaluations of the carcinogenic hazard to humans of fluoro-edenite fibrous amphibole, silicon carbide fibers and whiskers, and carbon nanotubes. As reported in our November 3, 2014, blog item, a summary of the findings was published in The Lancet Oncology in 2014. The Working Group, which met September 30-October 7, 2014, classified fluoro-edenite fibrous amphibole as carcinogenic to humans (Group 1). Regarding silicon carbide fibers and whiskers, the Working Group classified occupational exposures associated with the Acheson process as carcinogenic to humans (Group 1), and fibrous silicon carbide as possibly carcinogenic to humans (Group 2B). Although not unanimous, the Working Group classified silicon carbide whiskers as probably carcinogenic to humans (Group 2A) rather than possibly carcinogenic to humans (Group 2B). The Working Group classified single-walled and multi-walled carbon nanotubes as not classifiable as to their carcinogenicity to humans (Group 3), with the exception of a specific multi-walled carbon nanotube. Multi-walled carbon nanotubes-7 were classified as possibly carcinogenic to humans (Group 2B).
On June 1, 2017, in concert with industry partners, SEMI will host an information-sharing webcast concerning the new regulatory requirements for nanoscale materials under the Toxic Substances Control Act (TSCA). Jim Alwood, Program Manager in the U.S. Environmental Protection Agency’s (EPA) Chemical Control Division, will provide a summary and answer questions about the new TSCA Section 8(a) record-keeping and reporting requirements for nanoscale materials. The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials. Manufacturers, processors, and end-users of substances, chemicals, formulations, and mixtures considered to be nanoscale materials by EPA, are affected by the enacted regulation. As reported in our May 17, 2017, blog item, EPA is currently seeking comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final rule. The industry partners for the SEMI webcast include the NanoBusiness Commercialization Association.
Registration is now open for a May 24, 2017, webinar on “An Introduction to Voluntary Standards and Their Role in Enhancing the Quality of Scientific Research.” According to the National Nanotechnology Coordination Office (NNCO), the safe development and commercialization of nanotechnology depends on the availability of internationally agreed upon standards. Such standards enable the use of consistent terminology, measurement protocols, and well-characterized reference materials, and are thus foundational for precise and reproducible measurements. These measurements are essential for the reliable assessment of human and environmental exposure and hazard. The webinar will provide an introduction to voluntary standards, the nanomaterial measurement infrastructure, and how the development and use of standards enhances the quality of scientific research. Speakers will include:
- Shaun Clancy, Director, Product Regulatory Services, Evonik Corporation;
- Anil Patri, Director, Nanotechnology Core Facility, National Center for Toxicological Research, U.S. Food and Drug Administration; and
- Stacey Harper, Associate Professor, College of Agricultural Sciences, Oregon State University.
Ajit Jillavenkatesa, Senior Standards Policy Adviser, National Institute of Standards and Technology, will moderate the webinar. Viewers will be able to submit questions during a question and answer period. Registration is required and is on a first come, first served basis.
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452. The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule. The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials. More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.” EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.” Comments are due June 15, 2017.
The 14-page draft guidance, in the form of questions and answers, addresses questions within the following categories: what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality. While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply. Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported. More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”
The European Chemicals Agency (ECHA) has created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012. NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Classification, Labeling, and Packaging (CLP) regulation, and the Biocidal Products Regulation (BPR) for nanomaterials. ECHA states that the page includes information on NMEP’s mandate and activities, the list of the members, and the meeting schedule, which will also include the minutes of the meetings in the future. According to the web page, NMEP will meet May 16-17, 2017, and November 7-8, 2017.
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” EPA states in the pre-publication notice that the guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final rule. The final rule involves one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials. The notice lists the following North American Industrial Classification System (NAICS) codes to help readers determine whether the document may apply to them:
- Chemical Manufacturing or Processing (NAICS Code 325);
- Synthetic Dye and Pigment Manufacturing (NAICS Code 325130);
- Other Basic Inorganic Chemical Manufacturing (NAICS Code 325180);
- Rolled Steel Shape Manufacturing (NAICS Code 331221);
- Semiconductor and Related Device Manufacturing (NAICS Code 334413);
- Carbon and Graphite Product Manufacturing (NAICS Code 335991);
- Home Furnishing Merchant Wholesalers (NAICS Code 423220);
- Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS Code 423330); and
- Metal Service Centers and Other Metal Merchant Wholesalers (NAICS Code 423510).
EPA states that it will make the draft guidance available on its website at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under#guidance, and will also be available in Docket ID number EPA-HQ-OPPT-2010-0572. EPA states that it will accept comments regarding the guidance, but not regarding the rule itself, “which has already been finalized.” Comments will be due 30 days after the notice is published in the Federal Register. More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials