The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations. The memorandum states that NOP has received questions about the use of nanotechnology. The memorandum uses the term “engineered nanomaterials” to refer to substances specifically designed and manufactured to have unique properties or behavior attributable to particle size. The term “incidental nanomaterials” is used to refer to substances that are incidental byproducts of other manufacturing (e.g., homogenization, milling) or that occur naturally. The memorandum states that no engineered nanomaterial will be allowed for use in organic production and handling unless the substance has been: (1) petitioned for use; (2) reviewed and recommended by the National Organic Standards Board (NOSB); and (3) added to the National List of Allowed and Prohibited Substances through notice and comment rulemaking. The memorandum notes that to avoid conflicts about the presence of nanomaterials in substances regulated by other federal agencies, NOP is not establishing a separate definition for engineered nanomaterials. Instead, the descriptions in the U.S. Food and Drug Administration’s (FDA) Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology and the U.S. Environmental Protection Agency’s policies on regulating pesticides that use nanotechnology and control of nanoscale materials under the Toxic Substances Control Act “should be used as applicable.”
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.
Briefly, the key decisions articulated in EPA’s response to the petition are:
- EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.
- EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.
- EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”
- Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.
- EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.
- EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).
- EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
On March 25, 2015, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. 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. Comments will be due 90 days after the proposed rule is published in the Federal Register. EPA has posted a fact sheet on its website. EPA states that it anticipates holding a public meeting during the comment period, and it will announce the time and place of the meeting on its web page. More information is available in Bergeson & Campbell, P.C.’s March 25, 2015, memorandum.
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on March 10, 2015, an Opinion concerning exposure to silver nanoparticles that “stresses the research that has been carried out to examine the potential health and environmental effects of silver nanoparticles but notes that this is still insufficient to allow the health risks to be assessed.” ANSES states that, based on the conclusions of its April 2014 Opinion on the risks associated with manufactured nanomaterials, it recommends limiting the marketing of products containing silver nanoparticles to applications whose advantages have been clearly demonstrated. ANSES recommends encouraging research concerning physico-chemical characterization, exposure assessment, toxicology and ecotoxicology, assessment of antibacterial effectiveness, and bacterial resistance, as well as enhancing the traceability of data and consumer information on products containing silver nanoparticles. ANSES recommends that the use of silver nanoparticles (production, processing, utilization) be limited to applications whose advantages have been clearly demonstrated, and whose benefits to human health outweigh the risks for the environment.
ACS Nano, published by the American Chemical Society (ACS), has posted an article entitled “Nanomaterial Categorization for Assessing Risk Potential to Facilitate Regulatory Decision-Making.” The abstract of the article, which is co-authored by Lynn L. Bergeson, states:
For nanotechnology to meet its potential as a game-changing and sustainable technology, it is important to ensure that the engineered nanomaterials and nanoenabled products that gain entry to the marketplace are safe and effective. Tools and methods are needed for regulatory purposes to allow rapid material categorization according to human health and environmental risk potential, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review. Using carbon nanotubes as an example, we discuss how data from alternative testing strategies can be used to facilitate engineered nanomaterial categorization according to risk potential and how such an approach could facilitate regulatory decision-making in the future.
The article is available for purchase online.
The National Nanotechnology Initiative (NNI) published on March 11, 2015, its supplement to the President’s 2016 budget submitted to Congress. NNI states that the supplement serves as the NNI annual report. According to the annual report, in 2014, federal agencies invested $1.57 billion in nanotechnology-related activities. The President’s 2016 request calls for an investment of $1.50 billion, which the report states “affirm[s] the Administration’s continuing commitment to a robust U.S. nanotechnology effort.” Almost half of the budget request is focused on applied research and development (R&D) and support for the Nanotechnology Signature Initiatives (NSI), “reflecting an increased emphasis within the NNI on commercialization and technology transfer.” The NSIs are multiagency initiatives intended to focus on technology areas of national importance that may be more rapidly advanced through enhanced interagency coordination and collaboration.Continue Reading...
The National Nanotechnology Initiative (NNI) published on March 12, 2015, the proceedings of a September 15, 2014, meeting on “Realizing the Promise of Carbon Nanotubes: Challenges, Opportunities, and the Pathway to Commercialization,” held at the National Aeronautics and Space Administration (NASA) Headquarters. According to NNI, a number of common themes and potential future research and development priorities emerged:
- Increased efforts devoted to manufacturing, quality control, and scale-up;
- Improvements in the mechanical and electrical properties of carbon nanotube (CNT)-based bulk materials to approach the properties of individual CNTs;
- More effective use of simulation and modeling to provide insight into the fundamentals of the CNT growth process;
- Improved understanding of the properties of bulk CNT-containing materials at longer length scales;
- Standard materials and protocols to guide the testing of CNT-based products for commercial applications;
- Life cycle assessments for gauging commercial readiness; and
- Use of public-private partnerships or other collaboration vehicles to leverage resources and expertise to solve these technical challenges and accelerate commercialization.
NNI states that the outcomes of the meeting will help inform the future directions of the NNI Nanotechnology Signature Initiative “Sustainable Nanomanufacturing: Creating the Industries of the Future,” which aims to accelerate the development of industrial-scale methods for manufacturing functional nanoscale systems.
The Danish Environmental Protection Agency (EPA) published on March 6, 2015, the following reports concerning nanomaterials:
- Survey of products with nanosized pigments -- Focusing on products exempt from the Danish Nanoproduct Register: The main focus of the study is on paints, wood preservatives, glues, and fillers, as well as on colored textiles. According to the Danish EPA, the survey contributes to the overview of consumer products with nanomaterials on the Danish market and is intended to discuss whether and which pigments may be considered nanomaterials according to the definition of nanomaterial recommended by the European Commission (EC). This is done based on an initial mapping of pigments on the European Union (EU) market. The Danish EPA states: “Based on discussions with stakeholders, including trade organisations and industry, it is concluded that most pigments are likely candidates to be nanomaterials.”
- Exposure assessment of nanomaterials in consumer products: Under the agreement “Better Control of Nanomaterials,” the Danish EPA commissioned a number of projects to investigate and generate new knowledge on the presence of nanomaterials in products on the Danish market and assess the possible associated risks to consumers and the environment. This report is the first in a series of four from a project addressing consumer exposure and risk assessment of nanomaterials in products on the Danish market. The report evaluates existing methods/approaches/tools for assessing consumer exposure and risks associated with consumer nanoproducts, and identifies representative consumer nanoproducts from which to select and describe a total of 20 exposure scenarios for further risk assessment.
- Hazard assessment of nanomaterials in consumer products: This is the second report in the series of four from the project addressing consumer exposure and risk assessment of nanomaterials in products on the Danish market. The Danish EPA states that the consumer is potentially exposed to nanomaterials in their final, intended use (i.e., when the nanomaterials are part of a matrix). The report focuses on the hazard of nanomaterials when part of a consumer matrix. Free nanomaterials may be liberated during the use phase, however, and therefore the hazard of pristine nanomaterials is also described.
- Exposure to nanomaterials from the Danish Environment: This is the third report from the project addressing consumer exposure and risk assessment of nanomaterials in products on the Danish market. The Danish EPA states that the report evaluates the population’s exposure to nanoparticles from the environment and describes the risk associated with this exposure. According to the Danish EPA, the results should give proportionality to the possible risks from exposure to nanomaterials from use of consumer nanoproducts that are described in other parts/work packages of this project.
- Nanomaterials in Commercial Aerosol Products on the Danish Market: The report examines the use of aerosol spray products containing solid nanomaterials available to consumers on the Danish market. According to the Danish EPA, very few aerosol products with nanomaterials are found on the Danish market. The identified products include cleaning products, waterproofing products, and paint. The Danish EPA states that the nano content in many of the products is in the form of ordinary pigments that are nanosized. A simple risk assessment suggests the same risk profile of aerosol products with and without nano. Both can pose a hazard if used indoors in unventilated spaces. The Danish EPA cautions that spray products should in general be used outdoors or in ventilated rooms.
- Occurrence and effects of nanosized anatase titanium dioxide in consumer products: The survey maps the occurrence and effects of nanosized anatase titanium dioxide in a number of selected products on the Danish market. Based on available knowledge, an attempt has been made to assess if possible risks can be associated with their use. The Danish EPA states that the crystalline anatase form of titanium dioxide occurs in many products used as a pigment (paint, paper, plastic, cosmetics) or as a UV filter (e.g., plastic, sunscreens, and various coatings), but also in less widespread products where the photocatalytic properties prevalent in the anatase form are made use of (e.g., self-cleaning paints and construction materials). According to the Danish EPA, the occurrence of the anatase form in sunscreens was difficult to assess precisely as primarily Danish producers responded. To achieve the Nordic ecolabel “Svanen,” most of these avoid nanomaterials, which are banned in this context. Insufficient data made it impossible to assess if the products could represent a risk to human health. Regarding sunscreens, the Danish EPA states that “it is assessed that an unacceptable risk is not likely even in a summer scenario, where high amounts of sunscreen are used. Also, spray-application of self-cleaning paint was not assessed as presenting a risk based on available data.”
- Nanomaterials in the Danish environment -- Modelling exposure of the Danish environment to selected nanomaterials: Using modeling techniques, the report predicts where to find some of the most widespread nanomaterials in the environment in Denmark. The Danish EPA states that these findings “are to be used in an overall assessment of the impact of nanomaterials on the environment in Denmark.”
Environment Canada and Health Canada have released a February 2015 consultation document entitled Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List. Environment Canada and Health Canada propose a stepwise approach to address nanoscale forms of substances on the Domestic Substances List (DSL):
- Establishment of a list of existing nanomaterials in Canada;
- Prioritization of existing nanomaterials for action; and
- Action on substances identified for further work.
The proposed criteria for defining existing nanomaterials include, but are not limited to:
- The substance has a chemical composition that is identical to that of a bulk substance already listed on the DSL; AND
- The substance is in commerce in Canada at quantities above 100 kilograms (kg)/year; AND
- The substance is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; OR
- The substance is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.
Proposed criteria for substances to be excluded, unless they are intentionally manufactured to exhibit one or more nanoscale properties/phenomena, include, but are not limited to:
- Organic or organo-metallic pigments and dyes;
- Naturally occurring or incidentally produced nanomaterials; and
- Deoxyribonucleic acid, ribonucleic acid, proteins, peptides, liposomes, antibodies, viruses or a virus-like particles, organelles or other biological materials.
Questions for stakeholders include:
List of Existing Nanomaterials:
- Is the list of nanomaterials in Appendix A of this document a good preliminary reference list of existing nanomaterials in Canada?
- What additional criteria could be considered to identify existing nanomaterials?
- What methods can be used to collect information to develop a more comprehensive list or verify information on existing nanomaterials in commerce in Canada?
- What other sources of information are available to determine the commercial status of existing nanomaterials in Canada?
- What barriers exist to obtaining/providing information on existing nanomaterials in Canada?
- What factors should Environment Canada and Health Canada consider when prioritizing nanomaterials?
- What outcomes should Environment Canada and Health Canada consider when prioritizing nanomaterials?
Comments will be due 60 days after the document is posted on the Canadian Environmental Protection Act (CEPA) Environmental Registry. In June 2015, Environment Canada and Health Canada intend to conduct an information gathering survey and hold a stakeholder workshop to discuss the proposed approach and the information gathering survey.
EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed Publishes 2014 Annual Report
On February 16, 2015, the European Food Safety Authority (EFSA) published the 2014 annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed, which is intended to inform the public and the EFSA Advisory Forum about the Network’s specific activities and achievements. EFSA states that, during 2014, the Network followed-up on its priority areas and contributed to making inventories of applications of nanomaterials already present in the food/feed chain. According to EFSA, during its 2014 meeting, the Network dedicated most of its discussions to relevant research results for possible toxic effects following the oral route of exposure. EFSA’s summary states that a “new issue of concern is that absorption is not linear with dose: high dose studies are often used for tox testing for estimation of safe dose, while the high dose may result in aggregation, agglomeration, gelation and as a consequence dose-dependent absorption.” According to the summary, challenges also remain concerning the technical aspects for considering a material as a nanomaterial for the regulatory purpose of food labeling. The summary states that the NanoDefine project (FP7) is expected to deliver by 2017 an implementable test-scheme for regulatory purposes to distinguish nano from non-nano. Finally, EFSA states, “[t]he Network agreed that regardless the current challenges and regardless the % of nanoforms in the bulk material (particle size% or mass%), EFSA should assess the nano-fraction, no matter how small.”