NNI Publishes Outcomes of the 2015 EU-U.S.: Bridging NanoEHS Research Efforts Joint Workshop

The National Nanotechnology Initiative (NNI) published on March 23, 2015, the outcomes of the March 12-13, 2015, joint workshop held by the U.S. and the European Union (EU), “Bridging NanoEHS Research Efforts.”  The workshop was intended to promote and deepen the collaboration on nanotechnology environmental, health, and safety (nanoEHS) research.  Workshop participants reviewed progress toward U.S.-EU Communities of Research (COR) goals and objectives, shared best practices, and identified areas for cross-COR collaboration.  To address new challenges, the CORs were realigned and expanded with the addition of a COR on nanotechnology characterization.  The seven CORs now address:

  • Characterization;
  • Databases and Computational Modeling;
  • Exposure through Product Life;
  • Ecotoxicity;
  • Human Toxicity;
  • Risk Assessment; and
  • Risk Management and Control.

According to the workshop outcomes, the CORs support the shared goal of responsible nanotechnology development as outlined in the U.S. NNI Environmental, Health, and Safety Research Strategy, and the research strategy of the EU NanoSafety Cluster.  The CORs directly address several priorities described in these documents, including the creation of a comprehensive nanoEHS knowledge base and international cooperation on the development of best practices and consensus standards. 

EC Calls for Data on Colloidal Silver (Nano) in Cosmetic Products

On March 24, 2015, the European Commission (EC) announced a call for data on the ingredient “colloidal silver (nano).” According to the EC, it has received notification of several cosmetics products containing the ingredient “colloidal silver (nano)” (CAS No. 7440-22-4). The EC states that although this ingredient is not regulated in the cosmetics regulation, it is reported in the Cosmetic Ingredients and Substances (CosIng) database with antimicrobial functions. According to the applicants, the ingredient is used as antimicrobial in nano form, with a lowest cut off particle size of one nanometer (nm) and at maximum concentration up to 1.0 percent in cosmetic products. The EC states that it has concerns on the use of “colloidal silver (nano)” “because of the potential toxicity of its nanoparticles that enter into the cells and because the data submitted by the applicants seems to be insufficient to carry out a full risk assessment.” To prepare requests for scientific opinions to the Scientific Committee on Consumer Safety (SCCS), the EC invites interested parties to submit any relevant scientific information on the safety of “colloidal silver (nano)” used in cosmetic products, in particular data regarding all toxicological end-points and an indication on the suggested safe concentration limits. Interested parties, according to the EC, include Member States, manufacturers of cosmetic products, producers of the substances concerned, and relevant industry and consumers associations. Data are due June 30, 2015.

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

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.  The primary purpose of the paper is to draw the attention of the EC to emerging issues in the non-food area that have been identified by SCENIHR members as having the potential to significantly impact human health and/or the environment in the future.  The criteria used to identify an emerging issue include novelty of the stressor or process; scale of possible impacts on man and/or the environment; severity of impacts for particular organisms (priority for life threatening); urgency, i.e., the temporal nature of the likely changes (priority for rapid increases); not investigated in depth recently by a reputable scientific body; and anticipated to be increasingly important over time.  The emerging issues identified include the use of nanomaterials for medical imaging and drug delivery and graphene nanomaterials.

Comments Due July 6 on Proposed Reporting and Recordkeeping Requirements for Nanoscale Materials

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.  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 on the proposed rule are due July 6, 2015.  More information is available in Bergeson & Campbell, P.C.’s March 25, 2015, memorandum

USDA NOP Releases New Policy Memo on Nanotechnology

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.” 

EPA Issues Response to ICTA Petition Regarding Nanosilver

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. 

EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials

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.

French Agency Publishes Opinion on Silver Nanoparticles

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 Publishes Article on Nanomaterial Categorization for Assessing Risk Potential

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.

NNI Publishes Supplement to President's 2016 Budget

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.

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