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Tag Archives: nanomaterials

The EPA Inspector General’s Report

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency’s operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency’s operation."

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation …

FY 2012 National Defense Authorization Act: The Senate Version

On June 17, 2011, the Senate Committee on Armed Services announced that S. 1253, the National Defense Authorization Act for FY 2012 had been passed unanimously and had been reported out of Committee and sent on to the Senate for debate.

S. 1253 provided $200 million in funding for the "Rapid Innovation Program" established by PL 111-383, the 2011 National Defense Authorization Act.  $50 million of this is directed to the development of advanced materials, including nanomaterials, as described in S. Report 112-26

    2. Developing advanced materials: $50.0 million for increased investment in a broad range of materials technologies, both organic and inorganic, that can provide enhanced performance in extreme environments; enhanced strength and reduced weight for the spectrum of applications from aerospace to lighter soldier loads; enhanced survivability of ground, air, and naval systems; and tailored physical, optical, and electromagnetic properties for a wide variety of the challenging environments and unique properties demanded of military systems. Such materials could include advanced composites and metals, nanomaterials, and rare-earth alternatives. Investments could also address new techniques for manufacturing and processing these materials, including advancements in forming, joining, and machining. Whether increasing survivability or improving fuel efficiency for greater performance, advanced materials are a foundational enabling component of military systems across all services and all warfighting domains;

S. Rept. 112-26 also contains the following language, which doesnot appear in S. 1253 as reported:

Nanotechnology research

The Department of Defense (DOD) is one of 25 federal agencies that are part of the National Nanotechnology …

California Delays Implementation of “Safer Consumer Product Alternatives” Regulations

At the request of Linda S. Adams, California’s Secretary for Environmental Protection, the Department of Toxic Substances Control (DTSC) has postponed implementation of the controversial Safer Consumer Product Alternatives Regulations. The regulations, the result of legislation passed by the California State Assembly in 2008 (Chapter 559, Acts of 2008), were designed  to 

to establish a process by which chemicals of concern in products, and their potential alternatives, are evaluated to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern. The regulations would be required to specify actions that the department may take following the completion of the analysis, including imposing requirements to provide additional information, requirements for labeling or other types of product information, controlling access to or limiting exposure, managing the product at the end of its useful life, or funding green chemistry challenge grants, restrictions on the use of the chemical of concern in the product, or prohibitions on use.  

The proposed regulations drew criticism from both the environmental and industrial communities as being both not stringent enough or too stringent and broad. For example, Renee Sharp, California Director of the Environmental Working Group, has been quoted as stating that ". . . we cannot support these [regulations] . . . . they are so far away from anything they are supposed to do. These are worse than nothing.", while John Ulrich, Executive Director of the Chemical Council of California earlier this year criticized …

Massachusetts Issues Nano-EHS Guidance Document

This article originally appeared on the National Nanomanufacturing Network’s InterNano website on August 25, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Massachusetts’ Office of Technical Assistance and Technology (OTA) recently released its “OTA Technology Guidance Document: Nanotechnology – Considerations for Safe Development” which has been in development for the past couple of years. The document begins by noting the tremendous positive influence nanotechnology is predicted to have in the fields of biomedical devices, electronics, clean energy, and materials engineering, while at the same time acknowledging that “there are indications of potential harm from certain exposures and release of engineered nanoparticles.” OTA also believes that there “is little uncertainty” regarding available means to prevent potential workplace exposure to nanoscale materials. Simply put, despite unknown EHS risks, there is more than adequate knowledge to control potential exposure in OTA’s view.

The end of the report contains a bibliography of existing resources covering state-of-the-art workplace good practices for nanoscale materials. The bibliography includes the “usual suspect” documents and websites published by NIOSH, ICON, German government, British Standards Institute, ED/DuPont, NanoSafe, and ASTM. From these primary sources, OTA distills a basic set of good practices for entities working with nanoscale materials in Massachusetts.

First, establish a risk reduction plan for facilities working with nanoscale materials. Such a plan should have two levels. First, it should attempt to protect against direct and immediate worker exposure. Second, it should also attempt to protect against possible releases during transport, use, and disposal after the …

GAO Provides Recommendations Regarding EPA’s Effort to Regulate Nanomaterials

On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances — General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new …

Sweating the Small Stuff

Earlier this month, the Reuters news service (now part of Thomson Reuters) carried an article by Richard A. Liroff, "Nanomaterials: Why Your Company Should Sweat the Small Stuff", primarily aimed at management executives at companies using or contemplating using nanomaterials in their products or manufacturing processes.

Noting that nanomaterials present "the potential to yield extraordinary health, environmental, and other global social benefits", Liroff also notes, as with asbestos, the potential for nanomaterials to have "novel toxicity risks". Pointing out that regulatory agencies in Canada, California, and the EU are basically at the beginning stages of issuing regulations;  EPA is noted for having initiated "a handful of regulatory actions" but since most of these actions featured voluntary compliance rather than mandatory, their success rate is noted as "poor".

Mr. Liroff points out that corporate management will

need to exercise especially demanding due diligence to make sure you’re not taking on liabilities that you and your shareholders will come to regret.

With that in mind, Mr. Liroff poses several questions, largely focusing on suppliers of nanomaterials, that management should keep in mind while performing their due diligence and long term planning, including planning for the worst case scenario.

It’s important that management and shareholders ask these questions and heed the warnings

about the unknown and under-researched hazards of nanomaterials . . . . If these misgivings go unheeded, that would be tragic on multiple counts. Not only because the potential benefits from the burgeoning forms of nanotechnologies will founder and be lost on …

EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens

Last Friday, EPA’s Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:

"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"

FR 74,146 at 38188 (July 31, 2009).  The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:

  1. Introduction
  2. Life Cycle Stages
  3. Fate and Transport
  4. Exposure – Dose Characterization
  5. Characterization of Effects

The report is formidable in length, scope, and detail.  For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature.  For example:

  • Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;
  • Table 5-3 provides a summary of nano-TiO2 ecological effects; and
  • Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.

EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2."  Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected …

EPA Issues Clarification Regarding Carbon Nanotube SNURs

Readers may interested in learning that EPA issued a clarification today regarding its single-walled and multi-walled carbon nanotube SNURs previously issued in June 2009. EPA’s announcement follows.  Stay tuned . . .

Good afternoon.  On June 24, 2009, the U.S. EPA issued final Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 23 new chemicals, including two carbon nanotubes (nanoscale materials) (http://www.epa.gov/fedrgstr/EPA-TOX/2009/June/Day-24/t14780.pdf).  The SNURs will allow the commercialization of these specific carbon nanotubes under limited conditions to protect against unreasonable risks to human health and the environment.  

The SNURs require companies to notify EPA at least 90 days before manufacture, import, or processing of the specific carbon nanotubes for any activity not meeting the conditions specified in the rules at 40 C.F.R. 721.10155  and 40 C.F.R. 721.10156.

Upon reviewing the rules some stakeholders have asked EPA whether these SNURs apply to all variants of carbon nanotubes. This is not the case. These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMNs) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA’s New Chemicals Program.   The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

If you have any questions, please contact:

Zofia Kosim (202-564-8733) or kosim.zofia@epa.gov Jim Alwood (202-564-8974) or alwood.jim@epa.gov ——————————————————————– David E. Giamporcaro …

Zurich Insurance Unveils New Nanotechnology Exposure Protocol

Zurich North America recently published the June 2009 edition of its Industry Insight online magazine which focuses exclusively on nanotechnology issues. The magazine contains four informative articles which are well worth reading:

  • "At the leading edge: Zurich’s thought leadership on nanotechnology;"
  • "No small thing: The enormous potential of nano;"
  • "The kings of small things: The regulatory environment for nanotechnology development;" and
  • "Large risks from small things? Myth and reality of nano-risks."

Our readers may be particularly interested in the "leading edge" article in which Zurich describes its nanotechnology emerging risk activities dating back to 2006. The article discusses Zurich’s involvement in ANSI’s TAG to ISO/TC 229 Nanotechnologies standards and nomenclature group; its ongoing efforts to make sure its voice is heard in the ongoing regulatory debate surrounding certain nanoscale materials; and the formation of a new Zurich Nanotechnology Exposure Protocol™ (ZNEP™).

As Zurich explains, its new ZNEP™ is a risk assessment protocol designed to understand potential nano-related insurance risks:

"By working closely with corporate customers, collecting data on the specific nano-particles they were using, learning about the specific applications where they’re employed, and then combining this information, Zurich could form a global overview of nanotechnology and its various facets of risk. Such an activity would not only be a very good way to protect is business, but it could form a basis for providing risk management advice to its customers going forward."

Zurich is working with Seattle-based Intertox to implement its ZNEP™, which it also hopes will dramatically shorten the lag …

New Edition of Nanotechnology Law Report

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

  • EPA Issues Significant New Use Rules for Carbon Nanotubes
  • Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
  • Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
  • Are Nano Consumer Products Headed Underground?
  • Oversight of Next Generation Nanotechnology
  • Regulating Nanotechnologies
  • More Interesting Nano-Regulatory Developments
  • Nano Tug of War
  • Pumpkins & Nanoparticles
  • Green Nano
  • NanoBiotech 2009
  • Take two silver nanoparticles and call me in the morning
  • International Approaches to the Regulatory Governance of Nanotechnology
  • ETUC Resolution on Nanotechnologies and Nanomaterials
  • Private Spending on Nano Exceeds Government Spending
  • EMERGNANO Released

Are Nanoparticles Released by Compounding or the Cutting of Nano-Composites?

Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios.  While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings.  We examine two studies along these lines below.

C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 – 309 (2008).

This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell.  The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites.  The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."

The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form.  The particles were spherical in shape and ranged from 27 to 53 nm in diameter.  They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."

Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement …

ETUC Resolution on Nanotechnologies and Nanomaterials

The European Trade Union Confederation adopted a "Resolution on Nanotechnologies and Nanomaterials" in June of 2008. At the recent "Working and Living with Nanotechnologies" conference earlier this month, ETUC presented this resolution and a powerpoint that both summarized and expanded on issues raised by the resolution.

The resolution takes a very positive approach to nanotechnology, anticipating a massive increase in the total number of people employed in nanomanufacturing in Europe. More importantly, it looks at how to minimize potential worker exposure to manufactured nanoparticles and reduce the possible adverse effects of such exposure. In addition, the resolution calls for changes in product labelling and for national registers of nanoproducts to aid the consumer in deciding if they want to purchase a product.

On the whole, this is a moderately toned document that corporations in both Europe and the US presently involved in the commercialization of nanotechnologies and nanomaterials should take a look at and consider.…

Nanotechnology and the Consumer Product Safety Commission

Late last month, the Woodrow Wilson International Center for Scholar’s Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

 E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

 The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC’s jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC’s jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into …

New Report: Nanotechnologies for Energy and the Environment

Research and Market recently announced the publication of a new report addressing environmental uses and applications of nanomaterials.  The report covers many applications, environmental media, and toxicology, and, "describes nanotechnologies, nanomaterials, nanotechnology companies, universities and research centers related to nanotechnologies for new environmental technologies.  Areas covered by are leading edge research in emission reduction, environmental remediation and monitoring, green manufacturing, water filtration and treatment, energy conversion and storage, alternative energy and toxicology. "

The table of contents of the report is available here, and the full report can be purchased for EUR 1,584 (approximately $2,100.00).  …

Department of Defense is Watching “Nanomaterials”

The United States Department of Defense’s Materials of Evolving Regulatory Interest Team (MERIT) recently announced that it added "nanomaterials" to its emerging contaminants watch list.  The DoD defines "emerging contaminants" as those chemicals and materials with a "perceived or real threat to human health or environment," an "evolving regulatory interest," and "either no peer reviewed health standard or an evolving standard."  In addition, an emerging contaminant may have "insufficient human health data/science," or "new detection limits," or "new exposure pathways."…

First EPA Regulation Of Nanotechnology?

Rick Weiss reported in yesterday’s Washington Post that the EPA plans to regulate silver nanomaterials used in consumer products as "germ-killing" agents:

The decision — which will affect the marketing of high-tech odor-destroying shoe liners, food-storage containers, air fresheners, washing machines and a wide range of other products that contain tiny bacteria-killing particles of silver — marks a significant reversal in federal policy. * * *

Under the new determination, first reported on Tuesday by the Daily Environment Report, a Washington publication, and confirmed yesterday by the EPA, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will first have to provide scientific evidence that the product does not pose an environmental risk.…

Report by Former FDA Official Urges Greater Regulation of Nanoindustry

An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts.  Taylor analyzes existing FDA pre-market review and post-market monitoring powers over nanotechnology products and finds several insufficiencies.…

Review: “Nanotechnology and the FDA,” in Nanotechnology Law & Business

In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) — Nakissa Sadrieh and Parvaneh Espandiari — published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”

The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems. …

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