Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

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 use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO's Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

• Complete its plan to issue a Significant New Use rule for nanomaterials.
• Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
• Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

In addition, the Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should

• complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
• use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."

EPA's May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.

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The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.

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Inside EPA reports today that a "senior policy adviser for EPA's Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."

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Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .

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This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an initial nano-regulatory step, the paper recommends excluding “new” nanoscale materials not already on the Inventory from regulatory low volume exemptions, “thereby shifting a post-market audit activity to a pre-market assessment (i.e. new nanomaterials to be assessed under permit or certification categories prior to commercialization).” The suggestion is not unduly punitive, and a similar approach is already in use by the US EPA.

Additionally, the paper recommends modifying the Research and Development exemption for “new” chemical substances to require annual reporting of nanoscale materials produced in quantities exceeding 100 grams per year. While the paper could benefit from some explanation of why this specific threshold was selected, the idea of providing basic information on nanoscale materials used in sufficient quantities for research and development is not onerous.

The main rationale for these modifications is that the “uncertainty surrounding the hazards, exposure, and risk assessment methodologies . . . means that the determination of ‘no unreasonable risk’ or ‘non-hazardous’, both of which are prerequisites to a range of exemptions, is not expected to be straightforward,” and the accompanying need for a case-by-case approach to the responsible development of nanoscale chemical substances.

Regarding “existing” nanoscale chemical substances, the paper recommends that the Australian Government consider following up on their somewhat disappointing voluntary data call-ins under the NICNAS scheme (held in 2006 and 2008) with a study on “the feasibility of a mandatory notification and assessment program.” Such a program would be designed to establish a database of “existing” nanoscale chemicals in use in Australia and increase public confidence in regulatory oversight efforts. U.S. EPA is also considering a mandatory data call-in for nanoscale materials, while California has already issued a mandatory data call-in for carbon nanotubes and is targeting several additional nanoscale materials.

Australia’s DHA’s recommendations are well-balanced. Business and commercialization needs are recognized even though human and environmental, health, and safety regulatory needs are given priority. However, the paper largely ignores the most difficult topic in this space—whether nanoscale versions of “existing” chemicals already on the Australian Inventory of Chemical Substances should be considered “new” chemical substances for regulatory purposes, as suggested by Ludlow, Bowman, and Hodge in their review of Australia’s regulatory framework for nanotechnology, thus triggering pre-market approval requirements prior to commercialization. This issue has been argued back and forth in the US, the EU and other jurisdictions for quite some time, and it is unlikely that Australia will be able to avoid similar strong debate. It is perhaps the biggest issue facing regulators seeking to modify Australia’s industrial chemical legislative framework to fully cover both “new” and “existing” nanoscale materials.

Beyond the substantive regulatory changes noted above, the paper does an excellent job of explaining what “industrial nanomaterials” are, their current regulatory status in Australia, and national and international regulatory activities for nanoscale materials. Moreover, the paper is written in sharp, clear language. It provides lots of key questions for stakeholders to consider when thinking about these issues, as well as surveys and questionnaires encouraging feedback and input. The Australian Government is also sponsoring public consultation activities in most of the country’s larger metropolitan areas to explains the paper to stakeholders first-hand and to solicit additional input.

References

National Industrial Chemical Notification and Assessment Scheme (Department of Health and Aging, Australian Government). Proposal for Regulatory Reform of Industrial Nanomaterials. Public Discussion Paper. November 2009. Available from NICNAS. http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp

Ludlow K, Bowman DM, and Hodge GA. 2007. A Reveiw of Possible Impacts of Nanotechnology on Australia'a Regulatory Framework. Monash Centre for Regulatory Studies, Monash University, Melbourn.
 

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This article was contributed by Dr. Rosalinda Volpe, Executive Director, Silver Nanotechnology Working Group (SNWG) and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On November 3 – 6, 2009 the US Environmental Protection Agency (EPA) held a Scientific Advisory Panel (SAP) meeting in Arlington, Virginia to discuss the “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products.”[1] The meeting was well attended. Over seventy-five people from industry, regulatory, public interest, and academic sectors attended the meeting over three days. EPA received presentations and comments from the SAP panel members during the course of the meeting, as well as six presentations during the Public Comment period, and also received over 560 written comments which can be found on EPA’s website.

One group—The Silver Nanotechnology Working Group (SNWG)[2] —made a detailed presentation[3] to EPA supporting a fundamental regulatory consideration previously overlooked by many in attendance: nanosilver has been rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects. SNWG explained that nanosilver—often called by other names such as "colloidal silver" or "millimicron silver"—has been used in a wide range of consumer applications such as swimming pool treatments and drinking water filters with an established record under FIFRA of regulated and safe use dating as far back as the 1950’s. Thus, SNWG believes that nanosilver is not a “new” material requiring some type of special regulation and EPA needs to look beyond general conceptions of nano terminology and consider the broader established regulatory record of nanoscale silver products within the Agency. Simply put, SNWG believes that calls for treatment of nanosilver as a new material requiring development of expensive new test regimes and discriminatory regulation are difficult to justify.

Moreover, SNWG explained at the meeting that a detailed look at the history of silver within EPA shows that the toxicological studies that form the center of EPA’s existing general hazard limits for silver are derived from historical data from nanoscale silver materials and not conventional (bulk) silver as is often mistakenly assumed. For example, SNWG’s careful examination of EPA’s public registration database[4] for silver over a period of 6 decades revealed:

• The very first registered silver product was a colloidal nanosilver algaecide product that has been safely used by millions of consumers for over 50 years (registered since 1954).
• Every EPA silver registration between 1970 and 1990 was either a colloidal nanosilver or nanosilver-composite product.
• The very first NON-nanosilver product registered by EPA was not registered until 1994.
• An overall analysis reveals that today over 50% of all EPA registered silver products are in fact based on nanoscale silver.

Based on its analysis, SNWG took the formal position that EPA has a range of existing regulatory structures that have successfully addressed silver materials across the size spectrum for over 5 decades. Additionally, EPA has not any incidents of significance on the Agency’s formal incident reporting database (EPA OPP IDS) – indicating that thorough monitoring of real-life use supports the safety of these products.

The SWNG congratulated EPA for its record of successful monitoring and risk management for these materials despite different terminologies being used throughout this time period. Indeed, SNWG pointed out that with nanosilver there is perhaps more historical data and evidence of safe use than for many other regulatory materials, and the EPA has the opportunity to assess nanosilver products with confidence given this long history of safe use under existing EPA regulatons.

The SNWG is hopeful that the EPA and the other meeting attendees will examine SNWG’s position and supporting information in more detail to confirm that nanosilver has been successfully regulated for decades. If sufficient consideration is given, SNWG believes that EPA will conclude that there is no need to “fix” a regulatory process that is not “broken,” but has worked exceedingly well for decades in the case of nanosilver.

References

1.  EPA Scientific Advisory Panel meeting, Arlington VA (November 3 - 6, 2009).

2.  SNWG is an industry effort intended to foster the collection of data on silver nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

3.  SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presentation to Scientific Advisory Panel (November 4th, 2009).

4.  NPIRS Public.

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New Edition of Nanotechnology Law Report

Inside you will find:

• EPA Considering New Approach to Nanoscale Materials Under TSCA
• EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
• EPA Takes Aim at Antimicrobial Products Under FIFRA
• EPA Unveils New Principles for Chemical Management Reform
• EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
• EPA Withdraws Carbon Nanotube SNURs
• Press Release: New Contributing Editor for InterNano
• Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
• Nanoparticles and Deaths in the People’s Republic
• Sweating the Small Stuff
• Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
• Nanotechnology Legislation in the 111th Congress
• Mapping Nano
• Flight of the Nanobees

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Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

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In this article, we note a couple of recent EPA enforcement actions against manufacturers allegedly making unsubstantiated antimicrobial claims for their products – much like occurred in the IOGEAR computer keyboard/mice episode in 2008.  Although these products do not purport to use nanoscale materials, the alleged claims for these products are similar to those made by manufacturers for certain nano-based antimicrobial products. Thus, our readers may be interested in EPA’s actions.

The EPA issued a press release today stating that the parent company of North Face camping and outdoor gear faces up to $1,000,000 in fines for allegedly making unsubstantiated health-related claims for almost 70 of its shoe products using Agion silver ion technology. The EPA press release states:

“At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:  • ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’ • ‘Prevents bacterial and fungal growth’ • Continuous release of antimicrobial agents”

The fines are being sought by EPA under the Federal Insecticide Fungicide and Rodenticide Act which prohibits unsubstantiated public health claims regarding unregistered products.

From Agion’s website: “Agion technology operates at the surface of a product through the controlled release of silver ions which attack microbes and inhibit their growth in three different ways. We offer a variety of silver-based technologies to suit various manufacturing and product requirements.” 

In another press release, EPA publicized a complaint it filed “against Peoria, Ariz.-based Granite Marketing, Inc. for the alleged sale and distribution of an unregistered pesticide in violation of the Federal Insecticide, Fungicide and Rodenticide Act. The EPA is seeking up to $5,200 in civil penalties from Granite Marketing, Inc., located at 8190 W. Deer Valley Road, for offering for sale the unregistered antimicrobial pesticide known as Titania Antibacterial System.”

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A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 - 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address:
bailey.joseph@epa.gov.

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Eight months after EPA's interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA's Toxic Substances Control Act's ("TSCA") Interagency Testing Committee ("ITC") published a report in today's Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):

"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.  EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."

Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:

(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for which
such a report is required.

(B) The categories or proposed categories of use of each such
substance or mixture.

(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total amount
to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each of
its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such substance or
mixture.

(E) All existing data concerning the environmental and health
effects of such substance or mixture.

(F) The number of individuals exposed, and reasonable estimates
of the number who will be exposed, to such substance or mixture in
their places of employment and the duration of such exposure.

(G) . . . the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in such
manner or method.
 

Some of the nanoscale materials prompting ITC's interest appear to be: fullerenes; titanium oxide nanowires; titanium oxide nanoparticles; nano zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single-walled carbon nanotubes; multi-walled carbon nanotubes; carbon nanofibers; Se and Cd quantum dots; nanoceramic particles; and nanoclays.

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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 nanomaterials as part of a process to identify and prioritize research to inform future assessments of the potential ecological and health implications of these materials."

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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
Industry and Small Business Liaison
Environmental Assistance Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
East Building
1200 Pennsylvania Avenue, N.W. (MC7408M)
Washington, D.C. 20460
Phone: (202)564-8107
Fax: (202)564-8813

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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

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In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.

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Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."

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Nanotechnology Law Report -- Spring 2009

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On January 22, 2009, California's Department of Toxic Substances Control (DTSC) sent a formal request to several California manufacturers and/or importers of carbon nanotubes seeking information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information regarding carbon nanotubes.  The request was issued by DTSC under its authority granted under California's Health and Safety Code 699, Sections 57018-57020.

DTSC asked manufacturers to answer the following questions:

What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

What methods are you using to protect workers in the research, development and manufacturing environment?

When released, does your material constitute a hazardous waste under California Health &Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Recipients have one year to supply the requested information.

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Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

• "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
• "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
• "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
• "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA's overall conclusion is that:

"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."

My own view is that response to the NMSP has been lukewarm, at best.

Analysis of Current Submissions

As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials.  Seven additional companies have also committed to submitting data under the Basic Program at a future date.  The In-Depth Program has commitments from four companies thus far.   Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions. 

A chart from the interim report breaking down Basic Program submissions by material type follows.  Nanoscale metals and metal oxides predominate.  Many materials are still in the research and development stage.

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On January 12, 2009, US EPA published its first of two anticipated reports on the Nanoscale Materials Stewardship Program.  The "interim report," is 38-pages, and we'll have additional thoughts once we have a chance to digest the report.  EPA also states that it anticipates publishing a final report in early 2010. 

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In recent days, the US EPA's National Center for Environmental Research and the United Kingdom's Natural Environment Research Council, Physical Sciences Research Council, Department for Environment, Food and Rural Affairs, and Environment Agency announced a "joint research effort to develop and validate predictive tools and similar conceptual models that predict exposure, bioavailability and effects of manufactured nanomaterials in the environment."  The organizations are expected to issue a joint call to interested parties for the submission of predictive models that will be jointly evaluated by both countries.  The models will will likely cover "environmental fate, behaviour, interaction, bioavailability and effects focused on one or more classes of manufactured nanomaterials," as well as new detection methods and other topics.  Solicitations are expected in February 2009.

In the ongoing quest to close the "data gap," this is appears to be another useful partnership where two of worldwide leaders in nanotechnology development are combining resources and efforts to better understand the environmental impacts of nanomaterials.  Stay tuned for the call for models and research projects and also the eventual results of the partnership.

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This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

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Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."

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The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

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Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

1. Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
2. Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
3. Submit material characterization data within six months (see below);
4. Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
5. Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”
 

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

• Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
• Configuration of nanotube ends (e.g., open, capped);
• Description of any branching;
• Width/diameter of inner most wall/tube (average and range);
• Carbon unit cell ring size and connectivity;
• Alignment of nanotube along long axis (straight, bent, buckled);
• Hexagonal array orientation used in the manufacture of the nanotube;
• Particle size of catalyst used in the manufacture of the nanotube;
• Molecular weight (average and range); and
• Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

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The U.S. Environmental Protection Agency's Office of Inspector General (OIG) "helps the Agency protect the environment in a more efficient and cost effective manner.  [It] consist[s] of auditors, program analysts, investigators, and others with extensive expertise" who are tasked with evaluating EPA's ability to deliver on key Agency policies.  Risk Policy Report ran an article yesterday (October 14, 2008) indicating that EPA's OIG intended to assess EPA's nanotechnology efforts in FY 2009.  We tracked down the underlying document which is attached here.  Specifically, EPA OIG intends to conduct an "[a]ssessment of EPA's Efforts to Monitor, Evaluate, and Act on Threats from the Production, Use and Disposal of Nanotechnology Products/Nanomaterials."
 

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Last week, EPA and Thomas Swan & Co. Ltd. released the agency's first manufacturing consent order with regards to nanotubes.  The consent order was entered into between the two parties through the pre-manufacture notice (PMN) portion of the Toxic Substances Control Act (TSCA).

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Cambridge, Massachusetts Nanotechnology Advisory Committee
Recommends Registration of Engineered Nanoscale Materials

Deadline for Similar Voluntary Registration Program by U.S. EPA Closes  

Washington, D.C. – July 28, 2008 – Porter Wright attorney John C. Monica, Jr., served as part of the Nanotechnology Advisory Committee of Cambridge, Massachusetts (NAC), which, after a year of deliberation and information gathering, recommended that the City require the registration of engineered nanoscale materials within city limits. The Cambridge City Counsel is set to adopt those recommendations at a meeting scheduled for tomorrow. Cambridge – host to approximately one dozen nanotechnology-related businesses – is just the second U.S. city (behind Berkeley, California) to require registration of nanomaterials.

“Interest in regulating nanotechnology has increased in recent years due to the recognition that certain materials may take on new and unexpected properties when they are engineered at the nanoscale,” said Monica, a partner in the Washington, D.C. office of Porter Wright Morris & Arthur, LLP and a recognized national authority on nanotechnology product liability and environmental health and safety issues. “The City of Cambridge has approached nanotechnology in a very deliberate, considered manner and appears poised to take steps that promote public safety without stifling nanoscale innovation,” he continued.

The NAC – comprised of citizens, scientists, industrial hygienists, university faculty, nano-businesses, and private environmental consulting firms – also recommended that Cambridge’s City Counsel act to assist businesses with updates to health and safety plans for workers; educate the public; track health and safety developments; and monitor regulatory initiatives in other jurisdictions.

The City’s steps follow closely on the heels of the July 28, 2008 deadline for the first phase of the United States Environmental Protection Agency’s (EPA’s) voluntary registration program – the Nanoscale Materials Stewardship Program (NMSP). NMSP asked companies to report voluntarily to EPA existing data concerning nanoscale materials’ uses, hazards, exposure levels, and risk-management practices. To date, about 20 companies have provided or promised to provide information.

For more information regarding nanotechnology-related legal issues, visit www.nanolawreport.com.

Porter Wright Morris & Arthur LLP is a nationally recognized law firm with more than 250 lawyers in its offices in Washington, D.C.; Cincinnati, Cleveland, Columbus, and Dayton, Ohio; and Naples, Florida. Porter Wright provides counsel to a worldwide base of clients.

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As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.

J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.

Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.

TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.

FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information.  He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic."  Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.

DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."

Other recommendations by Mr. Davies beyond long-term regulatory action are:

Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.

Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.

Resource Requirements: increase regulatory agency budgets and staffing.

EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.

FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.

OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.

CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.

Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.

Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.

Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."

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With all of the interest in nanosilver generated by the recent EPA petition filed by the International Center for Technology Assessment, I thought I would post some background material on EHS issues surrounding silver.  A couple of disclaimers: the material is not comprehensive, and you might see parts of it again in "Nanotechnology Law and Policy" which should be published by Thomson-West legal publishers sometime in 2009 (if I can keep pace with the production schedule).

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The ink isn't dry yet, and we haven't had a chance to go through it in detail, but be aware that US EPA has officially released its Nanoscale Materials Stewardship Program.  Details on the program can be found here, and prior discussion can be found here. 

The Federal Register notice on the program's release is here (73 FR 4861), and addresses the comments submitted by interested parties during the draft phase.

More information will come as we have a chance to parse the material.

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Environmental Science & Technology recently released an editorial discussing nanotechnology safety issues and, more importantly, the recent debate over whether EPA should regulate nanoscale materials as new chemicals under TSCA.  The editorial succinctly sets forth EPA's position, as expressed by Jim Willis, EPA's Chemical Control Division Director, on the TSCA issue this way: 

In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory.

h/t to TGDaily.com.

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SmallTimes's September/October print edition just recently hit newsstands.   Featured in that magazine is our own John Monica's article entitled  "Ramping up the EPA's Nanoscale Material Stewardship Program."  (Co-blogger Michael Heintz has previously blogged about this program here and here.) 

The issue also contains a great article by Lynn Bergeson -- "The EPA's Toxic Substances Control Act: What you must know," and another by Barbara Goode -- "Framing the DuPont/ED Nano Risk Framework."

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In response to the Samsung Washing Machine "nanosilver" controversy last year, EPA indicated it would issue a federal notice concerning how it intends to treat silver ion generators under FIFRA. Many urged EPA to use this opportunity to issue a broad proclamation that all products containing nanoscale silver would be required to be registered as pesticides under FIFRA. NanoLawReport believed EPA would issue a significantly narrower ruling.

On Monday, EPA finally published its promised federal notice requiring products that emit silver ions or other antimicrobial substances to be registered as pesticides under FIFRA. EPA was clear that the notice is not intended to regulate nanotechnology as a whole, nor has the Agency even received information suggesting that the Samsung washing machine in question uses nanotechnology. Whether EPA will require other products containing nanosilver to be registered under FIFRA is likely to be decided on a case-by-case basis.

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Just a reminder to those interested in commenting on US EPA's draft documents concerning the Nanoscale Materials Stewardship Program (NMSP): comments are due to the Agency on or before September 10, 2007. 

US EPA is seeking comments on three draft publications: the "Concept Paper for the Nanoscale Materials Stewardship Program under TSCA, " the "TSCA Inventory Status of Nanoscale Substances - General Approach," and the Information Collection Request (ICR) in Support of EPA’s Stewardship Program for Nanoscale Materials.

The full text of all three can be found here.

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It has been a little over a year since the American Bar Association published its "Innovative Regulatory Approaches” to Nanotechnology discussion paper in June 2006.  During the intervening  period, EPA published its White Paper and its TSCA voluntary framework.  Both provide some general idea of where EPA is heading with environmental regulation, and in this context it is useful to take a glimpse back at the ABA paper.

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US EPA's long-awaited Nanoscale Materials Stewardship Program has finally been released for public comment and stakeholder involvement.  In fact, two Federal Register notices were issued today.  First, the notice on the Stewardship Program was issued.  Second, EPA issued a notice on the Information Collection Activities in Support of EPA's Stewardship Program for Nanoscale Materials.  Both notices and accompanying documents are available at EPA's website.

EPA will conduct a public meeting to discuss comments on this voluntary program on August 2, 2007 in Arlington, Virginia, and the comment period will run for 60 days from the date of the Federal Register notices, July 12, 2007.

Check back for more details as we review these materials.

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The Woodrow Wilson Center released a study entitled "EPA and Nanotechnology:  Oversight for the 21st Century," authored by a former high-level EPA administrator, J. Clarence Davies.  Mr. Davies argues that EPA oversight and regulation of nanotechnology is "urgently" needed.  The Wilson Center has the full text of the report available here.

The report is summarized in this Science Daily article.  The article notes the reaction from the Wilson Center's Project on Emerging Nanotechnologies:

"This new report seeks to encourage EPA, Congress, and others to create an intelligent oversight approach that empowers EPA and promotes investment and innovation in new nanotechnology products and processes," said David Rejeski, director of the Project on Emerging Nanotechnologies at the Wilson Center (PEN). "As both the chair and ranking minority member of the U.S. House of Representatives Committee on Science and Technology stated last year, 'Nanotechnology is an area of research that could add billions of dollars to the U.S. economy, but that won't happen if it is shrouded in uncertainty about its [environmental, health and safety] consequences.' "

The Science Daily article also summarizes the approach Davies recommends.  Specifically, it appears that Davies is focusing on creating an industry-EPA partnership to study the toxicity of nanotechnologies and creating an inter-agency coordinating group (possibly involving FDA and OSHA) to oversee nanotechnology regulation.   The eventual goal, it seems, is to amend the Toxic Substances Control Act (TSCA) to expand EPA's power to regulate the area.  It is promising that Davies' proposal involves significant industry cooperation in the development of any standards.  One must hope that any actual regulations or amendments to the TSCA that come from this type of approach are properly balanced to encourage innovation and America's entrepreneurial spirit while significantly mitigating any significant risk of harm from the use of nanomaterials.

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The long-awaited final White Paper from the United States Environmental Protection Agency (EPA) on nanotechnology and related regulatory issues was finally issued today.  According to the Federal Register notice, the 132-page document, available here, covers "a basic description of nanotechnology, why EPA is interested in it, potential environmental benefits...,risk assessment issues..., and a discussion of responsible agency development of nanotechnology and the Agency's statutory mandates."

It is this last topic that is particularly interesting to the regulated community.  More will be posted here when the White Paper is fully reviewed and considered.

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The Christian Science Monitor dedicated its editorial yesterday to the issue of nanotechnology safety, and endorsed the proposal set forth in November's Nature by fourteen scholars to discuss what lead author, Professor Andrew Maynard, termed the five "grand challenges" of nanotechnology safety.

Citing a Lux Research study, the CSM editorial indicated that by 2014, manufacturers will sell $2.6 trillion dollars' worth of products that use nanotechnology.   After praising EPA's decision to regulate "nanosilver," a decision that we have reported on at length here, CSM endorsed the Maynard proposal:

They include developing ways to detect nanomaterials in the air and water, learning how the shape of nanomaterials affects their toxicity, creating accurate models for predicting how nanomaterials act in the human body and the environment, and finding ways to engineer nanomaterials so that they are safe by design.

Both the chairman and ranking minority member of the House Science Committee have endorsed the paper and urged the White House and federal agencies to put together a plan to fund the scientists' recommendations in the fiscal 2008 budget.

The need to act is urgent. Otherwise the enormous benefits of nanotech risk falling victim to safety issues that could - and should - have been confronted already.

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JCM: My reading is EPA's new position on Samsung's washing machine has little to do with the alleged "nanoness" of the silver ion particles released by the machine. Rather, EPA is focused on the claimed antimicrobial properties of the material. Whether or not the silver ions are truly "nano" is not determinative. Under EPA's current thinking they would still be subject to FIFRA even if they were/are "full sized." Further, EPA has not even determined whether or not the washing machine truly uses nanotechnology, and has stated that such a finding is unnecessary for its ruling. Finally, EPA has made it clear that it evaluates all products on a case-by-case basis, and appears reluctant to make a categorical statement about all products containing nano-silver. Thus, while EPA's upcoming notice to be published in the Federal Register will be of great interest, my guess is that it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials.

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Since first being reported in the Washington Post, and relayed here, more information concerning EPA's proposed regulation of nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been uncovered.

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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.

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AUTHORED BY MICHAEL HEINTZ

Nanomaterials are becoming an increasing part of everyday life. Even now, man-made materials that measure one ten-thousandth the diameter of a human hair are found in products from computer chips and pesticides to stain-resistant fabrics and shampoo. As such, the U.S. Environmental Protection Agency is beginning to study the scientific properties of engineered nanomaterials to determine whether they should be regulated under the environmental statutes.

The cross-governmental National Nanotechnology Initiative, a partnership among several governmental agencies focused on research and sharing information about nanomaterials, states that to be nanotechnology, three factors must be met. The technology must 1) involve “an understanding and control of matter at dimensions of roughly 1 to 100 nanometers” (a nanometer is one-billionth of a meter); 2) “encompass nanoscale science, engineering, and technology”; and 3) involve “imaging, measuring, modeling and manipulating matter at this length scale.” Nanomaterials, thus, are purposefully engineered materials that measure between 1 and 100 nanometers. Interest is increasing in nanomaterials because their physical properties are governed by the laws of quantum mechanics, which produces “dramatic changes in [their] mechanical, optical, chemical, and electronic properties.”

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