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 and Recovery Act.

However, while EPA is armed with this authority and while EPA has shifted in recent years from depending on nanoindustries to voluntarily supply EPA with information on "production, importation, and use; exposures; risk management practices; hazards; pollution prevention; and physical and chemical properties" to a more active "regulatory approach", "to collect nanomaterials data from manufacturers of industrial chemicals", the OIG, after conducting "this performance evaluation in accordance with generally accepted government auditing standards", "identified a number of shortcomings": At least some of these shortcoming were attributable to the limitations of TSCA:

1) " . . . An absence of toxicity testing and environmental fate data, and a reliance on modeling . . . .Because EPA depends on information reported by industry, it can initially fail to identify chemical risks not self-disclosed by manufacturers."

2) "The program was limited by TSCA's requirement to protect claims of confidential business information (CBI) on industry data submissions. . . . Excessive CBI designations inhibit independent peer reviews, oversight by external parties, and information sharing across EPA offices".

Other short comings are based in structural problems:

1) "EPA doesnot have an agency-wide formal process to disseminate manufacturer data gathered from TSCA and FIFRA data calls." This data is shared between offices only via informal personal relationships (a.k.a "The Grapevine") such as can be found in any office setting. While this form of communication may work to a limited extent, its limits are obvious.

"Because of the growing number of nanomaterial products entering the marketplace and the anticipated receipt of TSCA and FIFRA data following approval of . . . requested information gathering rule changes, it will be increasingly necessary for . . .offices [in EPA] to formally share information anc coordinate their efforts."

Other short comings found by the OIG recall a line from the movie Cool Hand Luke :

Captain, Road Prison 36: What we got here is... failure to communicate.
 

"Through Federal Register notices, program office web pages, public presentations, and meetings EPA has sought to communicate information related to nanomaterials and to gather input from stakeholders. However, the agency as a whole has not provided a transparent overall message about nanomaterials to the general public. . . .The agency should be prepared to communicate to the public any nonconfidential risk information generated or collected through its FIFRA, TSCA, and reseach activities because nanomaterials is emerging issue, it will be important for EPA to keep the public informed on the benefits and risks, how the public might be exposed, and what regulatory approach the agency is taking."

Other short comings are based on the limitations created by (1) a lack of technology designed to detect nanomaterials or remove detected nanomaterials from the ambient atmosphere (" . . .the agency may not be able to monitor, identify, and remediate nanomaterial comtamination if it were to occur in the natural environment") and (2) resource limitations. EPA, like all Federal, State, County and Municipal agencies, constantly face the potential for budget cuts that would severely limit agency programs.

The OIG's report concludes with the recommendation that the EPA's Assistant Administrator for Chemical Safety and Pollution Prevention be tasked with developing "a formal process to assure the effective dissemination and coordination of nanomaterial information across relevant program offices."

While EPA has agreed with this recommendation and has created a "correction plan with milestone dates" to create a formal communications process and structure, other shortcomings, as discussed above, are rooted in the limitations of TSCA, FIFRa and other laws refered to above. Changes in those are outside of EPA's control, as are those caused by the vagaries of budgets and the appropriations process.

Legislation to reform and strengthen TSCA and EPA's regulatory authority have been introduced in both the Senate and the House in both the 111th and 112th Congresses. S.847, the Safe Chemicals Act of 2011, introduced by Senator Frank Lautenberg of New Jersey on April 14, 2011, is the most recent of these bills. Assigned to the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health, hearings on the bill were held on November 17, 2011. No further action on the bill has occured and with elections coming in November of this year, it is unlikely that the bill will be reported out of committee and sent to the Senate floor for debate.

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 Initiative (NNI) that was launched in 2001. The goals of the NNI are to: advance a world-class nanotechnology research and development (R&D) program; foster the transfer of new technologies into products for commercial and public benefit; develop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and support responsible development of nanotechnology. As a participant in the NNI, DOD leverages its own and other federal investments, primarily in basic research, to discover and exploit unique properties of materials at the nanoscale to enable new applications enhancing future weapon systems capabilities.

Given the broad applicability of nanotechnologies to important areas such as power and energy, electronics and sensors, and advanced materials and coatings, the committee seeks to ensure that the DOD is engaging with as broad a research community as possible to maximize its access to innovative ideas and products. Hence, the committee directs the Department to provide a briefing to the Committees on Armed Services of the Senate and the House of Representatives no later than 180 days after the enactment of this Act reviewing its sources of nanotechnology research and engineering for defense purposes. Furthermore, the briefing should address whether these sources are adequate to ensure that the Department has sufficient scientific and technical access across the spectrum

S. 1253 now awaits debate in thge Senate, as does HR. 1540, the House version of the FY 2012 National Defense Authorization Act. A likely scenario for both bills would be for the Senate to call up HR 1540 and amend it by substituting the language of S. 1253 after the enacting clause, which would send the amended bill back to the House. If the House agrees to the amendment, the bill would be passed and sent to President Obama to be signed into law or vetoed. A more likely scenario would be for the House to disagree with the amendment, sending it to a Conference Committee , which would be tasked with producing a comprise version that both the Senate and the House could agree to pass.

As with other legislation affecting nanotech, we'll monitor S. 1253's progress and provide updates.

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 the proposed regulations for creating a potential situation where ". . . every chemical in the state of California becomes a potentially regulated chemical and every industry becomes a potentially regulated industry".

In a letter to Assembly Member Mike Feuer, author of the legislation that lead to the proposed regulations, Secretary Adams noted the criticism of the proposed regulations:

A wide range of stakeholders, including those from industry, environmental groups, scientists and legislative leaders, have raised substantive and valid concerns about the most recent draft of the regulations. . . .

. . . . DTSC has agreed to take additional time to be responsive to the concerns raised and revisit the proposed regulations. I believe this extra time will allow us to create a workable program and address critical policy issues . . . .

I have asked DTSC and its regulation development team to reconvene the Green Ribbon Science Panel early next year to further vet the programmatic issues that have been brought to our attention via the public comment process.

As currently proposed, nanomaterials would have been exempted from the regulations, a change which occurred following hearings and public comment. To read the original proposed regulations, see here and here for the revised proposed regulations.

New Edition of NanoLawReport

Here is the Summer 2010 edition of NanoLawReport.  Heading out to the beach for a few days to top off the summer.  :)

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 nanoscale materials leave the manufacturing facility.

Second, evaluate potential worker exposure to nanoscale materials during the manufacturing process and then implement a hierarchy of exposure controls, including: substituting source materials with non-nano substances where appropriate, implementing engineering controls, using administrative controls, and requiring the use of personal protective equipment. This is all standard NIOSH-fare drawn from NIOSH’s excellent “Approaches to Safe Nanotechnology: Managing the Risks and Safety Concerns Associated with Engineered Nanoparticles.” OTA’s guidance document, however, does a good job of drawing out the most important “nuggets” of information from the NIOSH document in a few short pages.

Third, analyze whether unintentional release of nanoscale materials may occur with consumer use or disposal of the product. Along these lines, OTA recommends companies consider: labeling products as already suggested by BSI and the EU, warning potentially affected downstream users and others regarding potential EHS risks through the use of the Material Safety Data Sheets and other written warnings, complying with existing environmental laws such as the Toxic Substances Control Act, conducting an open and transparent risk and hazard testing regime for the product throughout its complete lifecycle, and recognizing that proactive prevention of EHS concerns is required for successful commercialization of nanotechnology.

In the end, OTA’s document is a helpful quick reference guide, but it does not cover any new ground or delve deeply into its existing source material. Businesses involved in nanomanufacturing should still consult the underlying source material cited in the document, as well as EHS and legal experts as necessary. Massachusetts should be commended, however, for putting out this basic guidance document and attempting to proactively address these issues.
 

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 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.

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 the shoals of public mistrust and rejection, but also because companies and their shareholders will see corporate financial values vaporize in the face of closed markets and possible litigation.

Liroff raised the specter of asbestos in this article and it's important to learn from what happened - and is still happening, since litigation over the effects of asbestosis is still being filed, decades after asbestos was used in factories and consumer products - to avoid exposure to possible litigation and the lose of their investment by shareholders.

 

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 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."

 

 

 

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
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

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 time between discovery of new nanotechnology-based inventions and their insurability.  Readers may also recall that Zurich's Director of Emerging Issues recently spoke on insurance issues at the very well-attended Nanotechnology Health and Safety Forum in Seattle, Washington.

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 techniques: (i) TSI Fast Mobility Particle Spectrometer for real time measurement; and (ii) personal air sampling using a special filter media designed to catch nanoparticles. 

The study concluded that "[t]he twin-screw extrusion process for compounding polymer nanocomposites tends to break up nanoparticle aggregates and mechanically disperse particles thoroughly during the extrusion process."  The study also found that "[nano]particle diffusion was enhanced by . . . poorly-performing local and general exhaust systems."

Interestingly, for part of the test the scientists applied a nominal engineering control by covering the open top of the extruder feeding tube throat with aluminum foil which they found "dramatically reduced" nanoparticle measurements.  They also found that consistently cleaning the lab after each use "reduced laboratory background nanoparticle concentration."

D. Bello et al., "Exposure to nanoscale particles and fibres during machining of hybrid advanced composite containing carbon nanotubes," 11 J. Nanopart Res 231 - 249 (2009).

The researchers in this study investigated whether and to what extent airborne nanoparticles were generated by wet and dry cutting of two hybrid carbon nanotube composites.  The dry cutting method employed a diamond coated band saw.  The wet cutting was performed using a diamond grit rotary cutting wheel with water lubricating the cutting surfaces during the process.  Because the scientists were interested in potential "worst case" scenarios, no vacuum or emission controls were used in tests.

The researchers found that wet cutting did not produce airborne nanoparticle emissions above background levels, but that dry cutting "generated statistically significant quantities of nanoscale and fine particles as compared to background (p<0.05), regardless of the composite type, . . . as expected."

Interestingly, the study also found that "CNTs, either individual or in bundles, were not observed in extensive microscopy of collected samples" for either wet or dry tests.


We will continue to track down and summarize these types of potential exposure studies.  Right now, they are few and far between.

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 account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

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).
 

Joint Risk Assessment Between DuPont and Environmental Defense

Pesticide & Toxic Chemical News reports that chemical manufacturer DuPont and the nonprofit organization Environmental Defense are developing a joint framework for risk assessment of nanomaterials.  The framework itself is for "the responsible development, production, use and disposal of nano-scale materials that identifies, manages, and reduces potential risks across all lifecycle phases."

The partnership agreement outlines the relationship, and includes such areas as human health hazards, release and exposure potential, and occupational and environmental risk management.  The framework will primarily focus on the industrial, chemical, and manufacturing industries, and each partner will bear its own costs of research.  Further, the parties plan to involve additional stakeholders throughout the project in an effort to form a framework that will be widely accepted across all areas of nanotechnology.  Once the partnership is complete (following publication of the findings) all information will be released publicly for consideration.  A draft framework is available here, and is open for comment.

MEH:  This is exactly the type of partnership that will forward the research and understanding of nanotechnology impacts and how to address them.  By having two differing views involved, an understanding can be reached that can then be spread to the industry at-large.  The more stakeholders that get involved in the process, the better the resulting research and regulations will be.  This partnership is an excellent first step, and both DuPont and Environmental Defense should be commended for their initiative.

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."

The watch list however, is different from the emerging contaminants action list.  The watch list includes those materials that DoD believes have a "probable mission or budge impact."  DoD then monitors events surrounding the listed material while conducting "rough impact analysis."  Other materials found on the watch list include: tungsten and its alloys, lead, beryllium, dichlorobenzenes, and dioxins, among others.  "DoD places materials on the Watch List when they are identified through the scanning phase as potentially affecting one or more DoD business areas. While the exact nature and magnitude of the potential impacts are unknown, the Department has identified these materials as having a potential to affect DoD functions. As a result, DoD is conducting Phase I assessments for each of these materials."

The difference between the watch list and action list is that under the watch list the DoD monitors developments concerning the listed material while expending minimal resources.  If the material is upgraded to the action list,  DoD has determined that the material is likely to impact the department, and it performs detailed analysis on the material while possibly expending "significant" resources on understanding the material.  Other activities performed once a material is upgraded to the action list include undertaking risk management actions and pollution prevention efforts by DoD.

This listing of nanomaterials, without more information, is interesting for a number of reasons.  First, the DoD's watch and action lists are selective in nature. There are only eighteen materials on these lists in total, so the addition of nanomaterials is significant.  We therefore see this action as a step towards regulation of nanotechnology by DoD's recognition of nanomaterials as potentially impacting department operations and the environment.  Second, it is hard to know what DoD will be watching by posting "nanomaterials" on its watch list.  Given the different types and functions of nanomaterials and nanoparticles, a blanket listing is vague at best.  However, because the DoD elected to list nanomaterials at all is proof that federal agencies are increasing their focus on nanotechnology in general.

While this listing does not cause any regulatory actions to be taken by DoD, an upgrade to the action list could certainly mean a significant change in course as to how one of the country's largest agencies addresses nanotechnology.

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.

The EPA plans to regulate these materials under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA").  Howard Lovy from NanoBot questions whether the EPA is really breaking new ground in its regulation, since it already regulates the use of silver as an anti-microbial agent. 

As always, I imagine, the devil is in the details.  While EPA might already regulate silver under FIFRA, it probably will not apply the same regulatory standards to "nano-silver."  It will be interesting to see how much safety testing EPA requires "nano-silver" manufacturers to use, and whether those manufacturers will conduct the testing necessary to pass muster (or whether they will simply abandon the project).  I'm reminded of the issue of OSHA regulation of nanomaterials:   only a few years back, manufacturers of carbon nanotubes were submitting MSDSs that were essentially the same as for graphite (which is used to make the nanotubes). 

Jonathan Adler of Case Law School and the Volokh Conspiracy emphasizes that the new regulations will only apply to companies that make germ-killing claims in connection with the marketing of  nano silver-containing products.

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.

The essence of Taylor's report is distilled in Table 2 on page 27 of the article, in a table entitled “Capacity of FDA’s Legal Authority to Achieve the Primary Goals of Regulatory Oversight for Nanotechnology Products.” The table provides a quick summary of how Taylor views the FDA’s current power to regulate the nanotechnology industry.

Specifically, Taylor identiies four FDA Pre-Market Oversight Goals:
1. Obtain information on new nanoproducts early in the development process;
2. “Define and enforce public safety standards for nano-materials, including the nature and extent of testing required to satisfy them;”
3. “Place the initial and continuing burden to demonstrate safety on the nanotechnology product’s sponsor;” and
4. “Review the nanotechnology product’s safety prior to marketing and improve conditions as needed to ensure safety.”

And four FDA Post-Market Oversight Goals:
1. “Require post-marketing monitoring and testing of nanotechnology products as needed to ensure safety;”
2. “Require timely adverse event reporting;”
3. “Inspect manufacturing establishments and examine records related to nanotechnology product safety;” and
4. “Remove from the market nanotechnology products that appear to pose a significant safety hazard and or no longer meet the applicable safety standard.” 

Taylor then evaluates what he perceives to be the effectiveness of FDA’s current authority to implement these goals across nine different product categories: Cosmetics, Whole Foods, Dietary Supplements, GRAS Food Ingredients, Food Additives, Food Packaging, Medical Devices, OTC Drugs, and New Drugs.

Medical Devices and New Drugs fare best under Taylor’s analysis, while Cosmetics, Whole Foods, and Dietary Supplements fall at the other end of his spectrum. Taylor’s analysis suggests, however, that virtually every product category could benefit from a strengthening of FDA’s existing regulatory authority.

Taylor further implies that FDA will not be able to reach the above-referenced goals unless Congress drastically increases its funding. To this end, Taylor asserts FDA’s 2007 budget falls 56% short of what it needs to perform the same tasks required of it in 1996.

The report concludes with helpful information concerning FDA’s existing nanotechnology activities, additional tools Taylor believes FDA needs to do its job, and several recommendations regarding how FDA should approach the significant gaps in the nano-regulatory picture he paints.

Regulating the Products of Nanotechnology: Does FDA Have the Tools it Needs?,” Taylor, M., Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, October, 2006.

 

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.

To frame the discussion, the authors quote FDA’s informal three-pronged definition of “nanotechnology:”

[the] research and technology or development of products that involve all of the following: the existence of materials or products at the atomic, molecular or macromolecular levels, where at least one dimension that affects the functional behavior of the drug/device product is in the length scale range of approximately 1-100 nanometers; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control or manipulate the product on the atomic scale.

The authors note the efficacy of this definition is currently under discussion within FDA’s CEDAR working group.

The article next addresses the likelihood of new nano-drugs and/or nano-drug delivery devices being treated by FDA as “combination products” (i.e., drug-device, drug-biologic, and device-biologic products), the development of which will be coordinated by FDA’s Office of Combination Products. The authors explain functionally how a nano-based “combination product” might be primarily assigned to one of three (3) FDA Agency Centers for premarket review and regulation based on a primary mode of action analysis (CDER, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health).

The highlight of the article is the authors’ opinion that existing FDA regulations adequately cover the types of nano-products currently being contemplated for submission as Investigational New Drugs to FDA. The authors note existing pharmaceutical testing includes the areas of pharmacology; safety pharmacology; absorption, distribution, metabolism and excretion; genotoxicity, developmental toxicity; irritation studies; immunotoxicology; carcinogenicity; and other product-specific tests. They conclude this existing preclinical testing is sufficient to detect any possible health risks posed by nano-drugs and/or nano-drug delivery devices.

In an effort to balance their conclusion, the authors then list eight (8) specific nanotechnology questions and eleven (11) safety considerations they believe need to be addressed by CDER. Notably, these considerations include whether ‘nanoparticles [will] gain access to tissues and cells that normally would be bypassed by larger particles,” and “[o]nce nanoparticles enter tissues, how long do they remain there and where do they concentrate.” The authors conclude that FDA may not currently have the ability to adequately address these issues, and propose “much of the currently ongoing research [may not be] focusing properly on the questions that may be most relevant to FDA as a regulatory agency.” The authors note that much of the current nano-testing is in vitro, and that in vivo studies should also be conducted in order to answer the most important questions presented.

The article concluded with the authors’ prediction that “we do not expect that the FDA will be issuing any new guidance to specifically focus on nanotechnology products, as these products will be covered by the existing guidance documents.” . . . and . . . “[i]n the meantime, and based on the available scientific knowledge, nanotechnology products will be handled on a case-by-case basis, as is the case for all other products submitted for review to the FDA.”