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 "Great Recession" continues to linger, hovering over the American economy like the cliched scene from bad Westerns of vultures circling in the desert sky. Although the economy has begun to show signs of recovery, the recessions effects are still being felt, particularly by State governments. With fewer tax revenues coming in, State legislatures and Governors are struggling to create balanced budgets, as mandated by many state Constitutions and laws.

The South Carolina State Legislature, on June 3rd, ratified H.4657, the FY 2010-2011 General Appropriations Bill, which provided funding for state agencies, the operations of state government, colleges and universities, etc., sending it on to Governor Mark Sanford to be signed into law.

As most Governors do, the South Carolina's Governor has the power of the line item veto; rather than vetoing an entire budget or act, a Governor can veto parts of the budget or act that he or she disagrees with. On June 9th, Governor Sanford exercised that power to veto 107 separate line items in the General Appropriations Bill, including $558,573 for in funding for the University of South Carolina's Nanotechnology Research Program.

In his veto letter to the Speaker and Members of South Carolina's House of Representatives, Gov. Sanford refered to the lines vetoed as representing "financially reckless policy". Among other lines vetoed by Governor Sanford was funding for county public libraries and for the State's Budget and Control Board's offices that provide revenue projections, monitor state spending, and make sure that vendors get paid for providing goods and services to the State.

In his letter, Gov. Sanford justified his veto of USC's nanotech research program by stating that ". . . we believe that public money put toward such research efforts should be matched with significant private investment. Unfortunately, to date we have not seen this program draw down a lot of private investment."

The South Carolina House and State Senate voted to override some of the vetoes, including the veto of funds for county public libraries. The veto of funding for USC's nanotech research program was sustained, along with 50 other vetoes. An AP article quoted a Republican member of the House as noting that if such budget cuts and their ripple effects continue " . . .we're going to wind up poor, barefooted, broke, and behind Mississippi."

Governor Sanford's term ends in January 2011, when a newly elected Governor is sworn into office.

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The Working Party on Manufactured Nanomaterials (“WPMN”) of the Organisation for Economic Co-operation and Development (“OECD”) has revised its nanomaterial testing guidance document, first published in 2009 to support nanotechnology safety in the industry.

The guidance manual was conceived primarily to assist sponsors of the OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials, who conduct testing in support of the WPMN's exploratory testing program. The manual addresses includes general and common issues in nanomaterials safety as well as specific consideration on sample preparation and dosimetry for the safety testing of manufactured nanomaterials. Specific consideration includes  i) physic-chemical properties; ii) ecotoxicity studies; iii) degradation, transformation and accumulation; and iv) health effects.

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The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.

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The 2010 New England Nanomanufacturing Summit, which will be held at the University of Massachusetts at Lowell from June 22-24, 2010, will highlight areas of practice in the field of nanomanufacturing that are near-term and may soon be capable of commercial development and marketing. The challenges facing production of nanoscale systems and devices make the topic especially relevant to those interested in the manufacture of real-world nanotechnology products. The Summit is soliciting abstracts for topical papers focusing on emerging technologies, applications, and research challenges in the field of nanomanufacturing, including environmental health and safety, nanoelectronics, nanomanufacturing strategies for multiscale nanomanufacturing, and bio-inspired processes, among others.

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The Silver Technology Working Group (“SNWG”) of the Silver Research Consortium LLC recently sent a letter to the Environmental Protection Agency (“EPA”) expressing concern about a proposed interpretation issued by the EPA’s Office of Pesticide Programs (“OPP”) of a nanoscale pesticide products regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136 et seq. (1996). SNWG contended that the pending Federal Register policy applicable to nanotechnology constituted a damaging change which could threaten all nano-related industries. Specifically, SNWG argued that the OPP’s new interpretation would: (1) establish a definition of “nanomaterial” that arbitrarily provides a size limit of 100 nm, “focus[ing] too heavily on size rather than the underlying properties of the…material;  (2) consider the presence of any nanoscale material in any registered pesticide to be reportable as having an unreasonable adverse effect, a proposition which contradicts the articulated purpose of FIFRA §6(a)(2); and (3) erroneously declares nanosilver and all other products containing nanomaterials to be “new” materials, even though, as SNWG contends, nanosilver materials allegedly have “decades of historical records of safe use.” SNWG further noted that these policy changes could stifle innovation and progress in the nanotechnology field, as well as create an unjustifiable and negative public perception of the technology. 

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Nanotechnology has often been touted as a new and potentially revolutionary way to improve nearly every aspect of modern life, but has also faced doubt from skeptics who have raised concerns about the downside to incorporating such innovative technology in everyday life. Possible dangers include the unintended consequences of the accumulation of nanoparticles in the human body or the environment. In response, risk management and insurance companies have begun to develop measures to address these concerns, from evaluating and underwriting nanorisks to taking risk management ideas to the nanotechnology community. One company, Zurich, has developed a web-based software product which looks at nanoparticle characteristics to assist nanotechnology users determine potential hazard levels. Another company, Lexington Insurance, has created a integrated coverage insurance policy specifically for nano clients, especially those who may need special assistance in gauging the level of risk management in the field.

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On Friday, May 28, 2010, debate on H.R. 5116, the America COMPETES Reauthorization Act of 2010, discussed here earlier, resumed. As readers may recall, in the earlier debate in the House, a motion to recommit the bill to committee and for it to be reported back with an amendment, had been adopted by the House.  On Friday, Rep. Bart Gordon, the sponsor of the bill, reported the bill back to the House, with amendments. In a series of votes, the majority of the proposed amendments, which would have reduced funding and the effectiveness of the bill in supporting innovative technologies and their commercialization, were defeated; only two amendments, adding sections 704, "No salaries for viewing pornography", which would prevent funds authorized under the bill from being used to pay the salaries of Federal employees disciplined for "viewing, downloading, or exchanging pornography, including child pornography, on a Federal government computer or while performing Federal government duties" and section 705,  which would prevent colleges and universities that have violated Section 983 of Title X from receiving any funds authorized by the America COMPETES Act for grants or contracts.

Title I, Subtitle A, the National Nanotechnology Initiative Amendments Act was not affected by the proposed amendments and survived intact.

Having been passed in the House, the bill now proceeds to the Senate for debate and hopefully passage in that body. Congress has now adjourned for the Memorial Day Recess and the Senate will not reconvene until June 8. As many observers have noted, the Senate has considerable work ahead of it, ranging from Immigration reform to Climate Change legislation and HR 5116 faces the possibility of not coming up for a vote prior to Congress adjourning for the elections in November.

As always, we will keep track of the bill's progress and update this site accordingly.

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In a notice in today's Federal Register the National Nanotechnology Coordination Office announced that it will be holding a public workshop on July 13-14, 2010, for the purpose of giving stakeholders (defined as representatives of the research community, the private sector and NGOs and members of the general public) a forum for presenting their input regarding updating the US National Nanotechnology Initiative Strategic Plan, last updated in 2007. Specifically, the Federal agencies that take part in the NNI are seeking input on the objectives of the strategic plan and on the approaches to achieving those objectives.

Pre-registration is required, since it's on a "first come, first served" basis. Those planning to attend the workshop, to be held at the Hotel Palomar in Arlington Virginia, may register online at http://www.nano.gov/html/meetings/strategicplan/register.html, via e-mail at strategy@nnco.nano.gov or via regular snail mail at Strategic Planning Workshop, c/o NNCO, 4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230. Registrations must be received by 4PM July 7, 2010.

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