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November 1, 2010

Monthly Update for November 2010

Bergeson & Campbell, P.C.

Synopsis Of The 2010 Congressional Mid-Term Elections: The 2010 Congressional mid-term elections will have a profound impact on policy and legislative developments of the U.S. Environmental Protection Agency (EPA), particularly as to the regulation of chemicals and pesticides. The dramatic decline in the number of elected Democratic members, especially the loss of the majority in the House of Representatives, will make for some significant differences in the prospects for EPA’s budget, legislative proposals, and policy initiatives. In the Senate, the Democrats not only lost much of their plurality, but also some of the newly elected members have indicated a very hard line attitude against any expansion in the role of government and an overriding concern on federal deficit spending, commitments that could affect the future of EPA and most other government agencies. As usual, Bergeson & Campbell, P.C. (B&C) will provide a more detailed outlook for the New Year at the close of 2010. The year 2011 promises to be eventful, even if by way of what does not occur. Many factors, including Committee leadership assignments, are as yet undetermined, but important considerations are already established. A more detailed memorandum is available online.


EPA Seeks Requests For Chemical Substance Nominations For IRIS 2011 Program: On October 18, 2010, EPA requested nominations for chemical substances for its 2011 Integrated Risk Information System (IRIS) agenda. 75 Fed. Reg. 63827. IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to specific chemical substances found in the environment. Nominations must be submitted by December 17, 2010.

NTP Schedules Workshop On Role Of Chemicals In Diseases: On October 18, 2010, the National Toxicology Program (NTP) announced that it will host a workshop in January 2011 to explore the role chemicals play in the development of diabetes and obesity. The workshop will examine high-throughput tests and other emerging types of tests that researchers hope can help to determine when environmental exposures to chemicals contribute to diabetes and obesity. The workshop illustrates a step federal agencies are taking as they respond to the 2007 National Research Council report, Toxicity Testing in the 21st Century: A Vision and a Strategy. That report called for testing strategies that could evaluate more chemicals, more health effects, and more life stages than is possible with traditional toxicological studies. Details about NTP’s workshop are available online.

EPA Announces Peer Consultation Workshop On Cumulative Mixtures Risk Of Selected Phthalates: On November 15, 2010, EPA announced that ICF International, an EPA contractor for external scientific peer consultation, will convene a panel of independent experts and conduct an external peer consultation workshop to: (1) review the recommendations for evaluation of the cumulative mixtures risk of phthalates as set forth in the National Academies of Science (NAS) report Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008); and (2) propose additional methods and approaches, not already captured in the 2008 NAS report, that may facilitate the assessment of risk(s) associated with exposure to cumulative mixtures of the six selected phthalates. 75 Fed. Reg. 69662. ICF International invites interested public parties to register to attend this workshop as observers. The public is invited to provide oral comments at the conclusion of each workshop day. Technical comments should be in writing and must be received by January 4, 2011. The peer consultation workshop will be held on December 8 and 9, 2010, in Arlington, VA. For more information, please consult the Federal Register.

EPA Proposes Revisions To FIFRA Procedures To Ensure Protection Of Data Submitters’ Rights: On November 5, 2010, EPA proposed revisions to the regulations at 40 C.F.R. Part 152, governing the procedures for the satisfaction of data requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 75 Fed. Reg. 68297. EPA states that these regulations have not been revised since they were first issued in 1984, so many of the proposed revisions accommodate statutory and procedural changes that have occurred since then (i.e., Food Quality Protection Act (FQPA), Pesticide Registration Improvement Renewal Act (PRIA II)) or reflect changes to EPA’s needs and practices since that time. A more detailed memorandum is available online.

21st Century Toxicology PPDC Workgroup Meeting Will Be Held On December 13, 2010: EPA will be hosting the 21st Century Toxicology PPDC Workgroup meeting on December 13, 2010. The meeting is free and open to the public and will be held at EPA’s Potomac Yard Building in Crystal City, VA. Through this workshop, EPA expects to broaden and strengthen stakeholder dialogue on the Office of Pesticide Programs’ strategic vision and application of 21st Century science in the context of integrated approaches for testing and assessment to inform better chemical risk decisions. More information is available online.

EPA Issues Guidance On Mercury Export Ban: On November 5, 2010, EPA issued instructions for filing exemption petitions under the Mercury Export Ban Act (MEBA), along with a questions-and-answers document on the law. The 2008 MEBA is intended to reduce the amount of mercury circulating in the environment by reducing the volume in international commerce. It prohibits the expert of mercury as of January 1, 2013, and requires the Department of Energy (DOE) to operate one or more mercury storage facilities in the United States. The law allows parties to petition EPA for an exemption from the Act. The instructions EPA released describe the types of information EPA would require. For example, petitioners must answer the question: “Is there no other source of elemental mercury available from domestic supplies (not including new mercury mines) in the country where the elemental mercury will be used?” More information is available online.

EPA Convenes National Meeting To Discuss Common Aquatic Life Effects Assessment For Pesticides Using Available Data: On November 1, 2010, EPA announced it will conduct a national stakeholders meeting to solicit input on methods being evaluated by the Office of Pesticide Programs (OPP) and the Office of Water (OW), with the support of the Office of Research and Development (ORD) to develop common characterizations of effects from pesticides on fish, other aquatic organisms, and aquatic plants in aquatic ecosystems. 75 Fed. Reg. 67088. The national meeting will be held in Washington, D.C., on December 1, 2010. EPA has developed a set of draft white papers that explore: (1) The use of various tools to estimate aquatic toxicity data; (2) approaches for deriving community level benchmarks; and (3) procedures for better integrating plant effects data into community level assessments. EPA is soliciting stakeholder input on the tools and approaches presented in the draft white papers via public comment and at the national meeting.

EPA Issues Draft Guidance On EDSP Weight-of-Evidence Determination: On November 4, 2010, EPA announced the availability for public review and comment of a draft guidance document titled Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening to Identify Candidate Chemicals for Tier 2 Testing. 75 Fed. Reg. 67963. This action is in compliance with a directive from the House Appropriations Committee Fiscal Year (FY) 2010 Report directing EPA to develop and publish criteria by October 30, 2010, for evaluating results of Tier 1 screening and determining whether a chemical should undergo Tier 2 analysis. The purpose of the weight-of-evidence (WoE) document is to set forth some of the general principles, criteria, and considerations EPA generally believes to be relevant under a WoE approach for evaluating data submitted as part of EPA’s two-tiered paradigm for screening and testing chemicals for endocrine activity (i.e., estrogen, androgen, and thyroid hormonal systems; E, A, and T) under the Endocrine Disruptor Screening Program (EDSP). This document provides a transparent scientific approach for broadly evaluating Tier 1 screening data to detect an interaction with E, A, and/or T hormonal systems and determine if additional Tier 2 testing is necessary. Comments must be received on or before January 3, 2011.

EPA Schedules Informational Meeting/Webinar On Understanding The 2011 IUR Electronic Reporting Tool (e-IURweb): EPA will convene on November 30, 2010, from 10:00 a.m. to 12:00 p.m., an informational meeting to help impacted entities develop a better understanding of the new 2011 e-IURweb electronic reporting tool. Use of EPA’s web-based reporting tool will be required to submit the 2011 IUR Form U. EPA will provide an overview and demonstration of the e-IURweb tool, including the enhanced CDX registration process, and will answer questions related to using the electronic tool. Technical staff will be available to discuss ways in which databases can interface with e-IURweb and to address issues concerning computer firewall settings. The meeting will be held at 12601 Fair Lakes Circle, Fairfax, VA 22033. There will be a live webinar for those not able to participate in person. Registration information, directions, and logistics for the meeting will be available through the IUR website online. Registration for meeting attendees and for the webinar will open the week of November 8, 2010.

EPA Denies Second Component Of Fishing Sinker Petition: On November 4, 2010, EPA denied the second component of a petition seeking a prohibition under the Toxic Substances Control Act (TSCA) to limit lead fishing sinkers. Specifically, the petition under TSCA Section 21 requested that EPA prohibit under TSCA Section 6(a) the manufacture, processing, and distribution in commerce of (1) lead bullets and shot; and (2) lead fishing sinkers. On August 27, 2010, EPA denied the first request due to a lack of authority to regulate lead in bullets and shot under TSCA. EPA’s decision was based on the exclusion of shells and cartridges from the definition of “chemical substance” in TSCA Section 3(2)(B)(v). On November 4, 2010, EPA denied the second request of several groups that filed on August 3, 2010. EPA denied the request because according to EPA, “the petitioners have not demonstrated that the action requested is necessary to protect against an unreasonable risk of injury to health or the environment, as required by TSCA section 21. The petitioners do not provide a sufficient justification for why a national ban of lead fishing sinkers and other lead fishing tackle is necessary given the actions being taken to address the concerns identified in the petition. The petitioners also have not demonstrated that the action requested — a uniform national ban of lead for use in all fishing gear — is the least burdensome alternative to adequately protect against the concerns identified in the petition, as required by section 6.” The EPA letter and additional information is available online.

EPA Subpoenas Halliburton For Data On Chemicals Used In Hydraulic Fracturing: EPA subpoenaed Halliburton Co. on November 10, 2010, for hydraulic fracturing data citing, among others, authority under TSCA Section 11(c). In response to a request from Congress to study hydraulic fracturing’s potential impact on drinking water, human health, and the environment, on September 9, 2010, EPA issued voluntary information requests to nine national and regional hydraulic fracturing service providers, including Halliburton. According to EPA, the data requested are integral to its Hydraulic Fracturing Study, which seeks to understand any potential relationships between hydraulic fracturing and drinking water. EPA requested information on the chemical composition of fluids used in the hydraulic fracturing process, data on the impacts of the chemicals on human health and the environment, standard operating procedures at hydraulic fracturing sites, and the locations of sites where fracturing was conducted. All but Halliburton agreed to submit “timely and complete information.” More information, including a link to the subpoena, is available online.

According to EPA’s November 9, 2010, letter to Halliburton, Halliburton’s response was “inadequate and inconsistent with the cooperation shown to date by the other eight companies.” EPA states that, since Halliburton does not appear to be committed to providing the requested information “on an expeditious schedule, EPA therefore is ordering” the requested information outlined in the subpoena, pursuant to the authorities cited therein. In the subpoena, EPA cites Section 11(c) of TSCA, Section 308 of the Clean Water Act (CWA), and Section 3007 of the Resource Conservation and Recovery Act (RCRA) and requests that the information be submitted to the Office of Pollution Prevention and Toxics (OPPT).


EPA Issues Final Mandatory GHG Rule: On October 28, 2010, EPA issued final amendments to specific provisions in the 2009 Final Mandatory Greenhouse Gas (GHG) Reporting rule to correct certain technical and editorial errors. 75 Fed. Reg. 66434. The final changes include additional information to better or more fully understand compliance obligations, corrections to data reporting elements so they more closely conform to the information used to perform emission calculations, and other corrections and amendments. The final rule amendments are effective on November 29, 2010.

Clean Air Act Permitting For GHGs: EPA Issues Guidance And Technical Information: On November 10, 2010, EPA made available guidance to assist state and local permitting authorities as they implement their Clean Air Act (CAA) permitting programs for GHG emissions. These tools include guidance on implementing the Prevention of Significant Deterioration (PSD) and Title V Operating Permit Programs for GHGs and technical resources to assist states and sources in identifying control measures for GHG emissions. EPA’s GHG Tailoring Rule, issued in May 2010, established an approach to permitting GHG emissions. EPA reports that it is working closely with permitting authorities and will take necessary actions to ensure that by January 2011: permitting agencies have the authority to permit GHGs, only the largest emitters of GHGs, as outlined in the GHG Tailoring Rule, will need to obtain permits, necessary guidance, technical information, and support are available, and the states have the mechanisms in place to ensure permitting can occur without any interruptions.

EPA states that the guidance does not establish a new approach for selecting best available control technology (BACT) for GHG emissions. The process starts by looking at all available emission reduction options and narrows the options by taking into account technical feasibility, cost, and other economic, environmental and technical considerations. The five-steps include: Step 1: Identify all available control technologies; Step 2: Eliminate technically infeasible options; Step 3: Evaluate and rank remaining control technologies based on environmental effectiveness; Step 4: Evaluate cost effectiveness of controls and energy and other environmental impacts; and Step 5: Select the BACT.

The GHG permitting guidance is available online. EPA will publish a notice in the Federal Register announcing the availability of the GHG permitting guidance and the opportunity for public comment.

White Papers on GHG Control Measures — These technical “white papers” focus on the industrial sectors listed below that emit the highest amounts of GHGs. They provide basic information on GHG control options to assist states and local air pollution control agencies, tribal authorities, and regulated entities implementing measures to reduce GHGs, particularly in the assessment of BACT under the PSD permitting program. These papers provide basic technical information that may be useful in a BACT analysis but they do not define BACT for each sector. The industrial sectors covered include: electric generating units; large industrial/commercial/institutional boilers; pulp and paper; cement; iron and steel industry; refineries; and nitric acid plants.

Enhancements to the Control Technology Clearinghouse (known as the RACT/BACT/LAER Clearinghouse, or the RBLC) — This website provides access to information and decisions about pollution control measures required by air pollution emission permits that will be issued for GHGs by state and local permitting agencies. The information is accessible to all permitting agencies working on similar projects. The expanded RBLC includes GHG control and test data, and a GHG message board for permitting authorities.

GHG Mitigation Strategies Database — EPA expects technology capable of reducing GHG emissions in various major industrial sectors will evolve. Recognizing the importance of tracking these developments, EPA has developed a new online tool which includes specific performance and cost data on current and developing GHG control measures. It also provides available data on other potential environmental impacts a GHG control measure may have. Currently, the database includes information on GHG controls for electric generating and cement production.

GHG Permitting Action Team — EPA has formed this team to help permitting authorities respond to GHG permitting questions. The GHG Permitting Action Team, comprised of experienced senior staff and permitting managers from EPA, will work together to provide a smooth transition to GHG permitting. Team members for each region and their contact information are listed on EPA’s GHG Permitting Webpage: online.

Background — The Clean Air Act Advisory Committee (CAAAC) provides advice and counsel to EPA on a variety of important air quality policy and technical issues. In October 2009, the CAAAC established a Climate Change Work Group which included representatives from state and local governments, a variety of industries, and environmental and public health non-profit organizations. In connection with it efforts, the Work Group issued two reports. The reports recommended that EPA develop a number of technical tools and resources, including GHG specific guidance to be used to assist permitting agencies in determining BACT for GHGs. The tools EPA is making available today respond to the recommendations and suggestions of the CAAAC Work Group. The recommendations are listed online.


On April 2, 2007, the Supreme Court found that GHGs, including carbon dioxide, fit within the definition of air pollutant in the CAA. Massachusetts v. EPA, 549 U.S. 497 (2007). The Court found that when responding to a rulemaking petition under section 202(a) of the CAA, EPA was required to determine whether or not GHG emissions from new motor vehicles cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare, or whether the science is too uncertain to make a reasoned decision.

On December 7, 2009, the EPA Administrator signed two distinct findings regarding GHGs under Section 202(a) of the CAA:

Endangerment Finding: The Administrator found that the current and projected atmospheric concentrations of the six, key, well-mixed GHGs — CO2, CH4, N2O, HFCs, PFCs, and SF6 –threaten the public health and welfare of current and future generations.

Cause or Contribute Finding: The Administrator found that the combined emissions of these well-mixed GHGs from new motor vehicles and new motor vehicle engines contribute to the GHG pollution which threatens public health and welfare. These findings, which were published December 15, 2009, do not impose any requirements on industry or other entities. They were a prerequisite to finalizing the GHG standards for light-duty vehicles, however. On December 18, 2008, EPA issued a memorandum, “EPA’s Interpretation of Regulations that Determine Pollutants Covered by Federal Prevention of Significant Deterioration (PSD) Permit Program” (known as the “Johnson Memo” or the “PSD Interpretive Memo”). Whether a pollutant is “subject to regulation” is important for the purposes of determining whether it is covered under the CAA permitting programs.

The PSD Interpretive Memo established that a pollutant is “subject to regulation” only if it is subject to either a provision in the CAA or regulation adopted by EPA under the CAA that requires control of emissions of that pollutant. On February 17, 2009, EPA granted a petition for reconsideration of this memorandum.

On March 29, 2010, the Administrator signed a notice conveying EPA’s decision to continue applying the PSD Interpretive Memo’s interpretation of “subject to regulation.” EPA concluded that the “actual control interpretation” is the most appropriate interpretation. EPA established that CAA permitting requirements apply to a newly regulated pollutant at the time a regulatory requirement to control emissions of that pollutant “takes effect” (rather than upon promulgation or the legal effective date of the regulation containing such a requirement). Based on the anticipated promulgation of the light-duty vehicle rule, the notice stated that the GHG requirements of the vehicle rule would trigger CAA permitting requirements for stationary sources on January 2, 2011.

On April 1, 2010, EPA finalized the light-duty vehicle rule controlling GHG emissions. This rule confirmed that January 2, 2011, is the earliest date that a 2012 model year vehicle meeting these rule requirements may be sold in the United States.

GHG emissions from the largest sources will, for the first time, be covered by the PSD Program on January 2, 2011, and by the Operating Permit Program on July 1, 2011. These permitting programs, required under the CAA, are proven tools for protecting air quality and can be used to control GHG emissions. But the thresholds established in the Act for other air pollutants, 100 and 250 tons per year, were based on traditional pollutants and were not designed to be applied to GHGs.

On May 13, 2010, EPA issued the final GHG Tailoring Rule. This rule effectively raised the thresholds for GHG emissions that define when permits under the PSD and Title V Operating Permit programs are required for new and existing industrial facilities. Without the GHG Tailoring Rule, the thresholds established in the CAA for other pollutants would apply to GHGs. The phased in approach, established in the Tailoring Rule, provides time for large industrial facilities and state governments to develop the capacity to implement permitting requirements for GHGs.

Starting in January 2011, large industrial facilities that must already obtain CAA permits for non-GHGs must also include GHG requirements in these permits if they are newly constructed and have the potential to emit 75,000 tons per year (tpy) of carbon dioxide equivalent (CO2e) or more or modify and increase GHG emissions by that amount. Starting in July 2011, in addition to facilities described above, all new facilities emitting GHGs in excess of 100,000 tpy CO2e and facilities making changes that would increase GHG emissions by at least 75,000 tpy CO2e, and that also exceed 100/250 tpy of GHGs on a mass basis, will be required to obtain construction permits that address GHG emissions (regardless of whether they emit enough non-GHG pollutants to require a permit for those emissions). Operating permits will be needed by all sources that emit at least 100,000 tons of GHG per year on a CO2e basis beginning in July 2011. Sources less than 50,000 tons of GHGs per year on a CO2e basis will not be required to obtain permits for GHGs before 2016. Congress established the New Source Review (NSR) program as part of the 1977 CAA Amendments and modified it in the 1990 Amendments. NSR is a preconstruction permitting program that serves two important purposes: (1) ensures the maintenance of air quality standards or, where there are not air quality standards, ensures that air quality does not significantly worsen when factories, industrial boilers, or power plants are modified or added. In areas that do not meet the national ambient air quality standards (NAAQS), so-called nonattainment NSR ensures that new emissions do not slow progress toward cleaner air. In areas that meet the standards, especially pristine areas like national parks, NSR’s PSD program ensures that (1) new emissions fall within air quality standards; and (2) state-of-the-art control technology is installed at new plants or at existing plants that are undergoing a major modification. New major stationary sources and major modifications at existing major stationary sources that meet emissions applicability thresholds outlined in the CAA and in existing PSD regulations must obtain a PSD permit outlining how they will control emissions. The permit requires facilities to apply BACT, which is determined on a case-by-case basis taking into account, among other factors, the cost and effectiveness of the control. The GHG technical information and guidance materials are accessible on EPA’s website online.


USPTO Expands Green Technology Pilot Program: On October 20, 2010, the U.S. Patent and Trademark Office (USPTO) announced that it is seeking comment on its expansion of the Green Technology Pilot Program. 75 Fed. Reg. 64692. USPTO implemented the Pilot Program on December 8, 2009, permitting patent applications pertaining to green technologies, including GHG reduction, to be advanced out of turn for examination and reviewed earlier. USPTO intends the Program to promote the development of green technologies, which could include technologies based on nanotechnology. USPTO initially limited participation to applications filed before December 8, 2009, but is now expanding the Pilot Program to include applications filed on or after December 8, 2009, and extending the Program until December 31, 2011. USPTO states that these changes will permit more applications to qualify for the Program, thereby allowing more inventions related to green technologies to be advanced out of turn for examination and reviewed earlier. Applicants may participate in the Green Technology Pilot Program without meeting the current requirements of the accelerated examination program (e.g., examination support document). Comments are due December 20, 2010. More information on the Pilot Program is available online. A more detailed memorandum is available online.

EC Begins Consultation On Recommendation On Definition Of The Term Nanomaterial: On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes. The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the EU. The EC proposes to define as a nanomaterial, any material meeting at least one of the following criteria:

  • Consists of particles, with one or more external dimensions in the size range 1 nanometer (nm)-100 nm for more than one percent of their number size distribution;
  • Has internal or surface structures in one or more dimensions in the size range 1 nm-100 nm; or
  • Has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.

The EC states that it intends to carry out a public consultation by 2012 and, if appropriate, review the adequacy of the definition “taking into account experience gained, scientific knowledge and the technological development.” More information is available online.

IJOEH Publishes Special Issue On Human And Environmental Exposure Assessment For Nanomaterials: The International Journal of Occupational and Environmental Health (IJOEH) has posted a special issue concerning human and environmental exposure assessment for nanomaterials. The issue includes articles such as “Understanding Workplace Processes and Factors that Determine Exposures to Engineered Nanomaterials,” “Nanotechnology and Exposure Science: What Is Needed to Fill the Research and Data Gaps for Consumer Products,” “Imaging and Characterization of Engineered Nanoparticles in Sunscreens by Electron Microscopy, under Wet and Dry Conditions,” and “Exposure Assessment: Recommendations for Nanotechnology-Based Pesticides.” The article entitled “Exposure Assessment: Recommendations for Nanotechnology-Based Pesticides,” authored by scientists from Oregon State University and the EU, includes the following six recommendations to assess exposure to nanotechnology-based pesticides:

  • Disclose nanoparticle characteristics in pesticide formulations for registration;
  • Apply an additional uncertainty factor for nanotechnology-based pesticides during the risk management process;
  • Use a route-specific approach for assessing exposure to nanotechnology-based pesticides;
  • Require nanotechnology-based pesticide products be tested in their commercial form, instead of the active and inert ingredients being evaluated separately;
  • Initiate health surveillance programs in parallel with introduction of novel nanotechnology-based pesticides; and
  • Conduct education and outreach activities on nanotechnology-based pesticide-specific issues and safe use practices.

The authors conclude that U.S. and European governments and agencies “will have to make complex decisions about the suitability of existing regulatory systems and determine whether new measures are needed if [nanotechnology-based pesticides] are adopted into the market.” The authors predict that regulators will have to make pending and future decisions with a high degree of uncertainty, including the lack of toxicity and human exposure data. The issue is available online.

ANEC And BEUC Announce 2010 Inventory Of Consumer Products Containing Nanomaterials: On October 25, 2010, the European Consumer Voice in Standardisation (ANEC) and European Consumers’ Organisation (BEUC) announced their 2010 inventory of consumer products containing nanomaterials. According to BEUC, ANEC and BEUC began monitoring the availability of products containing nanomaterials in 2009, and that year’s inventory listed only 151 products. The 2010 inventory includes 475 products in categories such as child products, food and drink, cosmetics, products for cars, and electronic devices. ANEC and BEUC support the Belgian Presidency’s proposal to ensure the traceability of nanomaterials. The inventory is available online.

NIOSH Posts Impact Sheet Stating That Breathing Nanoparticles May Result In Damaging Health Effects: The National Institute for Occupational Safety and Health (NIOSH) has posted an October 2010 Impact Sheet entitled “NIOSH Research Methods Demonstrate that Breathing Nanoparticles May Result in Damaging Health Effects,” which reports the results of recently published research concerning the health effects of inhaling single-walled carbon nanotubes. According to the Impact Sheet, NIOSH scientists invented a way to suspend nanotubes in air, thus allowing for control of the concentration of particles, unlike previous studies, which dosed the mice through aspiration. NIOSH scientists placed the mice into a controlled environment where they would breathe the air containing the particles, and studied the effects of exposure after one, seven, and 28 days. The Impact Sheet states that, although the effects were similar, the new results “demonstrated that carbon nanotubes were more potent when inhaled than when aspirated.” According to NIOSH, “this research has shown early indications of serious health outcomes that may have longer term effects such as cancer, and therefore, ongoing research is important to more clearly understand the implications of exposure to carbon nanotubes. This study and continued NIOSH research could soon help the development of occupational safety and health recommendations for carbon nanotubes that will protect the health of nanotechnology workers.” The Impact Sheet is available online.

NNI Issues Draft Strategic Plan On Nanotechnology Research: On November 1, 2010, the 25 federal agencies participating in the federal National Nanotechnology Initiative (NNI) requested public comment on its draft strategic plan to continue fostering these technologies. The document, developed with consultation from a broad array of stakeholders, represents the consensus “high-level” overview of research the agencies plan to conduct and/or support over the next three years. The term “high-level” means it describes research in broad terms rather than specific projects. The proposed budget for the NNI in FY 2011 is approximately $1.8 billion. Proposed initiatives in FY 2011 include supporting research to sue nanotechnologies for solar energy collection and conversion, supporting research that would apply nanotechnologies to a wide variety of manufacturing processes, and using nanotechnologies to improve the performance of electronics. More information is available online. Comment is due by November 30, 2010.

PEN Releases Report On Voluntary Initiatives To Regulate Nanotechnology: On November 4, 2010, the Project on Emerging Nanotechnologies (PEN) released a report entitled Voluntary Initiatives, Regulation, and Nanotechnology Oversight: Charting a Path, which reviews a number of voluntary options available for the oversight of nanotechnology products and processes. The report classifies the various types of voluntary initiatives and the partnerships that underlie them, and assesses the factors that are most likely to contribute to program success. The thesis of the report is that both non-regulatory and voluntary initiatives can play a constructive role in nanotechnology oversight. The report concludes that as nanotechnologies move forward, voluntary programs will play an important role in the governance portfolio available to the federal government, as well as states and municipalities. The report is available online.

NOSB Recommends Prohibiting Engineered Nanomaterials From Certified Organic Products: At the U.S. Department of Agriculture’s (USDA) National Organic Standards Board’s (NOSB) October 25-28, 2010, meeting, NOSB unanimously recommended that the USDA National Organic Program (NOP) prohibit engineered nanomaterials from certified organic products. NOSB considered a September 2, 2010, guidance document prepared by its Materials Committee concerning engineered nanomaterials in organic production, processing, and packaging. According to the Materials Committee, public comment “overwhelmingly agrees that nanotechnology in organic production and processing be prohibited at this time.” The Materials Committee notes, however, that “there is considerable debate and disagreement on what exactly nanotechnology is and what products of nanotechnology should be prohibited.” The Materials Committee requested that the NOP allow NOSB to call for a symposium “to discuss the issues related to the human-engineered portion of this science,” which “would help to clarify these confusing issues, and serve to educate both the Board and the NOP on this topic.” The Materials Committee proposed, and the NOSB approved, the following definition of engineered nanomaterials:

Engineered nanomaterials: substances deliberately designed, engineered and produced by human activity to be in the nanoscale range (approx 1-300 nm) because of very specific properties or compositions (e.g. shape, surface properties, or chemistry) that result only in that nanoscale. Incidental particles in the nanoscale range created during traditional food processing such as homogenization, milling, churning, and freezing, and naturally occurring particles in the nanoscale range are not intended to be included in this definition. All nanomaterials (without exception) containing capping reagents or other synthetic components are intended to be included in this definition.

The Materials Committee’s guidance document is available online.


ECHA Announces Second REACH Enforcement Project Targeting Formulators: On October 15, 2010, the European Chemicals Agency (ECHA) announced a plan to inspect companies that purchase chemicals to make formulations part of a 2011 enforcement project designed to test compliance with the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Enforcement authorities would “control the supply-chain related obligations for substances in the mixtures prepared by formulators as well as the CLP [classification, labeling, and packaging] notification requirements,” stated ECHA. The inspections are to take place across the EU and will be coordinated by the Forum for Exchange of Information on Enforcement, which consists of EU member state representatives and is convened by ECHA. ECHA reported the project would be known as “REACH-EN-FORCE 2,” following REACH-EN-FORCE 1, which published results in May showing that one in four inspected companies was not fully in compliance with REACH. More information on the REACH Forum for Exchange of Information on Enforcement is available online.


Congress is in recess and there are no developments to report. Our analysis of the results of the mid-term elections appears on page 1.


OSHA Proposes Interpretation Of Provisions For Feasible Administrative Or Engineering Controls Of Occupational Noise: On October 19, 2010, the Occupational Safety and Health Administration (OSHA) proposed to alter significantly its interpretation of the term “feasible administrative or engineering controls” as that term is used in the applicable sections of OSHA’s General Industry and Construction Occupational Noise Exposure standards. 75 Fed. Reg. 64216. Under the standard, which is codified at 29 C.F.R. Sections 1910.95(b)(1) and 1926.52(b), employers must use administrative or engineering controls, rather than personal protective equipment (PPE), to reduce noise exposures that are above acceptable levels, when such controls are feasible. This is consistent with OSHA’s long-standing approach to have employers rely on PPE as a last resort to reduce exposure to workplace hazards. In the October 19 notice, OSHA proposes to clarify that “feasible,” as used in the standard, has its ordinary meaning of “capable of being done.” OSHA intends to revise its current enforcement policy to reflect this interpretation. Comments on this interpretation are due December 20, 2010. A more detailed memorandum is available online.

Global Risk Assessment Dialogue Is Scheduled For January 2011: The Health and Consumers Directorate General of the EC intends to organize the 2nd International Conference on Risk Assessment in Brussels on January 25-28, 2011, following the successful 1st Conference held in Brussels on November 13-14, 2008. The Conference is organised in collaboration with the U.S. Office of Information and Regulatory Affairs (OIRA) of the Office of Management of Budget (OMB) and the Treasury Board of Canada Secretariat with the involvement of EU, United States, and Canada agencies and scientific bodies. The Conference aims at providing a Forum for global dialogue on risk assessment principles, methods, criteria, practices, and arrangements in the various jurisdictions around the world. The focus of the Conference is on scientific risk assessment as a central element of the risk analysis paradigm. The overall objectives of these Conferences are to facilitate the exchanges on practices and methods, to identify areas of mutual interest, promote collaborative projects, and formulate, where possible, consensus-based conclusions and recommendations, with a view to improve mutual understanding and enhance consistency. The Conference seeks to promote robust, effective, and recognized risk assessment approaches and, by that, at facilitating effective and efficient governance of international and global risks. Plenary and break out sessions will focus on the following themes: meeting the future challenges of risk analysis; working towards consistency in risk assessment; risk assessment terminology; uncertainty in risk assessment; exposure assessment; evaluating scientific evidence in risk assessment; and risk assessment of mixtures.

The draft program and the administrative arrangements are currently being developed. A dedicated Internet site will be available October 2010 for further information on the program and registration. In the meantime, interested parties should contact the Health and Consumers Directorate General using the following e-mail address:

OSHA Convenes Meeting On UN GHS: On November 12, 2010, OSHA invited the public to participate in an open, informal public meeting to discuss proposals in preparation for the 20th session of the United Nations Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (UNSCEGHS). 75 Fed. Reg. 69472. The UNSCEGHS meeting will be held December 7-9, 2010, in Geneva, Switzerland. OSHA, along with the U.S. Interagency GHS Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. Government positions for the UNSCEGHS meeting. The date for the public meeting is as follows: November 30, 2010, from 1:00 – 3:00 p.m., in Washington, D.C.

CPSC Posts Draft Final Rule Regarding Publicly Available Consumer Product Safety Information Database: The Consumer Product Safety Commission (CPSC) released an October 14, 2010, memorandum that includes its draft final rule concerning the publicly available, searchable database on the safety of consumer products, and other substances the CPSC regulates. The database is intended to provide a single point of access to reports of harm involving consumer products, manufacturer’s comments on the reports, and recall information. Under Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), CPSC must create and maintain the database within 18 months after CPSC submits a plan to Congress. CPSC submitted its plan on September 10, 2009, and the database must be established by March 2011. Once the database is operational, CPSC intends to conduct an awareness campaign to encourage consumers to visit the database site and to search the available information. More information is available online. A more detailed memorandum is available online.