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May 1, 2012

Monthly Update for May 2012

Bergeson & Campbell, P.C.


EPA Announces Webinar On TSCA Section 8(d) Electronic Reporting Tool: On May 11, 2012, the U.S. Environmental Protection Agency (EPA) announced that it will present a webinar on the use of the Toxic Substances Control Act (TSCA) Section 8(d) electronic reporting tool on May 22, 2012, from 1:00-3:00 pm EDT. The webinar will provide a walk through of the CDX (available online) registration process and the 8(d) reporting tool. Time will be allotted for questions related to the reporting tool. Questions related to specific reporting requirements will not be covered during this webinar. Register for the webinar online. EPA also provided a list of tentative dates for future webinars: July 17 – PMN Thin Client Preview; September 11 – 8(a) eReporting Tool Preview Webinar; September 18 – Section 4 eReporting Tool Preview Webinar; and September 20 – 8(d) eReporting Tool Refresher Webinar.

EPA Issues Direct Final Rule For SNURs: On April 25, 2012, EPA issued significant new use rules (SNUR) under TSCA for 23 chemical substances which were the subject of premanufacture notices (PMN). 77 Fed. Reg. 24613. Nine of these chemical substances are subject to TSCA consent orders issued by EPA. The action requires persons who intend to manufacture, import, or process any of these 23 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule is effective on June 25, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before May 25, 2012.

EPA Issues SNURs For 119 Chemicals: On April 27, 2012, EPA promulgated SNURs under TSCA for 119 chemical substances which were the subject of PMNs. 77 Fed. Reg. 25236. Four of these chemical substances are subject to TSCA consent orders issued by EPA. The four substances are: dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl siloxy copolymer (genetic name), which will be used to treat carpets; two alkyl acrylate-polyfluoro methacrylate-poly(oxalkylenediyl)-methacrylates (generic names), which will be used as additives; and poly6(oxyalkylenediyl), .alpha.-[[[methyl-3- [[[(polyfluoroalkyl)oxy]carbonyl]amino]pheynyl]ami no]carbonyl], which also will be used to treat carpets. This action requires persons who intend to manufacture, import, or process any of these 119 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule is effective on June 26, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before May 29, 2012. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before May 29, 2012, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

EPA Launches Bed Bug Information Clearinghouse: On April 23, 2012, EPA launched an online Bed Bug Information Clearinghouse. It contains peer-reviewed bed bug outreach materials from different sources such as governments, universities, and extension services. According to EPA, the goal of the Bed Bug Information Clearinghouse is to provide a “one-stop” location for communities to exchange information and outreach materials on the control, detection, and prevention of bed bugs. The Clearinghouse will include information in English and other languages as available. Some of the current information focuses on identifying and treating bed bug infestations in various types of situations. For more information on bed bugs, visit

EPA Posts Results Of OPP’s Consumer Survey On Insect Repellent Product Labeling: The Office of Pesticide Programs (OPP) conducted a national survey about insect repellents in 2011 to understand better how EPA might improve label information for these consumer products. The first part of the survey was used to understand why and how consumers purchase and use insect repellents, and what information consumers look for and understand on insect repellent labels. OPP then tested the usefulness of four potential marks that could be placed on the front of insect repellent labels as part of an effort to improve public health information on insect repellent labels. The marks showed how long a repellent may protect consumers from public health pests such as mosquitoes or ticks. The results of that survey are now available, and EPA invites the public to review them. To view the results, go online.

EPA DfE LCA On Advanced Batteries Available Online For Comment: EPA’s Offices of Pollution Prevention and Toxics (OPPT) and Research and Development (ORD) announced that the draft final report for the life-cycle assessment (LCA) conducted by the Design for the Environment (DfE)/ORD Li-ion Batteries and Nanotechnology Partnership has been posted on EPA’s DfE Program website. The LCA results for advanced batteries used in plug-in hybrid and electric vehicles are expected to help promote the responsible development of these emerging energy systems, including nanotechnology innovations, leading to reduced overall environmental impacts and the reduced use and release of more toxic materials. The LCA study identified key materials and processes within the batteries’ life cycles that are likely to pose the greatest environmental impacts, including occupational and public toxicity impacts, which will help the Li-ion battery industry to identify environmentally sound process, material, and design choices. The Partnership included battery manufacturers, suppliers, and recyclers, as well as representatives from academia, trade and research institutions, and the Department of Energy’s (DoE) Argonne National Laboratory. Comments are due on June 30, 2012.

EPA Seeks Information On Candidates For Integrated Risk Information System (IRIS): On May 7, 2012, EPA announced the IRIS 2012 agenda and requested scientific information on health effects that may result from exposure to the chemical substances included on the agenda, including assessments that EPA is starting this year. 77 Fed. Reg. 26751. While EPA is not expressly soliciting comments on this notice, EPA will accept information related to the following substances:

ChemicalCAS No.Projected Start
Carbonyl sulfide463-58-1FY12
Decamethylcyclopentasiloxane (D5)541-02-6FY13
Octamethylcyclotetrasiloxane (D4)556-67-2FY13
1,2-dichloroethane (ethylene dichloride)107-06-2FY13
Diisopropyl ether (DIPE)108-20-3FY12
Tert-amyl methyl ether (TAME)994-05-8FY12
4,4′-dimethyl-3-oxahexane (TAEE)919-94-8FY12
Mercury, elemental7439-97-6FY14
Methyl mercury22967-92-6FY14
Tungsten and related compounds7440-33-7FY14
Vanadium, elemental and compounds various FY13

New EPA Total Release Fogger Videos Encourage Safe Use Practices: On May 8, 2012, EPA announced that it has created a series of new videos to educate the public about potential hazards associated with the misuse of total release foggers in the home, and to encourage users to read label directions and take safety precautions when using foggers. According to EPA, total release foggers, also known as “bug bombs,” are pesticide products containing aerosol propellants that release their contents at once to fumigate an area. These products are often used in the home to kill cockroaches, fleas, and other pests. The new videos were created in both English and Spanish and emphasize three safety topics: keep foggers away from ignition sources; do not use more foggers than necessary; and vacate and ventilate the treated residence after fogger application. To view EPA’s new safe fogger use videos and to learn more about safety precautions to take when using foggers, visit online or online.

EPA Promotes Safer Alternatives To Nonylphenol Ethoxylates: On May 9, 2012, EPA released the final report on alternatives to nonylphenol ethoxylates (NPE) through the DfE Alternatives Assessment Program. NPEs are widely used surfactants with a range of industrial applications and are commonly found in consumer products, such as laundry detergents. When released into the environment, they can be persistent and highly toxic to aquatic organisms. The report identifies eight safer alternatives to NPE that meet EPA’s criteria for safer surfactants. The report provides information on the availability of safer alternatives, DfE’s hazard evaluation method for surfactants, and the progress being made in adopting safer surfactants. To date, the DfE Program has labeled more than 2,700 safer products, including detergents that contain only safer surfactants and other chemicals. All companies participating in the DfE Safer Detergents Stewardship Initiative have eliminated NPE from their product lines to meet DfE criteria. More information on the DfE Alternatives Assessment Program and the NPEs Report is available online.

EPA Issues Final TRI Rule Regarding Tribal Participation: On April 19, 2012, EPA announced new opportunities for tribal participation and engagement in the Toxics Release Inventory (TRI) Program. 77 Fed. Reg. 23409. Under the final rule, TRI reporting facilities located in Indian country are required to report to the appropriate tribal government of their relevant area instead of the state. The rule also improves and clarifies certain opportunities allowing tribal governments to participate more fully in the TRI Program. Because tribal governmental structures may vary, EPA is updating its terminology to refer to the principal elected official of the tribe as the “Tribal Chairperson or equivalent elected official.” EPA also amended its definition of “State”‘ for purposes of 40 C.F.R. Part 372 to no longer include Indian country, so as to avoid any confusing overlap in terminology for facilities located in Indian country. With regard to the procedures for EPA to modify the list of covered chemicals and TRI reporting facilities, the rule clarifies the opportunities available to tribal governments. EPA is including within the relevant provision an opportunity for the Tribal Chairperson or equivalent elected official to request that EPA apply the TRI reporting requirements to a specific facility located within the tribe’s Indian country. EPA is also clarifying that the Tribal Chairperson or equivalent elected official may petition EPA to add or delete a particular chemical respectively to or from the list of chemicals covered by TRI. The rule was effective immediately.

SAB Staff Office Director Discusses Upcoming IRIS Assessments: On May 11, 2012, Vanessa Vu, Ph.D., Director of EPA’s Science Advisory Board (SAB) Staff Office, discussed the formation of the new Chemical Assessment Advisory Committee (CAAC), a subcommittee of the SAB, and its role in performing upcoming IRIS chemical reviews. Dr. Vu provided a basic outline of the CAAC formation process: the Administrator will nominate members, take public comment on the nominations, and engage nominees in a face-to-face meeting (anticipated by mid-July 2012) before making final selections for the CAAC. Dr. Vu said that once the final list of chemicals (likely around six) was selected, the CAAC would be nominated and seated based on expertise around the chemicals chosen. Dr. Vu did not state a specific number of CAAC members that EPA hopes to empanel, but said the goal is to achieve continuity on the Committee and that it wants to have enough experts to place a number of dedicated CAAC members on each chemical-specific subcommittee.

The full CAAC will be a “Tier 2” committee, with the chemical-specific subcommittees considered an augmented subcommittee of the Tier 2 CAAC that are still subject to the Federal Advisory Committee Act (FACA) open government requirements. EPA plans to take public comments on specific experts to supplement the CAAC members on each chemical-specific panel once the full CAAC is seated/chosen (post-July 2012). Dr. Vu addressed concerns over drafting of CAAC charge questions; the level of meaningful interaction with the public during the IRIS review process; the short timing for releasing past charge questions, draft assessments, and panel nominees; and the membership of both the expert chemical-specific panels and the full CAAC itself. To help improve the process and provide meaningful public participation, Dr. Vu stated that one possible solution was to have the CAAC members give an overview of the charge questions, the public comments received, EPA’s stated response, and how the CAAC panel considered both and how it influenced its decision/review.

George Washington University Regulatory Studies Center Convenes Panel Discussion On Moving Forward With IRIS Reform: On April 18, 2012, the George Washington University Regulatory Studies Center convened a panel discussion entitled Moving Forward With IRIS Reform: Implementing National Academies’ Roadmap for Revisions. Panelists included Dr. Lynn R. Goldman, Dean of the School of Public Health and Health Services and former Assistant Administrator for Toxic Substances at EPA; Rebecca Clark, M.P.H., Acting Director of EPA’s National Center for Environmental Assessment (NCEA); Chuck Elkins, former Director of EPA’s Toxic Substances Program; Dr. Yiliang Zhu, Professor of Epidemiology and Biostatistics at the University of South Florida and member of the National Academy of Sciences’ (NAS) Institute of Medicine Committee on Shipboard Hazard and Defense; and Heidi R. King, Chief Economist on the U.S. House of Representatives Committee on Energy and Commerce. The panel discussion focused on how EPA could effectively implement suggested improvements found in Chapter 7 of the NAS National Research Council’s (NRC) assessment of the draft IRIS assessment of formaldehyde, which can be found online. The panelists’ presentations and an event summary are available online. A more detailed memorandum is available online.

EPA Issues PR Notice Concerning SDSs As Pesticide Labeling To Address Non-Alignment With OSHA’s New Hazard Communication Standard (HCS) (U.S. Implementation Of Globally Harmonized System Of Classification And Labeling Of Chemicals (GHS)): On April 20, 2012, EPA announced the availability of Pesticide Registration Notice (PR Notice) 2012-1, entitled “Material Safety Data Sheets as Pesticide Labeling.” 77 Fed. Reg. 23713. EPA issued the PR Notice on April 9, 2012, and EPA intends it to provide guidance to registrants concerning the relationship between EPA-approved labels for pesticides registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the material safety data sheet (MSDS, also referred to as safety data sheet (SDS)), required by the Occupational Safety and Health Administration (OSHA). The PR Notice explains how registrants can ensure their FIFRA labeling and SDSs comply with both agencies’ requirements. In addition, EPA is soliciting public comment on the information collection activities and related burden estimates associated with the guidance provided in PR Notice 2012-1. Comments on the information collection activities and related burden estimates are due June 19, 2012. PR Notice 2012-1 is effective immediately. A more detailed memorandum is available online.


EPA Issues Final Revisions To Unregulated Contaminant Monitoring Regulation For Public Water Systems: On May 2, 2012, EPA issued the third Unregulated Contaminant Monitoring Regulation (UCMR 3) listing the unregulated contaminants to be monitored and addressing the requirements for such monitoring. 77 Fed. Reg. 26072. The final rule describes analytical methods to monitor 28 chemical contaminants, and describes the monitoring for two viruses. The UCMR 3 final contaminant lists are:

List 1, Assessment Monitoring
CobaltChromium-6 (hexavalent chromium)
1,3-butadienePerfluorooctanesulfonic acid (PFOS)
Chloromethane (methyl chloride)Perfluorooctanoic acid (PFOA)
1,1-dichloroethanePerfluorononanoic acid (PFNA)
Bromochloromethane (Halon 1011)Perfluorohexanesulfonic acid (PFHxS)
Bromomethane (methyl bromide)Perfluoroheptanoic acid (PFHpA)
Chlorodifluoromethane (HCFC-22)Perfluorobutanesulfonic acid (PFBS)
List 2, Screening Survey
17-α-ethynylestradiol (ethinyl estradiol)Equilin
List 3, Pre-Screen Testing
Exhibit 2b – Total Chromium Monitoring
Total chromium 

The rule also issues in final amendatory language for a drinking water inorganic analysis table (Inorganic chemical sampling and analytical requirements). The rule is effective June 1, 2012.


EPA Adds Three Hazardous Waste Sites To Superfund’s National Priorities List: On May 9, 2012, EPA added three hazardous waste sites to the National Priorities List (NPL) established under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund). The three sites EPA added are: the Jervis B. Webb Co. (a former metal fabrication facility) in South Gate, California; the Southern Avenue Industrial Area (and adhesive manufacturer) in South Gate, California; and the Bremerton Gasworks in Bremerton, Washington.


EPA And Department Of Commerce Announce New Environmental Technology Export Initiative: On May 14, 2012, EPA Administrator Lisa P. Jackson and Department of Commerce Secretary John E. Bryson announced efforts to launch an environmental technology initiative to help create American jobs in the growing environmental industry. The Environmental Technologies Export Initiative builds on President Obama’s National Export Initiative, which aims to double U.S. exports by the end of 2014 and support millions of American jobs. Announced at EPA’s first Technology Market Summit, this initiative, which will include a comprehensive web-based portal, will promote American environmental technology, products, and services in the global marketplace, Administrator Jackson stated. The web-based tool, which is scheduled to be launched in the fall of this year and hosted on, will offer U.S. environmental companies detailed information on U.S. government support activities, including market research, scientific analysis, regulatory information, and financial support programs. EPA and Commerce are also partnering with trade associations to highlight potential growth opportunities for U.S. companies by increasing access to EPA’s scientific, technical, and regulatory information and Commerce’s foreign market analysis and export promotion infrastructure. When launched, this portal will provide a more systematic approach for U.S. companies looking to expand markets for their environmental products and services abroad.

EPA Releases Roadmap On Technology Innovation For Environmental And Economic Progress: As stated above, on May 14, 2012, EPA and the Department of Commerce announced efforts to launch an environmental technology initiative intended to help create American jobs in the growing environmental industry. EPA released a document entitled Technology Innovation for Environmental and Economic Progress: An EPA Roadmap, which states that EPA “will undertake policy, regulatory, financial, and voluntary actions, grounded in science, that will promote innovation along the entire continuum of technology development and deployment.” Specifically, according to the Roadmap, EPA “will advocate more cost-effective, innovative solutions that eliminate, or significantly reduce, adverse impacts to natural resources in a manner that promotes healthy, productive communities.” EPA states that its initial efforts will focus on four broad actions:

  • Designing EPA policies, regulations, standards, permits, and procedures to leverage technology innovation;
  • Catalyzing technology design, development, finance, commercialization, and adoption through partnerships with stakeholders;
  • Stimulating cross-Agency consideration, development, commercialization, and adoption of breakthrough technologies; and
  • Developing a new relationship with the investment community. EPA will take a number of steps to build relationships and improve communication.

The Roadmap is available online.


DTSC Schedules A Two-Day Training On Alternatives Assessment 101: California’s Department of Toxic Substances (DTSC) has scheduled a two-day seminar session on June 4-5, 2012, on its Safer Consumer Products draft regulation, which requires alternative assessments for certain priority chemicals and products. This two-day training from the University of Massachusetts (UM) is in partnership with DTSC. Participants will be introduced to the process of assessing safer alternatives for chemicals and products through sharing experiences with researchers from UM’s Toxics Use Reduction Institute (TURI) and the Lowell Center for Sustainable Production. DTSC staff will lead a discussion on the role of alternatives assessment in California’s draft Safer Consumer Products Regulation. For more information and to register, go online.


Amended Federal Regulation Will Require Contractors To Report Purchase Of Biobased Products: On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts. 77 Fed. Reg. 23365. According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products. Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract. DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.

White House Issues Bioeconomy Blueprint Reaffirming Commitment To Biobased Products: On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of the Blueprint’s goals. These include initiatives to encourage federal procurement of an expanded range of biobased products; take better advantage of large pharmaceutical data sets to speed drug development; apply the latest genomics discoveries to identify quickly emerging microbial threats; and accelerate research on non-embryonic stem cells as possible treatments for blood-related and neurological diseases. More information is available online.

USDA Proposes To Amend Guidelines For Designating Biobased Products For Federal Procurement: On May 1, 2012, USDA proposed to amend nine sections of 7 C.F.R. Part 3201, Guidelines for Designating Biobased Products for Federal Procurement, to incorporate statutory changes to Section 9002 of the Farm Security and Rural Investment Act (FSRIA) that were effected when the Food, Conservation, and Energy Act of 2008 (FCEA) was signed into law on June 18, 2008. Comments are due by July 2, 2012.


CRS Publishes Nanotechnology Policy Primer: The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion. Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead “may not be as large as it was for previous emerging technologies.” According to CRS, some research has raised concerns about the safety of nanoscale materials, and “[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation.” The CRS report is available online.

OECD Publishes New Document In Series On Safety Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however. OECD notes that “this document is a living document,” and was current at the time of WPMN’s ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials. The document is available online.

EU OSHA Announces French Report On Feasibility Of Epidemiological Surveillance System For Workers Exposed To Engineered Nanomaterials: The European Agency for Safety and Health at Work (EU OSHA) posted a notice on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials. The resulting report “draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues.” According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies. The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few. In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. The EU OSHA item is available online. While the French report is dated 2011, an English summary is dated 2012. The English summary is available online.

FDA Issues Two New Draft Guidance Documents On Nanotechnology In Food Substances and Cosmetics: On April 25, 2012, the U.S. Food and Drug Administration (FDA) announced the issuance of two new draft guidance documents on the use of nanotechnology in food and cosmetic products — “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives,” which is available online, and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” which is available online. 77 Fed. Reg. 24722. These documents follow FDA’s issuance in June 2011 of an over-arching guidance on determining whether an FDA-regulated product involves the application of nanotechnology — “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” which is available online. Comments on the guidance documents are due by July 24, 2012. As with all draft guidance documents, these documents are not binding and are potentially subject to change. They do, however, represent the direction and background of FDA’s thinking on this evolving topic. More information is available online.

PCAST Releases Fourth Assessment Of The NNI: On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of NNI. PCAST found that NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for FY 2013 for 15 agencies with budgets dedicated to nanotechnology R&D. PCAST’s report is available online. More information is available online.

ECHA Announces Updated Guidance For Registering Nanomaterials: On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update “needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline,” May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform. More information is available online.

EO On Promoting International Regulatory Cooperation Includes Emerging Technology: On May 1, 2012, President Barack Obama signed an Executive Order (EO) entitled “Promoting International Regulatory Cooperation,” which is intended to ensure that differing regulatory approaches taken by foreign governments do not unnecessarily limit the ability of American businesses to export and compete internationally. EO 13563, which Obama signed on January 18, 2011, states that the U.S. regulatory system must protect public health, welfare, safety, and the environment while promoting economic growth, innovation, competitiveness, and job creation. The May 1, 2012, EO calls for the Regulatory Working Group established by Executive Order 12866, and reaffirmed by EO 13563, to serve as a forum to discuss, coordinate, and develop a common understanding among agencies of U.S. government positions and priorities with respect to: international regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the federal government to support significant, cross-cutting international regulatory cooperation activities; and promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory approaches, as appropriate. The EO is available online.

Of significance to nanotechnology stakeholders, the EO calls for the Regulatory Working Group to examine appropriate strategies for engaging in the development of regulatory approaches through international regulatory cooperation, “particularly in emerging technology areas.” The Chair of the Regulatory Working Group is Cass R. Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB). Sunstein wrote a May 1, 2012, blog item on the EO, and requested comments on how to “reduce red tape and unjustified costs by increasing regulatory cooperation, in North America and beyond.” The blog item is available online.

SAICM Will Publish Comments On Adding Nanotechnology Activities To Global Plan Of Action: The Strategic Approach to International Chemicals Management (SAICM) Secretariat is expected to publish soon comments on Switzerland’s proposal that activities relating to nanotechnology be added to the SAICM Global Plan of Action. The proposal would include a new work area on nanotechnologies and manufactured nanomaterials, with corresponding activities, actors, and targets. The Secretariat will compile the comments to inform discussion at the third International Conference on Chemicals Management (ICCM3), which will be held September 17-21, 2012. The Nanotechnology Industries Association (NIA) submitted detailed comments on the proposal, which are available online. More information on ICCM2 is available online.

NNI Agencies Announce New Nanotechnology Signature Initiative: On May 14, 2012, the agencies participating in the NNI announced the fourth Nanotechnology Signature Initiative, “Nanotechnology Knowledge Infrastructure: Enabling National Leadership in Sustainable Design” (NKI). According to a press release issued by the National Nanotechnology Coordination Office (NNCO), this signature initiative will stimulate the development of models, simulation tools, and databases to enable the prediction of specific properties and characteristics of nanoscale materials. This will then accelerate commercialization of nanotechnology innovations that maximize benefits to humans and the environment while minimizing risks. NKI identifies four areas that will benefit from focused attention:

  1. A diverse collaborative community of scientists, engineers, and technical staff to support research, development, and applications of nanotechnology to meet national challenges;
  2. An agile modeling network for multidisciplinary intellectual collaboration that effectively couples experimental basic research, modeling, and applications development;
  3. A sustainable cyber-toolbox to enable effective application of models and knowledge to nanomaterials design; and
  4. A robust digital nanotechnology data and information infrastructure to support effective data sharing, collaboration, and innovation across disciplines and applications.

More information is available online.


ECHA Publishes REACH Guidance On Registration Of Monomers: On April 27, 2012, ECHA published an update to its REACH guidance on monomers and polymers that takes into account a 2009 European Union (EU) Court of Justice decision on the registration of reacted and unreacted monomers. ECHA states that the guidance clarifies “relevant concepts” relating to monomers under REACH, in particular Article 6(3) of the legislation. This article states that monomers are subject to REACH’s registration requirement if present in a polymer in a volume of at least 2 percent of the weight of the polymer, and if they meet REACH’s minimum tonnage thresholds. The EU Court of Justice in 2009 ruled against a group of companies that claimed that reacted monomers, or monomers that had been completely integrated into polymers, should not be subject to the full REACH registration process. REACH guidance is nonbinding but is intended to show the correct way to fulfill obligations under the EU chemicals law. REACH guidance documents are available online.

ECHA Seeks View On Phthalates: On May 7, 2012, ECHA requested comment on a new published review of the scientific evidence on the risk posed by the plasticizers diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP). Comments are due by July 31, 2012, after which the ECHA Committee for Risk Assessment will study the review report. Full text of the consultation on DINP and DIDP is available online.


Clean Water Act (CWA) Jurisdiction Bill Introduced: On April 27, 2012, Representative John Mica (R–FL), Chair of the House Transportation and Infrastructure Committee, and Representative Nick Rahall (D-WV), the ranking minority member of the Committee, introduced H.R. 4965, a measure intended to preserve existing rights and responsibilities with respect to waters of the United States. The bill provides that the Secretary of the Army and the EPA Administrator are prohibited from: (1) finalizing, adopting, implementing, administering, or enforcing the proposed guidance described in the notice of availability entitled “EPA and Army Corps of Engineers Guidance Regarding Identification of Waters Protected by the Clean Water Act” that appeared in the May 2, 2011, Federal Register; and (2) using the guidance or any substantially similar guidance, as the basis for any decision regarding the scope of the Federal Water Pollution Control Act or any rulemaking. H.R. 4965 further provides that the use of the Guidance or any substantially similar guidance by the Secretary or the Administrator as the basis for any rule would be grounds for vacating said rule. The legislation was prompted by concerns that the guidance in question extended jurisdiction of the CWA well beyond the perceived limits.

Regulatory Freeze/Jobs Bill Introduced: The House Oversight and Government Reform Committee reported out H.R. 4078 on April 27, 2012. With a substitute by Chair Darrell Issa (R-CA), the measure, styled the Regulatory Freeze for Jobs Act of 2012, prohibits any federal agency from taking any significant regulatory action until the Bureau of Labor Statistics (BLS) reports a monthly unemployment rate equal to or less than 6.0%. The bill defines as “significant” any regulatory action that meets any one of four tests: it is likely to: (1) have an annual cost to the economy of $100 million or more or adversely affect the economy, productivity, competition, jobs, the environment, public health or safety, small entities, or state, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with another agency’s action; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues. H.R. 4078 does permit an agency to take a significant regulatory action if the President determines that such regulatory action is: (1) necessary because of an imminent threat to health or safety or other emergency, for the enforcement of criminal laws, or for U.S. national security; or (2) issued to implement an international trade agreement. Finally, the bill allows judicial review of challenged agency actions and of determinations by the President under this Act. Commentators and critics have suggested that the bill, if enacted, would curb action by agencies for an extended period of time, given the unemployment rate stipulated.

Midnight Rule Relief Introduced: Representative Reid Ribble (R-WI) introduced on April 24, 2012, the Midnight Rule Relief Act of 2012. The Act provides that during the period after the general election, and until after the January 20 inauguration the following year, if the President is not reelected, then no agency may propose or finalize any “midnight rule” that the Administrator of OIRA finds is likely to result in: (1) an annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. The moratorium does not apply to a midnight rule if the President determines that the midnight rule is: (1) necessary because of an imminent threat to health or safety or other emergency; (2) necessary for the enforcement of criminal laws; (3) necessary for the national security of the United States; or (4) issued pursuant to any statute implementing an international trade agreement. The moratorium does not apply to a midnight rule that the Administrator of OIRA within OMB certifies in writing is limited to repealing an existing rule. Senator Ron Johnson (R-WI) has introduced a similar moratorium measure, S. 2368.

Renewable Chemical Production Act Introduced: Representatives Bill Pascrell, Jr. (D-NJ) and Brian Bilbrey (R-CA) introduced H.R. 4953, the Qualifying Renewable Chemical Production Tax Credit Act of 2012. The bill is designed to provide an amount (determined separately for each renewable chemical produced) equal to $0.15 per pound of eligible content of renewable chemical produced during the taxable year for chemicals produced from eligible biomass. Eligible content is defined in the Act as the biobased content percentage of the total mass of organic carbon in such chemical. Renewable chemical is defined as any which is produced in the United States from renewable biomass, is sold, or used for the production of polymers, plastics, or formulated products, or as polymers, plastics, or formulated products, and is not sold or used for the production of any food, feed, or fuel. The term does not include a chemical if the biobased content percentage of such chemical is less than 25 percent, or 10,000,000 pounds or more of such chemical was produced during calendar year 2000 from renewable biomass, or such chemical is not either the product of, or reliant upon, biological conversion, thermal conversion, or a combination of biological and thermal conversion, of renewable biomass. There are limits imposed on the amounts of permissible tax credits. The total amount of credits that may be allocated under such program cannot exceed $500,000,000, and the amount of credits that may be allocated to any taxpayer for any taxable year under such program cannot exceed $25,000,000.

Cosmetic Safety Act Introduced: On April 18, 2012, Representative Leonard Lance (R-NJ) introduced the Cosmetic Safety Amendments Act of 2012. If enacted, the authority of FDA regarding cosmetics would be expanded in the areas of requiring final manufacturer registration, obtaining an inventory of products and ingredients, establishing Good Manufacturing Practices (GMP), and mandating the submission of reports of serious adverse reactions. As to registration, every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States would have to register within 60 days after beginning such manufacture. If a cosmetic is processed in more than one establishment, registration shall be required only for the establishment that performs the final portion of the manufacturing operation. Once a company registers, FDA will establish and provide to the registrant a unique cosmetic establishment registration number. The manufacturer has the duty to keep the registration information current by withdrawing or amending the registration within 60 days after the information becomes no longer current and accurate. FDA is directed to compile and maintain an up-to-date and publicly available electronic list of establishments that are registered under this section. Another feature of the legislation is that FDA is directed to promulgate a regulation requiring that a domestic or foreign manufacturer, packer, or distributor whose name appears on the label of a cosmetic marketed in the United States submit to the Secretary a report containing information received concerning a serious and unexpected adverse event in the United States allegedly associated with the use of the product, no later than 15 business days after information concerning the adverse event is received at the place of business labeled on the product. A “serious” adverse event is one that results in death, a life threatening experience, inpatient hospitalization, a significant and persistent disability, or a congenital anomaly or birth defect. A report is unexpected if the event is not identified in the current labeling for the cosmetic. Lastly, FDA is required to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel in an approved final report that a cosmetic ingredient: “(1) is safe for use in cosmetic products without the need for specified conditions of use; (2) is safe for use in cosmetic products under specified conditions for use; (3) is not safe for use in a cosmetic product under any conditions of use; (4) requires more information in order to make a determination whether the ingredient is safe for use in a cosmetic product under any conditions of use; or (5) is the subject of any other type of determination by the Cosmetic Ingredient Review Expert Panel, shall be deemed to constitute a recommendation that the Secretary accept that determination for purposes of implementing and enforcing this chapter in accordance with the effective dates established under subsection (d). FDA shall be deemed to accept that determination and recommendation unless the Secretary at any time determines, by regulation or guidance, after public notice and an opportunity for public comment, to make a different determination.” CIR was established in the 1970s by the industry trade association with the support of FDA and the Consumer Federation of America.

RAPID Act Introduced: Representative Dennis Ross (R-FL) on April 18, 2012, introduced H.R. 4377, the Responsibly and Professionally Invigorating Development Act of 2012 or RAPID. The stated purpose of the legislation is to establish a framework and procedures to streamline, increase the efficiency of, and enhance coordination of agency administration of the regulatory review, environmental decision making, and permitting process for projects undertaken, reviewed, or funded by federal agencies. A major benefit of this coordination will be the earlier creation of jobs. Among other reforms are measures to corral perceived abuses of the environmental assessment process. RAPID sets a 4.5 year-maximum deadline to complete the review process, including an 18 month maximum for the Environmental Assessment and 36 month maximum for an Environmental Impact Statement; establishes a 180-day statute of limitations and a “get in or get out” rule that requires interested parties to comment and involve themselves early on in the process to maintain standing to bring a lawsuit later; allows lead agencies to accept existing relevant environmental documents, including those prepared under state laws that satisfy or exceed National Environmental Policy Act standards; and adopts established concepts, definitions, and best practices to ensure that the federal review and permitting process is efficient and transparent.

Senate Subcommittee Holds Hearing On EPA’s Mercury MACT Standard: EPA’s Maximum Achievable Control Technology (MACT) rule limiting emissions of mercury and other hazardous air pollutants from coal-fired power plants — the so-called Utility MACT — continues to be the touchstone for a heated debate between Republican lawmakers and the Obama Administration over the costs of environmental regulation and “EPA overreach.” The latest clash occurred in the Senate Environment and Public Works Subcommittee on Clean Air and Nuclear Safety, which on April 17, 2012, held a hearing to address the estimated health benefits of the rule. Testifying at the hearing were: Dr. Jerome Paulson, Chair, Council on Environmental Health for the American Academy of Pediatrics; Brenda Archambo, President of Sturgeon for Tomorrow; Susan Dudley, Director of the George Washington University’s Regulatory Studies Center; Jeff Holmstead, a former Assistant Administrator for Air and Radiation with EPA; and Dr. Charles Driscoll, Professor of Civil and Environmental Engineering at Syracuse University.

The Committee’s Ranking Minority member, James Inhofe (R-OK), began the hearing by sharply criticizing the rule. Inhofe stated that EPA admits the benefits of reducing mercury through this regulation “are astonishingly small – especially when considering the rule’s price tag, roughly $10 billion annually.” Inhofe added that the rule cannot be justified on its merits and claimed that the National Ambient Air Quality Standards (NAAQS) for particulate matter is sufficient to address emissions of mercury and other air toxics from power plants.

Bill To Delay EPA Air Rules Clears House Subcommittee: On April 17, 2012, the House Energy and Commerce Subcommittee on Energy and Power passed legislation that would block EPA from promulgating in final form three rules until the regulations’ impacts on gasoline prices can be fully assessed. The Gasoline Regulations Act (H.R. 4471) passed on partisan lines by a vote of 15-8. No Democrats voted for passage. The bill would specifically prevent EPA from issuing three pending final rules: the Tier 3 vehicle and gasoline standards, greenhouse gas standards for petroleum refineries, and the new ozone NAAQS. The delay would be for six months after an interagency task force submits its final report to Congress assessing the impacts on gasoline prices. The bill would allow seven months for the task force to complete its final report. The bill also would amend the Clean Air Act (CAA) to require EPA to consider cost and feasibility in setting new NAAQS for ozone.

House Approves Amendment Delegating To The States Authority To Regulate Coal Combustion Residues: EPA’s pending Resource Conservation and Recovery Act (RCRA) rule regarding coal combustion residues (CCR) has garnered much attention in Congress as lawmakers fear the impact that a RCRA hazardous waste designation for CCRs will have on products that incorporate CCRs as ingredients. The House on April 18, 2012, approved an amendment — the Coal Residuals Reuse and Management Act (H.R. 2273) — that would strip EPA of its authority to regulate CCRs as hazardous waste under RCRA; that authority would devolve to the states under the amendment to the Surface Transportation Extension Act (H.R. 4348). EPA proposed a rule in 2010 outlining two possible options for regulating coal ash. One option would regulate it as a special waste under RCRA, subjecting it to somewhat reduced hazardous waste regulation. The second option would regulate CCRs as non-hazardous waste and vest states with the responsibility of regulating the material.

Keystone Pipeline Would Proceed Under Amendment To Surface Transportation Bill: The House on April 18, 2012, passed another 90-day extension to the expiring surface transportation bill. Included in the legislation was an amendment that would approve the controversial Keystone XL pipeline. The Surface Transportation Extension Act (H.R. 4348), which would further extend transportation funding from June through September 30, was approved 293-127, with 69 Democrats voting for the bill. Passage of the Keystone amendment defies a veto threat from President Obama, who has said that he will not sign legislation that includes such an amendment.

Legislation Would Require Senate Confirmation Of EPA Regional Administrators: Senator James Inhofe (R-OK) introduced a bill on May 9, 2012, that would require Senate confirmation of EPA Regional Administrators. The EPA Regional Oversight Act of 2012 (S. 3053), responds to the recent tumult caused by remarks from former EPA Region 6 Administrator Al Armendariz, who sparked a firestorm of outrage for videotaped comments in which he suggested EPA should “crucify” companies in the oil and gas industry who violate EPA regulations. Mr. Armendariz resigned his post on April 29, 2012. EPA Administrators require Senate confirmation, but currently EPA’s ten Regional Administrators do not require such approval before being appointed.


White House Seeks To Reduce Regulatory Burdens: On May 10, 2012, the White House OIRA announced two actions in the Administration’s ongoing efforts to review and eliminate outdated and unnecessary regulations. OIRA Administrator Cass Sunstein stated President Obama signed an EO to make it a continuing obligation for federal agencies to review rules to assess their continued need and utility. The EO directs agencies to seek public comment on rules requiring review and requires agencies to provide the public with regular reports on their past efforts and future plans, with details and deadlines. The House Council for Economic Advisers (CEA) also issued a report on the regulatory review effort initiated under EO No. 13563 in January 2011. Among the “outdated” regulations scheduled for elimination and highlighted in the report is an EPA regulation that requires vapor recovery systems at gasoline stations. The EO also requires EPA and other federal agencies to submit reports on their regulatory reviews, beginning with a draft report September 12, and twice a year after that, and requires agencies to make those reports publicly available. The EO on identifying and reducing regulatory burdens may be found online. The CEA report, “Smarter Regulations Through Retrospective Review,” is available online.

EPA Announces New Science Advisor: On April 24, 2012, Administrator Jackson announced that Dr. Glenn Paulson will begin as Science Advisor in the Office of the Administrator. Dr. Paulson served as Assistant Commissioner for Science at the New Jersey Department of Environmental Protection, has worked as director of the Scientific Support Program for the Natural Resources Defense Council, and served as Senior Vice President at the National Audubon Society, where he managed the 2.5 million-acre Audubon wildlife sanctuary system. Dr. Paulson has directly managed emergency response, site assessment, and cleanup at more than 100 Superfund sites and RCRA facilities; reviewed cleanup plans for more than 5,000 Superfund, RCRA, and brownfield sites and facilities in the U.S. and Canada; and joined the New Jersey State Police Commander in leading the state’s response to the Three Mile Island accident.

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