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Monthly Federal Developments Memorandum
February 1, 2012

Monthly Update for February 2012

Bergeson & Campbell, P.C.

TSCA/FIFRA/IRIS/EPCRA

EPA’s Inspector Claims EPA Needs To Clarify Testing Authority For Endocrine Disruptors: On January 17, 2012, the U.S. Environmental Protection Agency (EPA) Inspector General (IG) stated that EPA needs to clarify the regulatory authority it will use to implement its Endocrine Disruptor Screening Program (EDSP) and the number of chemicals that may be evaluated under the Program. On December 13, 2011, EPA issued the EDSP for the 21st Century (EDSP21 Work Plan). According to the IG, the Work Plan does not adequately address how EPA will use its authority under the Toxic Substances Control Act (TSCA). The Work Plan describes, among other things, how EPA would incorporate computer and in vitro high throughput tests into its EDSP. The EPA IG’s latest memo is available online.

EPA Requires Use Of CDX For TSCA Section 5 Notifications And Supporting Documents: EPA reminded TSCA regulated entities that TSCA Section 5 Premanufacture and Significant New Use Notifications must, after April 6, 2012, be provided to EPA via the Internet using EPA’s Central Data Exchange (CDX). For information about registering with CDX and making TSCA Section 5 notification submissions, go to cdx.epa.gov and www.epa.gov.

EPA Issues Report From January 19, 2012, Chemical Data Reporting Workshop: On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortium Management, LLC (BCCM) convened a workshop at which invited EPA staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting (CDR) rule. EPA has recently issued a written report on its responses to the byproduct scenarios BCCM submitted. The written report is posted with EPA’s CDR training materials online. A copy of the report, along with a copy of EPA’s slides and recorded audio from the January 19, 2012, workshop, is also available at B&C’s website.

Dover Chemical Corporation In Ohio To Pay $1.4 Million For Unauthorized Production Of Chemical Substances: On February 7, 2012, EPA and the U.S. Department of Justice announced that Dover Chemical Corporation has agreed to pay $1.4 million in civil penalties for the unauthorized manufacture of chemical substances at facilities in Dover, Ohio, and Hammond, Indiana. The settlement resolves alleged violations of TSCA premanufacture notice (PMN) obligations for the production of various chlorinated paraffins. Dover Chemical produces the vast majority of the chlorinated products sold in the United States. As part of the settlement, Dover Chemical has ceased manufacturing short-chain chlorinated paraffins, which have persistent, bioaccumulative, and toxic (PBT) characteristics. More information is available online.

EPA Announces Web-based ePMN Webinar: EPA will host on February 16, 2012, from 12:00 p.m. to 2:00 p.m. (EST) a webinar on restructuring the ePMN software. EPA is looking to improve submission capabilities and streamlining ePMN submissions by moving to a web-based application. EPA will show some of the changes that are being considered and provide you an opportunity to ask additional questions related to the potential technology changes. Questions related to specific reporting requirements will not be covered in this webinar, and people are urged to direct inquiries to EPA’s TSCA hotline. Once users log in and download the software, they will have access to the meeting. Sign up to register for the webinar online.

Industry Progressing In Voluntary Effort To Reduce Toxic Chemicals: On February 10, 2012, EPA released the interim results of a voluntary effort by eight chemical manufacturers to reduce emissions and use of long-chain perfluorinated chemicals (LCPFC), including perfluorooctanoic acid (PFOA). EPA’s 2010/15 PFOA Stewardship Program was established in 2006 in partnership with DuPont, Solvay Solexis, Asahi Glass Company, Daikin America, Inc., Clariant International Ltd., 3M/Dyneon, Arkema Inc., and BASF (formerly Ciba Specialty Chemicals Corporation). The program set a goal of reducing facility emissions and product content of PFOA and related chemicals on a global basis by 95 percent, no later than 2010, and to work toward eliminating emissions and product content of these chemicals by 2015. The interim results released highlight the success companies participating in the partnership have made in reducing releases of PFOA and other LCPFCs. According to EPA, Daikin, DuPont, 3M/Dyneon, and Solvay Solexis have met the program’s intermediate goal of a 95 percent reduction in global emissions and product content by 2010. The companies continue to reduce emissions of LCPFCs and overall product content of LCPFCs. Additionally, more than 150 replacement chemicals have been developed. The eight participating companies have informed EPA that they are on track to phase out LCPFCs by the end of 2015. These actions are part of an ongoing effort outlined in 2009 that would further reduce exposure to LCPFCs by addressing their use in products from sources other than the eight companies participating in the stewardship program. For more information on these efforts, see the action plan online.

EPA Announces External Peer Review Of Draft Toxicological Review Of Vanadium Pentoxide Under The Integrated Risk Information System (IRIS) Program: On February 6, 2012, EPA announced that Versar, Inc., an EPA contractor for external scientific peer review, will convene an independent panel of experts and organize and conduct an external peer review meeting to review the draft human health assessment titled, “Toxicological Review of Vanadium Pentoxide: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-11/004A). 77 Fed. Reg. 5797. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA released the draft assessment for the purposes of public comment and peer review. The peer review panel meeting on the draft assessment for vanadium pentoxide will be held on March 7, 2012.

EPA Announces Peer Review Of Draft Toxicological Review Of 1,4-Dioxane: On February 13, 2012, EPA announced that Versar, Inc. will convene an independent panel of experts and organize and conduct an external peer review meeting to review the draft human health assessment titled, “Toxicological Review of 1,4-Dioxane: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-11/003). 77 Fed. Reg. 7576. The draft assessment was prepared by the NCEA within the EPA ORD. EPA is releasing this draft assessment for the purposes of public comment and peer review. The peer review panel meeting on the draft assessment for 1,4-dioxane will be held on March 19, 2012, beginning at 9:00 a.m. and ending at 5:00 p.m. (EDT).

GREEN CHEMISTRY DEVELOPMENTS

OEHHA Issues Final Regulations Concerning Toxics Information Clearinghouse: On January 18, 2012, the California Office of Environmental Health Hazard Assessment (OEHHA) issued final regulations that “specify the hazard traits, toxicological and environmental endpoints and other relevant data to be included” in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (DTSC) will develop. The Clearinghouse will be used, in part, to help DTSC identify chemicals of concern in consumer products as part of its Green Chemistry Initiative and Safer Consumer Products Alternatives regulations. The Clearinghouse also “will provide basic scientific information that will be available to agencies, the public, and industry and government scientists and engineers evaluating chemicals in consumer products.” The regulations were effective on January 19, 2012. More information is available online.

DTSC Posts 800-Page Document: DTSC has posted on its website an 800-page document that includes all the comments (there were 90 of them) that were submitted on the informal draft regulations for Safer Consumer Products Alternatives, which were released on October 31, 2011. DTSC describes them as the “informal comments,” since the regulations that were issued were “informal” draft regulations. The compilation of comments is available online.

CAA/CWA

EPA Will Not Enforce Boiler Notification Requirements: In a January 18, 2012, letter from Administrator Jackson to Senator Ron Wyden (D-OR), EPA stated that it will not enforce administrative notification requirements that were outlined in the March 2011 final rule setting emissions standards for boilers and incinerators. EPA intends instead to send new and existing sources a “no action assurance letter,” according to Administrator Jackson. Jackson’s announcement comes after the U.S. District Court for the District of Columbia vacated EPA’s decision to stay the standards for boilers and incinerators. Sierra Club v. Jackson, D.D.C. No. 11-1278. EPA published final rules in March 2011 setting emissions standards for boilers and incinerators, but it was under a court-ordered deadline, and EPA immediately announced it would reconsider the rules, a process that is ongoing. In May 2011, shortly before the rules were to go into effect, EPA delayed the effective date of the standards, but the district court vacated that decision on January 9, 2012.

OSHA

OSHA Regulatory Agenda Addresses PELs And Other Issues: The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) recently updated its semi-annual regulatory agenda. One of the major issues OSHA intends to tackle in 2012 is a “Review/Lookback of OSHA Chemical Standards.” OSHA first promulgated permissible exposure limits (PEL) in 1971, and many have not been reviewed or revised since that time. OSHA states that it is preparing a Request for Information (RFI) to be issued in August “seeking input from the public to help the Agency identify effective ways to address occupational exposure to chemicals.” In the regulatory agenda, OSHA states that “[t]here is widespread agreement among industry, labor, and professional occupational safety and health organizations that OSHA’s PELs are outdated and need revising in order to take into account newer scientific data that indicates that significant occupational health risks exist at levels below OSHA’s current PELs.”

Several other high priority regulatory items are also slated for issuance in 2012. Regarding OSHA’s proposed Injury and Illness Prevention Program (I2P2), the agenda states that OSHA will initiate a Small Business Regulatory Enforcement and Fairness Act (SBREFA) review early in the year on the program. I2P2 would require employers to find and fix hazards in the workplace and has been a top priority for OSHA Administrator David Michaels. OSHA held stakeholder meetings on I2P2 in June 2010 and just last month released a white paper explaining the benefits of the I2P2 program. OSHA’s regulatory agenda also states that the Hazard Communication Standard is inching closer to final rule stage. The agenda indicates that a final rule will be issued in February. The rule is intended to align the current hazcom standard with the Globally Harmonized Hazard Communication System (GHS). The proposed crystalline silica standard is also included in the agenda. The regulatory agenda states that a proposed rule on the standard will be published in February 2012.

NANOTECHNOLOGY

NRC Publishes A Research Strategy For Environmental, Health, And Safety Aspects Of Engineered Nanomaterials: On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. EPA asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges. To help guide research, the Committee noted the following four research categories, which it states should be addressed within five years:

  • Identify and quantify the nanomaterials being released and the populations and environments being exposed;
     
  • Understand processes that affect both potential hazards and exposure;
     
  • Examine nanomaterial interactions in complex systems ranging from subcellular to ecosystems; and
     
  • Support an adaptive research and knowledge infrastructure for accelerating progress and providing rapid feedback to advance research.

The Committee states that implementation of the strategy should also include the integration of domestic and international participants involved in nanotechnology-related research, including the National Nanotechnology Initiative (NNI), federal agencies, the private sector, non-governmental organizations (NGO), and the academic community. The Committee noted that the current structure of the NNI, which has no top-down budgetary or management authority to direct nanotechnology-related EHS research, hinders its accountability for effective implementation. In addition, according to the Committee, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. The Committee concluded that, to carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential. The report is available online.

NRDC Files Suit To Block EPA’s Conditional Registration Of Nanosilver: On January 26, 2012, the Natural Resources Defense Council (NRDC) filed a lawsuit in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA concerning its conditional registration of a pesticide product containing nanosilver as a new active ingredient for use as a preservative for textiles. NRDC states that it seeks to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles. On December 1, 2011, EPA announced its conditional approval of HeiQ AGS-20. As a condition of registration, EPA is requiring HeiQ to conduct a number of studies within four years, which EPA chose to allow time for protocol reviews prior to initiation of the studies, completion of the studies, and its review of the study results. NRDC states that it seeks to block EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.” NRDC’s press release is available online. B&C’s December 5, 2011, memorandum regarding the conditional registration is available online.

NRDC is challenging EPA’s actions under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b). This provision allows “any person” who claims to be adversely affected by an EPA order issued after a “public hearing” to obtain judicial review “praying that the order be set aside in whole or in part.” The “public hearing” component of the provision may have been EPA’s request for comment on its proposed decision conditionally to register HeiQ’s nanosilver product on August 13, 2010. The court’s review is limited to the record before it, and it does not undertake de novo review of EPA’s actions.

EPA Extends Comment Period For Proposed SNURs: In response to public comments, EPA provided the public more time to comment on the December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of PMNs. 77 Fed. Reg. 4947. Comments are now due March 19, 2012. Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW). The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers. These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the OSHA standards as best practices.

This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.

NanoRelease Project In Phase 2: The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products. To do this, the Project will: (1) examine full life cycles of nanomaterials in products; (2) work through specific release scenarios at key exposure points of the life cycle; (3) organize existing material characteristics data and measurement methods for those release scenarios; (4) develop a “state of the science” report for release measurement; and (5) carry out inter-laboratory testing to promote improvements, standardization, and widespread use of methods. The NanoRelease Project completed Phase 1 in 2011, resulting in the selection of multi-walled carbon nanotubes (MWCNT) in polymers as the first material to be evaluated through inter-laboratory studies of methods. In Phase 2, three Task Groups of more than 40 experts are evaluating: (1) measurement methods; (2) the effect of materials selected on release rates; and (3) identifying the key exposure/release scenarios. Each Task Group will produce a white paper on their respective topic. Phase 3 is scheduled to begin in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of MWCNT released from selected polymers. The NanoRelease Project is organized by Dr. Richard Canady of the ILSI Research Foundation, and is supported by the EPA, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute. More information is available online.

CIEL Claims REACH Insufficient To Regulate Nanomaterials: The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:

  • REACH does not define nanomaterials, and contains no nano-specific provisions;
     
  • Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
     
  • REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
     
  • REACH test guidelines fail to consider the special properties of nanomaterials.

CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.” The report is available online.

EPA Posts Summary Of 2011 Nanomaterial Case Studies Workshop: On February 9, 2012, EPA posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the NCEA to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials. The basis of the workshop was the report Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray. According to the summary report, the outcomes of this and future workshops in the series — prioritized information gaps and risk tradeoffs — will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.

The goal of this workshop was to prioritize responses to the question of what research or information is most needed to conduct a comprehensive environmental assessment of nanoscale silver used in disinfectant spray? The workshop used the nominal group technique (NGT) as the collective judgment tool to facilitate the discussion and prioritization of information needs among the group of diverse participants. The summary report lists prioritized research questions within the following research themes:

  1. Analytical Methods (120 points, 19 votes);
     
  2. Exposure and Susceptibility (120 points, 17 votes);
     
  3. Physical and Chemical Toxicity (115 points, 16 votes);
     
  4. Kinetics and Dissolution (98 points, 15 votes);
     
  5. Surface Characteristics (81 points, 14 votes);
     
  6. Sources and Release (76 points, 15 votes);
     
  7. Mechanisms of Nanoscale Silver Toxicity (72 points, 11 votes);
     
  8. Test Methods — Mammals/Humans (67 points, 11 votes);
     
  9. Ecotoxicity Test Methods (59 points, 10 votes);
     
  10. Is New Nano Unique? (59 points, 10 votes);
     
  11. Biological Effects (56 points, 10 votes);
     
  12. Ecological Effects Required for Risk Assessment (43 points, 9 votes);
  13. Communication, Engagement, and Education (43 points, 9 votes);
  14. Fate and Transport of Nano-Ag (39 points, 12 votes);
  15. Adequacy of Current Data (39 points, 6 votes);
  1. Dissolution (36 points, 9 votes);
     
  2. Information from Manufacturers (35 points, 10 votes);
  3. Adaptive Tolerance/Resistance (35 points, 8 votes);
  1. Metrics (33 points, 7 votes);
     
  2. Kinetics II (22 points, 5 votes);
     
  3. Benefits (9 points, 5 votes);
     
  4. Incentivize Research for Comprehensive Environmental Assessment (CEA) (8 points, 1 vote); and
     
  5. CEA Framework (1 point, 1 vote).

The workshop report is available online.

International Symposium On Assessing The Economic Impact Of Nanotechnology Will Be Held In March 2012: On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the “International Symposium on Assessing the Economic Impact of Nanotechnology.” The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. NNI, organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically “the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts.” Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration, which opened on February 10, 2012, will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly. More information is available online.

France Prepares Mandatory Nanomaterials Reporting Scheme: French authorities developed two texts dealing with a national commitment to introduce a compulsory declaration scheme for nanomaterials. The first is a decree defining how such a law would be applied. The second provides the information requirements that companies will have to meet to fulfill their obligations under the declaration. The second text, which was released in December 2011, is open for consultation until the end of March 2012. After the French Council of State approves the legislation, the authorities intend to publish the final decree in the next few weeks. The first declarations covering nanomaterials produced, imported, and distributed in France in 2012 are then expected in 2013. The draft decree is available online.

REACH

European Chemicals Agency Publishes Inventory Of Three Million Chemicals Sold In EU: On February 13, 2012, the European Chemicals Agency (ECHA) published an inventory of more than three million substance classification notifications, triggering a requirement for companies to “make every effort” to harmonize the classification and labeling of chemicals sold in the EU. Publication of the inventory provides an overview of the chemicals sector in the EU, describing the substances that are sold and giving the number of companies selling them. Companies selling chemicals in the EU that have not submitted notifications to ECHA for inclusion in the inventory are in breach of the CLP Regulation. The inventory results from companies’ efforts to reclassify their substances in accordance with the EU regulation on the classification, labeling, and packaging of chemicals (CLP Regulation (EC) No. 1272/2008), which implements in the EU the United Nations’ Globally Harmonized System for Classification and Labelling of Chemicals. The CLP Regulation required companies to submit the notifications to ECHA by January 4, 2011. ECHA reportedly received multiple notifications covering more than 100,000 substances. The ECHA classification and labeling inventory is available online.

LEGISLATIVE DEVELOPMENTS

Lawmakers Beat Up DHS Over Its Implementation Of The Chemical Facility Antiterrorism Standards: House lawmakers on February 3, 2012, bruised the U.S. Department of Homeland Security (DHS) over its implementation of the five-year-old Chemical Facility Antiterrorism Standards (CFAT) program, charging that DHS’s poor management of CFATs has significantly undermined the program and calls into question the viability of legislation to extend the program beyond its October 4, 2012, expiration date. Representative John Shimkus (R-IL), of the House Energy and Commerce Subcommittee on Environment and the Economy, rebuked DHS officials over the program, noting that DHS has failed to approve a single one of the security plans submitted by some 4,200 high-risk facilities. Shimkus has been a supporter of the CFATS program, but during the hearing he cautioned that his confidence in DHS is waning. He alleged that DHS was ignoring Congressional intent in the program and compared CFATS to “the unmanned police car positioned at the side of the highway – it wards off speeders, but not much else.” A Subcommittee memorandum issued before the hearing describes numerous faults in the program, including insufficient preparation of program personnel; “unsuitably high dependence” on contractors; poor accommodation of incoming staff; doubts linked to brief, incremental extensions to the initiative; and complications linked to formal task assignments and a unionized workforce. Rand Beers, Undersecretary for the Homeland Security Department’s National Protection and Programs Directorate and the Obama Administration official in charge of implementing CFATs, defended DHS’s actions while also noting challenges. Mr. Beers stated DHS had originally planned to complete reviewing all plans for high-risk sites before 2011, and that it continues to review the plans and implement improvements to how DHS oversees and implements the program. He stated the chemical program’s top staff had been assigned to implement more than 100 recommendations identified by an internal DHS assessment of the program. Representative Joe Barton (R-TX) was having none of that, however. He stated that “the industry has invested billions of dollars to upgrade security to CFATS requirements. This is beyond disappointing,” and added that Mr. Beers had “totally mismanaged this program” and called for Mr. Beers to resign if he could not right the ship. Democratic lawmakers laid the blame elsewhere. Representative Henry Waxman (D-CA) blamed program faults on a lack of Congressional action to flesh out the initiative’s goals and authorities. “The program was not established with carefully crafted legislation that defined its mission and forged a vision for its implementation.”

House Committee Holds Hearing On Legislation That Could Undermine EPA Consent Decrees: The House is considering two controversial bills intended to overhaul the way federal agencies enter into consent decrees with parties that sue the agencies over regulatory issues. The House Judiciary Subcommittee on Courts, Commercial and Administrative Law on February 3, 2012, held a hearing on the Federal Consent Decree Fairness Act (H.R. 3041) and the Sunshine for Regulatory Decrees and Settlements Act (H.R. 3862). Although the scope of both bills encompasses all federal agencies, the legislation is aimed at addressing how EPA uses consent decrees. Proponents of the legislation claim that the bills will address concerns that EPA is using consent decrees to create policy through an approach that skirts the standard rulemaking approach laid out by the Administrative Procedures Act. The bills’ sponsors and supporters claim that EPA is implementing a “sue and settle” approach with NGOs where NGOs sue EPA for missing a statutory deadline for a rule and then reach a decree setting a legal deadline for issuing the regulation at issue. At the February 3 hearing, Subcommittee Chair Howard Coble (R-NC) stated: “Although consent decrees are efficient, they are not a wise method to create regulations.” The bills’ opponents were equally vocal in their concern over the legislation. John Cruden, President of the Environmental Law Institute and former Deputy Assistant Attorney General, Environmental and Natural Resources Division, U.S. Department of Justice, at the hearing stressed the importance of consent decrees. He added that provisions in other laws already exist that provide for the ability to alter decrees or eliminate them after four years or when there is a turnover in an elected office. Democrats on the Subcommittee echoed this concern. Ranking member John Conyers (D-MI) stated that both of these bills “threaten to undermine a key tool in guaranteeing the rights and protections that Congress has enacted over the last two generations.”

House Holds Hearing On Transparency Of EPA Raw Data: The House Science, Space and Technology Subcommittee on Energy and Environment on February 3, 2012, held a hearing to discuss how EPA should make transparent and available to the public the raw data it generates for rulemaking and scientific purposes. As announced, the hearing was intended to be focused on legislation seeking to reauthorize the Environmental Research, Development and Demonstration Authorization Act, the 1976 law that created EPA’s ORD and the Science Advisory Board (SAB). That legislation has not been touched since 1981. Republican lawmakers, however, view the legislation as an opportunity to revamp the manner in which EPA handles and releases raw data. During the hearing, Republican lawmakers asked for EPA to release the raw data underlying its scientific assessments, even before that data have been peer reviewed. Deborah Swackhamer, EPA’s SAB Chair, advised against doing so, testifying that EPA should not release data that have not yet undergone some level of review. The underlying issue extends beyond EPA’s use of raw data. Three issues appear to be fuelling Republicans’ ire about EPA’s use of scientific data: (1) concerns about the IRIS assessments; (2) EPA’s draft scientific evaluation of groundwater contamination in Wyoming that EPA has tentatively linked to hydraulic fracturing; and (3) EPA’s general methodology for using science to develop its regulations.

EPA Takes Heat At House Hearing On Utility MACT: EPA’s Assistant Administrator for Air, Gina McCarthy, defended EPA’s Maximum Achievable Control Technology (MACT) rule for the utility industry during a House Energy and Commerce Subcommittee on Energy and Power hearing on February 8, 2012. Responding to lawmakers’ concerns that the rule will stifle construction of new power plants, McCarthy stated that the MACT rule will not preclude the construction of new utilities and that existing power plants can comply with the standards. At issue is the December 16, 2011, Mercury and Air Toxics Standards (MATS), the first national standards addressed at reducing emissions of mercury and other hazardous air pollutants from power plants. McCarthy testified that the standards will slash emissions of these dangerous pollutants by relying on widely available and proven pollution controls that are already in use at more than half of the nation’s coal-fired power plants. During the hearing, Republican lawmakers pressed McCarthy to demonstrate that the rule will not pose a barrier to new plant construction, due to growing concerns that the rule is so strict it will be difficult if not impossible for new coal plants to meet. Representative Michael Burgess (R-TX) asked McCarthy whether a new coal-fired plant could be built today given EPA’s rule. McCarthy replied that the rule will allow existing coal plants to continue operation. As an example, she cited an existing coal-fired power plant in New Jersey as being able to meet the MACT. But Republicans criticized her for only being able to cite one example of an existing plant that can meet the emissions limits for new facilities.

House Committee Passes Bill Blocking E15: The House Science, Space and Technology Committee on February 7, 2012, passed legislation that would stop EPA from authorizing sales of gasoline and ethanol fuel that contains up to 15 percent ethanol (E15). The bill, H.R. 3199, was introduced over concerns that increasing the concentration of ethanol in gasoline presents several uncertainties. Critics of the higher percentage fuel claim that it may reduce fuel efficiency, void vehicle warranties, or cause engine failure. H.R. 3199 would halt the E15 approval process and task the National Academies of Science with studying the potential impacts of E15.

House Subcommittee Chair Vows To Address Nuclear Waste, Electronic Hazardous Waste Manifest, And Superfund Cleanups In 2012: Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on the Environment and Economy, on February 9, 2012, laid out his Subcommittee’s agenda for the remainder of 2012. The agenda includes oversight of the Nuclear Regulatory Commission and an investigation into the Obama Administration’s “unlawful” termination of the Yucca Mountain nuclear waste repository site. He will also push for legislation implementing an electronic hazardous waste manifest system for tracking shipments of hazardous waste. Some 2.5 million to 5 million manifests are tracked annually at a cost between $200 million and $500 million per year, Shimkus stated. Modernizing the system and eliminating the need for paperwork could save $100 million a year, he estimated. Shimkus also stated he wants to hold a series of hearings to review EPA’s Superfund program to identify areas for improvement.

Senate Bill Would Require EPA To Establish Integrated Wastewater And Storm Water Permits: Senator Sherrod Brown (D-OH) on February 9, 2012, introduced legislation that would require EPA to revise the manner in which it issues wastewater and storm water permits under the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES). Specifically, the Clean Water Affordability Act (bill number not assigned yet) would require EPA to create an integrated permit that addresses both wastewater and storm water discharges. Under the bill, such permits would extend beyond the current five-year limit on NPDES permits.

House Subcommittee To Review Changes To The Clean Air Act (CAA): Representative Ed Whitfield (R-KY), Chair of the House Energy and Commerce Subcommittee on Energy and Power, announced on February 9, 2012, this his Subcommittee will hold a series of forums aimed at evaluating the CAA and assessing where the Act is and is not working well. Whitfield stated he hopes these forums will help propel legislation that will revamp the law, which last underwent major revisions in 1990.

President Sends $3.8 Trillion Budget To Congress; Proposes Cuts To EPA’s Budget: President Obama on February 13, 2012, sent Congress a $3.8 trillion budget for the federal government’s fiscal year (FY) 2013 operations. The budget is certain to fuel election-year battles over spending and taxes. The President is proposing a FY 2013 budget for EPA of $8.3 billion. This is about $105 million below the EPA’s enacted level for FY 2012. The majority of the cuts are coming from the Hazardous Substance Superfund Account and the State Revolving Funds (SRF) under the CWA and Safe Drinking Water Act. The budget also includes $50 million in savings by eliminating several EPA programs that have either completed their goals or can be implemented through other federal or state efforts. EPA’s overall staffing levels will remain relatively unchanged. Chemicals management programs are of increasing importance for EPA, as reflected by a substantial increase in EPA’s funding for its TSCA and related efforts. With respect to TSCA programs, EPA would receive $68 million, an increase of $11 million from FY 2012, “to reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to toxic chemical information.” EPA states that this funding will sustain its successes in managing the potential risks of new chemicals coming into the market and accelerating the progress to help ensure the safety of chemicals on the market that have not been tested for adverse human health and environmental effects. Despite the cuts in the SRFs, state governments would continue to receive substantial funding from EPA. The budget proposes $1.2 billion in categorical grants for states. This is an increase from FY 2012 levels and includes nearly $66 million for State and Tribal Air Quality Management grants, nearly $27 million for Pollution Control (CWA Section 106) grants, and about $29 million for the Tribal General Assistance Program. The budget proposal still maintains robust funding for SRFs. The proposal includes about $2 billion for Clean Water and Drinking Water SRFs. EPA states that this will allow the SRFs to finance over $6 billion in wastewater and drinking water infrastructure projects annually. The budget proposal also includes $755 million in funding for the Superfund program. EPA’s research efforts fared well under the proposal. EPA’s proposed budget provides $576 million to support research and innovation. Science to Achieve Results (STAR) grants are funded at $81 million to conduct research in key areas such as hydraulic fracturing, potential endocrine disruptors, and green infrastructure. A total $14 million investment will begin to assess potential impacts of hydraulic fracturing on air quality, water quality, and ecosystems. Compliance continues to be a centerpiece of action for EPA, as its budget proposal requests $36 million to support “Next Generation Compliance.” EPA describes this as a new enforcement model designed to enhance EPA’s ability to detect violations that impact public health. The three components of this approach are: promoting electronic reporting by facilities, modifying data systems to implement electronic reporting, and deploying modern monitoring technology. This will work toward improved compliance and transparency, and more efficient processes that do not rely on paper-based reporting, according to EPA. The budget also elevates the issue of electronic waste to a high priority. EPA states that its budget redirects funding to advance sustainable practices for electronic waste management. The budget “leverages EPA’s national leadership role to engage industry, producers, and consumers to advance the framework set forth in the National Strategy for Electronics Stewardship and address the growing need for responsible electronics design, purchasing, management, and recycling.”

Importantly, the NNI would receive about $1.76 billion under the President’s FY 2013 budget request for federal research and development, a 2.7 percent increase from fiscal 2012. The fiscal 2013 request would be a $70 million increase from the fiscal 2012 enacted level of $1.7 billion, according to the Office of Science and Technology Policy (OSTP). The allocation would be a 2.7 percent increase from fiscal 2012 when adjusted for the inflation rate.

MISCELLANEOUS

NTP Requests Comment On Nominations And Calls For Additional Nominations To Report On Carcinogens: On January 19, 2012, the National Toxicology Program (NTP) requested comment on several substances, mixtures, and exposure circumstances nominated for possible review for future editions of the Report on Carcinogens (RoC). 77 Fed. Reg. 2728. NTP also invites the nomination of additional substances. The substances nominated to the RoC are: alkenylbenzenes (selected dietary: estragole, myristicin, isosafrole); 1-bromopropane; carbon black; cumene; diesel exhaust particulates; ethylbenzene; helicobacter pylori; indium compounds; iron (excess) or iron overload; pentachlorophenol; shiftwork involving light at night; ortho-toluidine; trichloroethylene; uranium (depleted); viruses (selected): Kaposi’s sarcoma — associated herpesvirus, Epstein-Barr virus (EBV), human T-cell lymphotropic virus type 1 (HTLV-1), human immunodeficiency virus (HIV), and Merkel cell polyomavirus. NTP also solicits and encourages interested parties in nominating substances for the RoC. The deadline for submission of public comments on the nominated substances is February 28, 2012; comments submitted after this date will be considered as time permits. There is no deadline for submission of new nominations.

EPA Develops Test Plans, Verifies Performance Of Microbial Resistant Building Products: EPA’s Environmental and Sustainable Technology Evaluations (ESTE) project, managed by ORD’s Environmental Technology Verification (ETV) program in coordination with other EPA offices and private partnerships, has developed test/quality assurance plans and conducted testing on categories of building materials to verify microbial resistant claims. Protocol development has been completed for gypsum wallboard and other building materials, including flooring, ceiling tiles, duct liners; and insulation materials. On the ESTE website, study reports and verification statements appear for two specific products — insulation and flooring. Other sustainability criteria also assessed include volatile organic compound (VOC) and formaldehyde emissions. More information, including copies of the test/quality assurance plans, is available online.

ATSDR Announces Notice Of Development Of Set 25 Toxicological Profiles: On February 9, 2012, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the development of Set 25 Toxicological Profiles that will consist of four updated profiles. 77 Fed. Reg. 6800. ATSDR will make these profiles available to the public on or about October 17, 2012, and will solicit public comments at that time for a 90-day period. The following toxicological profiles are now being developed:

NameCAS Number
Hexachlorobenzene (UPDATE)118-74-1
Endosulfan (UPDATE)115-29-7
Endosulfan sulfate1031-07-8
Endosulfan-alpha95-99-98
Endosulfan-beta33213-65-9
1,1-Dichloroethane (UPDATE)75-34-3
Dinitrotoluenes (DNT) (UPDATE) 
2,3-DNT602-01-7
2,4-DNT121-14-2
2,5-DNT619-15-8
2,6-DNT606-20-2
3,4-DNT610-39-9
3,5-DNT618-85-9

Notice of the availability of drafts of these four updated toxicological profiles for public review and comment will be published in the Federal Register on or about October 17, 2012, with notice of a 90-day public comment period for each profile, starting from the actual release date. Following the close of the comment period, chemical-specific comments will be addressed, and, where appropriate, changes will be incorporated into each profile.

EPA Announces Lek Kadeli/Ramona Trovato As Acting Assistant Administrator/Deputy For ORD: On February 9, 2012, Administrator Lisa Jackson announced that with Paul Anastas’ impending departure from EPA, EPA is pleased to announce that Lek Kadeli will step in to serve as Acting Assistant Administrator for ORD. According to Administrator Jackson’s statement, Lek started his career with the EPA in 1990 as an analyst in the Office of the Comptroller. He served as the Senior Budget Officer in the Office of International Activities before becoming a valued member of the ORD team. During his tenure with ORD, Lek has held many leadership roles, including Deputy Lab Director of the National Exposure Research Lab and most recently Principal Deputy Assistant Administrator for Management. Lek also served as Acting Assistant Administrator during the first year of the Obama Administration. Jackson also announced that Ramona Trovato will serve as Lek’s Principal Deputy.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

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