Monthly Update for July 2012

TSCA/FIFRA/IRIS/EPCRA

EPA Publishes Extension Of CDR Rule: On June 18, 2012, the U.S. Environmental Protection Agency (EPA) published a final rule extending the Chemical Data Reporting (CDR) rule submission deadline for 2012 reports from June 30, 2012, to August 13, 2012. 77 Fed. Reg. 36170. Several entities requested an extension of the deadline due to a variety of CDR reporting challenges.

EPA Releases IRIS Assessment On Trimethylbenzenes: On June 29, 2012, EPA released its first Integrated Risk Information System (IRIS) assessment of trimethylbenzenes, components of gasoline and used to make other products. 77 Fed. Reg. 38799. The assessment proposes inhalation reference concentrations (RfC) and oral reference doses (RfD) for the three trimethylbenzenes it analyzed. The three isomers are: 1,2,3-trimethylbenzene (1,2,3-TMB); 1,2,4-trimethylbenzene (1,2,4-TMB); and 1,3,5-trimethylbenzene (1,3,5-TMB). Comment on the document must be submitted by August 28, 2012.

EPA Announces Availability Of Final Test Guidelines For Antimicrobial Products: On June 27, 2012, EPA announced the availability of two sets of final test guidelines: Series 810 — Product Performance Test Guidelines, specifically public health uses of disinfectants and sanitizers for use on fabrics and textiles (OCSPP 810.2400), air sanitizers (OCSPP 810.2500), and disinfectants and sanitizers for use in water (OCSPP 810.2600); and Series 850 — Ecological Effects Test Guidelines (Groups B, C, D, and F). 77 Fed. Reg. 38280 and 77 Fed. Reg. 38282. These guidelines are issued by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). Studies conducted according to these test guidelines may be used to satisfy FIFRA data requirements in 40 C.F.R. Parts 158 and 161, data-call-ins issued pursuant to FIFRA Section 3(c)(2)(B), data requirements appropriate for specific pesticide registration applications as needed, or data requirements to demonstrate the safety of a tolerance or tolerance exemption under FFDCA Section 408. EPA notes that, as guidance documents, the test guidelines are not binding on either EPA or any outside parties. The test guidelines are available online. More information is available online.

EPA Releases EDSP Comprehensive Management Plan: EPA released on June 28, 2012, an Endocrine Disruptor Screening Program (EDSP) “Comprehensive Management Plan,” that EPA states is intended to provide strategic guidance and outline critical activities that are planned for the EDSP for the remainder of Fiscal Year (FY) 2012 and through FY 2017. EPA states that although the plan is intended as an internal planning document, it made the Plan available to the public to be consistent with EPA’s stated objectives for transparency. The Plan is available online. EPA states it “anticipates that this management plan will be a living document and will be evaluated for revision on an annual basis.” More information is available online.

EPA Releases Guidance On Analyzing Cancers Linked To Chemical Exposure: On July 9, 2012, EPA issued guidance to assist scientists with understanding how to apply biological information from toxicity studies to assessments of chemical exposures and assess their potential ability to cause leukemia or related cancers. The document, Lymphohematopoietic Cancers Induced by Chemicals and Other Agents: Overview and Implications for Risk Assessment, addresses cancers related to the bone marrow, spleen, lymph nodes, thymus, and the production of blood cells. According to EPA, “the International Agency for Research on Cancer has identified over 100 agents as human carcinogens. Of these, approximately 25 percent have been shown to induce either leukemias or lymphomas in humans.” The guidance is available online.

EPA Revises Emergency And Hazardous Chemical Inventory Forms: Under a final rule published in the July 13, 2012, Federal Register, EPA has added new data elements and revised some existing data elements on the Emergency and Hazardous Chemical Inventory Forms (Tier I and Tier II) under Section 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 77 Fed. Reg. 41300. According to the notice, state and local implementing agencies requested that EPA add the new data elements since the additional information would be useful to develop or modify their community emergency response plans. EPA states that it revised some existing data elements in the chemical reporting section of the Tier II inventory form to make reporting easier for facilities and make the form more user-friendly for state and local officials. The final rule will become effective January 1, 2014.

EPA Will Hold Webinar On PMN Electronic Reporting Tool: EPA announced on July 13, 2012, that it will hold a webinar on July 25, 2012, from 1:00 – 3:00 p.m. (EDT) on the use of the premanufacture notice (PMN) thin client electronic reporting tool. According to EPA, the webinar will cover the highlights of the thin client tool, submitter roles, and show select portions of the tool. EPA will allot time for questions related to the reporting tool. In addition, EPA will explain industry beta testing, and submitters wishing to participate in the testing will be given instructions on how to request a user name and password. EPA states that it will not cover questions related to specific reporting requirements during the webinar. Registration is available online. An operator assisted conference call is required for this session (866-900-8984 Webinar ID 98754341). EPA asks participants to register and dial in at least 10 to 15 minutes before the start of the webinar.

CAA/CWA

D.C. Circuit Upholds Greenhouse Gas Rule: On June 26, 2012, a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit dismissed challenges from industry groups and certain states to EPA’s greenhouse gas (GHG) rule. Coalition for Responsible Regulation v. EPA, D.C. Cir., No. 09-1322. In this percuriam decision, the court upheld every major element of EPA’s regulation of GHGs: the endangerment finding for GHGs, the regulation of motor vehicle tailpipe emissions based on this finding; and the implementation of new prevention of significant deterioration (PSD) and Title V requirements based on the finding. Importantly, the court determined that EPA had a proper basis for its endangerment finding based on the broad scientific consensus that global warming is happening and that emissions of GHGs contribute to that warming. The court states: “This is how science works. EPA is not required to re-prove the existence of the atom every time it approaches a scientific question.” The court also found the petitioners lacked standing to challenge the regulation because it was intended to ease their permitting burden by limiting the number of sources that need to have permits. Additionally, the court denied challenges to EPA’s endangerment finding for GHGs and subsequent emissions standards for cars and light-duty trucks. The opinion by the U.S. Court of Appeals for the District of Columbia Circuit is available online.

NANOTECHNOLOGY

GAO Issues Report On Nanotechnology Information Performance: On June 20, 2012, the Government Accountability Office (GAO) issued a report urging the White House Office of Science and Technology (OSTP) to work with federal agencies to identify specific performance measures for environmental, health, and safety (EHS) research on nanotechnology. Without performance measures, time frames, and cost estimates, GAO states it will be difficult to evaluate the progress federal agencies are making to generate EHS information for nanomaterials. The report, Nanotechnology: Improved Performance Information Needed for Environmental, Health, and Safety Research, was requested by Senator Barbara Boxer (D-CA), Chair of the Senate Committee on Environment and Public Works. OSTP, the Consumer Product Safety Commission, EPA, the Department of Health and Human Services, and the National Science Foundation received the report’s recommendations and “neither agreed nor disagreed” with them, said GAO, the investigatory arm of Congress. In 2011, the National Science and Technology Council released three key documents on nanotechnology that provide guidance for agency leaders, program managers, and the research community on priorities, including EHS research. GAO stated these three documents included the National Nanotechnology Initiative Environmental, Health and Safety Research Strategy. The documents are helpful, but according to GAO, “progress toward achieving the strategy documents’ goals and research needs cannot be tracked because the NNI [National Nanotechnology Initiative] does not report specific performance information, such as performance measures, targets, or time frames.” GAO stated having cost estimates could help agencies, policymakers, and stakeholders assess whether investments are commensurate with identified needs. The office urged OSTP to coordinate development by NNI member agencies of performance measures, targets, and time frames for nanotechnology EHS research along with estimates of the costs and resources needed to achieve EHS research goals. The report is available online.

The Netherlands Publishes Report Examining The EC’s Recommended Definition Of Nanomaterial: The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider the implications for use in legislation. RIVM intends the report to provide the basis for discussions by policy makers and stakeholders on the use and further implementation of the recommended definition in national and international legal frameworks. RIVM concludes that, while the EC’s recommendation contains the relevant aspects, further guidance is necessary to ensure the definition is interpreted consistently. According to RIVM, the next step is to incorporate the definition into legal frameworks regarding the interpretation of the term nanomaterial. RIVM states that this will lead to the collection of “nano-specific” data, contributing to further insight into the “nano-specific” properties and the fate, kinetics, and effects of nanomaterials. This will help focus on the specific needs for risk assessment and risk management of nanomaterials. The report is available online.

EPA Announces Public Comment On Nanomaterial Case Study: EPA announced a 60-day public comment period for the external review draft document titled, “Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotubes and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles” (EPA/600/R- 12/043A). 77 Fed. Reg. 39236. The draft document is being issued by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD). It does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify what is known and unknown about MWCNT to support future assessment efforts. EPA is releasing this draft document for the purposes of public comment and peer review. This draft document is not final as described in EPA’s information quality guidelines, and it does not represent and should not be construed to represent Agency policy or views. EPA will consider public comments it receives in accordance with this notice when finalizing the draft document. EPA is also announcing a Public Information Exchange Meeting to: (1) Receive comments and questions on the draft “Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotubes and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles;” and (2) to provide information on the draft EPA nanomaterial case study and the workshop process that the draft document will be used in for identifying and prioritizing research gaps that could support future assessment and risk management efforts for MWCNT. This workshop process will be conducted independently by RTI International, a contractor to EPA. Comments must be received on or before August 31, 2012.

NIOSH eNews Includes Nanotechnology Update: The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”:

• A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help focus action to protect workers:
  • Review of the current evidence on the carcinogenic potential of carbon nanotubes (CNT), based on laboratory studies;
     
  • The role of physical and chemical properties related to cancer development;
     
  • CNT doses associated with changes to or damages in genes in laboratory animals and human tissue specimens;
     
  • Workplace exposures to CNT; and
     
  • Specific risk management actions needed to protect workers.
     
• A study linking nanoparticle exposure to cellular responses associated with autoimmune risks. In laboratory studies, exposures to certain types of nanoparticles produced cellular changes that are associated with risks for disorders of the autoimmune system such as rheumatoid arthritis.
   
• A recent paper highlighting the findings from an evaluation of the quality and completeness of information of nanomaterial safety data as it pertains to hazard identification, exposure controls, personal protective equipment, and toxicological information being communicated about the engineered nanomaterial. The study determined that the majority of the safety data sheets obtained in 2010-2011 provided insufficient data for communicating the potential hazards of engineered nanomaterials.
   
• In a paper published in June, NIOSH researchers scrutinize the “oxidative stress paradigm,” a widely accepted scientific model for understanding the processes that in general are associated with cellular damage, to better understand the processes that can occur from reactions to nanoparticles. The answer to this question will have important ramifications for the development of strategies for mitigation of potential adverse effects of nanoparticles.
   
• Recent findings indicating that improperly designed, maintained, or installed engineering controls may not be completely effective in controlling releases of nanomaterials into the workplace. Unprotected skin exposure to carbon nanofibers was noted in two instances and indicated the need for educating workers on the use of personal protective equipment.
   
• A summary of emission data collected at four facilities that volunteered to serve as test sites. The measurements indicated that specific tasks can release engineered nanomaterials into the workplace atmosphere and that traditional controls such as ventilation can be used to limit exposure. Much research is still needed to understand the impact of nanotechnology on health, and to determine appropriate exposure monitoring and control strategies.

The nanotechnology update is available online.

EC Scientific Committee Releases Guidance On Safety Assessment Of Nanomaterials In Cosmetics: On July 4, 2012, the EC Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to help compliance with the requirements for the safety assessment of nanomaterials intended for use in cosmetic products. The Guidance describes the need for special considerations in relation to the safety of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from the conventional form of the same materials. The Guidance includes the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients, i.e., general safety considerations, material characterization, exposure assessment, hazard identification and dose-response characterization, and risk assessment. The Guidance notes that the Cosmetics Regulation No 1223/2009 defines nanomaterial as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm,” and that this definition could be revised in light of the EC’s October 2011 Recommendation on the definition of a nanomaterial. According to the Guidance, if the Cosmetics Regulation definition were aligned to the Recommendation, it would provide further information on whether a material falls under the definition of a nanomaterial. The guidance is available online.

EPA Opens Registration Review Docket For Nanosilver: On July 6, 2012, EPA announced the establishment of a registration review docket for nanosilver. 77 Fed. Reg. 40048. Registration review dockets include information intended to assist the public in understanding the types of information and issues that EPA may consider during the course of registration reviews. According to the preliminary work plan, EPA has information that there are silver-based pesticide products that were registered without the registrant disclosing to EPA the presence or characteristics of the nanosilver in their products. EPA sent a letter in August 2009 to each registrant with silver-based products requesting a statement as to whether their products contained any amount of silver in any form having a dimension that measures between 1 and approximately 100 nanometers. Four registrants responded that their products, which were registered using data for conventional silver, contain nanosilver. In the preliminary work plan, EPA states it is identifying several other products, registered using data for silver chloride, as potentially containing nanosilver. The registration review for nanosilver includes these products, as well as the two HeiQ nanosilver products conditionally registered in December 2011. With the exception of the HeiQ products, EPA does not have information on the composition of the nanosilver or potential nanosilver in the selected products, and is proposing that the first phase of data submission be focused on determining the characteristics of the silver present in these products. According to EPA, if nanosilver is identified during the first phase of data submission, then the next phase of proposed data submission would be determining the form and concentration of silver released from the products identified to contain nanosilver. If nanosilver is found to be released, then the final phases of data submission will concern health effects, ecological effects, and environmental fate. Comments are due August 19, 2012. The registration review docket for nanosilver is available online.

OECD Issues Recommendations Regarding Inhalation Studies: On July 9, 2012, a group of experts convened by the Organization for Economic Cooperation and Development (OECD) issued recommendations regarding inhalation toxicity test guidelines to detect harm that could result from inhaled, engineered nanoparticles. A summary of the recommendations made by the experts is available online.

BSI Announces Standards Intended To Support The Nanotechnologies Market: The British Standards Institution (BSI) announced on July 9, 2012, the availability of three new standards and the development of a fourth standard intended to help mitigate the risks involved in manufacture and disposal of nanotechnology products. The three new Publicly Available Specifications (PAS) are:

• PAS 134:2012 — Terminology for carbon nanostructures, 2nd edition: Revised to help ensure the use of a consistent language across the disparate industries and technologists involved in this area;
   
• PAS 138:2012 — Guide to the disposal of manufacturing process waste containing manufactured nano-objects: Provides guidance regarding the disposal of manufactured nanomaterials and objects and will support manufacturers and others in making decisions as to the most appropriate way to dispose of their process waste; and
   
• PAS 139:2012 — Detection and characterization of manufactured nano-objects in complex matrices: Provides guidance concerning the detection and characterization of nano-objects and to those who want to understand their impacts on human and environmental health.

Additionally, BSI is developing a fourth PAS:

• PAS 137:2012 — Nanomaterials and nanotechnology-based products — Guide to regulations and standards: Provides guidance for United Kingdom (UK) organizations (including small- and medium-sized enterprises (SME)) by signposting regulation and standards relevant to the importation, manufacture, processing, distribution, and sale of nanomaterials and nanotechnology-based products, thereby assisting organizations in their business development and commercial success.

More information is available online.

OSHA

OSHA Extends Comment Period On 1,3-Butadiene Standard: On July 6, 2012, the Occupational Safety and Health Administration (OSHA) extended the comment period concerning its proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified by the 1,3-Butadiene Standard at 29 C.F.R. § 1910.1051. 77 Fed. Reg. 40087. The 1,3-Butadiene Standard requires employers to monitor employee exposure to 1,3-Butadiene; develop and maintain compliance and exposure goal programs if employee exposures to 1,3-Butadiene are above the Standard’s permissible exposure limits or action level; label respirator filter elements to indicate the date and time it is first installed on the respirator; establish medical surveillance programs to monitor employee health; and to provide employees with information about their exposures and the health effects of exposure to 1,3-Butadiene. OSHA has a particular interest in comments on the following:

• Whether the proposed information collection requirements are necessary for the proper performance of OSHA’s functions, including whether the information is useful;
   
• The accuracy of OSHA’s estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
   
• The quality, utility, and clarity of the information collected; and
   
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

Comments are due on September 4, 2012.

CSB Releases New Safety Video On Inherently Safety Design And Technology: On July 11, 2012, the U.S. Chemical Safety Board (CSB) released a new safety video that examines the concept of inherent safety and its application across industry; “Inherently Safer: The Future of Risk Reduction” stems from the August 28, 2008, explosion that killed two workers and injured eight others at the Bayer CropScience chemical plant in Institute, West Virginia. As a result of ongoing concern regarding the safety of the facility, Congress directed the CSB to commission the National Academy of Sciences (NAS) to study the feasibility of reducing or eliminating the inventory of methyl isocynanate (MIC) stored at the Bayer plant. The NAS study explored how the concept of “Inherent Safety” could be applied at the Bayer facility. The NAS panel noted that the goal of inherently safer design is not only to prevent an accident, but to reduce the consequences of an accident should one occur. The NAS report found that while Bayer and previous owners of the site incorporated some considerations of inherently safer technology, these companies “did not perform systematic and complete inherently safer process assessments on the processes for manufacturing MIC or the carbamate pesticides at the Institute site.” Thus large amounts of MIC, phosgene, and other toxic materials were produced or stored at the site for decades. The video discusses the four main components of inherently safer design as identified by the NAS study. They are substitute, minimize, moderate and simplify and are described as:

• Substitute: replacing one material with another that is less hazardous.
   
• Minimize: reducing the amount of hazardous material in the process.
   
• Moderate: using less hazardous process conditions such as lower pressures or temperatures.
   
• Simplify: designing processes to be less complicated, and therefore less prone to failure.

The eleven-minute video features interviews with NAS panel members and staff as well as commentary from the CSB Chair and investigators. The video is available to stream or download on www.CSB.gov and may be viewed on the CSB’s YouTube channel, USCSB. DVD copies of the CSB’s safety videos can be requested by completing the online request form available online.

CSB Releases 2012 – 2016 Strategic Plan: On July 12, 2012, the CSB released its 2012 – 2016 Chemical Safety Board Strategic Plan. The plan is an update of the 2007 – 2012 Chemical Safety Board Strategic Plan, and includes the CSB’s strategic goals, strategic objectives, and associated measures for managing and evaluating agency operations. The CSB’s updated strategic plan was developed by interviewing stakeholders in industry, academia, and other government agencies, as well as considering public comment, which was submitted to the Board for review. As a result, the final version of the plan includes a CSB Most Wanted Program that will allow the CSB to focus on outreach initiatives surrounding key CSB recommendations. In addition, there are measurable objectives and the final plan focuses on three main goals: Goal 1 — Conduct incident investigations and safety studies concerning releases of hazardous chemical substances; Goal 2 — Improve safety and environmental protection by ensuring that CSB recommendations are implemented and by broadly disseminating CSB findings through advocacy and outreach; and Goal 3 — Preserve the public trust by maintaining and improving organizational excellence. The strategic plan was approved unanimously by CSB board members and is available online.

REACH

European Chemicals Agency Proposes To Ban Ten Substances: On June 20, 2012, the European Chemicals Agency (ECHA) requested public comment on proposals to ban ten substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The substances have been prioritized for potential bans from the REACH candidate list of substances of very high concern (SVHC), which are chemicals that have been identified as particularly hazardous. The candidate list contains 84 entries. The ten substances slated for a ban are 1,2-dichloroethane, 2,2′-dichloro-4,4′-methylenedianiline, arsenic acid, bis(2-methoxyethyl) ether (diglyme), dichromium tris(chromate), formaldehyde, N,N-dimethylacetamide, pentazinc chromate octahydroxide, potassium hydroxyoctaoxodizincatedichromate, and strontium chromate. Comments are due by September 19, 2012. The ECHA consultation on ten substances to be recommended for phaseout under REACH is available online.

ECHA Adds Eight Chemicals To SVHC List: On June 18, 2012, ECHA confirmed the addition of eight chemicals to the REACH candidate list of SVHCs. The substances are all classified in the European Union (EU) as carcinogenic, mutagenic, or reprotoxic. According to ECHA, a public consultation produced no comments opposing the listings. The substances are: 1,2-bis(2-methoxyethoxy)ethane; 1,2-dimethoxyethane (or ethylene glycol dimethyl ether); 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-( 1H,3H,5H)-trione (ß-TGIC); 1,3,5-tris(oxiran-2-ylmethyl)-1,3,5-triazin ane-2,4,6-trione; 4,4′-bis(dimethylamino)benzophenone; formamide; lead(II) bis(methanesulfonate); and N,N,N’,N’-tetramethyl-4,4′-methylenedianili ne. Inclusion of the chemicals on the SVHC list triggers consultations and studies that could lead to a ban on the sale of the substances in the EU. Companies using the substances in their products in volumes above 0.1 percent by weight must notify ECHA by December 17, 2012. ECHA stated the substances had been listed alongside five others, the identities of which were disclosed on June 12, 2012: 4,4′-bis(dimethylamino)-4″-(methylamino)tri tyl alcohol; C.I. Basic Violet 3; C.I. Basic Blue 26; C.I. Solvent Blue 4; and diboron trioxide. The SVHC list now contains 84 substances. ECHA said four entries in the list had been consolidated into two, covering aluminosilicate refractory ceramic fibers and zirconia aluminosilicate refractory ceramic fibers. The candidate list of substances that could be banned under REACH is available online.

LEGISLATIVE DEVELOPMENTS

House Republicans Propose Deep Cuts To EPA FY 2013 Budget: On June 28, 2012, the House Appropriations Committee approved a FY 2013 spending bill with deep cuts to EPA’s budget. The bill slashes EPA’s funding by $1.4 billion, about 17 percent, compared to current funding. The cuts would be made mostly to state revolving funds for clean water and drinking water and state and tribal grant programs. If enacted, these cuts could bring EPA’s funding to below FY 1998 levels. It would cap EPA’s employee levels to 1992 staffing levels, cut funding for the EPA Administrator’s office by a third, and gut funding by 50 percent for EPA’s congressional affairs office. It also contains numerous riders that would block pending EPA regulations. Because the bill deviates from the August debt-ceiling agreement with the White House, President Obama has pledged to veto it. The standoff means that FY 2013 spending bills are not likely to be resolved by the end of the FY on September 30. Last year, most of the 12 annual bills were wrapped into a giant omnibus bill that was rammed through Congress in December.

Senate Rejects Measure To Curb EPA’s Utility MACT Rule: On June 20, 2012, the Senate defeated a resolution that would have essentially scrapped EPA’s Maximum Achievable Control Technology (MACT) rule for the utility industry. Senators voted 53-46 to defeat a motion to proceed on S. J. Res. 37, Senator James Inhofe’s (R-OK) Congressional Review Act resolution to kill the MACT rule. Senator Inhofe promised to continue his efforts, saying that “[o]ur fight is not over: we will continue to do everything possible to expose what the Obama EPA’s damaging regulatory regime will do to destroy jobs and weaken our economy.” Republicans likely will attempt to translate this legislative defeat into a political victory by bashing vulnerable Senate Democrats who voted to uphold the EPA rule. GOP candidates gunning to take down Democrats, which include Senators Claire McCaskill (MO), Sherrod Brown (OH), Bob Casey, Jr. (PA), and Jon Tester (MT) quickly took aim at the lawmakers’ votes to maintain rules that Republicans call economically harmful.

Senate Committee Holds Hearing On EPA’s Oil And Gas Air Rules: The Senate Environment and Public Works (EPW) Committee on June 19, 2012, held a hearing on EPA’s pending regulations establishing air standards for the oil and gas drilling industry. A focus of the hearing was EPA’s cost-benefit analysis and the emissions data EPA relied upon to establish emission limits for the industry sector. Gina McCarthy, EPA’s Assistant Administrator of Air and Radiation, spent much of her time before the Committee defending EPA’s approach from attacks by Republicans on the Committee, downplaying concerns that EPA overestimated methane and conventional pollutants emitted by the sector and used that data to set unnecessarily strict emissions limits. Assistant Administrator McCarthy touted the benefits in avoided health care costs EPA predicts will occur due to the rules, including reduced cancer risks from cuts in air toxics. But Senator John Barrasso (R-WY), ranking member of the EPW Clean Air Subcommittee, criticized EPA’s analysis, saying it “underestimates costs, overestimates benefits, and there are not really any saved health care costs.”

House Passes Energy Bill That Would Delay EPA Rules: House Republicans, defying another Presidential veto threat, on June 21, 2012, passed a broad energy package intended to accelerate oil and gas drilling. The bill would also delay EPA rules setting air pollution limits on the oil and gas drilling sector. By a vote of 248-163, the House easily passed the Strategic Energy Production Act of 2012 (H.R. 4480). The legislation is an amalgam of several environmental and energy measures previously passed out of the House Energy and Commerce Committee and Natural Resources Committee. The bill would force the Obama Administration to increase oil and gas leasing on federal lands if it draws oil from the Strategic Petroleum Reserve. The legislation also includes the Gasoline Regulations Act, which requires a cumulative analysis of the fuel price impacts from several EPA regulations — including upcoming Tier III fuels rules, refinery controls, and stricter ozone national ambient air quality standards (NAAQS) — before they can take effect. It would also amend the Clean Air Act and allow EPA to consider costs when revising NAAQS. Currently, EPA can only consider public health impacts when establishing or revising NAAQS. President Obama has pledged to veto the legislation.

House Subcommittee Holds Hearing On OSHA VPP: On June 28, 2012, the House Education and Workforce Subcommittee on Workforce Protection held a hearing on OSHA’s Voluntary Protection Program (VPP). Testifying before the Subcommittee were: Jordan Barab, Deputy Assistant Secretary of Labor for OSHA; Rob Henson, Process Technician with LyondellBasell; Dr. David I. Levine, UC Berkeley; Mike Lee, General Manager, Nucor Steel; and R. Davis Layne, Executive Director, Voluntary Protection Programs Participants’ Association (VPPPA). Their testimony can be viewed online. The witnesses largely praised VPP’s ability to help reduce injuries and illnesses, improve safety culture and cut costs for employers, but they also stressed the importance of oversight, accountability, and program integrity. In his opening statement, Subcommittee Chair Tim Walberg (R-MI) praised VPPs but added “VPP is not without its weaknesses” and referenced a 2009 GAO report that criticized OSHA’s oversight of the program. Mr. Barab responded that OSHA has worked to address many of the concerns in GAO’s report, and that OSHA must focus on the integrity and quality of VPP. Mr. Layne testified that VPP can prompt a culture change within participating sites, reduce injuries and illnesses, and help employees feel more valued and more likely to look out for the well-being of their peers. Dr. Levine, a professor of the Haas School of Business at the University of California Berkeley, was asked to testify largely based upon a recent study he co-authored that found OSHA inspections reduce occupational injuries and their associated costs without negatively impacting company performance or profits. He testified that “[t]he inspections we studied did what they were supposed to do. They reduced the number of injuries by 9 percent and reduced the cost of those injuries [in terms of workers’ compensation costs] by 26 percent.” Mike Lee, Vice President and General Manager of Nucor Steel Decatur, testified that a safer workplace means healthier employees and better morale. Nucor Steel has 20 VPP sites.

Surface Transportation Bill Signed: The bill, introduced on April 16, 2012, by Representative John Mica (R-FL), has become Public Law 112-141. Title VI of the new law deals with environmental streamlining. Among other provisions, it declares Congressional policy that it is in the national interest to expedite the delivery of surface transportation projects by substantially reducing the length of the environmental review process for such projects. To facilitate the needed reduction in time, the law exempts from further environmental reviews, approvals, licensing, and permit requirements under specified laws any road, highway, or bridge in operation or under construction that is damaged by an emergency disaster and reconstructed in the same location with the same dimensions and design as before the disaster. Other features include authorizing a state (at its own expense) to acquire real property interests for an approved surface transportation project before the completion of the environmental review process under the National Environmental Policy Act (NEPA) for the project without affecting subsequent project approval by the state or any federal agency. Further, the legislation authorizes the Secretary to use federal funds for a state’s early acquisition of real property interests for a surface transportation project and authorizes a state (at its own expense) to carry out design activities for a project before completion of the review process for such project under NEPA without affecting subsequent project approvals. Reimbursement of design costs to the state is also authorized, provided certain conditions are met. There are sections for revision of competitive bidding requirements for contracts for the construction of surface transportation projects, and repeal of the prohibition against commencement of the final design of a surface transportation project under a design-build contract before compliance with certain NEPA requirements.

FDA Reform Bill Signed: On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (Pub. Law No. 112-144). As previously reported in the legislative developments section of the June Update, the act amends the Federal Food, Drug, and Cosmetic Act (Act) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. The new law makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations and permits the FDA to change a classification of a medical device through an administrative order rather than by regulation. Other provisions include an expansion of reporting requirements for manufacturers of prescription drugs and incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period; and (2) eligibility for priority and fast track review. Two more provisions are the requirement for the FDA to expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and the inclusion of a risk-benefit analysis in the regulatory decision-making process for prescription drugs. The measure amends the Orphan Drug Act to extend through FY2017 the authorization of appropriations for grants and contracts for development of drugs for rare diseases and conditions and revises requirements for the reporting by drug manufacturers to FDA of a discontinuance or interruption in the production of life saving drugs. The new legislation directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH); and (5) develop and implement strategies to solicit patient participation in the medical product development process. The bill further directs the Secretary to “intensify and expand” its activities related to enhancing scientific knowledge regarding nanomaterials to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems.

Senate Committee Holds Hearing On Lead’s Impacts On Children’s Development And Public Health: On July 12, 2012, the Senate EPW Committee held a hearing entitled “The Latest Science on Lead’s Impacts on Children’s Development and Public Health.” The catalyst for the hearing was the recent USA Today series of articles on lead contamination around “legacy” lead smelting sites. The intent of the hearing was to gain a better understanding from the Centers for Disease Control and Prevention (CDC) and EPA on the sources and impact of lead on children. Committee Chair Senator Barbara Boxer (D-CA) opened the hearing by stating that the CDC blood lead level is currently set at 5 micrograms per deciliter (µg/dL), which is half of the 1991 level. She implied that even though this level was recently lowered, it may not be protective enough, emphasizing that the science now shows that no level of lead in the blood of children can be considered safe and that even low levels can have harmful effects.

Senator Frank Lautenberg (D-NJ) referred to the recent USA Today report on lead exposure in a New Jersey neighborhood near a smelting plant that closed in the 1980s and claimed that it was a “moral outrage” that the neighborhood soils still contain dangerous levels of lead. Witnesses included Dr. Christopher Portier, Director of the National Center for Environmental Health at the CDC and the Agency for Toxic Substances and Disease Registery, and Dr. John Vandenberg, Director of EPA’s NCEA in the ORD.

Senator Boxer called upon the members of the press present to let the public know that there is no safe level of lead in children’s blood. She stated that the issues related to lead exposure are not complicated or debatable. She stressed that the worst impacts are not reversible but that there are chances to minimize or remove exposure. Senator Boxer ended the hearing by stating that lead exposure is a national problem and that “we need to do everything we can to protect people” from lead exposure and that “this committee is going to stand very tall on this issue.” Witness statements are available online.

MISCELLANEOUS

EPA Activities To Promote Environmental Justice In The Permit Application Process: On June 26, 2012, EPA requested comment as part of its ongoing efforts under Plan Environmental Justice (EJ) 2014 to integrate environmental justice into all of its programs, on ways that EPA and permit applicants can meaningfully engage communities in the permitting process. 77 Fed. Reg. 38051. The notice describes and seeks comment on actions that EPA regional offices can take when issuing EPA permits to promote greater participation in the permitting process by communities that have historically been underrepresented in that process. The notice also announces the availability of draft best practices for permit applicants seeking EPA-issued permits (located in the appendix to the notice). The best practices are designed to encourage and assist permit applicants to reach out to neighboring communities when applying for permits that may affect the community’s quality of life, including their health and environment. Written comments must be received on or before August 27, 2012.

EC Publishes Third ATP To CLP Annex VI: The EC published the third adaptation to technical progress (ATP) of the EU’s Classification, Labeling, and Packaging of Substances and Mixtures (CLP) Regulation in the July 11, 2012, Official Journal of the European Union. The third ATP amends Annex VI to include updated classifications for substances already subject to those harmonized classifications and to include new harmonized classifications. The third ATP enters into force on July 31, 2012, and will apply on December 1, 2013, but may be applied voluntarily before that date. Updated classifications are included for trisodium hexafluoroaluminate, 2-ethoxyethanol, tetrahydrofuran, fuberidazole, and di-tert-butyl peroxide. New harmonized classifications are included for tris[2-chloro-1-chloromethyl)ethyl] phosphate, indium phosphide, trixylyl phosphate, tris(nonylphenyl) phosphite, diphenyl (2,4,6- trimethylbenzoyl)phosphine oxide, hexabromocyclododecane, abamectin (combination of avermectin B1a and avermectin B1b), acequinocyl, 4-tert-butylbenzoic acid, leucomalachite green, and metazachlor. The third ATP is available online.

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