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August 1, 2013

Monthly Update for August 2013

Bergeson & Campbell, P.C.

TSCA/FIFRA/EPCRA/IRIS

EPA Issues Direct Final Rule Adopting 2012 North American Industry Classification System (NAICS) Codes For TRI Reporting: On July 18, 2013, the U.S. Environmental Protection Agency (EPA) issued a direct final rule adopting the list of NAICS codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget (OMB) 2012 NAICS revisions. 78 Fed. Reg. 42875. The rule will be effective on October 16, 2013, unless adverse comment is submitted by August 19, 2013. Facilities would be required to use 2012 NAICS codes when reporting to TRI beginning with TRI reporting forms that are due on July 1, 2014, covering releases and other waste management quantities for the 2013 calendar year. EPA issued a proposed rule on the same day. 78 Fed. Reg. 42910. Comments are due August 19, 2013.

EPA Strengthens Chemical Assessment Process To Protect Public Health: On July 31, 2013, EPA announced changes to its Integrated Risk Information System (IRIS) Program that, according to EPA, will improve the scientific foundation of assessments, increase transparency, and allow EPA to produce more IRIS assessments each year. IRIS is a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants. These assessments are widely used and relied upon to inform decisions to protect public health and the environment. Consistent with recommendations from the National Research Council, EPA will now begin releasing preliminary materials and hold a public meeting early in the assessment development process to explain the criteria for selecting studies and to ensure that critical research was not omitted. Meeting with the public earlier in the process will result in more timely opportunities for the public to provide input into the assessment and comment on the information available for each chemical assessed. EPA is also using a new document structure for IRIS assessments that is clearer, more concise, and more systematic to make the information more accessible. To improve transparency, EPA is enhancing the IRIS website by providing more detailed information regarding assessment schedules, stakeholder meetings, and updates on IRIS progress. Additionally, EPA is implementing “stopping rules” for IRIS that will provide a cut-off point for accepting new data for individual IRIS assessments and raising scientific issues related to the assessment. With these changes, EPA’s goal is to increase the number of assessments being completed each year and provide more accurate assessment development timelines to the public. More information about IRIS is available at www.epa.gov/iris. More information about the IRIS process is available at www.epa.gov/iris/process.htm.

EPA Denies Petition To Ban HFSA: On August 12, 2013, EPA announced its decision to deny a petition asking it to ban the use of hydrofluorosilicic acid (HFSA). 78 Fed. Reg. 48845. The petition was filed by a group of American University students, alumni, and faculty to ban the use of HFSA to fluoridate drinking water under Toxic Substances Control Act (TSCA) Section 6. According to the petition, the chemical introduces arsenic, lead, and radionuclides into drinking water and is a “waste by-product” of the phosphate fertilizer manufacturing industry.

EPA Releases Draft Ethylene Oxide IRIS Review: On July 23, 2013, EPA released its draft IRIS carcinogenicity assessment for ethylene oxide and the draft peer review charge questions. 78 Fed. Reg. 44117. Comment on the review is due by September 5, 2013.

IRIS Office Announces Meeting Schedule: On August 9, 2013, EPA’s IRIS Program announced public meetings for calendar years 2013 and 2014 to obtain public input at specific stages in the process of developing an IRIS assessment. 78 Fed. Reg. 48674. EPA also announced the availability of preliminary materials for three chemicals, tert-butyl alcohol (tert-butanol), ethyl-tert-butyl ether (ETBE), and hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX), which will be discussed at the first public meeting scheduled for October 23-24, 2013. The preliminary materials for tert-butanol and ETBE are posted on the IRIS website, and the preliminary materials for RDX will be posted before the meeting. The 2013 and 2014 IRIS public meetings will be held on the following dates: December 12-13, 2013; February 26-27, 2014; April 23-24, 2014; June 25-26, 2014; September 3-4, 2014; October 29-30, 2014; and December 15-16, 2014. Please consult the Federal Register for more details.

ITC Issues Seventy-Second Report: On July 24, 2013, the TSCA Interagency Testing Committee (ITC) transmitted its 72nd ITC Report to the EPA Administrator. 78 Fed. Reg. 44858. In the 72nd ITC Report, the ITC revised the TSCA Section 4(e) Priority Testing List by removing 16 chemicals with insufficient dermal absorption rate data, 98 High Production Volume (HPV) Challenge Program orphan chemicals, and 50 diisocyanates and related compounds. The ITC removed 16 chemicals with insufficient dermal absorption rate data because information from dermal studies can be readily obtained through the Organization for Economic Cooperation and Development (OECD) and EPA databases or other authoritative scientific resources. The ITC removed the 98 HPV Challenge Program orphan chemicals because they no longer meet the ≥1 million pound criterion for the HPV Challenge Program. The ITC also removed the 50 diisocyanates and related compounds because their production or importation volumes were not reported to the 2006 Inventory Update Reporting (IUR) rule or the 2012 Chemical Data Reporting (CDR) rule. Comments must be received on or before August 23, 2013.

EPA Expands List Of Safer Chemical Ingredients: On July 24, 2103, EPA added over 130 chemicals to its Safer Chemical Ingredients List. For the first time, 119 chemicals that use fragrance for commercial and consumer cleaning products have been added to the list. The Safer Chemical Ingredients List, which now contains 602 chemicals, serves as a resource for manufacturers interested in making safer products; health and environmental advocates seeking to encourage the use of safer chemicals; and consumers seeking information on the ingredients in safer chemical products. It also serves as a guide for Design for the Environment (DfE) labeled products, which must meet EPA’s rigorous, scientific standards for protecting human health and the environment. More than 2,500 products are certified under the DfE Standard for Safer Products, including all-purpose cleaners, laundry and dishwasher detergents, window cleaners, car and boat care, and many other products. Using DfE-certified products significantly reduces exposures to chemicals, which helps protect families and the environment. The Safer Chemical Ingredients list was created in September 2012 and EPA continues to update the list with additional fragrances and chemicals. More information on the Safer Chemical Ingredients List is available online.

EPA Releases TRI 2012 Data: On July 25, 2013, EPA released the raw TRI data submitted for calendar year 2012. EPA’s analysis of these data will be available in October, and a final report published in December. The preliminary raw data for individual facilities are available online.

Groups Appeal TSCA Decision Precluding EPA Regulation Of Lead Bullets: On July 24, 2013, environmental groups appealed the dismissal of their lawsuit seeking to force EPA to regulate lead bullets under TSCA. Trumpeter Swan Society v. EPA, D.C. Cir., No. 13-05228. The groups, which include the Center for Biological Diversity and six other groups, appealed a May 23, 2013, federal district court ruling to the U.S. Court of Appeals for the District of Columbia. Judge Emmet Sullivan of the U.S. District Court for the District of Columbia concluded in a bench ruling that EPA lacked authority to regulate lead bullets under TSCA, as EPA had argued during court proceedings. EPA previously rejected two petitions from environmental groups to initiate a rulemaking on the issue of the lead bullets and shot.

OSHA

U.S. Chemical Safety Board Deems OSHA Responses To Recommendations Are “Unacceptable”: In a July 25, 2013, public meeting, members of the U.S. Chemical Safety Board (CSB) deemed “unacceptable” the responses by the Occupational Safety and Health Administration (OSHA) to seven longstanding recommendations on combustible dust, fuel gas, and the Process Safety Management (PSM) Standard. CSB also voted to make the adoption of a combustible dust standard for general industry to be the first priority in the CSB’s recently established “Most Wanted Safety Improvements” program.

Wal-Mart Signs Corporate-Wide Settlement Agreement To Resolve OSHA Violations: OSHA announced on August 7, 2013, that Wal-Mart Stores, Inc. (Wal-Mart) has entered into a corporate-wide settlement agreement with the U.S. Department of Labor (DOL) to improve safety and health conditions in all 2,857 Wal-Mart and Sam’s Club stores under federal jurisdiction. The settlement resolves two enforcement cases that began in 2011, and includes provisions for the retailer to enhance safety and health practices and training related to trash compactors, cleaning chemicals, and hazard communications corporate-wide. Under the settlement, trash compactors must remain locked while not in use, and may not be operated except under the supervision of a trained manager or other trained, designated monitor. Wal-Mart will also improve its hazard communications training and, for cleaning chemicals, will enhance its procedures to ensure that employees do not handle undiluted chemicals. The company must also ensure that a protective protocol is in place in case of any malfunctions with a store’s cleaning chemicals dispensing equipment. Wal-Mart will ensure employees are trained on the new procedures in a language, format, and vocabulary that the workers can understand. The settlement agreement is available online.

RCRA

EPA Reduces Regulatory Burden For Industrial Facilities Using Solvent Wipes: On July 31, 2013, EPA issued a final rule easing the hazardous waste management regulations under the Resource Conservation and Recovery Act (RCRA). 78 Fed. Reg. 46448. The final rule includes conditional exemptions for solvent-contaminated wipes, provided that businesses clean or dispose of them properly. The rule is based on EPA’s final risk analysis, which was peer reviewed in 2008 and published for public comment in 2009, that concluded wipes contaminated with certain hazardous solvents do not pose significant risk to human health and the environment when managed properly. EPA estimates that the final rule will result in a net savings of between $21.7 million and $27.8 million per year. The final rule excludes wipes that are contaminated with solvents listed as hazardous wastes under RCRA that are cleaned or disposed of properly. To be excluded, solvent-contaminated wipes must be managed in closed, labeled containers and cannot contain free liquids when sent for cleaning or disposal. Additionally, facilities that generate solvent-contaminated wipes must comply with certain recordkeeping requirements and may not accumulate wipes for longer than 180 days. EPA estimates that the final rule will result in a net savings of $18 million per year in avoided regulatory costs and between $3.7 million and $9.9 million per year in other expected benefits, including pollution prevention, waste minimization, and fire prevention benefits. More information about this rulemaking is available online. The rule is effective January 31, 2014.

NANOTECHNOLOGY

EC Committee Documents On Zinc Oxide And Titanium Dioxide Available For Comment: On July 26, 2013, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two documents for comment. The SCCS addendum to its opinion on zinc oxide (nano form) is available online. The SCCS opinion on titanium dioxide (nano form) is available online. Comments on both documents are due September 6, 2013.

ANSI Nanotechnology Standards Panel Launches Standards Database: On July 29, 2013, the American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) announced the launch of a new database compiling information concerning nanotechnology-related standards and affiliated activities. According to ANSI-NSP, the database is part of a larger effort by ANSI-NSP and its members and partners to increase the visibility of existing and in-development nanomaterials and nanotechnology guidance documents, reference materials, and standards. The database, which does not directly host the standards and other materials, is a free resource that provides information about standards and other relevant documents related to nanomaterials and nanotechnology-related products and processes. ANSI-NSP encourages standards-developing organizations, government bodies, and other relevant organizations to contribute information about their documents and standards. The database is available at nanostandards.ansi.org.

Particle and Fibre Toxicology Publishes MWCNT Inhalation Study Online: On July 30, 2013, Particle and Fibre Toxicology published a study entitled “Distribution and fibrotic response following inhalation exposure to multi-walled carbon nanotubes.” In the study, the authors tested the hypothesis that inhalation exposure to multi-walled carbon nanotubes (MWCNT) produces a fibrotic response and that the response is chronically persistent. Male C57BL/6 J mice were exposed in a whole-body inhalation system to a MWCNT aerosol, and the authors examined the fibrotic response in the alveolar region at up to 336 days after termination of exposure. The conclusion states: “Despite the relatively low fraction of the lung burden being delivered to the alveolar tissue, the average thickness of connective tissue in the alveolar region increased by 70% in the 336 days after inhalation exposure. These results demonstrate that inhaled MWCNTs deposit and are retained within the alveolar tissue where they produce a progressive and persistent fibrotic response up to 336 days post-exposure.” While a number of the authors are affiliated with the National Institute for Occupational Safety and Health (NIOSH), the study includes a disclaimer that the findings and conclusions are those of the authors and do not necessarily represent the views of NIOSH. The abstract is available online.

EPA Promulgates SNURs For Two Carbon Nanotube Substances: On August 7, 2013, EPA promulgated significant new use rules (SNUR) through a direct final rule for 53 chemical substances that were the subject of premanufacture notices (PMN), including two PMN substances whose reported chemical names include the term “carbon nanotube” (CNT). 78 Fed. Reg. 48051. Seven of the chemical substances, including the CNT substances, are subject to consent orders under TSCA Section 5(e). Persons who intend to manufacture or process any of the 53 chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The SNURs are effective October 7, 2013. Written adverse or critical comments, or notices of intent to submit adverse or critical comments, are due September 6, 2013. If EPA receives written adverse or critical comments, or notices of intent to submit adverse or critical comments, it will withdraw the relevant SNUR(s) before the effective date.

Lynn L. Bergeson Co-Authors Article On Use Of Alternative Test Strategies For Nanomaterial Safety Assessment: ACS Nano has published an article entitled “A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment,” which is co-authored by Lynn L. Bergeson. The article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test strategies (ATS) for decision-making analyses of engineered nanomaterials (ENM). After discussions, participants generated a short list of generally shared viewpoints, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. The article is available for purchase online. The article is available for purchase online.

NNI Will Hold Workshop On Stakeholder Perspectives On The Perception, Assessment, And Management Of The Potential Risks Of Nanotechnology: The National Nanotechnology Initiative (NNI) will hold a September 10-11, 2013, workshop concerning “Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology.” NNI is holding the workshop to facilitate stakeholder discussion of key elements needed to assess, manage, and communicate potential risks associated with use of nanomaterials and nanotechnology-enabled products, including:

  • Understanding of the state of practice for the consideration of risk used by industry, academia, and the general public;
     
  • Analysis of the role of comparative risk assessment in these evaluations, including decision analysis tools and gap analysis tools;
     
  • Identification, through case study presentations, of stakeholder values and risk perceptions that inform their decision making, and the potential integration of these values and perceptions into a practical framework for risk communication;
     
  • Current risk management practices in the emerging technology communities; and
     
  • Determination of steps to improve the linkage of risk assessment to risk management and risk communication.

The workshop will include three roundtable discussions on: the perspectives and needs of (1) small businesses and (2) large enterprises, both pertaining to the responsible development of nanotechnology, as well as a roundtable on (3) public risk perception and communication. NNI invites interested members of the general public and NNI stakeholders, including representatives from academia, industry, small business, non-governmental organizations, and government to attend. Registration is free and on a first-come, first-served basis. The main sessions will be webcast. More information is available online.

REACH

ECHA Issues Plan To Improve Chemical End Users Information: On July 17, 2013, the European Chemicals Agency (ECHA) published a 21-point plan of actions through 2018 to improve the quality and clarity of information provided to chemical users by registrants that submit dossiers under the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) law. The plan is available online. The action plan addresses key issues for “improving the quality of REACH exposure scenarios to ensure the safe use of chemicals in Europe,” according to ECHA. ECHA reports that companies can commit to the action plan by signing a charter pledging to support its aims. Action plan goals are to achieve a common understanding on the objectives of communication of chemical safety information; clarify the information needs of users of chemicals; promote standardization of information; help formulators, or producers of mixtures of chemicals, convert substance safe-use information into advice on the safe use of mixtures; and provide mixture safe-use information to professional end-users (for example, on mixtures, such as lubricants, used in industrial processes).

BIOBASED/RENEWABLE PRODUCTS

BRAG™ Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s consulting affiliate, B&C® Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.

EPA Announces Final 2013 Renewable Fuel Standards: On August 6, 2013, EPA signed its belated final rule establishing the 2013 renewable volume obligations (RVO) for the four fuel categories that are part of the federal Renewable Fuel Standard (RFS) Program under the Clean Air Act (CAA): cellulosic biofuel; biomass-based diesel; advanced biofuel; and total renewable fuel. These standards apply to all gasoline and diesel produced or imported in 2013. The final rule will become effective once it is published in the Federal Register. EPA’s final rule and fact sheet are available online. A more detailed memorandum is available online.

LEGISLATIVE DEVELOPMENTS

Senate Confirms Gina McCarthy As EPA Administrator: After four months of bruising and partisan debate and delays, the Senate on July 18, 2013, voted easily (59-40) to confirm Gina McCarthy to lead EPA as its next Administrator. Senators on both sides crossed the aisle to vote on the nomination. GOP Senators Lamar Alexander (TN), Susan Collins (ME), Bob Corker (TN), Jeff Flake (AZ), Kelly Ayotte (NH), and John McCain (AZ) joined Democrats in voting for McCarthy’s confirmation, while Joe Manchin (D-WV) broke ranks with his Democratic colleagues to vote with most Republicans against her nomination. Janet McCabe has stepped in as the Acting Assistant Administrator for Air and Radiation (McCarthy’s previous post), while Acting Administrator Bob Perciasepe will return to his post as Deputy Administrator. McCarthy wasted little time in laying out her priorities. In a July 22, 2013, video message to EPA employees, McCarthy said EPA “has a clear responsibility to act now on climate change,” adding that EPA has broached a “defining time” in its history as it prepares to regulate greenhouse gas emissions from power plants. In anticipation of strong opposition from industry, McCarthy channelled Vince Lombardy and exhorted EPA staff to gird themselves for a tough fight. “This agency has the courage to act. We can make it happen, but we need all hands on deck,” she said.

Senate Judiciary Committee Passes Two Bills Aimed At Curbing Power Of EPA: In two party-line votes, the Senate Judiciary Committee on July 24, 2013, passed two bills that seek to limit EPA’s and other federal agencies’ rulemaking authority. By a 13-9 vote, the Committee passed the Regulatory Accountability Act (H.R. 2122), which would amend the Administrative Procedure Act (APA) to require agencies to base all preliminary and final regulations on evidence and to consider the legal authority under which a rule may be proposed, the specific nature and significance of the problem the agency may address with the rule, any reasonable alternatives for the rule, and the potential costs and benefits associated with such alternatives. It would also require agencies to publish advance notice of proposed rulemakings for major rules and for high-impact rules (rules having an annual cost on the economy of $100 million or $1 billion or more, respectively) and for rules that involve a novel legal or policy issue arising out of statutory mandates. Also, the bill establishes criteria agencies must follow when issuing major guidance documents, defined as guidance that is likely to lead to an annual cost on the economy of $100 million or more, a major increase in cost or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or ability to compete. Under the bill, judicial review of rules is expanded and accelerated. It would allow immediate judicial review of agency rulemaking that is not in compliance with notice requirements set forth in the bill. The Committee also passed the Regulatory Decrees and Settlements Act (H.R. 1493). This bill seeks to end the so-called “sue and settle” tactics where a private party sues a federal agency on the grounds that the agency has failed to meet a statutory deadline, prompting the agency to settle, rather than litigate, the charges. Under the bill, sue and settle decrees would be prohibited until all parties affected by the proposed regulations have the chance to participate in the settlement proceedings.

House Judiciary Committee Passes Bills On NEPA And Regulatory Reviews: On July 31, 2013, the House Judiciary Panel passed the Responsibly and Professionally Invigorating Development (RAPID) Act (H.R. 2641), a bill seeking to streamline reviews of projects under the National Environmental Policy Act (NEPA). The bill would require federal agencies to meet deadlines for reviewing environmental impact statements (EIS) or environmental assessments (EA) under NEPA. It also would prohibit requiring more than one EIS and one EA for a project, except for supplemental environmental documents prepared under NEPA or environmental documents prepared pursuant to a court order. The Committee also passed the Regulatory Flexibility Improvements Act (H.R. 2542), which would require federal agencies to consider the indirect costs their rules would impose upon small businesses.

Protecting States’ Rights To Promote American Energy Security Act: On July 18, 2013, Representative Bill Flores (R-TX) introduced legislation intended to blunt the authority of EPA and other federal agencies in regulating hydraulic fracturing or “fracking.” The Protecting States’ Rights To Promote American Energy Security Act (H.R. 2728) would amend the Mineral Leasing Act of 1920 to block the Department of the Interior (DOI) from enforcing any federal regulation, guidance, or permit requirement regarding hydraulic fracturing, or any component of that process, relating to oil, gas, or geothermal production activities on or under any land in any state that has regulations, guidance, or permit requirements for fracking. It also would require DOI to “recognize and defer to State regulations, permitting, and guidance, for all activities related to hydraulic fracturing . . . relating to oil, gas, or geothermal production activities on Federal land regardless of whether those rules are duplicative, more or less restrictive, shall have different requirements, or do not meet Federal guidelines.” The House Natural Resources Committee on July 31, 2013, approved the bill. On a mostly party-line vote of 23-15, the panel sent the measure to the full House of Representatives, which is expected to debate the legislation later this year. Representative Jim Costa (D-CA) bucked Democratic colleagues in supporting the bill; Representative Jon Runyan (R-NJ) broke with Republicans to vote against it.

House Places EPA Budget On Chopping Block: EPA remains firmly in the sights of GOP leaders, as House Republicans on July 22, 2013, unveiled an appropriations measure that would cut to the bone EPA’s fiscal year (FY) 2014 funding by slashing more than one-third of EPA’s budget. The bill would concurrently block EPA from regulating greenhouse gas emissions from power plants. Republican lawmakers would cleave $2.8 billion from EPA’s FY 2014 coffers, a cut that is twice as deep as the 17 percent reduction proposed last year by the House GOP. Other controversial EPA rules would also be “defunded” by the legislation, including new source performance standards under the CAA, changes to the definition of “navigable waters” under the Clean Water Act (CWA), and financial assurance requirements for hard rock mining. Also blocked would be EPA’s Tier 3 rules, which will require petroleum refiners to reduce the sulfur content of gasoline. On July 23, 2013, the Appropriations Subcommittee on Interior, Environment, and Related Agencies, on a 7-4 party-line vote, passed the measure. The House Appropriations Committee began markup of the bill on July 31, but the next day tabled further action on the measure until they return from the August recess. This leaves a narrow window of just nine days for lawmakers to pass the measure before EPA’s FY 2013 funding expires at the end of September, although it is likely that Congress will pass a short-term Continuing Resolution (CR) to keep the government funding. Compounding the difficulties, however, is the fact that the Senate EPA funding bill actually increases its funding by about $600 million. Senate and House conferees on the measure thus will be starting at opposite ends of the funding debate on the measure.

House Passes Energy Consumers Relief Act; White House Wields Veto Threat: Before leaving town for the August recess, the House passed the Energy Consumers Relief Act (H.R. 1582) by a 232-181 vote on August 1, 2013, despite a veto threat by President Obama. The legislation, authored by Representative Bill Cassidy (R-LA), is intended to put greater interagency checks and balances on EPA and prevent costly regulations that threaten to destroy jobs and increase energy prices. It requires that before EPA finalizes any new energy-related rules estimated to cost more than $1 billion, EPA must submit a report to Congress detailing certain cost, benefit, energy price, and job impacts, and the Secretary of Energy, in consultation with other relevant agencies, must make a determination regarding the impacts of the rule. EPA would be prohibited from finalizing certain rules if they are determined to cause significant adverse effects to the economy. On July 23, 2013, the White House issued a Statement of Administration Policy vowing to veto H.R. 1582 should it reach the President’s desk. The Administration strongly opposes H.R. 1582, the statement said. The bill would require the Department of Energy (DOE) to undertake “duplicative, costly, and time consuming reviews of energy-related EPA rules, thereby delaying or permanently preventing EPA from fulfilling its legal obligations to protect public health and the environment,” the White House cautioned. Noting that existing law already requires agencies to submit cost-benefit analysis to Congress of any rule costing over $100 million annually, the statement said that H.R. 1582 would require agencies to waste limited analytical resources on a duplicative analysis.

Lawmakers adopted several amendments during floor debate on the measure. Most prominently, they voted 234-178 in favour of Representative Tim Murphy’s (R-PA) amendment to prevent EPA from factoring the “social cost of carbon” into rules unless a federal law is enacted that allows its consideration. Fifteen Democrats voted with almost all Republicans for the amendment, while three Republicans opposed it. The amendment vote was the latest scuffle over the recent White House increase in the social cost of carbon, a metric of estimated damages caused by heat-trapping emissions.

House Committee Approves Bill Subjecting Environmental Regulations To Additional Scrutiny: The House Energy and Commerce Committee on July 17, 2013, approved the Natural Gas Pipeline Permitting Reform Act (H.R. 1900) by a vote of 28-14. The bill would amend the Natural Gas Act to direct the Federal Energy Regulatory Commission (FERC) to approve or deny a certificate of public convenience and necessity within 12 months after providing public notice of the permit application for a natural gas pipeline project. It would also require the responsible agency issuing any federal license, permit, or approval regarding the siting, construction, expansion, or operation of a project for which a certificate is sought to approve or deny issuance of the certificate within 90 days after FERC issues its final environmental document regarding the project.

Senate Committee Confirms EPA Nominees; Hold Placed On Water Nominee: On July 23, 2013, the Senate Environment and Public Works (EPW) Committee held a hearing to discuss the nominations of three individuals to fill top slots at EPA: Kenneth Kopocis, nominated to be Assistant Administrator for the Office of Water (who was nominated nearly two years ago), Jim Jones, nominated to be Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), and Avi Garbow, nominated to be EPA General Counsel. While there were no challenges of the records or qualifications of any of the candidates, Republicans on the Committee expressed their concern of EPA’s decision to use guidance instead of rulemaking on some issues pertaining to water, directing a vast majority of their questions at Kopocis. The Committee butted heads over the next steps for the nominations of the three, and there was a palpable feeling of frustration present at the meeting. Both Democratic and Republican Committee members agreed, however, that Jones is an excellent choice for OCSPP, and no objections to his appointment were raised. On July 31, 2013, in a closed session, the Committee approved Jones and Garbow for their nominated positions. A hold, however, has been placed on the Kopocis nomination over Republican concerns about EPA’s attempts to clarify its jurisdiction under the CWA.

Responsible Electronics Recycling Act Introduced: Representatives Gene Green (D-TX) and Mike Thompson (D-CA) on July 24, 2013, introduced the Responsible Electronics Recycling Act of 2013 (H.R. 2791). The legislation seeks to ban exports of electronic wastes (e waste) whose improper disposal may create environmental, health, or national security risks. Specifically, H.R. 2791 creates a new section in RCRA that prohibits the export of “restricted electronic waste” from the U.S. to countries that are not members of the OECD or the EU. Restricted electronic equipment refers to any equipment that contains specific toxic materials at levels greater than those deemed non- hazardous by EPA. Under the legislation, tested and working equipment can still be exported to promote reuse. Products could also still be exported for warranty repair or due to recall. This legislative approach is consistent with the e-waste policies adopted by most other developed nations via international treaties, such as the Basel Convention and Basel Ban Amendment. The bill also creates a research program at DOE to help assess the recycling and recovery of Rare Earth Metals from electronics. This provision will help ensure the proper collection and recycling of precious and strategic metals.

House Bill Would Eliminate RCRA Exemption For Oil And Gas Wastes: For more than three decades, wastes generated from the exploration, development, and process of crude oil, natural, gas, and geothermal energy have been exempted from regulation as hazardous waste under RCRA. On July 25, 2013, Representative Matthew Cartwright (D-PA) introduced legislation seeking to abolish the exemption. The Closing Loopholes and Ending Arbitrary and Needless Evasion of Regulations (CLEANER) Act (H.R. 2825) garnered 44 co-sponsors and was endorsed by 137 organizations. The bill would amend Section 3001(b) of RCRA to give EPA one year to make a determination as to whether drilling fluids, produced waters, and other wastes associated with the exploration, development, or production of crude oil, natural gas, or geothermal energy should be regulated as hazardous waste and, if EPA determines the wastes should be regulated as hazardous, to promulgate specific regulations to control their management.

Federal Permitting Improvement Act Would Accelerate Environmental Permitting For Major Capital Projects: A bipartisan Senate bill seeks to streamline and accelerate the federal environmental permitting process for major capital projects in energy, transportation, manufacturing, and other sectors. Sponsored by Senator Robert Portman (R-OH), the Federal Permitting Improvement Act of 2013 seeks to improve reviews under NEPA and to increase government coordination by creating an interagency council led by the White House OMB to identify best practices and deadlines for required NEPA reviews of infrastructure. Projects with costs greater than $25 million would be subject to this accelerated approval process.

House Committee Subpoenas EPA On “Secret Science”: The House Science, Space and Technology Committee on August 1, 2013, issued a subpoena to EPA on data related to the so-called Harvard Six Cities Study and Cancer Prevention Study II. This is the first time in over two decades that the Committee has exercised its subpoena authority. The subpoena was served on EPA Administrator Gina McCarthy shortly after the Committee, in a 20-18 vote, authorized the measure. The Committee ordered her to appear before the panel August 19, 2013, with the requested documents. According to Committee staff, the data from these studies have not been publicly disclosed by EPA. These “secret science” data are used to justify cost-benefit analyses for virtually all major CAA regulations under this Administration, including: National Ambient Air Quality Standards for ozone and particulate matter; Maximum Achievable Control Technology standards for coal-fired power plants, industrial boilers, and Portland cement kilns; upcoming Tier 3 standards for transportation fuel; and Cross-State Air Pollution Rule, the Committee stated. Given the import of these data and how these outdated data going back to the 1970s are used to support EPA’s regulatory decisions, Committee Chair Lamar Smith (R-TX) believes these data should be made publicly available to the research community to independently review EPA’s conclusions.

House Committee Passes Fracking Bill: The House Science, Space, and Technology Committee on August 1, 2013, passed by voice vote the EPA Hydraulic Fracturing Study Improvement Act (H.R. 2850). Introduced on July 31, 2013, by Committee Chair Lamar Smith (R-TX), the bill is intended to limit EPA’s and other federal agencies’ ability to use an EPA study on whether “fracking” adversely impacts drinking water as the justification for promulgating new fracking rules. The legislation would also require EPA to adhere to White House and internal scientific integrity policies for peer review in conducting the study.

Flame Retardants Would Be Banned In Certain Products Under House Bill: The Decrease Unsafe Toxins Act (H.R. 2934) would amend the Consumer Product Safety Improvement Act of 2014 to prohibit the use of flame retardants in certain children’s products. Introduced by Representative Rose DeLauro (D-CT), the legislation seeks to ban the use of flame retardants in any children’s cushioned product. The products would be deemed hazardous substances under the Federal Hazardous Substances Act. A broad range of products would be impacted by the bill. Products that would be subject to the ban are any children’s product that contains resilient filling materials, including strollers, infant walkers, booster seats, car seats, changing pads, floor play mats, highchair pads, highchairs, infant swings, bassinets, infant seats, infant bouncers, nursing pads, playpen side pads, infant mattresses, infant mattress pads, and portable hook-on chairs.

Bill Seeks To Require Notice And Comment On White House Estimates Of Social Cost Of Carbon: A once obscure metric related to global warming is attracting much attention from lawmakers. The Social Cost of Carbon is an estimate that gauges the impact global warming has on society. A bill introduced on August 1, 2013, by Representative Duncan Hunter (R-CA) would require EPA to issue publicly any estimates on the social cost of carbon and to seek public comment on the estimates. The Social Cost of Carbon Transparency Enhancement Act of 2013 (H.R. 2886) was referred to the Committees on Oversight and Government Reform and Judiciary. Similar legislation (H.R. 3042) was introduced by Representative Tim Murphy (R-PA) on August 2, 2013.

Bill Would Amend RCRA To Strengthen Medical Waste Regulations: Representative Frank Pallone (D-NJ) on July 31, 2013, introduced the Medical Waste Management Act of 2013 (H.R. 2891). The bill would replace the current Subtitle J in RCRA with new provisions that would require tracking (including a manifest) for medical waste shipments. EPA would also be required to promulgate regulations on the labeling and packaging of medical waste, and standards for medical waste treatment, storage, and disposal facilities. The bill would also require EPA to issue regulations for generators of medical waste, including training requirements.

Senate Bill Would Subject EPA Rules To Review By Department Of Agriculture: Senators Mark Kirk (R-IL) and Joe Manchin (D-WV) on August 5, 2013, introduced a bill that continues the drumbeat of legislative attempts to “rein in” EPA. The bill (S. 1466) would require the Department of Agriculture to review all EPA rules, guidance, policy, memorandum, regulation, or statements of general applicability and determine whether the EPA actions would have a significant impact on agricultural entities. If the Department determines that an EPA action will have such an impact, it must ask EPA for additional information to facilitate a review of the action; produce an economic impact statement that contains a detailed estimate of potential costs to agricultural entities; identify individuals representative of potentially affected agricultural entities for the purpose of obtaining advice and recommendations from those individuals about the potential impacts of the publication item; and convene a review panel to analyze the item.

Bill Would Study Unique Challenge Of Tar Sands Oil Cleanup: Senator Maria Cantwell (D-WA) on August 2, 2013, introduced legislation to kick start investments in research and development to upgrade the nation’s oil spill response technology. The Oil Spill Technology and Development Act of 2013 (S. 1483) would encourage innovative approaches for responding to oil spills in the 21st century. The legislation would establish small, targeted grants to further the development of new technologies to contain and clean up oil spills. Additionally, the bill would require the United States Coast Guard to maintain a program for evaluating and implementing “best available technology” to ensure access to the most effective tools to respond to oil spill threats. Cantwell’s bill would also require research into methods of cleaning up oil spills in icy conditions and addressing the unique challenges of tar sands oil. Oil from tar sands is uniquely difficult to remove after a spill, because it is more corrosive than other types of oil and contains heavy metals. Types of tar sands oil are also known to sink, which makes it harder to contain and remove oil from the water’s surface.

Bills Fight To Save User Fees From Sequestration: Legislators in both houses of Congress have introduced bills that would exempt from sequestration certain user fees paid by applicants to the U.S. Food and Drug Administration (FDA) to speed up consideration of their submissions. In the Senate, Mark Pryor (D-AR) introduced the FDA User Fee Protection Act (S. 1413), while in the House Leonard Lance (R-NJ) sponsored the Food and Drug Administration Safety Over Sequestration Act of 2013 (H.R. 2725). In addition to general concerns, the regulated industry is specifically concerned about user fees collected to finance review of new drug applications. Those fees are already subject to sequestration. The industry trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), issued a press release explaining its position. It stated that “PhRMA remains deeply concerned about the impact of sequestration on the Food and Drug Administration’s (FDA) ability to fulfill its critical public health mission by fostering timely patient access to safe and effective new medicines and advancing regulatory science. PhRMA strongly supports the FDA Safety Over Sequestration Act of 2013, H.R. 2725, which would exempt future FDA user fees from sequestration.” As to the funds already sequestered, PhRMA stated that “[p]rescription drug user fees cannot, by law, be used for any purpose other than to support FDA’s human drug review program. Their sequestration does not decrease the nation’s deficit, but only serves to exacerbate the severe budgetary constraints of a historically underfunded agency. This is detrimental to patients, regulatory science and public health.”

MISCELLANEOUS

EPA Administrator Announces Senior Management Changes: Gina McCarthy, fresh off her confirmation by the Senate as EPA Administrator, on July 25, 2013, announced a shakeup of senior management positions. McCarthy shifted Arvin Ganesan from Associate Administrator for the Office of Congressional and Intergovernmental Relations (OCIR), to the position of Deputy Chief of Staff for Policy. Lisa Feldt, currently the Deputy Assistant Administrator in the Office of Solid Waste and Emergency Response (OSWER), will now serve as Associate Deputy Administrator. Ganesan’s slot as OCIR Associate Administrator will be filled by Laura Vaught, currently serving as the Deputy Associate Administrator for Congressional Affairs. In a July 25, 2013, e-mail to EPA staff, McCarthy said these changes reflect the recommendations a leadership team made after evaluating how the Administrator’s office is set up to function and coordinate with other Agency offices.

ATSDR Seeks Comment On Tox Profiles: On July 19, 2013, the Agency for Toxic Substances and Disease Registry (ATSDR) announced development of its 27th set of toxicological profiles. 78 Fed. Reg. 43205. ATSDR requested nominations from the Substance Priority List and/or other substances. Nominations are due by August 19, 2013.

GAO Issues Report On “Conflict-Free” Minerals Verification: On July 18, 2013, the Government Accountability Office (GAO) issued a report suggesting that corporate efforts to ensure that minerals used in their products are “conflict-free” may be impaired by regional instability and conditions in the Democratic Republic of Congo (DRC). Section 1502 of the Dodd-Frank Walt Street Reform and Consumer Protection Act directed the Securities and Exchange Commission (SEC) to require companies and foreign private issuers in the United States to report their use of gold, tantalum, tin, and tungsten from the DRC and adjacent countries. These so-called conflict minerals have reportedly been a source of income for armed groups in the region. The SEC issued a final rule implementing the Dodd-Frank requirement. Companies subject to the rule are required to file their first report in May 2014. The GAO report, mandated by the Dodd-Frank provision, states that initiatives could help companies verify the source of the minerals used in their products. Several such initiatives have already been set up. Such initiatives face threats from illegal armed groups. The report is available online.

District Court Upholds SEC’s Final Conflict Minerals Rule: On July 23, 2013, the U.S. District Court for the District of Columbia granted SEC’s motion for summary judgment in National Ass’n of Manufacturers v. SEC, No. 13-cv-00635. The plaintiffs challenged the SEC’s final conflict minerals rule, claiming it was arbitrary and capricious under the APA and that the disclosures required by the SEC and Congress violate the First Amendment. According to the court, the SEC “exercised its independent judgment in declining to adopt a de minimis exception.” The court “has no trouble” concluding that the SEC’s interpretation that it possessed discretion to determine whether a de minimis exception was appropriate was permissible. In particular, the court notes, plaintiffs complain that the SEC relied too heavily on the State Department’s assessment, and also that the SEC failed to analyze the various de minimis thresholds proposed by commentators during the rulemaking process. While the court “agrees that the SEC’s explanation arguably could have been more thorough in some respects, the Court cannot say that the Commission’s determination was unreasonable or devoid of a ‘rational connection’ in violation of the APA.” The SEC was “not required to exhaustively analyze each and every proposal it received during the rulemaking process.” Given the SEC’s “broader conclusion” that conflict minerals are often used in minute amounts, it believed that any type of categorical de minimis exception had the potential to swallow the rule and would be inappropriate. The court states that this analysis was sufficient to satisfy the SEC’s obligations under the APA. The court concludes that, finding no problems with SEC’s rulemaking and disagreeing that the “conflict minerals” disclosure scheme transgresses the First Amendment, plaintiffs’ claims lack merit. Accordingly, the court denied plaintiffs’ motion for summary judgment, and granted SEC’s and interveners’ cross-motions for summary judgment.

On August 12, 2013, the National Association of Manufacturers (NAM) gave notice of its appeal of the decision. The appeal will be decided by the U.S. Court of Appeals for the District of Columbia Circuit. There are no substantive claims yet in the papers by NAM. They are expected to be identical to the claims made previously in the District Court, which had themselves previously been presented to the Court of Appeals. The appeal may be briefed, argued, and decided relatively quickly. Because the decision in the District Court was based upon issues of law, the Court of Appeals will decide the same issues de novo, without regard to the decision below.

ITC Seeks Information To Support Investigation Of How EU Trade Restrictions Affect Exports Of U.S. SMEs: On July 30, 2013, the U.S. International Trade Commission announced that, following receipt of a letter from the United States Trade Representative (USTR), it instituted investigation No. 332-541, “Trade Barriers that U.S. Small and Medium-sized Enterprises Perceive as Affecting Exports to the European Union.” 78 Fed. Reg. 45969. According to the notice, USTR’s letter indicated that the U.S., in the Transatlantic Trade and Investment Partnership (TTIP) negotiations, “will seek to strengthen U.S.-European Union (EU) cooperation to enhance the participation of SMEs in transatlantic trade, and to address trade barriers that may disproportionately impact small businesses.” The Commission will base its report on available information, including information furnished by small- and medium-sized enterprises (SME) and interested parties. The Commission will address, where information is available, specific trade barriers in individual EU Member States, and provide, to the extent applicable, qualitative distinctions among the identified trade-related barriers. The Commission states that it will include suggestions gathered from SMEs or the relevant literature to strengthen U.S.-EU cooperation to enhance the participation of SMEs in transatlantic trade. The Commission will hold a public hearing on October 8, 2013. Requests to appear at the hearing are due September 13, 2013, and the deadline for filing pre-hearing briefs and statements is September 20, 2013. Post-hearing briefs and other written statements are due October 15, 2013. The Commission will transmit its report to USTR by January 31, 2014.

Executive Order Calls For Federal Review Of Safety Rules At Chemical Facilities: President Obama on August 1, 2013, issued an Executive Order (EO) ordering federal agencies to review safety rules at chemical facilities in response to the April explosion at a West, Texas, fertilizer plant that killed 15. The EO tasks federal agencies with examining new ways to store and safely secure ammonium nitrate, the culprit in the April explosion. The EO also directs agencies to determine whether additional chemicals should be covered by federal regulatory programs, calls for improved coordination among state and local agencies that deal with chemical plants, and tasks the federal government with modernizing its information sharing about chemical facilities. The EO directs specific federal agencies to undertake four broad efforts: improve operational coordination with state and local partners; enhance federal agency coordination and information sharing; modernize policies, regulations, and standards; and work with stakeholders to identify best practices. With respect to improving operational coordination with state and local partners, it charges federal agencies with improving coordination and information sharing with state and local governments. For example, the EO requires federal agencies to develop a plan within 90 days that identifies ways to ensure state homeland security advisors, State Emergency Response Commissions (SERC), Tribal Emergency Response Commissions (TERC), Local Emergency Planning Committees (LEPC), Tribal Emergency Planning Committees (TEPC), state regulators, and first responders have ready access to key information in a useful format to prevent, prepare for, and respond to chemical incidents. To enhance federal coordination and information sharing, the EO calls upon federal agencies to initiate innovative approaches for working together on a broad range of activities, such as identification of high-risk facilities, inspections, enforcement, and incident investigation and follow up. For example, the EO requires that federal agencies deploy a regional pilot program that will validate best practices and test innovative new methods for federal interagency collaboration on chemical facility safety and security. Additionally, federal agencies are specifically directed to modernize the collection and sharing of chemical facility information to maximize the effectiveness of risk reduction efforts and reduce duplicative efforts. To modernize policies, regulations, and standards, the EO states that agencies will examine new options to address the safe and secure storage, handling, and sale of explosive chemicals. Federal agencies will also determine if additional chemicals should be covered by existing federal regulatory programs, such as EPA’s Risk Management Program (RMP), the Department of Homeland Security’s (DHS) Chemical Facilities Anti-Terrorism Standards (CFAT), and DOL’s PSM Standards. In addition, agencies will consider whether to pursue an independent, high-level assessment of the U.S. approach to chemical facility risk management to identify additional recommendations for all levels of government and industry to reduce the risk of catastrophic chemical incidents in the future. Finally, the EO directs key federal agencies to convene a wide range of interested stakeholders, including representatives from industry, state, local, and tribal governments, non-governmental organizations, and the first responder community, to identify and share successes to date and best practices to reduce safety and security risks in the production and storage of potentially harmful chemicals, including through the use of safer alternatives, adoption of best practices, and potential public-private partnerships.

DOT Issues Emergency Order And Safety Advisory To Prevent Hazardous Materials Incidents Involving Trains: Spurred by the fatal July 6, 2013, train derailment in Lac-Mégantic, Quebec, Canada, the U.S. Department of Transportation’s (DOT) Federal Railroad Administration (FRA) on August 2, 2013, issued an Emergency Order and Safety Advisory to help prevent trains operating on mainline tracks or sidings from moving unintentionally. The Emergency Order is a mandatory directive to the rail industry, and failure to comply will result in enforcement actions against violating railroads, FRA stated. Under the Emergency Order, within the next 30 days, railroads must undertake the following measures:

  • No train or vehicles transporting specified hazardous materials can be left unattended on a mainline track or side track outside a yard or terminal, unless specifically authorized.
     
  • To receive authorization to leave a train unattended, railroads must develop and submit to FRA a process for securing unattended trains transporting hazardous materials, including locking the locomotive or otherwise disabling it, and reporting among employees to ensure the correct number of hand brakes are applied.
     
  • Employees who are responsible for securing trains and vehicles transporting hazardous materials must communicate with the train dispatchers the number of hand brakes applied, the tonnage and length of the train or vehicle, the grade and terrain features of the track, any relevant weather conditions, and the type of equipment being secured.
     
  • Train dispatchers must record the information provided. The dispatcher or other qualified railroad employee must verify that the securement meets the railroad’s requirements and verify that the securement meets the railroad’s requirements.
     
  • Railroads must implement rules ensuring that any employee involved in securing a train participate in daily job briefings prior to the work being performed.
     
  • Railroads must develop procedures to ensure a qualified railroad employee inspects all equipment that an emergency responder has been on, under, or between before the train can be left unattended.
     
  • Railroads must provide the Emergency Order to all affected employees.

In addition to the Emergency Order, FRA, together with the Pipeline and Hazardous Materials Safety Administration (PHMSA), issued a Safety Advisory detailing a list of recommendations railroads are expected to follow. DOT believes that railroad safety is enhanced through the use of multiple crew members, and the Safety Advisory recommends railroads review their crew staffing requirements for transporting hazardous material and ensure that they are adequate. Other recommendations in the Safety Advisory include conducting system-wide evaluations to identify particular hazards that may make it more difficult to secure a train or pose other safety risks and developing procedures to mitigate those risks.

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.