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September 1, 2014

Monthly Update for September 2014

Bergeson & Campbell, P.C.


Health Activists’ Petition Seeks Sunset Of CBI Claims: On August 21, 2014, six environmental health organizations filed a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition urges the U.S. Environmental Protection Agency (EPA) to initiate a rulemaking to require periodically the re-substantiation of confidential business information (CBI) claims made under TSCA. Under TSCA, EPA has 90 days within which to respond to the petition.

Draft IRIS Assessment Reaffirms Human Carcinogen Determination For Ethylene Oxide: On August 15, 2014, EPA’s Integrated Risk Information System (IRIS) review of ethylene oxide reaffirmed the determination made by the IRIS office in 2006 that ethylene oxide is a human carcinogen via the inhalation pathway. The Science Advisory Board (SAB) will convene a teleconference on September 30, 2014, to discuss the upcoming peer review of the assessment, which is scheduled for November 18-20, 2014. 79 Fed. Reg. 46799. For more details on the teleconference and peer review of the assessment, please consult the Federal Register.

Polyvinyl Chloride Disposal Should Be Regulated, Center Urges In Petition To EPA: On August 21, 2014, EPA announced that the Center for Biological Diversity petitioned EPA under TSCA Section 21 and Section 7004(a) of the Resource Conservation and Recovery Act (RCRA) to classify polyvinyl chloride (PVC) and some of the chemicals added to it as hazardous wastes under RCRA and to develop regulations for its disposal. The petition asks EPA to address PVC, vinyl chloride, and associated dialkyl- and alkylarylesters of 1,2-benzenedicarboxylic acid. The petition focuses on the Center’s reasons for believing that PVC and its additives are hazardous under RCRA when disposed. The petition neglects to specify what action the Center wishes EPA to take under TSCA, but asks EPA to regulate PVC under TSCA Section 6, which allows EPA to issue commercial restrictions on chemical substances bans. EPA’s announcement of the petition and a copy of the petition are available online.

IARC To Assess Carcinogenicity Of Certain Pesticides: On September 10, 2014, the International Agency for Research on Cancer (IARC) announced it will convene a panel to discuss the carcinogenicity of certain organochlorine insecticides and chlorphenoxy herbicides. The meeting is scheduled for June 2-9, 2015. IARC did not name the specific pesticides it will consider during that meeting. Scientists who wish to serve on the IARC panel must be nominated by October 10, 2014. Individuals and organizations that would like to observe the meeting must submit their requests to do so by February 2, 2015. Scientific information must be submitted to IARC’s panel by May 2, 2015. IARC’s announcement is available online.


EPA Releases Document Seeking To Clarify “Waters Of The U.S.” Rule: EPA on September 8, 2014, released a question and answer (Q&A) document seeking to clarify the scope and purpose of its proposed “Waters of the U.S.” rule. Issued jointly by EPA and the U.S. Army Corps of Engineers (Corps) on April 21, 2014, the proposal is intended to clarify protection under the Clean Water Act (CWA) for streams and wetlands in the wake of a tandem of Supreme Court decisions. 79 Fed. Reg. 22187. The Q&A document appears to be the latest attempt by EPA to blunt criticism on the rule from Republicans and certain business groups who contend that the proposal would significantly expand EPA’s jurisdiction under the CWA. The document states that Supreme Court decisions in 2001 and 2006 changed the test for determining which waters upstream of navigable waters should be protected under the CWA. The basis for determining jurisdiction under the CWA changed from whether degraded water quality would have an effect on interstate commerce, to a more technical and scientific understanding of water features and their connection and importance to downstream traditional navigable waters. In the proposed rule, EPA and the Corps are proposing to apply this principle, and in particular the “significant nexus” test, to clarify the waters that are vital to protect if the CWA is to be successful. The proposal also identifies waters that are not subject to the CWA. EPA states that it is not expanding the CWA. The proposed rule does not add protection to any new types of waters that have not historically been covered by the CWA, “nor does the rule in any way limit current regulatory and statutory exemptions and exclusions. Simply put, if an activity was exempted or excluded before this proposal, it will remain exempted or excluded. If you didn’t need a permit for a type of activity before, you won’t need one now,” EPA states in the Q&A document, which is available online.

EPA Updates Clean Air Applicability Index: On September 3, 2014, EPA announced that it has updated its Clean Air Act (CAA) Applicability Determination Index to include 64 new documents on applicability and monitoring issues. 79 Fed. Reg. 52319. The update includes new applicability determinations, alternative monitoring decisions, and regulatory interpretations made under the CAA’s New Source Performance Standards (NSPS), National Emission Standards for Hazardous Air Pollutants (NESHAP), and Stratospheric Ozone Protection Program. The index contains more than 3,000 documents from EPA that determine when air pollution standards apply to affected industries. The Applicability Determination Index is available online.

EPA Issues Timeline For Deciding Whether To Regulate Greenhouse Gas Emissions From Aircraft Engines: On September 3, 2014, EPA issued an “information paper” establishing its timeline for deciding whether it will regulate carbon dioxide (CO2) emissions from aircraft engine exhaust as a greenhouse gas (GHG). EPA states that it first would need to determine whether GHG emissions from aircraft engines cause or contribute to air pollution that endangers public health and/or welfare. EPA would then have to propose and issue in final the endangerment finding. According to the information paper, EPA would propose an endangerment finding in April 2015, and then propose standards to reduce GHG emissions from aircraft engine exhaust in 2016. The information paper is available online.

EPA’s Air Office Recommends Lowering Ozone NAAQS: EPA’s Office of Air Quality Planning and Standards (OAQPS) has concluded that there is adequate evidence for lowering the existing National Ambient Air Quality Standard (NAAQS) for ozone (O3) from 75 parts per billion (ppb) to between 70 ppb and 60 ppb. The recommendation is found in a 600 page long Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards, issued on August 29, 2014. In the policy assessment, OAQPS states that “The available scientific evidence and exposure/risk information provide strong support for considering a primary O3 standard with a revised level in order to increase public health protection, including for at-risk populations and lifestages. Staff concludes that it is appropriate in this review to consider a revised primary O3 standard level within the range of 70 ppb to 60 ppb.” The policy assessment is available online.


FDA’s CDRH Issues Small Entity Compliance Guide And Q&A: On August 13, 2014, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a Small Entity Compliance Guide for industry on the Unique Device Identification (UDI) system. This guide in intended to provide information to the medical device industry, including small businesses, on the final rule FDA issued September 24, 2013, establishing a UDI system. On August 20, 2014, CDRH released frequently asked questions guidance for industry on the UDI system. For more information, see online and Unique Device Identifier System: Frequently Asked Questions, Vol. 1 – Guidance for Industry and Food and Drug Administration Staff.

FDA’s CDRH Issues Draft Guidance: On August 14, 2014, FDA’s CDRH issued draft guidance for industry on “De Novo Classification Process (Evaluation of Automatic Class III Designation).” 79 Red. Reg. 47652. The draft provides guidance on the process for requesting assistance from FDA on device determinations known as the “de novo classification process.” Comments on the guidance are due October 14, 2014. For more details, see De Novo Classification Process (Evaluation of Automatic Class III Designation) – Draft Guidance for Industry and Food and Drug Administration Staff.

FDA’s CDRH Issues Final Guidance: On August 20, 2014, FDA’s CDRH posted a final guidance on the “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” along with an action plan (FDASIA Section 907 Action Plan). The guidance provides industry and FDA staff with specific recommendations for considering sex and other variables during study design. The Action Plan focuses on data quality, sub group participation, and data transparency. For more information, see online and FDASIA Section 907 Action Plan.

FDA’s OFVM Completes Review: On August 28, 2014, FDA announced completion of a review on how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed, and veterinary drugs. The chemical safety assessment was initiated in 2012 and is the first part of a three-part strategic review being conducted by the Office of Foods and Veterinary Medicine (OFVM). The working groups involved were conducting the review to ensure FDA is making effective and efficient use of resources. The most significant outcome is the Centers for Food Safety and Applied Nutrition (CFSAN) proposal for the development of a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients. For more information, see online.


Friends Of The Earth Focuses On Technology Risk: On August 25, 2014, Friends of the Earth (FOE) Australia announced that it will address concerns it has on issues ranging from nanotechnology to synthetic biology to geoengineering under a new campaign, the Emerging Tech Project. According to FOE too often technological innovations are not sufficiently regulated until too late, and that many technologies are converging in risky ways and have unprecedented global reach. More information is available online.

EPA Promulgates Final SNURs, Including Several For Nanomaterials: On September 2, 2014, EPA promulgated final significant new use rules (SNUR) under TSCA Section 5(a)(2) for 36 chemical substances that were the subject of premanufacture notices (PMN). 79 Fed. Reg. 51899. The substances include multi-walled carbon nanotubes (generic) (P-08-0392), multi-walled carbon nanotubes (generic) (P-09-257), multi-walled carbon nanofibers (generic) (PMNs P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126), and carbide derived nanocarbon (generic) (PMN P-11-290). Persons who intend to manufacture or process any of these 36 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 September 2, 2014, notice includes EPA’s response to comments. Two commenters suggested that EPA adopt the National Institute of Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of one microgram per cubic meter (µg/m3) for carbon nanotubes as a new chemical exposure limit (NCEL) for SNURs for carbon nanotubes. EPA responded that it “will not adopt the NIOSH REL as a NCEL at this time because EPA cannot determine that potential exposures at the REL may not present an unreasonable risk.” EPA states that it will consider the final NIOSH REL or other alternative exposure controls for carbon nanotubes if a submission requesting such is made under 40 C.F.R. Section 721.30. The final SNURs take effect November 3, 2014.

EC Publishes Responses To Public Consultation On Transparency Measures For Nanomaterials On The Market: The European Commission (EC) has posted responses received to its public consultation on transparency measures for nanomaterials on the market. The EC states that it received 202 responses — 100 respondents submitted the questionnaire for industry stakeholders, and 102 respondents submitted the questionnaire for other stakeholders. Fourteen respondents requested that their contributions would not be published. All other contributions are available on the EC’s website. The EC notes that some contributions are published in anonymous form upon request. The EC will publish a full summary and analysis of the public consultations “in due course.” The responses are available online.

NIOSH Scientist Appointed Convener Of International Nanotechnology Working Group: NIOSH announced in its September 5, 2014, eNews that an international committee unanimously selected Dr. Vladimir Murashov, special assistant for nanotechnology to the NIOSH Director, “to lead an international working group on the health, safety, and environmental aspects of nanotechnologies.” NIOSH states that the working group is part of a larger initiative by the International Organization for Standardization (ISO) to develop standardization in the nanotechnologies field. According to NIOSH, “[a]s convener, Dr. Murashov will guide the working group as they develop science-based standards to improve worker, consumer, and environmental protections by promoting good practice in the production, use, and disposal of nanomaterials and nanotechnology products.”

NNI And NASA Co-Sponsor Technical Interchange Meeting On Carbon Nanotubes: The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled “Realizing the Promise of Carbon Nanotubes — Challenges, Opportunities and the Pathway to Commercialization” on September 15, 2014. 79 Fed. Reg. 53220. The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and Space Administration (NASA). According to the notice, the objectives of the meeting are to identify, discuss, and report the technical barriers preventing the production of carbon nanotube-based materials with electrical and mechanical properties approaching theoretical values, and to explore ways to overcome these barriers. The notice states that the meeting “will assemble some of the Nation’s leading experts in carbon nanotube research and development, as well as executives and experts from the Federal government, academia, and private sector.” The meeting will be held at NASA Headquarters, in Washington, D.C. More information is available online.

Australian Pesticides And Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium: The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines. Key topics covered will include the benefits and potential risks; definitions, metrology, properties, and manufacturing; and human health and environmental considerations. APVMA intends to publish a draft nanotechnology report in late September 2014, which will provide a basis for discussion at the symposium. According to APVMA, it will encourage participants to comment on the report, “thereby contributing to a better regulatory framework for nanomaterials.” Registration for the symposium is now open. More information is available online.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) 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

National Academies Convenes Meeting On Genetically Modified Crops: On August 19, 2014, the National Academies announced the scheduling of a meeting on genetically engineered crops for September 15-17, 2014. The panel will consider the economic, environmental, food safety, regulatory, and related implications of genetically engineered crops. More information is available online.


DTSC Releases Draft Initial Priority Product Work Plan: On September 12, 2014, the California Department of Toxic Substances Control (DTSC) released its much anticipated draft Initial Priority Product Work Plan under the Safer Consumer Products Regulations. The Regulations require that DTSC, by October 2014, develop an Initial Priority Product Work Plan that describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. DTSC is seeking comments on its Work Plan, which can be submitted using the California Safer Products Information Management System (CalSAFER) until October 13, 2014. DTSC also is holding two workshops, one in Sacramento on September 25, 2014, and one in Cypress on September 29, 2014. The Work Plan is available online and more detailed memoranda about the Regulations and the Work Plan are available online.

NAS Panel Urges Integration Of Sustainability In EPA Activities: On September 10, 2014, a National Academy of Sciences (NAS) panel recommended that EPA systematically ensure sustainability tools are used its EPA initiatives in line with its statutory authorities. The report, “Sustainability Concepts in Decision-Making: Tools and Approaches for the U.S. Environmental Protection Agency,” discusses adoption of sustainability concepts throughout EPA and specifically addresses the relationship between risk assessment/management decision-making and sustainability tools and approaches. The panel specifically noted in embracing, sustainability tools “EPA will become better informed about the changing nature of risks that it is responsible for reducing and will gain a system-level view of key interrelationships among economic-environmental-societal spheres of activities.” The report is available online.

EPA Seeks Feedback From The Public On Proposed Label Options For Safer Products: On September 9, 2014, EPA redesigned its Design for the Environment (DfE) Safer Product Label to convey better to consumers and purchasers that products displaying the label meet the program’s rigorous standard to be safer for people and the environment. Comments are due October 31, 2014. EPA will display the proposed designs on DfE’s website.


DOT Proposes Rule To Harmonize HMR With International Standards: On August 25, 2014, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a proposed rule seeking to harmonize the hazardous materials regulations (HMR) with international regulations and standards. 79 Fed. Reg. 50741. The rule would revise proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. The comment period on the proposed rule closes on October 24, 2014. PHMSA believes the proposed changes are non-controversial and thus a 60-day comment period is ample. The main changes to the HMR proposed by PHMSA are:

  • Incorporate Revised Standards: PHMSA proposes to incorporate by reference the most recent versions of various international hazardous materials standards, including the 2015–2016 International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air, Amendment 37–14 to the International Maritime Dangerous Goods Code (IMDG Code), the International Atomic Energy Agency (IAEA) Safety Standards for Protecting People and the Environment; Regulations for the Safe Transport of Radioactive Material, No. SSR–6 (IAEA Regulations), 2012 Edition, and the 18th Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods (UN Model Regulations). PHMSA also proposes to update its incorporation by reference of the Canadian Transportation of Dangerous Goods Regulations and to adopt updated ISO standards.
  • Revise HMT Entries: PHMSA proposes amendments to the Hazardous Materials Table (HMT) at 49 C.F.R. Section 172.101 to add, revise, or remove certain proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, bulk packaging requirements, passenger and cargo aircraft maximum quantity limits. The proposed changes to the HMT mirror recent changes in the Dangerous Goods list of the 18th Revised Edition of the UN Model Regulations, the IMDG Code, and the ICAO Technical Instructions
  • Provide Exceptions for Marine Pollutants: PHMSA proposes an exception from the HMR for marine pollutants up to 5 liters (1.3 gallons) for liquids or 5 kilograms (11 pounds) for solids when these materials are packaged in accordance with the general packaging requirements of 49 C.F.R. Sections 173.24 and 173.24a. The proposed amendment would exempt small packages of hazardous material from the HMR that are regulated only because of the presence of one or more marine pollutants. PHMSA argues that materials in these quantities pose a low risk in transport and this proposal simplifies the current exceptions for marine pollutants and reduces impediments to transport of these goods.
  • Modification of the Marine Pollutant List: PHMSA is proposing to modify the list of marine pollutants in Appendix B to the HMT. PHMSA periodically updates its list based on changes to the IMDG Code and evaluation of listed materials.
  • Clarify Hazard Communication Size Requirements: PHMSA is proposing to add minimum sizes for the OVERPACK and SALVAGE markings. These markings would be characters at least 12 mm (.47 inches) high.
  • Revise Vessel Stowage Requirements: PHMSA is proposing to revise and add vessel stowage codes listed in column 10B of the HMT and segregation requirements in 49 C.F.R. Section 176.83 consistent with the IMDG Code. PHMSA also proposes to increase the required segregation distances between Division 4.3 dangerous when wet materials, Class 3 flammable liquids, and Division 2.1 flammable gases.
  • Addition of Entries for Adsorbed Gases in the Hazardous Materials Table: Consistent with amendments adopted into the UN Model Regulations, PHMSA is proposing to revise the HMT to include 17 new entries for adsorbed gases. PHMSA also proposes to add into the HMR a definition for adsorbed gas, authorized packagings, and safety requirements, including but not limited to quantity limitations and filling limits.
  • Harmonized Requirements for Lithium Batteries: PHMSA proposes harmonization with the latest version of the ICAO Technical Instructions to ensure that the information currently authorized by the HMR to be provided by means of an alternative document be included on a shipping paper for batteries transported under the provisions of 49 C.F.R. Section 173.185(c)(4)(v), which is equivalent to ICAO Packing Instructions 965 and 968. PHMSA also proposes requiring a “CARGO AIRCRAFT ONLY” label on packages containing small lithium metal batteries not packed in or with equipment.
  • Definition of Non-Bulk Packaging: PHMSA proposes to revise the definition of non-bulk packaging to include bags and boxes conforming to the applicable requirements for specification packagings in subpart L of 49 C.F.R. Part 178, if they have a maximum net mass of 400 kilograms (882 pounds) or less.

PHMSA states that if the amendments are not adopted in the HMR by January 1, 2015, the date most of the international standards above take effect, U.S. companies will be at an economic disadvantage. These companies will be forced to comply with a dual system of regulations, and PHMSA states that the amendments proposed in this rulemaking are intended to avoid this result. Moreover, PHMSA argues that the proposed revisions to the HMR will result in minimal burdens on the regulated community and that the majority of amendments in this proposal should result in cost savings and ease the regulatory compliance burdens.


ECHA Revises Mutagenicity Test Guidance: On August 19, 2014, the European Chemicals Agency (ECHA) released revised guidance on mutagenicity tests needed for chemical safety assessments (CSA) conducted for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The updated guidance makes REACH’s requirements consistent with a new and an updated testing protocol approved by the Organization for Economic Cooperation and Development (OECD). ECHA’s guidance also expands on the circumstances of when and how to use these and other tests or data from structure-activity analyses. More information is available online.

Nine Substances Of Very High Concern Listed Under REACH: On August 19, 2014, the EC officially designated nine chemicals as substances of very high concern (SVHC), meaning their continued uses will need to be “authorized” under REACH. In a separate action, Austria, Denmark, Germany, and Sweden announced their intent to nominate an additional ten chemicals as SVHCs. The regulation places nine chemicals on the Annex 14 list of the REACH regulation. Listing in Annex 14 means the substance cannot be used without specific authorization. The new regulation includes deadlines by which authorization requests must be filed. Depending on the chemical, the deadlines fall between February 22, 2016, and July 22, 2017. Among the nine chemicals is strontium chromate (EC No. 232-142-6; CAS No. 7789-06-2), which is made in or imported into the European Union (EU) in a total volume ranging between 1,000 metric tons and 10,000 metric tons (1,102-11,023 U.S. short tons) per year. Other chemicals the Commission added to Annex 14 are:

  • Oligomeric reaction products of formaldehyde with aniline (technical MDA) (EC No. 500-036-1; CAS No. 25214-70-4);
  • Ethylene dichloride (EC No. 203-458-1; CAS No. 107-06-2);
  • Arsenic acid (EC No. 231-901-9; CAS No. 7778-39-4);
  • Bis(2-methoxyethyl) ether (diglyme) (EC No. 203-924-4; CAS No. 111-96-6);
  • 2,2′-dichloro-4,4′-methylenedianiline (EC No. 202-918-9; CAS No. 202-14-4);
  • Dichromium tris(chromate) (EC No. 246-356-2; CAS No. 24613-89-6);
  • Potassium hydroxyoctaoxodizincatedichromate (EC No. 234-329-6; CAS No. 11103-86-9); and
  • Pentazinc chromate octahydroxide (EC No. 256-418-0; CAS No. 49663-84-5);

On August 4, 2014, Austria, Denmark, Germany, and Sweden filed information to support the nomination of several phthalates and other chemicals among ten compounds they stated should be classified as SVHCs. Those ten chemicals are:

  • Bis(2-ethylhexyl) phthalate (EC No. 204-211-0; CAS No. 117-81-7);
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) (EC No. 223-346-6; CAS No. 3846-71-7);
  • Dibutyl phthalate (EC No. 201-557-4; CAS No. 84-74-2);
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) (EC No. 247-384-8; CAS No. 25973-55-1);
  • Cadmium sulphate (EC No. 233-331-6; CAS Nos. 10124-36-4 and 31119-53-6);
  • Cadmium fluoride (EC No. 232-222-0; CAS No. 7790-79-6);
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatet radecanoate; DOTE (EC No. 239-622-4; CAS No. 15571-58-1);
  • Diisobutyl phthalate (EC No. 201-553-2; CAS No. 84-69-5);
  • Benzyl butyl phthalate (EC No. 201-622-7; CAS No. 85-68-7); and
  • A reaction chemical proposed by Austria.

For more information, the Commission’s regulation is available online. ECHA’s registry of intentions is available online.


House Passes Legislation Barring “Waters Of The U.S. Rule” Despite White House Veto Threat: On September 9, 2014, the House of Representatives passed the Waters of the United States Regulatory Overreach Protection Act (H.R. 5078) in the face of a veto threat from the White House. Passed by a largely partisan vote of 262-152, the bill would bar promulgation of the so-called “Waters of the United States” proposed rule and require EPA and the Corps to rewrite the regulation that is not based on the existing proposed rule. The bill would also require EPA and the Corps to craft the rule in collaboration with state and local agencies and under Congressional oversight. Issued jointly by EPA and the Corps on April 21, 2014, the proposal is intended to clarify protection under the CWA for streams and wetlands in the wake of a tandem of Supreme Court decisions. 79 Fed. Reg. 22187. The rule has attracted much criticism from GOP lawmakers and some industry groups, who contend generally that the rule would greatly expand EPA’s authority under the CWA. Passage of the bill comes despite a September 8, 2014, Statement of Administration Policy promising to veto the bill if it passes. The White House states that H.R. 5078 “would derail current efforts to clarify the scope of the CWA, hamstring future regulatory efforts, and create significant ambiguity regarding existing regulations and guidance. It would deny businesses and communities the regulatory certainty needed to invest in projects that rely on clean water.” The White House added that the bill “would further delay any action to clarify the scope of the CWA for up to two years by requiring State and local governments to engage in further consultations even though they were engaged and consulted during the development of the proposed rule and they continue to be consulted as the agencies proceed with rulemaking.”

House Subcommittees Hold Joint Hearing On Characteristics Of Bakken Crude Oil: On September 9, 2014, the House Science, Space, and Technology Subcommittees on Energy and Oversight held a joint hearing entitled Bakken Petroleum: The Substance of Energy Independence. The hearing examined the characteristics and behavior of crude oil produced from the Bakken region in North Dakota, Montana, and Canada pursuant to a report titled “Operation Safe Delivery Update” released by DOT’s PHMSA in July 2014. Testifying at the hearing were Timothy Butters, Deputy Administrator, PHMSA, DOT; Chris Smith, Principal Deputy Assistant Secretary, Office of Fossil Energy, U.S. Department of Energy (DOE); Kari Cutting, Vice President, North Dakota Petroleum Council; John Auers, Executive Vice President, Turner, Mason & Company; and Mark Zoanetti, Deputy Chief, Special Operations, Syracuse Fire Department. Due to increased production, insufficient pipeline capacity, and challenges associated with siting new pipelines, a substantial amount of the petroleum produced in the Bakken region is shipped by rail. During the hearing, GOP Representatives slammed the DOT and DOE officials for failing to provide clearer answers on how the characteristics of crude oil from the Bakken shale region stacks up against other light sweet crudes. Butters and Smith replied generally that these are not simple yes-or-no answers and that much more research regarding volatility, flammability, and ignitability needs to be done. The industry representatives reiterated their viewpoint at the hearing that Bakken crude is properly classified and is not any different than other sweet, light crudes. PHMSA will continue collecting samples through at least the end of 2014, Butters stated. Smith stated the Energy Department is considering supporting DOT by conducting additional research regarding the properties of crude oil extracted from tight oil formations and how those properties may relate to safely transporting them. In light of recent derailments, including accidents in Lac-Megantic, Quebec, and Casselton, North Dakota, Bakken petroleum shipped by rail has drawn increased scrutiny. In January 2014, PHMSA released a safety alert as part of its “Operation Classification,” an initiative dating back to March 2013 following derailments in the United States and Canada that focuses on how shippers classify petroleum products originating in the Bakken region. The PHMSA alert concluded that Bakken petroleum “may be more flammable than traditional heavy crude oil.” The PHMSA alert emphasized that offerors of hazardous materials must properly classify and describe hazardous materials before they may be transported, stressing the importance of appropriate packing group (PG) assignment of crude oil shipments. The alert also advised that “emergency responders should remember that light sweet crude oil, such as that coming from the Bakken region, is typically assigned a packing group I or II… this means the materials pose significant fire risk if released from the package in an accident.” In July 2014, PHMSA released a report titled “Operation Safe Delivery Update,” which concluded that “after months of unannounced inspections, testing, and analysis, Operation Classification has determined that the current classification applied to Bakken crude is accurate under the current classification system, but that the crude has a higher gas content, higher vapor pressure, lower flash point and boiling point and thus a higher degree of volatility than most other crudes in the U.S., which correlates to increased ignitability and flammability.” A webcast of the hearing, witness testimony, and member statements are available online.

House Energy And Commerce Subcommittee Holds Hearing On Clean Power Plan Proposed Rule: The House Energy and Commerce Subcommittee on Energy and Power on September 9, 2014, held a hearing entitled State Perspectives: Questions Concerning EPA’s Proposed Clean Power Plan. Testifying at the hearing were: Kenneth W. Anderson, Jr., Commissioner, Public Utility Commission of Texas; Travis Kavulla, Commissioner, Montana Public Service Commission; Henry Darwin, Director, Arizona Department of Environmental Quality; Tom Easterly, Commissioner, Indiana Department of Environmental Management; Paul Roberti, Commissioner, Rhode Island Public Utility Commission; Kelly Speakes-Backman, Commissioner, Maryland Public Service Commission; and David Danner, Chairman, Washington Utilities and Transportation Commission. The hearing webcast and witness testimony are available online. The focus of the hearing was to gain states’ perspectives on the proposed Clean Power Plan. On June 2, 2014, EPA announced a 645-page proposed rule for existing fossil fuel-fired power plants pursuant to CAA section 111(d) entitled “Carbon Emission Guidelines for Existing Stationary Sources: Electric Generating Units” (Clean Power Plan). The proposed rule is accompanied by hundreds of pages of fact sheets, legal and other memoranda, technical support documents, and a regulatory impact analysis. The proposal was published in the Federal Register on June 18, 2014, and comments are due October 16, 2014. The witnesses generally appeared split on their views of the rule’s potential impacts on the economy and the electricity grid.

Fifteen Republican Senators Slam Obama Over Clean Power Plan Proposed Rule: The Republican governors of 15 states on September 9, 2014, sent a letter to President Obama harshly criticizing the proposed Clean Power Plan rule that seeks to limit GHG emissions from existing electric utilities. The letter argues that EPA lacks the authority under CAA Section 111(d) to regulate power plants and that even if it did have such authority, EPA “overstepped this hypothetical authority when it acted to coerce states to adopt compliance measures that do not reduce emissions at the entities EPA has set out to regulate” (emphasis in original). The governors also argue that EPA lacks authority to regulate “outside the fence” and that in attempting to do so the proposal “not only exceeds the scope of federal law, but also, in some cases, directly conflicts with established state law.” The governors also take Obama to task over several “urgent and vexing compliance issues inherent in the proposal.” These include enforcement of state plans, availability and impacts of renewable energy, construction and funding for natural gas infrastructure, disposal of civil nuclear waste, and importing and exporting electricity. The letter was signed by the governors of Alabama, Alaska, Arizona, Idaho, Indiana, Mississippi, New Mexico, North Carolina, North Dakota, Oklahoma, Pennsylvania, South Carolina, Utah, Wisconsin, and Wyoming.

Senator Inhofe Questions EPA’s Methane Strategy: In a lengthy letter dated September 3, 2014, Senator James Inhofe (R-OK) criticized the White House and EPA for its “Methane Strategy” under President Obama’s Climate Action Plan. In the letter, sent to EPA Administrator Gina McCarthy, EPA Acting Assistant Administrator for Air and Radiation Janet McCabe, and Special Assistant to the President Dan Utech, Inhofe criticized white papers that EPA released in August 2014 that detail the sources of methane emissions that could come from the oil and natural gas sector and explored potential mitigation techniques to reduce methane emissions. Inhofe wrote that he had “serious concerns” with the white papers. “One of the most pressing concerns,” he wrote, “is that the White Papers demonstrate that EPA lacks fundamental knowledge of the intricacies of the oil and natural gas industry.” The aspect of the papers that he found “most alarming” “is the presentation of incomplete and often inaccurate methane emission data.” Taken as a whole, Inhofe wrote that the papers raise “questions about EPA’s policy making intent and whether it is interested in sound policy development or if it has predetermined to regulate methane and is simply building a case to do so, however crude it may be.” Inhofe called on EPA to convene roundtable discussions on the strategy and to take other review measures to ensure that its approach for addressing methane emissions does not severely impact the oil and natural gas sector. Inhofe’s letter is available online.


Five Foam Insulation Chemicals Proposed To Be CEPA Toxic: On August 15, 2014, Environment Canada and Health Canada proposed to identify five polyurethane foam insulation chemicals as toxic under the Canadian Environmental Protection Act (CEPA). The substances are: 1,1′-methylenebis[4-isocyanato-benzene; 1,1′-methylenebis[2-isocyanato-benzene; 1-isocyanato-2-[(4-isocyanatophenyl)methyl]-benzene; isocyanic acid, polymethylenepolyphenylene ester; and 1,1′-methylenebis[isocyanato-benzene. Two methylene diphenyl diamine (MDA) substances did not satisfy the toxicity criteria and have been dropped from review. The two MDA substances are 4,4′-methylenebis-benzenamine and formaldehyde polymer with benzenamine. More information is available online.

EPA OIG Reports EPA Risk Assessment Division Has Not Adhered To Quality Management Plan: On September 10, 2014, EPA’s Office of Inspector General (OIG) issued a report concluding that EPA’s Office of Pollution Prevention and Toxics (OPPT) Risk Assessment Division (RAD) has adhered to some but not all aspects of its current Quality Management Plan. RAD has not, according to OIG, fully implemented key aspects of its plan related to training, internal audits, and plan revisions. Additionally, unlike other Agency offices, RAD does not post its Quality Management Plan online as a good business practice. RAD is not ensuring managers and staff take in-house formal quality assurance training. RAD, instead, relies on branch chiefs and project managers to informally train staff through mentoring. OPPT is aware of the need to provide formal quality assurance training to its staff. The Quality Assurance Manager acknowledged the quality assurance training gap and plans to develop specific quality assurance training. Additionally, RAD did not conduct a formal quality assurance training needs assessment. The RAD Quality Assurance Coordinator has not conducted internal audits of quality assurance programs. Moreover, RAD has not revised its Quality Assurance Annual Report and Work Plan or Quality Management Plan when changes occurred to its program activities that involve major risk assessment responsibilities. Lastly, RAD does not post its Quality Management Plan on its Intranet, which can facilitate internal sharing and ease staff access. EPA needs to have accurate, reliable, and relevant Quality Management Plans because they are an essential part of valid and reliable decisions. Chemical risk assessments using high-quality data are critical to maintaining public trust in EPA. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop formal quality assurance training, direct RAD to conduct internal quality assurance audits and training needs assessments, and ensure that relevant RAD Quality Management Plans are updated when changes to quality assurance activities occur. In addition, OIG stated that OPPT needs to provide RAD’s Quality Management Plan on the OPPT Intranet and conduct a quality assurance analysis of OPPT to determine whether all divisions have fully implemented their Quality Management Plans. EPA agreed with OIG’s recommendations and has proposed acceptable corrective actions. OIG concluded all recommendations are resolved.

GAO Claims Agencies Neglect Why Rules Are “Significant”: According to the Government Accountability Office (GAO), the Office of Management and Budget (OMB) and federal agencies should be more transparent in explaining how a regulation is determined to be “significant” or not. In GAO’s report issued on September 11, 2014, Federal Rulemaking: Agencies Included Key Elements of Cost-Benefit Analysis, but Explanations of Regulations’ Significance Could Be More Transparent, of the more than 109 significant rules reviewed in the GAO report, 72 percent were silent on why they were classified as significant, either by agencies or the OMB’s Office of Information and Regulatory Affairs (OIRA), which is the office that evaluates federal regulations. A significant rule is a designation covering a broad range of rules, from relatively minor technical changes to those whose costs fall just under $100 million a year. Regulations that are believed to cost the economy $100 million or more annually are labeled “economically significant” — a classification that requires the issuing agency to do a more elaborate cost-benefit analysis than it would for “significant” rules. The GAO report was requested by Senator Ron Johnson (R-WS) and Senator Mark Warner (D-VA). The GAO report is available online.

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