Download PDF
August 1, 2014

Monthly Update for August 2014

Bergeson & Campbell, P.C.


IARC Classifies Dichloromethane, Other Substances As Human Carcinogens: In June, an expert panel of the International Agency for Research on Cancer (IARC) concluded that dichloromethane, a chemical substance used to make plastics, synthetic fibers, photographic films, and solvents, is a probable human carcinogen (Group 2A). IARC classified 1,2-dichloropropane (1,2-DCP), a solvent primarily used to make other chemicals, as a human carcinogen (Group 1). The expert panel based that conclusion on human studies from workers in a small Japanese printing plant. Two other chemicals considered, tetrafluoroethylene (TFE) and 1,3-propane sultone, were also classified as probable human carcinogens (Group 2A). Another chemical, perfluorooctanoic acid (PFOA), was classified as a possible carcinogen (Group 2B), according to IARC.

National Academies’ National Research Council Concludes Formaldehyde Causes Cancer: On August 8, 2014, the National Academies’ National Research Council (NRC) upheld the listing of formaldehyde as “known to be a human carcinogen” in the National Toxicology Program (NTP) 12th Report on Carcinogens (RoC). The Committee that wrote the NRC report found that the listing is supported by sufficient evidence from human studies that indicate a causal relationship between exposure to the chemical and at least one type of human cancer. The Committee reached the same conclusion after conducting both a peer review of the RoC and an independent assessment of the formaldehyde literature. In its independent assessment, the Committee considered human, animal, and mechanistic studies published through November 8, 2013, that focused on nasopharyngeal cancer, sinonasal cancer, and myeloid leukemia. It reportedly found sufficient evidence of carcinogenicity in human and animal studies and “convincing relevant information” that formaldehyde induces mechanistic events associated with the development of cancer in humans. Based on these findings, the Committee concluded that formaldehyde should be listed in the RoC as “known to be a human carcinogen.” Congress ordered the Academies to conduct the review following concerns with the RoC classifications of formaldehyde and styrene. The Omnibus Appropriations Bill for fiscal year (FY) 2012 (H. Rept. 112-331) directed the Department of Health and Human Services (HHS) to spend $1 million to have the National Academies peer review both classifications. Formaldehyde was first listed by NTP as “reasonably anticipated to be a human carcinogen” in 1981 before being upgraded to “known carcinogen” in the 2011 RoC. In its peer review of the RoC, the NRC found that NTP described the strengths and weaknesses of relevant studies in a way that was consistent and balanced, but noted that it would be more complete if it also discussed why weaker evidence did not alter the conclusion. In addition, NTP did not include a description of its interpretation of “limited” and “sufficient” evidence for human studies, which factors into whether a chemical is listed as reasonably anticipated to be or known to be a human carcinogen. The NRC Committee defined “limited evidence” in humans to be two or more studies of varied design that suggest an association between formaldehyde and a specific type of cancer but that cannot exclude alternative explanations such as chance, bias, or confounding factors. Evidence was deemed to be “sufficient” if those alternative explanations could be ruled out with confidence. On this basis, the Committee agreed that there is sufficient evidence to support an association between formaldehyde and cancer in humans. Pre-publication copies of Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens are available from the National Academies Press on the Internet at or by calling (202) 334-3313 or 1-800-624-6242

EPA Issues Insect Repellent Graphic: On July 18, 2014, the U.S. Environmental Protection Agency (EPA) issued in final a new graphic for insect repellent product labels that is intended to inform consumers of how long the products will be effective against insect pests when used as directed. EPA expects the graphic, which is voluntary, will appear on products beginning in early 2015. It shows the maximum duration that a product can be expected to repel ticks and/or mosquitoes based on efficacy data submitted by product registrants. Additional information on EPA’s repellency awareness graphic is available online.

EPA Announces New TRI Data: On July 21, 2014, EPA announced that the 2013 Toxics Release Inventory (TRI) preliminary dataset containing the most current TRI data is now available. These data include: what toxic chemicals a particular industrial facility is using; how much is being released into the environment; whether the facility is recycling or treating any of the toxic chemical waste, or burning any of it for energy recovery; and whether a facility initiated any pollution prevention activities in the most recent calendar year. Access to the data is through Envirofacts or through downloadable data files on the TRI website.

NTP Recommends Pentachlorophenol And Its Byproducts Be Classified As “Reasonably Anticipated To Be Human Carcinogens”: On July 22, 2014, NTP released a final monograph on pentachlorophenol (PCP) and byproducts of its synthesis and recommend that they should be labeled “reasonably anticipated to be human carcinogens.” NTP initially recommended that PCP and its byproducts be listed as “known to be human carcinogens,” which would have indicated a known causal relationship between exposure to PCP and its byproducts and cancer. NTP revised its draft report in March to propose labeling PCP and its byproducts “reasonably anticipated” to be carcinogens after a peer review panel concluded there was limited evidence indicating a causal relationship between PCP and cancer, but other explanations are possible. PCP is not now produced domestically. A company has reported producing the substance at a facility in Mexico, however. The NTP report will be submitted to HHS for review and, ultimately, for the Secretary to approve the NTP’s recommendation for PCP and its byproducts. The report is available online.

EPA Posts Materials On Ethylbenzene And Naphthalene: On July 31, 2014, EPA posted preliminary health effects, environmental, and other information it has found on ethylbenzene and naphthalene in preparation for the Integrated Risk Information System (IRIS) meeting on September 3-4, 2014. Ethylbenzene is an aromatic hydrocarbon in crude petroleum and gasoline. It is used to make styrene, solvents, and other products. Naphthalene is a polyaromatic hydrocarbon found in petroleum and coal. EPA’s preliminary information, timeline to submit comments, and docket numbers where comments can be posted are available online.

EPA Consolidates Information For Soil Fumigant Toolbox: On August 7, 2014, EPA announced that it has consolidated information on soil fumigants and placed it on a new “user-friendly” website. In an e-mail announcing the launch of its new Soil Fumigant Toolbox, EPA noted that the site is intended to reduce exposure to agricultural workers and the public. The website includes information on soil fumigants, buffer zones, and information targeted for communities, certified applicators of soil fumigants, and state and Tribal environmental agencies. EPA’s soil fumigant website is available online.


White House Launches Push To Shore Up Support For Proposed Clean Power Plan: The White House is launching a major effort to shore up support for EPA’s Clean Power Plan. Proposed by EPA on June 18, 2014, the initiative seeks to cut emissions of carbon dioxide (CO2) from existing fossil fuel-fired power plants by 30 percent by 2030. 79 Fed. Reg. 34830. Bergeson & Campbell, P.C. (B&C®) on July 22, 2014, held a webinar in conjunction with Pollution Engineering Magazine on the rule. The webinar can be viewed online for a limited time. EPA states that it has already received over 300,000 comments on the proposed rule. With the rhetoric heating up, the White House on July 29, 2014, released a report stating that that the costs of inaction on climate change would be catastrophic for the economy. Entitled The Cost of Delaying Action to Stem Climate Change, the report from the White House Council of Economic Advisers finds that delaying policy actions by a decade increases total mitigation costs by approximately 40 percent, and failing to take any action would risk substantial economic damage. Citing inaction by Congress on climate change, President Obama on July 29, 2014, announced a new suite of executive actions on climate change. Energy Secretary Ernest Moniz unveiled a series of actions, partnerships, and stakeholder commitments to help modernize the nation’s natural gas, transmission, and distribution systems and reduce methane emissions. The comment period on the proposal closes on October 16, 2014.

EPA Seeks Information Under Clean Air Act Accidental Release Prevention Requirements: On July 31, 2014, in response to Executive Order 13650, EPA requested comment on potential revisions to its Risk Management Program regulations and related programs under the Clean Air Act (CAA). 79 Fed. Reg. 44604. In the Request for Information (RFI), EPA seeks information and data on regulatory elements and process safety management approaches, the public and environmental health and safety risks they address, and the costs and burdens they may entail. EPA reportedly will use the information received in response to this RFI to inform what action, if any, it may take. Comments and additional material must be received on or before October 29, 2014.

EPA Proposes Addition Of Global Warming Potentials: On July 31, 2014, EPA proposed to add chemical-specific and default global warming potentials (GWP) for a number of fluorinated greenhouse gases (GHG) and fluorinated heat transfer fluids (HTF) to the general provisions of the Greenhouse Gas Reporting Rule. 79 Fed. Reg. 44332. Currently, these fluorinated GHGs and HTFs are not assigned GWPs under the rule. The proposed changes would increase the completeness and accuracy of the CO2-equivalent emissions calculated and reported by suppliers and emitters of fluorinated GHGs and HTFs. EPA is also proposing conforming changes to the provisions for the Electronics Manufacturing and Fluorinated Gas Production source categories. Comments must be received on or before September 2, 2014, unless a hearing is requested. If a hearing is requested, comments must be received on or before September 15, 2014.

GAO Report Faults EPA’s Management Of Fracking Wastewater Reinjected Into Wells: On July 28, 2014, the General Accountability Office (GAO) released a report faulting EPA’s oversight and regulation of hydraulic fracturing wastewater that is reinjected into wells. The reportDrinking Water: EPA Program to Protect Underground Sources from Injection of Fluids Associated with Oil and Gas Production Needs Improvement, reviewed EPA’s oversight of the Underground Injection Control (UIC) class II program under the Safe Drinking Water Act (SDWA). The report examined EPA and state roles, responsibilities, and resources for the program, safeguards to protect drinking water, EPA oversight and enforcement of class II programs, and the reliability of program data for reporting. EPA’s role in the UIC class II program is to oversee and enforce fluid injection into wells associated with oil and gas production, known as class II wells. EPA has approved 39 states to manage their own class II programs, and EPA regions are responsible for managing the programs in remaining states. Class II programs from the eight selected states that GAO reviewed have safeguards to protect against contamination of underground sources of drinking water. Programs in two states are managed by EPA and rely on EPA safeguards, while the remaining six programs are state managed and have their own safeguards that EPA deemed effective at preventing such contamination. According to the report, EPA and state program officials reported that these safeguards are protective, resulting in few known incidents of contamination.


FDA CDRH Issues Draft Guidance: On July 15, 2014, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a draft guidance document for industry on the Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. The draft guidance is intended to assist FDA reviewers in the risk benefit analysis portion of the submitter’s premarket notification submission or 510(k) substantial equivalence discussion and may help accommodate evolving technology. The guidance will also provide insight for submitters in demonstrating substantial equivalence in developing their 510(k) submission. For more information, see online.

FDA Office Of Health Affairs Issues Draft Guidance: On July, 15, 2014, FDA’s Office of Health Affairs issued draft guidance intended to provide information to institutional review boards’ (IRB) Clinical Investigators and Sponsors with respect to Informed Consent. The draft guidance is described as providing additional insight into the informed consent process as FDA continues to explore potential changes to the common rule and is to be utilized along with the informed consent requirements set forth in 21 C.F.R. Part 50. For more information, see online.

FDA CDRH Issues Guidance For Industry: On July 28, 2014, FDA’s CDRH published an industry guidance document entitled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. The draft was previously issued in December of 2011. The document is intended to provide industry and FDA staff information regarding the critical decision making process FDA uses in determining substantial equivalence by describing in greater detail the policies, regulations, and FDA practices with respect to the 510(k) review. For more information, see online.

FDA’s CDRH Issues Question And Answer Guidance: On July 30, 2014, CDRH issued a question and answer (Q&A) guidance document about the key provisions of Section 517A of the Federal Food, Drug, and Cosmetic Act (FFDCA), which contains information on certain significant decisions in the premarket review of device submissions, including current thinking on which types of decisions are not considered “significant” under this section of the Act. The Q&A also details “substantive summary” and how Section 517A relates to the Freedom of Information Act (FOIA). For more information, see online.

FDA CDRH Issues Draft Industry Guidance: On August 1, 2014, FDA’s CDRH issued a draft industry guidance document on the Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements. The draft document details devices that FDA would exempt from the premarket submission requirements (510(k)) as the FDA deems the devices mentioned as being well understood and do not present risks that require a 510(k). For specific devices and the draft guidance, see online.

FDA CDRH Issues Design Consideration For Devices Intended For Home Use Guidance: On August 5, 2014, FDA’s CDRH issued a guidance to industry on design considerations for devices intended for home use based on the previous draft document issued in December of 2012. The guidance provides insight for manufacturers developing devices that could have home use applications to assist them in minimizing common risks posed by home use devices and to greatly improve public health outcomes. For more details, see online.

FDA CFSAN Gluten-Free Food Labels: On August 5, 2014, the new rule from FDA’s Centers for Food Safety and Applied Nutrition (CFSAN) on gluten-free labeling provisions went into effect. The FDA gluten-free labeling final rule was published in August 2013. The final rule provides standard definitions to help consumers manage gluten-free diets and includes provisions that gluten-free foods must contain less than 20 parts per million (ppm) gluten. For more details, see online.

FDA CDRH Issues IVD Guidance: On August 6, 2014, FDA’s CDRH issued the In Vitro Companion Diagnostic Devices (IVD) guidance document, which had been issued as a draft in July 2011. The guidance defines IVDs, explains the role of FDA in oversight and clarifies application nuances, regulatory pathways, and statutory approval requirements. FDA in the guidance encourages sponsors in this category to consider meeting with the applicable FDA divisions to ensure proper product development plans. For more specifics, see online.


OECD Publishes Report Of Expert Meeting On Physical Chemical Properties Of Manufactured Nanomaterials And Test Guidelines: On July 15, 2014, the Organization for Economic Cooperation and Development (OECD) posted the July 2014 Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines. The Report presents the discussion and recommendations from the February 28-March 1, 2013, workshop on “Physico-chemical Properties of Manufactured Nanomaterials and Test Guidelines.” OECD notes that the workshop was organized “in close collaboration with the International Organization for Standardization Technical Committee on Nanotechnologies (ISO/TC 229),” which “provided an important dimension for the analysis of the physical-chemical properties of manufactured nanomaterials.” The discussion focused on selected endpoints and those existing OECD Test Guidelines and other methods and protocols that are being used to address them. The categories of endpoints selected included:

  1. State of Dispersion, Aggregation and Agglomeration of Nanomaterials;
  2. Size (and Size Distribution) of Nanoparticles;
  3. Surface Area and Porosity; and
  4. Surface Reactivity.

Four breakout groups were formed with the task to address the following questions:

  • Identify the relevance of these endpoints as additions to conventional physical-chemical characterization; and if relevant, outline possible methods (i.e., new OECD Test Guidelines) based on the outcomes of the OECD Testing Program and other sources of information;
  • Identify whether there is a need for specific guidance documents for testing and assessment of the physical-chemical properties of nanomaterials or adaptation of existing OECD Guidance Documents;
  • Discuss whether specific sections should be developed for the “Guidance on Sample Preparation and Dosimetry” (GSPD) on the basis of the experiences obtained in the Testing Program and other new developments in the area of testing and assessment of physical-chemical properties; and
  • Identify whether specific endpoints and/or OECD Test Guidelines are relevant to different categories of nanomaterials.

The Report is available online.

EC And SCENIHR Begin Public Consultation On Preliminary Opinion On Guidance On The Determination Of Potential Health Effects Of Nanomaterials Used In Medical Devices: The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. Guidance is provided on physico-chemical characterization of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices. The safety evaluation of nanomaterials used in medical devices is discussed in the context of the general framework for biological evaluation of medical devices as described in the International Organization for Standardization (ISO) 10993-30 1:2009 standard. Therefore, the risk assessment is performed taking into consideration type of device, type of tissue contact, and the duration of contact, thus identifying the specific exposure scenario. The Guidance is intended to provide information to help with safety evaluation and risk assessment of the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials. For the risk evaluation of the use of nanomaterials in medical devices, a phased approach is recommended based on potential release and characteristics of the nanomaterials. SCENIHR is seeking comments on the risk assessment related to the Guidance. Comments are due October 3, 2014. More information is available online.

NNCO Holds Webinar On 2011 EHS Research Strategy Progress Review: On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) held a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” Discussion focused on the research activities undertaken by the National Nanotechnology Initiative (NNI) agencies to advance the current state of the science as highlighted in the Progress Review. Representative research activities as provided in the Progress Review were discussed in the context of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy’s six core research areas: nanomaterial measurement infrastructure; human exposure assessment; human health; the environment; risk assessment and risk management methods; and informatics and modeling. The archived webcast is available online.

OECD Posts Report On Nanotechnology And Tire Industry: On July 24, 2014, OECD posted a report entitled Nanotechnology and Tyres: Greening Industry and Transport, which provides a risk management framework to enable site-specific or company-specific risk assessments or risk management strategies for using nanomaterials as additives in tires. OECD states that the report emphasizes the importance of:

  • The policies to support research in the environmental, health, and safety risks, as well as those to support the commercialization of nanotechnology research results, for fostering responsible innovation in the tire sector;
  • Using available tools to gain better insight into the socio-economic and environmental impacts of nanotechnology applications; and
  • Collaboration between governments and industry to address the specific challenges raised by the introduction of new nanomaterials in different industry sectors.

The report summarizes the conclusions of a two-year project, which was originally proposed and supported by the Business and Industry Advisor Committee to the OECD through the Tyre Industry Project of the World Business Council for Sustainable Development. The report is available online.

OSTP And NEC Seek Comments To Update Strategy For American Innovation: On July 29, 2014, the Office of Science and Technology Policy (OSTP) and the National Economic Council (NEC) published a Federal Register notice requesting public comments to provide input for an upcoming update of the Strategy for American Innovation. 79 Fed. Reg. 44064. According to the notice, the Strategy “helps to guide the Administration’s efforts to promote lasting economic growth and competitiveness through policies that support transformative American innovation in products, processes, and services and spur new fundamental discoveries that in the long run lead to growing economic prosperity and rising living standards.” The national priority areas outlined in the 2011 Strategy include nanotechnology. The 2011 Strategy states:

The President is committed to investments in innovation that promise to drive better health, future economic growth, and quality jobs in America. . . . The National Nanotechnology Initiative (NNI) is investing in areas such as nanoelectronics, which will foster a revolution in computing comparable to the transition from the vacuum tube to the transistor. And the FY 2012 Budget is making substantial investments to accelerate breakthroughs in advanced manufacturing technologies that can provide foundations for private sector investment and growth.

The July 29, 2014, Federal Register notice includes a number of questions, grouped into the following categories of innovation policy topics:

  • Overarching questions;
  • Innovation trends;
  • Science, technology, and research and development priorities;
  • Skilled workforce development;
  • Manufacturing and entrepreneurship;
  • Regional innovation ecosystems;
  • Intellectual property/antitrust;
  • Novel government tools for promoting innovation; and
  • National priorities.

Comments are due September 23, 2014.

House Subcommittee Examines Breakthrough Nanotechnology Opportunities For America: On July 29, 2014, the House Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade held a hearing on “Nanotechnology: Understanding How Small Solutions Drive Big Innovation.” Witnesses included:

  • James M. Tour, Ph.D., T.T. and W.F. Chao Professor of Chemistry, Professor of Computer Science, Materials Science and Nanoengineering, Smalley Institute for Nanoscale Science and Technology, Rice University;
  • Christian Binek, Ph.D., Associate Professor Physics and Astronomy, University of Nebraska – Lincoln;
  • Milan Mrksich, Ph.D., Henry Wade Rogers Professor of Biomedical Engineering, Chemistry and Cell and Molecular Biology, Northwestern University; and
  • Jim Phillips, Chairman and Chief Executive Officer, NanoMech, Incorporated.

Subcommittee Chair Lee Terry stated that “nanotechnology is poised to drive the next surge of economic growth across all sectors.” According to Dr. Binek, nanotechnology has the potential to transform a range of industries, in fields such as information technology, medical applications, energy, water supply with strong correlation to the energy problem, smart materials, and manufacturing. Dr. Tour encouraged steps to help the U.S better compete with markets abroad, and suggested Congress work with industry, tax experts, and universities to design an effective incentive structure to increase industry support for research and development. Professor Mrksich discussed the economic opportunities of nanotechnology, and obstacles to realizing these benefits. According to Mrksich, current challenges “include the development of strategies to ensure the continued investment in fundamental research, to increase the fraction of these discoveries that are translated to technology companies, to have effective regulations on nanomaterials, to efficiently process and protect intellectual property to ensure that within the global landscape, the United States remains the leader in realizing the economic benefits of the nanotechnology industry.” Mr. Phillips testified: “It’s time for America to lead. . . . We must capitalize immediately on our great University system, our National Labs, and tremendous agencies like the National Science Foundation, to be sure this unique and best in class innovation ecosystem, is organized in a way that promotes nanotechnology, tech transfer and commercialization in dramatic and laser focused ways so that we capture the best ideas into patents quickly, that are easily transferred into our capitalistic economy so that our nation’s best ideas and inventions are never left stranded, but instead accelerated to market at the speed of innovation so that we build good jobs and improve the quality of life and security for our citizens faster and better than any other country on our planet.” An archived webcast of the hearing and witness testimony are available online.

European Industry Associations Call For Balanced Policy On Nanomaterials: Fifteen European industry associations, including the Nanotechnology Industries Association (NIA) and the European Chemical Industry Council (CEFIC), have endorsed a brochure entitled “Europe needs safe and innovative nanotechnologies and nanomaterials.” According to the brochure, the associations “support the European Commission conclusion that the current European regulatory framework adequately covers nanomaterials, is science-based and proportionate.” The brochure highlights seven key points:

  1. Nanotechnologies provide solutions;
  2. Europe needs nanotechnologies to achieve the goals of the EU 2020 strategy;
  3. Safety is paramount;
  4. Openness and transparency are vital;
  5. The comprehensive European regulatory framework in place has the capacity to govern the production and use of nanomaterials;
  6. A common workable definition system for defining nanomaterials is welcome; and
  7. Europe cannot afford to miss out on the opportunities provided by nanotechnologies and the benefits they bring.

The brochure is available online.

NNCO Schedules Public Meeting: On August 7, 2014, NNCO, on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), announced that it will hold a workshop entitled “Sensor Fabrication, Integration, and Commercialization” on September 11 and 12, 2014. 79 Fed. Reg. 46282. The workshop will bring together experts from a wide-range of application areas, stages of product development, and manufacturing. The goal of the workshop is to identify key challenges faced by sensor developers and determine the critical needs of the community, especially with respect to necessary standards, testing facilities, and advances in manufacturing. The workshop will include case study examples of commercialization success, a small business panel focused on challenges faced in the commercialization of sensors, and breakout sessions to address explicitly the RFI questions regarding standards, testing, manufacturing, and commercialization. For more information, please consult the Federal Register.

Registration Open For SRA Nano Risk Analysis (II) Workshop: Registration is now open for Nano Risk Analysis (II), a workshop to explore how a multiple models approach can advance risk analysis of nanoscale materials. The workshop, which is being organized by the Emerging Nanoscale Materials Specialty Group (ENMSG) of the Society for Risk Analysis (SRA) and co-sponsored by B&C, will be held September 15-16, 2014, in Washington, D.C. The workshop will bring together experts from diverse disciplines to explore ways that Alternative Testing Strategies (ATS) may be combined to create a Weight of Evidence (WOE) or “multiple models” approach to inform context — specific decisions about risk from exposure to novel nanoscale materials. The goal is to advance a common understanding of the state of the science, early lessons, current opportunities, and next steps for developing ATS for use in decision making for nanoscale materials. The output of the workshop will be a set of recommendations reported to the OECD Working Party on Manufactured Nanomaterials (WPMN) and via peer reviewed publications and web-based portals about ways in which these approaches may be practically applied in the near term to improve environmental decision making by governmental and industrial organizations. More information is available online.


BRAG Biobased Products News And Policy Report: B&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

EPA Issues Final RFS Renewable Identification Number (RIN) Quality Assurance Program: On July 18, 2014, EPA issued in final additional regulatory provisions that are intended to assure reasonable oversight of RIN generation and promote greater liquidity in the RIN market. 79 Fed. Reg. 42078. Under the Renewable Fuel Standard (RFS) program, producers and importers of renewable fuel generate RINs that are used by petroleum refiners and importers to demonstrate compliance with their renewable fuel volume obligations. Several cases of fraudulently generated RINs led to inefficiencies and a significant reduction in the overall liquidity in the RIN market, resulting in greater difficulty for smaller renewable fuel producers to sell their RINs. EPA believes this rule will help ensure the use of the required renewable fuel volumes. The rule includes a voluntary quality assurance program and related provisions intended to meet these goals. The program also includes elements designed to make it possible to verify the validity of RINs from the beginning of 2013. Additionally, EPA issued in final a number of new regulatory provisions to ensure that RINs are retired for all renewable fuel that is exported and to address RINs that become invalid downstream of a renewable fuel producer. The provisions of the regulatory action become effective September 16, 2014.

EPA Proposes To Extend Deadlines For RFS Compliance: On August 8, 2014, EPA proposed to extend two reporting deadlines for the 2013 compliance period under the RFS program. 79 Fed. Reg. 46387. The proposed action would affect the annual compliance and attest engagement reporting requirement deadlines for regulated parties. The annual compliance reports and attest engagement reports for the 2013 RFS compliance period would not be due until 30 days and 90 days, respectively, following publication of the final rule establishing the 2014 renewable fuel percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel in the Federal Register. In that it is unclear whether the final RFS rule will be issued, the deadline has been more or less extended indefinitely. This proposed action would ensure, according to EPA, timely amendment of existing deadlines, before compliance obligations would otherwise go into effect. If EPA receives no adverse comment, it will not take further action on the proposed rule. Comments must be received on or before September 15, 2014.

USDA Revises BioPreferred Program: On July 31, 2014, U.S. Department of Agriculture (USDA) issued in final changes to a federal procurement preference program known as BioPreferred, designed to steer federal agencies and contractors to favor those products that have the “highest level practicable” of biobased content. 79 Fed. Reg. 44641. The final rule, issued by USDA’s Office of Procurement and Property Management, explains how USDA will determine what feedstocks or “intermediate ingredients” such as fibers, resins, and chemicals qualify for use in biobased products and thus would receive preferential treatment under federal procurement rules. The USDA action updates its Guidelines for Designating Biobased Products for Federal Procurement to reflect changes Congress made to the program with passage of the Food, Conservation and Energy Act of 2008 requiring USDA to “automatically designate” final products that are composed of 50 percent or more biobased material as preferred for procurement purposes. USDA stressed in its notice that the revisions “do not affect products that have already been designated” for federal procurement preference by the department.


California Postpones Priority Product Work Plan Workshops: On August 12, 2014, the California Department of Toxic Substances Control (DTSC) announced it is postponing the workshops to discuss the draft Priority Products Work Plan. The workshops, originally scheduled for August 19 and 25, 2014, will be rescheduled for times in September. According to the notice, DTSC wants to provide ample time for both review of the draft Work Plan in advance of the workshops, and stakeholder input during and after the workshops via written comments. During the workshops, DTSC staff will present an overview of the Work Plan and will explain the process by which future Priority Products will be chosen from the product categories outlined in the Work Plan. DTSC reminded stakeholders that the Work Plan imposes no requirements on responsible entities, it is only intended to provide signals to the marketplace regarding the scope of product categories that will be under evaluation over the next three years; More information will be posted as it becomes available online.


Chemical Safety Board Issues Preliminary Findings Into Freedom Industries Spill In West Virginia And Final Report On AL Solutions Fatal Dust Explosion: The U.S. Chemical Safety Board (CSB) on July 16, 2014, issued two reports: an update on the investigation into the Freedom Industries spill, and a final report on the AL Solutions fatal dust explosion. In an update on the investigation into the chemical storage tank leak that contaminated the drinking water of up to 300,000 residents of nine West Virginia Counties, CSB stated that it has found no evidence of formal, industry-approved inspections performed on any of the chemical storage tanks at Freedom Industries prior to the January 9, 2014, leak. Some 10,000 gallons of 4-methylcyclohexane methanol (MCHM), mixed with propylene glycol phenyl ethers (PPH), leaked from a tank at the facility and entered the Elk River. Informal inspections may have occurred, preliminary findings indicate, but investigators found a lack of appropriate engineering inspections with prescribed frequency and rigor. CSB commissioned an inspection of the tank that released the chemical and similar tanks. The investigation found that two small holes in the bottom of a 48,000-gallon tank were caused by corrosion, likely resulting from water leaking through holes in the roof and settling on the tank floor. Furthermore, CSB found a similar hole in the bottom of a nearby tank containing the same chemical. Other tanks showed signs of pitting and metallurgical damage, investigators reported. The growing corrosion in these tanks went unnoticed by Freedom Industries until the January 9, 2014, spill. Also on July 16, 2014, CSB released its final report, safety recommendations, and accompanying safety video into a fatal combustible dust explosion at the AL Solutions metal recycling facility in New Cumberland, West Virginia. The report reiterates a recommendation that the Occupational Safety and Health Administration (OSHA) made in a general industry combustible dust standard, something OSHA has been calling for since its definitive 2006 study on these accidents.

OSHA Issues Supplemental Notice Of Proposed Rulemaking To Improve Reporting And Tracking Of Work-Related Injuries And Illnesses: On August 14, 2014, OSHA published a Supplemental Notice of Proposed Rulemaking (supplemental notice) that is intended to improve the reporting and tracking of work-related injuries and illnesses. 79 Fed. Reg. 47605. OSHA issued the supplemental notice as a follow-up to its November 8, 2013, proposed rule that would amend OSHA’s regulation on the annual injury and illness reporting requirements by adding three new electronic reporting obligations. 78 Fed. Reg. 67254. During the comment period on the November rule, some stakeholders expressed concern that the proposal could motivate employers to under-record injuries and illnesses and that the proposal could promote workplace policies and procedures that deter or discourage employees from reporting work-related injuries and illnesses. To protect the integrity of the injury and illness data, the supplemental notice extends the comment period on this issue for 60 days, until October 14, 2014. The supplemental notice also seeks comment on 14 specific questions:

  • Are you aware of situations where employers have discouraged the reporting of injuries and illnesses?
  • Will the fact that employer injury and illness statistics will be publicly available on the Internet cause some employers to discourage their employees from reporting injuries and illnesses?
  • Are you aware of any studies or reports on practices that discourage injury and illness reporting?
  • Do you or does your employer currently inform employees of their right to report injuries and illnesses?
  • Are there any difficulties or barriers an employer might face in trying to provide such information to its employees?
  • How might an employer best provide this information?
  • What procedures do you or does your employer have about the time and manner of reporting injuries and illnesses?
  • Are you aware of any examples of reporting requirements that are unreasonably burdensome and could discourage reporting?
  • How should OSHA clarify the requirement that reporting requirements are reasonable and not unduly burdensome?
  • Are you aware of employer practices or policies to take adverse action against persons who report injuries or illnesses?
  • Are you aware of any particular situations where an employee decided not to report an injury or illness to his or her employer because of a fear that the employer would take adverse action against the employee?
  • What kinds of adverse actions might lead an employee to decide not to report an injury or illness?
  • Are there any employer practices that OSHA should explicitly exclude to ensure that employers are able to run an effective workplace safety program?
  • What other actions can OSHA take to address the issue of employers who discourage employees from reporting work-related injuries and illnesses?


DOT Proposes Comprehensive Rulemaking For The Safe Transportation Of Crude Oil: On August 1, 2014, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a proposed rule intended to improve the safe transportation of large quantities of flammable materials by rail — particularly crude oil and ethanol. 79 Fed. Reg. 45016. The proposal responds to several catastrophic railcar derailment disasters all involving crude oil and resulting in fatalities. DOT also issued on August 1, 2014, a companion Advance Notice of Proposed Rulemaking (ANPRM). 79 Fed. Reg. 45079. PHMSA is proposing new operational requirements for certain trains transporting large volumes of Class 3 flammable liquids; enhancements in tank car standards; and revisions of the general requirements for offerors to ensure proper classification and characterization of mined gases and liquids, including crude oil. The proposal, if issued in final as written, would require the phase out of the use of older DOT-111 tank cars for the shipment of Packing Group I flammable liquids by October 1, 2017, including most Bakken crude oil, and October 1, 2018, and October 1, 2020, for Packing Group II and III, respectively. The proposal also seeks information on expanding comprehensive oil spill response planning requirements for shipments of flammable materials. The proposal is based on information obtained under a 2013 Notice of Proposed Rulemaking (NPRM) issued by PHMSA, one of many initiatives PHMSA is careful to outline in the proposed rule in response to the rash of railcar incidents involving the transport of flammable liquids. DOT proposes to define the term “high-hazard flammable train” (HHFT) as a train carrying 20 or more tank carloads of flammable liquids, including crude oil and ethanol. DOT proposes the implementation of a written sampling and testing program for all mined gases and liquids to address: the frequency of sampling and testing; sampling at various points along the supply chain; sampling methods that ensure a representative sample of the entire mixture; testing methods to enable better analysis, classification, and characterization of material; statistical justification for sample frequencies; and duplicate samples for quality assurance. DOT is also proposing that offerors be required to certify that a compliant sampling and testing program is in place, document the testing and sampling program, and make program information available to DOT personnel upon request. Carriers would also be required to perform a routing analysis for HHFT that would consider 27 safety and security factors and select a route based on findings of the route analysis. The rule proposes new standards for tank cars constructed after October 1, 2015, and that are used to transport flammable liquids as part of a HHFT. DOT is requesting comment on three options for enhanced tank car standard requirements: require tank cars to have 9/16 inch steel, be outfitted with electronically controlled pneumatic (ECP) brakes, and be equipped with rollover protection; require the 9/16 inch steel requirement, but not require ECP brakes or rollover protection; and require 7/16 inch steel, but not require ECP brakes or rollover protection. The proposal also seeks to require that existing tank cars that are used to transport flammable liquids as part of a HHFT be retrofitted to meet the selected option for performance requirements. The proposal would also require HHFTs carrying one million gallons of Bakken crude oil to notify State Emergency Response Commissioners (SERC) and appropriate other emergency responders about the transport of this material in their state. Comment is also requested on reduced operating speeds. The ANPRM seeks comment on oil spill response plans (OSRP) to HHFTs based on thresholds of crude oil. The ANPRM asks specific questions the responses to which will facilitate the development of a proposed rule that would adjust threshold quantities to trigger OSRP requirements. Comments on both the NPRM and ANPRM are due on September 30, 2014.

DOT Proposes Hazardous Materials “Reverse Logistics” Program: DOT’s PHMSA on August 11, 2014, published a NPRM that would add a section to the Hazardous Materials Regulations (HMRs) creating regulatory provisions for the “reverse logistics” of hazardous materials. 79 Fed. Reg. 46748. PHMSA proposes a definition for “reverse logistics” for hazardous materials that are intended to be returned to or between a vendor, distributor, manufacturer, or other person for the purpose of returning the product for credit, recalling a product, replacement of the product, or similar reasons. The primary aim of the NPRM is to reduce the regulatory burden that applies to hazardous materials that are returned to retail or wholesale establishments. Under the current HMRs, a product that is a hazardous material that is returned to a retail establishment, for example, would generally be subject to full regulation under the HMRs. DOT proposes to create a new section — 49 C.F.R. Section 173.157 — that would apply specifically to reverse logistics. That new section would establish regulations for the shipment of hazardous material in the reverse logistics supply chain; define training requirements associated with reverse logistics shipments; provide authorized packaging for reverse logistics shipments; and set segregation requirements for reverse logistics shipments. The proposed rule would also amend the so-called “single shipper provision” at 49 C.F.R. Section 173.159(e) for shipments of lead acid batteries. The comment period on the proposed rule closes on October 10, 2014.

PHMSA/FAA Issue Final Rule Revising Standards For The Transportation Of Lithium Ion Batteries: On August 6, 2014, DOT’s PHMSA, in consultation with the Federal Aviation Administration (FAA), issued a final rule modifying the requirements governing the transportation of lithium cells and batteries. 79 Fed. Reg. 46012. The final rule revises hazard communication and packaging provisions for lithium batteries and harmonizes the HMRs with applicable provisions of the United Nations (UN) Model Regulations, the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the International Maritime Dangerous Goods (IMDG) Code. The final rule: replaces equivalent lithium content with Watt-hours for lithium ion cells and batteries; adopts separate shipping descriptions for lithium metal batteries and lithium ion batteries; revises provisions for the transport of small and medium lithium cells and batteries, including cells and batteries packed with, or contained in, equipment; revises the requirements for the transport of lithium batteries for disposal or recycling; harmonizes the provisions for the transport of low production and prototype 3 lithium cells and batteries with the ICAO Technical Instructions and the IMDG Code; and adopts new provisions for the transport of damaged, defective, and recalled lithium batteries. The rule became effective on August 6, 2014, but DOT also allowed a six-month voluntary delayed effective date, until February 6, 2015.

DOT Final Rule Bars Parties Who Fail To Pay Civil Penalties From Hazmat Transport: DOT’s PHMSA on August 7, 2014, issued a final rule that bars air carriers, rail carriers, or other regulated entities that fail to pay delinquent hazardous materials (hazmat) civil penalties from transporting hazardous materials. 79 Fed. Reg. 46194. The rule becomes effective on September 8, 2014, and would apply to parties transporting hazardous materials that fail to pay civil penalties issued on or after that date. The scope of the rule is broad — it applies to all parties transporting hazardous materials and that are regulated by PHMSA, FAA, the Federal Railroad Administration, and the Federal Motor Carrier Safety Association.

DOT Proposes Changes To Procedures For Approvals And Special Permits: DOT’s PHMSA on August 12, 2014, issued a NPRM to revise standard operating procedures and evaluation criteria for its special permit and approvals under its HMRs. 79 Fed. Reg. 47047. Under the HMRs, special permits allow an entity to transport hazardous materials in a manner not covered by the regulations but as safely as an authorized action. Approvals are hazardous materials transport activities allowed under the HMRs that require written consent from PHMSA. Under the Moving Ahead for Progress in the 21st Century Act (MAP-21), DOT is required to issue a rulemaking that provides standard operating procedures to support the issuance of special permits and approvals, and objective criteria to support the evaluation of special permit and approvals applications. DOT states that its NPRM does not change previously established special permit and approval policies. Rather, it states that publishing the procedures and criteria would offer additional clarity to hazardous materials shippers and carriers regarding the special permit and approvals application and renewal processes, improve the completeness of applications, and speed up application processing times. The comment period on the proposed rule closes on October 14, 2014.


EU Commission Issues First Hazardous Substance Authorization: The EU Commission recently granted the first ever authorization under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) for a hazardous substance. Specifically, Rolls-Royce plc was authorized to use bis (2-ethylhexyl) phthalate (DEHP) in the manufacturing process for airplane blades. The authorization expires in 2022. According to the Commission, whatever risk the application invites is adequately controlled by Rolls-Royce.


House Passes Bill Exempting Pesticide Applications From NPDES Permitting Requirements: The House of Representatives on July 31, 2014, passed the Reducing Regulatory Burdens Act of 2013 (H.R. 935), which would exempt pesticide applications near or on waters of the U.S. from the requirement to obtain National Pollutant Discharge Elimination System (NPDES) permits under the Clean Water Act (CWA). The bill would also amend Section 3(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to prohibit EPA or a state from requiring a permit under the CWA for a discharge from a point source into navigable waters of a pesticide authorized under FIFRA for sale, distribution, or use, or the residue of such a pesticide, resulting from application of the pesticide. The bill now heads to the Senate, where its prospects are unclear. Senator Barbara Boxer (R-CA), Chair of the Environment and Public Works Committee, opposes the bill. The legislation was introduced in March 2013 by Representative Bob Gibbs (R-OH). Without passage of the bill, Gibbs states that 365,000 pesticide users will be required to obtain NPDES permits. The bill’s supporters contend that legislative action on this issue has been needed since January 2009, when the U.S. Court of Appeals for the Sixth Circuit vacated an EPA regulation that exempted pesticide applications in or near water from NPDES permitting requirements. Nat’l Cotton Council v. EPA, 553 F.3d 927.

House Committee Passes Three Bills Curbing EPA’s Authority Under The CWA: The House Transportation and Infrastructure Committee on July 16, 2014, passed a trio of bills that would limit EPA’s rulemaking and permitting authorities under the CWA. The Waters of the United States Regulatory Overreach Protection Act of 2014 (H.R. 5078) would prohibit EPA and the U.S. Corps of Engineers (Corps) from issuing in final their April 21, 2014, “Waters of the United States” proposed rule. 79 Fed. Reg. 22187. Instead, H.R. 5078 would require EPA and the Corps to issue a proposed rule jointly with state and local officials based on consensus recommendations, which would be subject to public review. The bill also would block the interpretive rule, which the two agencies issued along with the proposed Waters of the U.S. rule, that attempts to clarify which agricultural practices would be exempt from CWA dredge-and-fill permits. The Regulatory Certainty Act (H.R. 4854) defines the exact period EPA is allowed to restrict or deny a CWA dredge-and-fill (wetlands) permit under CWA Section 404(c). The bill also clarifies that EPA lacks authority to approve or veto a Section 404 permit before the Corps has completed its review of the permit application or after the Corps has issued the permit. The Coal Jobs Protection Act of 2014 (H.R. 5077) preserves the authority of each state to make determinations relating to the state’s water quality management program, and restricts EPA’s ability to second-guess a state’s permitting and water quality standards decision. Specifically, the legislation would prohibit EPA from using its 2011 conductivity guidance, which was recently upheld by the U.S. Court of Appeals for the District of Columbia Circuit, set time limits for the processing of a Section 404 permit, and limit EPA’s and the Corps’ ability to redefine ”fill material” that determines whether discharges are regulated under Section 404 or the more stringent Section 402 permits. The bill also would protect the state’s authority in identifying total maximum daily loads (TMDL) for its waters and impaired waters list and would offer states the opportunity to take over portions of the Section 404 permitting program.

Senators Introduce Bill To Block EPA From Using “Secret Science” To Justify Regulations: On July 16, 2014, Senators John Barrasso (R-WY), David Vitter (R-LA), Mike Enzi (R-WY), Jim Inhofe (R-OK), Jim Risch (R-ID), Jeff Flake (R-AZ), Deb Fischer (R-NE), and Mike Crapo (R-ID) introduced legislation to prohibit EPA from using “undisclosed” science to justify new rules and regulations. The Secret Science Reform Act of 2014 (S. 2613) would specifically block EPA from proposing, issuing, or disseminating regulations or assessments based upon science that is not made publicly available. Under the legislation, EPA “would not be able to propose, finalize, or disseminate a covered action such as issue a new regulatory standard or regulation unless all scientific and technical information relied on to support such a standard or regulation is specifically identified and publicly available so there can be independent analysis and substantial reproduction of research results,” according to a statement from Barrasso. Information covered under the bill includes materials, data, and computer models, among other information. Companion legislation in the House (H.R. 4012) passed the House Science Committee on June 24, 2014 by a voice vote.

House Subcommittees Hold Joint Hearing On IRIS Reform: The House Science, Space, and Technology Subcommittees on Oversight and Environment on July 16, 2014, held a joint hearing entitled “Status of Reforms to EPA’s Integrated Risk Information System.” In May, the NRC released a report, Review of EPA’s Integrated Risk Information System (IRIS) Process. The report is a follow-up assessment of how EPA is implementing recommendations from an NRC review published in April 2011 on EPA’s formaldehyde assessment. In the 2011 report, NRC “strongly faulted EPA’s methodology in crafting its draft assessment, warning of a pattern of problems in how the agency crafts assessments for its Integrated Risk Information System (IRIS) database that could continue to hamper future risk studies.” The hearing examined EPA’s actions in response to both NRC reports to evaluate the status of IRIS reforms. The Science, Space, and Technology Committee has convened several hearings on this program, the most recent in 2011. Initially, these hearings focused on the IRIS interagency review process, and delved into the role of the White House and other agencies to determine the extent of their involvement in IRIS’ chemical risk assessments. The focus of the most recent hearings, however, has shifted to reviewing the efficacy of EPA’s overall IRIS process. Testifying at the hearing were Dr. David Dorman, Member, Committee to Review EPA’s IRIS Process, NRC; Dr. Kenneth Olden, Director, National Center for Environmental Assessment, EPA; Rena Steinzor, Professor of Law, University of Maryland, and President, Center for Progressive Reform; and Michael Walls, Vice President of Regulatory and Technical Affairs, American Chemistry Council. Member statements and witness testimonies are available online.

House Bill Would Limit Total Regulatory Costs For Federal Agencies: The National Regulatory Budget Act of 2014, introduced by Representatives Steve Scalise (R-LA) and Doug Collins (R-GA) on July 24, 2014, would place a limit on the total costs that federal agencies could impose through regulations. The bill would establish the Office of Regulatory Analysis (OAR), which would be required to provide an annual regulatory analysis of federal rules for the upcoming FY and their estimated cost on the economy. The legislation also creates a National Regulatory Budget, which allows Congress to set a cap on the total economic cost of new federal regulations to be implemented in the coming FY. Congress would also set caps on the regulatory cost allowed by individual agencies. The legislation requires that all newly proposed regulations receive an OAR estimate before being implemented. Agencies that fail to comply with the OAR will be subject to a 0.5 percent reduction in their appropriation based on their previous budget amount.

Senate Bill Would Accelerate Phase-Out Of PBT Chemicals In Products: On July 24, 2014, Senator Jeff Merkley (D-OR) introduced a bill that would phase out the use of persistent, bioacumulative, and toxic (PBT) chemicals in “everyday objects like popcorn bags and pizza boxes, and can end up in the food we eat,” according to a statement from Merkley’s office. The Protecting America’s Families from Toxic Chemicals Act (S. 2656) would require federal regulators to phase out most applications of PBTs within the next five years. The phase-out would apply to all uses, except where the elimination of a chemical would damage national security, or would cause a significant disruption to the economy, and where there is no alternative. Examples of chemicals addressed in the bill include mercury, lead, flame retardants, and others. The bill would vest EPA with the authority to define what properties made a chemical a PBT. EPA also would be given the authority to define what standard of proof companies or sectors would have to meet to persuade it that a chemical’s use is essential to the economy or national security.

Senate Committee On Environment And Public Works Holds Hearing On EPA Clean Power Plan: On July 23, 2014, the Senate Environment and Public Works Committee held a hearing on EPA’s sweeping proposed Clean Power Plan. EPA Administrator Gina McCarthy was the sole witness at the hearing. A webcast of the hearing and McCarthy’s testimony are available online. Republicans challenged EPA’s legal authority to regulate CO2 from power plants and asked McCarthy whether the Natural Resources Defense Council (NRDC) received undue deference from EPA in the proposed rule’s development. McCarthy rejected both of those assumptions.

Highway And Transportation Funding Act Of 2014 Sent To President: The Senate on July 29, 2014, overwhelmingly passed the Highway and Transportation Funding Act of 2014 (H.R. 5021). The bill is now sitting on President Obama’s desk; he is expected to sign the legislation. Passed by a 79-18 vote, the bill continues from October 1, 2014, through May 31, 2015, and authorizes appropriations through that period for specified federal-aid highway programs under: the Moving Ahead for Progress in the 21st Century Act (MAP-21), the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) Technical Corrections Act of 2008, the Transportation Equity Act for the 21st Century (TEA-21), the National Highway System Designation Act of 1995, and the Intermodal Surface Transportation Act of 1991 (ISTEA). The bill authorizes over $26 billion for federal-aid highway and highway safety construction programs. It extends the authorization of appropriations for specified National Highway Traffic Safety Administration (NHTSA) safety programs and Federal Motor Carrier Safety Administration (FMCSA) programs, authorizes appropriations for hazardous materials (hazmat) transportation safety projects, and authorizes expenditures from the Hazardous Materials Emergency Preparedness Fund.

House Passes Legislation To Amend Endangered Species Act; White House Threatens Veto: On July 29, 2014, the House, by a party line 233-190 vote, passed legislation amending the Endangered Species Act (ESA). The 21st Century Endangered Species Transparency Act (H.R. 4315) is an amalgam of four separate bills (H.R. 4315, 4316, 4317, and 4318) introduced by Republicans. The bill would require more disclosure of essential data and litigation costs and require consideration of state, county, and Tribal data. The bill would also require federal agencies to publish on the Internet all data used in ESA listing determinations. In a Statement of Administration Policy issued on July 29, 2014, the White House pledged to veto the bill. The Administration believes the bill “would rigidly constrain science, public input, and data in making Endangered Species Act (ESA) determinations.” H.R. 4315 would also require several changes detrimental to the implementation of the ESA, which provides a critical safety net for America’s native fish, wildlife, and plants and which has produced remarkable successes, the White House stated.

Senate Committee Holds Hearing On The Climate Impacts Of Climate Change: On July 29, 2014, the Senate Budget Committee held a hearing to examine the economic and budgetary consequences of climate change, focusing on the cost of inaction, and opportunities to reduce federal fiscal exposures through greater resilience to climate change and extreme weather. Testifying at the hearing were Alfredo Gomez, Director, Natural Resources and Environment, GAO; Mindy Lubber, Ceres, Boston, Massachusetts; Sherri W. Goodman, CNA Military Advisory Board, Arlington, Virginia; W. David Montgomery, NERA Economic Consulting, Washington, D.C.; and Bjorn Lomborg, Copenhagen Consensus Center, Copenhagen, Denmark. Witness testimonies and a webcast of the hearing are available online.

House Bill Would Repeal EPA Clean Power Plan Proposal And Revise Cost-Benefit Analysis: Claiming that the Obama Administration is “hell bent on waging a war on affordable energy and well-paying jobs,” Missouri Republican Ann Wagner on July 29, 2014, introduced legislation that would repeal EPA’s Clean Power Plan and would revise the manner in which EPA conducts cost-benefit analysis. The EPA Regulatory Domestic Benefit Act (H.R. 5300) would repeal the proposed rule. Wagner claims that EPA used domestic costs in calculating the cost-benefit analysis for the rule, but accounted for the international benefits from a 30 percent cut in power plant carbon emissions by 2030. Using this accounting method that she called “unconventional,” the rule had higher benefits than costs. Under her legislation, EPA would only be allowed to use benefits within the United States.

Senate Committee Approves Chemical Security Reauthorization Bill: The Senate Homeland Security and Governmental Affairs Committee on July 30, 2014, approved an amended version of legislation reauthorizing the Department of Homeland Security’s (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) program for four years. The bill (H.R. 4007) would provide a procedure for expedited approvals of site security plans at many chemical facilities and expanded protections for whistle blowers. The House passed its version of the bill on July 8, 2014, although it reauthorized the CFATS program for only three years.

Senate Bill Seeks To Boost Renewable Energy: Senator Mark Begich (D-AK) on July 30, 2014, introduced the Renewable Energy Environmental Research Act of 2014. The bill (S. 2705) seeks to make scientific research the federal government has performed more accessible to those interested in developing renewable energy projects, particularly marine energy. The bill directs the National Oceanic and Atmospheric Administration (NOAA) to implement a research program to collect, monitor, and distribute environmental data to assist in the development of renewable energy, particularly related to ocean energy. Examples of the type of information made available would be tidal data for use in choosing locations for wave energy infrastructure or wind data for siting wind turbines.

House Committee Holds Hearing Faulting EPA’s Clean Power Plan Rule: The House Committee on Science, Space, and Technology held a July 30, 2014, hearing entitled “EPA’s Carbon Plan: Failure by Design.” Testifying at the hearing were Jeffrey Holmstead, Partner, Bracewell & Giuliani LLP; Charles McConnell, Executive Director, Energy & Environment Initiative, Rice University; David Cash, Commissioner, Massachusetts Department of Environmental Quality; and Gregory Sopkin, Partner, Wilkinson, Barker, Knauer LLP. Member statements, witness testimonies, and a webcast of the hearing are available online. The hearing examined EPA’s approach to implementing its proposed Clean Power Plan rule. Chairing the hearing, Energy Subcommittee Chair Cynthia Lummis (R-WY) stated that with this “most sweeping regulatory proposal[] in America’s history . . . EPA is continuing its regulation rampage, attempting to take control of our nation’s electric system without any legal or scientific justification.” She added that the implications of this overreach are staggering and that the rule could shut down power plants, raise energy prices, and threaten energy security.

House Small Business Committee Holds Hearing Examining Whether EPA Is Meeting Obligations To Small Businesses: On July 30, 2014, the House Committee on Small Business held a hearing entitled “Regulatory Overreach: Is EPA Meeting Its Small Business Obligations?” Testimony was heard from Bob Perciasepe, EPA Deputy Administrator. The Committee examined EPA’s alleged failure to assess the economic impacts of both the recently issued Waters of the United States proposed rule and the Clean Power Plan proposed rule. Under the Regulatory Flexibility Act (RFA), EPA must thoroughly assess how these rules would impact small businesses and consider ways to reduce the rules’ negative consequences. It must also conduct outreach to small businesses before the rules are proposed to get direct input from small businesses. The Committee has concluded that “EPA is not fully complying with the letter or spirit of the RFA.” In a memorandum issued by the Committee, it further states that “EPA’s indifference to the law unfortunately demonstrates its lack of concern about the real-world consequences of its actions for American small businesses.” Committee Chair Sam Graves (R-MO) opened the hearing by stating that “EPA’s power grab goes beyond the agency’s mission and infringes on the rights of individuals and small business owners, and it will potentially have costly economic consequences.” He urged EPA to “withdraw the costly ‘waters’ rule, and reevaluate these decisions entirely.” Hearing information, including testimony and a webcast of the hearing, is available online.

Senate Committee Approves EPA Assistant Administrator And Chemical Safety Board Nominees: The Senate Environment and Public Works Committee on July 30, 2014, approved two individuals nominated for EPA Assistant Administrator positions and one person for the Chemical Safety Hazard Investigation Board (CSHIB). The Committee approved Ann Elizabeth Dunkin to be EPA Assistant Administrator Environmental Information; Jane Toshiko Nishida to be EPA Assistant Administrator for International and Tribal Affairs; and Manuel H. Ehrlich, Jr.

Lawmakers Introduce Bill On Water Conservation Measures: On July 31, 2014. Senators Barbara Boxer (D-CA) and Dianne Feinstein (D-CA), and Representatives Grace Napolitano (D-CA) and Peter DeFazio (D-OR), introduced W21: Water in the 21st Century, legislation that the bill’s sponsors claim would help communities better prepare for the future by providing new incentives and investments to help residents, businesses, and local water agencies to conserve, recycle, and manage limited water supplies. The legislation would expand rebates and grants for water conservation and efficiency; support local investments in water recycling and improved groundwater management and storage; invest in research into water-saving technologies and desalination; and establish an open water data system. The bill (H.R. 5363) seeks to bolster EPA’s WaterSense program, which promotes water conservation in products, buildings, and landscapes through information and rebates. The bill authorizes $50 million to administer the program and $700 million for rebates, through FY 2019, and then funds them at FY 2019 levels adjusted for inflation thereafter. It also creates a new grant program for local water systems to conserve water, increase water efficiency, or reuse water; modify or relocate existing water system infrastructure made or projected to be made inoperable by climate change impacts; preserve or improve water quality; and other projects. The bill also provides $250 million in loan guarantees and $150 million in matching grants to help support projects on a regional scale, including water recycling, ground water management, water storage, and water conveyance infrastructure. It establishes an open water data system at the Department of the Interior, reauthorizes the Water Resources Research Act at $9 million a year through 2020, reauthorizes the Water Desalination Act at $3 million a year through 2020, and directs the Secretary of the Army to review reservoir operations and assess whether there is a benefit in adjusting operations to take into account improved forecasting data. The bill also would establish Drought Resilience Guidelines for state and local agencies through EPA in coordination with USDA, Commerce, and Interior.

Bill Would Amend NEPA: On July 31, 2014, Representative David McKinley (R-WV) introduced legislation amending the National Environmental Policy Act (NEPA). The bill (H.R. 5358) would amend NEPA to clarify that no federal agency shall be required to consider the social cost of carbon in its NEPA evaluations. The bill was referred to the Committee on Natural Resources.

Bill Would Fold EPA Into Department Of Energy: Representative Marsha Blackburn (R-TN) on July 31, 2014, introduced H.R. 5322, a bill that would consolidate the Department of Energy (DOE) and EPA into a new Department of Energy and the Environment (DOEE). Blackburn introduced similar legislation in 2012. She claims that GAO has made clear that significant savings can be achieved through the consolidation of duplicative or fractured programs in the federal government, including DOE and EPA programs. Blackburn claims her legislation will achieve billions of dollars in cost savings by combining duplicative functions, and improve the administration of America’s energy and environmental policies by ensuring a coordinated approach.

Senate Bill Would Create Fund For Carbon Capture: Senator John Walsh (D-MT) on August 1, 2014, introduced a bill to establish a Carbon Capture and Sequestration (CCS) Deployment Acceleration Fund. The bill, S. 2776, is intended to promote the establishment of at least ten commercial-scale CCS units in the U.S. over the next decade. The bill was referred to the Committee on Energy and Natural Resources.

House Science Committee Chair Urges EPA To Stop “Hiding Truth” About Clean Power Plan Proposed Regulations: On August 13, 2014, House Science, Space, and Technology Committee Chair Lamar Smith (R-TX) sent a letter to EPA Administrator Gina McCarthy criticizing EPA’s “limited analysis” of its proposed Clean Power Plan rule and requesting more comprehensive, independent analysis before EPA moves forward. Smith states in the letter that “[f]or too long the EPA has hidden the truth from the American people. In order to regain public trust, the agency should rely on robust, objective and well-grounded technical analysis of its climate regulations. Flaws in recent EPA analyses amplify concerns about the real impacts of these regulations. Americans deserve an opportunity to see the facts.” Citing a GAO report released last week that Smith states highlights “a pattern of shoddy EPA analysis,” the letter goes on to say that “t was revealed that EPA relied on decades old data and ignored important factors. The independent watchdog warned that EPA cannot ensure that it’s [analysis] provide the public with a clear understanding of its decision making.” In his letter, Smith wrote that “[c]redible analysis is critical to a well-informed debate concerning climate change and energy policy choices now before American people. EPA’s incomplete modeling disregards a number of technical, regulatory, and economic realities. Americans deserve the bottom line: what does it cost and what will we get for the money?” The letter calls on EPA to provide comprehensive analysis that takes real-world contingencies into account rather than rely on models and science that are hidden from the public. Smith simultaneously sent a letter to the non-partisan Energy Information Administration (EIA) to conduct independent analysis using the same underlying data and assumptions that EPA uses. The letter states that “tandem analysis by EPA and EIA would allow for a side-by-side comparison of results and provide a more comprehensive accounting of the possible impacts of the agency’s proposal.” The letter requests the analysis be conducted by September 15, 2014.


USDA Withdraws Proposal To Share Information With State And Tribal Agencies: On July 18, 2014, USDA withdrew a proposed rule that would have amended the regulations regarding genetically engineered (GE) organisms regulated by USDA by adding provisions for sharing certain business information with state and Tribal government agencies. 79 Fed. Reg. 41934. USDA withdrew the proposed rule to ensure its ability is maintained to protect confidential business information (CBI) from disclosure. On February 27, 2013, the Animal and Plant Health Inspection Service (APHIS) proposed to share certain CBI contained in permit applications and notifications for importations, interstate movements, and releases into the environment of regulated GE organisms only with those state or Tribal agencies that have jurisdiction over GE agricultural crops and/or products, to enable the state and Tribal governments to review and comment on notifications and permit applications received by APHIS and to provide information, comments, and recommendations to APHIS. Since publication of the proposed rule, USDA discovered potential vulnerabilities under FOIA. While CBI is protected from mandatory public disclosure under FOIA, 5 U.S.C. Section 552(b)(4), USDA conducted an in-depth review of FOIA and determined that disclosure of CBI to state and Tribal regulatory officials may constitute a waiver of this FOIA exemption. Specifically, under FOIA, the states are considered members of ”the public.” Because disclosure to one member of the public means disclosure to the general public, APHIS may be required to disclose the CBI shared with state and Tribal regulatory officials to anyone who requests the same information under FOIA. FOIA mandates that federal agencies must or may withhold CBI, and USDA is committed to protecting CBI. Therefore, USDA decided to withdraw the February 27, 2013, proposed rule to ensure protection of CBI provided to APHIS in notifications and permit applications.

EPA Announces Availability Of Risk Assessment Forum White Paper: On August 12, 2014, EPA announced the availability of the Risk Assessment Forum White Paper: Probabilistic Risk Assessment Methods and Case Studies and its companion document Probabilistic Risk Assessment to Inform Decision Making: Frequently Asked Questions (FAQ). 79 Fed. Reg. 47105. The drafts were released for public comment, and externally peer reviewed by experts from academia, industry, environmental groups, and other government agencies. These documents describe how PRA can be applied to enhance the scientific foundation for decision making across the Agency. They were created in response to recommendation of numerous advisory bodies, including the Science Advisory Board (SAB) and NRC. This white paper and accompanying FAQ explain how EPA can use probabilistic methods to address data, model, and scenario uncertainty and variability by capitalizing on the wide array of tools and methods that comprise PRA. Both documents address issues such as variability and uncertainty, their relevance to decision making, and the PRA goal of providing quantitative characterization of the uncertainty and variability in estimates of hazard, exposure, or risk. The difference between the white paper and the FAQs document is the level of detail provided about PRA concepts and practices and the intended audience (e.g., risk assessors for the white paper vs. decision makers) for the FAQ document.

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.