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June 1, 2015

Monthly Update for June 2015

Bergeson & Campbell, P.C.


EPA Denies Petition To Ban Triclosan: On May 13, 2015, the U.S. Environmental Protection Agency (EPA) denied a petition submitted in January 2010 by Food & Water Watch and Beyond Pesticides seeking to ban triclosan, an antibacterial compound. According to EPA, “the information available at this time does not support granting the majority of the relief requested. The agency notes, however, that it is currently engaged across various programs in assessing the risks posed by triclosan, such as the risk assessment process in the registration review program, which includes a comprehensive review of human health and ecological risks … and the risk assessment process for biosolids (under CWA). Depending on the results of these assessments, the EPA may consider regulatory action.” The response is available online.

EPA Proposes SNURs For 30 Chemicals: On June 10, 2015, EPA proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 30 chemical substances that were the subject of premanufacture notices (PMN). 80 Fed. Reg. 32879. The proposal would require persons who intend to manufacture (including import) or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. The proposal includes, among other chemical substances, functionalized carbon nanotubes. Comments must be received on or before July 10, 2015.

EPA Announces Registration Of Nanosilver Pesticide Product: On May 19, 2015, EPA issued a conditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” This silver-based product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew. Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories, among other products. EPA’s decision reportedly was based on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant and data from the scientific literature. These data show that plastics and textiles treated with NSPW-L30SS release exceedingly small amounts of silver. Based on this evaluation, EPA determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing conventional silver products. EPA is also requiring the company to generate additional data to refine EPA’s exposure estimates. On August 27, 2013, EPA posted a proposed registration decision document to the docket for public comment. Responses to these comments, along with the current decision document, are available at in Docket ID # EPA-HQ-OPP-2012-0594.

Pollinator Health Task Force Issues National Strategy To Promote The Health Of Honey Bees And Other Pollinators: On May 19 2015, President Obama’s interagency Pollinator Health Task Force, co-chaired by the Secretary of Agriculture and the Administrator of EPA, issued its long-awaited “National Strategy to Promote the Health of Honey Bees and Other Pollinators,” ands its “Pollinator Research Action Plan.” The work was undertaken in response to President Obama’s June 20, 2014, memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators,” pursuant to which the Pollinator Health Task Force was formed and direction was given to develop a Pollinator Research Action Plan, Public Education Plan, and Public-Private Partnerships, and to identify steps the agency Task Force members will take to increase and improve pollinator habitat. Notable issues are raised by the documents. The Strategy states that it “expands and adds to actions already being undertaken by Federal departments and agencies to reverse pollinator losses and restore populations to healthy levels.” The Strategy includes several components: Pollinator Research Action Plan; plans for expanding education and outreach; opportunities for public-private partnerships; and improving pollinator habitat. Key items include the fact that the Strategy is a catalog of agency activities across the federal government. Like the President’s 2014 memorandum, the emphasis is on enhancing and expanding habitat and forage opportunities for pollinators, especially honey bees. The three strategic goals are repeated often: reduce honey bee colony losses, protect monarch butterflies, and increase pollinator habitat acreage. What is more pronounced in the Strategy when compared to the 2014 directive from the President is an emphasis on the monarch butterfly. Though mentioned in the President’s memorandum, protecting the monarch butterfly is now among the three central, overarching goals of the Strategy. More information is available at

EPA Issues Proposal To Mitigate Exposure To Bees From Acutely Toxic Pesticide Products: On May 29, 2015, EPA released its Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products and requested comment on a proposal to adopt mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar application of pesticides that are acutely toxic to bees on a contact exposure basis, unless the application is made in accordance with a government-declared public health response. 80 Fed. Reg. 30644. The label restrictions would prohibit applications of pesticide products that EPA has identified as acutely toxic to bees, during bloom when bees are known to be present under contract. As part of this mitigation proposal, the 48-hour notification exception for crops under contracted pollination services during bloom for all neonicotinoid product labels would be removed. These restrictions are intended to reduce the likelihood of acute exposure and mortality to managed bees under contract. EPA is not proposing at this time to require new language for pesticide labels for managed bees not under contract pollination services. This does not, however, alter EPA’s previous actions intended to impose more specific restrictions on neonicotinoid pesticides through label language addressing potential risks to bees not under contract for pollination services. EPA is also seeking comment on a proposal to rely on efforts made by states and tribes to reduce pesticide exposures for application sites not under contracted services, through development of locally-based measures, specifically through managed pollinator protection plans. These plans would include local and customizable mitigation measures to address certain scenarios that can result in exposure to pollinators. EPA will consider this information in determining whether this scenario needs the mitigation indicated in the proposed language. EPA states that the proposed actions are consistent with the Presidential Memorandum issued in June 2014 to reduce the effect of factors that have been associated with pollinator declines in general, as well as the mandate to engage state and tribal partners in the development of pollinator protection plans. Comments on the proposal are due by June 29, 2015. More information concerning the notice is available in Bergeson & Campbell, P.C.’s (B&C®) blog post on EPA Issues Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products and more information on the Presidential Memorandum and the National Strategy is available in B&C’s blog post on Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators.

EO 13650 Improving Chemical Facility Safety And Security – Report For The President: Year-One Achievements: In recognition of the one-year anniversary of EO 13650 Actions to Improve Chemical Facility Safety and Security – A Shared Commitment: Report for the President, the EO Working Group released a fact sheet on the accomplishments on improving chemical facility safety and security since the publishing of the Report to the President.

  • Fact Sheet: Actions to Improve Chemical Facility Safety and Security
    • The EO Working Group’s fact sheet provides the latest information on the actions that have been taken under the five elements in the EO 13650 consolidated Federal Action Plan:
      • Strengthening community planning and preparedness.
      • Enhancing federal operational coordination.
      • Improving data management.
      • Modernizing policies and regulations.
      • Incorporating stakeholder feedback and developing best practices.

As part of an ongoing federal effort to improve chemical risk management, advance safety, and protect human health and the environment, the documents below are related to the Working Group’s joint progress.

  • How to Better Prepare Your Community for a Chemical Emergency: A Guide for State, Tribal and Local Agencies
    • EPA’s new guide provides background on the Emergency Planning and Community Right-to-Know Act (EPCRA), the law governing local preparedness for chemical emergencies and public awareness of chemicals in their communities.
    • The guide also covers the following:
      • Overview of EPCRA requirements.
      • Roles and responsibilities of State Emergency Response Commissions (SERC)/Tribal Emergency Response Commissions (TERC) and Local Emergency Planning Committees (LEPC)/Tribal Emergency Planning Committees (TEPC).
      • Developing an emergency response plan.
      • Tools for planning and response.
      • Fire department roles in emergency planning.
      • Working with chemical facilities on planning and prevention.
      • Engaging the community.
      • Public access to information under EPCRA.
  • Chemical Safety Alert: Safer Technology and Alternatives
    • This alert is intended to introduce safer technology concepts and general approaches, explains the concepts and principles, and gives brief examples of the integration of safer technologies into facility risk management activities.
    • Sources of information on process hazard analysis and inherently safer approaches to process safety are provided.
    • The Occupational Safety and Health Administration (OSHA) and EPA are committed to developing voluntary guidance for facility owners and operators that will offer a more thorough examination of alternative measures and safety techniques and how these might be applied to existing processes to further reduce chemical and process risks.
  • Chemical Advisory: Safe Storage, Handling, and Management of Solid Ammonium Nitrate Prills
    • EPA, OSHA, and the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) have issued this revised Advisory as part of an ongoing federal effort to improve chemical risk management, advance ammonium nitrate (commonly referred to as AN) safety, and protect human health and the environment.
    • This advisory contains information on recent and past accidents involving AN, on the hazards of AN, how to manage these hazards, and appropriate steps for community emergency planning and proper emergency response.
    • This advisory is intended to broadly disseminate lessons learned from recent incidents involving AN so that such incidents can be prevented in the future.
    • It also provides a list of information resources, including relevant codes and standards, industry publications, and applicable statutes and regulations, that will help facilities handling AN and first responders better understand the hazards so they can effectively manage the risks.
    • The information provided is not intended to cover:
      • All the hazards, safe practices, or technical challenges associated with the manufacturing of AN;
      • Liquid fertilizers containing AN;
      • Manufacturing, storage, or use of explosives or blasting agents containing AN; or
      • The transportation of AN or AN containing products.
  • NFPA 400 Hazardous Materials Code, Chapter 11 for Ammonium Nitrate Revised
    • The National Fire Protection Association (NFPA) has revised its NFPA 400 Hazardous Materials Code.
    • Chapter 11 of the Code, which covers solid forms of AN, such as fertilizer-grade mixtures with 60 percent or more AN by weight, and liquid forms containing more than 70 percent AN by weight in quantities above 1,000 pounds, was modified to address the serious hazard created by the presence of combustible materials in contact with AN.

EPA Establishes CSAC: On June 12, 2015, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced the establishment of the Chemical Safety Advisory Committee (CSAC) and solicited nominations for membership on the Committee. 80 Fed. Reg. 33517. The purpose of the CSAC, which is established under the Federal Advisory Committee Act, is to provide expert scientific advice, information, and recommendations to the Office of Pollution Prevention and Toxics (OPPT) on the scientific basis for risk assessments, methodologies, and pollution prevention measures or approaches. Comments are due by July 13, 2015.


FDA Issues Proposed Rule To Amend 1994 OTC Antiseptic Drug Products: On May 1, 2015, the U.S. Food and Drug Administration (FDA) issued a proposed rule to modify the 1994 tentative final monograph for over-the-counter (OTC) antiseptic drug products. 80 Fed. Reg. 25165. FDA is proposing to “establish new conditions under which OTC health care antiseptic active ingredients are generally recognized as safe and effective (GRAS/GRAE).” The proposal includes additional safety and effectiveness data requirements. The products of interest in the proposed rule are health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient preoperative skin preparations. Several tables in the proposed rule detail specific actives along with the FDA proposed “category” for each. The comment period for the proposed rule ends October 28, 2015.

FDA Announces Availability Of Grant Funds To Support ICH Activities: On May 18, 2015, FDA announced the availability of grant funds to support the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). 80 Fed. Reg. 28274. FDA has been a key stakeholder, along with the European Union (EU) and Japan, in working with the ICH to develop global pharmaceutical standards. FDA intends to award one fund for fiscal year 2016 and to continue awarding funds through fiscal year 2020. The funds are to support the ICH in its efforts to develop international guidelines for implementation in areas around developing high quality medicines in the most efficient and cost effective manner, preventing unnecessary duplication of efforts in clinical trials, minimizing the use of animal testing without compromising safety and effectiveness, and providing public assurances that the rights, safety, and well-being of subjects are protected during clinical trials. The application due date is September 30, 2015. The expiration date is October 1, 2015.

FDA Publishes Draft Guidance On Patient Preference Information: On May 18, 2015, FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance entitled “Patient Preference Information — Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.” 80 Fed. Reg. 28277. The guidance details how FDA recommends collection and incorporation of patient preference data into various submissions, including premarket approval applications (PMA), Humanitarian Device Exemptions (HDE) applications, and de novo requests. This draft guidance is part of FDA’s ongoing activities to integrate patient preference into regulatory decision-making. The comment period for the draft guidance closes August 17, 2015.

FDA Issues Draft Guidance On Adaptive Designs: On May 18, 2015, FDA’s CDRH issued draft guidance entitled “Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.” 80 Fed. Reg. 28276. The purpose of the draft guidance is to provide industry and FDA staff guidance on planning and implementing adaptive design for clinical studies into medical device development for premarket approval. The guidance is not intended for “clinical studies of combination products or codevelopment of a pharmaceutical product with an unapproved diagnostic test.” The comment period for the draft guidance closes August 17, 2015.

FDA Announces Draft Guidance For Industry: On June 1, 2015, FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of draft guidance for industry entitled “Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products.” 80 Fed. Reg. 31050. The draft guidance provides industry with details of which elements of the chemistry, manufacturing, and controls (CMC) information, beyond variations established during the application process, requires reporting to FDA if changed for approved drug and biologic products. This draft is intended to clarify “what CMC information in an application constitutes an established condition” and recommended mechanisms for reporting. Comments on the draft guidance are due by July 31, 2015.

FDA Issues Final Rule Amending Veterinary Feed Directive: On June 3, 2015, FDA issued its final rule amending the Veterinary Feed Directive (VFD). 80 Fed. Reg. 31707. The final rulemaking is part of the ongoing efforts of the Animal Drug Availability Act (ADAA) of 1996 and is aimed to improve the efficiency of the VFD program and to facilitate the transition of current OTC feed use to their new VFD status. The final rule includes changes to the proposed rule in addition to changes to the current VFD regulations that are reflective of input FDA received from stakeholders from 2010-2013. The final rule changes key definitions, modifies certain provisions, and clarifies requirements. The rule is effective October 1, 2015. In addition, FDA issued a draft guidance for industry (GIF) #120 entitled “Veterinary Feed Directive Regulation Questions and Answers” to provide details to impacted parties on the VFD requirements under the final rule. 80 Fed. Reg. 31520. The comment period for the draft guidance closes August 3, 2015.

FDA Establishes New Voluntary Importer Program: On June 5, 2015, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) announced it was establishing a new voluntary fee-based program entitled “The Voluntary Qualified Importer Program (VQIP)” as part of ongoing activities under the Food Safety Modernization Act (FSMA). 80 Fed. Reg. 32136. The program is intended to create benefits for participants that include an expedited entry and reduced sampling process for the importation of food from foreign suppliers. The goal for FDA is to allow it to focus resources in areas that pose a higher risk to the supply chain. FDA estimates about 200 applications will be reviewed within the first year of the voluntary program. Draft guidance is available and contains details on the program, including application processes, facility certification information, user fees, and conditions that might cause FDA to revoke a voluntary participant’s eligibility. Comments are due by August 19, 2015.

FDA Issues Guidance For Animal Feed Additive Petitions: On June 12, 2015, FDA’s Center for Veterinary Medicine (CVM) issued guidance for industry (GFI) #221 entitled “Recommendations for Preparation and Submission of Animal Feed Additive Petitions.” 80 Fed. Reg. 33528. The guidance provides industry details on the types of information CVM recommends for inclusion in animal feed additive petitions. The guidance includes general format considerations, chemical identity and composition recommendations, intended use and labeling details, intended effect, analytics and methodology, safety evaluation outline, proposed tolerances for animal species used for human food, proposal for regulation placement, and environmental assessment as required under the National Environmental Policy Act (NEPA). The guidance is not intended to cover all aspects of the petition and for certain technically complex areas refers to other GFI’s for further consideration.


Court Rejects Challenges To RCRA Rule On Nonhazardous Secondary Materials: On June 3, 2015, the U.S. Court of Appeals for the District of Columbia Circuit rejected all challenges to EPA’s final rule exempting from Resource Conservation and Recovery Act (RCRA) regulation certain nonhazardous secondary materials (NHSM) burned for energy recovery in solid waste incinerators or industrial boilers. EPA promulgated the NHSM rule in 2013. 78 Fed. Reg. 9112. In the rule, EPA defined the NHSM that are solid wastes when burned and thus must be burned in solid waste incinerators, and those NHSM that would be considered fuels when burned and thus could be burned in industrial boilers that are subject to less stringent air emission standards. The rule also promulgated legitimacy criteria for determining on a case-by-case basis if other materials could be exempted from the stricter incinerator regulatory standards; it also excluded used tires and coal refuse. Environmental groups sued over the broad exclusions, while industry petitioners argued that EPA exceeded its RCRA authority in regulating as solid waste certain materials sent to third parties. In the case, Eco Servs. Operations LLC v. EPA, D.C. Cir., No 11-1189, the court held that EPA appropriately exercised its discretion under RCRA in promulgating the rule. In an unusual move, however, the court did not publish the four page opinion, despite the fact that hundreds of pages of briefs were filed in the case. The court stated that it had “accorded the issues full consideration and has determined that they do not warrant a published opinion.”

EPA Issues Technical Guides On Vapor Intrusion: EPA on June 11, 2015, released two long-awaited technical guidance documents intended to assist regulators in assessing and remediating vapor intrusion at contaminated sites being addressed under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The primary guide is entitled “Technical Guide for Assessing and Mitigating the Vapor Intrusion Pathway from Subsurface Vapor Sources to Indoor Air.” In it, EPA provides guidance for vapor intrusion sites being investigated under CERCLA, RCRA Corrective Action, and brownfield sites. The second guidance document is the “Technical Guide for Addressing Petroleum Vapor Intrusion at Leaking Underground Storage Tank Sites” and provides guidance for vapor intrusion from releases of petroleum hydrocarbons from underground storage tanks. Both guidances are available online.

DOT/Hazardous Materials

DOT Extends Emergency Order Requiring Crude Oil Train Data Be Provided To Emergency Responders: The U.S. Department of Transportation (DOT) on May 28, 2015, extended “until further notice,” a 2014 emergency order requiring state first-responder groups to receive data on crude-by-rail shipments. DOT announced the extension in a letter to eight Senate Democrats after they expressed concern that DOT’s recent final rule on high hazard trains could erode disclosure standards. DOT’s action ensures that SERCs and local officials will continue to get crude-by-rail information.

Obama Nominates Permanent FRA And PHMSA Administrators: President Obama has nominated acting Federal Railroad Administration (FRA) Chief Sarah Feinberg to serve as the agency’s permanent administrator. The post has been vacant since Joseph Szabo left on January 9, 2015. Feinberg is a former Facebook and Bloomberg executive and ex-aide to Rahm Emanuel who has also served as Chief of Staff to Transportation Secretary Anthony Foxx. Obama also nominated Marie Therese Dominguez, a Principal Deputy Assistant Secretary of the Army for civil works, to lead DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA).


Army And EPA Issue Controversial Waters Of The United States Rule: On May 27, 2015, the U.S. Army Corps of Engineers (Corps) and EPA issued a prepublication of the controversial Clean Water Act (CWA) Waters of the United States (WOTUS) final rule. EPA and the Corps promulgated the rule to clarify the scope of the CWA’s jurisdiction in the wake of Supreme Court decisions in 2001 and 2006 that muddied the water. The rule does not establish any new regulatory requirements. Instead it seeks to clarify the scope of the “waters of the United States” that are subject to jurisdiction under the CWA. EPA claims that the final rule “makes the process of identifying waters protected under the CWA easier to understand, more predictable, and consistent with the law and peer-reviewed science.” EPA also states that the rule does not create any new permitting requirements and maintains all previous exemptions and exclusions under the CWA. EPA proposed the rule in April 2014 and received millions of comments on it. The rule’s new definition of the term “waters of the United States” spans over nine pages in the pre-publication copy of the rule. The final rule interprets the CWA to cover those waters that require protection to restore and maintain the chemical, physical, or biological integrity of traditional navigable waters, interstate waters, and territorial seas. The rule defines “waters of the United States” to include eight categories of jurisdictional waters. EPA states that the jurisdictional categories reflect the current state of the best available science and are based upon the law and Supreme Court decisions. The first three types of jurisdictional waters — traditional navigable waters, interstate waters, and the territorial seas — are jurisdictional by rule in all cases. The fourth type of water, impoundments of jurisdictional waters, is also jurisdictional by rule in all cases. The next two types of waters, “tributaries” and “adjacent” waters, are jurisdictional by rule, as defined, because the science confirms that they have a significant nexus to traditional navigable waters, interstate waters, or territorial seas. For waters that are jurisdictional by rule, no additional analysis is required. The final two types of jurisdictional waters are those waters found after a case-specific analysis to have a significant nexus to traditional navigable waters, interstate waters, or the territorial seas, either alone or in combination with similarly situated waters in the region. Many in Congress and within the business community oppose the rule in what they perceive to be “regulatory overreach” by EPA. The rule is almost certain to be the target of litigation and ongoing efforts by lawmakers to block the rule’s implementation.

EPA Releases Draft Assessment On The Potential Impacts To Drinking Water Resources From Hydraulic Fracturing Activities: EPA on June 4, 2015, released, and is soliciting public comment on, its highly anticipated draft assessment on the potential impacts of hydraulic fracturing activities on drinking water resources in the United States. The draft assessment is available online. EPA’s assessment shows hydraulic fracturing activities (or fracking) “have not led to widespread, systemic impacts to drinking water resources.” The report also found, however, that fracking does pose some potential vulnerabilities in the water lifecycle that could impact drinking water. EPA’s review found specific instances where well integrity and waste water management related to hydraulic fracturing activities impacted drinking water resources, but they were small compared to the large number of hydraulically fractured wells across the country. The report identifies potential vulnerabilities to drinking water resources, but notes that some of these vulnerabilities are not unique to hydraulic fracturing. EPA also released nine peer-reviewed EPA scientific reports that were part of its overall hydraulic fracturing drinking water study. EPA will issue the report in final after it has been reviewed by the Science Advisory Board (SAB) and undergone public review and comment. On June 5, 2015, EPA announced that the SAB will hold teleconferences and a public meeting on the draft assessment. 80 Fed. Reg. 32111. Please consult the Federal Register for more details.

Court Rejects Challenges To Proposed Clean Power Plan: The U.S. Court of Appeals for the D.C. Circuit on June 9, 2015, dismissed as premature challenges to EPA’s proposed Clean Power Plan (CPP). In re: Murray Energy Corp., D.C. Cir., No. 14-1112, West Virginia v. EPA, D.C. Cir., No. 14-1146. Judge Brett Kavanaugh wrote in the majority opinion: “Petitioners are champing at the bit to challenge EPA’s anticipated rule restricting carbon dioxide emissions from existing power plants. But EPA has not yet issued a final rule. It has issued only a proposed rule. Petitioners nonetheless ask the Court to jump into the fray now. They want us to do something that they candidly acknowledge we have never done before: review the legality of a proposed rule. But a proposed rule is just a proposal … We do not have authority to review proposed agency rules. In short, we deny the petitions for review and the petition for a writ of prohibition because the complained-of agency action is not final.”

EPA Takes First Steps To Address Greenhouse Gas Emissions From Aircraft: EPA on June 10, 2015, issued an endangerment finding under the Clean Air Act (CAA) stating that greenhouse gas (GHG) emissions from commercial aircraft contribute to the pollution that causes climate change, endangering the health and welfare of Americans within the meaning of Section 231(a) of the CAA. While the endangerment finding is a first step towards regulating GHG emissions from aircraft, EPA is not at this time proposing aircraft engine GHG emission standards. In the finding, EPA states that aircraft remain the single largest GHG-emitting transportation source not yet subject to GHG standards. U.S. aircraft emit 11 percent of GHG emissions from the transportation sector in the U.S., 3 percent of total U.S. GHG emissions, 29 percent of GHG emissions from all aircraft globally, and 0.5 percent of total global GHG emissions, according to the finding. EPA makes this finding specifically with respect to the six GHGs: carbon dioxide (CO2), methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride. EPA finds that GHG emissions from engines used in U.S. subsonic jet aircraft with a maximum takeoff mass (MTOM) greater than 5,700 kilograms and in subsonic propeller driven (e.g., turboprop) aircraft with a MTOM greater than 8,618 kilograms, contribute to the GHG air pollution that endangers public health and welfare. Examples of covered aircraft would include smaller jet aircraft such as the Cessna Citation CJ2+ and the Embraer E170, up to and including the largest jet aircraft such as the Airbus A380 and the Boeing 747. Other examples of covered aircraft would include larger turboprop aircraft, such as the ATR 72 and the Bombardier Q400. EPA is not at this time proposing a contribution finding for GHG emissions from engines used in military aircraft or smaller aircraft such as smaller turboprops, smaller jet aircraft, piston-engine aircraft, and helicopters. EPA also issued an Advance Notice of Proposed Rulemaking (ANPR) on the process for setting an international CO2 emissions standard for aircraft at the International Civil Aviation Organization (ICAO), and describes and seeks input on the potential use of Section 231 of the CAA to adopt and implement the corresponding international aircraft engine emissions standard domestically.

EPA Issues SIP Call To Address Startup, Shutdown, And Malfunction Issues: On June 12, 2015, EPA issued a final rule to ensure states have plans in place that are consistent with the CAA and recent court decisions concerning startup, shutdown, and malfunction (SSM) operations. 80 Fed. Reg. 33839. It responds to a petition for rulemaking filed by the Sierra Club by addressing outdated provisions in State Implementation Plans (SIP) regarding emissions that occur during SSM events. This final action specifically: responds to the Sierra Club petition; clarifies EPA’s SSM Policy to assure consistency with the CAA and recent court decisions; and issues EPA’s findings that the SSM provisions in the SIPs of 36 states do not meet CAA requirements and accordingly issues a “SIP call” for each of those states. In the SIP call, EPA directs the affected 36 states to correct specific SSM provisions in their SIPs. The affected states have until November 22, 2016, to submit their amended SIPs to EPA. Exemptions from emission limits during periods of SSM exist in a number of state rules, some of which were adopted and approved into SIPs by EPA many years ago. Recent court decisions have held that under the CAA, such exemptions are not allowed in SIPs. Other court decisions have remanded similar exemptions in National Emissions Standards for Hazardous Air Pollutants (NESHAP), which EPA is also correcting in separate actions. Section 110(k)(5) of the CAA provides a mechanism commonly called a “SIP call” for correcting SIPs that EPA finds to be substantially inadequate to meet CAA requirements.

EPA Determines CAA Obligations Met For Seven HAPs: On June 3, 2015, EPA issued a final rule stating that it has met its statutory obligations under the CAA to establish emission standards for source categories accounting for not less than 90 percent of the aggregated emissions of each of seven specific hazardous air pollutants (HAP). 80 Fed. Reg. 31470. The rule became effective upon its publication. Section 112(c)(6) of the CAA requires EPA to take actions with respect to the sources of seven specific, persistent, bioaccumulative HAPs: alkylated lead compounds; polycyclic organic matter; hexachlorobenzene; mercury; PCBs; 2,3,7,8-tetrachloridibenzofurans; and 2,3,7,8-tetrachlorodibenzo-p-dioxin. EPA is required to ensure that source categories responsible for at least 90 percent of the aggregate emissions of each of these seven HAPs be subject to standards under CAA Sections 112(d)(2) or 112(d)(4). In the final rule, EPA lists almost 70 national emission standards that it has promulgated to address emissions of these HAPs. EPA thus concluded that it has met the CAA Section 112(c)(6) statutory obligation.

NACAA Issues Menu Of Options For States To Meet CPP Goals: The National Association of Clean Air Agencies (NACAA) on May 21, 2015, issued a menu of options intended to help state clean air agencies meet their goals under EPA’s CPP. The 465 page technical document identifies a range of technologies, programs, and policies that state clean air agencies might employ to reduce GHG emissions from the power sector as part of a CPP implementation plan. Entitled Implementing EPA’s Clean Power Plan: A Menu of Options, the tool begins with 25 detailed chapters, each of which explores various approaches to GHG reduction in the electric sector. Each chapter starts with a short description of the pros and cons of the approach. Next, the regulatory backdrop, policy underpinnings, implementation experience, and GHG reduction potential associated with the approach are discussed. Each chapter then looks at co-benefits of the approach, including benefits to society and the utility system. Costs and cost-effectiveness are also explored. Finally, in Chapter 26, the document examines a variety of emerging technologies and other important policies that regulators may wish to consider as they formulate plans to reduce power sector GHG emissions. Each of these chapters may be downloaded either individually or as part of the complete document.

EPA Proposes Renewable Fuel Standards For 2014-2016 And Biomass-Based Diesel Volume For 2017: On June 10, 2015, EPA proposed annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to all motor vehicle gasoline and diesel produced or imported in the years 2014, 2015, and 2016. 80 Fed. Reg. 33100. Under Section 211 of the CAA, EPA must set renewable fuel percentage standards every year at specified levels. Due to constraints in the fuel market to accommodate increasing volumes of ethanol and limits on the availability of non-ethanol renewable fuels, however, EPA states that the volume targets specified in the CAA for 2014-2016 cannot be achieved. EPA thus is proposing to establish a cellulosic biofuel volume for all three years that is below the applicable volume specified in the CAA and is also proposing to rescind the cellulosic biofuel standard for 2011. Relying on statutory waiver authorities, EPA is proposing to adjust the applicable volumes of advanced biofuel and total renewable fuel for all three years. The comment period on the rule closes July 27, 2015.

Court Of Appeals Upholds EPA’s Approach For Designating NAAQS Attainment Areas: In a broad ruling, the U.S. Court of Appeals for the District of Columbia Circuit rejected challenges from states and environmental groups that argued that EPA violated the CAA when it determined attainment and non-attainment areas for the ozone National Ambient Air Quality Standard (NAAQS). Finding that “EPA complied with the Constitution, reasonably interpreted the [Clean Air] Act’s critical terms and wholly satisfied — indeed, in most instances, surpassed — its obligation to engage in reasoned decision-making,” the court unanimously rejected challenges to EPA’s process. In the case, Mississippi Commission On Environmental Quality v. EPA, et al., environmental groups challenged nonattainment designations and states sought to eliminate nonattainment designations that they oppose. The court also rejected attacks made on constitutional grounds by Texas and Mississippi on the NAAQS program as a whole. The court upholds EPA’s interpretation of key statutory terms as “reasonable,” and defers to EPA’s use of computer modeling and other techniques to designate areas in attainment or nonattainment. The court also deferred to EPA on which deadlines states must meet to have air monitoring data included in attainment reviews. The court also stuck to its precedent in upholding EPA’s multi-step methodology for determining which outlying parts of a metropolitan nonattainment area should be included in that area. On the whole, the court broadly supported EPA and easily brushed aside petitioners’ challenges.


NIOSH Announces Paper Outlining Risks To Health Care Workers From Nano-Enabled Medical Products: The National Institute for Occupational Safety and Health (NIOSH) announced that in a paper published May 7, 2015, online ahead of print in the Journal of Occupational and Environmental Hygiene, “NIOSH authors Vladimir Murashov and John Howard highlight occupational risk mitigation practices for nano-enabled medical products throughout their life cycle for major health care workplace settings.” The manuscript highlights occupational risk mitigation practices for nano-enabled medical products throughout their life cycle for all major workplace settings, including: (1) medical research laboratories; (2) pharmaceutical manufacturing facilities; (3) clinical dispensing pharmacies; (4) health care delivery facilities; (5) home health care; (6) health care support; and (7) medical waste management. It further identifies critical research needs for ensuring worker protection in the health care industry.

NanoBCA Holds Roundtable In Washington, D.C.: On May 19-20, 2015, the NanoBusiness Commercialization Association (NanoBCA) held its 2015 DC Roundtable. The National Economic Council (NEC) and White House Office of Science and Technology Policy (OSTP) invited participants to attend a May 20, 2015, White House Forum on Small Business Challenges to Commercializing Nanotechnology. During the forum, participants discussed small business challenges to commercializing nanotechnology, with an emphasis on how private-sector led collaborations and partnerships (including public-private partnerships) can help overcome those challenges. Lynn L. Bergeson attended the Roundtable on behalf of the innovation community. Questions addressed during the forum included how the use of nanotechnology as a component of a much larger value-add system has impacted the thinking of nanotechnology commercialization. According to Bergeson, the nanotech industry would benefit from enhanced technological literacy within the federal family to keep face with the rapid speed of innovation. Bergeson also noted the need for greater sharing of information among the federal regulatory community to help ensure greater awareness of innovation and the application of governance frameworks to products of innovation requiring federal reviews of one form or another.

In recognition of the importance of nanotechnology research and development, representatives from companies, government agencies, colleges and universities, and non-profits announced a series of new and expanded public and private initiatives that complement the Obama Administration’s efforts to accelerate the commercialization of nanotechnology and expand the nanotechnology workforce. NanoBCA announced that it is partnering with Venture for America and working with the National Science Foundation (NSF) to promote entrepreneurship in nanotechnology. Three companies (PEN, NanoMech, and SouthWest NanoTechnologies) are offering to support the NSF’s Innovation Corps program with mentorship for entrepreneurs-in-training and, along with three other companies (NanoViricides, mPhase Technologies, and Eikos), will partner with Venture for America to hire recent graduates into nanotechnology jobs, thereby strengthening new nanotech businesses while providing needed experience for future entrepreneurs.

EPA Promulgates SNUR For Graphene Nanoplatelets: On June 5, 2015, EPA promulgated through a direct final rule SNURs for 22 chemical substances that were the subject of PMNs, including graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN Number P-14-763). 80 Fed. Reg. 32003. This substance is subject to a TSCA Section 5(e) consent order that includes the following requirements:

  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator (where there is a potential for inhalation exposure).
  2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the material safety data sheet (MSDS).
  3. Manufacturing, processing, or use of the PMN substance only as described in the consent order.
  4. No use of the PMN substance using an application method that generates a vapor, mist, or aerosol.
  5. Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substances specified in the consent order.
  6. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States.

The SNUR designates as a significant new use the absence of these protective measures. EPA states that it determined that the results of certain particle size distribution and material characterization testing would be needed for the PMN substance. According to EPA, the company has agreed to submit the full chemical characterization testing described in the testing section of the consent order within the timeframes identified in the order. Depending on the results of the characterization testing, additional toxicity testing may be required at a confidential aggregate manufacture volume, as detailed in the consent order. The June 5, 2015, rule will take effect on August 4, 2015.

OECD Finds Standard Test Guidelines For Normal Chemical Substances Are In Most Part Suitable For Nanomaterials: The Organization for Economic Cooperation and Development (OECD) issued a June 9, 2015, press release entitled “OECD chemical studies show way forward for nanomaterial safety.” The press release states:

  • Today the OECD marked the end of a seven-year experimental testing program, investigating 11 commercially viable nanomaterials across over 110 different chemical tests;
  • The results were coordinated from across 11 countries with tests and data generated from dozens of government agencies, universities, research institutions, and businesses; and
  • Over 780 studies on the specific properties of nanomaterials were undertaken to fill in the gaps of our understanding of nanomaterials.

The 11 nanomaterials tested include cerium oxide; dendrimers; fullerenes (C60); gold nanoparticles; multi-walled carbon nanotubes; nanoclays; silicon dioxide; silver nanoparticles; single-walled carbon nanotubes; titanium dioxide (NM100-NM105); and zinc oxide. OECD states: “The tests showed that the standard test guidelines used for normal chemical substances are in the most part suitable for use on nanomaterials. Changes to the Test Guidelines to better understand the intrinsic properties of nanomaterials are now providing a clear framework for OECD countries to move forward in the examination of nanomaterials.” According to OECD, its testing program “gives member governments confidence that the use of the OECD test guidelines to determine the impact that nanomaterials may have on the environment or human health are suitable in the most part.” OECD states that it will now focus on how the test guidelines can be better adapted “to make sure that the intrinsic properties of nanomaterials are fully accounted for.”

EPA Issues Proposed SNUR For Functionalized Carbon Nanotubes: On June 10, 2015, EPA issued proposed SNURs for 30 chemical substances that were the subject of PMNs, including functionalized carbon nanotubes (generic) (PMN Number P-13-793). 80 Fed. Reg. 32879. On October 27, 2014, EPA promulgated a SNUR for this PMN substance through a direct final rule. EPA withdrew the SNUR on December 23, 2014, after receiving notice of intent to submit adverse comments. According to the June 10, 2015, Federal Register notice, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk to human health or the environment. The notice states:

EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects.

EPA notes that a notice of intent to comment adversely has been submitted. EPA “awaits the adverse comment during the open comment period.” Comments on the proposed SNUR are due July 10, 2015.

CPSC And NNI Will Hold Workshop On Quantifying Exposure To Engineered Nanomaterials From Manufactured Products: The Consumer Product Safety Commission (CPSC) is sponsoring a July 7-8, 2015, workshop, co-sponsored by the National Nanotechnology Initiative (NNI), entitled “Quantifying Exposure to Engineered Nanomaterials from Manufactured Products — Addressing Environmental, Health, and Safety Implications.” This is a technical workshop to determine the state of the science and the tools and methods available to characterize and quantify exposure to engineered nanomaterials from consumer products. The U.S. federal regulatory agencies participating in the NNI have put forth a risk-based regulatory agenda regarding engineered nanomaterials. Because risk is calculated based on both hazard and exposure, this approach requires exposure data. A main goal of this approach is to bridge toxicology with exposure science. Registration is on a first-come, first-served basis and will be limited to 120 people.


BRAG Biobased Products News And Policy Report: B&C’s consulting affiliate, B&C Consortia Management, L.L.C. (BCCM), 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

USDA Issues Final Rule Amending Voluntary Labeling Program For Biobased Products: On June 15, 2015, the U.S. Department of Agriculture (USDA) issued final amendments to the regulations concerning the Voluntary Labeling Program for Biobased Products. 80 Fed. Reg. 34030. The rule is intended to incorporate statutory amendments to Section 9002 of the Farm Security and Rural Investment Act signed into law on February 2, 2014. Among other changes, USDA has deleted the definitions of BioPreferred product, Designated item, and Mature market products and revised the definition of Biobased product, and added new definitions. Other changes have been made. The rule is effective on July 15, 2015.


TSCA Modernization Act Formally Introduced In House; Passes Energy And Commerce Committee: Representative John Shimkus (R-IL) on May 26, 2015, formally introduced his TSCA Modernization Act of 2015 (H.R. 2576). Shimkus chairs the House Energy and Commerce Subcommittee on the Environment and the Economy, which unanimously approved a draft version of the bill on May 14, 2015. Shimkus revised the legislation after the Subcommittee’s passage. B&C’s detailed analysis of the bill is available online. The Energy and Commerce Committee on June 3, 2015, unanimously approved the bill by a 47-0 vote. California Democrat Anna Eshoo abstained. She had offered and then withdrew an amendment seeking to clarify that state chemical controls and enforcement would be preempted only when it is impossible to comply with both state and federal laws. An archived webcast of the markup and related materials are available online. The full House is expected to take the bill up in the last week of June.

House Committee Passes Bill Requiring Greater Transparency In Rulemaking: The House Committee on Oversight and Government Reform on May 19, 2015, passed legislation that would require information about forthcoming regulations to be posted publicly for at least six months before a rule could take effect. The panel approved the All Economic Regulations Are Transparent (ALERT) Act along a party-line vote of 20-17. The bill would require federal agencies to submit monthly updates to the Office of Information and Regulatory Affairs (OIRA) at the White House Office of Management and Budget (OMB) on each rule they expect to propose in the upcoming year. The bill would prevent a rule from taking effect until certain information about it has been posted online for at least six months. The bill was approved by the House Judiciary Committee on April 15, 2015, and the House passed similar legislation in 2014.

Bill Seeks To Amend CAA To Promote Manufacturing: Senator Shelley Moore Capito (R-WV) on May 21, 2005, introduced a bill that would amend the CAA to promote manufacturing. The Promoting New Manufacturing Act would require that EPA post publicly the number of new source review (NSR) air pollution permits it has approved each fiscal year and the percentage completed within one year. The bill requires EPA to disclose the number of NSR permits it has processed each year from 2008 through 2014 within 60 days of the law taking effect. It would also require EPA to disclose the average time it takes the Environmental Appeals Board to issue a final decision in appeals of the permits. The bill is intended to bring greater transparency to the CAA NSR permitting process and EPA’s progress in granting NSR permits.

Senators Introduce Carbon Tax Bill: On June 10, 2015, Senators Sheldon Whitehouse (D-RI) and Brian Schatz (D-HI) introduced the American Opportunity Carbon Fee Act, which would levy an escalating tax on CO2 emissions. The legislation is projected to reduce U.S. CO2 emissions by more than 40 percent by 2025 compared to 2005 levels. The fee would start at the Administration’s central social cost of carbon estimate ($45/metric ton in 2016) and increase annually by a real 2 percent. When emissions fall 80 percent below 2005 emissions, the annual adjustment would fall to inflation. The fee would be assessed on fossil fuels when mined, extracted, or imported, on large emitters of non-fossil-fuel-based GHGs, and on producers and importers of industrial gases with high global warming potential. The fee on fossil fuels would be increased to account for the amount of methane that escapes during the extraction and distribution of these fuels. Under the bill, the revenue generated by the tax would exceed $2 trillion in the first decade. These funds would be used to: reduce the top marginal corporate income tax rate from 35 percent to 29 percent; offer workers an annual inflation-adjusted $500 refundable tax credit to offset payroll taxes paid ($1,000 for married couples filing jointly); provide Social Security and veterans’ program beneficiaries and other retired and disabled Americans with an inflation-adjusted annual benefit beginning at $500; and allow states to deliver additional funds to low-income and rural households and workers transitioning to new industries.

Senate Environment And Public Works Committee Holds Hearing On Ozone NAAQS: The Senate Environment and Public Works Committee on June 4, 2015, held a hearing to examine the challenges and implications of EPA’s proposed NAAQS for ozone. EPA in November 2013 proposed to revise the primary NAAQS to a level within the range of 0.065 to 0.070 parts per million (ppm) from the current 0.075 ppm. The proposal has generated significant controversy over its potential cost impacts. The hearing also addressed three bills addressing the ozone NAAQS: S. 638, which would amend the CAA with respect to exceptional event demonstrations; S. 751, to improve the establishment of any lower ground-level ozone NAAQS; and S. 640, which would delay the review and revision of the ozone NAAQS. Testifying at the hearing were Kanathur Srikanth, Director, National Capital Region Transportation Planning Board, Metropolitan Washington Council of Governments; Gary Moore, Judge/Executive, Boone County Kentucky, President of the National Association of Regional Councils; Dr. Gregory Diette, Johns Hopkins University; Michael McKee, Chairman, Uintah County Commission; and Larry Greene, Executive Director, Sacramento Metropolitan Air Quality Management District. A webcast of the hearing, member statements, and witness testimonies are available online. In his opening remarks, Committee Chair James Inhofe (R-OK) stated that EPA’s ozone proposal “is the most expensive regulation in history with projected costs of $1.7 trillion and 1.4 million lost jobs.” He noted that up to 67 percent of counties fail to meet the proposed lower standards, “which means if this rule goes forward, they will face a legacy of EPA regulatory oversight, stiff federal penalties, lost highway dollars, restrictions on infrastructure investment, and increased costs to businesses.” Committee Minority Leader Barbara Boxer (D-CA) countered that the ozone standard “will save lives and protect the health of our children and families.”

Senate Resolution Would Create Committee To Review Rules: Senator Michael Rounds (R-SD) on May 20, 2015, introduced a resolution (S. Con. Res. 17) that would establish a joint select committee to review regulations. The Regulation Sensibility Through Oversight Restoration (RESTORE) Resolution would establish a Joint Select Committee on Regulatory Reform. The committee would be charged with reviewing the process by which rules are promulgated by agencies, as well as holding hearings on regulatory overreach. In addition, the committee would be charged with reviewing the Code of Federal Regulations for rules that should be repealed and to submit legislative recommendations to Congress.

Senate Bill Seeks To Enhance Safety For Crude Oil Rail Shipments: On May 22, 2015, Senator Charles Schumber (D-NY) introduced The Eliminating Dangerous Oil Cars and Ensuring Community Safety Act (S. 1462). The bill would accelerate the phase-out of DOT-111 and CPC-1232 tank cars and would also go beyond the requirements set forth in DOT’s final rule on crude oil rail transports. It would broaden the reduced speed requirements by limiting trains to 40 MPH in communities with a population density equal to or greater than 20 people per mile. Routes used by trains carrying crude oil or ethanol also would be required to have positive train control systems installed by 2018. The legislation would also require more thorough oil response plans for trains carrying certain products.

White House Threatens Veto Over HazMat Funding: The White House on June 1, 2015, threatened to veto legislation appropriating fiscal year 2016 funds for hazardous materials transportation and pipeline safety programs. In a Statement of Administration Policy, the White House stated that it “strongly opposes” House passage of H.R. 2577, which makes appropriations for DOT, the Department of Housing and Urban Development, and related agencies for fiscal year 2016. With respect to hazardous materials transportation funding, the policy statement claims that “the bill does not provide adequate funding for DOT to continue and further its focus on the safe movement of energy products throughout the transportation system by supporting enhanced inspection levels, investigative efforts, research and data analysis and testing in the highest risk areas.” The statement criticizes holding funding for Federal Railroad Administration’s Safety and Operations at fiscal year 2015 levels, claiming that doing so “inhibits its ability to hire critically needed safety inspectors to focus on the movement of crude oil across the Nation.” The bill was approved by the House Rules Committee on June 1, 2015. It would fund DOT’s PHMSA programs at $145.9 million, some $62 million less than requested by the White House.

Senate Bill Would Exempt Certain Pesticide Applications From CWA Permitting: On June 3, 2015, Senators Mike Crapo (R-ID) and Claire McCaskill (D-MO) introduced legislation that they claim “would eliminate a costly and redundant [EPA] regulation affecting pesticide users.” The Sensible Environmental Protection Act (SEPA) (S. 1500) seeks to clarify Congressional intent concerning federal regulation of pesticides and codify longstanding interpretation of regulatory statutes. The Senators claim that pesticide regulation under FIFRA is sufficient to regulate pesticide applications near bodies of water, and that permits under the CWA are duplicative and unnecessary. SEPA clarifies that CWA permits are not required for pesticide applications in or near water. The bill also requires EPA to report back to Congress on whether the FIFRA process can be improved to better protect human health and the environment. The legislation seeks to untangle regulatory requirements created by a 2009 decision by the U.S. Court of Appeals for the Sixth Circuit. The court vacated an EPA rule that exempted pesticide applicators from the need to apply for a National Pollutant Discharge Elimination System (NPDES) permit under the CWA. See Nat’l Cotton Council v. EPA, 2009 BL 1441, 553 F.3d 927, 68 ERC 1129 (6th Cir. 2009)).

House Bill Would Require Studies On Petroleum Coke: On June 3, 2015, Representative Robin Kelly (D-IL) introduced legislation that would require EPA and other federal agencies to study the public health and environmental impacts of the growing production of petroleum coke. The Petroleum Coke Transparency and Public Health Protection Act (H.R. 2636) would also require certain agencies to study petroleum coke’s storage and use, and promulgate regulations governing its storage and transportation.

House Bill Slashes EPA Funding: House appropriators have introduced a fiscal year 2016 funding bill for EPA that slashes the Agency’s budget by almost 9 percent from its fiscal year 2015 funding levels and is more than 13 percent below what the White House requested for fiscal year 2016. The bill would cut EPA’s budget to $7.4 billion, down $718 million from 2015 levels. The bill also denies the President’s request for an increase in the staff ceiling; instead, the bill would reduce the maximum number of full time EPA employees for the fifth consecutive year. The legislation also includes several policy riders blocking EPA from taking action on controversial rules. It would prohibit EPA from spending any funds during fiscal year 2016 to: require CAA permits for GHG emissions from livestock operations, implement the CPP, and regulate lead in ammunition or fishing tackle. The bill was passed on June 10, 2015, by the House Appropriations Subcommittee on Interiors, Environment and Related Agencies. It now moves to the full Appropriations Committee for consideration.

Senate Committee Approves Bill Blocking Waters Of The United States Regulation: The Senate Environment and Public Works Committee on June 10, 2015, approved The Federal Water Quality Protection Act (S. 1140), which would force EPA to withdraw its final Waters of the United States rule. The Committee voted along party lines and rejected all Democratic amendments to the bill. The legislation now heads to the Senate floor.

Senate Bill Would Eliminate Fracking Exemptions For Oil And Gas Discharges: Senator Ben Cardin (D-MD) on June 11, 2015, introduced a bill that he states is intended “to remove loopholes that exempt oil and gas companies involved in hydraulic fracturing (fracking) from the Clean Water Act.” The Focused Reduction of Effluence and Stormwater Runoff Through Hydraulic-Fracturing Environmental Regulation Act (FRESHER Act) (S. 1554) “creates consistent national standards that are needed to protect water resources by requiring oil and gas companies to have a plan to protect streams from runoff and acquire a simple permit,” Cardin stated. The bill would amend the CWA to require the Department of the Interior to conduct a study with respect to stormwater runoff from oil and gas operations. The FRESHER Act would also seek to require oil and gas companies to have a plan to protect streams from runoff and follow the same permitting laws as other industries.


EPA Advises Facility Operators To Minimize Releases During Hazardous Weather Events: As hurricane season approaches, EPA on May 22, 2015, issued a Hazardous Weather Release Prevention and Reporting Alert to remind facility operators of certain regulations that require minimization of chemical releases during process shutdown operations. The alert specifies operational release minimization requirements and clarifies reporting requirements, including exemptions. The alert and requirements are available online.

EPA Reportedly Challenged In Managing Chemical Risks: On May 28, 2015, the Office of Inspector General (OIG) issued its FY 2015 EPA Management Challenges Report. In it, OIG considers key management challenges confronting EPA. According to the Government Performance and Results Act Modernization Act of 2010, major management challenges are programs or management functions, within or across agencies, that have greater vulnerability to waste, fraud, abuse, and mismanagement where a failure to perform well could seriously affect the ability of an agency or the federal government to achieve its mission or goals. The Reports Consolidation Act of 2000 requires OIG to report what it considers the most serious management and performance challenges facing the Agency. OIG used audit, evaluation, and investigative work, as well as additional analysis of Agency operations, to identify the challenges presented in the report. The report provides detailed summaries of each challenge identified below:

The EPA Needs to Improve Oversight of States Authorized to Accomplish Environmental Goals
Limited Controls Hamper the Safe Reuse of Contaminated Sites
The EPA Faces Challenges in Managing Chemical Risks
The EPA Needs to Improve Its Workload Analysis to Accomplish Its Mission Efficiently and Effectively
The EPA Needs to Enhance Information Technology Security to Combat Cyber Threats
The EPA Continues to Need Improved Management Oversight to Combat Fraud and Abuse and Take Prompt Action Against Employees Found to be Culpable

The report notes that EPA’s ability effectively to ensure that the production and use of chemicals does not harm human health or the environment is dependent upon statutory authorities, availability of data required by laws, and the effectiveness of EPA’s program management. Limited authorities and data on chemical toxicities and exposures inhibit EPA’s effective implementation of the laws that regulate chemical use and production. In addition, EPA’s management and oversight of its implementation of existing authorities and initiatives to reduce chemical risks are falling short in several programs.

EPA Issues Guidance For Including Environmental Justice In Rulemakings: On May 29, 2015, EPA issued Guidance on Considering Environmental Justice During the Development of Regulatory Actions. The guidance is available online. The guidance is intended to help EPA staff incorporate environmental justice (EJ) into the process followed at EPA for developing regulations, also known as the Action Development Process (ADP). The guidance describes the legal and policy frameworks at EPA for rule writers to consider EJ. It also identifies the information EPA staff should consider to determine whether there are EJ concerns involved in the regulation being developed. The guidance highlights the kinds of questions about EJ that EPA staff should ask and address in each step of the rulemaking process. It also provides strategies and techniques for improving meaningful involvement by minority and low-income populations in key stages in the ADP. The guidance attempts to integrate “EJ considerations into the fabric of the ADP – from the point when [EPA] first starts considering a rule, then through its promulgation and implementation.”

EPA-OSHA Issue Chemical Safety Alert On Inherently Safer Technology: EPA and OSHA on June 9, 2015, issued an “alert” backing voluntary use of inherently safer technologies (IST) to reduce risks and improve safety at chemical plants. The Chemical Safety Alert: Safer Technologly and Alternatives explains the concepts and principles of IST and also provides examples of how to integrate IST into facility risk management activities. The alert states that “[t]he first choice for managing chemical hazards and risks is the use of Inherently Safer Technology (IST) or Inherently Safety Design (ISD).” In the alert, EPA and OSHA outline a process that facilities may follow to incorporate IST, and urges companies to understand thoroughly the hazards of the chemicals and processes they use. The alert includes a hierarchy of controls and a flow chart to help companies identify practical and cost-effective alternatives to make facilities safer.

EPA Holds Webinars On eDisclosure, EPA’s Plan To Modernize The Implementation Of The Audit Policy, And The Small Business Compliance Policy: On June 10 and June 15, 2015, EPA held webinars on its plan to modernize implementation of its Audit Policy and Small Business Compliance Policy. EPA is developing eDisclosure, a new centralized, web-based system for more efficiently receiving and processing violations disclosed to EPA under its self-disclosure policies under the Audit Policy and Small Business Compliance Policy. Those using eDisclosure, which EPA intends to launch in fall 2015, will be required to: (1) register with the system; (2) promptly disclose their violations online within 21 days of discovery; and (3) submit an online Compliance Report certifying that any noncompliance was timely corrected. Disclosures will be categorized as “Tier 1” or “Tier 2” disclosures. Tier 1 disclosures include EPCRA violations that meet all Audit Policy or Small Business Compliance Policy conditions, but do not include: (1) CERCLA Section 103/EPCRA Section 304 chemical release reporting violations; or (2) EPCRA violations with significant economic benefit as defined by EPA. For disclosures that qualify as Tier 1, eDisclosure will automatically issue an electronic Notice of Determination (eNOD) confirming that the violations are resolved with no assessment of civil penalties, conditioned on the accuracy and completeness of the submitter’s certified eDisclosure. Tier 2 disclosures include: (1) all non-EPCRA violations; (2) EPCRA violations where the violator can only certify compliance with Audit Policy Conditions 2-9 (i.e., discovery was not systematic), and (3) EPCRA/CERCLA violations excluded from Tier 1. For disclosures that qualify as Tier 2, eDisclosure will automatically issue an electronic Acknowledgement Letter (AL) confirming EPA’s receipt of the disclosure, and promising that EPA will make a determination as to eligibility for penalty mitigation if and when it considers taking an enforcement action for environmental violations. To obtain an eNOD, Tier 1 disclosers must correct their violations: (1) within 60 days of the date of discovery to obtain penalty mitigation under the Audit Policy; or (2) within 90 days of the date of discovery to obtain penalty mitigation under the Small Business Compliance Policy. Extensions of the correction deadlines are available only for Tier 2 disclosures, and some extension requests require the discloser to provide an online explanation or justification. EPA states that it will spot check Tier 1 disclosures for possible errors and inconsistencies. Tier 1 eNODs are conditional upon the accuracy of the representations made by the submitter. EPA will screen Tier 2 disclosures for criminal violations and other serious issues. According to EPA, if and when it considers taking enforcement action for environmental violations, it may determine that Tier 2 disclosures are not eligible for penalty mitigation. Consultants, attorneys, or other agents may disclose violations through eDisclosure on behalf of a regulated entity. All eDisclosure users must be identify-proofed and specify on whose behalf the filing is being made. After considering input received as a result of the June 10 and 15, 2015, webinars, EPA will build out the eDisclosure system and intends to launch it in fall 2015. When EPA launches eDisclosure, it will publish a Federal Register notice describing in detail how it will implement the Audit Policy and Small Business Compliance Policy. EPA states that pre-existing unresolved EPCRA disclosures can be resubmitted through eDisclosure within 90 days of its launch, but pre-existing disclosures that are subject to audit agreements will be resolved outside eDisclosure through a Notice of Determination (NOD), Consent Agreement and Final Order (CAFO), or Consent Decree (CD). More information is available in EPA’s eDisclosure Information Sheet.

EFSA Issues Call For Data On The Health And Environmental Effects Of Neonicotinoid Pesticides: On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the EU from the use of the three neonicotinoid pesticide active substances: clothianidin, imidacloprid, and thiamethoxam (the substances).

The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to restrict the use of the substances, which at the time included prohibiting use of the active substances clothianidin, thiamethoxam, and imidacloprid as a seed or soil treatment and for pre-flowering applications on crops attractive to bees and for cereals other than winter cereals. In May 2013, the Commission also stated that within two years it would initiate a review of any new scientific information.

EFSA is urging national authorities, research institutions, industry, and other interested parties to submit all information on the effects, exposure, and risks of the three substances regarding bees — honeybees, bumble bees, and solitary bees — when used as seed treatments and granules. This can include:

  • Literature data, including grey literature and any other data from research activities relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules. Data that have been provided and identified as relevant by EFSA in its published systematic literature review report need not be submitted, however.
  • Study reports conducted specifically to assess the risk to bees from the three substances applied as seed treatments and granules, and not yet considered under the previous EFSA assessments (EFSA Journal 2013;11(1): 306630673068).
  • National evaluations and/or monitoring data relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules that are available at the Competent Authorities of Member States and not yet considered under the previous EFSA assessments, listed in the above bullet.
  • Data that EFSA stated were not relevant in its published systematic literature review report may be submitted only if accompanied with a scientific rationale supporting their relevance.

The notice states that all information should be submitted by September 30, 2015. Any information submitted can be claimed as confidential by following procedures set forth in Article 63 of Regulation (EC) No 1107/2009. EFSA will review the material provided from this call for data and offer conclusions concerning an updated risk assessment following receipt of a follow-up mandate from the European Commission.

OECD Releases Chemical Classification Search Functions: The OECD issued on June 12, 2015, a new search function intended to make it easier to find how chemicals have been classified in accordance with the United Nation’s Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. The OECD added the search capability to its existing eChemPortal website. The website allows users to search global reports and data sets by chemical name and number, chemical property, and now by GHS classification . The GHS searching section of the OECD’s eChemPortal website is available online.

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.