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July 1, 2015

Monthly Update for July 2015

Bergeson & Campbell, P.C.


EPA Seeks Comment On Series 810 Test Guidelines: On June 17, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability for comment of several Series 810, non-binding, draft test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP). 80 Fed. Reg. 34638. The test guidelines provide guidance on conducting testing by the public and companies that are subject to EPA data submission requirements under OCSPP’s major statutory mandates. EPA made available for comment the following 810 Series draft test guidelines: OCSPP Test Guideline 810.2000 — General Considerations for Testing Antimicrobial Agents, OCSPP Test Guideline 810.2100 — Sterilants & Sporicides Recommendations for Efficacy Testing, and OCSPP Test Guideline 810.2200 — Disinfectants for Use on Hard Surfaces — Efficacy Data Recommendations. EPA published the notice announcing the final test guidelines for these product performance testing guidelines for antimicrobial agents in the March 16, 2012, Federal Register (77 Fed. Reg. 15750). Since then, EPA has received information from the users that these test guidelines are confusing and in some cases, inaccurate. The test guidelines have been re-formatted to be more user friendly, correct technical information, and include updates from policy documents published after 2012. The guidelines are available in; they are grouped by series under Docket ID numbers EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576. Comments are due August 17, 2015.

EPA Opts Not To Continue IRISTrack: On June 16, 2015, EPA announced its decision not to continue IRISTrack, a database to report the status of chemical assessments undertaken by the EPA’s Integrated Risk Information System (IRIS). EPA has decided instead to update the IRIS web page by the fall of 2015 to include assessment schedules. The EPA IRIS web page now posts and updates a table showing the status and next steps for IRIS assessments for 23 chemicals the program currently is evaluating and it identifies which of the seven IRIS assessment stages each chemical is in. Assessment information to be posted on the table in the future will include the result of EPA’s effort to prioritize assessments on the 2012 IRIS agenda, which EPA continues to say will be released later this year. At the urging of the National Academies and Congress, the IRIS program is transforming itself to a program capable of producing clear assessments in a timely fashion. One expected element of the IRIS program transformation is the release of its multiyear work plan — the IRIS agenda — describing which chemicals EPA will work on over the next four or five years. Kenneth Olden, National Center for Environmental Assessment (NCEA) Director, announced last October that a near-final work plan would soon be released by EPA. In addition to the changes to the IRIS web page, EPA announced that an IRIS meeting scheduled for August 26-27, 2015, has been rescheduled to September 24, 2015, and a risk assessment workshop focusing on exposure assessment that had been scheduled for October 19-21, 2015, will be held January 27-29, 2016. The August meeting was reportedly rescheduled to accommodate scheduling associated with the end of summer and the Labor Day holiday. The rescheduled October meeting will focus on state-of-the-science methods to evaluate various exposure scenarios and associated human health effects, exposures to multiple pollutants, and other topics. EPA’s updated IRISTrack web page is available online. EPA’s announcement on additional website changes that will be coming and the rescheduled August meeting is available online. Information on the exposure workshop in January 2016 is available online.

EPA Makes Available Endocrine Disruptor Assays And Computational Tools: On June 19, 2015, EPA announced how it is planning to incorporate an alternative scientific approach to screen chemicals for their ability to interact with the endocrine system. 80 Fed. Reg. 35350. The proposed new methods would serve as an alternative for three of the eleven current assays in the Endocrine Disruptor Screening Program (EDSP) Tier 1 screening battery, specifically the estrogen receptor binding (ER), estrogen receptor transactivation (ERTA), and uterotrophic assays. These computational high-throughput (HTP) tools will have the potential to impact significantly the prioritization for testing and will have a significant impact on List 2 test orders. EPA states that use of these alternative methods will accelerate the pace of screening, decrease costs, and reduce animal testing. In addition, this approach advances the goal of providing sensitive, specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment. EPA has stated its commitment to the development of HTP and computational tools to improve regulatory science, as recommended in the 2007 National Research Council (NRC) report, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” and to meet its statutory obligations in the face of challenging budget constraints. EPA specifically seeks comment on targeted issues, including the use of the ToxCast™ “ER Model” for bioactivity as an alternative method for the current ER binding and ERTA Tier 1 screening assays; the use of the ToxCast™ “ER Model” for bioactivity as an alternative method for the current uterotrophic Tier 1 screening assay; and the use of results from the ToxCast™ “ER Model” for bioactivity on over 1,800 chemicals as partial screening for the estrogen receptor pathway. Comments are due by August 18, 2015.

NTP Concludes Flame Retardant Causes Cancer In Rodents: On June 25, 2015, a scientific peer review panel advising the National Toxicology Program (NTP) concluded that a mixture of polybrominated dephenyl ethers (PBDE) showed clear evidence of causing liver cancers in both rodent species. The panel reviewed a mixture of closely related PBDEs that would have been found in pentabromodiphenyl ether (penta-BDE), a flame retardant voluntarily phased out of U.S. production in 2004. If the peer review panel’s conclusion is made final after additional scientific reviews and penta-BDE is deemed a carcinogen, it could trigger related chemical classification adjustments, including a process that leads to a chemical being placed on California’s Proposition 65 list, likely resulting in hazard communication warnings in workplaces and labeling requirements. The NTP’s draft report on penta-BDE, along with the summary of the recommendations made by its peer review panel, are available online under “June 25.”

Court Of Appeals Grants Writ Of Mandamus Requiring EPA To Take Final Action On Chlorpyrifos Petition: On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the court is impatient about what it perceives to be the slow pace of review by EPA. The petitioners sought such a writ in 2012, and the court denied that request without prejudice in 2013. EPA took action in 2012 that addressed seven out of the ten issues originally raised by the petitioners, and the court found in 2013 that the time taken by EPA to address the petition was “not unreasonable in light of the complexity of the issue.” On March 26, 2015, EPA wrote to the petitioners stating that it intends to deny their petition to cancel registrations and revoke tolerances for chlorpyrifos. EPA bases this anticipated decision on a new human health risk assessment incorporating a physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) model that allows EPA to estimate human risk directly rather than extrapolating from animal data. Based on this model, EPA determined that label changes are needed to mitigate certain occupational exposures and localized drinking water exposure, and has requested comment on these findings. EPA counsel represented during oral argument in the case that EPA could complete its review of the comments and take action on the petition by mid-September 2015. In response, the court issued an order directing EPA either to submit a status report by June 30, 2015, stating whether EPA intends to issue in final its preliminary denial, or whether EPA has decided instead to grant the petition in whole or in part. If the petition will be denied, EPA must issue the final denial decision by September 15, 2015. The court did not require EPA to respond to all of the comments on the risk assessment, or to determine what mitigation measures will ultimately be required, by the September deadline. Although EPA would typically prefer to complete all related tasks and to compile a comprehensive administrative record before issuing the final decision denying the petition to cancel chlorpyrifos, that would be very challenging to do in this instance. The comment period for the current risk assessment closed on April 30, 2015, and EPA must evaluate and respond to detailed comments on a complex assessment, one which has some important issues subject to serious dispute by the affected registrants.

EPA Releases Endocrine Disruptor Screening Program Tier 1 Assessments: On June 30, 2015, EPA released the first Tier 1 assessments in the EDSP, a significant benchmark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential interactions of the remaining 52 chemicals with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system. EPA evaluated the data from 11 screening assays (five in vitro and six in vivo), along with other scientifically relevant information (OSRI) comprised of existing toxicology studies and peer reviewed published literature, and drew preliminary conclusions about the potential of these 52 chemicals to disrupt endocrine functions. Importantly, EPA noted that “a result indicating potential should not be construed as meaning that EPA has concluded that the chemical is an endocrine disruptor.” The individually published weight-of-evidence (WoE) assessments and anticipated data evaluation records (DER) can be accessed online for the 52 chemicals involved in the Tier 1 screening assessment. EPA summarized its conclusions from EPA’s Tier 1 WoE assessments as follows:

  1. No evidence of potential interaction with any of the endocrine pathways was identified for 20 chemicals.
  2. Fourteen chemicals showed potential interaction with one or more pathways, but based on the available information, do not pose a risk for endocrine disruption.
  3. Eighteen chemicals showed potential interaction with the thyroid pathway, 17 of which also showed interaction with the androgen pathway and 14 with the estrogen pathway.

To explore further any potential adverse effects on the endocrine system that may be caused by the 18 chemicals that EPA categorized in the third group, EPA has recommended certain Tier 2, multigenerational studies across various species. EPA has not yet issued its final Tier 2 non-mammalian OCSPP test guidelines (890 Series). It is expected that the release of these remaining guidelines will signal the approach of the Tier 2 test orders, which EPA is likely to issue in 2016. Although a formal public comment period is not expected to be opened for the Tier 1 assessments, affected registrants should have the opportunity to respond directly to EPA regarding WoE assessments and forthcoming DERs. This release of the Tier 1 WoE assessments, the anticipated release of Tier 2 test guidelines, along with EPA’s commitment to further the development of HTP assays and computational tools (see EPA Makes Available Endocrine Disruptor Assays And Computational Tools above) also will significantly influence the prioritization of List 2 chemicals in the EDSP and timing of the List 2 test orders. The revised List 2 includes 109 chemicals for Tier 1 screening. As with List 1, List 2 candidates reportedly were selected based on EPA’s review concerning their possible presence in public drinking water and/or registration review status within EPA, and not because of their potential to interfere with the endocrine systems of humans or other species.

EPA Releases Guidance Document On Antimicrobial Pesticide Use Site Index: On July 1, 2015, EPA issued a notice announcing the availability of and requested comment on a proposed guidance document amending regulations setting forth data requirements to support applications to register a pesticide product. 80 Fed. Reg. 37610. The final rule contains the data requirements specifically applicable to antimicrobial pesticides, which were codified in 40 C.F.R. Part 158, subpart W. The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201. The data requirements applicable to a pesticide product depend in part on the product’s use pattern. The general use patterns are broad designations and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site. EPA has developed the Use Site Index (USI) to assist antimicrobial pesticide applicants and registrants and EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product. EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns. The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia. Comments are due by July 31, 2015.


FDA Seeks Comment On Whether Certain CFC-Containing Products Are No Longer Essential: On June 29, 2015, the U.S. Food and Drug Administration (FDA) requested comment on whether certain products containing ozone-depleting substances (ODS), including chlorofluorocarbons (CFC), are no longer essential because alternatives are available or because they are no longer being marketed. 80 Fed. Reg. 36937. Essential-use products are exempt from FDA’s ban on the use of CFC propellants in FDA-regulated products and the EPA ban on the use of CFCs in pressurized dispensers, according to FDA. CFCs reduce the amount of ozone in the stratosphere and thereby increase the amount of ultraviolet radiation reaching the Earth. FDA is seeking comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act (CAA). The comments will assist FDA in “striking an appropriate balance that will best protect the public health, both by ensuring the availability of an adequate number of alternatives and by curtailing the release of ODSs,” the notice states. Specifically, FDA stated it is seeking comment on whether sterile aerosol talc administered intrapleurally by thoracoscopy for human use is still essential. Sterile aerosol talc is marketed for intrapleural administration in two non-ODS formulations — powder and aerosol. The route of administration, indications, and level of convenience appear to be the same for the ODS and non-ODS formulations of sterile aerosol talc. Comments are due August 28, 2015.


EPA Makes Substantive Changes To RCRA UST Regulations For First Time In Almost 30 Years: EPA on July 15, 2015, issued a final rule revising the Resource Conservation and Recovery Act (RCRA) regulations for underground storage tanks (UST). 80 Fed. Reg. 41566. The changes take effect on October 13, 2015. These are the first substantive changes EPA has made to the UST regulations since promulgating the 40 C.F.R. Part 280 regulations in 1988. The revisions implement key portions of the Energy Policy Act of 2005, but they also address the causes of ongoing releases from UST systems. EPA states that there are approximately 6,000 releases annually from UST systems, and that the most common causes occur in piping and are due to overfills associated with deliveries or releases at dispensers. The revisions are intended to address the causes of these releases. EPA also states that release detection equipment is only detecting about half of the releases they should detect and so it is promulgating revisions to the secondary containment and leak detection requirements. EPA’s revisions to the UST regulations fall into four categories: new requirements for operation and maintenance of UST systems; addressing UST systems deferred in the 1988 regulations; changes to improve release prevention and release detection; and general updates to the 1988 UST regulations. The most significant changes address operator requirements and secondary containment. With respect to operator requirements, EPA is promulgating a new Subpart J to the Part 280 regulations, establishing operator training requirements to ensure properly trained individuals operate all regulated UST systems. EPA has created three categories of UST operators — A, B, or C — that are defined by their level of responsibility. Operators must be trained to ensure they perform their duties in a way that prevents releases. Class A operators must be trained so that they can make informed decisions regarding compliance and determine whether appropriate people are performing the operation, maintenance, and recordkeeping requirements for UST systems. For Class B operators, the training program must teach and evaluate their knowledge and skills to implement UST regulatory requirements on typical UST system components or site-specific equipment at UST facilities. For Class C operators, the training program must teach and evaluate their knowledge to take appropriate action, including notifying appropriate authorities, in response to emergencies or alarms caused by spills or releases from UST systems. The final rule also adds new requirements for secondary containment and interstitial monitoring of new and replaced tanks and piping along with under-dispenser containment (UDC) of new dispenser systems. Data from release sites show a higher number of releases from single walled tanks and piping when compared to secondarily contained systems. EPA believes the new requirements will prevent regulated substances from reaching the environment and ensure a consistent level of environmental protection for regulated UST systems. The secondary containment requirement applies to new or replaced underground tanks and piping regulated under Subtitle I, except those excluded by regulation in 40 C.F.R. § 280.10(b) and those partially excluded by regulation in 40 C.F.R. § 280.10(c). Petroleum and hazardous substance USTs must meet the secondary containment requirement with the corresponding use of interstitial monitoring for release detection. EPA is requiring owners and operators to install tank and piping secondary containment that: will contain regulated substances leaked from the primary containment until they are detected and removed; will prevent the release of regulated substances to the environment at any time during the operational life of the UST system; and is monitored for a leak at least once every 30 days using interstitial monitoring. In addition, EPA is eliminating the deferrals for several types of UST systems. Consequently, USTs that are field-constructed tanks, part of airport hydrant fuel distribution systems, or tanks used for storing fuel solely for emergency power generators will, on the rule’s effective date, become subject to regulation as USTs under the 40 C.F.R. Part 280 regulations. EPA is also partially excluding wastewater treatment tank systems that are not part of a wastewater treatment facility regulated under Sections 402 or 307(b) of the Clean Water Act (CWA), USTs containing radioactive material, and emergency generator UST systems at nuclear power plants.


Pope Calls For Swift Action To Curb Climate Change: Pope Francis on June 17, 2015, called for swift action to curb climate change and environmental degradation and called for a radical transformation of politics, economics, and individual lifestyles. Pope Francis’ call to action came in a 184-page encyclical that is audaciously ambitious in its scope. The encyclical portrays a relentless exploitation and destruction of the environment, for which the Holy Father attributed to apathy, the reckless pursuit of profits, excessive faith in technology, and political shortsightedness. The most vulnerable victims are the world’s poorest people, he declared, who are being dislocated and disregarded. Pope Francis laid blame on fossil fuels and human activity while warning of an “unprecedented destruction of ecosystems, with serious consequence for all of us” if swift action is not taken. Developed, industrialized countries were mostly responsible, he stated, and were obligated to help poorer nations confront the crisis.

EPA Issues Waters Of The United States Rule: On June 29, 2015, EPA issued the final CWA Waters of the United States (WOTUS) rule. 80 Fed. Reg. 37053. The rule becomes effective on August 28, 2015. In accordance with 40 C.F.R. Part 23, however, EPA states that the rule will be considered issued for purposes of judicial review on July 13, 2015. The 120-day period for filing judicial challenges to the rule thus begins on that date. The rule is aimed at clarifying when smaller waters are subject to CWA jurisdiction following prior Supreme Court decisions that muddied the issue. There are questions, however, as to which courts should hear these challenges. The 120-day timeframe for judicial challenges referenced by EPA applies only to the appellate courts under CWA Section 509, but it is unclear whether appellate courts would have the jurisdiction to hear challenges to the rule. Under most environmental statutes, judicial review of final EPA rules are brought before courts of appeal rather than a federal district court. CWA Section 509, however, states that only specific types of rules must be initiated at the appellate level. It provides that challenges to approval or promulgation of any effluent limitation “or other limitation” under Sections 301, 302, 306, or 405, permit approvals under Section 402, or individual water quality control strategies under Section 304 must seek initial review in an appeals court. The WOTUS rule does not appear to fall within a specific section of the water law, however, thus complicating the issue of which court has jurisdiction. With their lawsuits in the chamber and ready to fire, 18 states wasted no time after the rule was published and filed suit in federal courts challenging the rule. The lawsuits generally make similar arguments that the rule is a vast “land grab” and an unlawful expansion of federal jurisdiction. Since the rule’s publication, 28 states and over a dozen industry and trade groups — including the U.S. Chamber of Commerce and the National Federation of Independent Businesses — have filed suit over the rule.

EPA Regions Issue General NPDES Stormwater Permit: On June 16, 2015, EPA Regions 1, 2, 3, 5, 6, 7, 8, 9, and 10 issued their final 2015 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater discharges from industrial activity, also referred to as the Multi-Sector General Permit (MSGP). 80 Fed. Reg. 34403. This permit replaces the existing permit covering stormwater discharges from industrial facilities in EPA Regions 1, 2, 3, 5, 6, 9, and 10 that expired September 29, 2013, and provides coverage for industrial facilities in areas where EPA is the NPDES permitting authority in EPA Regions 7 and 8. The MSGP consists of 44 separate regional EPA general permits that may vary from each other based on state or tribal certifications and water quality-based requirements. As with earlier permits, this permit authorizes the discharge of stormwater associated with industrial activities in accordance with the terms and conditions described therein. Industrial dischargers have the option to instead seek coverage under an individual permit. An individual permit may be necessary if the discharger cannot meet the terms and conditions or eligibility requirements in this permit. EPA is issuing this permit for five years. The permit became effective on June 4, 2015.

EPA Issues Final Water Quality Criteria For 94 Pollutants: On June 29, 2015, EPA issued final revised recommended ambient water quality criteria for the protection of human health for 94 chemical pollutants to reflect the latest scientific information and implementation of existing EPA policies found in Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000). 80 Fed. Reg. 36986. EPA’s recommended ambient water quality criteria for the protection of human health provide technical information for states and authorized tribes to establish water quality standards (i.e., criteria) to protect human health under the CWA. These criteria recommendations supersede EPA’s previous recommendations.


NanoRem Announces Initial Ecotoxicity Results: Taking Nanotechnological Remediation Processes from Lab Scale to End User Applications for the Restoration of a Clean Environment (NanoRem) is a research project funded through the European Commission (EC) FP7. On May 6, 2015, NanoRem issued a press release announcing that no significant toxicological effects were found on soil or water organisms when ecotoxicological tests were undertaken for a range of nanoparticles that could be used for remediation projects:

  • NanoFer 25S, made from nanoscale zero-valent iron, used for the remediation of chlorinated hydrocarbons in the large scale flume pilot experiment, and at Spolchemie I, Czech Republic;
  • Carbo-Iron, a composite made from activated carbon and zero-valent iron, to be used for the remediation of chlorinated hydrocarbons in the large-scale flume pilot experiment, and at Balassagyarmat, Hungary;
  • Fe-Oxide, nanoscale goethite, used for the remediation of toluene in the large-scale container pilot experiment, and at Spolchemie II, Czech Republic;
  • Fe-Zeolites, aluminosilicate containing an iron catalyst, used in lab-scale remediation studies; and
  • Bionanomagnetite, with and without five percent Pd, nanomagnetite produced by bacteria, used in lab-scale remediation studies.

Ecotoxicity testing will continue for any new nanoparticles or formulations developed as the NanoRem project progresses.

ECHA Asks Registrants To Consider New OECD Data On Nanomaterials: The European Chemicals Agency (ECHA) issued a June 9, 2015, press release reminding registrants to consider the Organization for Economic Cooperation and Development’s (OECD) dissemination of hazard information on the following nanomaterials, and to update their dossiers accordingly:

  • 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.

ECHA “encourages registrants of these substances to carefully assess the new data. When relevant, they should take this information into account and update their registration dossiers accordingly to ensure the safe use of their substances.”

White House OSTP Calls For “Nanotechnology-Inspired Grand Challenges For The Next Decade”: On June 17, 2015, the Office of Science and Technology Policy (OSTP) published a request for information (RFI) seeking suggestions for “Nanotechnology-Inspired Grand Challenges for the Next Decade.” 80 Fed. Reg. 34713. The notice states: “A Nanotechnology-Inspired Grand Challenge should be an ambitious but achievable goal that harnesses nanoscience, nanotechnology, and innovation to solve important national or global problems and has the potential to capture the public’s imagination.” According to OSTP, the challenge should “inspire different sectors to invest resources to achieve the ambitious goal and stimulate a network of activities that will drive scientific ideas towards commercial products while catalyzing new discoveries.” An effective grand challenge has the following characteristics:

  • A measurable end-point that is highly ambitious but achievable;
  • Requires advances in fundamental scientific knowledge, tools, and infrastructure for successful completion;
  • Has clear intermediate milestones (measurable and valuable in their own right) that will be achieved en route to the final goals;
  • Drives the need for collaboration between multiple disciplines, some of which do not normally interact, causing multiple organizations to come together to collaborate and to share resources and information to solve the challenge;
  • Spans efforts from discovery and fundamental science to engineering demonstration and commercialization; i.e., catalyzes the transition of technologies from laboratory to market;
  • Is too big to be undertaken by one or even a few organizations;
  • Is exciting enough to motivate decision makers to provide funding and resources and multiple organizations to collaborate, share resources, and information to solve the challenge; and
  • Captures the imagination of the public, thereby facilitating strong support for the resources required to achieve the goals.

The RFI includes examples developed by the National Nanotechnology Initiative (NNI) agencies, working with the National Nanotechnology Coordination Office and OSTP. By 2025, the nanotechnology research and development (R&D) community is challenged to:

  • Increase the five-year survival rates by 50 percent for the most difficult to treat cancers;
  • Create devices no bigger than a grain of rice that can sense, compute, and communicate without wires or maintenance for ten years, enabling an “internet of things” revolution;
  • Create computer chips that are 100 times faster yet consume less power;
  • Manufacture atomically-precise materials with 50 times the strength of aluminum at half the weight and the same cost;
  • Reduce the cost of turning sea water into drinkable water by a factor of four; and
  • Determine the environmental, health, and safety characteristics of a nanomaterial in a month.

OSTP seeks input from nanotechnology stakeholders, including researchers in academia and industry, non-governmental organizations (NGO), scientific and professional societies, and all other interested members of the public. Responses are due July 16, 2015.

EPA Extends Comment Period On Nanoscale Chemical Proposed Rule: On July 2, 2015, EPA extended comment period on its April 6, 2015, proposed rule concerning the reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. 80 Fed. Reg. 38153. The notice extends the comment period from July 6, 2015 to August 5, 2005. On June 11, 2015, EPA held a public meeting to discuss the proposed rule. More information regarding the meeting is available in our June 24, 2015, memorandum, EPA Holds Public Meeting on TSCA Section 8(a) Proposed Rule.

Australia Publishes Final Report On Regulatory Considerations For Nanotechnologies For Pesticides And Veterinary Medicines: The Australian Pesticides and Veterinary Medicines Authority (APVMA) published on July 6, 2015, the final report entitled Nanotechnologies for pesticides and veterinary medicines: regulatory considerations. According to the report, its objective is to highlight the regulatory issues that need to be considered when bringing agricultural or veterinary (agvet) chemical products of nanotechnology to the Australian market. The report addresses relevant aspects of nanotechnology including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The report states: “Every attempt has been made to ensure the information on this rapidly-evolving field was current at the time of writing. The report represents a first attempt to offer a blueprint on the regulatory considerations applicable to nanotechnology in Australian agriculture and animal husbandry.” According to the report, the general consensus is that, for the foreseeable future, existing regulatory frameworks developed for macroscale chemicals will be used to regulate nanomaterials. Over time, the report states, the framework will evolve as new information highlighting limitations in the current risk assessment paradigm becomes available. APVMA intends to use the report to develop a final regulatory approach for nanotechnology products, including:

  • Building capability and expertise so new products can be evaluated effectively;
  • Analyzing the data requirements;
  • Enhancing the existing regulatory framework if required as knowledge evolves; and
  • Continuing to engage with the international scientific community so that the latest research is being considered.

ACS Hosts Webinar On Nano-Inspired Grand Challenges: On July 7, 2015, the American Chemical Society (ACS) held a webinar to address the White House’s recently announced Nanotechnology-Inspired Grand Challenges for the Next Decade. The webinar featured ACS Nano Editor-in-Chief Paul Weiss and the White House OSTP’s Lloyd Whitman.

OECD Issues New Publications In Series On The Safety Of Manufactured Nanomaterials: OECD has issued the following publications in its Series on the Safety of Manufactured Nanomaterials:

  • No. 55 — Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates at Workplaces: The primary goal of this publication is to describe a reliable formal methodology for conducting consistent exposure related measurements and assessments of aerosols containing engineered nano-objects and their agglomerates and aggregates in workplace operations. This publication presents a harmonized tiered approach that is “systematic, consistent, practical, and flexible for conducting field-based, real-time workplace release and exposure measurement and assessment” to airborne nano-objects and their agglomerates and aggregates and off-line analyses of measurement samples.
  • No. 56 — Analysis of the Survey on Available Methods and Models for Assessing Exposure to Manufactured Nanomaterials: The OECD Working Party for Manufactured Nanomaterials (WPMN) Steering Group 8 agreed to conduct an informal survey as an initial step in compiling information regarding methods and models for assessing exposure to manufactured nanomaterials. The results were intended to develop an inventory of available methods and models used to assess human and environmental exposure to manufactured nanomaterials. The survey gathered information on a variety of types of methods and models, including those used to set priorities, screen nanomaterials, develop detailed assessments of exposure, and other types of methods or models.
  • No. 57 — Guidance Manual Towards the Integration of Risk Assessment into Life Cycle Assessment of Nano-Enabled Applications: Based on the conclusions of a 2011 workshop on “Environmentally Sustainable Use of Manufactured Nanomaterials,” the OECD WPMN Steering Group 9 Project on the Environmentally Sustainable Use of Manufactured Nanomaterials developed this guidance manual intended to support decision making in various situations; including research, innovation, product development, scaling-up of production, marketing, and end-of-life, as well as regulatory decisions. This publication aims to incorporate knowledge of risk analyses of the environmental impact in life cycle assessment studies as decision-making tools during both upstream (R&D) and downstream (industrialization, usage, re-use, end-of-life management: recycling, recovery, destruction) phases of a nanostructured product.

EC JRC Publishes Options For The Review Of The EC Nanomaterial Definition: The EC Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial. The report is the last in a series of three, and provides scientific support to the EC in its review of the definition used to identify materials for which special provisions might apply (e.g., for ingredient labeling or safety assessment). According to JRC, as the definition should be broadly applicable in different regulatory sectors, “the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental and manufactured nanomaterials. Furthermore, size as the sole defining property of a nanoparticle, as well as the range of 1 nm to 100 nm as definition of the nanoscale should be maintained.” JRC notes that several issues seem to deserve attention in terms of clarification of the definition and/or provision of additional implementation guidance, however, including:

  • The terms “particle,” “particles size,” “external dimension,” and “constituent particles.”
  • Consequences of the possibility of varying the current 50 percent threshold for the particle number fraction (if more than half of the particles have one or more external dimensions between one nanometer (nm) and 100 nm, the material is a nanomaterial). Variable thresholds may allow regulators to address specific concerns in certain application areas, but may also confuse customers and lead to an inconsistent classification of the same material based on the field of application.
  • Ambiguity on the role of the volume-specific surface area (VSSA). The potential use of VSSA should be clarified and ambiguities arising from the current wording should be eliminated.
  • The methods to prove that a material is not a nanomaterial. The definition makes it very difficult to prove that a material is not a nanomaterial. This issue could be resolved by adding an additional criterion.
  • The list of explicitly included materials (fullerenes, graphene flakes, and single wall carbon nanotubes even with one or more external dimensions below one nm). This list does not include non-carbon based materials with a structure similar to carbon nanotubes. A modification (or removal) of the current list could avoid inconsistencies.
  • A clearer wording in the definition could prevent the misunderstanding that products containing nanoparticles become nanomaterials themselves.

According to JRC, many of the issues addressed in the report can be clarified by developing new or improved guidance. JRC notes that relying only on guidance documents for essential parts of the definition may lead to unintended differences in the implementation and decision making, however. Therefore, the report identifies and discusses possibilities to introduce more clarity in the definition itself. JRC states that it will continue to support the review process of the definition and its implementation in European Union (EU) legislation.


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

White House Directs EPA, FDA, And USDA To Update The Coordinated Framework For The Regulation Of Biotechnology: With little fanfare or advanced notice to the general public, on July 2, 2015, the White House OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and the United States Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. A July 2, 2015, OSTP blog item entitled “Improving Transparency and Ensuring Continued Safety in Biotechnology” notes that the complexity of the array of regulations and guidance documents developed by EPA, FDA, and USDA “can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.” The memorandum states that the objectives “are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” More information is available in our memorandum online.


GOP Appropriators Pass Bills Cutting EPA Budget And Blocking Controversial Rules: Republican appropriators on both sides of the aisle have passed bills that would severely cut EPA’s budget and block the promulgation of high profile and controversial regulations. The House Appropriations Committee voted along party lines to send its $30.17 billion Interior Department-EPA Fiscal Year (FY) 2016 spending bill to the floor. That legislation put EPA’s budget at $7.4 billion, slashing about nine percent or $718 million from FY 2015 enacted spending. On June 18, 2015, the Senate Appropriations Committee passed legislation slashing EPA’s budget by some $539 million. The House bill contains provisions that would block EPA from spending funds implementing its WOTUS rule and the controversial Clean Power Plan. The Senate bill also went after EPA’s Clean Power Plan, but would allow states to move forward with their own plans to comply with the Clean Power Plan if they wished, but the federal government would not be able to take action against states that refuse to comply. Both bills also would block EPA from issuing a new ozone National Ambient Air Quality Standard (NAAQS) until 85 percent of counties not yet in compliance with the 2008 NAAQS are in attainment.

CBO Releases Cost Estimate Of Frank R. Lautenberg Chemical Safety For The 21st Century Act: On June 5, 2015, the Congressional Budget Office (CBO) released an estimate of how much it would cost to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), as ordered reported by the Senate Committee on Environment and Public Works (EPW) on April 28, 2015. CBO states that it estimates that EPA would incur additional administrative costs over the FYs 2016-2020 period to meet the new requirements imposed by S. 697. CBO notes that it also estimates that EPA would collect sufficient fees from chemical manufacturers and processors to offset the cost of conducting the activities proposed under the legislation. According to CBO, EPA spending on new administrative activities in FYs 2016-2020 would total $72 million. This would be offset by the $80 million in new fees it would collect during this period.

Bill Would Reinstate Superfund Taxes: Representative Earl Blumenauer (D-OR) on June 15, 2015, introduced a bill that would reinstate the expired excise and corporate income taxes previously used to fund the Superfund Trust Fund. The taxes expired in 2003. They were enacted as part of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and applied to crude oil, refined oil products, certain hazardous chemicals, and imported products using those hazardous chemicals. They also included a corporate environmental income tax on corporations with a modified alternative minimum taxable income above $2 million. The bill, the Superfund Reinvestment Act (H.R. 2768), would reinstate those taxes, but at inflation-adjusted rates. The proposed excise tax on crude oil and refined oil products would be 16.3 cents per barrel, as opposed to the previous 9.7 cents per barrel. The excise taxes on hazardous chemicals would go up from $0.22-$4.87 per ton to $0.51-$11.35 per ton. The corporate income tax rate of 0.12 percent would remain the same but only apply to modified alternative minimum taxable incomes of greater than $3.735 million. The legislation also would expand the definition of crude oil to include tar sands and shale oil.

Senate Bill Would Repeal Renewable Fuel Standard: On June 16, 2015, Senator Bill Cassidy (R-LA) introduced legislation to repeal the Renewable Fuel Standard (RFS) under the CAA. Under the RFS, EPA sets the volumes of ethanol and biodiesel that are required to be blended into the U.S. transportation fuel supply. In introducing the bill (S. 1584), Senator Cassidy stated that EPA has overstepped its authority and has mismanaged the fuel standard. EPA’s mandates overestimate how much ethanol consumers will purchase and the fuel supply can handle, threatening jobs by driving up costs for producers, refiners, farmers, and families, Senator Cassidy stated. He added that EPA’s mandate has led to price increases on corn-based products and meat products produced using corn feed.

EPW Committee Holds Hearing On RCRA CCR Final Rule: The Senate EPW Committee on June 17, 2015, held an oversight hearing to examine EPA’s final rule under RCRA to regulate disposal of coal combustion residuals (CCR) from electric utilities. Testifying at the hearing were Alexandra Dunn, Executive Director and General Counsel, Environmental Council of the States; Frank Holleman, III, Senior Attorney, Southern Environmental Law Center; Mike Kezar, General Manager, South Texas Electric Cooperative on behalf of the National Rural Electric Cooperative Association; Danny Gray, Executive Vice President of Charah Inc., on behalf of the American Coal Ash Association; and Nancy Cave, North Coast Director, South Carolina Coastal Conservation League. Member statements and a webcast of the hearing are available online.

Bill Would Establish Cost Benefit Analysis Requirements For Independent Agencies: Legislation that would require the Chemical Safety and Hazards Investigation Board, the Federal Energy Regulatory Commission, and other independent federal agencies to analyze the costs and benefits of new regulations and to minimize their costs when possible was reintroduced on June 19, 2015, by Senators Rob Portman (R-OH), Mark Warner (D-VA), and Susan Collins (R-ME). The Senators have introduced this bill in each of the last two sessions of Congress. Under the bill, independent agencies would submit significant proposed and final rules for review by the Office of Information and Regulatory Affairs (OIRA). OIRA would not have the authority to reject a rule based on its cost benefit analysis; it could evaluate the quality of the agencies’ analysis and place its assessment in the public record.

House Overwhelmingly Passes TSCA Modernization Act: By a vote of 398-1, the House of Representatives on June 23, 2015, passed H.R. 2576, the TSCA Modernization Act. Introduced by John Shimkus (R-IL), the legislation represents the first chance in decades to amend TSCA. Our detailed memorandum summarizing the legislation is available online.

Over Veto Threat, House Passes Bill Allowing States To Opt Out Of Clean Power Plan: The House of Representatives on June 24, 2015, passed legislation that would allow states to opt out of compliance with EPA’s Clean Power Plan. The vote was 247-180. Eight Democrats voted for the bill; only four Republicans did not. Introduced by Ed Whitfield (R-KY), the Ratepayer Protection Act (H.R. 2042) extends the deadline for compliance with the final Clean Power Plan. The extension period begins 60 days after the notice of promulgation of a final rule appears in the Federal Register and ends following any judicial review, on the date a judgment becomes final, and no longer subject to further appeal or review, in all actions (including those under the CAA) that are filed during that 60-day period. Also, under the bill a state is not required to adopt or submit a state plan and would not be subject to a federal plan if either plan would have a significant adverse effect upon the state’s residential, commercial, or industrial ratepayers or upon the reliability of the state’s electricity system. The White House has vowed to veto the legislation.

Senate Committee Approves PHMSA Funding Bill: On June 25, 2015, the Senate Appropriations Committee approved a FY 2016 bill funding the Pipeline and Hazardous Materials Safety Administration (PHMSA) and that includes several policy directives for the agency. The Transportation and Housing and Urban Development and Related Agencies Appropriations bill includes $246 million in funding for PHMSA. The bill funds PHMSA’s hazardous materials safety program at $49 million, about $3 million less than the FY 2015 funding level.

House Passes Bill Slashing EPA Budget; White House Threatens Veto: On June 26, 2015, the House passed legislation (H.R. 2822) appropriating funds for EPA’s FY 2016 operations. The bill would cut EPA’s $8.13 billion budget by $718 million, or about 13 percent below FY 2015 funding levels. The bill also includes provisions blocking implementation of several EPA regulatory programs, including the Greenhouse Gas Limits for Power Plants and WOTUS rules. As a result, the White House issued a Statement of Administration Policy on June 23, 2015, threatening to veto the bill. The White House claims that the bill “drastically underfunds” EPA’s operating budget. It also decries the prohibitions on “necessary” EPA rules.

WOTUS Rule Draws Scrutiny From Both Houses Of Congress: Now that the WOTUS rule has been published in the Federal Register, it is drawing fire from GOP members in both houses of Congress. On July 14, 2015, the House Oversight and Government Reform Committee issued a subpoena seeking all documents and communications considered by the White House OMB during its review of the final WOTUS rule. Also on July 14, Republican members of the Senate EPW Committee issued a letter to EPA seeking legal justification for the rule. Republican members in both houses are expressing frustration with EPA’s perceived failure to respond to Congressional inquiries on the rule.


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 call for data complies with the decision taken by the EC 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. 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 EC. The notice states that all information should be submitted by September 30, 2015.

California Superior Court Denies PANNA Petition For Writ Of Mandate: On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of PANNA for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA.

The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level. PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives. For more information, please consult B&C’s Pesticide Law and Policy Blog.

U.S. District Court Affirms FIFRA Arbitration Award: On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15). The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated by the parties in the midst of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) arbitration proceeding, and continued its refusal to pay after the Task Force successfully moved the arbitrator to issue an award enforcing the settlement agreement. The court determined it has jurisdiction because FIFRA “confers jurisdiction on the judiciary to enforce [such] arbitration awards” in federal court and Tagros’ participation in the arbitration allowed the court to exercise jurisdiction over Tagros. The court found that the arbitration award must be confirmed in full absent evidence of fraud, misrepresentation, or other misconduct by one of the parties, and no such allegations were put forth. The court also granted the Task Force’s motion seeking permission to register this judgment in other district courts based on information that Tagros’ assets were not in the District of Columbia and evidence of assets in other jurisdictions.

This decision adds to a growing number of recent cases where companies have sought judicial enforcement of a FIFRA arbitration award. Judicial judgments enforcing arbitration awards, in addition to judicial authority to register such judgments in districts where assets are available, are tools data owners are increasingly using to obtain the compensation owed.

Canadian Province Issues Final Neonic Reduction Rule: The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides. These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.

The new rules create a new class of pesticides, known as “Class 12 pesticides.” This class applies to corn seed grown for grain or silage, and soybean seeds treated with the following neonicotinoid insecticides: imidacloprid, thiamethoxam, and clothianidin. The new regulations will not apply to popping corn, sweet corn, corn used for the production of seed, or soybean seeds planted for the purpose of producing a soybean seed crop of certified status. The new system established by these regulations took effect on July 1, 2015, and will be phased in over time. For more information, please consult B&C’s Pesticide Law and Policy Blog.

California Adds Substances To Biomonitoring Program List: On June 30, 2015, California added the entire class of fluorinated organic chemicals, known as perfluoroalkyl and polyfluoroalkyl substances (PFAS), to the state’s list of designated chemicals for its biomonitoring program. The designated chemicals list is used to select priority substances for biomonitoring studies. A scientific advisory panel for the program, called Biomonitoring California, recommended adding PFASs to the list in March, in part because a large number of the substances are being used to replace perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA). The list includes several PFASs, but others not on the list have been identified in biomonitoring studies, according to California Office of Environmental Health Hazard Assessment (OEHHA) documents. PFASs are used to make textiles, carpets, and leather more resistant to water, dirt, and grease; to create grease- and water-proof coatings on paper plates and pizza boxes; in chrome plating; and in firefighting foams. Biomonitoring California’s updated list of designated chemicals is available online. OEHHA’s document on PFASs 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.