Monthly Update for April 2014
EPA Makes TSCA Notifications Of Substantial Risk Amendable To Electronic Reporting: On March 19, 2014, the U.S. Environmental Protection Agency (EPA) announced that notifications of substantial risk under Section 8(e) of the Toxic Substances Control Act (TSCA) and voluntary For Your Information (FYI) submissions may now be filed electronically using EPA's electronic document submission system, the Central Data Exchange (CDX). 79 Fed. Reg. 15329. Use of this electronic reporting option will, according to EPA, streamline and reduce the administrative costs and burdens of submitting paper-based notifications of substantial risks and FYI submissions. EPA encourages submitters of TSCA Section 8(e) notifications of substantial risk and voluntary submissions, including FYI submissions, to adopt electronic reporting as the preferred submission method.
EPA Schedules SAB Review Of Three Gasoline Components: On March 25, 2014, the EPA Science Advisory Board (SAB) Staff Office announced two meetings of the Chemical Assessment Advisory Committee Augmented for the Review of the Draft Trimethylbenzenes Assessment (CAAC-TMB Panel). 79 Fed. Reg. 16324. A public teleconference will be held to discuss the charge questions, to learn about the development of the Agency's draft Integrated Risk Information System (IRIS) Toxicological Review of Trimethylbenzenes (August 2013 Revised External Review Draft), and to learn about the Health and Environment Research Online (HERO) database prior to a face-to-face meeting that will be held in Arlington, VA. The purpose of the meeting is to receive a briefing on EPA's enhancements to the IRIS Program, including the process for developing IRIS assessments, and to conduct a peer review of the Agency's draft IRIS Toxicological Review of Trimethylbenzenes. The public teleconference will be held on May 22, 2014, from 1:00 p.m. to 5:00 p.m. (Eastern Time). The public face-to-face meeting will be held on June 17-June 19, 2014. A briefing on EPA's enhancements to the IRIS Program will be held on June 17, 2014, from 9:00 a.m. to 12:00 p.m. The peer review of the Agency's draft IRIS Toxicological Review of Trimethylbenzenes will commence on June 17, 2014, from 1:15 p.m. to 5:30 p.m. (Eastern Time). The peer review will continue on June 18-19, 2014, from 8:30 a.m. to 5:00 p.m. (Eastern Time).
EPA Issues Proposed Agricultural Worker Protection Standard Revisions: On March 19, 2014, EPA proposed to update and revise the existing worker protection regulation for pesticides. 79 Fed. Reg. 15444. The proposed changes respond to extensive stakeholder review of the regulation and its implementation since 1992, and reflect current research on how to mitigate occupational pesticide exposure to agricultural workers, pesticide handlers, and others. EPA is proposing to strengthen the protections provided to agricultural workers and handlers under the worker protection standard by improving elements of the existing regulation, such as training, notification, communication materials, use of personal protective equipment, and decontamination supplies. Comments must be received on or before June 17, 2014.
EPA Requests Comment On Pesticide Volatilization: On March 26, 2014, EPA announced the availability for comment of several important draft guidance documents. 79 Fed. Reg. 16791. These documents detail EPA's approach in developing a pesticide volatilization screening methodology for human health. Once final, these guidance documents will be posted on EPA's website, to promote consistent risk assessment practices and provide transparency for pesticide registrants and other interested stakeholders. Comments must be received on or before May 27, 2014.
EPA Announces Workshop On Formaldehyde IRIS Assessment: On March 27, 2014, EPA announced that it will convene a workshop on its IRIS assessment of formaldehyde, which EPA is currently revising. This assessment addresses both noncancer and cancer human health effects that may result from chronic inhalation exposure to formaldehyde. To facilitate discussion of several scientific issues pertinent to the assessment, EPA will convene a state-of-the-science workshop. This workshop will be open to the public, broadcast by webinar/teleconference, and will take place in the Washington, D.C. metro area. The upcoming workshop is scheduled for April 30, 2014, and May 1, 2014.
EPA Schedules Meeting On Formaldehyde Proposal: On a related front, EPA announced on April 8, 2014, that it will convene a public meeting on April 28, 2014, to discuss a proposed rule that would apply nationwide existing limits set by California for formaldehyde emissions from composite wood products. 79 Fed. Reg. 19305. The proposed regulation would be combined with a related proposal requiring a third-party certification of composite wood and would implement the 2010 Formaldehyde Standards for Composite Wood Products Act. EPA extended the comment period on the proposed rule until May 8, 2014.
EPA Opens Pesticide Dockets For Review And Comment: On March 28, 2014, EPA opened the public comment period for several pesticide registration reviews. 79 Fed. Reg. 17539. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. The following 17 pesticides are set to undergo registration review:
Aminopyralid, Docket ID No. EPA-HQ-OPP-2013-0749;
Azadioxabicyclooctane, Docket ID No. EPA -HQ-OPP-2013-0604;
Bacillus licheniformis strain SB3086, Docket ID No. EPA -HQ-OPP-2014-0184;
Clopyralid, Docket ID No. EPA -HQ-OPP-2014-0167;
Fenamidone, Docket ID No. EPA -HQ-OPP-2014-0048;
Formic acid, Docket ID No. EPA -HQ-OPP-2014-0105;
Imazethapyr, Docket ID No. EPA -HQ-OPP-2013-0774;
Kaolin, Docket ID No. EPA -HQ-OPP-2014-0107;
Lithium hypochlorite, Docket ID No. EPA -HQ-OPP-2013-0606;
MCPA, Docket ID No. EPA -HQ-OPP-2014-0180;
MCPB and salts, Docket ID No. EPA -HQ-OPP-2014-0181;
Organic esters of phosphoric acid, Docket ID No. EPA -HQ-OPP-2013-0373;
Potassium hypochlorite, Docket ID No. EPA -HQ-OPP-2014-0157;
TAED, Docket ID No. EPA -HQ-OPP-2013-0608;
Tepraloxydim, Docket ID No. EPA -HQ-OPP-2014-0246;
Thiabendazole and salts, Docket ID No. EPA -HQ-OPP-2013-0175; and
- Thiophanate-methyl and carbendazim, Docket ID No. EPA -HQ-OPP-2014-0004.
Information on these registrations must be received on or before May 27, 2014.
EPA Schedules Workshop On NAS Recommendations On Assessing Risks To Endangered And Threatened Species From Pesticides: On April 2, 2014, EPA announced that it will hold on April 22, 2014, a one-day workshop to provide a forum for stakeholders to offer scientific and technical feedback on the joint interim approaches issued in November 2013 by EPA, the Fish and Wildlife Service, National Marine Fisheries Service, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences (NAS) report entitled Assessing Risks to Endangered and Threatened Species from Pesticides. 79 Fed. Reg. 18546. EPA states that the workshop is an opportunity for stakeholders and agencies to continue their dialogue on the technical aspects of implementing the NAS recommendations, building upon public meetings held in November and December 2013, and enhancing the stakeholder engagement process that was issued in final in March 2013. All requests to participate in the workshop must be received by April 15, 2014. Participation via webinar will be available online. Participation via conference call-in is available at 1-866-299-3188, Code: 7033057887. EPA states that the meeting agenda will be available online.
EPA Publishes PR Notice Regarding Web-Distributed Labeling For Pesticide Products: EPA announced on April 4, 2014, the availability of Pesticide Registration Notice (PR Notice) 2014-1 entitled "Web-Distributed Labeling for Pesticide Products." 79 Fed. Reg. 18908. EPA states that the PR Notice provides guidance to the registrant concerning the process by which registrants can make legally-valid versions of pesticide labeling available through the Internet. The PR Notice provides guidance concerning how EPA intends to implement web-distributed labeling under this voluntary system. EPA believes shorter, relevant labeling could be clearer and easier for the user to understand, improving compliance with pesticide labeling requirements and thereby protecting human health and the environment from unintentional misuse of pesticides. Web-distributed labeling would also allow for more rapid updates to pesticide labeling, meaning risk mitigation measures and new uses can reach the user more quickly than under the current paper-based system. The PR Notice defines terms used related to web-distributed labeling and includes suggested language that registrants can use on the labeling affixed to or accompanying the pesticide container to reference the web-distributed labeling portion of labeling. It recommends content, function, and security for the website associated with a product's web-distributed labeling. Finally, the PR Notice suggests a process by which registrants can request that a product's labeling include web-distributed labeling and outlines what information EPA expects to receive. More information is available online.
EPA Proposes To Revise A Rule Clarifying Federal Jurisdiction Over Waters And Wetlands: EPA and the U.S. Army Corps of Engineering (Corps) issued a joint proposed rule clarifying that all natural and artificial tributaries and wetlands that are adjacent to or near larger downstream waters would be subject to federal Clean Water Act (CWA) protections. The proposal also would allow EPA and the Corps to seek comment on a case-by-case basis on whether the aggregate effect of geographically isolated wetlands and other waters that "significantly" affect the physical, biological, and chemical integrity of federally protected downstream waters are jurisdictional. The rulemaking is much anticipated and significant because it seeks to clarify the definition of which waters or wetlands are considered "waters of the U.S." under the CWA, and thus within U.S. regulatory jurisdiction, triggering federal requirements. The EPA pre-publication proposed rule on waters of the U.S is available online.
EPA Proposes To Add Three Materials To List Of Non-Waste Fuels: On April 14, 2014, EPA issued a proposed rule that would add three materials to the list of categorical non-waste fuels under the Resource Conservation and Recovery Act (RCRA) Non-Hazardous Secondary Materials (NHSM) rule. 79 Fed. Reg. 21006. The proposal would amend the standards at 40 C.F.R. Section 241.4 that exempt certain non-hazardous materials from regulation as solid wastes when used as fuels or ingredients in combustion units. These exemptions allow the materials to be burned in commercial, industrial, and institutional boilers that are regulated under Section 112 of the Clean Air Act (CAA), rather than solid waste incineration units that are more stringently regulated under CAA Section 129. The proposed rule would exempt the following categories of materials from regulation as solid waste when burned as a fuel in combustion units: (1) construction and demolition (C&D) wood processed from C&D debris according to best management practices; (2) paper recycling residuals, including old corrugated cardboard (OCC) rejects, generated from the recycling of recovered paper and paperboard products and burned on-site by paper recycling mills, the boilers of which are designed to burn solid fuel; and (3) creosote treated railroad ties that are processed and combusted in units designed to burn both biomass and fuel oil. Combustors of C&D wood must obtain a written certification from C&D processing facilities that the C&D wood has been processed by trained operators in accordance with best management practices. Best management practices for purposes of this categorical listing must include sorting by trained operators that excludes or removes the following materials from the final product fuel: non-wood materials (e.g., polyvinyl chloride and other plastics, drywall, concrete, aggregates, dirt, and asbestos), and wood treated with creosote, pentachlorophenol, chromated copper arsenate, or other copper, chromium, or arsenical preservatives. In addition, C&D processing facilities that use positive sorting -- where operators pick out desirable wood from co-mingled debris -- must either: (1) exclude all painted wood from the final product fuel; (2) use X-ray Fluorescence to ensure that painted wood included in the final product fuel does not contain lead-based paint; or (3) require documentation that a building has been tested for and does not include lead-based paint before accepting demolition debris from that building. C&D processing facilities that use negative sorting -- where operators remove contaminated or otherwise undesirable materials from co-mingled debris -- must remove fines (i.e., small-sized particles that may contain relatively high concentrations of lead and other contaminants) and either: (1) remove painted wood; (2) use X-ray Fluorescence to detect and remove lead-painted wood; or (3) require documentation that a building has been tested for and does not include lead-based paint before accepting demolition debris from that building. Comments must be received on or before June 13, 2014.
EPA Extends Comment Period On NODA On Practices To Enhance Effectiveness Of RCRA In The Retail Sector: On April 10, 2014, EPA extended the comment period on its February 14, 2014, Notice of Data Availability (NODA) seeking information on ways to enhance the effectiveness of the RCRA hazardous waste program in the retail sector. 79 Fed. Reg. 19905. EPA extended the comment period to May 30, 2014.
EPA Calls For 2014 Presidential Green Chemistry Challenge Award Nominations: On March 18, 2014, EPA issued a press release seeking nominations for EPA's Presidential Green Chemistry Challenge Awards. Nominations are due to the Agency by April 30, 2014. EPA's press release about the awards and entry process is available online.
NanoDiode Survey Seeks European Citizens' Views On Nanotechnologies: NanoDiode is conducting a survey concerning Europeans' preferences for nanotechnologies. According to NanoDiode, the results will be used "to inspire policy makers, researchers and companies across Europe." NanoDiode states that stakeholder engagement and dialogue is essential to the responsible development of nanotechnologies in Europe, and invites lay consumers to participate in the survey. NanoDiode, which is funded by the European Union (EU), establishes a coordinated program for outreach and dialogue throughout Europe. It integrates engagement activities along the innovation value chain by combining "upstream" public engagement (by way of dialogues that integrate societal needs and expectations into the policy debate) with "midstream" engagement (by organizing open innovation workshops at the level of research and development) and "downstream" strategies for education and communication. The survey is available online.
America Competes Reauthorization Act Would Reauthorize NNI: On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs. The bill would reauthorize the National Nanotechnology Initiative (NNI) "to ensure the United States remains a leader in the development of new technologies and products based on breakthroughs in our understanding of materials at the atomic and molecular level." Under the bill, the National Nanotechnology Coordination Office (NNCO) would develop and maintain a public database of projects funded under at least the environmental, health, and safety (EHS) program component area, or any successor program component area. The database would include a description of each project, its source of funding by agency, and its funding history. The bill states that the National Nanotechnology Program will include research on: (1) the development of instrumentation and tools required for the rapid characterization of nanoscale materials and for monitoring of nanoscale manufacturing processes; and (2) approaches and techniques for scaling the synthesis of new nanoscale materials to achieve industrial-level production rates. On March 6, 2014, the bill was referred to the House Committee on Science, Space, and Technology and to the Committee on Education and Workforce. On March 11, 2014, the bill was referred to the Science, Space, and Technology Subcommittee on Research and Technology. More information is available online.
Germany Releases Study Assessing Impacts Of European Register Of Products Containing Nanomaterials: In March 2014, the German Federal Environment Agency (UBA) issued a report entitled Assessment of Impacts of a European Register of Products Containing Nanomaterials, which was intended to analyze the impacts of a European register of products containing nanomaterials (ENPR). The study identified the sectors and companies that would be affected by an ENPR, and estimated the number of notifiers and notifications, categories of substances, concerned mixtures, and articles. Based on that result, the study quantified the administrative costs for notifiers and the competent authority, and described the benefits of an ENPR for public authorities, consumers, and notifiers. The report includes a preliminary remark from Öko-Institut e.V., which performed the study. The preliminary remark notes that during the study, various difficulties occurred, resulting in a lower reliability of calculations. Complications included companies "not interested or not able to substantiate the high burden that they allocate to such a register with reliable figures," as well as "quite a number of companies [that] do not seem to have knowledge of the possible content of nanomaterials in their products." According to the report, "an ENPR could bring additional value for public authorities, consumers and companies involved in nanotechnology." The report concludes that an ENPR would "help to avoid a multiplication of administrative costs" to both companies manufacturing or importing products containing nanomaterials and the national competent authorities that would be responsible for a register at the Member State level. The report states: "Finally, from a legal point of view it can be discussed whether a register is the proportionate instrument in the light of the precautionary principle to govern the safe use of nanomaterials and products containing them. However, the introduction of an ENPR is the mildest legal instrument to control the production and use of nanoproducts compared to a restriction, a ban or a moratorium on one or more of these products." The report is available online.
EU NanoSafety Cluster Begins Database Survey: The EU NanoSafety Cluster announced on March 18, 2014, the availability of an online nanosafety database survey. According to the EU Nanosafety Cluster, this is the first survey in a biannual effort to collect, organize, and share up-to-date information about nanosafety-related databases worldwide. The EU NanoSafety Cluster will continuously update the list of databases "with new valuable insight along its development." The objective is to help owners and administrators of nanosafety-related databases increase awareness of their databases and to ensure interoperability of data. Reponses to the survey are due April 18, 2014. The survey is available online.
NNI Publishes Supplement To President's 2015 Budget: On March 25, 2014, the NNI published a supplement to President Obama's 2015 budget request submitted to Congress on March 4, 2014. The supplement provides a description of the activities underway in 2013 and 2014 and planned for 2015 by the federal government agencies participating in the NNI, primarily from a programmatic and budgetary perspective. NNI states that it is based on the NNI Strategic Plan and reports actual investments for 2013, estimated investments for 2014, and requested investments for 2015 by Program Component Area. NNI states that the President's 2015 budget provides over $1.5 billion for NNI, "reflect[ing] nanotechnology's potential to significantly improve our fundamental understanding and control of matter at the nanoscale and to translate that knowledge into solutions for critical national issues." According to NNI, the investments in 2013 and 2014 and proposed for 2015 "continue the emphasis on accelerating the transition from basic R&D to innovations that support national priorities, while maintaining a strong base of foundational research, to provide a pipeline for future nanotechnology-based innovations." The supplement is available online.
ECHA Report Includes Recommendations For Exposure Assessment And Risk Characterization Of Nanomaterials Under REACH: On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterisation of nanomaterials: Best practice for REACH registrants. The report summarizes the outcomes of the third (and last) meeting of the Group Assessing Already Registered Nanomaterials (GAARN). The September 30, 2013, meeting focused on discussing the approach and challenges faced by participant registrants when documenting the human health and environmental exposure assessment and risk characterization of their substances while registering them under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The report states that the outcomes of the discussion "can be viewed as generic recommendations for the exposure assessment and risk characterisation of NMs under REACH, while considering the present scientific knowledge on the field of nanotoxicology and practice, as well as challenges from participating registrants." The report states that the provisions that apply to the registration of nanomaterials are the same as those for any other chemical substance, but notes that, "in line with scientific developments, there are specific considerations that registrants should report in specific endpoint sections, as this information will facilitate the evaluation of the adequacy of the tests performed and data obtained with regard to the safety assessment of NMs." According to the report, the registration dossier should contain a comprehensive physicochemical characterization of the registered nanoform(s). Only when well-characterized nanoforms are reported in the dossier, can a read-across approach or use of existing data be considered for the purpose of hazard assessment. Registration dossiers including nanomaterials and bulk substances under the same technical dossier should include specific exposure scenarios for nanomaterials if these differ from the exposure scenarios developed for the bulk materials. The report states that, "[i]n principle, the existing risk assessment paradigm developed for traditional chemicals" should also apply to nanomaterials. According to the report, comprehensive risk assessments for nanomaterials currently present challenges both for human health and the environment. The following conclusions can be drawn:
Regarding the risk assessment for workers, due to the lack of validated modelling tools for nanomaterial exposure, field measurement data are currently preferred to support the risk assessment. If possible, the risk assessment should follow a multi-metric approach. The use of qualitative approaches is allowed to support measured or estimated exposure data. Concerning RMMs, the conventional control technologies to handle dusty materials are applicable to NMs and provide good control if implemented and maintained correctly.
With regards to the environment, the lack of specific hazard data complicates the risk assessment. Moreover, there are significant limitations in the applicability of conventional exposure assessment models. Registrants are advised to collect information on environmental release when possible (RIPoN 3). The current report proposes best practice to achieve realistic exposure data that can be used in environmental risk assessments.
In general, it is important to conclude with the reminder of the legal obligation that registration dossiers need to be updated with new nano-specific studies as scientific developments are progressing. Safe use claims under REACH should be based on explicit and transparent documentation supporting the hazard, exposure and risk assessment of NMs. Registrants are reminded that a lack of (hazard) data does not automatically mean that there is a lack of specific hazards or risks for a substance.
The report is available online.
EPA Stops Sale Of Unregistered Food Containers Containing Nanosilver: On March 31, 2014, EPA announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA's press release, the company's Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain nanosilver as an active ingredient, and the company markets other products as containing nanosilver, which the company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states:
During a November 13, 2013 EPA inspection of the company's facility in Englewood, New Jersey, a Pathway representative acknowledged that the company sold plastic products containing nano silver. The label for the Kinetic Go Green Premium food storage container stated that the product contained nano silver technology and that the nano-sized particles of silver helped to reduce the growth of bacteria and mold, allowing foods to stay fresh up to three times longer. In addition, the company's product description touted the benefits of nano silver in its products and the company's website contained several claims that describe how the nano silver particles destroy, kill or reduce the growth of mold, fungus and bacteria.
EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Wal-Mart, and other large retailers directing them not to sell these products. More information is available online.
European Non-Governmental Organizations Publish Position Paper On The Regulation Of Nanomaterials: In April 2014, the Center for International Environmental Law (CIEL) and its European partners published a position paper on the regulation of nanomaterials at a meeting of the EU competent authorities. According to the position paper, current EU legislation "does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance." The position paper asks the European Commission (EC) to produce "concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials." The position paper states that:
Nanomaterials are different from other substances;
Risk from nanomaterials must be assessed;
Nanomaterials should be thoroughly evaluated;
Information on nanomaterials must be collected and disseminated; and
- REACH enforcement activities should tackle nanomaterials.
The position paper is available online.
EPA Awards Grant To Study The Life Cycle Of Nanomaterials: EPA has awarded a $5 million, four-year grant to investigators led by Arizona State University to study the life cycle of nanomaterials. According to EPA's description of the award, the project involves an interdisciplinary team of chemists, toxicologists, scientists, engineers, and social scientists to evaluate the trade-offs between intended function of nanomaterials in products and risks to humans and the environment across their life cycle from creation, through use and disposal. The description states that researchers will evaluate four product lines expected to have variable nanomaterial release rates (i.e., dispersed in liquids used in industrial manufacturing (e.g., polishing agents), dispersed in products (e.g., foods), embedded in composite polymers (e.g., thermoplastics, membranes for water filtration), and coated on the surfaces of flexible polymeric materials (e.g., textiles) using four high-volume nanomaterials (titanium dioxide, silicon dioxide, nanosilver, and multi-wall carbon nanotubes) that exhibit properties unique from each other and properties similar to other emerging nanomaterials. The description states that the results are expected to:
Reduce uncertainty in risks from nano-enabled products for the public, manufacturing communities, and regulatory agencies;
Provide the framework for existing and future nano-enabled product designs that preserve commercial value while minimizing adverse environmental health and safety effects;
Train a diverse group of undergraduate, graduate, and post-doctoral scientists to work as a network and produce integrated research products; and
- Educate the public on the importance of the life cycle perspective for maximizing the benefits of nano-enabled products.
More information is available online.
USDA And NNI Will Hold Workshop On Commercialization Of Cellulose Nanomaterials: USDA and NNI will hold a May 20-21, 2014, workshop entitled "Cellulose Nanomaterial -- A Path Towards Commercialization." The workshop is intended to bring together high level executives from government and multiple industrial sectors to identify pathways for the commercialization of cellulose nanomaterials and facilitate communication across industry sectors to determine common challenges. NNI states that the primary goal of the workshop is to identify the critical information gaps and technical barriers in the commercialization of cellulose nanomaterials with expert input from user communities. According to NNI, the workshop also supports the December 2013 announcement by USDA Secretary Thomas Vilsack regarding the formation of a public-private partnership between the USDA Forest Service and the U.S. Endowment for Forestry and Communities to advance rapidly the commercialization of cellulose nanomaterials. NNI notes that, in addition, the workshop supports the goals of the NNI Sustainable Nanomanufacturing Signature Initiative. More information is available online.
BRAG™ Biobased Products News And Policy Report: Bergeson & Campbell, P.C.'s consulting affiliate, B&C® Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG™). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.
DOT PHMSA Amends Hazardous Materials Regulations: On March 18, 2014, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued several amendments to the Hazardous Materials Regulations (HMR). 79 Fed. Reg. 15033. These amendments involve the adoption of several long-standing special permits and certain competent authority approvals into the C.F.R., specifically 49 C.F.R. Parts 171-180. The final rule is intended "to provide wider access to the regulatory flexibility offered in special permits and approvals and to eliminate the need for numerous renewal requests, reducing paperwork burdens and facilitating commerce while maintaining an appropriate level of safety." Of special note, PHMSA is also revising the approval renewals section -- 49 C.F.R. Section 107.705(c) -- to allow holders to continue to use expired approvals as long as they apply for a renewal 60 days prior to their expiration date. For detailed specifics, please refer to the Federal Register notice. The rule is effective April 17, 2014.
OSHA Issues Final Rule Revising Standards For Electrical Power Generation, Transmission, And Distribution: On April 11, 2014, for the first time in over 40 years, the Occupational Safety and Health Administration (OSHA) issued a final rule revising the workplace standards for workers performing electric power generation, transmission, and distribution work. 79 Fed. Reg. 20316. The rule revises the construction standard for electric power line work to make it more consistent with the corresponding general industry standard, according to OSHA. The updated standards include new or revised provisions for host and contract employers to share safety-related information with each other and with employees, as well as for improved fall protection for employees working from aerial lifts and on overhead line structures. In addition, the standards adopt revised approach-distance requirements to better ensure that unprotected workers do not get dangerously close to energized lines and equipment. The final rule also adds new requirements to protect workers from electric arcs. General industry and construction standards for electrical protective equipment are also revised under the final rule. The new standard for electrical protective equipment applies to all construction work and replaces the existing construction standard, which was based on out-of-date information, with a set of performance-oriented requirements consistent with the latest revisions of the relevant consensus standards. The new standards address the safe use and care of electrical protective equipment, including new requirements that equipment made of materials other than rubber provide adequate protection from electrical hazards. OSHA estimates the final rule will result in monetized benefits of $179 million annually, with net benefits equal to about $130 million annually. The rule is effective on July 10, 2014.
Representative Eshoo Opens Inquiry Into CERCLA Cleanup Shortfalls In Silicon Valley: Representative Anna Eshoo (D-CA), senior member of the House Energy and Commerce Committee, has opened an inquiry with EPA regarding a recent investigative report on the effectiveness of the Superfund program at sites in the Silicon Valley region of California and across the country. In a letter to EPA Administrator Gina McCarthy, Eshoo is requesting more information on the extent to which EPA monitors the interstate transport and treatment of hazardous waste from Superfund sites, alternative cleanup methods, and if EPA has enough regulatory authority in this area. In the March 28, 2014, letter, Eshoo wrote that she has "serious concerns about the effectiveness of the Superfund program and the associated pollution that is created by the collection, transport, and treatment of toxic pollutants from Superfund sites." She adds that she is concerned that EPA "is failing to properly monitor and regulate the emissions associated with remediating the toxic pollutants recovered from Superfund sites, as reported in a March 17, 2014, article from the Center for Investigative Reporting and the Guardian U.S." She requested that EPA respond to three concerns:
Does EPA monitor the carbon dioxide emissions generated in the interstate transportation and treatment of hazardous waste or dioxin emissions from carbon regeneration facilities? To what extent does EPA monitoring or regulations of these emissions protect human health and the environment?
Has EPA investigated scientifically and financially feasible alternatives to the current methods being used to treat hazardous waste sites, in particular contaminated groundwater? If not, does EPA plan to investigate such alternatives?
- Does EPA have sufficient regulatory authority to monitor and control toxic pollutants generated after removal from the Superfund site, or is Congressional action necessary to grant additional authority?
House Passes Bill Blocking Implementation Of Stream Protection Rule: The House on March 25, 2014, passed a bill that would block the implementation of a rule intended to protect rivers and streams from effects of coal strip mining. The Preventing Government Waste and Protecting Coal Mining Jobs in America (H.R. 2824), sponsored by Ohio Republican Bill Johnson and passed by a vote of 229-192, would task the Office of Surface Mining and Reclamation and state agencies with implementing a stream buffer protection rule implemented in 2008. The bill is intended to shield coal mining from regulation that some fear would severely impact the industry. The bill would amend the Surface Mining Control and Reclamation Act of 1977 to require state programs for regulation of surface coal mining to incorporate the rule concerning excess spoil, coal mine waste, and buffers for perennial and intermittent streams published by the Office of Surface Mining Reclamation and Enforcement on December 12, 2008. It also requires the Secretary of the Interior to publish notice of a determination when all states that wish to assume exclusive jurisdiction of such mining regulation have incorporated the rule in their programs, assess the effectiveness of the rule's implementation for five years, and report to Congress an evaluation of the rule's effectiveness, any ways in which it inhibits energy production, and any proposed changes to the rule. The bill also prohibits the issuance of any regulations regarding stream buffer zones or protection before publication of the report. The White House has threatened to veto the legislation. In a March 5, 2014, Statement of Administration Policy, the White House states that the bill "limits a State's ability to tailor stream safeguards or maintain currently adopted standards, creates needless regulatory and legal uncertainty, and requires States to waste significant taxpayer dollars adopting a rule that has been vacated by a Federal court."
EPA Administrator Defends EPA FY 2015 Budget Request: Appropriations season has begun on Capitol Hill, and EPA Administrator Gina McCarthy defended EPA's fiscal year (FY) 2015 budget request in several hearings before Senate and House Committees. On March 26, 2014, McCarthy testified before the Senate Environment and Public Works (EPW) Committee. McCarthy's testimony and a webcast of the EPW hearing are available online. The following day, McCarthy sat before the House Appropriations Subcommittee on the Interior, Environment and Related Agencies to explain and defend EPA's budget request. Her testimony and the webcast of that hearing are also available online. On April 2, 2014, she testified before the House Energy and Commerce Subcommittee on Energy and Power and the Subcommittee on Environment and the Economy. McCarthy's testimony, member statements, and a webcast of the hearing are available online. On April 9, 2014, she testified before the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies. At all hearings, McCarthy testified that EPA's budget request of $7.89 billion for FY 2015 reflects EPA's efforts to meet the challenges it faces today and into the future. Despite these challenges, McCarthy testified that EPA remains dedicated to protecting public health and the environment, "and we know we must target staff and resources and find new ways to fulfill our mission. We will focus those resources in a way that will allow EPA to be more effective and efficient." Much of McCarthy's time was spent responding to queries from Republican Committee members regarding EPA's climate change efforts. McCarthy generally testified that addressing the threat from a changing climate is one of the greatest challenges of this and future generations. The request for climate change and air quality is $1.03 billion, a $41 million increase over FY 2014 funding levels; it designates $199.5 million specifically for climate change work. She added that EPA has included an additional $10 million and 24 full time equivalent (FTE) employees in FY 2015 to support the President's climate action plan. Responding to sometimes aggressive remarks from Committee members regarding EPA's regulations for power plants, McCarthy stated that EPA will focus resources on the development of "common sense and achievable greenhouse gas standards for power plants -- the single largest source of carbon pollution."
Senate Committee Passes Chemical Safety And Drinking Water Protection Act Of 2014: A bill that would strengthen regulations for chemical storage facilities was easily passed by the Senate EPW Committee on April 3, 2014. The Chemical Safety and Drinking Water Protection Act of 2014 (S. 1961) was sponsored by West Virginia Senator Joe Manchin (D) and introduced in response to the chemical spill in January along the Elk River in West Virginia. The bill would amend the Safe Drinking Water Act to direct EPA or authorized states to carry out a state chemical storage facility source water protection program. These programs must provide for the oversight and inspection of each covered chemical storage facility to prevent the release of chemicals into the water supply in watersheds with public water systems that rely on surface water. EPW Chair Barbara Boxer (D-CA) offered an amendment to clarify which chemical storage tanks would be subject to the law. Other amendments adopted during the markup of the bill would allow states to opt out of implementing the program and clarified that the federal law would not interfere with state programs. Further, they would ensure that emergency response plans are consistent with existing contingency plans under the CWA. Another amendment added a provision to authorize $20 million in grants to be doled out to states that carry out the protection programs.
House Subcommittee Holds Hearing On Water Trading Programs: The House Transportation and Infrastructure Subcommittee on Water and Environment on March 25, 2014, held a hearing evaluating alternative approaches to cleaning up water bodies that have been damaged by excess nutrients. The hearing focused on water quality trading programs. This concept would allow nonpoint sources such as farms to reduce voluntarily reductions in their discharges to water bodies and then to sell these reductions to point source discharges. Opening statements, witness testimony, and a webcast of the hearing are available online.
Senate Bill Would Block EPA From Denying Certain Permits: On March 25, 2014, Senators David Vitter (R-LA) and Joe Manchin (D-WV) introduced a bill that would prohibit EPA from vetoing CWA permits for dredge and fill operations that have already been approved by the Corps. The Regulatory Fairness Act (S. 2156) would restrict EPA from objecting to or denying a permit under limited conditions. The bill would allow EPA to object only when the Corps publishes a notice identifying a particular site or mine for which the permit for disposal of dredged material would be issued. The bill would also allow EPA to object to the permit for a site, only after a notice-and-comment period, on grounds ''the discharge of dredged or fill material into such defined area will have an unacceptable adverse effect on municipal water supplies, shellfish beds and fishery areas (including spawning and breeding areas), wildlife, or recreational areas.'' The bill is a response to EPA's denial of a permit for the Mingo Logan coal mine in West Virginia, which the Corps issued and which EPA vetoed.
ACCTION Bill Introduced In Senate: Senator Heidi Heitkamp (N-ND) on March 25, 2014, introduced a bill intended to meet long-term environmental goals and make sure that coal remains a part of the U.S. energy portfolio. Specifically intended to reduce the carbon footprint of coal-fired power, the Advanced Clean Coal Technology Investment in Our Nation (ACCTION) Act (S. 2152) seeks to increase the efficiency of utilities or to use carbon capture and sequestration (CCS) technologies that remove carbon dioxide before it enters the atmosphere. The bill incentivizes utilities to invest in technologies that reduce the carbon footprint of coal-fired power. This is done through federal funding programs, federal support for private investment, and reports to Congress that provide recommendations on how best to support future CCS projects in the U.S. The bill supports the development and implementation of technologies that reduce the carbon footprint of coal-fired power plants through the development of large-scale carbon storage programs to support the commercial-scale application of enhanced oil recovery and geologic storage of carbon dioxide. It also would increase the accessibility of funds, enhance research and development on advanced coal and CCS, and increase the tax credit for CCS projects.
Senate Bill Would Expand Scope Of Phthalates Ban In Children's Products: Seeking to close a loophole in the Consumer Product Safety Improvement Act of 2008 (CPSIA), New York Democratic Senator Kirsten Gillibrand on March 12, 2014, introduced a bill that would amend the CPSIA to ban phthalates in all children's products. The bill, S. 2120, would close what some public health groups say is a key loophole in the CPSIA, which bans phthalates only in children's toys or child care articles, but does not address phthalates in other children's products, such as backpacks and pencil cases. Senator Gillibrand's bill would expand the prohibition to all children's products. The term "children's products" would have the same meaning as that term in Section 3(a) of the Consumer Product Safety Act, which defines the term to mean a "consumer product designed or intended primarily for children 12 years of age or younger." The bill would also add three types of phthalates to the ban: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP). The CPSIA currently limits the concentrations of six phthalates in children's toys and child care articles to 1,000 parts per million.
House Oversight Committee Subpoenas EPA For Documents Related To Pebble Mine Permit Veto: After what he characterized as "nearly two years of obstruction," House Oversight and Government Reform Committee Chair Darrell Issa (R-CA) subpoenaed EPA Administrator Gina McCarthy on March 20, 2014, for documents related to the proposed Pebble Project, near Bristol Bay, Alaska. On March 14, 2014, Issa, Subcommittee Chair James Lankford (R-OK), and Subcommittee Chair Jim Jordan (R-OH) sent a letter to EPA Inspector General Arthur Elkins, Jr. requesting an investigation into EPA's decision to rely on a rarely-used provision of the CWA to preemptively veto the proposed Pebble Project.
Inhofe Introduces Bill To Force EPA To Report Job Losses "Caused" By Regulations: Senator James Inhofe (R-OK), ranking member of the EPW Committee, on March 26, 2014, introduced the EPA Employment Impact Analysis Act (S. 2161), a bill that would prohibit EPA issuing any major regulation in final until EPA analyzes the economic impact of its current air regulations. The bill is cosponsored by 29 Republican Senators. Senator Inhofe claimed that "EPA does not know the full cost of its existing regulations, yet it continues to create and implement new ones to the detriment of job creation and economic opportunity in the U.S." He accused EPA of systematically distorting its findings on the economic impact of its regulations. He stated that EPA has failed to comply with CAA Section 321(a), which requires EPA to report how its air regulations are affecting job creation across the entire economy. Inhofe's legislation cites a number of examples where he claims EPA concluded that a regulation would result in the creation of jobs, yet the National Economic Research Associates (NERA), an economic consulting firm, using a "whole economy" model, reported that the same regulation would result in thousands of job losses. Below are three examples cited in the legislation:
Utility Maximum Achievable Control Technology (MACT) rule (77 Fed. Reg. 9301): EPA's analysis estimated that implementation of the final rule would result in the creation of 46,000 temporary construction jobs and 8,000 net new permanent jobs. NERA's whole economy analysis found that the rule would have a negative impact on the income of workers in an amount equivalent to 180,000 to 215,000 lost jobs in 2014, and 50,000 to 85,000 lost jobs each year thereafter.
Cross State Air Pollution rule (76 Fed. Reg. 48208): EPA's analysis estimated that implementation of the final rule would result in the creation of 700 jobs per year. NERA's whole economy analysis found that the rule would result in the elimination of a total of 34,000 jobs from 2013 to 2037.
- Boiler MACT rule (76 Fed. Reg. 15608): EPA's analysis estimated that implementation of the final rule would result in the creation of 2,200 jobs per year. NERA's whole economy analysis found that the rule would result in the elimination of 28,000 jobs per year from 2013 to 2037.
Pipeline Modernization Bill Introduced In The House: Representative Charles Rangel (D-NY) on March 27, 2014, introduced legislation that would require operators of high-risk natural gas pipelines to accelerate the repair and replacement of the pipelines. The Pipeline Modernization and Consumer Protection Act (H.R. 4338), introduced on March 27, would require operators of gas distribution facilities and utilities to implement an integrity management program and accelerate the repair, rehabilitation, and replacement of gas piping or equipment that is leaking or may pose high risks of leaking or may no longer be fit for service due to inferior materials, poor construction practices, lack of maintenance, or advanced age. The bill also would require PHMSA to issue guidance identifying best practices for prioritizing the repair and replacement of high-risk pipelines.
Senate Committee Approves Extension Of Renewable Energy Production Tax Credit: The Senate Finance Committee on April 3, 2014, approved legislation that includes a $13.4 billion retroactive extension of the renewable energy production tax credit. The production tax credit, which provides 2.3 cents per kilowatt hour for electricity produced from wind and other renewables, was among the energy credits added to the legislation as part of a modified tax extenders bill released the morning of the markup. The credit was part of the Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act.
Senate EPW Committee Passes Brownfields Bill: On April 3, 2014, the Senate EPW Committee passed S. 491, the Brownfields Utilization, Investment and Local Development Act of 2013. The bill would authorize $250 million each year in grants to nonprofit organizations for brownfield cleanups.
Jane Nishida Nominated For EPA Assistant Administrator For International And Tribal Affairs: On April 4, 2014, President Obama nominated Jane Nishida to serve as Assistant Administrator (AA) for EPA's Office of International and Tribal Affairs (OITA). Ms. Nishida currently is serving as the acting AA for the office. Ms. Nishida previously led the regional and bilateral affairs office within OITA. She also was the senior environmental institutions specialist at the World Bank from 2004 to 2011 and Secretary of the Maryland Department of Environment from 1995 to 2002. From 1991 to 1995, she was the Maryland executive director of the nonprofit Chesapeake Bay Foundation. Her confirmation will be subject to Senate approval.
House Committee Approves Bill Limiting EPA's CWA Veto Authority: The House Transportation and Infrastructure Committee on April 9, 2014, passed a bill that would limit EPA's authority to revoke dredge-and-fill permits issued under CWA Section 404. The bill, H.R. 524, would prohibit EPA from altering or revoking these permits when they have been issued by the Corps. The bill now moves to the House for a floor vote.
Senator Udall Introduces Quartet Of Bills To Improve Water Efficiency: On April 9, 2014, Senator Tom Udall (D-NM) introduced four bills intended to encourage innovative solutions to improve water efficiency. The Smart Water Resource Management Conservation and Efficiency Act (S. 2225) would fund smart water system pilot projects in three to five cities across the country. Communities would compete for grant funding to develop innovative demonstration projects and to create a "smart-grid" for water. The pilots would serve as models for other communities. The WaterSense Efficiency, Conservation, and Adaptation Act (S. 2226) would permanently authorize and enhance EPA's existing WaterSense program, providing a dedicated source of funding for the water equivalent of EPA's EnergyStar program. WaterSense is an EPA-industry partnership effort to set voluntary technical standards for water appliances such as toilets, showerheads, and landscape irrigation systems that are at least 20 percent more efficient without sacrificing performance. The bill also establishes a grant program called the "Blue Bank" to provide water and sewer utilities with grants to improve water supply management, efficiency, and encourage reuse. The Water Efficiency Improvement Act (S. 2227) would provide a 30 percent tax credit of up to $2,000 per taxpayer on the purchase of products that are certified under the EPA WaterSense program. The Community Water Enhancement Act (S. 2228) provides grants for rural communities seeking smart water systems, alternative water sources, and more efficient use of current supplies.
NTP Announces Reports For Two Chemicals: On March 18, 2014, the National Toxicology Program (NTP) announced that it will convene a meeting on May 22, 2014, to peer review two draft technical reports on a water disinfection byproduct and a metal working fluid. 79 Fed. Reg. 15135. The notice states that draft technical reports on bromodichloroacetic acid (Chemical Abstracts Service (CAS) Number 71133-14-7), the water disinfection chemical, and CIMSTAR 3800 (no CAS Number listed), the metal working fluid, will be available by April 10, 2014. NTP is drafting reports on each chemical's long-term carcinogenicity, for bromodichloroacetic acid through dosed water exposure and for CIMSTAR 3800 through inhalation exposure. The meeting to peer review the draft technical reports will take place in Research Triangle Park, NC, and be broadcasted by webcast on May 22, 2014. Persons wishing to make oral comments must register by May 15, 2014. Written public comment is due May 8, 2014. The draft technical reports and registration information will be available online.
USTR Announces Intent To Engage In Environmental Goods Talks: On March 21, 2014, Michael Froman, Ambassador for the U.S. Trade Representative (USTR), notified Congressional leaders that the Obama Administration will launch negotiations on a new trade agreement in the World Trade Organization (WTO) that is intended to eliminate tariffs on scores of environmental goods. In letters to Speaker of the House John Boehner and Senate Majority Leader Patrick Leahy, Ambassador Froman stated that the Obama Administration will seek to "negotiate and conclude a comprehensive agreement to liberalize trade in environmental goods." The agreement will build on U.S. leadership in the Asia-Pacific Economic Cooperation (APEC) forum on environmental goods, and maintain momentum in the WTO for the kinds of "fresh, credible approaches" to trade negotiation. The Administration's efforts will focus initially on removing tariffs for 54 goods in the APEC List of Environmental Goods that purportedly contribute to green growth and sustainable development. The goods include solar panels, wind turbines, wastewater treatment filters, and similar items.
NTP To Convene Toxicology Workshop: On March 28, 2014, NTP, along with EPA and North Carolina State University, announced that they would convene a workshop on May 5-6, 2014, on how aquarium fish can be used to test environmental toxics' and molecules' potential effects on human health. The workshop is intended to "explore and discuss how aquatic models may be used to (i) screen and prioritize compounds for further in vivo testing (ii) to assess mechanisms of chemical toxicity and how this knowledge can impact the environment and human health." Registration information and the draft agenda are available online.
USTR Requests Comment On Environmental Goods Negotiations: On March 28, 2014, USTR requested comments on U.S. interests and priorities with respect to planned negotiations on a WTO Environmental Goods Agreement to eliminate tariffs on a set of environmental goods. 79 Fed. Reg. 17637. USTR also will hold a June 5, 2014, hearing on the initiative, to be conducted by the interagency Trade Policy Staff Committee. Fourteen WTO members announced on January 24, 2014, their interest in negotiating an agreement to eliminate tariffs on environmental goods, such as solar panels, wind turbines, and catalytic converters, needed to protect the environment and to address climate change. The 14 nations are Australia, Canada, China, Costa Rica, the EU, Hong Kong, Japan, Korea, New Zealand, Norway, Singapore, Switzerland, Chinese Taipei, and the U.S. The list of the 54 goods that USTR stated is the starting point for establishing the agreement's scope is available online. Comments are due May 5, 2014.
SEC Issues Guidance On Conflict Minerals: On April 7, 2014, the Securities and Exchange Commission (SEC) issued guidance in the form of "frequently asked questions" (FAQ) to help publicly traded companies with conflict minerals disclosure requirements. Under the Dodd-Frank Wall Street Reform Consumer Protection Act, in August 2012, the SEC adopted a rule requiring companies and foreign private issuers in the U.S. to report their use of "conflict minerals" -- gold, tantalum, tin, and tungsten from the Democratic Republic of Congo and adjacent countries -- if those minerals are "necessary" to a product made by the stock issuers. Covered issuers are those that must file reports with the SEC under Exchange Act Section 13(a) or 15(d), according to the FAQ document. The rule is broadly applicable and expected to affect 6,000 SEC-reporting issuers and their suppliers. The first disclosures on a new Form SD -- covering the reporting period of January 1 to December 31, 2013 -- must be submitted to the SEC by May 31, 2014. The FAQs are available online.
Appellate Court Affirms In Part Decision Upholding SEC's Conflict Minerals Rule, But Finds Rule Violates The First Amendment: The U.S. Court of Appeals for the District of Columbia Circuit issued on April 14, 2013, its decision in the industry challenge to the SEC's conflict minerals rule, affirming the lower court's decision except regarding free speech claims. Nat'l Ass'n of Mfrs. v. SEC, No. 13-5252. The court held that the SEC did not act arbitrarily and capriciously by choosing not to include a de minimis exception. According to the court, the Dodd-Frank Wall Street Reform Consumer Protection Act is silent with respect to both a threshold for conducting due diligence, and the obligations of uncertain issuers. The court states that the SEC used its delegated authority to fill those gaps, and nothing in the statute foreclosed it from doing so. The court rejected appellants' argument that the SEC's due diligence threshold was arbitrary and capricious. The court states that the SEC "adopted a lower due diligence threshold to prevent issuers from 'ignor[ing] . . . warning signs' that their conflict minerals originated in covered countries." The court acknowledges that the persons-described provision refers expressly to manufacturers, but notes that it is silent on the obligations of issuers that only contract for their goods to be manufactured and that this silence allows the SEC to use its delegated authority in determining the rule's scope. The court found no problems with the SEC's costside analysis. The court did, however, find that the Act and the SEC's final rule violate the First Amendment to the extent the statute and rule require regulated entities to report to the SEC and to state on their website that any of their products have "not been found to be 'DRC conflict free.'" The court remanded the case for further proceedings consistent with its opinion. The decision is available online.
Human Health Risk Assessment Available: On April 15, 2014, EPA announced the availability of the Framework for Human Health Risk Assessment to Inform Decision Making. 79 Fed. Reg. 21239. EPA's Risk Assessment Forum developed the document to assist in developing a framework for conducting human health risk assessments. The document is available online.