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February 1, 2016

Monthly Update for February 2016

Bergeson & Campbell, P.C.


NAS Hosts Workshop On Low Dose Toxicity: On February 3, 2016, the National Academies of Sciences (NAS), Engineering, and Medicine Low Dose Committee heard presentations on several chemicals and the potential effect each may have on reproductive systems. The chemicals considered included: bisphenol A, dioxin, and phthalates. The Committee will assess whether these three chemicals are suitable as case studies for review by the U.S. Environmental Protection Agency (EPA) in its pursuit of identifying toxicity tests that are predictive of human health and environmental concerns from exposure to such chemicals. More information is available online.

EPA Announces Publication Of 2014 TRI National Analysis: On January 21, 2016, EPA published the 2014 Toxics Release Inventory (TRI) National Analysis report. The report is EPA’s summary and interpretation of the most recent data on toxic chemical releases and pollution prevention activities at more than 20,000 U.S. industrial facilities subject to reporting. In the National Analysis, data on chemical releases to air, water, and land, and information about what companies are doing to prevent these releases, can be accessed. For the first time, the TRI National Analysis is available through its own dedicated website. In a related development, EPA announced on February 10, 2016, the TRI program will be located within the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It was previously located within EPA’s Office of Environmental Information (OEI). The move was made with the intent of “streamlining the EPA’s chemical management efforts and to make TRI a more integral part of the EPA’s chemical management and pollution prevention efforts,” according to a statement from EPA.

Ninth Circuit Denies EPA Motion For Vacatur: On January 25, 2016, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied EPA’s motion for voluntary vacatur of the registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration. DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.” DowAgro opposed EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the cancellation process by having the court vacate the registration. The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place. The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.” After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo. The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand. DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.” DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief. This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA. More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.

EPA Announces New PRD Director: On February 1, 2016, EPA announced Yu-Ting Guilaran has been selected as Director of the Pesticide Re-evaluation Division (PRD), effective February 7, 2016. Guilaran has been the Biological and Ecological Analysis Division (BEAD) Director since 2013 and with EPA for nearly 25 years. Prior to joining the Office of Pesticide Protgrams (OPP), Guilaran worked in EPA’s Office of Water, Office of International and Tribal Affairs, and Region 10’s Superfund program. Guilaran holds BS and MS Degrees in Civil Engineering with emphasis in environmental engineering from the University of Washington in Seattle.

EPA Issues Draft General Permit NPDES Regulations For Discharges From Pesticides: On January 26, 2016, EPA published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides, regulations that apply to discharges of pesticides to waters of the United States (WOTUS). 81 Fed. Reg. 4289. The draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP that will expire on October 31, 2016. EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs. Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year. Comments are due March 11, 2016. More information is available online.

Bayer Announces That It Will Not Submit Voluntary Cancellations: Significant issues concerning the scope of EPA’s authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by Bayer Crop Science LP (Bayer) under the trade name Belt. Bayer announced on February 5, 2016, that it will not comply with a request by EPA that Bayer “voluntarily” cancel its registered flubendiamide products. In a January 29, 2016, letter, EPA stated that flubendiamide and a degradate compound are “mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates.” Based primarily on EPA’s ecological risk assessment, EPA has determined “that the continued use of the currently registered flubendiamide products will result in unreasonable adverse effects on the environment.” Bayer disagrees strongly with the EPA risk assessment, because Bayer believes it is based on overly conservative modeling estimates that cannot be reconciled with actual monitoring and environmental fate data for this pesticide. Conditional registrations for pesticides containing flubendiamide were first granted by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) in 2008. As one condition of registration, EPA required Bayer to conduct specific environmental fate studies, which have now been submitted and reviewed. EPA also adopted an initial expiration date for all registrations of flubendiamide products of July 31, 2013, which EPA later agreed to extend several times to allow time for further review and discussion of the submitted data. The current dispute with Bayer involves a specific condition that EPA included in its preliminary acceptance letter for this active ingredient, which EPA contends obligates Bayer to request voluntary cancellation of the registrations now that EPA has made a finding of unreasonable adverse effects. Bayer characterizes the condition in question as “unlawful,” and argues that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) before the registrations can be cancelled. Because Bayer has not submitted the “voluntary” cancellation requests demanded by EPA, EPA has stated that it will initiate the cancellation process for conditional registrations established by FIFRA Section 6(e). Although this process affords Bayer an opportunity for an administrative hearing, the issues in a conditional registration hearing under FIFRA Section 6(e) are limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks. Bayer argues that the condition as it was originally imposed by EPA was improper and denies statutory due process rights, and that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) rather than the limited hearing provided under FIFRA Section 6(e). This dispute presents important legal questions, including what authority EPA has under FIFRA to impose time limitations or expiration dates for pesticide registrations, the rights a registrant has when it applies to amend or to renew a time-limited registration, and the nature of the conditions that EPA may lawfully impose for a conditional registration under FIFRA Section 3(c)(7).

EPA Issues Final SNUR For Three vLCCPs: On February 12, 2016, EPA issued a final rule imposing Significant New Use Rule (SNUR) restrictions on three very long chain chlorinated paraffins (vLCCP), alkyl chain length of C21 and above. 81 Fed. Reg. 7455. According to EPA, these substances are potentially highly bioaccumulative and persistent and toxic, and are expected to form degradation products of shorter chain chlorinated compounds of similar characterization. The SNUR is effective April 12, 2016.


New York State Issues Emergency Regulation Classifying PFOA As Hazardous Substance; Asks EPA To Do The Same And Set PFOA Drinking Water Standard: Responding to an environmental contamination issue in Hoosick Falls, on February 3, 2016, New York Governor Andrew Cuomo (D) directed the New York State Department of Environmental Conservation (NYSDEC) to issue an emergency regulation to classify perfluorooctanoic acid (PFOA), the contaminant found in the Hoosick Falls’ water supply, as a hazardous substance under New York’s Superfund law. This provides NYSDEC with the legal authority to pursue New York State Superfund designation and remediation of the village using state Superfund resources. Cuomo also ordered the New York State Department of Health (NYSDOH) to conduct a risk analysis to establish a drinking water guidance level for PFOA. Cuomo’s orders come a month after EPA officials warned Hoosick Falls residents not to drink public water or use it for cooking due to the presence of PFOA. There is no federal drinking water standard for PFOA, although EPA has a non-enforceable provisional health advisory of 0.04 parts per billion (ppb) to protect against short-term exposures. To remedy that gap, on January 14, 2016, NYSDEC and NYSDOH officials wrote EPA Administrator Gina McCarthy urging EPA to “take vigorous action to address the presence of [PFOA] in drinking water and groundwater.” The letter asks EPA to lower the 0.04 ppb provisional health advisory for PFOA to account for “the most current scientific evidence,” and that EPA “act expeditiously to adopt a protective maximum contaminant level (MCL)” for PFOA. The letter also urges EPA to designate PFOA as a hazardous substance under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and to “review the remaining uses of PFOA under the Toxic Substances Control Act and curtail it whenever less toxic alternatives are available.”

EPA Adds Three Materials To List Of Categorical Non-Waste Fuels: In a final rule issued on February 8, 2016, EPA amended its Non-Hazardous Secondary Materials (NHSM) rule under the Resource Conservation and Recovery Act (RCRA) to add three categories of materials that will be regulated as fuels rather than wastes when burned. 81 Fed. Reg. 6687. Promulgated by EPA in 2011 and codified at 40 C.F.R. Part 241, the NHSM rule establishes standards and procedures for identifying whether NHSM are solid wastes when burned as fuels in combustion units. Those NHSM categorized by EPA as solid wastes when combusted must be burned in units meeting the Clean Air Act (CAA) Section 129 standards for solid waste combustion units. NHSM EPA identifies as fuels can be combusted in units meeting the less stringent CAA Section 112 standards for commercial, industrial, and institutional boilers or, if the combustion unit is a cement kiln, the CAA Section 112 emissions standards for Portland cement kilns. In the final rule, EPA added construction and demolition (C&D) wood processed from C&D debris according to best management practices to the list of categorical non-waste fuels. EPA also added paper recycling residuals generated from the recycling of recovered paper, paperboard and corrugated containers and combusted by paper recycling mills whose boilers are designed to burn solid fuel and creosote treated railroad ties (CTRT). To qualify as a non-waste fuel, however, railroad ties must be processed and combusted in units designed to burn both biomass and fuel oil as part of normal operations and not solely as part of start-up or shut-down operations. CTRTs can also qualify for the designation if they are combusted at units at major source pulp and paper mills or power producers subject to 40 C.F.R. Part 63, Subpart DDDDD that combust CTRTs and have been designed to burn biomass and fuel oil, but are modified to use natural gas instead of fuel oil, as part of normal operations and not solely as part of start-up or shut-down operations. The rule becomes effective on March 9, 2016.

EPA Proposes To Add Subsurface Intrusion To Hazard Ranking System: On February 4, 2016, EPA announced that it is issuing a proposed rule that would add subsurface intrusion as a component to the Hazard Ranking System (HRS) under CERCLA. The HRS is the primary mechanism EPA uses to evaluate sites for placement on the CERCLA National Priorities List (NPL). EPA uses the HRS to evaluate the potential risk posed by contaminated sites and to help it determine whether a site warrants listing on the NPL. Sites with an HRS score of 28.50 or higher are generally eligible for placement on the NPL. EPA will take comment on the proposed rule for 60 days after publication in the Federal Register. More information is available online.

EPA Will Hold A Preliminary Imidacloprid Pollinator Risk Assessment Technical Briefing Webinar: EPA will hold an online briefing on February 18, 2016, on its preliminary pollinator risk assessment for imidacloprid, a neonicotinoid insecticide, from 1:00 p.m. to 2:30 p.m. (EST). Register for the webinar online. The webinar is intended to inform the public about the results of EPA’s recently released preliminary pollinator risk assessment for imidacloprid. For people who are unable to attend, the session will be recorded and linked from the Federal Pollinator Health Task Force: EPA’s Role web page.


FDA Issues Technical Amendments To Final Rule: On January 22, 2016, the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) issued technical amendments to a final rule as part of ongoing activities with the implementation of the Food Safety Modernization Act (FSMA). 81 Fed. Reg. 3714. The technical amendments are specific to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food issued August 2015. The amendments correct “editorial and inadvertent errors” from the final rule. The amendments were effective immediately.

FDA Announces OMB Approval For Collection Of Information On Voluntary Labeling: On February 2, 2016, FDA CFSAN announced that the Office of Management and Budget (OMB) has approved the collection of information regarding “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants.” 81 Fed. Reg. 5470. FDA submitted the proposal for approval in December of 2015 in response to several ongoing State measures. The approval expires January 31, 2019.

FDA Announces FY 2017 Budget: On February 9, 2016, FDA announced it would seek an eight percent increase in its budget for fiscal year (FY) 2017. The budget total of $5.1 billion is necessary to meet the ongoing implementation of the FSMA. Several new rules were issued last year that implement the core of FSMA; FDA is seeking additional funds to support these efforts. The other areas FDA is seeking to increase its budget are those relating to improving the safety and quality of medical products and to invest in the FDA’s infrastructure to support increased legislative mandates.


EFSA Publishes Nano Network 2015 Annual Report: The European Food Safety Authority (EFSA) published on January 11, 2016, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (Nano Network) annual report for 2015. The report states that, during 2015, the Nano Network followed-up on its four priority topics: (1) the need for an inventory of nanomaterials in products on the market; (2) the analysis and monitoring of products under development and on the market; (3) the need for suitable measuring methods, e.g., for physico-chemical properties; and (4) the need for validated test methods in vitro and in vivo. Topics recommended for the 2016 program include:

  • Discussing implementation of the novel food regulation;
  • Making more materials available for research through cooperation from industries and/or through reference material development while expanding the Joint Research Center’s (JRC) repository;
  • Discussing the idea of pooling ongoing safety research to extract the data in a harmonized way; and
  • Receiving an update on the implementation of the risk assessment approach as applied by the Netherlands, and debating its wider application.

Danish EPA Assesses Administrative Burdens Of Nano Product Register: On January 12, 2016, the Danish Environmental Protection Agency (Danish EPA) posted a report entitled Assessment of the administrative burdens on businesses with a reporting obligation to the Danish Nanoproductregister. Danish EPA estimated the administrative burden of businesses reporting to the Danish nano product register using the standard cost method. According to Danish EPA, interviews with companies and industry associations contributed to estimates for the measurement of administrative burdens, and provided input to the evaluation of corporate barriers experienced by the first submitters to the register. Danish EPA states that the interviews also contributed “to the experience and learning inputs relative to improvement opportunities and other models for mapping and provision of knowledge about nanomaterials in products.”

Society For The Study Of New And Emerging Technologies Launches New Website And Twitter Account, Will Hold Annual Meeting In October: The Society for the Study of New and Emerging Technologies (S.NET), an international association promoting intellectual exchange and critical inquiry about the advancement of new and emerging technologies in society, has launched a new website and twitter account. S.NET represents diverse communities, disciplines, viewpoints, and methodologies in the social sciences and humanities. It also welcomes contributions from scientists and engineers that advance the critical reflection of nanoscience and other emerging technologies. Its eighth annual meeting, “The Co-Production of Emerging Bodies, Politics and Technologies,” will be held October 12-14, 2016, in Bergen, Norway. The meeting will examine questions such as how emerging technologies such as nanotechnology or synthetic biology shape institutions, citizen organizations, and other political agencies, and how these emerging technologies are shaped by politics. The conference organizers invite proposals for papers, panels, film viewings, art exhibits, installations, and other creative formats.

NIOSH Releases Draft CIB On Silver Materials: On January 21, 2016, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. 81 Fed. Reg. 3425. The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. According to the draft CIB, “[a]lthough the experimental animal and cellular studies are useful for showing potential risks from exposure to silver nanomaterials, NIOSH considers the currently available data to be too limited to develop a REL for silver that is specific to particle size.” Instead, NIOSH recommends that effective risk management control practices be implemented so that worker exposures to silver nanomaterials do not exceed the NIOSH recommended exposure limit (REL) of ten micrograms per cubic meter (µg/m3) (eight-hour time-weighted average) for silver metal dust, fume, and soluble compounds, measured as a total airborne mass concentration. NIOSH “recommends additional prudent measures including conducting workplace exposure and hazard assessments and medical surveillance of workers potentially exposed to silver nanomaterials.” The draft CIB provides recommendations for the safe handling of silver nanoparticles, and proposes research needs to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles. The Federal Register notices states that special emphasis will be placed on discussion of the following:

  • Whether the health hazard identification, risk estimation, and discussion of health effects of silver and silver nanomaterials are a reasonable reflection of the current understanding of the scientific literature;
  • Workplaces and occupations where exposure to silver and silver nanomaterials may occur; and studies on health effects associated with occupational exposure to silver dust and fume;
  • Current strategies for controlling or preventing exposure to silver and silver nanomaterials (e.g., engineering controls, work practices, personal protective equipment);
  • Current exposure measurement methods and challenges in measuring workplace exposures to silver nanomaterials; and
  • Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

During the public meeting, NIOSH will allow commenters to provide oral comments on the draft CIB, to inform NIOSH about additional relevant data or information, and to ask questions on the draft CIB and NIOSH recommendations. The Federal Register notice states that the forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. The meeting will be open to a limited number of participants through a conference call phone number and will be webcast live on the Internet. Due to the limited spaces, notification of intent to attend the meeting must be made no later than March 9, 2016. NIOSH seeks public comments on the draft CIB, and will hold a public meeting to discuss the CIB on March 23, 2016. On February 10, 2016, NIOSH extended the comment period, and comments are due April 22, 2016. 81 Fed. Reg. 7124.

OECD Publishes Reports Concerning Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has posted the following reports concerning nanomaterials:

  • Considerations for Using Dissolution as a Function of Surface Chemistry to Evaluate Environmental Behaviour Of Nanomaterials in Risk Assessments: A Preliminary Case Study Using Silver Nanoparticles — The December 18, 2015, report discusses preliminary findings on dissolution by media type, provides recommendations, compares silver nanoparticles to other nanomaterials, and summarizes additional needs.
  • Physical-Chemical Parameters: Measurements and Methods Relevant for the Regulation of Nanomaterials — The January 21, 2016, OECD workshop report summarizes the June 18-19, 2014, OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on Nanomaterials Physical-Chemical Parameters. The main objectives of the meeting were to identify the appropriate test methods for physical-chemical parameters for manufactured nanomaterials, building on the experience from the OECD Testing Program, the knowledge acquired through the research done by physical-chemical and metrology experts, and if possible, to determine which test methods are appropriate for both a particular parameter and particular types of nanomaterials. The report includes the following recommendations: a decision tree needs to be developed for particle size; technical guidance is needed on the application of electron microscopy for determining the size and size distribution and shape of particulate materials; and guidance needs to be developed in tandem to the decision tree on dispersion protocols, while considering defining smallest dispersible size. For all the physical-chemical properties discussed, the group saw the need to identify the appropriateness of techniques/methodologies for specific measurands for different nanomaterial chemical/structural-based categories; to develop a guidance document based on the chemical identification descriptors/behaviors needed leading to selection of techniques/methodologies; to develop guidance on available methods for chemical composition, giving consideration to functional tests when appropriate; and to develop guidance on how to determine crystallinity, where results for the bulk are not sufficient, focusing on which methods to use when, including how to deal with surface crystallinity.
  • Approaches on Nano Grouping/Equivalence/Read-Across Concepts Based on Physical-Chemical Properties (GERA-PC) for Regulatory Regimes — The January 22, 2016, document presents responses to, and findings from, a 2013 questionnaire survey on approaches to develop or use concepts of grouping, equivalence, and read-across based on physical-chemical properties (GERA-PC) of nanomaterials for their human health and ecosystem hazard assessment in regulatory regimes. The survey was proposed following the results of the WPMN work on risk assessment approaches to strengthen and enhance regulatory risk assessment capacity. Thirteen responses were received from eight OECD member countries (Australia, Canada, Denmark, Germany, Japan, Switzerland, the United Kingdom, and the U.S.), one regional organization (the European Union (EU)), and one OECD partner (the Business and Industry Advisory Committee to the OECD (BIAC)).

OSTP Posts Blog Item On Educating And Inspiring Students Through Nanotechnology: The Office of Science and Technology Policy (OSTP) posted a blog item on January 25, 2016, on “Educating and Inspiring Students through Nanotechnology.” The blog item states that to reap the benefits of nanotechnology, “we must train our Nation’s students for these high-tech jobs of the future.” The blog item announces that a new six-part video series, “Nanotechnology: Super Small Science,” shows how to educate and inspire students though nanotechnology. The blog lists the other following examples of the National Nanotechnology Initiative’s (NNI) efforts “to educate and inspire our Nation’s students”:

  • The Generation Nano: Small Science, Superheroes contest, hosted by the National Science Foundation (NSF) and NNI, challenges high school students to design nanotechnology-enabled gear for an original superhero. Submissions are due February 2, 2016.
  • The National Nanotechnology Coordination Office (NNCO) and the National Institute of Standards and Technology collaborated with Fairfax County Public Schools in Virginia to develop the middle school video series Innovation Workshop: Nanotechnology, which was recently distributed nationwide. Students at Western Carolina University, with guidance from the NNCO, have created educational animations about nanotechnology that are featured on Science Matters, Community Idea Stations. These videos and animations are also available through
  • NNCO is expanding the teacher resources on and working with nanoHUB to develop a searchable database for nanoeducation. The blog notes that this portal “addresses a critical challenge identified at the NSF Nanoscale Science and Engineering Education (NSEE) Workshop: the difficulty educators face in finding appropriate lesson plans, laboratories, and other resources for teaching nanoscience and engineering in their classrooms.”
  • NNCO is coordinating a growing, national Nano & Emerging Technologies Student Network. The network consists of student-run clubs at colleges and that are focused on raising awareness of current and potential applications of emerging technologies, as well as promoting opportunities for student research and internships. The network will convene for the first time in summer 2016 at the TechConnect World Innovation Conference and Expo at the National Harbor in Maryland.

OSTP Seeks Nanotechnology Commercialization Success Stories: On February 2, 2016, OSTP published in the Federal Register a request for information (RFI) seeking examples of commercialization success stories stemming from U.S. government-funded nanotechnology research and development (R&D) since the inception of the NNI in 2001. 81 Fed. Reg. 5505. OSTP states that the information gathered in response to this RFI may be used as examples to highlight the NNI’s impact or to inform future activities to promote the commercialization of federally funded nanotechnology R&D. Depending on the nature of the feedback, OSTP may use responses to shape the agenda for a workshop to share best practices and showcase commercial nanotechnology-enabled products and services. OSTP also posted a blog item regarding the RFI, which describes “pioneering nanotechnology research by two 2015 National Medal of Science and one National Medal of Technology and Innovation recipients [that] has found its way into multiple commercial products.” OSTP invites responses from commercial entities, academic institutions, government laboratories, and individuals who have participated in federally funded R&D; collaborated with federal laboratories; used federally funded user facilities for nanoscale fabrication, characterization, and/or simulation; or have otherwise benefited from NNI agency resources. Responses are due February 29, 2016.

EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments For Registration Of Nanomaterials: On February 2, 2016, the European Commission (EC) published an inception impact assessment concerning “Possible amendments of Annexes to REACH for registration of nanomaterials.” According to the inception impact assessment, the EC identified a need for more specific requirements for nanomaterials to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers to attain the aims of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. This initiative intends to solve how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers. The inception impact assessment identifies the following options:

  • Baseline scenario — no EU policy change;
    • Option 1: No change;
  • Options of improving implementation and enforcement of existing legislation or doing less/simplifying existing legislation:
    • Option 2: Clarifying the existing information requirements;
    • Option 3: Soft law measures;
    • Option 4: Scientific-technical recommendations tailoring information requirements;
    • Option 5: Reduced information requirements; and
    • Option 6: Exhaustive information requirements.

The chosen option, if different to the baseline scenario, will take the form of a draft EC implementing regulation amending certain REACH Annexes, and the EC will submit it to the REACH Committee for opinion in accordance with REACH Article 133(4) before its adoption by the EC. The inception impact assessment states that work on the impact assessment was expected to conclude by the end of 2015.


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

APHIS Seeks Comment On Potentially Significant Changes To Regulations Regarding GE Organisms: According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to “prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The notice identifies “reasonable alternatives and potential issues” to be evaluated in the EIS and requests public comments to define further the scope of the alternatives and environmental impacts and issues for APHIS to consider. Comments are due by March 7, 2016.

Dates And Locations Of “Modernizing The Regulatory System For Biotechnology Products” Meetings Announced: On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the “Modernizing the Regulatory System for Biotechnology Products” memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the FDA website. The second of the three meetings will be held on March 9, 2016, at EPA’s Region 6 office in Dallas, Texas. The third meeting will be held on March 30, 2016, at the University of California’s David Conference Center in Davis, California. A Federal Register notice will be published with additional details on meeting times, agendas, and how to participate.


Coal Ash Recycling Legislation Introduced In Senate: Senators John Hoeven (R-ND) and Joe Manchin (D-WV) on January 20, 2016, introduced legislation that would amend RCRA to encourage the recovery and beneficial use of coal combustion residuals (CCR). The bill (S. 2446) would create a state-based approach to regulating CCRs. “This bill ensures that EPA’s coal ash disposal standards are enforced with proper oversight from our states, instead of the approach taken by EPA in the [April 2015] final rule, which regulates coal ash and enforces the requirements through litigation. Coal ash is a byproduct of coal-based electricity generation that has been safely recycled for buildings, roads, bridges and other infrastructure for years,” stated Hoeven. “The overregulation of coal ash by the EPA would threaten vital industries and unnecessarily cost West Virginia and the nation more jobs,” added Manchin. EPA’s final rule regulates CCRs as a non-hazardous waste under RCRA. 80 Fed. Reg. 21302 (Apr. 17, 2015). But critics of the rule argue that it does not create an effective enforcement mechanism for the disposal of coal ash as it relies on citizen-suit litigation to enforce coal ash disposal standards. The Hoeven-Manchin legislation seeks to remedy this situation. It would continue to authorize states to create permit programs to enforce coal ash disposal standards, while responding to EPA feedback on earlier legislation by requiring states to set up their permit program through a traditional EPA application process and giving EPA final approval of a state’s permit program prior to implementation. It would also seek to ensure that state permit programs require timely and effective groundwater monitoring of CCR disposal sites, and require protective lining and properly engineered disposal structures needed to protect communities and the environment. States that choose not to create a permit program or that do not have an approved application from EPA will be regulated directly by EPA.


EPA Announces Personnel Changes: EPA announced in early January several personnel announcements regarding senior leadership who are transitioning from an Acting capacity to formally assume their new official positions. Joel Beauvais will lead the Office of Water as the Deputy Assistant Administrator for Water. Beauvais had been the Associate Administrator for Policy for the past two years, where he has served as one of the key policy advisors. Previously, Beauvais was Associate Assistant Administrator in the Office of Air and Radiation and Special Counsel to the Office of the Administrator. Laura Vaught will serve as the Associate Administrator of the Office of Policy. Vaught most recently served as the Associate Administrator for Congressional and Intergovernmental Relations (OCIR). Prior to coming to OCIR, Vaught worked as Chief of Staff for Congressman Rick Boucher and as staff on the House Committee on Energy and Commerce. Nichole Distefano Beier will serve as the Associate Administrator for OCIR. Beier has been in OCIR for over two years serving as the Deputy Associate Administrator for Congressional Affairs. Prior to coming to EPA, Beier worked as senior legislative counsel for Senator Claire McCaskill.

OEHHA To Launch Online Tool Regarding Proposition 65 Exposures: On January 19, 2016, the California Office of Administrative Law signed off on a regulation establishing the framework for a new online tool to advise the public about exposures to chemicals listed under Proposition 65. The tool will be housed in a new website that will include information on exposure routes to chemicals, suggested ways to diminish exposures, and links to information. The regulation is to take effect on April 1, 2016.

U.S. Chemical Safety Board Releases Video Identifying Findings And Recommendations On West Fertilizer Company Explosion And Fire: On January 29, 2016, the U.S. Chemical Safety Board (CSB) released a safety video regarding the April 17, 2013, fire and explosion at the West Fertilizer Company in West, Texas, which resulted in 15 fatalities, more than 260 injuries, and widespread community damage. The fire and explosion occurred when about 20 tons of fertilizer grade ammonium nitrate (FGAN) exploded after being heated by a fire at the storage and distribution facility. The CSB’s safety video, entitled “Dangerously Close: Explosion in West, Texas,” includes a 3D animation of the fire and explosion as well as interviews with CSB investigators and Chairperson Vanessa Allen Sutherland. The video can be viewed on the CSB’s website. The CSB found that several factors contributed to the severity of the explosion, including poor hazard awareness. CSB concludes that this lack of awareness was due to several factors, including gaps in federal regulatory coverage of ammonium nitrate storage facilities. The video details safety recommendations made to the Occupational Safety and Health Administration (OSHA) and the EPA to strengthen their regulations to protect the public from hazards posed by FGAN.

ATSDR Releases Draft Glutaraldehyde Tox Profile: On February 3, 2016, the Agency for Toxic Substances and Disease Registry (ATSDR) released a draft Toxicological Profile for Glutaraldehyde. 81 Fed. Reg. 5756. Written comments must be received on or before May 3, 2016.

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