Blogs

On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018.  The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders...

On December 15, 2017, the U.S. Environmental Protection Agency (EPA) announced its release of preliminary ecological and human health risk assessments for three neonicotinoid insecticides:  clothianidin, thiamethoxam, and dinotefuran, as well as a preliminary ecological risk assessment for imidacloprid, assessing risks to birds, mammals, non-target insects, and plants.  The assessments are available in the dockets linked below: Imidacloprid Registration Review Docket ID...

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present...

The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials.  The...

By Lauren M. Graham, Ph.D. On December 4, 2017, Bio-on, a leading Italian biotechnology company in the bioplastic sector, announced the continuation of its collaborative agreement with AkzoNobel, a member of BRAG.  Following the close of a successful collaboration on the 2014 Synergistic Fouling Control Technologies-SEAFRONT project, International Paint Ltd., a business unit of AkzoNobel, and Bio-on have agreed to investigate the use of Bio-on’s biodegradable and biobased...

By Lauren M. Graham, Ph.D. On December 8, 2017, the U.S. Department of Commerce (DOC) issued in the Federal Register a notice on the postponement of final determinations of sales in less than fair value (LTFV) investigations into biodiesel from Argentina and Indonesia and the extension of provisional measures.  As reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “DOC Initiates Biodiesel Antidumping, Countervailing...

By Kathleen M. Roberts On December 4, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment regarding an extension of a previously approved ICR regarding biobased procurements.  Pursuant to Federal Acquisition Regulation (FAR) clause 52.223-2, prime contractors are required to report annually the product types and dollar...

By Kathleen M. Roberts On December 8, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register regarding its plans to submit an information collection request (ICR) to the Office of Management and Budget (OMB) on recordkeeping and reporting for the Renewable Fuel Standard (RFS) program.  The notices states that the ICR aims to streamline and update estimates related to the RFS program and consolidate all RFS estimates into one, consistent, and...

The American Bar Association (ABA) Pesticides, Chemical Regulation, and Right-to-Know (PCRRTK) Committee is collaborating with David Rejeski, Director of the Technology, Innovation, and Environmental Project at the Environmental Law Institute (ELI), on a project involving the law, regulation, and policy of cannabis.  David has written extensively on the topic, one example of which is his article “Cannabis. The ‘Next Big Thing’ for the Environment?”  Federal Insecticide,...

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following...

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s...

In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  WHO developed the Guidelines, which provide recommendations on how best to protect workers from the potential risks of manufactured nanomaterials (MNM).  According to WHO, its recommendations are intended to help policy-makers and professionals in the field of occupational health and safety in making decisions about the best...

On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit.  This was not entirely unexpected, as the U.S. Court of Appeals for...

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii.”  ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp. nauplius.  ISO states that ISO/TS...

On November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in 2017.  According to the report, INRS action on manufactured nanomaterials has three objectives:  (1) making knowledge on hazards available to the working world; (2) designing tools for identifying, characterizing, and measuring occupational exposures;...

By Lauren M. Graham, Ph.D. On December 1, 2017, Neste, a member of BRAG, announced that its Ham Trick (Kinkkutemppu in Finnish) campaign was awarded two prestigious marketing and communications competitions.  The Ham Trick, which is a campaign in which Neste collects and recycles ham waste fat from 100,000 households throughout Finland for manufacturing renewable diesel, won gold at the 2017 European Excellence Awards (EEA) and bronze in the PR category at the Eurobest awards....

By Lauren M. Graham, Ph.D. On November 29, 2017, the Ontario Ministry of the Environment and Climate Change (Ministry) issued proposed amendments to the Ethanol in Gasoline regulation (O. Reg. 535/05) and the Greener Diesel -- Renewable Fuel Content Requirements for Petroleum Diesel Fuel (O. Reg. 97/14) under the Environmental Protection Act, R.S.O. 1990, c.E.19.  Among the proposed changes is an increase from a 5 percent ethanol blending mandate to 10 percent starting in 2020; a...

By Kathleen M. Roberts On November 29, 2017, the U.S. Department of Energy (DOE) announced that a collaboration between the National Renewable Energy Laboratory (NREL) and Oak Ridge National Laboratory (ORNL) resulted in the successful modification of a microorganism to produce a versatile fermentation intermediate that can be upgraded into valuable biobased fuels and chemicals.  NREL’s cellulosic ethanol fermentation organism (Zymomonas mobilis), is capable of exclusively...

By Kathleen M. Roberts On November 30, 2017, the U.S. Environmental Protection Agency (EPA) issued its final 2018 volume requirements under the Renewable Fuel Standard (RFS) program for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel.  A pre-publication of the final rule is available now.  The final rule sets the annual percentage standards for cellulosic biofuel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and...

On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products.  The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will be due in February 2019.  According to KEMI, the purpose of the new notification...

On December 8, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice that it is withdrawing its direct final rule issued on October 25, 2017, to update the voluntary consensus standards that were originally published in the Toxics Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016.  EPA issued both a direct final rule and a proposed rule...

On December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  Comments were initially due on December 9, 2017; they are now due on January 12, 2018.  EPA...

In December 2017, Germany’s Federal Environment Agency (UBA) published a report entitled Clarification of methodical questions regarding the investigation of nanomaterials in the environment:  Development of a decision support tool for the investigation of nanomaterial’s environmental behaviour based on dispersion behaviour and dissolution in relation to various environmental parameters.  UBA states that for an adequate and valid interpretation of data regarding the environmental fate and...

On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA).  EPA offered brief prepared remarks and previously solicited questions from stakeholders.  Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents...

The Dutch National Institute for Public Health and the Environment (RIVM) published a brochure entitled “The European Union Observatory for Nanomaterials:  A step forward?” on November 30, 2017.  RIVM concludes that the European Union (EU) Observatory for Nanomaterials (EUON) will have a limited contribution to reducing the uncertainty regarding the safety of nanomaterials.  Although several EU Member States, including the Netherlands, supported a mandatory EU-wide registration system for...

On November 30, 2017, the National Nanotechnology Initiative (NNI) published a supplement to the President’s 2018 budget.  The supplement also serves as NNI’s annual report and summarizes the progress made in achieving NNI’s goals, the research and development (R&D) activities and plans of the participating agencies, and the agency investments in each program component area.  The President’s 2018 Budget requests $1.2 billion for the NNI, “a...

By Lauren M. Graham, Ph.D. Royal Dutch Shell (Shell) announced a collaboration with bio-bean, a clean technology company, that will power London’s buses using a biofuel made partly from waste coffee grounds.  Bio-bean collects waste coffee grounds from high street chains and factories, dries and processes the grounds, and then extracts the coffee oil, which Argent Energy, bio-bean’s fuel partner, processes into a blended B20 biofuel.  The biofuel contains a 20 percent...

By Lauren M. Graham, Ph.D. On November 22, 2017, Neste, a member of BRAG, announced exclusive partnerships with four California fuel distributors that will provide public and private fleets access to a consistent and high-quality supply of Neste MY Renewable Diesel.  Through the partnerships with IPC (USA), Inc., Ramos Oil Company, Van De Pol Petroleum, and Western States Oil, Neste renewable diesel will be available to customers in Southern California, Northeast California, the...

By Kathleen M. Roberts DOE’s Bioenergy Technologies Office (BETO) is hosting an Advanced Development and Optimization (ADO) Workshop on December 12-13, 2017, in Golden, Colorado.  At the workshop, BETO intends to discuss how the new ADO program area can best serve stakeholders in developing the bioenergy industry, and to raise awareness of existing assets from past investments and discuss future needs and opportunities for maximizing these assets’ value.  The ADO...

By Kathleen M. Roberts On November 27, 2017, the U.S. Department of Energy (DOE) issued an announcement for its second funding opportunity announcement (FOA) for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for fiscal year (FY) 2018.  The Phase I Release 2 FOA will provide funding for innovations that address multiple research and development programs throughout DOE, including the Office of Energy Efficiency and Renewable Energy...

By Lauren M. Graham, Ph.D. On November 30, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing its decision to deny several petitions requesting that EPA initiate a rulemaking to change the point of obligation for compliance under the Renewable Fuel Standard (RFS) program.  Under the RFS program, refiners and importers of gasoline and diesel fuel are identified as “obligated parties” responsible for compliance with the RFS...

On November 29, 2017, the Senate Environment and Public Works Committee approved the nomination of Andrew R. Wheeler, Esquire for U.S. Environmental Protection Agency (EPA) Deputy Administrator.  Mr. Wheeler currently works as a Principal at Faegre Baker Daniels Consulting providing guidance on federal regulatory and legislative environmental and energy issues.  He began his environmental policy career at EPA in 1991 when he was Special Assistant to the Information Management Division...

On behalf of its project partner, the Institute of Occupational Medicine, NanoReg2 seeks information from organizations that manufacture, make, use, distribute, or dispose of nanomaterials.  NanoReg2 states that, as part of the NanoReg2 Project, it is trying to find out what organizations know and understand about worker and end-user risk from nanomaterials and the concept of Safe-by-Design.  NanoReg2 encourages participation from individuals who are involved in product development, health...

On November 30, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of its final determination on whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted. The notice states that EPA has made its final determination that revision is warranted based upon three...

On November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions.  It granted the American Chemistry Council’s (ACC) (and other industry groups) motion...

Germany’s Federal Environment Agency (UBA) published a November 2017 report entitled Considerations about the relationship of nanomaterial’s physical-chemical properties and aquatic toxicity for the purpose of grouping.  The report notes that, based on the variety of existing nanomaterials with numerous modifications, “the effort of investigating environmental fate and effects will be tremendous.”  As a result, it will be necessary to group nanomaterials that feature...

On November 22, 2017, the U.S. Environmental Protection Agency (EPA) announced it was releasing a preliminary list of chemical substances reported under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) rule that includes substances reported to EPA through November 10, 2017, and that it will be updated approximately once per month.  EPA states that it is making this list available to help keep the stakeholder community informed of the status of reporting...

In October 2017, the European Commission (EC) Directorate-General for Research and Innovation published a report entitled An ecosystem to accelerate the uptake of innovation in materials technology:  Report by the High Level Group of EU Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials.  The High Level Group of European Union (EU) Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials examined the barriers...

On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals.  EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R....

As reported in our October 11, 2017, blog item, on October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  Comments were due November 6, 2017.  The EC has posted the comments online.  In all, 36 comments were...

On November 30, 2017, the European Chemicals Agency (ECHA) will hold a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  ECHA states that the main focus will be on the registration and read-across of nanoforms, but the webinar will also cover updates for information requirements for human health and the environment.  According to the agenda,...

By Kathleen M. Roberts On November 14, 2017, the Governors' Biofuels Coalition announced that grain and ethanol industry stakeholders, including the U.S. Grains Council, the Renewable Fuels Association (RFA), and Growth Energy, sent a letter to U.S. Trade Representative Robert E. Lighthizer to request that the U.S. suspend Brazil’s designated country status as a result of a 20 percent tariff on ethanol exports to Brazil.  The tariff is to be assessed on all current and future...

By Lauren M. Graham, Ph.D. On November 13, 2017, Neste, a member of BRAG, announced it has entered into an agreement with American Airlines to explore opportunities to reduce the airline’s environmental footprint.  To achieve this goal, the companies are evaluating in-flight and on-the-ground opportunities to utilize Neste’s renewable fuels.  One aspect of the collaboration will involve complementary efforts to facilitate acceptance and commercialization of High Freeze...

By Lauren M. Graham, Ph.D. On November 9, 2017, the U.S. Department of Commerce (DOC) issued affirmative final determinations in the countervailing duty (CVD) investigations of imports of biodiesel from Argentina and Indonesia.  Following a nine month investigation, DOC determined that Argentina and Indonesia are providing unfair subsidies to its producers of biodiesel at rates from 71.45 to 72.28 percent and 34.45 to 64.73 percent, respectively.  As a result, U.S. Customs and...

By Kathleen M. Roberts On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program.  The program aims to support the generation of new information that will assist federal regulatory agencies in making science-based decisions about the effects of introducing genetically engineered (GE) organisms, including microorganisms,...

By Lauren M. Graham, Ph.D. On October 31, 2017, the U.S. Environmental Protection Agency (EPA) sent its final rule to set the Renewable Fuel Standard (RFS) volumes for 2018 and 2019 to the U.S. Office of Management and Budget (OMB) for review.  Under the Clean Air Act (CAA), EPA must issue a final rule to set standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel by November 30, 2017.  Typically, OMB review is the last step before the...

In October 2017, the presentations and report for the June 20, 2017, Second European Conference on “Standardization for Nanotechnologies and Nanomaterials:  Reliable data for an effective management of nanomaterials” were posted.  The European Committee for Standardization (CEN)/Technical Committee (TC) 352 “Nanotechnologies,” together with the CEN-European Committee for Electrotechnical Standardization (CENELEC) Management Center, the European Commission (EC), and the European...

On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting.  EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on...

Nanotechnology The National Science Foundation (NSF) Nanoscale Science and Engineering (NSE) grantees conference on progress in nanotechnology will be held December 12-13, 2017.  The conference will highlight the research and education activities of ongoing NSE grant projects.  It will include a combination of keynotes, panels, posters, program information sessions, discussions of research trends, and principal investigator meetings with NSF program directors.  The...

On September 26-27, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) held an Expert Dialogue regarding the opportunities and risks of the application of nanotechnologies in the automotive sector.  The Expert Dialogue provided an overview of current and future applications of nanomaterials in automobiles.  A number of the presentations are available online, in German.  Since 2006, the NanoDialogue has been conducted as part of the German...