Blogs

By Lauren M. Graham, Ph.D. On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  FDA states the purpose of the public meetings is “to provide the public with...

By Lauren M. Graham, Ph.D. USDA awarded Spero Energy Inc. a Small Business Innovation Research (SBIR) grant for $100,000 to conduct research and development to increase the availability and competitiveness of biobased products within the agricultural market.  Spero Energy is an Indiana-based company focused on the development of cost competitive processes for the conversion of biomass to renewable chemicals and fuels.  The SBIR grant aims to support the development of a series of...

By Lauren M. Graham, Ph.D. On September 22, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) awarded six grants totaling nearly $21.1 million to support the development of new jet fuel, biobased products, and biomaterials from renewable sources.  The funding is provided through NIFA’s Agriculture and Food Research Initiative (AFRI) Sustainable Bioenergy and Bioproducts (SBEBP) Challenge Area.  Grant recipients include:...

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423.  During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the...

On October 12, 2017, the Organization for Economic Cooperation and Development (OECD) announced the release of 17 new, updated, corrected, or deleted Test Guidelines.  The Test Guidelines include three specifically developed for nanomaterials.  OECD states that Test Guideline 318:  Dispersion Stability of Nanomaterials in Simulated Environmental Media provides a simple and effective tool that can analyze the dispersion stability of nanomaterials in aqueous media.  It is one of the...

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.  The draft regulation states that: Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in Annexes I,...

As reported in our August 30, 2017, blog item, the “Technology Development Pathways:  Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017.  According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact.  Keynote presentations will highlight the pathways companies have taken to get from research to commercialization.   Panel discussions will focus on specific...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

By Lauren M. Graham, Ph.D. On September 26, 2017, the U.S. Department of Energy (DOE) announced the selection of an additional project for the Bioenergy Technologies Office’s (BETO) Advanced Algal Systems Program funding opportunity announcement (FOA).  DOE is awarding up to $3.5 million to the National Renewable Energy Laboratory (NREL) to more than double the productivity of biofuel precursors from algae.  Researchers aim to improve productivity by increasing algal...

By Lauren M. Graham, Ph.D. On October 4, 2017, EPA issued a NODA in the Federal Register to provide supplemental information and an opportunity for further public comment on potential reductions in the 2018 biomass-based diesel, advanced biofuel, and total renewable fuel volumes, and/or the 2019 biomass-based diesel volume under the RFS program.  The NODA follows the Agency’s July 21, 2017, proposed rulemaking on the volume requirements and provides additional information on...

By Lauren M. Graham, Ph.D. Last week, Senators Chuck Grassley (R-IA) and Joni Ernst (R-IA) responded to the U.S. Environmental Protection Agency’s (EPA) Notice of Data Availability (NODA) regarding the Renewable Fuel Standard (RFS) volume requirements (see EPA Issues NODA Regarding RFS Program).  On September 27, 2017, Ernst sent a letter to President Trump expressing concern over the proposed reduction in the volume requirements for 2018 and 2019.  In the letter, Ernst...

By Kathleen M. Roberts On September 28, 2017, the Senate Committee on Agriculture, Nutrition, and Forestry held a hearing titled “Rural Development and Energy Programs: Perspectives for the 2018 Farm Bill” to gather stakeholder input regarding the programs under the Farm Bill that are working or need improvement.  In his opening statement, Committee Chair Pat Roberts (R-KS) stated that it is critical for the next Farm Bill to support renewable energy and biobased product...

On October 4, 2017, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on the nomination of four U.S. Environmental Protection Agency (EPA) officials: Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William L. Wehrum, Esquire, for AA of the Office of Air and Radiation (OAR); Matthew Leopold, Esquire, for General Counsel; and David Ross, Esquire, for AA of the Office of Water (OW). More...

The European Commission (EC) Joint Research Center (JRC) has published the NANoREG Toolbox for the Safety Assessment of Nanomaterials.  As reported in our May 8, 2017, blog item, JRC previously published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal...

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.  This action requires persons who intend to manufacture (defined by...

On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff):  EPA Microbiology Laboratory Branch (MLB) SOP MB-28:  Procedure for the Production and Storage of Spores of Clostridium difficile for Use in the Efficacy Evaluation of Antimicrobial Agents; and EPA MLB SOP MB-31:...

On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569).  The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017).  The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on...

On October 24, 2017, the Nanotechnology Industries Association (NIA) will hold a webinar on Safe by Design for nanomaterials.  NIA states that the webinar is free and open to all actors interested in nanomaterials and their safe management throughout their lifecycle, using the principles of Safe by Design from the earliest development stages.  According to NIA, the webinar will bring together projects active in the creation of Safe by Design across Europe to inform participants of the...

The U.S. Senate Committee on Environment and Public Works (EPW) has rescheduled the full committee hearing on four U.S. Environmental Protection Agency (EPA) nominations to Wednesday, October 4, 2017, at 10:00 a.m. (EDT).  The four nominations are: Michael Dourson, Ph.D., for Assistant Administrator of the Office of Chemical Safety and Pollution Prevention (OCSPP); Matthew Leopold, Esquire, for General Counsel; David Ross, Esquire, for Assistant Administrator for Water; and William L....

On September 25, 2017, Petitioners Safer Chemicals Healthy Families and Environmental Defense Fund (EDF) (collectively Petitioners) in Ninth Circuit Case Nos. 17-72260 and 17-72501 (regarding review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation) filed a joint opposition to the U.S. Environmental Protection Agency’s (EPA) motion to transfer to the Fourth Circuit and hold cases in abeyance.  On September 14, 2017,...

On September 29, 2017, Switzerland notified the European Commission (EC) of a draft amendment to the Ordinance on Protection against Dangerous Substances and Preparations.  The notification states that the Ordinance on Protection against Dangerous Substances and Preparations regulates the risk assessment of chemicals and the requirements to be fulfilled for using and placing on the market of chemicals that could endanger human health or the environment.  According to the...

By Lauren M. Graham, Ph.D. On September 21, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that its Specialty Chemicals business is studying plans to build a world-class plant for its Bermocoll® business, which supplies non-ionic cellulose ethers for the paint and buildings and construction industries.  AkzoNobel uses a unique solvent-free process to manufacture the water soluble and virtually odorless Bermocoll cellulose...

By Kathleen M. Roberts On September 20, 2017, the U.S. International Trade Commission (ITC) published in the Federal Register a notice of the scheduling of the final phase of antidumping (AD) and countervailing duty (CVD) investigations of biodiesel imports from Argentina and Indonesia.  ITC will hold a hearing in connection with the final phase of the investigations at 9:30 a.m. (EST) on November 9, 2017, in Washington, D.C.  Requests to appear at the hearing are due by November...

By Lauren M. Graham, Ph.D. On September 20, 2017, U.S. Secretary of Energy Rick Perry announced that DOE selected eight projects related to the optimization of integrated biorefineries (IBR) to negotiate for up to $15 million in DOE funding.  The projects aim to solve critical research and developmental challenges encountered for the successful scale-up and reliable operations of IBRs, to decrease capital and operating expenses, and to focus on the manufacture of advanced or cellulosic...

By Lauren M. Graham, Ph.D. On September 19, 2017, the U.S. Department of Energy (DOE) announced 18 projects from the Macroalgae Research Inspiring Novel Energy Resources (MARINER) program will receive $22 million in funding through the Advanced Research Projects Agency-Energy (ARPA-E).  The MARINER projects aim to develop tools to address the technological challenges to growing and harvesting macroalgae efficiently and cost-effectively for use as a feedstock for biofuels and other...

On September 26, 2017, the U.S. Environmental Protection Agency (EPA) announced that it has launched the Smart Sectors program in the Office of Policy.  82 Fed. Reg. 44783.  Based on EPA’s Sector Strategies program, the Smart Sectors program “will re-examine how EPA engages with industry in order to reduce unnecessary regulatory burden, create certainty and predictability, and improve the ability of both EPA and industry to conduct long-term regulatory planning while also...

The European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide.  In May 2016, France submitted a CLH proposal for titanium dioxide, stating that titanium dioxide should be considered as being potentially carcinogenic to humans when inhaled and thus be classified as category 1B-H350i.  France proposed that the classification...

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies...

On September 19, 2017, California’s Court of Appeal for the First Appellate District reversed a trial court decision denying a petition by the Pesticide Action Network North America (PANNA) challenging the approval by the California Department of Pesticide Regulation (DPR) of amended labeling for two previously registered pesticides containing the active ingredient dinotefuran, a neonicotinoid:  Dinotefuran 20SG, manufactured by Mistui Chemicals Agro, Inc.; and Venom Insecticide,...

On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN): PRN 2017-1:  Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels.  It addresses...

On September 18, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs to Manage Pesticide Funds More Efficiently.”  OIG states that it conducted the audit “to determine whether EPA manages the Pesticides Reregistration and Expedited Processing Fund (known as the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] Fund) and the Pesticide Registration Fund (known as the...

By Lauren M. Graham, Ph.D. On September 13, 2017, Neste, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced it is collaborating with Genève Aéroport to make flying more sustainable.  Neste will be providing renewable jet fuel for aircraft operations from Genève Aéroport.  The goal is for one percent of the jet fuel consumed annually at Genève Aéroport to be composed of renewable jet fuel by late 2018. ...

By Kathleen M. Roberts The National Biodiesel Board (NBB) announced that on September 13, 2017, New York Governor Andrew Cuomo signed legislation that introduces bioheating fuel tax credits and bioheating fuel tax requirements to three New York counties.  The bill (S5422A) requires all home heating oil sold for use in Nassau, Suffolk, and Westchester counties on or after July 1, 2018, to contain at least five percent biodiesel (B5).  Assemblyman Steve Englebright and Senator Phil...

By Kathleen M. Roberts Researchers from the U.S. Department of Energy (DOE) have linked changes in rainfall and other environmental stressors during crop growth to potential deleterious effects on biofuel production.  The study demonstrates that the effect of weather conditions on crop yields can significantly impact the downstream processing of those crops for biofuel production.  Researchers compared the production of biofuel from switchgrass harvested after a major drought to...

By Lauren M. Graham, Ph.D. On September 11, 2017, the U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt sent a letter to Senator Sheldon Whitehouse (D-RI) in response to the request by Senator Whitehouse and four other Democratic Senators to explain Carl Icahn’s role in shaping the Renewable Fuel Standard (RFS) program.  According to Pruitt, Icahn did not exercise excessive influence on the U.S. biofuels policy while acting as an advisor of President...

The U.S. Environmental Protection Agency (EPA) promulgated on September 21, 2017, significant new use rules (SNUR) for 37 chemical substances that were the subject of premanufacture notices (PMN).  Six of the chemical substances, including carbon nanotube (generic) and nanocarbon (generic), are subject to consent orders issued by EPA under Section 4 of the Toxic Substances Control Act.  The SNURs require persons who intend to manufacture (defined by statute to include import) or...

On September 15, 2017, the European Commission (EC) began a public consultation on the revision of the 2011 EC Recommendation on the definition of nanomaterial.  The EC intended the definition to achieve consistent application of the term nanomaterial across all legislation.  The definition includes descriptors that the EC intended to review by December 2014 to ensure that the definition corresponds to the needs.  In particular, the review must examine issues where there...

The hearing on the nominations of four U.S. Environmental Protection Agency (EPA) officials by the U.S. Senate Committee on Environment and Public Works (EPW) scheduled for September 20, 2017, has been postponed without any specific reasons; a new hearing date has not been provided.  Bergeson & Campbell, P.C. (B&C®) will be monitoring the Senate EPW Committee calendar for the new hearing date. More information on the nominees is available in our blog item Senate EPW Committee...

On September 19, 2017, the U.S. Environmental Protection Agency (EPA) announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual.   Updates to Chapter 15: Company Name and Address, include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation.  Updates to Chapter 16: Graphics and Symbols, include...

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than...

On September 14, 2017, the U.S. Environmental Protection Agency (EPA) filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA:  Safer Chemicals Healthy Families v. EPA, Case No. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth...

The U.S. Senate Committee on Environment and Public Works (EPW) has announced that it will hold a hearing on the following U.S. Environmental Protection Agency (EPA) nominations on Wednesday, September 20, 2017, from 10:00 a.m. to 12:00 p.m. (EDT): Michael Dourson, Ph.D., for Assistant Administrator of the Office of Chemical Safety and Pollution Prevention (OCSPP).  Dr. Dourson is a professor in the Risk Science Center, Environmental Health, at the University of Cincinnati, Ohio,...

The International Organization for Standardization (ISO) has published standard ISO/TS 80004-13:2017, “Nanotechnologies — Vocabulary — Part 13:  Graphene and related two-dimensional (2D) materials.”  According to ISO, over the last decade, interest has arisen in graphene due to its “many exceptional properties.”  More recently, other materials with a similar structure have also shown promising properties, including monolayer and few-layer versions of hexagonal boron nitride,...

By Lauren M. Graham, Ph.D. On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.  The U.S. Department of Defense (DOD) asked NAS to develop the framework to: Guide an assessment of the security concerns related to advances in synthetic biology; Assess the level of concern warranted for various advances and identify...

By Lauren M. Graham, Ph.D. On September 5, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that its Specialty Chemicals business signed an application agreement with Itaconix to develop innovative biobased chelates for consumer and industrial detergents and cleaners.  According to Peter Kuijpers, AkzoNobel General Manager of Chelates and Micronutrients, biobased chelates are replacements for the phosphate compounds that are being...

By Kathleen M. Roberts On August 29, 2017, the government of the province of Ontario, Canada announced $25.8 million has been allocated to the Low Carbon Innovation Fund (LCIF) as a part of the province’s Climate Change Action Plan.  The funding will be used to support emerging, innovative technologies in areas such as alternative energy generation and conservation, new biofuels or bioproducts, next-generation transportation or novel carbon capture and usage technologies. ...

By Kathleen M. Roberts On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million.  The projects aim to develop high-impact tools and techniques that will increase the productivity of algae organisms to reduce the costs of producing algal biofuels and bioproducts.  In total, DOE has awarded over $16 million in funding to the initiative.    The project winners...

On September 13, 2017, the U.S. Environmental Protection Agency (EPA) issued three supporting documents for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.”  This FIFRA SAP meeting will be held on November 28-30, 2017, from 9:00 a.m. -...

In August 2017, the Toxics Use Reduction Institute (TURI), a research, education, and policy center established by the Massachusetts Toxics Use Reduction Act of 1989, published a nanomaterials fact sheet.  The fact sheet is part of a series of chemical and material fact sheets developed by TURI that are intended to help Massachusetts companies, community organizations, and residents understand the use of hazardous substances and their effects on human health and the environment. ...

The Netherlands National Institute for Public Health and the Environment (RIVM) announced on September 6, 2017, that an RIVM researcher, Joris Meesters, modified SimpleBox, a distribution model for chemicals, to create SimpleBox4nano, a model to calculate concentrations of nanoparticles in water, soil, and air.  SimpleBox4nano includes new processes that specifically apply to nanoparticles, such as the clustering of particles.  Meesters tested the model using three metal oxide...