Blogs

By Lynn L. Bergeson On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258.  EPA issued the notice of availability in the Federal Register on March 27, 2019.  84 Fed. Reg. 11538.  This is an important document addressing tricky jurisdictional issues that have plagued EPA for years.  Comments on the draft guidance are due by May 28, 2019.  For a...

The International Organization for Standardization (ISO) has published standard ISO/TR 19733:2019, “Nanotechnologies — Matrix of properties and measurement techniques for graphene and related two-dimensional (2D) materials.”  ISO states that since graphene was discovered in 2004, it has become one of the most attractive materials in application research and device industry due to its supreme material properties such as mechanical strength, stiffness and elasticity, high electrical and...

On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258.  EPA issued the notice of availability in the Federal Register on March 27, 2019.  84 Fed. Reg. 11538.  Comments on the draft guidance are due by May 28, 2019.  EPA states that the draft guidance is intended to “provide guidance on identifying product label...

On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was updating its Residual Time to 25% Bee Mortality (RT25) Data Table with information it has collected since the table was first published in 2014.  EPA states that the “RT25 data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies...

Registration is available for the National Nanotechnology Initiative’s (NNI) April 9, 2019, webinar on “Characterization and Quantification of Engineered Nanomaterials:  Drivers of NanoEHS Research.”  The speaker will be Dr. Robert MacCuspie, Natural Immunogenics Corp., and Dr. Debra Kaiser, National Institute of Standards and Technology, will moderate.  The webinar will examine the significant progress in characterization and measurement of engineered...

On March 22, 2019, the U.S. Environment Protection Agency (EPA) issued a memorandum stating that it was releasing 24 studies in the Colour Index (C.I.) Pigment Violet (PV) 29 docket (Docket No. EPA-HQ-OPPT-2018-0604) that were reviewed by EPA to develop its Draft Risk Evaluation for C.I. PV 29.  EPA states that these studies are being made available to the public prior to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) expert panel peer...

The March 18, 2019, episode of the National Nanotechnology Initiative’s (NNI) podcast series, “Stories from the NNI,” is a conservation with Dr. Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH).  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and Dr. Geraci discuss how NIOSH works with industry to ensure workplace safety, the progress that has been made in the...

By Lynn L. Bergeson In February 2019, the University of Utah published the article Algal lipid extraction using confined impinging jet mixers.  The article outlines the University of Utah engineers’ latest discovery of a new method for rapid lipid harvesting which is essential to energy parity for microbial derived biofuels.  This newly developed technique is not only faster but also more efficient, and uses confined impinging jet mixers (CIJM) to improve lipid extraction from...

By Lynn L. Bergeson On March 19, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the delay of the spring release for BRS’ updated permitting system in APHIS eFile.  The release is now expected to occur in mid-summer 2019, with periodic updates provided by APHIS BRS as the anticipated release approaches.  In its announcement, APHIS BRS highlighted its commitment to bringing a permitting system that takes...

By Lynn L. Bergeson On March 18, 2019, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development (R&D) Technical Advisory Committee.   84 Fed. Reg. 9769.  The meeting will take place in Arlington, Virginia, on March 27 - 28, 2019, and will include discussions on developing advice and guidance promoting R&D leading to the production of biobased fuels and products.  The tentative agenda includes updates not only on DOE Biomass...

By Lynn L. Bergeson On March 18, 2019, (EPA) announced a public hearing to be held for the proposed rule: “Modifications to Fuel Registrations to Provide Flexibility for E15: Modifications to RFS RIN Market Regulations.”  84 Fed. Reg. 9734.  The proposed rule would implement regulatory changes allowing E15 to take advantage of a Renewal Fuels Standard (RFS) program waiver. Currently, the 1-psi Raid Vapor Pressure (RVP) waiver only applies to ten percent ethanol (E10) during...

By Lynn L. Bergeson On February 27, 2019, Senators Rand Paul (R-KY) and Chuck Grassley (R-IA) introduced the Fuel Choice and Deregulation Act of 2019 (S. 581).  The legislation would remove “burdensome” regulations on domestic energy production.  The bill “provides new economic opportunity for Kentucky farmers by allowing fuel producers and automobile manufacturers to innovate and bring new products to market that will lower costs for consumers, increase domestic...

The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for fiscal years (FY) 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020.  CPSC seeks comment on the following questions: What are the priorities CPSC should consider emphasizing...

The National Nanotechnology Initiative’s (NNI) 2019 public webinar series on the environmental, health, and safety effects of nanomaterials (nanoEHS) will begin on April 9, 2019, at 12:00 p.m. (EDT) with a presentation by Dr. Robert MacCuspie (Natural Immunogenics Corp.) on “Characterization and Quantification of Engineered Nanomaterials:  Drivers of NanoEHS Research.”  Upcoming webinars will include “Environmental, Health, and Safety Resources for Handling, Transporting, and...

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by...

On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include: Seven...

On March 15, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the solubility of synthetic amorphous silica (SAS).  The EC asked whether the SCCS considers that SAS are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation.  Having considered the data provided in this dossier and that available...

On March 18, 2019, the U.S. Environmental Protection Agency (EPA) released new tools intended to help companies, organizations, and individuals fulfill their reporting requirements under the mercury reporting requirements rule.  Those required to report under the mercury rule can now do so online through the Mercury Electronic Reporting (MER) application accessed through EPA’s Central Data Exchange (CDX).  EPA states that it designed this reporting tool “to be user-friendly, with drop-down...

On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate.  One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI).  The second decision (Hautala et al. v. EFSA, Case T-329/17) related to a...

On March 15, 2019, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler signed a final rule prohibiting the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution to and by retailers; requiring manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions;...

By Lynn L. Bergeson On March 5, 2019, the Lawrence Livermore National Laboratory (LLNL) announced that their researchers have 3D printed live cells that are able to convert glucose to ethanol and carbon dioxide gas.  The substance produced from this conversion resembles beer.  This means that this newly developed technology can lead to highly efficient biocatalysis.  According to LLNL’s announcement, the use of live microbes rather than inorganic catalysts is advantageous...

By Lynn L. Bergeson On March 11, 2019, scientists at the University of California Berkeley (UC Berkeley) published a study on nature microbiology on the gut anatomical properties of the passalid beetle that helps it transform decaying wood into energy-rich materials.  Passalid beetles’ digestive tracts contain microbes that provide a roadmap for the production of affordable, nature-derived bioproducts and biofuels.  The structure of these beetles’ guts allows for different...

By Lynn L. Bergeson On March 13, 2019, the European Commission (EC) published a fact sheet on the sustainability for biofuels specified.  EC adopted a delegated act that sets out the criteria for determining high low indirect land-use change (ILUC) risk feedstock for biofuels and the criteria for certifying ILUC-risk biofuels, bioliquids, and biomass fuels.  ILUC-risk fuels consist of fuels produced from food and feed crops that significantly expand globally into land with high carbon...

By Lynn L. Bergeson On, March 12, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) announced the publication of two draft documents related to the potential deregulation of a soybean variety GE for increased yield and resistance to the herbicide glufosinate.  The draft documents are Draft Plant Pest Risk Assessment (PPRA) and Draft Environmental Assessment (dEA) for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance. The PPRA will examine any...

By Lynn L. Bergeson On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon.  In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S.  According to...

The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available: Carlos Eduardo Lima da Cunha, EC, “EU...

GAO released on March 6, 2019, a report entitled High-Risk Series:  Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas.  GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges.  GAO’s report describes the status of high-risk areas and outlines actions necessary to assure further progress.  GAO states that in the...

The International Organization for Standardization (ISO) has published standard ISO/TR 21386, “Nanotechnologies — Considerations for the measurement of nano-objects and their aggregates and agglomerates (NOAA) in environmental matrices.”  The standard provides some considerations for the collection of environmental samples to be analyzed for manufactured NOAA, considerations to distinguish manufactured NOAA from background levels of naturally occurring nanoscale particles of the same...

The European Commission’s (EC) Joint Research Center (JRC) opens its scientific laboratories and facilities, including its Nanobiotechnology Laboratory, to people working in academia and research organizations, industry, and small and medium enterprises (SME).  JRC opened a call on February 1, 2019, for the Nanobiotechnology Laboratory for the following priority topics: Nanomaterial characterization, including their interactions with biological systems (culture media, proteins);...

On March 8, 2019, President Trump signed S. 483, the “Pesticide Registration Improvement Extension Act of 2018,” which reauthorizes the Pesticide Registration Improvement Extension Act (PRIA 4) through fiscal year 2023, updates the fee collection provisions and authorities available under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and addresses worker protection matters.  The text is available at Congress.gov, which has not yet been updated to confirm...

The Nebraska Ethanol Board’s 2019 Emerging Issues Forum focuses on the federal biofuels policy landscape and emerging industry trends.  B&C and BRAG are proud sponsors.  Richard E. Engler, Ph.D., will be presenting “Legal & Regulatory Considerations for Renewable Chemical Production -- Brief Overview from the Experts.”

By Lynn L. Bergeson On February 21, 2019, scientists Abdon Pena-Francesh and Melik C. Demirel, at Pennsylvania State University, published an article on the use of squid teeth tandem repeat proteins that can be functionally used for biodegradable fibers and films.  The flexible and tough material results from a protein present in the squid teeth, which can be grown biosynthetically by E. coli bacteria.  This biosynthetic expression of squid teeth proteins presents a number of...

By Lynn L. Bergeson On February 28, 2019, DOE announced that scientists at the Los Alamos National Laboratory (LANL) have been working on molecular tools that reside naturally within microbial cells.  Microbes typically use these tools to carry out their metabolism and other life-sustaining processes; LANL researchers, however, have been using the tools to produce fuel precursors and bioproduct building blocks.  With the addition of a biosensor in the microbes, light allows the...

By Lynn L. Bergeson In honor of Women’s History Month (March), DOE’s Bioenergy Technologies Office (BETO) will be celebrating women working on bioenergy R&D projects at DOE’s national laboratories. Each week of March, BETO will highlight the contributions that these women make to strengthen the U.S. bioeconomy.  Activities include the promotion of female scientists and administrators that power BETO-funded bioenergy research on social media and a webinar titled...

By Lynn L. Bergeson On March 4, 2019, DOE announced an opportunity for funding up to $31 million in support of advancing the H2@Scale concept.  The H2@Scale concept focuses on enabling affordable and reliable large-scale hydrogen generation across multiple sectors in the U.S.  Large-scale hydrogen generation, transport, storage, and utilization can “unite our Nation’s abundant energy resources,” according to U.S. Secretary of Energy Rick Perry.  By producing...

By Lynn L. Bergeson On March 1, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced $51.5 million for innovative research of technologies for trucks, off-road vehicles, and fuels.  Of particular interest to DOE EERE are: Gaseous fuels research, including natural gas, biopower, and hydrogen; Heavy duty freight electrification; Hydrogen infrastructure and fuel cell technologies for heavy duty applications; and Energy efficient off-road...

The House Energy and Commerce Subcommittee on Environment and Climate Change announced on March 6, 2019, that it will hold a hearing on March 13, 2019, on “Mismanaging Chemical Risks:  EPA’s Failure to Protect Workers.”  The Subcommittee will address how the U.S. Environmental Protection Agency (EPA) “is systemically ignoring worker risks in its implementation of the Frank R. Lautenberg Chemical Safety Act and other worker protections.”  Energy and Commerce Chairman Frank Pallone,...

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated...

On February 14, 2019, the Senate approved S. 483 to reauthorize the Pesticide Registration Improvement Extension Act (PRIA 4).  The Senate bill did not have the specific categories and timelines of earlier reauthorization language, referring instead to more general legislative language that the Senate approved during the Farm Bill authorization in 2018.  Legislation in this new session of Congress was necessary since PRIA was not reauthorized as part of the appropriations language...

From June 11-13, 2019, the American Chemical Society (ACS) will be hosting their annual Green Chemistry and Engineering (GC&E) Conference and the International Conference on Green and Sustainable Chemistry in Reston, VA.  BRAG will be proudly presenting an abstract titled:  “The Role of Regulations in Circular Economy -- Challenge of New Chemical Bias.”  Under the “Entrepreneurs Driving the Circular Economy -- Opportunities and Challenges” GC&E...

By Lynn L. Bergeson On February 14, 2019, scientists in China published an article revealing a new methodology developed to safely transform methanol into ethanol.  Given methanol’s toxicity, this recently uncovered method allows for a more secure, user-friendly, sustainable technology that can be more broadly applied.  The scientific article reports a photo-driven one-step conversion of methanol to ethanol at ambient temperature.  A relatively simple process, the...

By Lynn L. Bergeson On February 26, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency & Renewable Energy’s (EERE) Bioenergy Technologies Office (BETO) announced the sponsorship of a new project to harness algae strains for bioenergy.  Called Development of Integrated Screening, Cultivar Optimization and Verification Research (DISCOVR), the project is a multi-laboratory consortium including the Pacific Northwest National Laboratory, the Los Alamos National...

By Lynn L. Bergeson On February 15, 2019, U.S. President Donald Trump signed into law a bill originally introduced in early 2017 by Representative Nita Lowey (D-NY) titled the Consolidated Appropriations Act, 2019 (2019 Appropriations Act). Of interest to stakeholders in the biobased sector is Section 428, which covers policies relating to biomass energy.  In this section, responsibilities assigned to the U.S. Secretary of Energy, Secretary of Agriculture, and EPA Administrator are...

By Lynn L. Bergeson On February 22, 2019, the U.S. Environmental Protection Agency (EPA) published a notice of a proposed partial consent decree in Sierra Club v. Pruitt.  This notice is in response to a complaint filed by the Sierra Club in October 2017 to the District of Columbia Court.  The complaint alleged that former EPA Administrator Scott Pruitt “failed to perform a non-discretionary duty to assess and report to Congress on the environmental and resource conservation...

The National Nanotechnology Coordination Office (NNCO) announced on February 28, 2019, that it is planning a number of activities to celebrate the 15-year anniversary of the National Nanotechnology Initiative (NNI).  Upcoming events will include: Special anniversary episodes of “Stories from the NNI” podcast series. Experts from academia, government, and industry share their perspectives on key research and development advances in nanotechnology.  They also discuss how...

On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar:  Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See...

This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides:  past, present, and future. In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we...

The February 2019 issue of the European Chemicals Agency’s (ECHA) Newsletter includes an interview with Eva Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham and leader of the European Union (EU) NanoSafety Cluster Coordination Team, on research on the safety of nanomaterials.  The NanoSafety Cluster coordinates the funding of research projects at the European level that address the safety aspects of nanomaterials and the related...

On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Under the proposed rule, products that...