Blogs

On November 22, 2016, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on additional coatings for titanium dioxide (nano form) as an ultraviolet (UV)-filter in dermally applied cosmetic products.  The EC asked if SCCS considered safe the use of cetyl phosphate, manganese dioxide, and triethoxycaprylylsilane as coatings for titanium dioxide (nano) used as a UV-filter in dermally-applied cosmetic products.  SCCS...

The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and...

ASTM Committee D20 on Plastics and CEN TC411 issued a call for presentation abstracts for the Workshop on Degradable, Biodegradable, and Biobased Products Standards.  The 2017 workshop is designed to facilitate a discussion on standards development and implementation regarding testing and specification of biobased, degradable, and biodegradable materials.   Topics for presentation and panel discussions include:   ?   Biobased/renewable resource content testing, specification,...

On November 8, 2016, the Roundtable on Sustainable Biomaterials (RSB) announced its members voted unanimously to publish revised Principles & Criteria that streamline the requirements and make them more user-friendly. The decision was announced at the Annual Assembly of Delegates meeting in Hanoi, Vietnam.   RSB stated the amendments will offer:   ?   A new user-friendly format, enabling easy understanding of how to apply the standard;    ?   Streamlined and...

On November 3, 2016, the European Commission announced that 144 new green and low-carbon projects from 23 Member States will be funded by a €222.7 million investment from the European Union (EU) budget, which will be combined with €175.9 from additional investments.  The funding comes from the LIFE programme, the EU’s funding body for the environment and climate action, with the goal of progressing Europe towards a more sustainable future.   The selected projects align...

On October 27, 2016, EPA approved an Efficient Producer petition submitted by Redfield Energy, LLC (Redfield Energy) granting “a pathway for the generation of renewable fuel (D-code 6) Renewable Identification Numbers (RINs) under the Renewable Fuel Standard (RFS) program for the production of non-grandfathered ethanol” produced by dry milling.  The Efficient Producer petition process is designed to accelerate the registration process for starch and grain sorghum ethanol...

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of November 11, 2016, the U.S. Environmental Protection Agency (EPA) has issued a notice in the Federal Register of a public hearing for the proposed “Renewables Enhancement and Growth Support Rule.”  The proposed rule updates the regulatory structure to allow biofuel producers to process and convert biomass at different facilities, update fuel...

The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA states that it will “describe its review process for new...

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called...

The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020.  Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the priorities of the federal government’s new “High-Tech Strategy” (HTS), which has as its objective the solution of...

The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription): Career Staff Cooperation Expected...

On November 10, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register for a public hearing for the proposed “Renewables Enhancement and Growth Support Rule.”  The proposed rule, available on EPA’s website, was signed by EPA’s Administrator on October 3, 2016, but has not yet been published in the Federal Register.  This proposed rule will enhance the renewable fuel standard (RFS) program as well as other fuel regulations to...

On November 1, 2016, the Biotechnology Innovation Organization (BIO) issued a call for panel session proposals for the 2017 World Congress on Industrial Biotechnology.  Leaders from biotechnology, bioenergy, chemical, consumer products manufacturing, and agricultural industries as well as academia and financial sectors industries are invited to submit proposals to present on groundbreaking research and partnerships in the industrial biobased industry.  Specific program tracks for the...

On November 3, 2016, the United Nations Environment Programme (UNEP) released the seventh UNEP Environment Emissions Gap Report, presenting a scientific assessment of global progress towards emissions reductions created by the United Nations Framework Convention on Climate Change (UNFCCC).  The report found that if all Paris Agreement pledges to reduce emissions global temperature are achieved, global temperatures will still rise to more than 2°C over preindustrial levels.  UNEP...

On November 9, 2016, Inside EPA published “ New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms.   Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:   Richard Engler, a...

The International Organization for Standardization (ISO) recently published ISO/TR 18196:2016, “Nanotechnologies — Measurement technique matrix for the characterization of nano-objects.”  The document provides a matrix intended to guide users to commercially available techniques relevant to the measurements of common physiochemical parameters for nano-objects.  Some techniques are also applicable to nanostructured materials.  As scientific advances are made and additional...

In November 2016, the Organization for Economic Cooperation and Development (OECD) published the following new reports in its Series on the Safety of Manufactured Nanomaterials: Although the OECD website lists an additional report, Titanium Dioxide:  Summary of the Dossier, its link does not work....

On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency.  Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA’s process and criteria for identifying high priority...

On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816.  The 2016 NPDES Pesticide General Permit (PGP)...

The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments.  EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide,...

The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase...

On October 19, 2016, EPA delivered the proposed Renewable Fuel Standard (RFS) volume standards for 2017 and biobased diesel standards for 2018 via proposed rule to the White House Office of Management and Budget (OMB).  This proposed rule will increase the renewable fuel volume requirements as reported in the Biobased and Renewable Products Advocacy Group (BRAG®) post “EPA Releases Proposed Renewable Fuel Volume Requirements.”  The proposed volume requirements are:...

On November 1, 2016, the U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD) announced a meeting of the Board of Scientific Counselors’ (BOSC) Chemical Safety for Sustainability Subcommittee meeting via notice in the Federal Register.  This meeting will be held at the U.S. Environmental Protection Agency’s (EPA) Main Campus Facility in North Carolina, and will be open to the public.  Those interested in attending must register online by...

On October 26, 2016, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee via notice in the Federal Register.  This meeting will work to develop advice and guidance promoting the research and development (R&D) of biobased fuels and products.  The agenda for the meeting includes an update on U.S. Department of Agriculture (USDA) biomass R&D activities, an update on DOE biomass R&D activities, and...

On November 1, 2016, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2016 National Nanotechnology Initiative Strategic Plan.  The 21st Century Nanotechnology Research and Development Act of 2003 requires National Nanotechnology Initiative (NNI) agencies to develop an updated Strategic Plan every three years.  The 2016 Strategic Plan represents a consensus among the NNI agencies on the high-level goals and priorities of the NNI and on specific...

On November 1, 2016, the National Institute for Occupational Safety and Health (NIOSH) published a blog item entitled “Never fear!  NEAT 2.0 is here! — How to perform nanomaterial exposure assessment in the workplace.”  NIOSH notes that in 2009, it developed and was the first to recommend using the nanoparticle emission assessment technique (NEAT).  According to NIOSH, NEAT made use of a condensation particle counter to identify tasks that result or can result in the...

On October 13, 2016, the European Chemicals Agency (ECHA) announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial.  The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products to control other arthropods (product-type 18).  ECHA’s October 13, 2016, annex to a news...

On October 27, 2016, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) for three chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (generic).  According to the notice, the PMN states that the substance will be used as a thin film for electronic device applications.  Based on structure-activity relationship (SAR) analysis of test data on analogous carbon nanotubes and other...

On October 17, 2016, the Industrial Biotechnology Innovation Centre (IBioIC) announced over £3 million in investments over six synthetic biology projects.  IBioIC was founded by Ingenza Ltd, GlaxoSmithKline plc (GSK), and INEOS to connect academic expertise in synthetic biology with industrial capabilities from businesses in the area.  IBioIC focuses on biotechnology in health, industrial, agriculture, and marine areas.  Recipients of the £3 million in funding are:...

On October 18, 2016, the Biotechnology Innovation Organization (BIO) sent a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of expiring renewable energy tax credits.  The Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling...

On October 12, 2016, EPA convened a public advisory committee teleconference of the Biogenic Carbon Emissions Panel.  This advisory meeting discussed comments from chartered Science Advisory Board (SAB) members from the draft report on EPA’s Framework for Assessing Biogenic CO2 Emissions from Stationary Sources.  The SAB panel announced plans to overhaul the current draft report to provide emission examples at various time scales.  This change, to include longer time spans,...

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register .  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental...

In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the...

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues — Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and...

On November 21, 2016, the International Organization for Standardization (ISO) released ISO/TR 18637:2016, “Nanotechnologies — Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs).”  ISO notes that occupational exposure limits (OEL) are generally substance-specific.  In some case, there is insufficient data to develop an OEL, especially for substances such as nano-objects and...

The fifth Nanosafe conference was held November 7-10, 2016, in Grenoble, France.  The conference included panel discussions on responsible development with non-governmental organizations; urban particles mitigation:  what is reasonably possible; and nanomedicine:  benefit-risk.  Topics addressed during the conference included: Presentations from the conference are now available....

On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter.  EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.”  The proposed rule would amend the TSCA SNU...

The Algae Biomass Summit is the largest algae conference in the world.  This is where leading producers of algae products go to network with industry suppliers and technology providers, where project developers converse with utility executives, and where researchers and technology developers rub elbows with venture capitalists.  Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) is a proud sponsor.  B&C Senior...

The American Chemical Society (ACS) has announced the 2016 Heroes of Chemistry at the ACS Fall National Meeting.  Of the four products showcased by the awards, Honeywell UOP’s Honeywell Green Jet Fuel™ represented the biobased industry.  This biobased jet fuel “is cleaner burning than conventional jet fuel and can be blended up to a 50/50 ratio with petroleum-based jet fuel.”  The awardees were Chad Cavan, Ralph Davis, Donald Eizenga, Daniel Ellig, Stanley...

On October 11, 2016, the Biofrontiers platform, a group of industry and civil society stakeholders brought together by the European Climate Foundation, released policy recommendations for the European Union’s (EU) 2030 climate policy.  The group stated that the transport sector has become the largest source of carbon emissions in the EU, and is therefore an urgent area to tackle following the Paris climate change agreement.  Policy recommendations put forth by the Biofrontiers...

On October 11, 2016, Microvi Biotechnologies Inc. (Microvi) announced that it had been awarded a grant by the U.S. Department of Energy (DOE) for work on new biocatalytic technology that converts the methane and carbon dioxide (CO2) found in biogas into valuable liquid chemicals.  This technology utilizes the biogas created at landfills and wastewater treatment plants that is usually burned off into the atmosphere due to the current burdensome conversion process.  Microvi’s...

On October 18, 2016, the U.S. Environmental Protection Agency (EPA) announced that it has opened nominations for the 2017 Presidential Green Chemistry Challenge Awards (PGCCA).  Since 1996, these awards have honored companies and institutions that develop processes and products to help protect public health and the environment.  EPA’s strong support for the adoption of green chemistry has helped strengthen the development and commercialization of green chemistry products, leading...

Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA):  The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Conditions of use is a centralizing concept under which the U.S....

On September 27, 2016, the National Institute for Occupational Safety and Health (NIOSH) Board of Scientific Counselors (BSC) met, and its discussion included engineering controls and nanomaterials.  Kevin H. Dunn, Sc.D., CIH, a NIOSH Division of Applied Research and Technology (DART) mechanical engineer and member of NIOSH’s Nanotechnology Research Center, provided an update to the BSC on NIOSH’s evaluations, findings, recommendations, and guidance for reducing occupational exposures to...

The 2016 Sustainable Nanotechnology Organization (SNO) conference will be held November 10-12, 2016.  The conference sessions will be organized around selected “systems,” and sessions will be populated with talks on applications, effects and implications, analytical methods, and lifecycle aspects of nanomaterials within each system.  The aims are to identity where nanomaterials and nanotechnology can improve the sustainability of each system and to foster integration of...

On October 4, 2016, Canada’s Ecofiscal Commission (EFC) published a report,  Course Correction: It’s Time to Rethink Canadian Biofuel Policies, arguing for the termination of biofuel subsidies.  The report claims that Canadian biofuel policies have reduced greenhouse gas (GHG) emissions an average of three million tonnes annually, accounting for less than 0.5 percent of Canada’s total GHG emissions.  Annual costs of the biofuel policies were estimated to be C$640...

On October 11, 2016, EPA published a notice in the Federal Register seeking applications for the 2017 Safer Choice Partner of the Year Awards.  The Partner of the Year Awards were developed in 2015 to recognize Safer Choice stakeholders advancing the goals of the Pollution Prevention Act, as well as the Safer Choice program through safer chemistry.  There are five broad categories of the awards: ?   Formulators/Product Manufacturers of both Consumer and Institutional/ Industrial...

On October 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register.  This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or...

On October 11, 2016, the U.S. Environmental Protection Agency (EPA) announced that it would be taking expedited action on reducing exposures to the following persistent, bioaccumulative, and toxic chemicals (PBT).  As stated in our blog item Deadline for Requesting Risk Evaluation for PBT Chemicals Fast Approaching, Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, outlines a procedure requiring...

The following documents have been filed in the Anderson v. McCarthy proceedings in the U.S. District Court for the Northern District of California:  (1) U.S. Environmental Protection Agency’s (EPA) Notice of Motion and Motion for Summary Judgment; (2) Defendant-Intervenors CropLife America, et al.’s Notice of Motion and Motion for Summary Judgment; and (3) Plaintiffs’ Memorandum of Points and Authorities in Support of Motion for Summary Judgment. EPA’s documents are...