Blogs

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016.  EPA would also accept such notices for chemical substances that were processed.  The recent TSCA amendments require...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of...

The National Nanotechnology Coordination Office (NNCO) periodically holds webinars to share information with the general public and the nanotechnology research and development community.  Upcoming webinars include the following:...

The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules.  AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.”  Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is not up-to-date and is unofficial.  The German documents are...

In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l’état nanoparticulaire.  The report analyzes nanomaterial declarations received in 2016 for reporting year 2015.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with...

On December 22, 2016, the California Department of Toxic Substances Control (DTSC) announced that the public comment period for the draft Alternatives Analysis (AA) Guide for the Safer Consumer Products (SCP) program has been extended to February 3, 2017. The guide, which was released on December 19, 2016, aims to help relevant stakeholders navigate all phases of the SCP AA process and provide useful approaches, methods, resources, tools and examples of how to fulfill SCP's...

On December 29, 2016, the U.S. Department of Agriculture (USDA) Commodity Credit Corporation (CCC) published in the Federal Register a notice of available funds regarding the Biofuel Production Incentive (BPI) for companies refining biofuel from certain domestically grown feedstocks. The notice aims to improve transparency and simplify the process of administering CCC funds to support the Farm-to-Fleet program by identifying a specific BPI payment rate. The Farm Service Agency (FSA), which...

On December 28, 2016, the Department of Energy (DOE) announced that six projects had been selected for a funding opportunity of up to $12.9 million titled “Project Definition for Pilot- and Demonstration-Scale Manufacturing of Biofuels, Bioproducts, and Biopower.”  The projects, which revolve around technology development plans for the manufacture of advanced or cellulosic biofuels, bioproducts, refinery-compatible intermediates, and biopower in a pilot- or demonstration-scale...

Last week, the U.S. Environmental Protection Agency (EPA) published two announcements in the Federal Register regarding an extension of the comment period for the proposed Renewables Enhancement and Growth Support (REGS) rule and the proposed denial of petitions for the rulemaking to change the Renewable Fuel Standard (RFS) Point of Obligation.   On December 9, 2016, ten biodiesel and agricultural industry stakeholders, including the Renewable Fuels Association, Growth Energy, American...

The American Innovation and Competitiveness Act (S. 3084) would amend the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports.  The strategic plan would be released every five instead of every three years, and the triennial review would be renamed the quadrennial review and be prepared every four years instead of every three.  The evaluation of the NNI, which is submitted...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with...

By Lynn L. Bergeson and Carla N. Hutton On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology...

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A — Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and...

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A — Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and...

Lynn L. Bergeson was quoted in the December 28, 2016, Bloomberg BNA Daily Environment Report story “Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump” (subscription required): Biobased chemical and fuel manufacturers want their products to be treated equally with their fossil fuel-based counterparts under the incoming administration’s policies. […]  Lynn Bergeson, managing partner of the Washington D.C.-based Bergeson...

On December 15, 2016,  Fuels America sent a letter to President-elect Donald Trump on behalf of the nation's renewable fuels sector encouraging Trump’s continued commitment to the Renewable Fuel Standard (RFS) Program.  Fuels America stated that the RFS Program has promoted the growth of the American biofuels industry and has helped to correct the imbalance that exists in the global oil market by ensuring competition among fuel producers, in addition to stimulating economic...

On December 15, 2016,  the U.S. Department of Energy (DOE) issued a funding opportunity announcement (FOA) of up to $8 million dollars, subject to appropriations, for innovative technologies that assist in the advancement of algae bioenergy and bioproducts.  The FOA consists of two topic areas, including strain improvement for the development of enhanced algal strains, and algae cultivation biology improvement for the development of increased areal productivity and biofuel yield....

On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity...

The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace:  A New Approach for Advancing Worker Safety and Health.  The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility.  According to the paper, research on sustainability does not include occupational safety and health.  The paper notes that...

On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register.  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural...

On February 7-9, 2017, a conference focused on new tools and approaches for nanomaterial safety assessment will be held in Malaga, Spain.  The conference is jointly organized by five major Seventh Research Framework Program (FP7) projects:  NANOSOLUTIONS, GUIDEnano, Sustainable Nanotechnologies (SUN), NanoMILE, and eNanoMapper.  It will present the main results achieved in the course of the projects, fostering a discussion about their impact...

On December 5, 2016, Nagpur Municipal Corporation (NMC) launched the Aapli bus service, India’s first green bus service, in Nagpur, which includes five buses that will run on ethanol biofuel.  Nitin Gadkari, the Union Minister for Road Transport and Highways, aims for Nagpur to be the first city to have all of its buses powered by biofuel through the addition of new green buses and the conversion of existing diesel-run buses.  During the launch event...

On December 5, 2016, China's National Energy Administration (NEA) published a five-year plan that aims to increase ethanol production to four million tons by 2020 despite the government maintaining strict control over the use of food grains.  The target remains unchanged from the previous five-year plan that ended in 2015.  NEA intends to increase the share of non-fossil fuel consumption from 12 percent to 15 percent by 2020, in part through the vigorous development of...

As previously reported in the BRAG Biobased and Renewable Products Update of October 21, 2016, EPA announced that it has opened nominations for the 2017 Presidential Green Chemistry Challenge Awards (PGCCA).  EPA’s strong support for the adoption of green chemistry has helped strengthen the development and commercialization of green chemistry products, leading to significant environmental benefits alongside economic benefits.  Previous PGCCA winners annually eliminate...

On December 6, 2016, EPA held a hearing on its proposed Renewables Enhancement and Growth Support rule.  The proposed rule would update the regulatory structure to allow biofuel producers to process and convert biomass at different facilities, update fuel regulations to allow for more high-ethanol fuel blends in flex fuel vehicles, and permit cellulosic biofuels to be produced from new feedstock sources.  Testimony provided by Growth Energy and the Renewable Fuels Association (RFA)...

On December 12, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule, Renewable Fuel Standard Program:  Standards for 2017 and Biomass-Based Diesel Volume for 2018, in the Federal Register.  This final rule sets the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and diesel produced or imported in 2017, as reported in the Biobased and Renewable Products Advocacy...

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3...

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice requesting public comment on whether a revision of the current size standard definitions for small manufacturers and processors, that are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA), is warranted at this time.  Under amended TSCA Section 8(a)(3)(C), the EPA Administrator, after consultation with the Administrator of the Small Business Administration...

The European Chemicals Agency (ECHA) announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation have moved to the next consultation step and been sent to the Member State Committee for review: ECHA suggests that potential registrants for the 2018 deadline may be interested in viewing the revised draft documents.  As reported in our June...

On November 15, 2016, the Federal Institute for Risk Assessment (BfR) published a report, in English, entitled Nanoview — Influencing factors on the perception of nanotechnology and target group-specific risk communication strategies.  In 2007, BfR conducted a survey concerning the public perception of nanotechnology.  Given the newness of nanotechnology and that large sections of the population did not have any definite opinions or knowledge of it, BfR conducted a follow-up...

On November 29, 2016, the United Kingdom (UK) Department of Transportation published proposed legislative changes to the Renewable Transport Fuel Obligation (RTFO), which is open for consultation until January 22, 2017.  Among the proposed changes is an increase in the blending mandates to 9.75 percent by volume for 2020.  The three main proposals outlined detail increasing the supply of waste derived fuels, encouraging the production of advanced renewable fuels, and setting a maximum...

On November 30, 2016, Neste, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), released a statement in response to the publication of the European Commission’s (EC) proposal on the revised Renewable Energy Directive (Directive) for 2021 to 2030.  The aim of the Directive is to raise renewable energy usage in Europe to 27 percent by 2030.  In the revised Directive, the EC introduced a mandate requiring fuel suppliers to include a minimum...

On November 29, 2016, Green Biologics, Inc. (Green Biologics) announced that its high purity biobased n-butanol and acetone received certification under the U.S. Department of Agriculture’s (USDA) BioPreferred® program.  Both products, which are produced through the fermentation of sugars from renewable feedstocks, were certified as 100 percent biobased.  In the early stages of its first commercial production facility, Green Biologics aims to produce commercial n-butanol and...

On December 6, 2016, EPA announced its funding of $1.3 million in investments to 13 Small Business Innovation Research (SBIR) projects.  All 13 projects are focused on producing innovative and creative solutions to the country’s current environmental issues.  Each company will receive a SBIR Phase I contract for up to $100,000 to develop their green technology.  Companies that successfully complete Phase I can apply for a Phase II contract of up to $300,000 to commercialize...

On December 1, 2016, the Government Accountability Office (GAO) testified at a hearing before the U.S. Senate Subcommittee on Regulatory Affairs and Federal Management, Committee on Homeland Security and Governmental Affairs regarding the feasibility of the Renewable Fuel Standard (RFS) program .  GAO stated that the goals of the program, to reduce greenhouse gas (GHG) emissions and expand the nation’s renewable fuels sector, were unlikely to be met as envisioned due to the limited...

On December 7, 2016, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of the Toxic Substances Control Act (TSCA), due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities.  The proposed action is significant for...

On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the European Commission (EC) on the European Union Observatory for Nanomaterials (EU-ON).  According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of nanomaterials (e.g., the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, biocides,...

On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final.  This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s...

On November 30, 2016, the White House published a blog item, “President Obama’s Top Ten Actions to Accelerate American Entrepreneurship,” and posted a fact sheet on President Obama’s entrepreneurship accomplishments.  The tenth action is “Unleashed entrepreneurship in the industries of the future, including clean energy, biotechnology, the commercial space industry, nanotechnology, drones, robotics, advanced manufacturing, and more.”  The fact sheet lists several...

Registration is now open for a December 7, 2016, National Nanotechnology Initiative (NNI) webinar, “Water Sustainability through Nanotechnology:  Increasing Water Availability.”  NNI states that water demand in the U.S. is projected to increase over the next several decades.  In addition to increased demand, many U.S. aquifers are being depleted at unsustainable rates, which may lead to increased challenges in locating usable water sources in the future.  During...

On November 14, 2016, the U.S. Department of Agriculture (USDA) and its partners celebrated the successful journey of the first commercial flight powered in part by a new renewable fuel made from wood waste. The demonstration flight, operated by Alaska Airlines, was made possible due to a five-year $39.6 million research project to develop a viable renewable fuel source from cellulose-rich wood harvest leftovers funded by USDA’s National Institute of Food and Agriculture and led...

During the Safer Choice Partner and Stakeholder Summit on November 15- 16, 2016, EPA announced that new product categories were under consideration for the Safer Choice chemical program, including arts and crafts, home improvements, food grade and marine lubricants, and paints and coatings. EPA invited suggestions from participants regarding additional product categories to consider; Summit participants were supportive of an increase to the number of chemicals, products, and product categories...

On November 23, 2016, EPA Administrator, Gina McCarthy, signed the final rule on the RFS volume standards for 2017 and biobased diesel standards for 2018. This final 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:   ?   Cellulosic biofuel, from 230 million gallons in 2016 to 311...

On November 22, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register of an opportunity to comment on petitions requesting EPA initiate a rulemaking process to reconsider its regulations that impose the obligation for compliance with the Renewable Fuel Standard (RFS) annual standards on gasoline and diesel fuel refiners and importers, as well as on EPA’s proposed denial of the petitions. As the notice states, EPA is looking for petitioners...

On November 16, 2016, the White House filed the Mid-Century Strategy for Deep Decarbonization with the United Nations Framework Convention on Climate Change under the Paris climate deal. The strategy highlights the role that U.S. government-funded research, development, and demonstration (RD&D) had on the technological advances of the last century, and the potential to increase the pace and reduce the costs of decarbonization using the full power of U.S. RD&D efforts focused on clean...

As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act...

On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document.  According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard.  The Draft National Standard contains risk management measures applicable for each Environment Schedule under the...

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are: 1,4-dioxane1-bromopropaneTrichloroethylene (TCE)Carbon tetrachlorideHexabromocyclododecane (HBCD)Methylene chloridePigment violet 29Perchloroethylene...

On October 13, 2016, OCSiAl announced that it is the first manufacturer of single wall carbon nanotubes (SWCNT) to complete Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration.  According to OCSiAl, the registration was successfully completed thanks to the collaboration between OCSiAl’s Health and Safety Department, Envigo, and Intertek, which jointly completed the work involved in demonstrating compliance with the standards and requirements of...