Blogs

The tenth Helsinki Chemicals Forum was held on June 14-15, 2018, in Helsinki, Finland.  According to the Conference Report, prepared by Chemical Watch, 168 delegates from 37 countries attended.  The final debate at the Forum used nanomaterials as a case study to argue whether product stewardship can replace regulation.  Roger Drew, ToxConsult, moderated the debate between David Azoulay, Center for International Environmental Law (CIEL) and David Warheit,...

By Lynn L. Bergeson On July 16, 2018, the National Science Foundation (NSF) announced a $12 million investment in the Semiconductor Synthetic Biology for Information Processing and Storage Technologies (SemiSynBio) program, a partnership between NSF and Semiconductor Research Corporation (SRC).  Researches expect that integrating biological structures with semiconductor technology could increase current data storage capabilities by 1,000 times, while using less energy than current...

By Lynn L. Bergeson On July 16, 2018, Anellotech and Suntory announced that a new milestone had been reached in developing a 100 percent biobased plastic bottle. Anellotech is using a thermal catalytic process called Bio-TCatTM to confirm non-food based feedstocks into BTX aromatics, renewable chemicals that are structurally identical to traditional plastic components.  The BTX is now undergoing purification studies to make bio-paraxylene, a key chemical for the renewable bottles....

By Lynn L. Bergeson On July 18, 2018, the U.S. Environmental Protection Agency (EPA) held a Public Hearing for Proposed Renewable Fuel Standards (RFS) for 2019 and Biomass-Based Diesel Volume for 2020.  The National Biodiesel Board (NBB) testified at this meeting that EPA should set the 2020 Biomass-based Diesel volume at 2.8 billion gallons, stating that it aligns with the goals that Congress set for the RFS program, the volume is achievable in 2020, and that it will better fulfill...

The July 19, 2018, issue of the European Commission’s (EC) Health-EU Newsletter includes an editorial entitled “The only concern to have about sunscreen is … did you remember to put it on?” written by Qasim Chaudhry, Chair of the Scientific Committee on Consumer Safety (SCCS) and Ulrike Bernauer, Chair of the SCCS Working Group on Nanomaterials in Cosmetic Products.  According to the editorial, nanomaterials as cosmetic ingredients serve various functions, including as...

On July 17, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) announced the availability of a study that it commissioned, Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market.  The study presents the results of a critical review of the relevance and reliability of data sources, methods, parameters, and determining factors to...

On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by the U.S. Environmental Protection Agency (EPA) to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC).  The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug,...

By Lynn L. Bergeson On July 5, 2018, VTT Technical Research Centre of Finland Ltd announced that it had developed a 100 percent biobased, thermally formable, biodegradable material, that is suitable for furniture applications.  This product is an attractive alternative to wood and other biocomposite materials that are already available in the market, with the added benefit of formality and coloring properties.  "All the goals we set were achieved: the material is 100% bio-based,...

By Lynn L. Bergeson On July 2, 2018, Midwest AgEnergy announced that the North Dakota Industrial Commission, a division of North Dakota’s State Department of Mineral Resources, Oil and Gas, had awarded it a $83,810 grant to research using North Dakota barley to produce ethanol with a protein concentrate byproduct for use in aquaculture.  This would be the first ethanol produced North Dakota from a feedstock other than corn, and would include an expansion of the Dakota Spirit...

By Lynn L. Bergeson On July 10, 2018, the U.S. Department of Agriculture’s (USDA) Office of Procurement and Property Management announced it was amending the Guidelines for Designating Biobased Products for Federal Procurement to add 12 sections that designate product categories within which biobased products will be afforded federal procurement preference by federal agencies and their contractors via a final rule.  83 Fed. Reg. 31841.  The Federal Register publication...

By Lynn L. Bergeson On July 3, 2018, the U.S. Environmental Protection Agency (EPA) announced it was holding a public hearing for the proposed rule “Renewable Fuel Standard Program:  Standards for 2019 and Biomass-Based Diesel Volume for 2020” on July 18, 2018, at 9:00 a.m. in Ypsilanti, Michigan.  83 Fed. Reg. 31098.  The proposed rule was published in the Federal Register on July 10, 2018.  83 Fed. Reg. 32024.   The notice states that the public...

On July 9, 2018, the National Institute for Occupational Safety and Health (NIOSH) published a one-page document on its Nanotechnology Research Center (NTRC), which conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures.  NTRC’s accomplishments include: Publishing 101 journal articles in the peer-reviewed scientific literature during 2017; Publishing a new chapter in...

The Organization for Economic Cooperation and Development (OECD) published a July 4, 2018, report entitled Investigating the Different Types of Risk Assessments of Manufactured Nanomaterials:  Identifying Tools Available for Risk Management Measures and Uncertainties Driving Nano-Specific Data Needs.  The report presents the findings from a survey conducted in 2016 that aimed at investigating the different types of risk assessment.  The survey was conducted to gather the...

The NanoSafety Cluster announced that its projects NanoReg2 and Gracious, which focus on grouping, have come together with the Organization for Economic Cooperation and Development (OECD) Working Party for Manufactured Nanomaterials (WPMN) to host a two-day conference in Paris on September 12-13, 2018.  The “Scientific workshop on Grouping of Nanomaterials” will immediately follow the September 11, 2018, WPMN meeting on physico-chemical parameters framework for the risk...

By Lynn L. Bergeson On June 27, 2018, representatives from 11 European companies and universities gathered in Örnsköldsvik, Sweden, to kick-off the EU-funded Rewofuel project.  This three-year, €19.7 million (about $23 million) project will demonstrate and evaluate how to best use wood residues from the forest industry to produce biofuels, with a long-term goal of starting new biorefineries across Europe. Rewofuel is a collaborative project that is expected to run for...

By Lynn L. Bergeson On June 27, 2018, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) issued a new report, Moving Beyond Drop-In Replacements: Performance-Advantaged Biobased Chemicals Workshop Summary Report, that summarizes presentations and discussions from a workshop BETO held in June 2017 to gather stakeholder input on the research and development necessary for novel biobased compounds and functional replacements.  DOE states that...

By Lynn L. Bergeson On June 28, 2018, the U.S. Senate passed S.3042 -- Agriculture Improvement Act of 2018 (Farm Bill) with a vote of 86-11. This bill includes mandatory funding for Energy Title programs, including the Biomass Research and Development Initiative; the Biobased Markets Program; the Biorefinery, Renewable Chemical and Product Manufacturing Assistance Program; the Bioenergy Program for Advanced Biofuels; the Rural Energy for America Program (REAP); and the Biomass Crop...

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  Potential future developments suggested in the scientific literature...

The European Commission (EC) announced on June 15, 2018, that researchers from the European Union (EU)-funded NANOPACK project found a solution for extending food shelf-life by using smart antimicrobial surfaces applied to active food packaging.  According to the EC, the researchers are now running five pilot production runs of the new polymer composite, based on tiny nanotube formations, to test its technical, industrial, and commercial viability.  The researchers “form...

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology. According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to engineer...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of enactment of...

By Lynn L. Bergeson On June 26, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced it was seeking public comment on a draft Environmental Assessment (EA) and a preliminary Plant Pest Risk Assessment (PPRA) prepared in response to a petition from Nuseed Americas Inc. (Nuseed) to deregulate a canola variety genetically engineered to convert oleic acid to docosahexaenoic acid (DHA).  83 Fed. Reg. 29742.  APHIS will...

By Lynn L. Bergeson On June 20, 2018, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that the Fuels Institute and the national laboratories that comprise the DOE Co-Optimization of Fuels and Engines initiative would be co-hosting a series of collaborative, single-day stakeholder meetings entitled the Octane Workshop Series across multiple locations from July 9-12, 2018, to “review current research on the role of octane and other fuel...

By Lynn L. Bergeson On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the...

By Lynn L. Bergeson On June 26, 2018, Scott Pruitt, Administrator of the U.S. Environmental Protection Agency (EPA), signed a proposed rule that includes 2019 Renewable Fuel Standard (RFS) percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel, as well as 2020 renewable volume obligations (RVO) for biomass-based diesel.   These blend levels increase requirements from 2018 but are still lower than the statutory levels set by...

NanoMONITOR announced on June 25, 2018, that the NanoMONITOR Monitoring Station is available upon request to use in facilities to obtain robust data on the concentration of engineered nanomaterials.  NanoMONITOR’s brochure states that access is provided on a transnational basis with no charge to the user.  According to NanoMONITOR, by developing a real-time information and monitoring system, NanoMONITOR supports the risk assessment of nanomaterials under the...

On June 25, 2018, the U.S. Environmental Protection Agency (EPA) held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA's Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals.  A list of those chemicals is available here.  Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer...

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018.  Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next. On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance...

On June 25, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano).  The EC received eight notifications of cosmetic ingredients containing the copolymers in nano forms.  According to the applicants, the ingredients are used in nano-coated form in leave-on cosmetic products with maximum reported concentration limits of 0.06 percent. ...

On June 21, 2018, during the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) webinar, EPA discussed the new draft risk-based strategy for ensuring the performance of public health antimicrobial products and announced the intended replacement of the former Antimicrobial Testing Program (ATP) with the new Antimicrobial Product Evaluation Program (APEP).  Comments on the draft risk-based strategy may be submitted to EPA until July 16, 2018. Public health...

On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury).  The final rule applies to any person who manufactures (including imports) mercury or...

On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days;  comments on these documents are now due by August 16, 2018.  EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try...

The “2nd Quantifying Exposure to Engineered Nanomaterials from Manufactured Products (QEEN II) Workshop” will be held October 9-10, 2018, in Washington, D.C.  Sponsored by the Consumer Product Safety Commission (CPSC) and co-hosted by the National Nanotechnology Initiative (NNI), the Workshop will highlight new research on the tools and methods available to characterize and quantify effective population exposures, as well as the presence and release potential of...

On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497).  These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the...

On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), presented “New TSCA and Green Chemistry Innovation” at the American Chemical Society’s (ACS) Green Chemistry & Engineering Conference in Portland, Oregon. This presentation covered specific changes to the Toxic Substances Control Act (TSCA) and the impact of those changes for new chemicals, including innovative “green”...

By Lynn L. Bergeson On June 14, 2018, the European Union (EU) reached a deal on the Renewable Energy Directive (REDII),which sets new targets for renewables. REDII represents stricter targets than those discussed in Brussels in 2014, upping the percentage of the EU’s energy that must come from renewable sources to 32 percent of total energy consumption by 2030. The agreement also states that at least 14 percent of transportation fuel must come from renewable sources by 2030, and includes a...

By Lynn L. Bergeson On June 18, 2018, DOE’s Bioenergy Technologies Office (BETO)-funded Algae Technology Educational Consortium (ATEC) announced its first graduates from the algal certificate program at Santa Fe Community College in Santa Fe, New Mexico.  DOE states that these first ATEC graduates “received their Associate Applied Science Degree in Controlled Environment Agriculture with a certificate in Algae Cultivation” on May 12, 2018. The program was conceptualized...

By Lynn L. Bergeson On June 18, 2018, the U.S. Department of Energy (DOE) announced it would be releasing $40 million in funding for “31 projects to advance research in the development of microbes as practical platforms for the production of biofuels and other bioproducts from renewable resources.”  Projects were chosen by competitive peer review under two separate DOE Funding Opportunity Announcements, one for Systems Biology of Bioenergy-Relevant Microbes and another for...

By Lynn L. Bergeson On June 4, 2018, several biofuel and agricultural groups, including the Renewable Fuels Association, the Biotechnology Innovation Organization, the American Coalition for Ethanol (ACE), and the National Biodiesel Board, among others, petitioned the U.S. Environmental Protection Agency (EPA) regarding EPA’s Renewable Fuel Standard (RFS) obligations.  The ACE announcement states that the petition asks EPA to “change its regulations to account for lost volumes...

On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).”  EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to...

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals.  Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified...

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our May 26, 2016, memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed...

On June 14, 2018, the U.S. Environmental Protection Agency (EPA) announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use.  The prepublication version of the NOA is available...

By Lynn L. Bergeson On June 5, 2018, Brazil’s National Energy Policy Council (CNPE) set a target to reduce fuel emissions ten percent by 2028. These targets are part of the RenovaBio law, passed in December 2017, that aims to meet Brazil’s commitments under the Paris Climate Agreement by increasing the share of ethanol and biodiesel in Brazil’s fuel mix and reducing greenhouse gas emissions. Andre Rocha, president of the National Sugarcane/Ethanol Forum, a group of 16...

By Lynn L. Bergeson On June 12, 2018, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that it would be hosting the Chemical Catalysis for Bioenergy (ChemCatBio) Consortium’s Webinar titled “Accelerating the Catalyst Development Cycle” on June 27, 2018, at 2:00 p.m. (EDT).  ChemCatBio Consortium is a research and development consortium dedicated to identifying and overcoming catalysis challenges for biomass conversion...

By Lynn L. Bergeson On June 8, 2018, petitioners in the District of Columbia Circuit (D.C. Circuit) case Coffeyville Resources Refining, et al. v. EPA filed their final briefs in the case challenging EPA’s final rule that established:  (1) the annual percentage standards for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel that apply to all motor vehicle gasoline and diesel produced or imported in the year 2017; and (2) the applicable...

By Kathleen M. Roberts  On June 13, 2018, representatives of the Biobased and Renewable Products Advocacy Group (BRAG®) and representatives of the Biotechnology Innovation Organization (BIO) met with U.S. Environmental Protection Agency (EPA) staff to discuss the two groups’ white paper, “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals.”  BRAG and BIO...

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...