Blogs

On February 13, 2020, the Nanotechnology Industries Association (NIA) published a position paper entitled ‘Nanoplastics’:  Use of suitable terminology for representation in waste, degradation of plastics and presence in the environment.  In the paper, NIA and its members urge caution and clarity when referring to plastics as small particles or fragments.  NIA states that “nanoplastics” is a “non-specific and ambiguous term, and qualifiers should be considered for...

The U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause...

On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures.  In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability...

The U.S. Environmental Protection Agency (EPA) will host a conference call on February 24, 2020, from 12:30 to 1:00 p.m. (EST) to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  In light of the recent publication of the preliminary list of manufacturers/importers subject to risk evaluation fees, as reported in our January 29, 2020, blog item, EPA states that it will give a brief overview of the fees...

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) issued the prepublication version of its long-anticipated fees rule under amended Toxic Substances Control Act (TSCA) Section 26(b) entitled User Fees for the Administration of the Toxic Substances Control Act.  EPA states that the proposed rule will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed...

The Scientific Committee on Consumer Safety (SCCS) announced on February 6, 2020, that the European Commission (EC) has requested scientific advice on the safety of nanomaterials in cosmetics.  The EC seeks advices on two questions: The EC requests that SCCS determine the nanomaterials, as published in the recent catalogue of nanomaterials of 2019, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and...

By Lynn L. Bergeson On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The focus of the workshop will be on FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, deter anticompetitive behaviors in the biologic marketplace, and discourage false or misleading statements about...

By Lynn L. Bergeson On February 4, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it is searching for professionals to fill vacant general engineer and physical scientist positions. Resumes can be submitted directly to EERE’s hiring staff with information on the position of interest and EERE office (Solar, Geothermal, Vehicles, and Buildings, among others). Should EERE be interested in a particular resume, DOE’s Human...

By Lynn L. Bergeson On February 3, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a notice requesting comments and feedback on its draft instructions on testing methods under the National Bioengineered Food Disclosure Standard (Standard). According to the Standard, which became effective in 2019, with a mandatory compliance date of January 1, 2022, foods that do not contain bioengineered (BE) material do not require label disclosure. USDA’s...

By Lynn L. Bergeson On February 6, 2020, EPA issued its final rule setting 2020 renewable fuel percentage standards under its Renewable Fuel Standard (RFS) Program. The final rule established the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in 2020. The volume requirements set are below the statutory volume targets. In addition to the 2020 annual...

On February 3, 2020, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of an interim registration review decision for glyphosate.  EPA previously issued a proposed interim registration review decision (PID) for glyphosate for comment in April 2019.  At the time EPA issued the glyphosate PID for comment, EPA also issued a draft human health risk assessment and a preliminary ecological risk assessment for...

The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2020 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® describes TLVs® as health-based values representing the...

On February 5, 2020, the Nanotechnology Entrepreneurship Network (NEN) will hold a webinar on insights from the U.S. Patent and Trademark Office (USPTO) from 12:00 p.m. to 1:00 p.m. (EST).  The National Nanotechnology Initiative (NNI) notes that a key stop on the technology development pathway is protecting the underlying intellectual property.  Entrepreneurs intending to commercialize an emerging technology, such as a nanomaterial or a nanomaterial-enabled product,...

The U.S. Environmental Protection Agency (EPA) Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices.  EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental...

The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in...

The National Toxicology Program (NTP) published a Federal Register notice on January 31, 2020, announcing that the Board of Scientific Counselors (BSC) will meet on February 21, 2020.  During the meeting, BSC will review and provide advice on programmatic activities.  According to the preliminary agenda for the meeting, the meeting will include a presentation by Dr. Anil Patri, Food and Drug Administration, National Center for Toxicological Research,...

On January 29, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has activated its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides (Guidance) in response to the discovery of the novel coronavirus (2019-nCoV).  According to the World Health Organization (WHO), coronaviruses cause numerous illnesses, from the common cold to Severe Acute Respiratory Syndrome (SARS).  First identified in Wuhan, China, the 2019-nCoV coronavirus is a new strain...

By Lynn L. Bergeson On January 22, 2020, three trade associations announced the launch of a strategy to tackle the transition into 100 percent biofuels for heating oil in English and Irish homes. A United Kingdom (UK) based trade association, the Oil Firing Technical Association (OFTEC) has partnered with the Tank Storage Association (TSA) and the UK and Ireland Fuel Distributors Association (UKIFDA) to launch a future vision for liquid fuels, titled “Supply Chain Strategy for Liquid...

By Lynn L. Bergeson On January 28, 2020, Bergeson & Campbell, P.C. (B&C®) published a memorandum on the regulatory developments of the Sustainable Chemistry R&D Act of 2019 (Act), which was passed by the U.S. House of Representatives late last year. The memorandum not only provides an overview of the proposed legislation, its implementation, and limitations, but also highlights the important milestones that could be achieved if the bill passes. The proposed bill seeks to broaden...

By Lynn L. Bergeson On January 29, 2020, Congressman Paul D. Tonko (D-NY) and other House Democrats unveiled a five-year, $760 billion investment framework to repair and upgrade the U.S. infrastructure to create jobs while reducing carbon pollution, improving safety, and supporting economic activity. Called the “Moving Forward Framework for the People,” the plan includes measures to increase climate resiliency and put the United States on a path toward zero carbon pollution from...

By Lynn L. Bergeson On January 27, 2020, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced that it is accepting comments on its proposed revisions to regulations implemented under the Federal Seed Act (FSA). The proposed rule includes revisions to seed labeling, testing, and certification requirements, including new eligibility standards and the recognition of current breeding techniques. Revised FSA regulations would add certain seed species to the...

By Lynn L. Bergeson On January 24, 2020, as part of its sustainable transportation efforts, DOE announced a collaborative project with the International Motor Sports Association (IMSA) to encourage the development of advanced fuels and efficient technologies in motorsports. Focused on vehicles at the racetrack, the collaboration was formalized by a Memorandum of Understanding (MOU) that names the combined effort the Green Racing Program (GRP). GRP aims to emphasize the importance of promoting...

By Lynn L. Bergeson Also on January 23, 2020, DOE announced that up to $64 million will be available in funding to advance innovations that will build new markets for the H2@Scale initiative. H2@Scale is an initiative focused on exploring the potential for wide-scale hydrogen production and utilization in the United States to enable resilience and sustainability of the power generation and transmission sectors. The initiative’s goal is to align diverse multibillion-dollar domestic...

By Lynn L. Bergeson On January 23, 2020, the U.S. Department of Energy (DOE) announced the availability of more than $96 million in funding for bioenergy research and development (R&D) in support of the U.S. bioeconomy. DOE’s funding efforts also align with its own goal to provide secure, affordable, and reliable domestic energy options for consumers and business. This funding opportunity announcement (FOA) aims to advance DOE’s Bioenergy and Technology Office’s (BETO)...

On January 24, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of carbon tetrachloride, “a solvent primarily used in the manufacturing of chlorinated compounds and petrochemicals.”  Carbon tetrachloride is the seventh of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA published a Federal Register notice on January 27, 2020, announcing the availability of the draft...

On February 24, 2020, the European Chemicals Agency (ECHA) will hold a webinar on “Registering nanoforms:  practical advice.”  As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Beyond this date, companies must have a registration compliant with these requirements to manufacture or import...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether...

On January 24, 2020, the U.S. Environmental Protection Agency (EPA) posted a December 13, 2019, memorandum to Docket EPA-HQ-OPP-2011-0370, the nanosilver registration review docket.  The memorandum lists the 12 products for which EPA issued a generic data call-in (GDCI) as part of the nanosilver case (5042).  EPA issued the DCIs on August 31, 2019, and states that they can be accessed in the docket. EPA Reg. NumberPC CodeNano-Naming IDDCI Number83587-3072591Nanosilver...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required...

The National Nanotechnology Coordination Office (NNCO) is scheduled to publish on January 27, 2020, a Federal Register notice concerning public meetings under the National Nanotechnology Initiative (NNI).  According to the notice, the NNCO will hold one or more workshops, webinars, networks, and Community of Interest teleconferences between the publication date of the Federal Register notice and December 31, 2020.  Attendance information, including...

By Lynn L. Bergeson Bergeson & Campbell, P.C. (B&C®) has launched the complete suite of TSCA TutorTM regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and...

By Lynn L. Bergeson Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is...

By Lynn L. Bergeson  On January 23, 2020, DOE announced that up to $133 million will be available for new and innovative advanced vehicle technologies research designed to increase affordable, efficient, and secure transportation energy. This Fiscal Year (FY) 2020 opportunity will be funded by DOE’s Office of Energy Efficiency and Renewable Energy (EERE) and supports priorities in: (1) advanced engine and fuel technologies; (2) lightweight materials; (3) new energy efficient mobility...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 21, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs Office announced the launch of the U.S. Small Business Administration’s (SBA) Tibbetts Awards. The Tibbetts Awards recognize companies, organizations, and individuals exemplifying the best of the best in the SBIR and STTR programs. Named after the founder of the SBIR program, Roland...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 16, 2020, the U.S. Department of Agriculture (USDA) announced the issuance of a Request for Information (RFI) to assist with the creation of its new program called Higher Blends Infrastructure Incentive Program (HBIIP). A USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. Requesting feedback from all interested...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com.  Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing.  In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a...

We are pleased to announce that Lynn L. Bergeson will present at the 9th Nano Conference hosted by the Sustainable Nanotechnology Organization (SNO) and Nanotechnology, Occupational and Environmental Health (NanOEH) Committee.  Abstracts for the October 4-6, 2020, Conference are due March 6, 2020.  As reported in our December 9, 2019, blog item, the Conference will address: Green/advanced synthetic materials and manufacturing; Nanomedicine, nanodrugs,...

The March 1, 2020, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2019 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides...

As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA organized a webinar on November 12, 2019, on the revised annexes and how companies can prepare to meet the new requirements.  ECHA states that the first part of the webinar explained what a nanoform is and how to build a set of similar...

The U.S. Environmental Protection Agency (EPA) will hold its next Enforcement and Compliance History Online (ECHO) webinar on February 18, 2020, at 1:30-2:30 PM (EST).  The webinar will provide an overview of the data in ECHO and guide users through using the site to answer environmental compliance and enforcement questions.  EPA states that the focus of this session will be a collection of short, step-by-step demonstrations geared toward new and infrequent users.  EPA will...

By Lynn L. Bergeson On January 10, 2020, the National Farmers’ Union of Scotland (NFUS) announced its pursuit for high level solutions to machinery problems linked to biofuel content. According to NFUS, many Scottish and UK farmers are experiencing issues because of the percentage of biofuel content in fuel for farming machinery. In December 2019, NFUS submitted a letter to Grant Shapps, Member of Parliament (MP) and Secretary of State for Transport, requesting long-term solutions for this...

By Lynn L. Bergeson On January 10, 2020, DOE announced that it will provide up to $75 million for research and development (R&D) of sustainable bioenergy crops within a period of five years. The bioenergy crops to be developed should be tolerant of environmental stress and resilient to changing environment conditions. Funded projects will focus on better comprehending the genetic and physiological mechanisms influencing plant productivity, resource use, and resilience, among other factors....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 13, 2020, U.S. Representative Cindy Axne announced that the Government Accountability Office (GAO) has responded to a bipartisan letter submitted by members of the House Biofuels Caucus (HBC) requesting an investigation into misuse of small refinery exemptions (SREs) by the U.S. Environmental Protection Agency (EPA). Submitted in August 2019, the bipartisan letter requested that GAO examine EPA’s review and approval of SRE...

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing.  A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic...

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order...

The U.S. Environmental Protection Agency (EPA) promulgated a final rule on January 13, 2020, to adjust the level of the maximum (and minimum) statutory civil monetary penalty amounts under the statutes it administers, including the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 1751.  EPA states that this action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the...

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.”  In this richly detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our best informed judgment as to the shape of key developments we are likely to see in...

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.”  In this richly detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our best informed judgment as to the shape of key developments we are likely to see...