Blogs

On November 22, 2019, the European Commission (EC) Directorate-General for Internal Market, Industry, Entrepreneurship, and Small- and Medium-Sized Enterprises (SME) requested two scientific opinions from the Scientific Committee on Consumer Safety (SCCS): Request for a scientific opinion on platinum (nano)-colloidal platinum (nano) (Chemical Abstracts Service (CAS) No. 7440-06-4, EC No. 231-116-1) and acetyl tetrapeptide-17 colloidal platinum (nano) (CAS and EC Nos. not available); and Request...

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...

By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...

By Lynn L. Bergeson On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the...

On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements. ...

The National Nanotechnology Initiative (NNI) announced on November 19, 2019, the launch of the Nanotechnology Entrepreneurship Network (NEN), “a new community of interest to support entrepreneurs interested in commercializing nanotechnologies.”  According to NNI, NEN will bring new and seasoned entrepreneurs together with the people and resources available to support them.  NNI states that NEN will provide a forum for sharing best practices for advancing nanotechnology...

On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855).  Of primary interest in the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are the draft human health and ecological risk assessments.  Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical...

The European Commission (EC) announced on November 15, 2019, that it published an updated catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  As reported in our June 19, 2017, blog item, the EC first published a catalog in June 2017.  The catalog compiles information that responsible persons shared with the EC through the cosmetic products notification portal (CPNP) as of December 31, 2018.  The catalog lists 27 nanomaterials used...

On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time.  EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access the...

On November 12, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanomaterials in Europe’s workplaces:  what are the risks and how can they be managed?” and written by Elke Schneider, European Agency for Health and Safety at Work (EU-OSHA).  Schneider states that at the EU level, the requirements for managing nanomaterials and their potential risks are the same as those for managing other hazardous substances.  Under the EU’s...

The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program.  At the meeting, EPA will: Provide an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA”;...

By Lynn L. Bergeson On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) held a webinar on the Green Chemistry Challenge Awards Program.  Participants learned about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation covered award eligibility, the application process, and evaluation criteria.  There were also questions from the webinar participants. As reported in Bergeson &...

By Lynn L. Bergeson On November 12, 2019, DOE published a Funding Opportunity Announcement (FOA) for topics for its Fiscal Year (FY) 2020 Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Phase I Release 2 funding. Participating in this FOA are the following DOE program offices: Office of Cyber Security, Energy Security, and Emergency Response (CESER);   Office of Defense Nuclear Nonproliferation (NNSA);   Office of Electricity (OE);   EERE;...

By Lynn L. Bergeson On November 8, 2019, the U.S. Department of Energy (DOE) announced that $12 million will be available in funds for new projects to support research and development (R&D) and education and workforce development to increase plastics recovery, recycling, reuse, and remanufacturing. Designed for U.S. manufacturers, 12 to 18 exploratory and full R&D projects and four to eight education and workforce development projects will be funded by DOE’s Reducing Embodied...

The U.S. Environmental Protection Agency (EPA) announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on: Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and Test Market Exemption Applications (TMEA); Notices of Commencement of Manufacture or Import (NOC); and Test information submitted under Section 5 of the Toxic Substances Control Act (TSCA). EPA notes that it is required...

The German Environment Agency (UBA) will hold a conference on December 5-6, 2019, on “Advanced Materials — 1st Thematic Conference.”  UBA uses the term “advanced materials” to refer to a heterogeneous group of new or modified materials with improved properties for intended applications.  According to UBA, for a certain number of these new materials, their potential risk may not be driven by their chemical identity alone but may also be determined by their physical and morphological...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 12, 2019, announcing the availability of its response to a petition it received under Section 21 of the Toxic Substances Control Act (TSCA) from Public Employees for Environmental Responsibility (PEER).  84 Fed. Reg. 60986.  As reported in our August 23, 2019, blog item, PEER petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries...

On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants. As reported in our September 20, 2019, blog item, EPA...

On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 60363.  EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for...

By Lynn L. Bergeson On November 4, 2019, 60 organizations unified in an effort to urge U.S. President Donald Trump to reconsider EPA’s proposed amendments to the Renewable Fuel Standard (RFS) program. Signed by organizations such as the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, the letter to the President indicates flaws within the aforementioned proposal released on October 15, 2019. Arguing that the proposed...

By Lynn L. Bergeson On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these...

By Lynn L. Bergeson On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The Committee will hear from the following witnesses: Panel 1 Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor.  ...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 7, 2019, announcing the availability of the draft risk evaluation for N-methylpyrrolidone (NMP) and soliciting public comment.  84 Fed. Reg. 60087.  EPA’s draft risk evaluation findings include: EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily...

On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science?  The Future of Science in EPA Rulemaking.”  The Committee will hear from the following witnesses: Panel 1 Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor. Panel 2 Dr....

On November 4, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics.  The Guidance updates SCCS’s 2012 Guidance (SCCS/1484/12) on the safety assessment of nanomaterials in cosmetic products.  It covers the main elements of safety assessment — general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard...

On November 4, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft risk evaluation for N-methylpyrrolidone (NMP), which includes more than 30 uses of NMP in adhesives, sealants, paints and arts and craft paints, paint and coating removers, adhesive removers, and degreasers.  EPA’s draft risk evaluation findings include: EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included...

The most recent episode of the National Nanotechnology Initiative’s (NNI) podcast series, Stories from the NNI, features Lynn L. Bergeson.  Ms. Bergeson shares her perspective on the intersection of nanotechnology and the law.  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), speaks with Ms. Bergeson regarding her perspective on the intersection of nanotechnology and the law.  To celebrate the 15-year anniversary of the...

On October 31, 2019, as required by the 2018 Farm Bill, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service published its interim rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule).  The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including: Requirements for state/tribal plans for states pursuing regulatory authority over hemp production; Recordkeeping requirements; Licensing requirements;...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 23, 2019, the Alliance to End Plastic Waste (AEPW) announced a partnership with innovation platform Plug and Play to develop an accelerator program focused on the plastics value chain to identify start-ups with innovative ideas addressing plastic waste. Named the End Plastic Waste Innovation Platform (EPWIP), this initiative will focus on solutions to lower the impact of plastic waste in the environment. Focus areas include but are...

By Lynn L. Bergeson On October 25, 2019, Iowa State University’s (ISU) Vice President for Research, Dan Kirkpatrick, announced that Sundeep Vani, Ph.D., has joined the team as the Chief Technology Officer (CTO) for Biobased Products, a newly created role. Announced in an ISU press release, Dr. Vani’s role will be to serve as a conduit between research and industry. Dr. Vani will work closely with the Biobased Product platform leader, Brent Shanks, his team, and the Iowa Innovation...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 28, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental proposal on adjustments to the percentage standards for 2020 that result from the amended definitions of two terms used to calculate the percentage standards under the Renewable Fuel Standard (RFS). Signed and pre-published on October 15, 2019, by EPA Administrator Andrew Wheeler, the notice of the proposed rule is no surprise....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. USDA Deputy Under Secretary Donald LaVoy and DOE Under Secretary of Energy Mark W. Menezes announced on October 24, 2019, a Memorandum of Understanding (MOU) signed between the two departments to promote rural energy and the development of technologies to support and advance rural and agricultural communities and domestic manufacturing. Required under Section 6501 of the 2018 Farm Bill, the MOU is meant to improve collaboration and coordination...

By Lynn L. Bergeson On October 30, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. The first meeting is scheduled for November 19, 2019, from 8:00 a.m. to 5:00 p.m. (EST), and the second meeting will take place on November 20, 2019, from 8:00 a.m. to 1:30 p.m. (EST) in Washington, D.C. The purpose of the committee is to advise the Secretaries...

On October 29, 2019, the U.S. Environmental Protection Agency published a Federal Register notice announcing the availability of the draft Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride (MC).  84 Fed. Reg. 57866.  As reported in our October 26, 2019, blog item, EPA is submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review.  SACC will convene an in-person public meeting to consider and...

On October 24, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is proposing narrow updates to the Worker Protection Standard’s (WPS) provision on the Application Exclusion Zone (AEZ) requirements.  By narrowing updates to the WPS, EPA states that it will “improve the long-term success of the agency’s Application Exclusion Zone requirements” and “would improve enforceability for state regulators and reduce regulatory burdens for farmers.”  EPA believes...

On October 30, 2019, the U.S. Environmental Protection Agency (EPA) announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI)...

On September 24 – 26, 2019, the European Commission’s (EC) Joint Research Center (JRC) hosted the 2019 Global Summit on Regulatory Science (GSRS19), which focused on nanotechnology and nanoplastics.  Co-organized with the Global Coalition for Regulatory Science Research, GSRS19 covered nanotechnology research and its role in enhancing regulatory decision making, including methods, standards, and applications.  In addition, GSRS19 also introduced methods and approaches to...

Registration has begun for the National Nanotechnology Initiative’s (NNI) November 12, 2019, webinar, “Global Harmonization of Nanoinformatics:  A Case Study in Convergence and Team Science.”  The webinar, part of NNI’s 2019 series on the environmental, health, and safety effects of nanomaterials (nanoEHS), “will share how engaged and collaborative communities in the United States, Europe, and elsewhere have provided an infrastructure capable of supporting sustainable design of...

The U.S. Environmental Protection Agency will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC).  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will hold an in-person public meeting to consider and review the draft risk evaluation...

The U.S. Environmental Protection Agency will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC).  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will hold an in-person public meeting to consider and review the draft...

The International Organization for Standardization (ISO) has published standard ISO/TS 21236-1:2019, “Nanotechnologies — Clay nanomaterials — Part 1:  Specification of characteristics and measurement methods for layered clay nanomaterials.”  The standard specifies characteristics to be measured of layered clay nanomaterials in powder form and chemically modified ones and describes their relevant measurement methods.  According to the standard abstract, there are...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 16, 2019, the University of Surrey, United Kingdom, announced that its researchers have partnered with colleagues from France, Germany, and Spain to start working on a new technique to tackle plastic waste. According to the university’s article, this novel technique may revolutionize the recycling industry. The plan is to create engineered microbial communities that will digest two types of plastic polymers -- polyethylene...

By Lynn L. Bergeson On October 22, 2019, Frank Pallone, Jr. (D-NJ), Energy and Commerce (E&C) Committee Chair, and Paul Tonko (D-NY), Environment and Climate Change Subcommittee (ECCS), announced that a legislative hearing will be held on October 29, 2019, at 10:30 a.m. (EDT) on Capitol Hill. Titled “Protecting the RFS: The Trump Administration’s Abuse of Secret Waivers,” the hearing will focus on the EPA’s mismanagement of the Renewable Fuel Standard (RFS) Program...

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2019, that it settled with Miles Chemical Company Inc. for failing to report timely chemical substances it imported.  Under the settlement, the company will pay a $45,000 penalty.  According to EPA, between 2012 and 2015, Miles Chemical Company failed to submit timely forms to EPA documenting the import of large quantities of two chemicals.  EPA notes that under the Toxic Substances Control Act (TSCA), chemical...

On October 17, 2019, the U.S. Environmental Protection Agency (EPA) released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish.  The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish.  EPA states that the “guide is written in a universal form of Spanish...

On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV).  Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019.  It is co-sponsored by Representative John Moolenaar (R-MI).  The bill is intended to...

By Lynn L. Bergeson In response to EPA supplemental proposal outlined above, on October 15, 2019, U.S. Senator James Lankford (R-OK) issued a statement expressing his disappointment with EPA’s RFS mandates. Senator Lankford’s statement reads in part: The RFS has been a problem since day one, and the proposed increase to the mandate only further complicates a broken federal requirement to blend biofuels into gasoline. This proposal continues allowing exemptions for small refineries...

By Lynn L. Bergeson On October 15, 2019, EPA Administrator, Andrew Wheeler, signed a supplemental notice of the proposed rule on the Renewable Fuel Standard (RFS) that proposes to establish the cellulosic biofuel, advanced biofuel, and total renewable fuel volumes for 2020 and the biomass-based diesel volume for 2021. Although the rule does not change the volumes for 2020 and 2021 proposed in July 2019, it proposes and seeks comment on adjustments to the way that annual renewable fuel...

By Lynn L. Bergeson On October 15, 2019, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service (RBCS) announced via the Federal Register the solicitation of applications for funds under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program). Under the Program, USDA provides guaranteed loans to fund the development, construction, and retrofitting of commercial scale biorefineries using eligible technology. The loans are also...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies.  EUON conducts up to three studies annually that are intended to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it is looking for studies that address: Questions relating to the health and safety of nanomaterials, including hazard and risk...