Blogs

By Lynn L. Bergeson On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar...

By Lynn L. Bergeson On August 9, 2019, the U.S. Environmental Protection Agency (EPA) published a report on its compliance with the law titled EPA Exceeded the Deregulatory Goals of Executive Order 13771. Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, includes regulatory savings goals for FYs 2017 and 2018, EPA’s deregulatory actions, and its compliance with the Office of Management and Budget’s (OMB) goal-setting requirements. EO 13771 was issued...

By Lynn L. Bergeson On August 12, 2019, the U.S. Department of Energy (DOE) announced its Fiscal Year (FY) 2020 Phase I Release 1 funding opportunity for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. In its announcement, DOE encourages small businesses with strong research capabilities in science or engineering to apply. DOE’s Funding Opportunity Announcement (FOA) includes participation from its Advanced Scientific Computing...

The U.S. Environmental Protection Agency (EPA) has named Dr. Lynn Dekleva as Associate Deputy Assistant Administrator for New Chemicals.  Dr. Dekleva joined EPA in October 2018 as a Science Advisor, working to streamline and improve EPA’s processes and timeliness concerning the review of new chemicals under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Dr. Dekleva is an environmental engineer with degrees in environmental microbiology, medical technology, and biology....

Registration has begun for the National Nanotechnology Initiative’s (NNI) September 10, 2019, webinar on “Respiratory Effects of Engineered Nanomaterials in Relation to Physicochemical Properties.”  The speaker will be Dr. Junfeng (Jim) Zhang, Nicholas School of the Environment and Duke Global Health Institute, Duke University, and Dr. William Boyes, U.S. Environmental Protection Agency, will moderate.  NNI states that the interaction between engineered nanomaterials...

On August 1, 2019, the German Chemical Industry Association (VCI) announced the availability of a guidance document on the safe recovery and disposal of wastes containing nanomaterials.  According to VCI, wastes containing nanomaterials can be generated in the production or use of nanomaterials.  Such wastes can occur in the production of substances, mixtures, or products; in the processing and repair of products; or in the disposal of products at the end of their life...

Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply...

The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or...

On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos.  On August 8, 2019, New York, California, Hawaii, Maryland, Vermont,...

The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA made the following initial determinations on risk: Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use.  EPA notes that these initial determinations are not its final determinations...

By Lynn L. Bergeson On August 6, 2019, the Utility Workers Union of America (UWUA) announced its partnership with The Power for America Training Trust Fund (P4A) for the launch of a renewable energy specialist apprenticeship program. Certified by the U.S. Department of Labor (DOL), the program aims at assisting individuals with a path to employment for highly demanded jobs in the renewable energy sector. Under this program, individuals will be taught specialized skills in the fields of solar...

By Lynn L. Bergeson On August 6, 2019, the Minnesota Department of Agriculture (MDA) announced four grants aiming to expand biofuel access and production to advance the state’s renewable energy efforts. Awarded to four recipients by MDA’s Agricultural Growth, Research and Innovation (AGRI) Program, the grants total more than $500,000. One Bioenergy/Biochemical Pilot Project Grant was awarded, providing funding to advance bioenergy and biochemical production technology to a commercial...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 26, 2019, U.S. Senator Pat Toomey (R-PA) announced that he is working with U.S. Senator Dianne Feinstein (D-CA) on the Restore Environmental Sustainability to Our Renewable Energy (RESTORE) Act. In an effort to end what Toomey describes as an “egregious form of corporate welfare that hurts the environment and drives up the cost of everything,” the RESTORE Act would abolish the corn ethanol mandate under the Renewable Fuel...

By Lynn L. Bergeson On July 29, 2019, the U.S. Department of Energy (DOE) announced that $50 million of funding is now available for innovative research of technologies for trucks, off-road vehicles, and gaseous fuels research. Funded through DOE’s Office of Energy Efficiency and Renewable Energy (EERE), “it is important our trucking industry has access to advanced technologies, such as electrification and fuel cells, as a way to move goods efficiently and economically,” stated...

On August 1-2, 2019, the National Nanotechnology Initiative (NNI) held “The Future of the NNI:  A Stakeholder Workshop.”  The NNI has played a pivotal role in fostering and advancing a dynamic nanotechnology ecosystem in support of the initiative’s four goals:  advance world-class research; foster commercialization; develop and sustain research infrastructure; and support the responsible development of nanotechnology.  Building on this foundation, experts from the...

As reported in our February 1, 2019, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2019 list of chemical substances and other issues under study.  Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®).  On July 30, 2019,...

On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X.  This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data...

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a...

In May 2019, the Nordic Council of Ministers published a working paper entitled The applicability of the GHS classification criteria to nanomaterials.  The goal of the project was to review the applicability of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to manufactured nanomaterials, taking into account the progress of international scientific work.  The report notes that the Organization for Economic Cooperation and Development (OECD) Working...

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a...