Blogs

On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions.  The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.  According to the Agenda item, the final rule effective date is “To Be Determined” (TBD).  The January 12, 2017, final rule requires one-time reporting for existing...

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64).  The editorial states that the Program’s primary goal was to investigate potential applications of existing nanomaterials in healthcare, the consumer industry, and in the environment, and to identify, characterize, and minimize the possible risks associated with their...

The BIO World Congress on Industrial Biotechnology takes place July 23-26, 2017, at the Palais des congrès de Montréal.  Bergeson & Campbell, P.C. (B&C®) will co-host a Bioeconomy Leaders and Innovators Reception with Sterne, Kessler, Goldstein & Fox P.L.L.C. from 6:00-7:30 p.m. on July 25, 2017.  Enjoy cocktails and hors d’oeuvres while engaging with colleagues to exchange ideas and explore the prospect of establishing new partnerships. ...

By Lauren M. Graham, Ph.D. On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS.  The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies...

By Kathleen M. Roberts On July 5, 2017, the U.S. Environmental Protection Agency (EPA) issued proposed volume requirements under the Renewable Fuel Standard (RFS) program for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2018, as well as biomass-based diesel for 2019.  The proposal lowers the blending requirement for all renewable fuel with the exception of biomass-based diesel, which maintains the 2017 blending requirement.  The proposed volume requirements...

By Lauren M. Graham, Ph.D. On June 29, 2017, Representatives Bill Pascrell (D-NJ), Ryan Costello (R-PA), Brian Fitzpatrick (R-PA), and Linda Sánchez (D-CA) introduced the Renewable Chemicals Act of 2017 to the House.  If enacted, the legislation would create a targeted, short-term tax credit for the production of qualifying renewable chemicals from biomass and for investments in renewable chemical production facilities.  The tax credit would be provided based on job...

On July 10, 2017, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the  issuance of  significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e).  These are the first rules with consent orders negotiated...

On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in Center for Biological Diversity (CBD), et al. v. U.S. Environmental Protection Agency (EPA), Case No. 14-1036, resolving jurisdictional and substantive issues following complaints alleging that EPA violated Section 7(a)(2) of the Endangered Species Act (ESA) by failing to make an effects determination or to consult with the U.S. Fish and Wildlife Service (FWS) or the National Marine...

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  According to a pre-publication version of the final rule, manufacturers and processers, or persons who intend to manufacture or process these chemical...

In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities.  EPA uses an Annual Commitment System (ACS) to track annual regional performance information and...

According to the July 7, 2017, issue of the Chemicals Management Plan Progress Report, Health Canada and Environment and Climate Change Canada are in the process of prioritizing nanoscale forms of substances on the Domestic Substances List.  As reported in our July 27, 2015, blog item, Canada conducted a mandatory information-gathering survey under Section 71 of the Canadian Environmental Protection Act, 1999.  Canada states that the survey identified 53 substances as...

On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA).  82 Fed. Reg. 31592.  The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to...

To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations and to recommend those it considers to be of high priority.  According to information on its website, IARC will convene its next Advisory Group in 2018/2019.  IARC encourages the general public, the scientific community, national health agencies, and...

On June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials.  In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.”  In Cases A-014-2015 and A-015-2015, registrants appealed the same 2015 ECHA decision requesting information on synthetic amorphous silica (SAS) following a substance evaluation by the Netherlands Competent...

On June 1, 2017, in the People’s Republic of China (China), the newly revised Regulation on Pesticide Administration (RPA) became effective.  The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017, and published as Decree Number 677 of the State Council of China (China Decree 677) on April 1, 2017.  It requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation....

The Center for the Environmental Implications of NanoTechnology (CEINT) seeks comments on the NANoREG-proposed ISA-TAB-nano templates.  According to CEINT, the ISA-TAB-nano file sharing format, developed under the National Cancer Informatics Program Nanotechnology Working Group (NCIP NanoWG), is an accepted ASTM standard (ASTM International E2909-13).  In 2016, the European Union NANoREG project adopted and adapted the ISA-TAB-nano format to organize consistently the results...

By Lynn L. Bergeson and Margaret R. Graham On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the...

On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances.  82 Fed. Reg. 27254.  EPA states that this...

A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document.  These...

The BIO World Congress on Industrial Biotechnology takes place July 23-26, 2017, at the Palais des congrès de Montréal, and features two new tracks on Flavors, Fragrances and Food Ingredients, and Agricultural Crop Technologies and Biomass Supply.  Bergeson & Campbell, P.C. (B&C®) will co-host a Bioeconomy Leaders and Innovators Reception on July 25, 2017, with Sterne, Kessler, Goldstein & Fox P.L.L.C.  More details to come.  Richard E. Engler, Ph.D.,...