Blogs

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By Lynn L. Bergeson On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity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