By Lynn L. Bergeson On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL)...
October 4, 2019
FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P
By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...
According to an item in the September 2019 issue of NIOSH eNews, the National Institute for Occupational Safety and Health (NIOSH) is working with RTI International to distribute a survey to companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials. The item states that the goal of the survey is to assess the impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of...
October 3, 2019
EPA Publishes TSCA SACC Meeting Minutes and Final Report on Draft Risk Evaluation for PV29
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29). SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation. As reported in our...
The GreenTech Conference brought together leaders from some of the world’s most innovative companies in engaging with policymakers, lawmakers, technologists and NGOs to explore environmental protection in an era of transformative technological change. Bergeson & Campbell, (B&C®) was a proud sponsor....
On October 2, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and soliciting public comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP) A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy). EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants...
October 1, 2019
EPA Announces Revised Service Fees for Pesticide Registration Applications Under PRIA 4
On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019. The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019. The revised fees will remain in effect...
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review. The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC...
WEBINAR — RCRA Improvements Rule: An Update and Discussion, October 16, 2019, 1:00 p.m. – 2:00 p.m. EDT: Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “RCRA Improvements Rule: An Update and Discussion,” covering revisions of the regulations that address closure, waste determinations, contingency plans, and emergency preparedness and prevention, among other new requirements that will affect almost 700,000 facilities. Christopher R....
This past spring, the United States Environmental Protection Agency (EPA) issued a first-ever final rule under Section 6(a) of the Toxic Substances Control Act (TSCA) banning the use of methylene chloride in consumer paint and coating removal products. Although this rule was long in the making, this type of chemical ban of selected products is likely to be seen more routinely in the months and years ahead. This article reflects upon EPA’s broad authority under...