Archives

November 29, 2016

EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are: 1,4-dioxane1-bromopropaneTrichloroethylene (TCE)Carbon tetrachlorideHexabromocyclododecane (HBCD)Methylene chloridePigment violet 29Perchloroethylene...
November 14, 2016

James V. Aidala Comments in BNA Daily Environment Report Regarding Trump Transition at EPA

The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription): Career Staff Cooperation Expected...
November 11, 2016

EPA Biotech Review Staff Prepares To Handle Engineered Microorganism TSCA Submissions

On November 9, 2016, Inside EPA published “ New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms.   Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:   Richard Engler, a...
October 28, 2016

EPA Proposes SNUR for Functionalized Carbon Nanotubes (Generic)

On October 27, 2016, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) for three chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (generic).  According to the notice, the PMN states that the substance will be used as a thin film for electronic device applications.  Based on structure-activity relationship (SAR) analysis of test data on analogous carbon nanotubes and other...
October 25, 2016

“Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products”

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues — Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and...
October 21, 2016

EPA Reopens Comment Period for TSCA SNU Regulations

On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter.  EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.”  The proposed rule would amend the TSCA SNU...
October 14, 2016

EPA Announces Public Meeting To Comment On Algae Guidance Documents

On October 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register.  This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or...
October 11, 2016

EPA Submits Final TSCA Rule on Nanomaterials to OMB for Review

On October 7, 2016, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.  EPA issued a proposed rule, under Section 8(a) of the Toxic Substances Control Act (TSCA), on April 6, 2015.  EPA proposed to require persons that manufacture or process certain chemical...
September 23, 2016

Sign Up For “The New TSCA” Webinar 4: Preemption, PBTs, Fees, and Judicial Review

Tuesday, September 27, 2016 8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time Register Today Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted, and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in "The New TSCA: What You Need...
September 15, 2016

EPA Convenes Second Industry Stakeholder Meeting on Development of Fees Rule

On September 13, 2016, the U.S. Environmental Protection Agency (EPA) convened its second industry stakeholder meeting to discuss the development of a fees rule under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182, “new TSCA”); a copy of the presentation is available here.  Under new Toxic Substances Control Act (TSCA) Section 26(b)(4)(E), EPA is required to solicit input in support of fees rulemaking.  EPA convened its first...