All Knowledge & Insights By Date

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.”  EPA states in the pre-publication notice that the guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors...

The U.S. Environmental Protection Agency (EPA) published on May 12, 2017, a Federal Register notice delaying the effective date of the January 12, 2017, rule concerning Toxic Substances Control Act (TSCA) Section 8(a) reporting requirements from May 12, 2017, to August 14, 2017.  EPA notes that Section 553(b)(1)(B) of the Administrative Procedure Act (APA) allows EPA to take action without providing an opportunity for notice or comment when it for good cause finds...

Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017.  President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base).  The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff...

On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition.  That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016.  What...

On March 29, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notice releasing its initial inventory report of mercury supply, use, and trade in the United States pursuant to Section 8(b)(9)(10) of the amended Toxic Substances Control Act (TSCA).  Specifically, the report is a “compilation of readily available, previously published data on the supply, use and trade elementary mercury and mercury compounds,” and its purpose is to “identify...

On March 8, 2017, Senator James Lankford (R-OK) introduced S. 578, the “Better Evaluation of Science and Technology Act” or “BEST Act,” a bill that would amend title 5 of the United States Code, commonly referred to as the Administrative Procedure Act (APA), to “provide requirements for agency decision making based on science.”  Although the BEST Act does not refer to the recently amended Toxic Substances Control Act (TSCA), it is apparent that it plans...

On March 2, 2017, Kathleen M. Roberts, Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), participated as a panelist alongside four other trade associations in the “Domestic Policy Forum” at the 2017 Advanced Bioeconomy Leadership Conference (ABLC2017).  Ms. Roberts discussed the challenges facing the bioeconomy, including the implementation of the amendments to the Toxic Substances Control Act (TSCA), issues with the TSCA nomenclature system,...

We are pleased to announced that Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton published an article, “Practitioner Insights:  A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” in the January 26, 2017, issue of Bloomberg BNA’s Daily Environment Report.  The article reviews and analyzes the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act,...

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of...

As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act...

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...

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...

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...

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...

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...

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...

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...

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...

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...