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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...

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...

ChemCon The Americas is a global chemical control conference offering authoritative speakers, in-depth sessions, and a global perspective on existing and emerging chemical regulatory schemes.  ChemCon The Americas 2016 will be held October 17 – 21, 2016, in Toronto, Canada.  Highlights from the diverse and substantive program planned for Toronto include: The full ChemCon agenda is available online. A video overview of the ChemCon experience — the sessions,...

Monday, September 12, 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 "The New TSCA: What You...

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are: New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several...

Monday, September 12, 2016 8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time Register Today Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) and Chemical Watch have collaborated to present a series of complimentary webinars on the reformed Toxic Substances Control Act (TSCA). Webinar 3 — Inventory, CDR, and CBI will cover: Section 8 Reporting and Retention of Information   Small...

Monday, September 12, 20168:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time Register Today With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016....

On August 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice of the establishment of a Science Advisory Committee on Chemicals (SACC) under Section 9(a) of the Federal Advisory Committee Act and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The notice also solicits comments and requests nominations for new members of the SACC.  The SACC expects to...

On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology,...

On September 12, 2016, Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®); Richard E. Engler, Ph.D., B&C Senior Chemist; and Kathleen M. Roberts, Vice President of B&C Consortia Management, L.L.C. (BCCM), will present "The New TSCA: Information and Reporting (Sections 8 & 14)" in conjunction with Chemical Watch. This free webinar is the third in Chemical Watch's Toxic...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed changes to the existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as well as changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator...

On July 15, 2016, Environmental Leader published "What Does the Loss of 'Green Chemistry' Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®). Ms. Bergeson expanded on a previous blog post titled "Inside EPA Reports On Loss Of Green Chemistry Provision From TSCA Reform," stating: "While...

The House’s Office of the Law Revision Counsel has posted the U.S. Code version of the Toxic Substances Control Act, as revised by the Frank R. Lautenberg Chemical Safety for the 21st  Century Act, Public Law No. 114-182.  The U.S. Government Publishing Office (GPO) has not yet posted the official version of the public law, but is expected to soon.  The GPO version of the public law will be available at https://www.gpo.gov/fdsys/....

On July 1, 2016, Inside EPA published “Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform,” an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology...

An Environmental Law Institute Seminar and Webinar, Complimentary for members, $50 for non-members. On June 22, 2016 President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act for the first time since its passage in 1976. While environmental organizations, public health advocates, the regulated community, and EPA have all supported updating the law since at least 2009, political challenges seemed destined to prevent...

On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology...

On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage.  This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans.  EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30,...

On June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182.  A link to the presentation is available online. The topics from the webinar included: More information concerning EPA’s implementation of the Act is available on EPA’s website....

On June 22, 2016, President Obama signed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) during a signing ceremony. Lautenberg represents years of negotiation and is a towering achievement to enhance the U.S. Environmental Protection Agency's (EPA) authority to review industrial and consumer chemicals and provide the public with confidence that chemical products do not pose unreasonable risks. Of particular interest to biobased chemical manufacturers...

In a June 22, 2016, blog post on The Hill‘s Congress Blog, Lynn L. Bergeson laid out four reasons why the American public has reason to celebrate the signing into law of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, “a comprehensive and vastly improved domestic chemical management law”: Read the full blog post at The Hill: TSCA reform: renewing public confidence in chemical control....

On May 24, 2016, the U.S. House of Representatives passed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the long-awaited Toxic Substances Control Act (TSCA) Reform. Senate approval is expected, with the bill being signed into law soon after. The current, and likely final, version of the bill does not contain the sustainable chemistry provision in Section 27 entitled "Development and Evaluation of Test Methods and Sustainable Chemistry" that was...

According to an item in the Spring 2016 Regulatory Agenda, the U.S. Environmental Protection Agency (EPA) is “developing a final rule related to” its April 6, 2015, proposal to require reporting and recordkeeping requirements under Section 8(a) of the Toxic Substances Control Act (TSCA) for certain chemical substances when they are manufactured or processed at the nanoscale.  EPA proposed to require persons that manufacture, import, or process, or intend to manufacture, import, or process...

As we are poised to witness the reauthorization of the Toxic Substances Control Act (TSCA) — the first revision of our domestic chemical management law in 40 years — stakeholders will need immediately to understand what the "new TSCA" means for their industrial operations and strategically adjust their global operations to the new law. In late 2015, Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) convened a...

On February 19, 2016, Kathleen M. Roberts, Executive Director of BRAG, presented "Achieving Critical Policy Changes through Consortia" at the 2016 Advanced Bioeconomy Leadership Conference (ABLC2016). Ms. Roberts presented as part of The Bioeconomy R&D Consortia Summit and discussed the work being done by BRAG to level the regulatory playing field for biobased chemicals. BRAG has successfully petitioned the U.S. Environmental Protection Agency (EPA) to make Chemical Data...

On February 18, 2016, Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®), presented at Cellulosic Fuels: First Commercials and Beyond, a session at the ABLC2016. Dr. Engler's presentation, "TSCA and the Cellulosic Revolution," covered Toxic Substances Control Act (TSCA) nomenclature, chemical Inventory, and model manufacturing process issues for cellulosic products. The presentation discussed the differences in nomenclature between Class I and...

There is still no definitive answer as to whether the green/sustainable chemistry provisions in S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, will survive the U.S. Senate and House of Representatives conference committee process as lawmakers confer and prepare the final compromise legislation of the Toxic Substances Control Act (TSCA) reform bill.  Passed by the Senate on December 17, 2015, S.697 includes sustainable chemistry provisions in Section 27 entitled...

According to an item in the U.S. Environmental Protection Agency’s (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  EPA’s April 6, 2015, proposed rule includes one-time reporting for existing nanoscale materials and one-time reporting for new discrete...

REGISTER TO ATTEND THE "TSCA REFORM PANEL SUMMIT," OR TO VIEW THE LIVE WEBCAST, AT THE ELI WEBSITE. George Washington University (GWU) Milken Institute School of Public Health, GWU Law School, Environmental Law Institute, Arnold & Porter LLP, and Bergeson & Campbell, P.C. Present:  TSCA Reform Panel Summit: What's Happening Now, and What's Next? Thursday, November 19, 2015, 12:00 – 1:30 p.m. (EST) George Washington University Milken Institute School of Public...

On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the...

On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows: These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and...

The July 20, 2015, Federal Register includes a notice for direct final action to amend the electronic reporting regulations for Section 5 under the Toxic Substances Control Act (TSCA). The U.S. Environmental Protection Agency (EPA) action goes into effect on January 19, 2016, unless adverse comments are received by August 19, 2015. The rule requires the use of new electronic premanufacture notice (e-PMN) software that is reportedly easier to use. The rule also adds the...

The U.S. Environmental Protection Agency (EPA) has extended the comment period on its April 6, 2015, proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  Comments will now be due August 5, 2015.  EPA will publish a Federal Register notice announcing the extension during the week of June 29, 2015.  EPA proposes to require persons that manufacture or process these chemical substances to...

On June 2 and 3, 2015, the House Committee on Energy and Commerce held a markup hearing for the TSCA Modernization Act of 2015 (H.R. 2576) after years of progress on Toxic Substances Control Act (TSCA) Reform. The bill was praised for its bipartisan support as well as the removal of burdensome testing that has hindered the implementation of TSCA. The modernized TSCA will change how EPA regulates existing chemicals, with EPA first deciding if...

Part 3 of Biofuels Digest's "Thought Leadership" series highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products was published May 18, 2015. Summaries of the first two "TSCA and the Bioeconomy" articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., were summarized...

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 25 chemical substances that were the subject of premanufacture notices (PMN).  The SNURs require persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that...

The U.S. Environmental Protection Agency (EPA) published a notice in the May 8, 2015, Federal Register announcing a public meeting on June 11, 2015, to discuss EPA’s April 6, 2015, proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. This is a very important opportunity for stakeholders to offer comments on a rulemaking that has important implications for the nano community....

? PR Newswire, "Cargill Acquires OPX Biotechnologies' Fermentation Technology" ? Bio-Based Industries: Public-Private Partnership, "Bio-Based Industries Workshop Selected For Open Days" ? Plastics Today, "Bayer MaterialScience Introduces Biobased PU for Fashion and Footwear" ? DesignNews, "Chemical Industry, Environmentalists Unite on Toxic Substances Control Act Legislation" ? Times-Call Business, "Cargill Acquires Boulder-based OPX...

Biofuels Digest is running a "Thought Leadership" series of articles highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products. The articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., cover key points throughout the manufacturing and commercialization process at which...

On April 28, 2015, the U.S. Senate Committee on Environment and Public Works (EPW Committee) passed by a 15-5 vote a version of S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This action by the EPW Committee paves the way for consideration of S. 697 — legislation to reform the Toxic Substances Control Act of 1976 (TSCA) — by the full U.S. Senate. The authors of S. 697, Senators David...

The Oil Price Information Network (OPIS) spoke with BRAG's Richard E. Engler, Ph.D., Senior Policy Advisor with B&C, regarding the application of the Toxic Substances Control Act (TSCA) to oils made from algae feedstocks and other non-traditional bio-materials. The resulting article, "TSCA Nomenclature May Be Barrier for Advanced Biofuels," from the OPIS Ethanol & Biodiesel Newsletter is excerpted below, and reprinted in full at the link with permission from OPIS. TSCA...

On April 14, 2015, the U.S. House of Representatives’ Energy & Commerce Committee’s Subcommittee on Environment and the Economy held a hearing on the TSCA Modernization Act of 2015 discussion draft (TMA-DD). An analysis of the April 7, 2015, TMA-DD is available on the Bergeson & Campbell, P.C. (B&C®) website. The April 14, 2015, witnesses’ testimonies are posted on the Energy & Commerce Committee website....