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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 questions it needs...

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: Medaka Extended One Generation Reproduction Test (MEOGRT), OCSPP Test Guideline 890.2200; Larval Amphibian Growth and Development Assay (LAGDA), OCSPP Test...

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 requirement that...

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 a chemical poses an unreasonable risk under its...

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 activity.  The required...

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 Vitter (R-LA) and Tom Udall (D-NM), were able to secure the support of four...

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.

The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register.  EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production...

On Wednesday, March 18, 2015, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The following individuals testified during the hearing: James Jones, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA); Dr. Richard Denison, Senior Scientist, Environmental Defense Fund; Dr. Edward McCabe, Senior Vice President and Chief...

The Advanced Bioeconomy Leadership Conference (ABLC) is underway in Washington, and the discussions and presentations have been lively. At the opening "Policy Outlook" forum Wednesday morning, Biofuels Digest Editor Jim Lane welcomed the leaders gathered, including more than 130 C-level attendees, and introduced the heads of the "7 families" on the dais representing the key trade groups involved in biobased policy, one of which is the Biobased and Renewable Products Advocacy Group (BRAG®). In...

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs).  The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  The consent order requires the following...

On January 16, 2015, the U.S. Environmental Protection Agency (EPA) granted a petition from the Biobased and Renewable Products Advocacy Group (BRAG®) to add "biodiesel" as a chemical category for partial reporting exemption at 40 C.F.R. Section 711.6(b)(2)(iv) under the Chemical Data Reporting (CDR) rule and will be proceeding with a direct final rule to be published later in January. The approved biodiesel category on the partial reporting exemption list will include the following chemicals:...

The Biobased and Renewable Products Advocacy Group (BRAG®) is pleased to share the Bergeson & Campbell, P.C. (B&C®) announcement that Richard E. Engler, Ph.D., will be joining B&C as a Senior Policy Advisor. Dr. Engler's experience as a senior staff scientist in the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT), and as leader of EPA's Green Chemistry Program, will be extremely helpful for BRAG members as they continue to navigate the...

Many of the top policymakers, leaders, and stakeholders in the bioeconomy gathered in San Francisco this week for ABLCNext. The Biobased and Renewable Products Advocacy Group's (BRAG®) Executive Director Kathleen Roberts participated in the opening panel of the conference, "US Elections, What Happened, What Now," where she and other trade group leaders discussed likely impacts on the bioeconomy with the swing toward Republicans in federal and state races. Regarding the outlook...

The October 2014 issue of Industrial Biotechnology features the article Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act (TSCA), written by Lynn L. Bergeson, Of Counsel with the Biobased and Renewable Products Advocacy Group (BRAG®), Charles M. Auer, former Director of the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), and Oscar Hernandez, former Director of the Risk Assessment Division...

On August 21, 2014, a coalition of environmental, health, and labor groups filed a 23-page petition with EPA requesting that the Agency "establish time limits for confidentiality claims for chemical information submitted by industry under the Toxic Substances Control Act (TSCA)." According to Earthjustice's press release, change is needed because currently "[u]nder TSCA, industry is given wide latitude to claim such information confidential, making it unavailable to state and...

More reports from attendees at last week's sold out, three-day Sustainable Futures (SF) workshop, co-sponsored by the Biobased and Renewable Products Advocacy Group (BRAG®), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU): "I would highly recommend SF training to others. The risk-screening models are a great tool that can be utilized to identify and reduce risk early in the product development process. The instructors at the workshop were...

On August 5-7, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU) co-hosted a Sustainable Futures (SF) Training Workshop at GWU’s campus in Washington, D.C. During the sold out, three-day workshop, participants learned about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals. The intensive, hands-on training allowed...

Bergeson & Campbell, P.C. (B&C®) has created an online hub for news, information, and commentary on Toxic Substances Control Act (TSCA) reform that is available at www.TSCAreform.org. B&C's lawyers, scientists, regulatory specialists, and business consultants relentlessly participate in and track developments regarding ongoing TSCA reform efforts and related state regulatory initiatives such as California's Safer Consumer Products Regulations and related developments...

On April 10, 2014, the U.S. Environmental Protection Agency (EPA) released its strategic plan through 2018. A copy of the plan is available online. It includes statements by EPA reinforcing its commitment to enhancing implementation of the Toxic Substances Control Act of 1976 (TSCA) and the federal Renewable Fuel Standard (RFS) over the next four years. In the 99-page document, EPA reiterates its position supporting enhancing TSCA. To that end, EPA stresses that "[p]otential legislative...

We are very pleased to announce some of the speakers who are scheduled to participate in the session the Biobased and Renewable Products Advocacy Group (BRAG™) is hosting May 13, 2014, at BIO World Congress, titled "Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process": * Tracy Williamson, Ph.D., Chief, Industrial Chemistry Branch, Office of Pollution Prevention and Toxics, EPA; * David...

On March 13, 2014, the U.S. Environmental Protection Agency (EPA) sent a pre-rule notice to the White House Office of Management and Budget (OMB) on "Hydraulic Fracturing Chemicals and Mixtures." This action shows that EPA is moving forward on a rulemaking under TSCA Sections 8(a) and 8(d) to obtain data on chemical substances and mixtures used in hydraulic fracturing. Hydraulic fracturing is a process used in oil and gas production. EPA explained in the Fall 2013 Unified Agenda that...

On March 12, 2014, the House Energy and Commerce Environment and the Economy Subcommittee held a hearing to discuss the Discussion Draft of the Chemicals in Commerce Act (CICA). CICA, which was released last week by Subcommittee Chair John Shimkus (R-IL), is designed to reform the Toxic Substances Control Act (TSCA). The Biobased and Renewable Products and Advocacy Group (BRAG™) reported on the release of CICA. That report is available online. Eleven witnesses testified at the hearing....

It is reported that House Energy and Commerce's Subcommittee on the Environment and Economy Chair John Shimkus (R-IL) is working on draft legislation to reform TSCA, which Shimkus expects to introduce and on which he expects to hold a hearing in the coming weeks. B&C has issued a memorandum providing an overview of the Subcommittee's fifth hearing on TSCA reform held on February 4, 2014. The memorandum is available online. There is a renewed sense of urgency for TSCA reform to be...

On February 10, 2014, the U.S. House Committee on Transportation and Infrastructure convened a field hearing in Charleston, West Virginia, on "The Charleston, West Virginia Chemical Spill." On January 9, 2014, a coal processing chemical, 4-methylcyclohexane methanol (MCHM), stored in an aboveground tank owned by Freedom Industries leaked into the Elk River in West Virginia. The leak compromised the water supply to nine counties in the state affecting some 300,000 residents. Due to a...

On February 10, 2014, the House Committee on Transportation and Infrastructure is scheduled to hold a field hearing in Charleston, West Virginia, to examine the effects of and response to the January 9, 2014, chemical spill into the Elk River. More information on the hearing is available online.

On February 4, 2014, the Senate Committee on Environment and Public Works' Subcommittee on Water and Wildlife held a hearing on "Examination of the Safety and Security of Drinking Water Supplies Following the Central West Virginia Drinking Water Crisis." A full list of witnesses is available online. Senator Mark Udall (D-CO) spoke at the hearing and stressed the need for reform of TSCA in the wake of the January 9, 2014, chemical spill in West Virginia. Senator Udall has been...

On January 28, 2014, the pro-safer chemicals coalition Safer States released a report in which it found that "at least 33 states are considering policies [to enhance chemical safety]. Some would change disclosure rules for manufacturers, so that concerned consumers will know what chemicals are in their products. Some would phase out the use of chemicals like bisphenol A, formaldehyde and toxic flame retardants." The report is available online. There is increased momentum for chemical...

On January 9, 2014, 7,500 gallons of a coal processing chemical, 4-methylcyclohexane methanol, stored in an above-ground tank owned by Freedom Industries leaked into the Elk River just upstream from the local water utility's intake pipe serving Charleston, West Virginia. Regulators banned residents' use of the water for five days. Since the release, concerns have been expressed about the adequacy of information regarding the chemical's safety and health risks, an issue that has been...

In an article appearing in the January/February 2014 issue of The Environmental Forum, a publication of the Environmental Law Institute, the Biobased and Renewable Products Advocacy Group's (BRAG™) Lynn L. Bergeson and Kathleen M. Roberts discuss the latest developments in the U.S. Environmental Protection Agency's (EPA) approach under the Toxic Substances Control Act (TSCA) to biobased chemicals, and offer strategies on how biobased chemical manufacturers can best navigate current...

As the new year begins, there are several predictions on the path for reform of TSCA. The vehicle for reform is expected to be S. 1009, the Chemical Safety Improvement Act (CSIA), bi-partisan legislation introduced last year by Senator David Vitter (R-LA), Ranking Member of the Senate Committee on Environment and Public Works (EPW), and the late Senator Frank Lautenberg (D-NJ). Senator Vitter and Senator Tom Udall (D-NM) are now working to move CSIA forward through the legislative process. A...

Intuitively, entities in the "biobased" space may think the "naturally occurring" substance exemption under the Toxic Substances Control Act (TSCA), the law that governs chemical products in the U.S., applies to their "biobased" materials. The scope of the exemption is limited, however, and complications arise when companies mistakenly assume a material is naturally occurring and therefore exempt from TSCA. Learn more about this important issue online.  

It has been reported that the U.S. House of Representatives Energy and Commerce Committee's Subcommittee on Energy and Power Chair John Shimkus (R-IL) has listed reform of the 1976 Toxic Substances Control Act (TSCA) among his top priorities for 2014. Chair Shimkus has stated publicly that the House is still determining how best to draft and move TSCA reform legislation, but he expects a House TSCA reform bill to be introduced by the spring, with action on it likely next summer. Chair...

This week, the Biobased and Renewable Products Advocacy Group (BRAG™) participated in the Biotechnology Industry Organization's Pacific Rim Summit on Biotechnology and Bioenergy in San Diego, California. The Summit included over 400 attendees with broad interest and involvement in biofuels and renewable chemicals. During the Summit, BRAG Executive Director Kathleen M. Roberts gave a presentation titled "The Here and Now of TSCA," in which she emphasized the criticality of...

On December 4, 2013, EPA published a final rule requiring the electronic submission of certain documents under the Toxic Substances Control Act (TSCA). EPA is promulgating amendments to reporting requirements under TSCA Section 4 (including test rules and Enforceable Consent Agreements (ECA)), TSCA Section 5, TSCA Section 8(a) Preliminary Analysis Information Rule (PAIR) at 40 C.F.R. Part 712, and TSCA Section 8(d) Health and Safety Data Reporting Rules at 40 C.F.R. Part 716. A copy of the rule,...

On Wednesday, November 13, 2013, the House Committee on Energy and Commerce held a hearing on CSIA, a bill to reform TSCA. CSIA was introduced earlier this year by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ). Senator Vitter and Senator Tom Udall (D-NM) are now working to move CSIA forward through the legislative process. A Law360 article recently published by Lynn Bergeson contains a detailed discussion of the significance and provisions of this legislation. With 25...

Attendees at the Society for the Commercial Development of Industrial Biotechnology's (SCD-iBIO) 2nd Annual "Commercializing Global Green" forum in Philadelphia this week participated in a practical, in-depth three-hour workshop presented by the Biobased and Renewable Products Advocacy Group (BRAG™) on the critical policy, legislative, and regulatory issues impacting the commercialization of renewable chemicals. Lynn L. Bergeson, Managing Partner of Bergeson & Campbell,...

The number of Significant New Use Rules (SNUR) issued by EPA has greatly increased in recent months, causing long and costly delays for companies trying to market biobased chemicals and products. The Biobased and Renewable Products Advocacy Group (BRAG™) is holding a workshop to help companies avoid these delays by explaining how, when, and to which entity or entities in the value chain the Toxic Substances Control Act (TSCA) applies, and what a renewable chemical innovator must do to...

On October 29, 2013, hundreds of parents and children participated in a "stroller brigade" on Capitol Hill during which they lobbied Senate offices to provide greater protections against harmful chemicals during reform of the Toxic Substances Control Act (TSCA). The stroller brigade also joined actress Jennifer Beals at a press conference on TSCA reform sponsored by the Safer Chemicals, Healthy Families Coalition. Following the July 31, 2013, Senate Environment and Public Works hearing...

On October 7, 2013, House Committee on Energy and Commerce Ranking Member Henry Waxman (D-CA) sent a letter to American Chemistry Council (ACC) President Calvin Dooley asking him whether ACC is "abandoning its 2009 principles for reform of the Toxic Substances Control Act." The letter is available online. In his letter, Representative Waxman tells Dooley that he has been hopeful that reform of the Toxic Substances Control Act (TSCA) would include many of the principles for reform...

The U.S. government is shut down until the U.S. Senate and House of Representatives approve the same version of legislation to fund it and the President then signs it into law. House Republicans have been trying to tie funding the government with defunding certain parts of the Affordable Care Act (ACA), which went into effect on October 1. The Senate has rejected every funding bill sent to it by the House because each has contained provisions to marginalize the ACA. The Senate has also rejected...

If the Continuing Resolution (CR) currently funding the government is allowed to expire on September 30, it could prove devastating to the U.S. Environmental Protection Agency (EPA). Unlike other federal agencies, EPA cannot claim exceptions for many of its employees. In the event the CR expires, as EPA Administrator Gina McCarthy asserted in public remarks this week, EPA "would effectively shut down." It would only have skeletal staff and would surely impact Renewable Fuel Standard...