All Knowledge & Insights By Date

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

On September 18, 2013, the U.S. House Committee on Energy and Commerce held a hearing on "Regulation of Existing Chemicals and the Role of Pre-Emption under Sections 6 and 18 of the Toxic Substances Control Act." This was the third hearing in a series held by the Committee on the Toxic Substances Control Act (TSCA). It comes at a time when the Senate Committee on the Environment and Public Works (EPW) is also considering TSCA...

Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed — a great product, a great brand, inspiring leadership, and vision — biobased product companies need to understand how the U.S....

The U.S. Environmental Protection Agency (EPA) is scheduled to announce in the January 8, 2013, Federal Register the availability of its 2012 Regulatory Agenda. EPA’s Regulatory Agenda includes the following notice concerning nanoscale materials: Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting...

On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA...

On December 30, 2011, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs to Manage Nanomaterial Risks More Effectively. According to OIG, the purpose of its review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG states that it found “that EPA does not currently have sufficient information or processes to effectively manage the human health and...

The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.”  EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are...

On September 22, 2011, during a meeting of nano interests in Washington, D.C., the following people spoke:...

The U.S. Environmental Protection Agency’s (EPA) July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:...

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must...

On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit...

The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:...

NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency’s (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of...

On November 22, 2010, the U.S. Environmental Protection Agency (EPA) submitted a proposed Toxic Substances Control Act (TSCA) Section 8(a) reporting rule to the Office of Management and Budget (OMB) for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require persons who manufacture nanoscale materials notify EPA of certain information including available use, production volume, methods of manufacture and processing, exposure and release information, and...

The U.S. Environmental Protection Agency (EPA) has posted a June 17, 2010, document entitled “Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials.” According to the Interim Guidance, EPA prepared it “to serve as a guide when developing screening level exposure and environmental fate and transport assessments for nanomaterials,” such as those submitted under the Toxic...

According to a report released on June 25, 2010, by the U.S. Government Accountability Office (GAO), the U.S. Environmental Protection Agency (EPA) faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because EPA lacks the technology to monitor and characterize these materials, or the statutes include volume-based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials. In...