Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has asked users of the Toxics Release Inventory (TRI) Program’s website to complete a website satisfaction survey. EPA states that it wants users to find information easily on the TRI website and ensure that the information is complete and understandable. EPA asks users to “take 5 minutes and tell us what you like about the website and data access tools and how we can improve them.” EPA asks for responses by June 30, 2021.

The TRI website allows users to search to identify industrial facilities in their communities that release chemicals into the air, water, and land. Users can learn what chemicals these facilities release, how these facilities are reducing releases, and potential health impacts of these releases.

Tags: TRI

 

By Lynn L. Bergeson
 
On June 10, 2021, the Retail Industry Leaders Association’s (RILA) Retail Compliance Center (RCC) and Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), presented “TSCA - It Is Not What You May Think.” While the Toxic Substances Control Act (TSCA) has long been regarded as a law applying to chemical producers, reforms made in 2016 have drawn many retailers, product manufacturers, and other “article” manufacturers into TSCA’s reach. Nothing illustrates this more clearly than a recent final rule under Section 6(h) limiting or prohibiting the manufacture (including import), processing, and/or distribution in commerce of five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)). This complimentary webinar, intended for large and small retailers, product stewards, and professionals throughout the product supply chain, covered:

  • What TSCA is and why it matters to retailers;
  • What retailers need to know about their products;
  • What the PIP (3:1) case study signals about the potential reach of TSCA; and
  • What steps to take to prepare for new regulations.

A full recording of this webinar is available now, along with slides and detailed responses to the Q&A portion of the event.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 15, 2021, the winners of the 2021 Green Chemistry Challenge Awards. EPA states that “[g]reen chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the 2021 winners “developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges, and spur innovation and economic development.” The 2021 winners are:

  • Professor Srikanth Pilla of Clemson University, South Carolina, for creating the first nonisocyanate polyurethane foam. Traditional polyurethane foams are widely used in the plastics industry and are typically manufactured from diisocyanates, a potential human carcinogen. This new foam is made using lignin, a natural polymer from pulp and paper waste that is derived from vegetable oils and uses no isocyanates. According to EPA, the lignin-based foams have the same mechanical properties as traditional polyurethane foams and were specifically designed for chemical recycling at the end of their life, making the foam a more environmentally friendly option.
     
  • XploSafe, Oklahoma, for creating PhosRox, a novel sorbent used to make fertilizer. The product simultaneously removes ammonia, phosphate, and nitrate from contaminated waters. The resulting material is a granulated time-release fertilizer that can help lower dependence on manufactured fertilizers by recycling nutrients. According to EPA, this product will also help wastewater treatment operators maintain compliance with regulations and potentially generate revenue from the sale of the resulting fertilizer. EPA states that when this is added to agricultural soils, it will not only release plant nutrients slowly but, in future years, could enhance the nutrient-holding capacity of the soil, preventing fertilizer runoff and protecting the watershed.
     
  • Colonial Chemical, Tennessee, for developing environmentally friendly, high performing Suga®Boost surfactants. While many surfactants used in traditional cleaners are made from petroleum-based materials and can be highly toxic, EPA states that SugaBoost surfactants are plant-based, biodegradable, generate no air emissions or wastewater discharges, and do not contain known carcinogens or endocrine disruptors. According to EPA, they perform as well as or better than “toxic, energy-intensive petroleum-based surfactants, creating the potential to yield huge environmental improvements in the cleaning industry.”
     
  • Bristol Myers Squibb, New York, for a new class of sustainable reagents -- substances used to cause a chemical reaction. The new reagents use less solvent and are derived from limonene, a waste product from discarded citrus peels, which increases sustainability and decreases environmental impact. They also can tolerate air and moisture better than traditional reagents, eliminating the need for expensive technology and specialized shipping and storage.
     
  • Merck, New Jersey, for developing a green and sustainable manufacturing process for a drug used to treat chronic coughs. According to EPA, by incorporating green chemistry techniques into the manufacturing process, the team not only replaced two highly toxic and hazardous chemicals, it also reduced carbon monoxide and carbon dioxide emissions. According to EPA, life-cycle assessment data show that these changes are expected to decrease the carbon footprint of manufacturing this drug by more than 80 percent.

EPA recognized the winners during the virtual American Chemical Society Green Chemistry & Engineering Conference. EPA states that the 2021 awards have special meaning because it is also the 25th anniversary of the Green Chemistry Challenge Awards. During the quarter century of the Green Chemistry program, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 128 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for annually reducing the use or generation of hundreds of millions of pounds of hazardous chemicals and saving billions of gallons of water and trillions of BTUs in energy. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2021 submissions and made recommendations to EPA for the 2021 winners.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 14, 2021, the Senate confirmed by voice vote Michal Freedhoff to be the Assistant Administrator for Chemical Safety and Pollution Prevention of the U.S. Environmental Protection Agency (EPA). As reported in our January 22, 2021, blog item, Freedhoff was onboarded in January 2021 as Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention. On April 14, 2021, President Joseph Biden nominated Freedhoff for Assistant Administrator for Chemical Safety and Pollution Prevention. According to Biden’s announcement, Freedhoff has more than 20 years of government experience, most recently as the Minority Director of Oversight for the Senate Environment and Public Works Committee. She began her Congressional service in 1996 in then-Representative Ed Markey’s (D-MA) office as a Congressional Science and Engineering fellow after receiving a Ph.D. in physical chemistry at the University of Rochester. Freedhoff also served on the staffs of the House Science Committee, the House Select Committee on Energy Independence and Global Warming, the House Energy and Commerce Committee, and the House Natural Resources Committee. The announcement states that Freedhoff’s legislative work includes the 2016 re-authorization of the Toxic Substances Control Act (TSCA), 2019 legislation to address per- and polyfluoroalkyl substances (PFAS) contamination, the fuel economy provisions in the 2007 Energy Independence and Security Act, and a law requiring the creation of an online database of potential consumer product safety defects.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our January 6, 2021, blog item, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894). The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce of the five PBTs, with certain exceptions. In accordance with Biden-Harris Administration Executive Orders and directives, as well as “[‌n]ewly-raised compliance issues” associated with the PIP (3:1) rule, EPA announced on March 8, 2021, that it would ask for additional public comment. EPA also issued a temporary 180-day “No Action Assurance” (NAA) indicating that the Agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.
 
Under the final rule, each person who manufactures PIP (3:1) for any use after March 8, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(1). Each person who processes or distributes in commerce PIP (3:1) or PIP (3:1)-containing products for any use after July 6, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(2). The final rule clarifies that the downstream notification requirement applies only to those scenarios where a product has an accompanying safety data sheet (SDS). EPA also included an alternative method of compliance for downstream notification. If a manufacturer, processor, or distributor chooses, they may include specified text on their label, instead of on their SDS.
 
EPA’s NAA applies only to the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. It does not apply to the downstream notification requirements or to the downstream notification requirements for manufacturers that began March 9, 2021. Processors and distributors should review the regulations now to ensure that they are prepared to begin providing downstream notifications on July 7, 2021. Information regarding Bergeson & Campbell, P.C.’s TSCA services is available on our website.


 

By Christopher R. Blunck, Carla N. Hutton, and Lynn L. Bergeson
 
On June 11, 2021, the Office and Management and Budget released its “Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions” (Regulatory Agenda). It includes an entry for an interim final rule planned by the U.S. Environmental Protection Agency (EPA) entitled “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Reconsideration and Extension of Certain Compliance Dates.” This action, planned for publication in September 2021, would be in follow-up to EPA’s March 16, 2021, proposed rule that sought additional public comment on final rules published on January 6, 2021, covering five persistent, bioaccumulative, and toxic (PBT) chemicals, i.e., decabromodiphenyl ether; 2,4,6-tris(tert-butyl)phenol; hexachlorobutadiene, pentachlorothiophenol; and phenol, isopropylated phosphate (3:1) (PIP (3:1)).
 
In the March 16, 2021, proposed rule, EPA stated that it sought additional public comment in “accordance with the January 21, 2021, Executive Order entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis” and other Biden-Harris Administration Executive orders and other direction.” EPA stated also in the proposed rule that it is “aware of and plans to consider revisions in response to implementation issues that have been raised by a range of stakeholders” and that “[‌i]n particular, EPA is seeking comment on newly-raised issues associated with the March 8, 2021, compliance date in the PIP (3:1) rule for certain regulated articles.”
 
Concurrent with EPA’s announcement on March 8, 2021, of the March 16, 2021, proposed rule that opened the PBT rules for comment, EPA issued a temporary 180-day “No Action Assurance” (NAA) indicating that EPA would exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. EPA stated that it “is taking this [NAA] action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.” EPA stated that the NAA “is to remain in effect until either (1) 11:59 PM ET, September 4, 2021, or (2) the effective date of a final action addressing the compliance date for the prohibition on processing and distributing in commerce of PIP (3:1); including in PIP (3:1)-containing articles, whichever occurs earlier.”
 
The Regulatory Agenda entry for the interim final rule states that EPA intends to address compliance date issues in the action, and that if it “determines to further amend the recent final [PBT] rules, EPA will address those amendments in one or more future Regulatory Agenda entries.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA). Below is a brief summary of the actions. More detailed information and an insightful commentary are available in our forthcoming memorandum that will be posted on our website.

Proposed TSCA Rule to Require Reporting on PFAS Manufactured in the United States

The fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Withdrawing Compliance Guide on PFAS SNUR

In accordance with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review, EPA states that it has withdrawn a compliance guide that EPA believes weakened the July 27, 2020, final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances (85 Fed. Reg. 45109). The final rule prohibits companies from importing certain long-chain PFAS as part of a “surface coating” on articles without prior EPA review and approval. EPA states that examples of articles that could contain these PFAS as part of a surface coating include, but are not limited to, automotive parts, carpet, furniture, and electronic components.

As reported in our January 20, 2021, blog item, EPA issued the compliance guide in January 2021 in the last days of the previous Administration and limited what would be considered a “surface coating” subject to the SNUR. EPA states that “[t]he guide was never deemed necessary by career staff and its development was directed by political officials serving in the last Administration.” Additionally, EPA prepared the final guide without considering or addressing comments submitted by the public. After further review, EPA “determined that the guide inappropriately narrowed the scope and weakened the prohibitions included in the SNUR.”

Implementing NDAA Requirements to Report PFAS to TRI

The NDAA provided a framework for additional PFAS to be added to TRI on an annual basis. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a SNUR under TSCA. EPA issued a final rule on June 3, 2021, incorporating these requirements into the Code of Federal Regulations for TRI (86 Fed. Reg. 29698). Per the NDAA requirements, the PFAS additions became effective as of January 1, 2021. Reporting forms for these PFAS will be due to EPA by July 1, 2022, for calendar year 2021 data.

Tags: PFAS, SNUR, Section 8, TRI,

 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week, I sat down with Heather J. Blankinship, Senior Manager with B&C® Consortia Management (BCCM), a Bergeson & Campbell (B&C®) affiliate, and Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to discuss chemical testing under the Toxic Substances Control Act (TSCA). Since Congress amended TSCA in 2016, the U.S. Environmental Protection Agency (EPA) has been slowly ratcheting up required chemical testing under TSCA Section 4. Congress gave EPA expanded testing authority under the 2016 Amendments, and EPA is exercising its new authority to compel chemical data production. These test orders authorize EPA to demand the production of new test data by the manufacturers and sometimes processors of the chemical substances at issue. Transactionally, this means that competitors in the marketplace band together to generate the data EPA seeks. We discuss the reality of quickly forming these consortia and the business and scientific challenges consortia managers face in complying with these federally enforceable test orders. It is not as easy as you may think!

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 27, 2021, that it has invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of a proposed risk management action under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by N-methylpyrrolidone (NMP). EPA will hold two identical consultation webinars, one on July 7, 2021, and the other on July 13, 2021. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluation, the tools available to manage the unreasonable risks from NMP, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. Comments are due August 27, 2021.
 
EPA states that in addition to these environmental justice consultations, it is executing a “robust” outreach effort that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management regulations. EPA notes that while outreach and stakeholder engagement on risk management activities for NMP move forward, it is “actively reviewing” the final risk evaluation to ensure it uses the best available science and protects human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration. EPA will keep stakeholders updated as it makes decisions and determines next steps.
 
More information on EPA’s final risk evaluation of NMP is available in our December 29, 2020, memorandum, “EPA Releases Final Chemical Risk Evaluation for NMP.”


 

A Timely and Essential Complimentary Conference
Wednesday, June 30, 2021
9:00 a.m. - 4:30 p.m. (EDT)
Register Now

Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Five Years Later.” This complimentary virtual conference marks the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Leading panelists will reflect on the challenges and accomplishments, while offering unique insights into the decision-making process of top U.S. Environmental Protection Agency (EPA) officials.
 
Confirmed speakers from government, non-governmental organizations (NGO), industry, and academia include:

Additional speakers will be announced as they are confirmed.
 
Mark your calendar for June 30, 2021, to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in this day-long exploration of the issues and regulations surrounding TSCA.

More information about “TSCA Reform - Five Years Later” is available at the ELI website and a recording will be made available to all participants after the conference. Details about previous TSCA Reform events can be found at “TSCA Reform – Four Years Later,” “TSCA: Three Years Later,” “TSCA Reform at 2 Years” and “TSCA Reform: One Year Later.”


 
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