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.
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By Lynn L. Bergeson and Carla N. Hutton

The Internal Revenue Service announced on June 24, 2022, that it has posted frequently asked questions (FAQ) on the Superfund chemical excise tax. The FAQs detail what the Superfund chemical excise tax is, how the tax is computed, and who may be liable for the tax. The Superfund chemical taxes will be reported on Form 720, Quarterly Federal Excise Tax Return, and Form 6627, Environmental Taxes. The excise taxes were reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The IRS notes that there are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” Specifically, the reinstated taxes impose an excise tax on the sale or use of a taxable chemical by the manufacturer, producer, or importer of the taxable chemical. They also impose an excise tax on the sale or use of a taxable substance by the importer of the taxable substance. The IRS states that the FAQs provide general information. According to the IRS, at the time of publication of these FAQs, 151 substances are listed as taxable substances. The IRS states “[t]hat number will likely change as substances are added to or removed from the list of taxable substances.” The FAQs added June 24, 2022, include:

Q1.      What are the Superfund chemical excise taxes?

Q2.      When do the Superfund chemical excise taxes go into effect?

Q3.      What is a taxable chemical?

Q4.      What is a taxable substance?

Q5.      How are substances added to or removed from the list of taxable substances?

Q6.      How do I calculate the section 4661 tax?

Q7.      I am an importer of taxable substances. How do I calculate the section 4671 tax?

Q8.      What happens if an importer does not calculate the section 4671 tax?

Q9.      Will the IRS prescribe tax rates for taxable substances?

Q10.    Who is responsible for reporting and paying Superfund chemical excise taxes?

Q11.    How are the Superfund chemical excise taxes reported?

Q12.    When is the first return due?

Q13.    Are semimonthly deposits required?

Q14.    Under what circumstances is registration required?

Q15.    Is there a way to check the status of an application for Activity Letter G registration?

More information on the Superfund excise tax on certain chemical substances is available in our May 19, 2022, memorandum.

Tags: IRS, Superfund, tax

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On June 22, 2022, the Senate Committee on Environment and Public Works will hold a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).


 
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B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. Register here.

Full Agenda (subject to change):

9:15 a.m. - 9:30 a.m. Welcome and Overview of Virtual Forum

 
9:30 a.m. - 10:00 a.m. Morning Keynote Discussion

Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)
10:15 a.m. - 11:45 a.m. Panel 1: The Interface of Science and Policy under TSCA
 
This panel will examine key issues at the interface of science and policy under TSCA, including the continuing role of animal studies in supporting risk evaluations, the potential use of New Approach Methodologies (NAM) to inform safety determinations for new and existing chemicals, scientific integrity and the TSCA program, methodologies for systematic review, and more. 
 
Moderated by James J. Jones, President, J. Jones Environmental
12:00 p.m. - 1:30 p.m. Panel 2: New Chemical Review
 
The TSCA New Chemicals Program was strengthened in the 2016 Lautenberg Amendments and what the law requires has been vigorously debated. This panel will discuss opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, use of Significant New Use Rules (SNUR) and Section 5(e) orders, and more.
 
Moderated by Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
1:45 p.m. - 3:15 p.m. Panel 3: Risk Evaluation and Management
 
With the “first 10” evaluations completed, this panel will look back at the lessons learned and areas for improvement; discuss EPA efforts to enhance these evaluations through risk determinations for fenceline communities, revised worker protection assumptions, and the “whole chemical approach”; examine the asbestos risk management proposal and other emerging risk management approaches; evaluate the impact of resource constraints on meeting statutory deadlines; discuss the role of environmental justice considerations; and more.
 
Moderated by Robert M. Sussman, Principal, Sussman & Associates
3:30 p.m. - 5:00 p.m. Panel 4: TSCA Regulation of Articles

TSCA requirements can apply to “articles,” a manufactured good or finished product.  This panel will discuss the potential role of articles as contributors to health and environmental concerns, EPA’s push to remove traditional exemptions of articles and resulting compliance and implementation challenges, potential new rules for per- and polyfluoroalkyl substances (PFAS) and asbestos requiring reporting on articles, and the application of SNURs and risk management rules to articles, and more.
 
Moderated by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C.
5:00 p.m. – 5:10 p.m. Concluding Remarks and Adjournment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Join B&C, ELI, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA. Full program and registration available online.
 
Materials from the 2021 conference are available at https://www.lawbc.com/news/recording-of-tsca-reform-five-years-later-conference-and-other-resources-av


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On June 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:

  • Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
     
  • Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
     
  • Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
     
  • Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
     
  • Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.

EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has published the draft fiscal year (FY) 2023-2024 National Program Guidances (NPG) for public comment. The NPGs set forth the strategies and actions EPA and its state and Tribal partners intend to undertake to protect human health and the environment. The draft FY 2023-2024 NPGs include an NPG for the Office of Chemical Safety and Pollution Prevention (OCSPP). Work in this NPG directly supports Goal 7, “Ensure Safety of Chemicals for People and the Environment,” in EPA’s FY 2022 - 2026 EPA Strategic Plan. OCSPP’s draft NPG also integrates the Strategic Plan’s goal to tackle climate change, advance environmental justice and civil rights, and consider the health of children and other vulnerable populations in implementing its programs. OCSPP’s program priorities include:

  • Pesticide Cooperative Agreements with States and Tribes;
  • Pollinator Protection Efforts;
  • Revised Pesticide Worker Protection Standard Rule;
  • Revised Certification of Pesticide Applicators Rule;
  • Region-Specific Pesticide Priorities on Those Areas of Greatest Need Nationally;
  • Toxics Release Inventory (TRI);
  • Lead Risk Reduction; and
  • Pollution Prevention (P2).

For each priority, the draft NPG includes a description, strategy, activities, and measures. The draft NPG also includes sections on implementing Tribal work; flexibility and grant planning; federal civil rights responsibilities, including Title VI of the Civil Rights Act of 1964; and FY 2023-2024 National Program Measures. Comments on the draft NPGs are due July 14, 2022.

Tags: NPG, OCSPP, P2, TRI

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA Section 15(3)(B). EPA notes that TSCA Section 12(b), and the regulations set forth at 40 C.F.R. Section 707.60, require any person who exports or intends to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA Sections 5 or 6 to notify EPA of such exportation to a particular country. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. The complaint states that Vorbeck has claimed the identity of the carbon nanomaterial as TSCA confidential business information (CBI). Vorbeck has subsequently submitted a TSCA Section 12(b) export notification for the carbon nanomaterial.
 
Based upon the facts alleged in the complaint, and upon the nature, circumstances, extent, and gravity of the violations alleged, as well as Vorbeck’s ability to pay, effect on ability to continue to do business, any history of prior such violations of TSCA, the degree of culpability, and such other matters as justice may require, EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). As reported in our March 25, 2022, blog item, EPA announced on March 24, 2022, that it issued a second round of test orders under TSCA Section 4 to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. The VI seeks judicial review of the test order under federal law, including but not limited to the Administrative Procedure Act (APA), TSCA, and EPA’s regulations promulgated thereunder. The VI seeks a determination that, inter alia, the test order violates these authorities; is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; is without observance of procedure required by law; is unsupported by substantial evidence; and is otherwise contrary to law. The VI asks that the court hold unlawful, vacate, enjoin, set aside, and remand the test order.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with the Office of Chemical Safety and Pollution Prevention (OCSPP), proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA.

EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.

EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

  • Using data to develop predictive models and use of predictive models in data-poor environments:
    • Read across and analogue selection;
    • Chemical structures and cheminformatics; and
    • Quantitative structure-activity relationships (QSAR);
  • Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:
    • Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
    • Reference data curation to support validation;
  • Computational modeling, bioinformatics, and/or statistics;
  • Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);
  • Systems biology;
  • Human health and ecological risk assessment;
  • Exposure modeling and/or assessment, including near-field and far-field sources;
  • Knowledge of TSCA; and
  • Environmental fate of chemicals.

Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.


 
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Bergeson & Campbell, P.C.’s (B&C®) May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.
 
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. During the webinar, Ms. Sellers outlined barriers and enablers to the circular economy, including practical challenges like supply chain limitations and industry frameworks; Dr. Engler highlighted how the Toxic Substances Control Act (TSCA) regulates discarded substances used as feedstocks by others and articles that may contain contaminants that could affect how an article is classified by the U.S. Environmental Protection Agency (EPA) under TSCA; and Mr. Stanislaus reviewed policy issues, including waste management hierarchy, circular economy hierarchy, and other mechanisms that incentivize sustainability.
 
We encourage you to view the webinar, listen to the All Things Chemical® episodes “Trends in Product Sustainability and Circularity — A Conversation with Kate Sellers” and “How Can Battery Production Be Greener? — A Conversation with Mathy Stanislaus,” read ERM’s report Circularity: From Theory to Practice, and subscribe to B&C’s informative blogs and newsletters.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 24, 2022, that it is extending the public comment period for the April 12, 2022, proposed rule that would prohibit ongoing uses of chrysotile asbestos to give stakeholders more time to review the proposed regulation and prepare comments. EPA is extending the comment period an additional 30 days, from June 13, 2022, to July 13, 2022.
 
As reported in our April 7, 2022, memorandum, the proposed rule would ban chrysotile asbestos, the only known form of asbestos that is currently imported into the United States and is found in products like asbestos diaphragms used by the chlor-alkali industry, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets also imported into the United States. EPA also proposed targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). The proposed disposal and recordkeeping requirements would take effect 180 days after the effective date of the final rule.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders:

  • 1,1,2-Trichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,1,2-trichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that this correction does not change the obligations that apply to manufacturers and processors of 1,1,2-trichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,1,2-trichloroethane.
     
  • 1,2-Dichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloroethane.
     
  • 1,2-Dichloropropane: EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloropropane. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloropropane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloropropane.
     
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA): EPA states that it amended the list of recipients to replace INEOS USA LLC with INEOS Enterprises US Holdco LLC. The effective date for INEOS Enterprises US Holdco LLC is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain March 29, 2022. EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to TBBPA. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TBBPA, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TBBPA.
     
  • o-Dichlorobenzene: EPA amended Appendix D -- Order Recipient Selection. EPA states that Appendix D referred to p-dichlorobenzene, although it should have referred to o-dichlorobenzene. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of o-dichlorobenzene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of o-dichlorobenzene.
     
  • Phosphoric acid, triphenyl ester (TPP): EPA amended the list of recipients to replace Axalta Coating Systems LLC with ChemSpec Ltd. The effective date for ChemSpec Ltd is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain as March 29, 2022. EPA also amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to TPP. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TPP, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TPP.
     
  • Trans-1,2-dichloroethylene: EPA amended the list of recipients to add the companies listed below. The effective date for the order for these companies will be five days after April 20, 2022, when the modification was signed. The effective date of the order for the companies listed in the March 24, 2022, order will also have the effective date of five days from April 20, 2022, when the modification was signed (i.e., both the companies listed below and the companies in the order signed on March 24, 2022, for trans-1,2-dichloroethylene will have an effective date five days after April 20, 2022, the date the memorandum was signed):
    • Chemical Compounding Co;
    • Dow Inc;
    • MicroCare LLC;
    • Occidental Chemical Holding Corp;
    • Olin Corp; and
    • Versum Materials Inc.

EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to trans-1,2-dichloroethylene. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of trans-1,2- dichloroethylene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of trans-1,2-dichloroethylene.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 19, 2022, the availability of the meeting minutes and final report for the March 15-17, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0 under the Toxic Substances Control Act (TSCA). According to the meeting minutes and final report, SACC “agreed that the methodological document was well organized and generally well written.” SACC states that it “had difficulty reproducing results that were relevant to understanding and reviewing the document and indicated multiple limitations and uncertainties,” however. SACC suggested the methodology could only be used as part of a tiered approach to evaluate risk to fenceline communities and should not be used to evaluate risks in isolation. The screening level approach may be protective for the specific exposure pathways included, but it may not be protective overall because potential key exposure pathways are excluded and because it does not consider cumulative exposures, multiple source exposures, aggregate exposures, and double/aggregate and occupational exposures from workers living near and working at the facilities. Some SACC members also suggested that additional risk factors, such as stress, poverty, cultural practices, and diet, should be considered for a comprehensive assessment.
 
The meeting minutes and final report states that the accuracy and/or completeness of the data used to develop the screening analysis were not adequately supported in the document, and SACC decided it did not defensibly represent actual exposure of fenceline communities. Overall, SACC indicated the basis for several model inputs was insufficiently transparent and that, in particular, daily life activities of all communities disproportionately impacted by chemical exposures was missing in this current version. SACC recommended the term “fenceline” be refined to include the characteristics, behaviors, and realities of communities exposed through means that are not dependent on being within a limited radius from a chemical facility. SACC agreed that Version 1 of the screening tool for fenceline communities “is currently not adequate for evaluating potential exposures relevant to tribes, indigenous populations, subsistence lifestyles, cultural practices, or other unique circumstances. The pathways by which people in unique communities are exposed to chemicals of the contaminated areas are much broader than those represented in the current defining criteria of ‘Fenceline Communities.’” To make the tool applicable for any unique community, the meeting minutes and final report state that additional exposure scenarios and relevant data must be applied.
 
SACC recommended that knowledgeable community representatives “be intrinsically involved for perspective on how such information is applied in a screening endeavor, as well as the relevance and pedigree of values used to inform exposure algorithms, and relevance of default data and assumptions.” Complementary to this process is the need for enhanced and meaningful outreach to “fenceline communities” and all parties interested in these screens. SACC offered specific commentary and suggestions, along with a collection of references. A meeting transcript is available.


 
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By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) announced the publication of information collected during the 2020 Chemical Data Reporting (CDR) cycle to increase public awareness of chemicals being manufactured in communities and to enable citizen and stakeholder access and use of the reported information. The CDR rule requires manufacturers (including importers) of certain chemicals listed on the Toxic Substances Control Act (TSCA) Inventory to report data to EPA every four years. Manufacturers (including importers) are required to report if they meet certain production volume thresholds, generally 25,000 pounds or more of a chemical at any single site. CDR is the most comprehensive source of basic exposure-related information on chemicals in U.S. commerce. EPA states that the collection of CDR information “is essential to meeting the agency’s information needs, especially for prioritization, risk evaluation, and risk management of chemicals under TSCA.” According to EPA, CDR information enables it to develop an understanding of the types, amount, end uses, and possible human exposure to inform its identification, evaluation, and management of risks to human health and environmental risks.

The 2020 CDR information primarily covers manufacture, processing, and use activities for calendar year 2019. The data released include company and site information, manufacturing (including import) information, production volume, and processing and use data, as well as information on chemicals not included in previous releases. According to EPA, this includes chemicals that lost their confidential status on the TSCA Inventory because one or more manufacturers reported the chemical identities as non-confidential during the 2012, 2016, and/or 2020 CDR reporting periods. Therefore, the 2020 CDR database will include information related to those chemical identities that could not be revealed publicly in previous publications of CDR data.

The 2020 CDR data are available in downloadable files on EPA’s CDR web pages. EPA states that it will also soon make the data available in ChemView. Resources about using the CDR database and interpreting the CDR data are also available from EPA’s CDR website.

Tags: CDR

 
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By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022.

The proposed rule includes:

Provisions Intended to Increase Transparency

  • Changes intended to ensure that the existence and scope of a CBI claim is clear and limited to information the submitter views as confidential;
  • A provision to address inappropriate or overly broad CBI claims in public copies of TSCA submissions, especially health and safety related information, that specifies a process for the submitter to correct promptly those issues early in the CBI review and that EPA would promptly deny any remaining inappropriate claims. These changes are expected to remove ambiguity about the scope or validity of claims, permitting more rapid review of valid CBI claims and public access to non-CBI information.
  • Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents, such as scientific studies, both of which would make more data available to the public more quickly.
  • Requirements for electronic communication and maintaining current and accurate contact information to ensure more prompt delivery of required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.

Provisions Intended to Modernize CBI Procedures and Ensure Consistency with Amended TSCA

  • Clear and uniform guidance on requirements for assertion and maintenance of CBI claims, including a standard set of substantiation questions used to support a CBI claim.
  • Requirements for electronic reporting of virtually all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors EPA has observed to:
    • Ensure better procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names);
    • Articulate better and more narrowly the confidential information that is being claimed; and
    • Clarify CBI provisions that apply to individual data elements, such as where CBI claims are not permitted or where upfront CBI substantiation is not required to support a claim.
  • Establishment of a new section of the TSCA regulations to consolidate and standardize how TSCA CBI claims must be asserted and substantiated.
  • Requirements that health and safety information be submitted using an appropriate Organization for Economic Cooperation and Development (OECD) Harmonized Template (when available), a format that will allow data to be more readily used and shared within EPA while allowing submitters to indicate CBI claims more clearly for EPA consideration.

EPA seeks public comment on all aspects of the proposed rule and the Economic Analysis prepared in support of it. In addition to specific requests for comment included throughout the proposed rule, EPA invites specific comment on:

  • EPA’s interpretation of the coverage of TSCA Section 14(a) (proposed Section 703.1) and how this may impact submitters of information to EPA under other statutes, such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is particularly interested in comments on the treatment of FIFRA studies on inert ingredients under TSCA Section 14(b)(2).
  • The applicability of the proposed new or revised requirements to submissions received before the effective date of the subsequent final rule. Specifically, EPA requests comment on whether each proposed new or revised requirement should apply only to submissions received on or after the effective date of the final rule; to all submissions received on or after the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments; or to all submissions regardless of submission date.
  • The proposed substantiation questions (proposed Section 703.5(b)), especially the proposal to omit a trade secrets-specific question; on how the patents question might be modified to elicit more pertinent information; and comment on the alternative substantial competitive harm question.
  • The proposed list of information that might be included with health and safety information, but that might be permissible to withhold as confidential (proposed Section 703.5(b)(6)). EPA is also interested in comment on alternatives to the proposal that might better ensure that health and safety information is not inappropriately treated as confidential.
  • The proposed approach to CBI claim deficiencies (proposed Section 703.5(e)) and on alternative approaches.
  • Whether submitting templated data should be required (proposed Section 703.5(g)).
  • The option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied (proposed Section 703.5(j)).
  • Selection of the representative subset, including possible alternative representative selection methods (proposed Section 703.7).
  • Whether bona fide or pre-notice inquiries or correspondence should be considered part of a representative subset of TSCA submissions (proposed Section 703.7).
  • On the proposed approach to determining when a TSCA Section 14(g) CBI review period begins and how amendments to the submission are included in the review (proposed Section 703.7).
  • The proposed and alternative possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory, as described in proposed Sections 720.102 and 725.190.
  • On how to incorporate whether a substance may be readily reverse engineered into EPA’s substantive review criteria in proposed Section 703.7(f).

Our forthcoming memoranda will include a detailed summary of the proposed rule and an insightful commentary.

Tags: CBI

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On May 12, 2022, the White House Office of Science and Technology Policy’s (OSTP) National Science and Technology Council’s (NSTC) Strategy Team on Sustainable Chemistry will host the second webinar in a series regarding the team’s tasks of defining, assessing, and preparing a strategic plan in the area of sustainable chemistry in response to direction in the National Defense Authorization Act of 2020. The presenters in the webinar will discuss the science, technology, and innovation needs of the chemical industries, including carbon capture, sustainable process design, and chemical separation technologies. Speakers will include:

  • Dionisios (Dion) G. Vlachos, University of Delaware;
  • Joan F. Brennecke, University of Texas at Austin; and
  • Jennifer Wilcox, Principal Deputy Assistant Secretary in the Office of Fossil Energy and Carbon Management at the U.S. Department of Energy.

Registration is now open.

Tags: OSTP, NSTC, Webinar,

 
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