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 Center for Environmental Health (CEH) announced on June 29, 2021, that it filed suit against three companies in the U.S. District Court for the District of Columbia for alleged violations of the Chemical Data Reporting (CDR) rule. According to CEH, an investigation found that four companies imported 65 chemicals that are subject to reporting under the CDR rule. CEH states that the chemicals “include several recognized carcinogens, including benzene, butadiene, trichloroethylene, isoprene, di(2-ethylhexyl)phthalate, di-isononyl phthalate, carbon black and arsenic.” In February 2021, CEH notified the importers of the apparent violations in accordance with Section 20(b) of the Toxic Substances Control Act (TSCA). One of the four companies, Tribute Energy, “approached CEH and entered into an agreement to audit its operations and come into compliance. CEH is not taking legal action against Tribute in recognition of its good faith and commitment to following the law.” CEH filed suit against the other three companies under TSCA Section 20(a). The three companies are 3N International, Harwick Standard Distribution Corp., and Braskem Inc. CEH notes that the U.S. Environmental Protection Agency (EPA) has designated some of the chemicals as high-priority substances under TSCA and is conducting risk evaluations to determine whether they present an unreasonable risk to human health or the environment. CEH states that “CDR reporting is critical in determining these risks because, according to EPA, the ‘exposure information [reported] is an essential part of developing risk evaluations and . . . collecting this exposure information is critical to [EPA’s] mission of characterizing exposure [and] identifying potential risks.’” CEH asks that the court order the companies to report their imports in compliance with the CDR rule and restrain the companies from any other ongoing violations of CDR reporting requirements.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to the rule consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). EPA states that it is taking this action because the TSCA Interagency Testing Committee (ITC) added these chemical substances to the TSCA Section 4(e) Priority Testing List through its 69th and 74th Reports. EPA will use the submitted information to inform the risk evaluations currently underway for 20 high-priority substances and for future prioritization.
 
The table below lists the high-priority substances and organohalogen flame retardants included in the final rule.
 

Chemical Substance Chemical Abstracts Service Registry Number
High-Priority Substances
1,3-Butadiene 106-99-0
Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) 85-68-7
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester) 84-74-2
o-Dichlorobenzene 95-50-1
p-Dichlorobenzene 106-46-7
1,1-Dichloroethane 75-34-3
1,2-Dichloroethane 107-06-2
trans-1,2-Dichloroethylene 156-60-5
1,2-Dichloropropane 78-87-5
Dicyclohexyl phthalate 84-61-7
Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester) 117-81-7
Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-methylpropyl) ester) 84-69-5
Ethylene dibromide 106-93-4
Formaldehyde 50-00-0
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB) 1222-05-5
4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) 79-94-7
Phosphoric acid, triphenyl ester (TPP) 115-86-6
Phthalic anhydride 85-44-9
1,1,2-Trichloroethane 79-00-5
Tris(2-chloroethyl) phosphate (TCEP) 115-96-8
Organohalogen Flame Retardants
Bis(2-ethylhexyl) tetrabromophthalate 26040-51-7
Bis(hexachlorocyclopentadieno)cyclooctane 13560-89-9
1,2-Bis(2,4,6-tribromophenoxy)ethane 37853-59-1
1,1'-Ethane-1,2-diylbis(pentabromobenzene) 84852-53-9
2-Ethylhexyl-2,3,4,5-tetrabromobenzoate 183658-27-7
2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate 20566-35-2
2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane] 3072-84-2
Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine 85535-85-9
N,N-Ethylene-bis(tetrabromophthalimide) 32588-76-4
Pentabromochlorocyclohexane 87-84-3
(Pentabromophenyl)methyl acrylate 59447-55-1
Pentabromotoluene 87-83-2
Perbromo-1,4-diphenoxybenzene 58965-66-5
Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester 6294-34-4
Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester 38051-10-4
Propanoic acid, 2-bromo-, methyl ester 5445-17-0
Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) 21850-44-2
Tetrabromobisphenol A bis(2-hydroxyethyl) ether 4162-45-2
Tetrabromobisphenol A diallyl ether 25327-89-3
Tetrabromobisphenol A dimethyl ether 37853-61-5
2,4,6-Tribromoaniline 147-82-0
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene 3278-89-5
Tris(2-chloroethyl)phosphite 140-08-9
Tris(1-chloro-2-propyl)phosphate 13674-84-5
Tris(2-chloro-1-propyl)phosphate 6145-73-9
Tris(2,3-dibromopropyl)phosphate 126-72-7
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione 52434-90-9
Tris(1,3-dichloro-2-propyl)phosphate 13674-87-8
Tris(tribromoneopentyl)phosphate 19186-97-1
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine 25713-60-4

 
The final rule will be effective July 29, 2021. Requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021. Information specified in the final rule is due to EPA by September 27, 2021. Detailed information about the final rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA proposes to require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:

  • Identifying the chemical substances that would be subject to reporting;
  • Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
  • Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
  • Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
  • Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
  • Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
  • EPA’s use and publication of certain non-confidential business information (CBI) data;
  • Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
  • Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.

Comments are due August 27, 2021. EPA states that “[‌u]nder the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.” More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”


 

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. Speakers will dive into a host of topics, including the systems of risk evaluation and risk management, environmental justice, regulating per- and polyfluoroalkyl substances (PFAS), new chemicals, and more. Register online.

Full Agenda:

9:00 a.m. - 9:30 a.m.

 

Welcome and Overview of Virtual Forum
Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University
9:30 a.m. - 10:00 a.m. Morning Keynote Discussion
Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)

10:00 a.m. - 10:45 a.m.

 

 

 

 

 

 

Panel 1: Risk Evaluation under TSCA
With the EPA under the Trump Administration completing 10 evaluations and the EPA conducting another 23 under the Biden Administration, there are differences of opinion over what the law requires and the best way to assess chemical risks. This panel will share perspectives on these issues and discuss whether and how the new Administration might revisit the 10 completed evaluations.
Panelists:
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.
Penny Fenner-Crisp, Ph.D., Environmental Protection Network
Suzanne Hartigan, Ph.D., Senior Director, Regulatory and Technical Affairs, American Chemistry Council
Jon Kalmuss-Katz, Supervising Senior Attorney, Earthjustice

11:00 a.m. - 11:45 a.m.

 

 

 

 

 

 

Panel 2: Risk Management under TSCA
The new regulatory frontier associated with the 2016 TSCA amendments is determining how best to manage chemical risks found to be unreasonable. This panel will discuss EPA’s authority under the Lautenberg amendments and options for deploying its risk management authority.
Panelists:
Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC, Moderator
Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
Randy S. Rabinowitz, Executive Director, OSH Law Project LLC
Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
Kimberly Wise White, Ph.D., Vice President, Regulatory and Technical Affairs, American Chemistry Council

11:45 a.m. - 12:30 p.m.

 

 

 

 

 

 

Panel 3: TSCA and Environmental Justice
The TSCA amendments offer enormous opportunities to help eliminate environmental injustice by evaluating and managing chemical risks. This panel will consider how TSCA can be leveraged to address concerns regarding environmental justice.
Panelists:
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C., Moderator
Dianne Barton, Council Chair, National Tribal Toxics Council
Marianne Engelman Lado, Deputy General Counsel, Environmental Initiatives, Office of General Counsel, U.S. Environmental Protection Agency
Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.
Adrienne Hollis, Senior Climate Justice and Health Scientist, Union of Concerned Scientists
12:30 p.m. - 1:30 p.m. Luncheon Keynote
Hon. Jeffrey Alan Merkley, U.S. Senator, Oregon (invited)

1:45 p.m. - 2:45 p.m.

 

 

 

 

 

 

Panel 4: New Chemicals Review
The TSCA New Chemicals Program was modified in the 2016 amendments and what the law requires has been vigorously debated. This panel will discuss the evolution of EPA’s implementation of Section 5 under the past Administration and now under the Biden Administration.
Panelists:
Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP, Moderator
Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C.
Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, Natural Resources Defense Council

3:00 p.m. - 3:45 p.m.

 

 

 

 

 

 

 

Panel 5: TSCA and PFAS
This panel will address how TSCA authorities can be used to address concerns about both new and existing PFAS, as this class of substances continues to gain significant attention.
Panelists:
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Dennis R. Deziel, Bergeson & Campbell, P.C. and former Administrator, Region I, U.S. Environmental Protection Agency
Liz Hitchcock, Director, Safer Chemicals, Healthy Families
Robert J. Simon, Vice President, Chemical Products and Technology and Chlorine Chemistry, American Chemistry Council
Betsy Southerland, Issue Team, Toxic Substances Control Act (TSCA), Environmental Protection Network

3:45 p.m. - 4:15 p.m.

 

 

 

 

Panel 6: TSCA Litigation Update
Unsurprisingly, TSCA litigation is on the rise five years into implementation of the new law. This panel will discuss key issues in dispute and where the courts might be headed.
Panelists:
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C., Moderator
Martha E. Marrapese, Partner, Wiley Rein LLP
Gavin McCabe, Special Assistant Attorney General, New York State Office of Attorney General

4:15 p.m. - 4:30 p.m.

 

Concluding Remarks and Adjournment
Scott Fulton, President, Environmental Law Institute
John Pendergrass, Vice President, Programs & Publications, Environmental Law Institute

 
Join ELI, Bergeson & Campbell, P.C., 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.


 

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!

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2021 Bergeson & Campbell, P.C.  All Rights Reserved


 

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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition for the following reasons:

  • Request for prioritization under TSCA Section 6 and related testing under TSCA Section 4(a)(2)(B): Because TSCA Section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for phosphogypsum and process wastewater, EPA is treating this portion of the request as a petition for action under the APA. Petitioners assert that “should EPA initiate prioritization but find that the development of new information is necessary to finalize a prioritization decision for phosphogypsum and process wastewater, EPA should exercise its authority under section 4(a)(2)(B) to obtain that information and establish priority.” EPA states that because it is not addressing the request for prioritization and has not otherwise initiated prioritization on phosphogypsum or process wastewater, it is not in a position to exercise its authority under TSCA Section 4(a)(2)(B) in the manner and for the reason described by petitioners.
  • Request for significant new use rule (SNUR) under TSCA Section 5: TSCA Section 21 does not provide for the submission of a petition seeking the initiation of a rule under TSCA Section 5. EPA states that SNURs are issued under the authority of TSCA Section 5(a)(2). Since TSCA Section 21 does not provide an avenue for petitioners to request the initiation of a proceeding to make a determination by rule under TSCA Section 5(a), EPA is treating this portion of the request as a petition for action under the APA.
  • Request for issuance of a test rule under TSCA Section 4(a)(1)(A): According to the notice, TSCA Section 21 does provide for the submission of a petition seeking issuance of a test rule under TSCA Section 4(a)(1)(A). EPA states that it finds that the petitioners have not met their burden as defined in TSCA Sections 4(a)(1)(A) and 21(b)(1) because the petitioners have not provided the facts necessary to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.

More information about the petition is available in our March 12, 2021, memorandum, “EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater.”


 
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