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) proposed on April 12, 2022, to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. 87 Fed. Reg. 21706. EPA proposes under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA proposes that these prohibitions take effect two years after the effective date of the final rule. EPA also proposes to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA further proposes to prohibit manufacture (including import), processing, and distribution in commerce of: aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA also proposes disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. Comments on the proposed rule are due June 13, 2022. A detailed analysis of the proposed rule is available in our April 7, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it has 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. EPA states that after reviewing reasonably available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit information on avian and aquatic environmental hazard and consumer exposure. The chemicals are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

According to EPA, this is the third time it has used its new authority to issue test orders under Section 4 of amended TSCA. As reported in our January 15, 2021, blog item, in January 2021, EPA issued test orders for nine chemicals -- the eight chemicals above plus 1,1-dichloroethane -- requiring testing on aquatic environmental hazard and inhalation and dermal exposures for workers. EPA states that the information obtained through the orders will help ensure that its risk evaluations are “robust, credible, and use the best available data.”
 
EPA has posted a document describing the process of developing, drafting, and issuing Section 4 test orders. Companies subject to test orders may provide EPA with existing data, if available, or may conduct new tests. EPA states that companies are “encouraged to form consortia to consolidate costs and burden and avoid unnecessary duplication of testing.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of Inventory listings to address errors with the chemical identities submitted in the original reporting forms. The regulated community will have until April 26, 2022, to submit any final Inventory corrections. EPA also announced the discontinuation of the related form and associated approval of the collection activities under the Paperwork Reduction Act (PRA). The revocation will be effective May 31, 2022. All final Inventory corrections must be received on or before April 26, 2022.
 
After April 26, 2022, EPA does not intend to accept requests to correct original Inventory reporting forms. If, after April 26, 2022, a person discovers for any reason an error in the specific chemical identity of a chemical substance submitted on an original Inventory reporting form, a premanufacture notice (PMN) or exemption notice may need to be filed if the chemical substance is not already listed on the TSCA Inventory.
 
EPA notes that this action does not impact its authority for initiating, at its discretion, corrections to the Inventory should EPA determine on its own that, for example, a chemical substance listed on the Inventory has been unintentionally misidentified. EPA states that only in this situation will it, at its discretion, request and accept documentation from a company to support an Inventory correction in lieu of requiring a PMN or exemption notice. This action also does not impact EPA’s regular maintenance of the Inventory that can include nomenclature updates and correcting minor errors to listings.
 
EPA’s unilateral decision seems ill-considered and unwise. At the least, EPA should seek comment from the TSCA stakeholder community to inform its judgment.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 22, 2022, the release of the updated Mercury Electronic Reporting (MER) application and compliance guide for calendar year 2021 data reporting. According to EPA, the updates make it easier to report information about the supply, use, and trade of mercury. The mercury rule applies to any person who manufactures (including imports) mercury or mercury-added products (including pre-assembled products that contain mercury-added components) or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). This information is required to be submitted every three years using the online MER application, accessed through EPA’s Central Data Exchange (CDX).
 
EPA states that it updated the mercury inventory reporting rule compliance guide to reflect the new requirement to report pre-assembled products that contain mercury-added components, such as a watch with a mercury-added battery. According to EPA, the guide explains the requirements for manufacturers and importers to report information about the supply, use, and trade of mercury to EPA; provides an overview of the legal requirements; and describes how EPA intends to use the information it collects. Diagrams and examples are provided to help companies determine whether they must report information about mercury to EPA.
 
EPA updated the MER application to include a drop-down year list to allow users to report for previous reporting years and to make the system easier for EPA to maintain. According to EPA, the updated resources will help it carry out the statutory requirements to identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use in the United States. This will further assist the United States in its implementation of the Minamata Convention on Mercury, a global treaty to protect human health and the environment from the adverse effects of mercury. The deadline to report 2021 data is July 1, 2022. More information on the mercury inventory reporting rule is available in our June 25, 2018, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA noted that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule followed a final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. More information on the proposed rule is available in our October 25, 2021, memorandum. It is not clear when OMB will complete its review or if the final rule will be published prior to the current March 8 compliance deadline.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 14, 2022, that it will reopen the comment period for its draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). As reported in our December 29, 2021, memorandum, EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable risk determination for HBCD as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use (COU) evaluated in the risk evaluation. Second, EPA proposes that the risk determination should be explicit that it does not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA “finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” EPA will publish a Federal Register notice on February 17, 2022, to reopen the comment period for 15 days. Comments will be due March 3, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on February 3, 2022, that it has resumed publishing notices of substantial risks provided by companies under Section 8(e) of the Toxic Substances Control Act (TSCA) to its ChemView database. EPA states that as the initial phase of its effort to develop an efficient and automated publication process, it started publishing notices received since the procedure lapsed in 2019 due to resource limitations. As resources allow, EPA will “continue to strive” to make non-confidential business information (CBI) versions of TSCA Section 8(e) notices publicly available in ChemView more quickly. EPA’s announcement includes the following questions and answers (Q&A):

What are TSCA section 8(e) notices?

Section 8(e) of TSCA states that “Any person who manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.” 15 U.S.C. 2607(e). EPA guidance defines the term substantial-risk information as information which reasonably supports the conclusion that a chemical substance or mixture presents a substantial risk of injury to health or the environment and ‘‘substantial risk of injury to health or the environment’’ as a risk of considerable concern because of (a) the seriousness of the effect and (b) the fact or probability of its occurrence. Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.

The nature and extent of information in TSCA section 8(e) notices varies greatly, ranging from short memos providing limited information to fully detailed laboratory study reports. TSCA 8(e) notices may provide very preliminary data, often on substances that have not yet made it into commercial production. As such, the data provided in TSCA section 8(e) notices can be sparse, incomplete, qualitative or quantitative, and as such, may or may not be amenable to robust review or suitable for use in hazard or risk assessments or regulatory decision-making.

How are TSCA section 8(e) notices obtained by EPA?

TSCA section 8(e) notices (and related “FYI” notices) -- those containing confidential business information (CBI) and non-CBI versions -- are submitted by companies to EPA either electronically via EPA’s Central Data Exchange (CDX) or in hard copy via mail. For more information on submitting TSCA section 8(e) notices: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/reporting-tsca-chemical-substantial-risk-notice[.]

What does EPA do when it receives a TSCA section 8(e) notice?

Upon receipt of a TSCA section 8(e) notice, these notices are uploaded to the internal Chemical Information System (CIS), EPA’s National Archives and Records Administration (NARA) approved e-record keeping system for TSCA records, including TSCA section 8(e) notices.

How do EPA Risk Assessors Access and Use TSCA section 8(e) notices?

TSCA section 8(e) notices are available to OPPT chemical risk assessors via an internal system, the Chemical Information System (CIS), that makes available any document that is submitted under TSCA to EPA staff. EPA assessors with requisite and up-to-date CBI training and clearance have access to both the CBI and non-CBI versions of TSCA section 8(e) notices as soon as they are uploaded to CIS -- electronically submitted notices are available immediately upon receipt, and paper submissions are typically available within 2 days of receipt. TSCA section 8(e) notices also undergo initial processing which includes entry of information such as effects/endpoint, type of effect, type of test, dose, duration, route of administration, species tested, etc. into an internal database. When the TSCA section 8(e) submission contains sufficient detail, EPA may task its contractor to summarize the human health or ecological hazard information for use in chemical assessments.

Data extracted from TSCA section 8(e) notices may also be incorporated into several internal CBI databases and computational tools (e.g., Analog Identification Methodology, ECOSAR) that are also available to EPA assessors.

EPA risk assessors routinely use the information included in TSCA section 8(e) notices in both TSCA new and existing chemical risk assessment activities. In the new chemicals program, chemicals with toxicity information that was submitted to the Agency via TSCA section 8(e) notices are often used as analogs to “read-across” to assess potential risks to new chemicals that have similar chemical structures but that lack test data. As described previously, TSCA section 8(e) data is also incorporated into AIM or ECOSAR, computational tools used routinely to assess potential risks of new chemicals.

For TSCA section 6 existing chemical risk evaluations, TSCA section 8(e) notices are an integral part of the information included within the TSCA Systematic Review process -- in the gray literature data stream identification and evaluation workflow. For example, the scopes of the risk evaluations for the 20 high priority substances and Manufacturer Requested Risk Evaluations (MRREs) currently underway clearly demonstrate where data from TSCA section 8(e) notices may be included (e.g., in the literature inventory trees and evidence maps). In addition, data contained in TSCA section 8(e) notices have also been used to inform the need for issuance of TSCA section 4 test orders to conduct testing of existing chemicals or to fill data gaps in lieu of conducting new testing.

How can the public access 8(e) notices?

Although not required by statute, EPA has a long history of making data contained in TSCA section 8(e) substantial risk notices publicly available. From 1976-2017, data from TSCA section 8(e) notices were compiled into the TSCATS (Toxic Substances Control Act Test Submissions) and TSCATS2 databases). The TSCATS database information was also made publicly available via the National Library of Medicine (NLM)’s TOXNET. When NLM discontinued TOXNET in December 2019, it made the TSCATS data publicly available for download (https://www.nlm.nih.gov/databases/download/toxlinesubset.html).

In 2013, EPA established its public-facing non-CBI ChemView portal, and began efforts to transfer electronically available non-CBI versions of TSCA section 8(e) notices and the data contained within them (i.e., from the TSCATS databases and/or TOXNET) into ChemView. However, beginning in 2019, EPA was not able to continue the regular publication of TSCA section 8(e) notices to the ChemView database. This heavily manual process was conducted by a single staff person who retired in December 2018. Other staff within the unit that would historically also do this type of work were fully occupied conducting other work to increase transparency associated with TSCA new chemicals submissions in response to a commitment made by the past EPA Administrator to Senator Carper (D-DE).

However, TSCA section 8(e) notices have continued to be available to the public via EPA’s Docket Center. Anyone can make a request to receive non-CBI versions of TSCA section 8(e) notices received by the agency either in person or via email (.(JavaScript must be enabled to view this email address)). Upon request and compilation (which can take time, depending upon the complexity of the request) the docket center will provide the requestor the information via email or other electronic media (e.g., CD). The public may also view paper copies of non-CBI versions of TSCA section 8(e) notices received by the Agency in person at the Docket Center Reading Room (due to COVID, this option is currently by appointment only). Find information about contacting EPA’s docket center reading room.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 

By Lynn L. Bergeson and Carla N. Hutton

Public Employees for Environmental Responsibility (PEER) announced on January 5, 2022, that it filed suit in the U.S. District Court for the District of Columbia to compel the U.S. Environmental Protection Agency (EPA) to disclose reports submitted pursuant to Section 8(e) of the Toxic Substances Control Act (TSCA). According to the complaint, PEER submitted a Freedom of Information Act (FOIA) request in November 2021 seeking records demonstrating how EPA deals with Section 8(e) reports. PEER states that it requested both Section 8(e) reports submitted to EPA and internal policies regarding publicly posting and using Section 8(e) reports. PEER notes that its FOIA request “built upon information reported in a November 2021 article in The Intercept noting that EPA had only posted one 8(e) report publicly since 2019 and describing disagreement over how the EPA processes 8(e) reports internally.”

In its announcement, PEER states that TSCA requires industry to notify EPA within 30 days when it obtains information that reasonably supports the conclusion that a chemical substance presents a substantial risk of injury to health or the environment. According to PEER, in early 2019, EPA stopped posting these industry reports in its public-facing database or on an easily searchable internal database. While industry submitted and EPA published more than 1,000 substantial risk reports from 2017 through 2018, PEER states that since 2019, EPA has posted only one to the public database. EPA scientists informed PEER that another approximately 1,240 reports have been received but sequestered.

PEER states that “[a]n EPA spokesperson told a news reporter that the person who had been responsible for posting these reports had retired in December 2018; and the agency lacked fundings to replace this single employee. However, at the same time, the agency finances an online tool enabling chemical companies to track their products through the approval process – internally called the ‘pizza tracker.’”

PEER asks the court to enter an order declaring that EPA wrongfully withheld requested documents and to issue a permanent injunction directing EPA to disclose all wrongfully withheld documents.


 
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