By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2021, that it is expanding the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. EPA states that under the Emergency Planning and Community Right-to-Know Act (EPCRA), “the EPA Administrator has the discretionary authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of releases of the chemical at the facility, or other factors the Administrator deems appropriate.” According to EPA, exposure to ethylene oxide can cause cancer in humans and damage DNA. Other effects include eye, skin, nose, throat, and lung irritation, as well as harm to the brain and nervous system. Workers in facilities that use ethylene oxide and people in communities located adjacent to these facilities, including historically underserved communities, have the highest chance of being exposed to ethylene oxide. EPA notes that because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by ethylene oxide.
 
In October 2021, EPA sent letters to 31 facilities providing notice that EPA was considering exercising its discretionary authority. After corresponding with many of the facilities, EPA has issued a determination extending TRI reporting requirements to 29 of the 31 facilities for ethylene oxide and to 16 of the 31 facilities for ethylene glycol. According to EPA, because ethylene glycol is produced using ethylene oxide, these chemicals may co-occur at facilities. EPA states that it believes these 29 contract sterilization facilities, which do not currently report to TRI, use the highest amounts of ethylene oxide in the contract sterilization sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for ethylene oxide. EPA notes that it considered additional factors, such as the facilities’ proximity to a population center (e.g., the number of people, including children under the age of five living near the facilities), their history of releases of ethylene oxide and ethylene glycol (e.g., past receipt of TRI reporting forms on ethylene oxide and ethylene glycol from these facilities), and other factors the Administrator deemed appropriate (e.g., proximity of the facilities to nearby schools and communities, especially those with potential environmental justice concerns and concerns for facility workers).
 
EPA did not to extend TRI reporting requirements to two of the 31 facilities initially contacted. According to EPA, one of the facilities conveyed to EPA that they had sold the establishment they previously used for sterilization and no longer perform sterilization work at that facility. Another facility informed EPA that their facility uses ethylene oxide in quantities far below the amount that would trigger TRI reporting in a year due to their sterilization technology and scale of operations.
 
Beginning in January 2022, these 29 facilities should start tracking their activities involving ethylene oxide (and ethylene glycol, if applicable) releases and other waste management quantities as required by EPCRA, similar to any other facility subject to TRI reporting requirements. If reporting thresholds are met, the facilities must submit TRI data beginning in 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the docket identification (ID) number associated with the relevant chemical. The 20 high-priority chemicals are:

• p-Dichlorobenzene;
• 1,2-Dichloroethane;
• trans-1,2-Dichloroethylene;
• o-Dichlorobenzene;
• 1,1,2-Trichloroethane;
• 1,2-Dichloropropane;
• 1,1-Dichloroethane;
• Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester);
• Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester);
• Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester);
• Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester);
• Dicyclohexyl phthalate;
• 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA);
• Tris(2-chloroethyl) phosphate (TCEP);
• Phosphoric acid, triphenyl ester (TPP);
• Ethylene dibromide;
• 1,3-Butadiene;
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
• Formaldehyde; and
• Phthalic anhydride.

The docket ID number and contact information for each chemical lead is available in the memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 16, 2021, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) on asbestos (part 1: chrysotile asbestos). According to an item in the fall 2021 Unified Agenda, the TSCA Section 6(a) rulemaking is needed to address the unreasonable risks of chrysotile asbestos that were identified in a risk evaluation completed under TSCA Section 6(b). EPA reviewed the exposures and hazards of chrysotile asbestos, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors. As reported in our January 4, 2021, memorandum on the final risk evaluation, EPA found unreasonable risks to human health for the following uses of chrysotile asbestos:

• Consumers and Bystanders: EPA found unreasonable risks to consumers and bystanders from all consumer uses of chrysotile asbestos. Most consumer products containing chrysotile asbestos have been discontinued. Consumer products still available and for which EPA found unreasonable risk include aftermarket automotive brakes/linings and certain gaskets. Risks to consumers can come from the inhalation of chrysotile asbestos; and
   
• Workers and Occupational Non-Users (ONU): Commercial chrysotile asbestos uses for which EPA found unreasonable risk to workers include chlor-alkali diaphragms, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets. Additionally, EPA found unreasonable risks to workers nearby but not in direct contact with chrysotile asbestos for the use of chlor-alkali diaphragms, sheet gaskets, brake blocks, and other gaskets. Risks to workers and ONUs can come from the inhalation of chrysotile asbestos.

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By Lynn L. Bergeson and Carla N. Hutton

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

• Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
   
• Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
   
• New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
   
• Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022;
   
• Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
   
• 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
   
• Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
   
• Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
   
• Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
   
• Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
   
• Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes 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 notes 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 follows a recently-issued 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. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
   
• TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

• Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
On November 8, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule revising the regulations associated with persons who must report data to the mercury inventory established under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 61708. The revisions implement an order issued by the U.S. Court of Appeals for the Second Circuit on June 5, 2020, that vacated the exemption at 40 C.F.R. Section 713.7(b)(2) for persons who import pre-assembled products that contain a mercury-added component. As a result, such persons are now required to report pursuant to 40 C.F.R. Section 713.7(b). EPA states that the rule is effectuating the vacatur ordered by the Second Circuit by making necessary amendments to the corresponding text in 40 C.F.R. Section 713.7(b). The final rule will be effective on December 8, 2021. EPA states in its November 2, 2021, press release that the final rule “offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is July 1, 2022.” EPA will update the mercury inventory reporting rule compliance guide and other supporting materials to reflect these new reporting requirements.
 
As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule and its reporting requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).

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By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2021, the U.S. Environmental Protection Agency (EPA) announced its response to a petition submitted under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. 86 Fed. Reg. 59931. EPA states that TSCA Section 6(a) authorizes it to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If EPA determines that there is unreasonable risk to health or the environment, then EPA must, by rule, issue regulations to the extent necessary so that the chemical substance no longer presents such risk. EPA notes that TSCA Section 3(2)(B), which defines “chemical substance,” excludes “tobacco or any tobacco product,” however. Under Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” EPA states that it finds that the petitioner has not met its burden as defined in TSCA Sections 6(a) and 21(b)(1) “because cigarettes are not a product that can be regulated under TSCA section 6(a).”

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By Lynn L. Bergeson and Carla N. Hutton
 
On October 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed to amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 59684. Specifically, EPA is proposing 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 also announced its intention to commence a new rulemaking effort on PIP (3:1) and four other persistent, bioaccumulative, and toxic (PBT) chemicals that have been regulated under TSCA Section 6(h). EPA states that it is anticipating issuing a proposal to this end in 2023. Comments on the proposed rule are due December 27, 2021. More information is available in our October 25, 2021, memorandum, “EPA Proposes Further Extension of Compliance Dates for PIP (3:1)-Containing Articles.”

Commentary

As anyone in this commercial space will attest, the proposal to extend the compliance date is good news. The deadline is still very aggressive for many, and case-specific requests for time beyond that deadline are essential. A thorough review of the notice is essential and urged.

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By Lynn L. Bergeson and Carla N. Hutton
 
On October 7, 2021, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) completed its review of a proposed rule on “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension.” The U.S. Environmental Protection Agency (EPA) announced on September 3, 2021, an extension of certain compliance dates for Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)) to March 8, 2022, “to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule to ensure that supply chains are not disrupted for key consumer and commercial goods.” The proposed rule reviewed by OIRA is expected to propose further extensions to certain article-related compliance dates. More information on EPA’s September 3, 2021, announcement is available in our memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals include:

• Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under the Toxic Substances Control Act (TSCA). The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
   
• Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.

EPA will publish a notice in the Federal Register extending the deadline. A pre-publication version of the notice is available on EPA’s website. EPA has also posted a “historic” question and answer document about reporting under TSCA Section 8(d). Detailed information about the reporting 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.”

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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 Richard E. Engler, Ph..D., Director of Chemistry with Bergeson & Campbell, P.C. (B&C^®) and The Acta Group (Acta^®), to discuss the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals, especially those found in finished products, what EPA refers to as “articles.” The Toxic Substances Control Act (TSCA) has always applied to the products, or articles, that contain chemical substances of interest to EPA under TSCA. While EPA previously used that authority somewhat sparingly, the 2016 Amendments to TSCA have jump-started a new wave of regulations that expressly apply to articles. EPA is required under TSCA to regulate certain PBTs, and EPA issued a final rule earlier this year that inspired chaos in the business community, especially in the electronics sector and its complicated supply chain. Rich and I discuss these PBT rules and help explain what may well be the new normal with regard to the regulation of finished products under TSCA.

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