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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 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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 18, 2021, the U.S. Environmental Protection Agency (EPA) invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of proposed risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by trichloroethylene (TCE) and perchloroethylene (PCE). EPA will hold two identical consultation webinars, one on June 16, 2021, and the other on July 6, 2021. EPA states that both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from TCE and PCE, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA invites national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. Comments are due August 20, 2021.
 
In addition to these environmental justice consultations, EPA states that 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.
 
While outreach and stakeholder engagement on risk management activities for TCE and PCE will continue to move forward, EPA is actively reviewing final risk evaluations to ensure they use the best available science and protect human health and the environment, in accordance with Executive Orders and other direction provided by the Biden-Harris Administration. EPA states that it will keep stakeholders updated as it makes decisions and determines next steps. More information on EPA’s final risk evaluations for TCE is available in our November 24, 2020, memorandum and on EPA’s final risk evaluation for PCE in our December 17, 2020, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2021, the U.S. Environmental Protection Agency (EPA) began environmental justice consultations regarding the development of risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) for Asbestos, Part 1: Chrysotile Asbestos and Pigment Violet 29 (PV29). EPA will hold two identical consultation webinars, on June 1, 2021, and June 9, 2021. EPA states that it is offering these repeated sessions to increase opportunities for participation. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from Asbestos, Part 1: Chrysotile Asbestos and PV29, and an opportunity for 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. The environmental justice consultation period end August 13, 2021.

EPA states that in addition to these environmental justice consultations, it is implementing a “robust outreach effort” on risk management 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 actions. More information on EPA’s final risk evaluation for Asbestos, Part 1: Chrysotile Asbestos is available in our January 4, 2021, memorandum and on EPA’s final risk evaluation for PV29 in our January 25, 2021, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 28, 2021, announcing a 30-day comment period on the Toxic Substances Control Act (TSCA) Interagency Testing Committee’s (ITC) revisions to the Priority Testing List.  86 Fed. Reg. 22414.  In the 74th ITC Report, ITC revised the TSCA Section 4(e) Priority Testing List by adding the following 15 high-priority substances designated pursuant to TSCA Section 6(b) and 24 organohalogen flame retardants:

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
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-(2methylpropyl) ester) 84-69-5
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
Phthalic anhydride 85-44-9
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) 79-94-7
1,1,2-Trichloroethane 79-00-5
Organohalogen Flame Retardants
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-(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
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(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(tribromoneopentyl)phosphate 19186-97-1
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine 25713-60-4

ITC requests that EPA add these chemical substances and the other five high-priority substances and six organohalogen flame retardants currently on the Priority Testing List to 40 C.F.R. Section 716.120(a), the list of substances subject to the TSCA Section 8(d) Health and Safety Data Reporting rule (40 C.F.R. Part 716).  The rule requires manufacturers (including importers) of chemical substances and mixtures added to the Health and Safety Data Reporting rule to submit lists and copies of unpublished health and safety studies to EPA.  Comments are due May 28, 2021.
 
EPA notes that in addition to the chemical substances being added to the Priority Testing List in the 74th ITC Report, the Priority Testing List includes two alkylphenols, 45 High Production Volume (HPV) Challenge Program orphan chemicals, cadmium, a category of cadmium compounds, six non-phthalate plasticizers, 25 phosphate ester flame retardants, two other flame retardants, nine chemicals to which children living near hazardous waste sites may be exposed, and 19 diisocyanates and related compounds.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings.  EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.”  EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
 
Information about chemical reporting is available on the TSCA Chemical Data Reporting web page.  EPA notes that the chemical data reports for 2016 to 2019 were due from industry manufacturers by January 29, 2021.  The Substance Registry Services web page offers a search function to find out if a specific chemical is on the TSCA Inventory.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” 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.  EPA “is taking this 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.”


 
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