EPA Publishes TSCA Scope Documents

Friday, September 4, 2020

On September 4, 2020, the U.S. Environmental Safety Company (EPA) printed two Federal Register notices concerning the chance evaluations for the 20 high-priority chemical compounds designated in December 2019. Within the first discover, EPA introduced the provision of the ultimate scope paperwork for the chance evaluations to be performed beneath the Poisonous Substances Management Act (TSCA) for the 20 high-priority substances. 85 Fed. Reg. 55281. The scope doc for every chemical substance consists of the situations of use (COU), hazards, exposures, and the doubtless uncovered or vulnerable subpopulations (PESS) that EPA plans to think about in conducting the chance analysis for the chemical substance. Within the second discover, EPA introduced the provision of the ultimate checklist figuring out producers topic to payment obligations for EPA-initiated danger evaluations beneath TSCA Part 6. 85 Fed. Reg. 55283. We’ll complement this memorandum subsequent week after we have now reviewed the scopes intimately.

Last Scope Paperwork

As reported in our December 20, 2019, memorandum, EPA printed the ultimate checklist of high-priority chemical compounds on December 20, 2019. The 20 chemical compounds encompass seven chlorinated solvents, six phthalates, 4 flame retardants, formaldehyde, a perfume additive, and a polymer precursor:

Chemical Substance
Chemical Abstracts Service (CAS) Registry Quantity (RN)
Docket ID Quantity
1,3-Butadiene
106-99-0
EPA-HQ-OPPT-2018-0451
o-Dichlorobenzene (Benzene, 1,2-dichloro-)
95-50-1
EPA-HQ-OPPT-2018-0444
p-Dichlorobenzene (Benzene, 1,4-dichloro-)
106-46-7
EPA-HQ-OPPT-2018-0446
1,1-Dichloroethane
75-34-3
EPA-HQ-OPPT-2018-0426
1,2-Dichloroethane
107-06-2
EPA-HQ-OPPT-2018-0427
trans-1,2-Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-)
156-60-5
EPA-HQ-OPPT-2018-0465
1,2-Dichloropropane
78-87-5
EPA-HQ-OPPT-2018-0428
Ethylene dibromide (Ethane, 1,2-dibromo-)
106-93-4
EPA-HQ-OPPT-2018-0488
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
1222-05-5
EPA-HQ-OPPT-2018-0430
4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
79-94-7
EPA-HQ-OPPT-2018-0462
Phosphoric acid, triphenyl ester (TPP)
115-86-6
EPA-HQ-OPPT-2018-0458
1,1,2-Trichloroethane
79-00-5
EPA-HQ-OPPT-2018-0421
Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-, 1,1′,1″-phosphate)
115-96-8
EPA-HQ-OPPT-2018-0476
Butyl benzyl phthalate (1,2-Benzenedicarboxylic acid, 1- butyl 2-(phenylmethyl) ester)
85-68-7
EPA-HQ-OPPT-2018-0501
Dibutyl phthalate (1,2-Benzenedicarboxylic acid, 1,2- dibutyl ester)
84-74-2
EPA-HQ-OPPT-2018-0503
Dicyclohexyl phthalate
84-61-7
EPA-HQ-OPPT-2018-0504
Phthalic anhydride (1,3-Isobenzofurandione)
85-44-9
EPA-HQ-OPPT-2018-0459
Formaldehyde
50-00-0
EPA-HQ-OPPT-2018-0438
Di-ethylhexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)
117-81-7
EPA-HQ-OPPT-2018-0433
Di-isobutyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester)
84-69-5
EPA-HQ-OPPT-2018-0434

Feedback had been acquired throughout two 45-day remark intervals following the announcement of the draft scope paperwork for the chance evaluations to be performed for 13 of the 20 high-priority substances and the remaining 7 of the 20 high-priority substances. In line with EPA, feedback addressed the final method to the chance analysis course of (e.g., assortment, consideration, and systematic overview of related info), the precise parts of the scope paperwork (e.g., hazard, publicity, and PESS), info particular to the chemical substances (e.g., related research, assessments, and COU), and matters past the draft scope doc part of the method (e.g., danger administration). EPA states that it thought-about these feedback, as relevant and acceptable, in creating the ultimate scope paperwork. EPA has printed a response to feedback doc that comprises a complete abstract of and response to public feedback acquired on the 20 draft scope paperwork.

Every ultimate scope doc consists of the COU, hazards, exposures, and the PESS EPA plans to think about. EPA states that the ultimate scope doc for every danger analysis consists of the next elements:

The COU, as decided by the Administrator, that EPA plans to think about within the danger analysis;

The possibly uncovered populations that EPA plans to guage; the ecological receptors EPA plans to guage; and the hazards to well being and the atmosphere that EPA plans to guage;

An outline of the fairly obtainable info and the science approaches that EPA plans to make use of;

A conceptual mannequin that describes the precise or predicted relationships between the chemical substance, the COU inside the scope of the analysis and the receptors, both human or environmental, with consideration of the life cycle of the chemical substance — from manufacturing, processing, distribution in commerce, storage, use, and disposal — and identification of human and ecological well being hazards EPA plans to guage for the publicity situations EPA plans to guage;

An evaluation plan that identifies the approaches and strategies EPA plans to make use of to evaluate publicity, hazards, and danger, together with related uncertainty and variability, in addition to a method for utilizing fairly obtainable info and science approaches; and

A plan for peer overview.

EPA states that based mostly on public feedback acquired, it was capable of replace COU offered within the draft scope paperwork and settle for further information or info from stakeholders that was helpful in figuring out the ultimate the scope of the chance evaluations. As well as, EPA thought-about public feedback to tell higher the publicity pathways, routes, receptors, PESS, and hazards that EPA plans to think about within the danger evaluations for the 20 high-priority substances. EPA notes that because of the Ninth Circuit Court docket of Appeals’ choice in Safer Chemical substances, Wholesome Households v. U.S. EPA, 943 F.3d 397, 425 (ninth Cir. 2019), “EPA will not exclude legacy makes use of or related disposal from the definition of ‘situations of use.’ Slightly, when these actions are meant, recognized, or fairly foreseen, these actions can be thought-about makes use of and disposal, respectively, inside the definition of ‘situations of use.’”

Last Record Figuring out Producers Topic to Payment Obligations

EPA is asserting the ultimate checklist of producers (together with importers) of the 20 high-priority substances which are chargeable for payment funds. EPA can also be offering the checklist of corporations that licensed to having ceased manufacturing by March 20, 2019, and haven’t any plans to restart manufacturing within the subsequent 5 years, in addition to people who licensed to not manufacturing the chemical substance within the five-year interval previous publication of the preliminary lists. EPA states that it believes the requirement to self-identify was enough to determine further producers (together with importers). Producers (together with importers) on the preliminary lists had a chance to certify via EPA’s Central Information Alternate (CDX) that: that they had already ceased manufacturing previous to March 20, 2019, and won’t manufacture (together with import) for 5 years; or they haven’t manufactured the chemical substance within the five-year interval previous publication of the preliminary lists. If EPA acquired such a certification assertion from a producer, then EPA didn’t embrace the producer on the ultimate checklist, and the producer is not going to be obligated to pay the payment.

In line with the discover, EPA discovered that the broad scope of the present TSCA charges rule “unintentionally imposes doubtlessly vital burdens on importers of chemical substances in articles, and producers of byproducts and impurities, and that sure stakeholders could be obligated to undertake vital and burdensome efforts to try to find out the presence of the 20 Excessive-Precedence Substances of their merchandise and processes.” EPA introduced on March 25, 2020, plans to provoke a brand new rulemaking course of to think about proposing exemptions to the present rule’s self-identification necessities related to EPA-initiated danger evaluations for producers that: import the chemical substances in an article; produce the chemical substances as byproducts; and produce or import the chemical substances as impurities.

EPA states that it was requested whether or not a producer that has ceased manufacture of one of many 20 high-priority substances previous to the cutoff date for ceasing manufacture or import of a chemical substance (apart from manufacture within the three classes impacted by the deliberate regulatory change), and that additionally commits to not manufacturing the chemical sooner or later 5 years, apart from in those self same three classes, needs to be topic to payment obligations. EPA responded that in gentle of its rulemaking announcement, it doesn’t anticipate to determine entities who in any other case meet the factors for “cessation” aside from manufacture or potential manufacture in one of many three classes — and who certify as such within the “Further Data” area in CDX — on the ultimate lists of accountable payment payers. Lastly, entities had the chance to certify as to whether or not they meet the definition of a “small enterprise concern” as outlined within the Charges Rule and qualify for an 80 % decreased payment quantity.

In line with EPA, the ultimate checklist of producers differs from the preliminary lists for a number of causes. For instance, many Chemical Information Reporting (CDR)/Toxics Launch Stock (TRI) producers recognized on the preliminary checklist had both ceased manufacturing previous to the cutoff dates or weren’t producers (or importers) of the chemical substances. EPA didn’t embrace such entities on the ultimate lists. Different entities from the preliminary lists, in accordance with the deliberate regulatory change, that solely manufactured (or imported) chemical compounds as a byproduct, impurity, or in an article and licensed as such, weren’t included within the ultimate checklist. EPA states that different entities that weren’t included on a preliminary checklist, similar to importers of chemical substances for laboratory or analysis and improvement (R&D) use that imported volumes beneath the CDR 25,000-pound threshold, self-identified as a producer (together with importer) through the reporting interval and had been subsequently included on a ultimate checklist. In line with EPA, the one firm that self-identified for tris(2-chloroethyl) phosphate (TCEP) imported a really small amount in 2019 for R&D use solely. EPA states that it used the discretion provided by the TSCA charges rule to not accumulate a payment from this one firm. Consequently, there are not any charges related to the chance analysis for TCEP.

EPA states that “[i‌]n recognition of the unprecedented and unexpected challenges to the financial system because of public well being emergency, the Company is exploring choices for cost flexibilities, together with cost plans and prolonged due dates for charges.” EPA notes that producers may additionally type a consortium to pay charges. The consortium should notify EPA {that a} consortium has fashioned inside 60 days of the publication of the ultimate scope of a danger analysis. As soon as established, the consortium would decide how the payment could be cut up among the many members, and in the end paid to EPA. Data on forming a consortium is obtainable in our March 2, 2020, memorandum, “The Important Worth of Forming TSCA Consortia.”