SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This action is directed to the public in general and may be of particular interest to those involved in the manufacture (defined under TSCA section 3(9) to include import), processing, distribution, use, and disposal of trans -1,2-dichloroethylene, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, State and local governments, Tribal Nations, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the relevant technical contact listed under FOR FURTHER INFORMATION CONTACT .

B. What is the Agency's authority for taking this action?

The Agency is conducting these risk evaluations under TSCA section 6, (15 U.S.C. 2605) which requires that EPA conduct risk evaluations on chemical substances and identifies the minimum components EPA must include in the risk evaluations. Each risk evaluation must be conducted consistent with the best available science, be based on the weight of the scientific evidence, and consider reasonably available information, and not consider costs or non-risk factors (15 U.S.C. 2625(h), (i), and (k)). See also the implementing procedural regulations at 40 CFR part 702. ( printed page 55338)

C. What action is the Agency taking?

EPA is announcing the availability of and seeking public comment on the draft risk evaluation under TSCA for trans -1,2-dichloroethylene. EPA used the best available science to prepare the draft risk evaluation and preliminarily determined, based on the weight of scientific evidence, that trans -1,2-dichloroethylene does pose unreasonable risk to human health driven primarily by certain COUs analyzed in the draft risk evaluation.

D. What should I consider as I submit my comments to EPA?

1. Submitting CBI

Do not submit CBI through www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at www.epa.gov/​dockets/​commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703, as applicable.

2. Tips for Preparing Comments

When preparing and submitting your comments, see the commenting tips at www.epa.gov/​dockets/​commenting-epa-dockets.

II. Background for trans-1,2-Dichloroethylene

A. What is trans-1,2-dichloroethylene?

Trans -1,2-dichloroethylene is primarily used in a solvent, reaction product, cleaning agent (degreaser), surface modifier, and processing aid. Workers and occupational non-users (ONUs) may be exposed to trans -1,2-dichloroethylene through the inhalation route and workers through the dermal route associated with manufacturing, processing, use, or disposal of trans -1,2-dichloroethylene. Consumers may be exposed to trans -1,2-dichloroethylene through the dermal and inhalation routes during intended product use as a cleaner, degreaser, or propellant. Environmental releases to air, water, and land occur from industrial and waste handling facilities. Trans -1,2-dichloroethylene is expected to be persistent in air and water but is not expected to sorb to soil.

B. The Risk Evaluation of trans-1,2-Dichloroethylene

In December 2019, EPA announced its designation of trans -1,2-dichloroethylene (Docket ID: EPA-HQ-OPPT-2018-0465) as a high-priority substance for risk evaluation under TSCA (84 FR 71924 (FRL-10003-15-OCSPP)). In April 2020, EPA published and sought public comment on the draft scope of the trans -1,2-dichloroethylene risk evaluation (85 FR 19941 (FRL-10007-11-OCSPP)), and, after considering public comments, issued the final scope on September 4, 2020 (85 FR 55281 (FRL-10013-90-OCSPP)).

In this draft risk evaluation, EPA assessed human health risk to workers (including ONUs), consumers, and the general population, including fenceline communities and potentially exposed susceptible subpopulations (PESS), exposed to environmental releases of trans -1,2-dichloroethylene. Specifically, EPA evaluated acute, intermediate, and chronic non-cancer risks to workers and ONUs; acute and intermediate non-cancer risks to consumers; and acute, intermediate, and chronic non-cancer to the general population (including fenceline communities and PESS). This draft risk evaluation also assessed acute and chronic risks to the environment, specifically to aquatic and terrestrial species.

C. Request for Comment

EPA seeks feedback on the assessment of risk presented in the draft risk evaluation for trans -1,2-dichloroethylene, a copy of which is available in the docket, and encourages all potentially interested parties, including individuals, governmental and non-governmental organizations, non-profit organizations, academic institutions, research institutions, and private sector entities to comment on the draft risk evaluation. To the extent possible, the Agency asks commenters to please cite any public data related to or that support comments provided, and to the extent permissible, describe any supporting data that is not publicly available.

EPA welcomes specific input on each section of the draft risk evaluation, and is particularly interested in:

• information that may inform exposure assumptions for occupational exposure scenarios (OESs) (e.g., whether and how exposure controls and PPE are used for each of the COUs, the frequency of occupational task[s] per shift), especially related to the use of trans -1,2-dichloroethylene as a blowing agent;
• information on the number of facilities involved in the vapor degreasing;
• information to inform and refine the occupational exposure assessment of the Manufacturing as a Byproduct OES, including monitoring data;
• information on the frequency of batch manufacturing within a facility to inform the occupational exposure assessment;
• additional information on PPE use for the two COUs: (1) Processing—Incorporation into a formulation, mixture, or reaction product—Solvents (which become part of product formulation or mixture) and (2) Incorporation into a formulation, mixture, or reaction product—Solvents (for semiconductor manufacturing); and
• other information on any relevant studies or other data sources that were not identified by EPA.

III. Next Steps

After consideration of comments received from the public on the draft risk evaluation and input from the Scientific Advisory Committee on Chemicals (SACC) peer review, EPA will issue final risk evaluation of trans -1,2-dichloroethylene. Under TSCA section 6, EPA must use the final risk evaluation as a basis to determine, based on the weight of scientific evidence, whether or not the chemical presents an unreasonable risk to human health or the environment under the chemical's COUs. This includes risks to subpopulations who may be at greater risks than the general population, such as children and workers. TSCA prohibits EPA from considering non-risk factors ( e.g., costs/benefits) during risk evaluation.

For more information about the TSCA risk evaluation process for existing chemicals, go to www.epa.gov/​assessing-and-managing-chemicals-under-tsca.

Authority:15 U.S.C. 2601 et seq.

91 FR 55337