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 TBBPA, 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 this risk evaluation 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.

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 TBBPA. EPA used the best available science to prepare the draft risk evaluation and preliminarily determined, based on the weight of scientific evidence, that TBBPA poses unreasonable risk to human health and the environment 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 to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://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 https://www.epa.gov/​dockets/​commenting-epa-dockets.

II. Background

A. What is TBBPA?

TBBPA is a crystalline solid used as an additive and reactive flame retardant. As an additive flame retardant, TBBPA is incorporated into polymers and used in electronic enclosures and electronic consumer products with an outer plastic casing. As a reactive flame retardant, TBBPA is primarily used in epoxy resin printed circuit boards. TBBPA is used in fabric, textile, leather products, and construction materials. Workers may be exposed to TBBPA through inhalation of dust or dermal contact during the manufacturing, processing, use, or disposal of TBBPA. Consumers may be exposed to TBBPA through dermal or oral exposure to products, as well as inhalation of dust. TBBPA is primarily released to the environment through land disposal. Environmental TBBPA release can also occur through air and water releases. TBBPA has been found in drinking water, ground water, ambient air, indoor air, fish, human breast milk, and dust and soil.

B. The Risk Evaluation of TBBPA

In December 2019, EPA announced its designation of TBBPA (Docket ID EPA-HQ-OPPT-2018-0462) as a high priority substance for risk evaluation under TSCA (84 FR 71924) (FRL-10003-15). In April 2020, EPA published and sought public comment on the draft scope of the TBBPA 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).

III. Request for Comment

EPA seeks feedback on the assessment of risk presented in the draft risk evaluation for TBBPA, 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 are not publicly available.

EPA welcomes specific input on each section of the draft risk evaluation, particularly input on the following:

• Non-cancer human health hazard conclusions (e.g., selection of intermediate and chronic endpoints);
• Cancer human health hazard conclusions (e.g., conclusion of non-genotoxic mode of action and preliminary cancer classification);
• Exposure assumptions for occupational exposure scenarios (e.g., how exposure controls and personal protective equipment are used, the frequency of occupational task(s) per shift, use of respirators with an Assigned Protection Factor higher than 10 during higher exposure tasks);
• Modeling assumptions for conditions of use without Toxics Release Inventory data (e.g., use as a laboratory chemical); ( printed page 36140)
• Domestic manufacturing as a reasonably foreseen use and any information regarding domestic manufacturing being reestablished in the United States;
• Information that may inform assessment of water releases and environmental impacts (e.g., percent of TBBPA in waste disposal streams); and
• Relevant studies or other data sources not identified by EPA.

IV. Next Steps

After consideration of comments received from the public on the draft risk evaluation and input from the SACC peer review, EPA will issue a final risk evaluation for TBBPA. Under TSCA section 6, EPA must determine in the final risk evaluation, 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 consideration of risks to potentially exposed susceptible 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 https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca.

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

91 FR 36138