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Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations B. What is the Agencys authority for taking this action?

I. General Information A. Does this action apply to me?
You may be potentially affected by this action if you manufacture defined by statute to include import any of the chemical substances that are listed in 40
CFR 716.120d of the regulatory text of this document. The following list of North American Industrial Classification System NAICS codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Chemical manufacturers including importers, NAICS codes 325 and 324110, e.g., persons who manufacture defined by statute to include import one or more of the subject chemical substances.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through http
www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI
information in a disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM as CBI and then identify electronically within the disk or CDROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your comments, see the commenting tips at https www.epa.gov/dockets/
commenting-epa-dockets.
II. Background
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A. What action is the Agency taking?
EPA is issuing a final rule pursuant to TSCA section 8d to require manufacturers including importers of chemical substances listed in this document and on the ITCs TSCA
section 4e Priority Testing List to submit lists and copies of certain unpublished health and safety studies to EPA. The regulatory text of this document lists the chemical substances and their Chemical Abstracts Service Registry Numbers CASRN that are being added to the Health and Safety Data Reporting rule. It also lists the specific data reporting requirements imposed by this final rule.

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EPA promulgated the Health and Safety Data Reporting rule under TSCA
section 8d 15 U.S.C. 2607d, and it is codified at 40 CFR part 716. EPA is using this TSCA section 8d rule in accordance with 40 CFR 716.105 to gather information on chemical substances. These studies are expected to provide EPA with useful information for conducting TSCA activities such as prioritization and risk evaluation.
The Agency adds substances to the rule via rule or notice, in accordance with 40 CFR 716.105a or b, respectively. The rule requires certain past, current, and prospective manufacturers which under TSCA
includes importers to submit copies and/or lists of unpublished health and safety studies on the listed chemical substances that they manufacture. In some cases, EPA may also require processors to comply with the rule.
The TSCA section 8d Health and Safety Data Reporting rule provides for the addition of TSCA section 4e Priority Testing List chemical substances to the list of chemical substances subject to the rule see Table of Chemicals, 40 CFR 716.120 Ref. 1.
Whenever EPA announces the receipt of an ITC Report, EPA may, amend the TSCA section 8d Health and Safety Data Reporting rule by adding the recommended or designated chemical substances to the TSCA section 4e list.
In doing so, EPA must provide a 14-day period measured from the date of publication of the Federal Register document announcing the rule for persons to submit information showing why a chemical substance, mixture, or category of chemical substances should be withdrawn from the amendment. The amendment adding these chemical substances to the Health and Safety Data Reporting rule is effective July 29, 2021.
If EPA withdraws a chemical substance from the amendment, a Federal Register document announcing this decision is to be published no later than July 29, 2021.
C. Comments Received on the 74th Report of the ITC
EPA received seven public comments on the 74th Report of the ITC. One comment requested additional information be provided for why certain organohalogen flame retardants being added to the Priority Testing List PTL.
Several comments questioned whether requiring 8d reporting for a chemical substance for which EPA has issued a Section 4 Test Order would be redundant and/or produce data in time
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for use in a risk evaluation under TSCA
section 6 on the applicable chemical substance. EPA also received a comment on chemicals substances to remove from the PTL. Additionally, one commenter recommended additional activities for EPA to conduct related to fulfilling data needs e.g., via the use of Test Orders pursuant to section 4 of TSCA.
EPA has reviewed the comments and continues to believe that it is appropriate to list these chemical substances in this document onto the ITCs TSCA section 4e Priority Testing List to prompt EPA to implement their authority pursuant to TSCA section 8d, to require manufacturers including importers to submit lists and copies of certain unpublished health and safety studies to EPA. The 74th ITC
Report provided the basis for its inclusion of all chemical substances that were added to the PTL. Regarding possible redundancies of published and previously submitted information under other TSCA programs, under 40 CFR
716.20a certain studies are exempt from the copy and list submission requirements of 40 CFR 716.30 and 716.35. Within EPAs current timeline for risk evaluations under TSCA section 6, data received via this 8d action would be received in time for use in risk evaluations for chemical substances that have been designated as high-priority substances, and data received on the other chemical substances listed in this document would help inform future prioritization activities, as well as help inform other agency decisions involving such chemical substances. In regard to chemical substances being recommended for deletion from the PTL
and for requests for certain activities to be undertaken in regard to certain chemical substances, EPA will consider such recommendations during future ITC discussions and during decisionmaking related to its various TSCA
statutory authorities.
D. Why is this action issued as a Final Rule?
The regulations at 40 CFR 716.105b and c establish the process for this action to amend the TSCA section 8d Health and Safety Data Reporting rule.
III. Final Rule A. What chemical substances are added?
In this document, EPA is adding chemical substances to the TSCA
section 8d Health and Safety Data Reporting rule. This addition implements 40 CFR 716.105b, which generally provides that chemical substances, mixtures, and categories of
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