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Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations chemical substances that have been added to the TSCA section 4e Priority List by the Interagency Testing Committee, established under section 4
of TSCA, will be added to 716.120
. . . This addition also addresses the request of the TSCA ITC in its 74th Report Ref. 2 to add certain chemical substances listed in that report to the TSCA section 8d Health and Safety Data Reporting rule. The specific chemical substances being added to the rule are listed in the regulatory text at the end of this document.

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B. What are the reporting requirements?
Listed in this unit are the reporting requirements for the chemical substances added by this final rule to the TSCA section 8d model Health and Safety Data Reporting rule. The specific types of health and safety studies that must be reported for each of the chemical substances added to the Health and Safety Data Reporting rule as a result of this document can be found in Unit III.C.
1. Persons who, in the 10 years preceding the date a chemical substance is listed, either have proposed to manufacture including import or have manufactured including imported the listed chemical substance must submit to EPA, during the 60-day reporting period specified in 40 CFR 716.65 and according to the reporting schedule set forth at 40 CFR 716.60, a copy of each specified type of health and safety study which is in their possession at the time the chemical substance is listed in part 716.
2. Persons who, at the time the chemical substance is listed in part 716, propose to manufacture including import or are manufacturing including importing the listed chemical substance must submit to EPA during the 60-day reporting period specified in 40 CFR
716.65 and according to the reporting schedule set forth at 40 CFR 716.60:
i. A list of the specified types of health and safety studies known to them but not in their possession at the time the chemical substance is listed.
ii. A list of the specified types of health and safety studies that are ongoing at the time the chemical substance is listed and are being conducted by or for them.
iii. A list of the specified types of health and safety studies that are initiated after the date the chemical substance is listed and will be conducted by or for them.
iv. A copy of each specified type of health and safety study which is in their possession at the time the chemical substance is listed.

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v. A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated i.e., listed in accordance with reporting requirements in Unit III.B.2.iii. and iv., respectively and is now completeregardless of completion date.
3. Persons who, after the time the chemical substance is listed in part 716, propose to manufacture including import the listed chemical substance must submit to EPA during the reporting period specified in 40 CFR
716.65 and according to the reporting schedule set forth at 40 CFR 716.60:
i. A list of the specified types of health and safety studies known to them but not in their possession at the time they propose to manufacture including import the listed chemical substance.
ii. A list of the specified types of health and safety studies that are ongoing at the time they propose to manufacture including import the listed chemical substance and are being conducted by or for them.
iii. A list of the specified types of health and safety studies that are initiated after the time they propose to manufacture including import the listed chemical substance and will be conducted by or for them.
iv. A copy of each specified type of health and safety study which is in their possession at the time they propose to manufacture including import the listed chemical substance.
v. A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated i.e., listed in accordance with reporting requirements in Unit III.B.3.iii. and 3.iv., respectively and is now completeregardless of the completion date.
The reporting described in Unit III.B.
is required by September 27, 2021. Any person who manufactures including imports or who proposes to manufacture including import the listed chemical substance from July 29, 2021 to September 27, 2021 must inform EPA by submitting a list of any studies initiated during the period from July 29, 2021 to September 27, 2021 within 30
days of their initiation, but in no case later than October 27, 2021. In addition, if any such person has submitted lists of studies that were ongoing or initiated during the period from July 29, 2021 to September 27, 2021 to EPA, such person must submit a copy of each study within 30 days after its completion, regardless of the studys completion date. See 40 CFR 716.60 and 716.65.
Detailed guidance for reporting unpublished health and safety data and
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explanations of reporting exemptions is provided at 40 CFR part 716.
Persons reporting under this rule may also assert CBI claims for certain information included in their submission. TSCA section imposes the following requirements:
CBI claims must be asserted must be asserted at the time the information claimed as CBI is submitted to EPA.
Information submitted with a confidentiality claim may be made public without further notice.
Information claimed as CBI must be substantiated at the time of submission, with the exception of those types of information exempt from substantiation under TSCA section 14c2.
All persons making a CBI claim must provide a standard statement concerning the need for the CBI claim and a certification that the statement of need is true and correct.
Where a specific chemical identity is claimed as CBI, a structurally descriptive generic name must be provided for disclosure to the public.
The 8d reporting application accommodates these requirements, incorporating the required statements and certifications, and will prompt the submitter to provide substantiation prior to making a submission that includes CBI claims.
C. What types of studies must be submitted?
Pursuant to 40 CFR 716.20b5 and 716.50, the types of unpublished health and safety studies that must be reported and the chemical grade/purity requirements that must be met or exceeded in individual studies for the chemical substances added to the Health and Safety Data Reporting rule as a result of this document are as follows:
Under this rule, manufacturers including importers of High-Priority Substances are required to submit the following:
Lists and copies of unpublished health and safety studies for all HighPriority Substances specified in this rule on health effects, such as toxicity studies in vivo and in vitro on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetics absorption, distribution, metabolism, or elimination, including modelling studies, in humans or animals.
All unpublished studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 CFR
716.50 are also required under this rule.

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