§716.5. Persons who must report. — Inbound Citations

(1) Except as provided in §§ 716.5, 716.20, and 716.50, persons must send to EPA copies of any health and safety studies in their possession for the substances or mixtures listed in § 716.120. Persons are responsible for submitting copies on only the substances or listed mixtures which they: Have manufactured, imported, or processed or proposed to manufacture, import, or process (including as known byproducts) within the 10 years preceding the effective date for reporting on the substances or listed mixtures; manufacture, import, or process on the effective date for reporting on the substances or listed mixtures; and propose to manufacture, import, or process following the effective date for reporting on the substances or listed mixtures. Persons who list studies as ongoing or initiated under § 716.35(a) (1) and (2) must submit them when they are completed.

(a) Except as provided in §§ 716.5, 716.20, and 716.50, persons subject to this rule must send lists of studies to EPA for each of the listed substances or listed mixtures (including as a known byproduct) in § 716.120 which they are manufacturing, importing, or processing, or which they propose to manufacture (including import) or process.

(1) As of the date a person becomes subject to this part, a list of ongoing health and safety studies being conducted by or initiated for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.

(2) After the date a person becomes subject to this part, a list of studies initiated by or for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.

(3) As of the date a person becomes subject to this part, a list of unpublished health and safety studies known to them of which they do not have copies. The name and address of any person known to them to possess a copy of the unpublished study must accompany each entry on the list. For purposes of this section only, an unpublished study will be considered to be “known to” a person, if the study can be discovered by a file search in accordance with § 716.25.

(4) A list of unpublished studies which have been sent to a Federal Agency with no claims of confidentiality. The submission must for each study: Identify the study by title, state the name and address to whom the study was sent, and the month and year in which the study was submitted. Any study identified will be treated as if it were submitted under section 8(d) and will be available for public disclosure under section 14(b) of TSCA. Persons subject to this requirement may submit either a list of unpublished health and safety studies previously submitted to any Federal agency without claims of confidentiality in accordance with § 716.35(a)(4), or copies of each such study in accordance with § 716.30.

(a) Except as provided in § 716.5 and paragraphs (b) and (c) of this section, submissions under §§ 716.30 and 716.35 must be submitted using the electronic method specified in §§ 716.30(c) and 716.35(c), on or before 60 days after the effective date of the listing of a substance or mixture in § 716.120 or within 60 days of proposing to manufacture (including import) or process a listed substance or listed mixture (including as a known byproduct) if first done after the effective date of the substance or mixture being listed in § 716.120.

Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d) relating to a listed chemical substance or listed mixture [hereinafter “rule”], the reporting period for a listed chemical substance or listed mixture will terminate 60 days after the effective date on which the listed chemical substance or listed mixture is added to 40 CFR 716.120. EPA may require reporting for a listed chemical substance or listed mixture beyond the 60 day period in a rule promulgated under 15 U.S.C. 2607(d), however EPA will not extend any reporting period later than 2 years after the effective date on which a listed chemical substance or listed mixture is added to 40 CFR 716.120. After the applicable reporting period terminates, any person subject to the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a copy of any such study within 30 days after its completion, regardless of the study's completion date.

Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d) relating to a listed chemical substance or listed mixture [hereinafter “rule”], the reporting period for a listed chemical substance or listed mixture will terminate 60 days after the effective date on which the listed chemical substance or listed mixture is added to 40 CFR 716.120. EPA may require reporting for a listed chemical substance or listed mixture beyond the 60 day period in a rule promulgated under 15 U.S.C. 2607(d), however EPA will not extend any reporting period later than 2 years after the effective date on which a listed chemical substance or listed mixture is added to 40 CFR 716.120. After the applicable reporting period terminates, any person subject to the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a copy of any such study within 30 days after its completion, regardless of the study's completion date.