§716.35. Submission of lists of studies. — Inbound Citations

(a) Excluding paragraph (a)(3) of this section, the following types of studies are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.

(2) These studies are limited to section 8(e) submissions, studies submitted during section 4 proceedings, studies submitted with premanufacture notices or significant new use notices, and studies submitted “for your information” (FYI submissions) in support of EPA's TSCA Existing Chemicals Program. Studies which have been initiated pursuant to a TSCA section 4(a) test rule, for which the person has submitted a letter of intent to conduct testing in accordance with the provisions of § 790.25 of part 790 of this chapter, are exempt from the list submission requirements of § 716.35.

(3) Except for those studies described in paragraph (a)(2) of this section, studies previously submitted to any Federal agency with no claims of confidentiality are exempt only from the copy submission requirements of § 716.30, and must be listed in accordance with the provisions of § 716.35.

(4) Studies conducted or initiated by or for another person who is subject to, and who will report the studies under §§ 716.30 and 716.35.

(5) This exemption applies only to those substances within categories listed under § 716.120(c).

(6) The following types of studies when the subject of the study is a mixture known to contain a substance or listed mixture listed under § 716.120.

(7) Analyzed aggregations of monitoring data based on monitoring data acquired more than 5 years preceding the date the substance or listed mixture was added to the list under § 716.120.

(8) Analyzed aggregations of monitoring data on mixtures known to contain one or more substances or listed mixtures listed in § 716.120, when the monitoring data are not analyzed to determine the exposure or concentration levels of the substances or listed mixture listed under § 716.120.

(9) Studies on a substance or listed mixture listed under § 716.120 that the person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as an impurity. When reporting of such studies is to be required, that reporting will be separately proposed in the Federal Register.

(10) Studies of chemical substances or listed mixtures previously submitted by trade associations in accordance with the provisions of § 716.30.

(10) For purposes of this paragraph, the term organohalogen flame retardant includes any substances listed in paragraph(d) of this section under the category “Organohalogen flame retardants”. For any organohalogen flame retardant, all unpublished studies on health effects (including toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity); toxicokinetics (absorption, distribution, metabolism, or elimination), including modelling studies, in humans or animals; environmental fate; physical-chemical properties if performed as described in 40 CFR 716.50; and occupational (both users and non-users), general population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the organohalogen flame retardant in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter's own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies requirements under 40 CFR 716.35 and the submission of studies requirements under this rule.

EPA may, by letter, request a person to submit or make available for review the following information after the initial reporting under §§ 716.30 and 716.35. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.

(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.

(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) Submission of underlying data of the kind described in § 716.10(a)(4) by persons who submit copies of studies under § 716.30 or list studies under § 716.35(a)(1) or § 716.35(a)(2).

(2) Persons must submit studies listed as ongoing or initiated under § 716.35(a)(1) and (2) within 30 days of completing the study, using the method specified in §§ 716.30(c) and 716.35(c).

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.

(a) Submission of underlying data of the kind described in § 716.10(a)(4) by persons who submit copies of studies under § 716.30 or list studies under § 716.35(a)(1) or § 716.35(a)(2).

(1) Persons subject to the listing requirements of § 716.35(a)(2) must inform EPA of the initiated study within 30 days of its initiation.

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.

(c) Submission of copies of studies by persons listed under § 716.35(a)(3) as possessing them.

(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.