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40 C.F.R. § 721.537

Organosilane ester.

§ 721.537 Organosilane ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as an organosilane ester (PMN P-96-1661/P-95-1654) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(r) (370,000 kilogram (kg)) (90-day subchronic inhalation study in rats-(40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5). A person may not manufacture or import the substance beyond the aggregate production volume limit, unless that person conducts this study on the substance and submits all final reports and underlying data in accordance with the procedures and criteria specified in paragraphs (a)(2)(i)(A), (a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) of this section.

(A) Each study required to be performed pursuant to this section must be scientifically valid. Scientific valid means that the study was conducted according to:

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