§720.50. Submission of test data and other data concerning the health and environmental effects of a substance. — Inbound Citations

(1) Each person who submits a notice must provide the information described in § 720.45 and specified on the notice form, to the extent such information is known to or reasonably ascertainable by the person. In accordance with § 720.50, the notice must also include any test data in the person's possession or control, and descriptions of other data which are known to or reasonably ascertainable by the person and which concern the health and environmental effects of the new chemical substance.

(v) The submitter does not provide information that is required by section 5(d)(1)(B) and (C) of the Act and § 720.50.

(x) Test data (§ 720.50).

(g) Submitters of health and safety studies or information from such studies must provide such data in templated form, using an appropriate OECD harmonized template, if such template is available for the data type (https://www.oecd.org/ehs/templates/). Individual test or data submission rules or orders may specify an appropriate template or templates. Submission of templated data is not a substitute for submitting a full study report where a specific TSCA rule or order requires submission of the full study report (e.g., § 720.50(a) of this subchapter, or according to the terms of a specific order under section 5(e) of the Act).

(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.

(2) The submission may be declared incomplete if at any time during the applicable review period the submitter submits additional or revised information without demonstrating to EPA's satisfaction that the additional or revised information in the amended notice was not known to or reasonably ascertainable by the submitter at the time of initial notice submission (e.g., new information as described in § 720.40(f) or information from testing in progress at the time of the original submission, as described in § 720.50(a)(4)), unless it relates to administrative or non-substantive amendments (e.g., changing the technical point of contact) or amendments made at the request of EPA.

(a) Any person who submits a notice under this part must retain documentation of information in the notice, including (1) other data, as defined in § 720.50(b), in the submitter's possession or control; and (2) records of production volume for the first three years of production or import, the date of commencement of manufacture or import, and documentation of this information. This information must be retained for five years from the date of commencement of manufacture of import.

(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.