§158.32. Format of data submissions. — Inbound Citations

(c) Each application must include a list of the data submitted with the application, together with a brief description of the results of the studies. The list of data submitted may be the same as the list required by § 158.32 or § 161.32, as applicable, of this chapter. The summary must state that it is releasable to the public after registration in accordance with § 152.119.

(2) Upon submission to EPA, each document must be accompanied by a signed and dated document containing either the statements in paragraph (c)(2)(i) or (ii) of this section. No claims or markings on the document or any attachments, other than these statements and attachments submitted in accordance with paragraph (c)(3) of this section, will be recognized as asserting a claim of confidentiality. The format of data submissions is set forth in § 158.32.

(e) In submitting scientific studies, follow the procedures set forth in § 158.32 or § 161.32 of this chapter, as applicable.

(c) A Notification submitted under this section must comply with the following procedures, but is not required to comply with the format and other provisions governing submission of data in §§ 158.32 and 158.33 or §§ 161.32 and 161.33 of this chapter. However, because data submitted with the Notification may subsequently be used to support other regulatory actions (e.g., used in EUP or registration applications), it is recommended that such data comply with EPA requirements in §§ 158.32 and 158.33 of this chapter.

(1) Each Notification must be accompanied by a transmittal document that clearly identifies the EPA action supported as a Biotechnology Notification Review.

(2) Five copies of each Notification must be submitted to EPA.

(3) Any claims of confidentiality for information submitted in the Notification must be made as described in paragraph (d) of this section.