Agency review of SNAP submissions.

§ 82.180 Agency review of SNAP submissions.

(a) Processing of SNAP notices—(1) 90-day review process. The 90-day review process will begin once EPA receives a submission and determines that such submission includes data on the substitute that are complete and adequate, as described in § 82.178. The Agency may suspend or extend the review period to allow for submission of additional data needed to complete the review of the notice.

(2) Initial review of notice. The SNAP Document Control Officer will review the notice to ensure that basic information necessary to process the submission is present (i.e., name of company, identification of substitute, etc.). The SNAP Document Control Officer will also review substantiation of any claim of confidentiality.

(3) Determination of data adequacy. Upon receipt of the SNAP submission, the Agency will review the completeness of the information supporting the application. If additional data are needed, the submitter will be contacted following completion of this review. The 90-day review period will not commence until EPA has received data it judges adequate to support analysis of the submission.

(4) Letter of receipt. The SNAP Document Control Officer will send a letter of receipt to the submitter to confirm the date of notification and the beginning of EPA's 90-day review period. The SNAP Document Control Officer will also assign the SNAP notice a tracking number, which will be identified in the letter of receipt.

(5) Availability of new information during review period. If critical new information becomes available during the review period that may influence the Agency's evaluation of a substitute, the submitter must notify the Agency about the existence of such information within 10 days of learning of such data. The submitter must also inform the Agency of new studies underway, even if the results will not be available within the 90-day review period. The Agency may contact the submitter to explore extending or suspending the review period depending on the type of information received and the stage of review.

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