(a) A submission under this part is not complete, and the review period does not begin, if:
(1) The wrong person files the submission.
(2) The submitter does not attach and sign the certification statement as required by § 725.25(b).
(3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature.
(4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of the Act and § 725.160 or 725.260, as appropriate.
(5) The submitter does not provide information required by § 725.25, § 725.155, § 725.255, § 725.355, or § 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter.
(6) The submitter has asserted confidentiality claims and has failed to:
(i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by § 725.80(b)(2).
(ii) Comply with the substantiation requirements as described in § 725.94.
(7) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 725.25(f).
(8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in § 725.25(g).
(9) The submitter does not remit the fees required by § 700.45(c) of this chapter.
(10) The submitter does not include an identifying number and a payment identity number.
(11) The submitter does not submit the notice in the manner set forth in § 725.25(c).
(b)
(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission.
(2) If EPA obtains additional information during the review period for any submission that indicates the original submission was incomplete, the Director, or a designee, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.
(c) The notification that a submission is incomplete under paragraph (b) of this section will include:
(1) A statement of the basis of EPA's determination that the submission is incomplete.
(2) The requirements for correcting the incomplete submission.
(3) Information on procedures under paragraph (d) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.
(d) Within 10 days after receipt of notification by EPA that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submission as complete or modify the requirements necessary to complete the submission.
(e)
(1) EPA will consider the objections filed by the submitter. The Director, or a designee, will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within 10 days of receiving the objections.
(2) If the Director, or a designee, determines, in response to the objection, that the submission was complete, the review period will be deemed suspended on the date EPA declared the submission incomplete, and will resume on the date that the submission is declared complete. The submitter need not correct the submission as EPA originally requested. If EPA can complete its review within the review period beginning on the date of the submission, the Director, or a designee, may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.
(3) If the Director, or a designee, modifies the requirements for completing the submission or concurs with EPA's original determination, the review period will begin when EPA receives a complete submission.
(f) If EPA discovers at any time that a person submitted materially false or misleading statements in information submitted under this part, EPA may find that the submission was incomplete from the date it was submitted, and take any other appropriate action.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 83 FR 52723, Oct. 17, 2018]