40 CFR § 720.65 - Acknowledgement of receipt of a notice; errors in the notice; incomplete submissions; and false and misleading statements.

§ 720.65 Acknowledgement of receipt of a notice; errors in the notice; incomplete submissions; and false and misleading statements.

(a)Notification to the submitter.EPA will acknowledge receipt of each notice by sending a letter via CDX or U.S. mail to the submitter that identifies the premanufacture notice number assigned to the new chemical substance and date on which the review period begins. The review period will begin on the date the notice is received by the Office of Pollution Prevention and Toxics Document Control Officer. The acknowledgment does not constitute a finding by EPA that the notice, as submitted, is in compliance with this part.

(b)Errors in the notice.

(1) Within 30 days of receipt of the notice, EPA may request that the submitter remedy errors in the notice. The following are examples of such errors:

(i) Failure to date the notice form.

(ii) Typographical errors that cause data to be misleading or answers to any questions to be unclear.

(iii) Contradictory information.

(iv) Ambiguous statements or information.

(2) In the request to correct the notice, EPA will explain the action which the submitter must take to correct the notice.

(3) If the submitter fails to correct the notice within 15 days of receipt of the request, EPA may extend the notice period under section (5)(c) of the Act, in accordance with § 720.75(c).

(c)Incomplete submissions.

(1) A submission is not complete, and the notification period does not begin, if:

(i) The wrong person submits the notice form.

(ii) The submitter does not sign the notice form.

(iii) Some or all of the information in the notice or the attachments are not in English, except for published scientific literature.

(iv) The submitter does not submit the notice in the manner set forth in § 720.40(a)(2).

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

(vi) The submitter does not provide information required on the notice form and by § 720.45 or indicate that it is not known to or reasonably ascertainable by the submitter.

(vii) The submitter does not submit a second copy of the submission with all confidential information deleted for the public file, as required by § 720.80(b)(2).

(viii) 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 § 720.40(g).

(ix) The submitter does not submit data which the submitter believes show that the chemical substance will not present an unreasonable risk of injury to health or the environment, if EPA has listed the chemical substance under section 5(b)(4) of the Act, as required in § 720.40(h).

(x) The submitter does not include an identifying number and a payment identity number as required by 40 CFR 700.45(e)(3).

(2)

(i) If EPA receives an incomplete submission, the Director, or his or her delegate, will notify the submitter within 30 days of receipt that the submission is incomplete and that the notice review period will not begin until EPA receives a complete notice.

(ii) If EPA obtains additional information during the notice review period that indicates the original submission was incomplete, the Director, or his or her delegate, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.

(3) The notification that a submission is incomplete under paragraph (c)(2) (i) or (ii) of this section will include:

(i) A statement of the basis of EPA's determination that the submission is incomplete.

(ii) The requirements for correcting the incomplete submission.

(iii) Information on procedures under paragraph (c)(4) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.

(4) Within ten 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 a complete notice or modify the requirements necessary to complete the submission.

(5)

(i)EPA will consider the objections filed by the submitter. The Director, or his or her delegate, 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 ten days of receiving the objections.

(ii) If the Director, or his or her delegate, determines, in response to the objection, that the submission was complete, the notice review period will be deemed suspended on the date EPA declared the notice incomplete, and will resume on the date that the notice is declared complete. The submitter need not correct the notice as EPA originally requested. If EPA can complete its review within 90 days from the date of the original submission, the Director, or his or her delegate, may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.

(iii) If the Director, or his or her delegate, modifies the requirements for completing the submission or concurs with EPA's original determination, the notice review period will begin when EPA receives a complete notice.

(d)Materially false or misleading statements. If EPA discovers at any time that person submitted materially false or misleading statements in the notice, EPA may find that the notice was incomplete from the date it was submitted, and take any other appropriate action.

[48 FR 21742, May 13, 1983, as amended at 75 FR 785, Jan. 6, 2010]