§ 720.75 - Notice review period.

§ 720.75 Notice review period.

(a) Length of notice review period. The notice review period specified in section 5(a) of the Act runs for 90 days from the date the Document Control Officer for the Office of Pollution Prevention and Toxics receives a complete notice, or the date EPA determines the notice is complete under § 720.65(c), unless the Agency extends the period under section 5(c) of TSCA and paragraph (c) of this section.

(b) Suspension of the running of the notice review period.

(1) A submitter may voluntarily suspend the running of the notice review period if the Director or his or her delegate agrees. If the Director does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the notice review period. The suspension must be for a specified period of time.

(2)

(i) Oral requests. A request for a suspension of 15 days or less may be made orally, including by telephone, to the submitter's EPA contact for that notice. Any request for a suspension exceeding 15 days must be submitted in the manner set forth in paragraph (b)(2)(ii) of this section. The running of the notice review period will be suspended upon approval of the oral request by the Director or her or his delegate.

(ii) Written requests. Requests for suspensions exceeding 15 days must be submitted electronically to EPA via CDX using e-PMN software. Requests for suspensions of 15 days or less may also be submitted electronically to EPA via CDX using e-PMN software. See § 720.40(a)(2)(ii) for information on how to access the e-PMN software. The running of the notice review period will be suspended upon approval of the written request by the Director or her or his delegate.

(c) Extension of notice review period.

(1) At any time during the notice review period, EPA may determine that good cause exists to extend the notice review period specified in paragraph (a) of this section.

(2) If EPA makes such a determination, EPA will:

(i) Notify the submitter that EPA is extending the notice review period for a specified length of time, and state the reasons for the extension.

(ii) Issue a notice for publication in the Federal Register which states that EPA is extending the notice review period and gives the reasons for the extension.

(3) The initial extension may be for a period of up to 90 days. If the initial extension is for less than 90 days, EPA may make additional extensions. However, the total period of extensions may not exceed 90 days for any notice.

(4) The following are examples of situations in which EPA may find that good cause exists for extending the notice review period:

(i) EPA has reviewed the notice and determined that there is a significant possibility that the chemical substance will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial 90-day period.

(ii) EPA has reviewed the submission and is seeking additional information.

(iii) EPA has received significant additional information during the notice review period.

(iv) The submitter has failed to correct a notice after receiving EPA's request under § 720.65(b).

(d) Notice of expiration of notice review period. EPA will notify the submitter that the notice review period has expired or that EPA has completed its review of the notice. Expiration of the review period does not constitute EPA approval or certification of the new chemical substance, and does not mean that EPA may not take regulatory action against the substance in the future. After expiration of the statutory notice review period, in the absence of regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the chemical substance even if the submitter has not received notice of expiration.

(e) Withdrawal of a notice by the submitter.

(1)

(i) A submitter may withdraw a notice during the notice review period by submitting a statement of withdrawal in a manner set forth in this paragraph. The withdrawal is effective upon receipt by EPA of the CDX submission.

(ii) Submission of withdrawal notices. EPA will accept statements of withdrawal only if submitted in accordance with this paragraph. Statements of withdrawal must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See § 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(2) If a manufacturer (including importer) which withdrew a notice later resubmits a notice for the same chemical substance, a new notice review period begins.

[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995; 71 FR 33641, June 12, 2006; 75 FR 786, Jan. 6, 2010; 78 FR 72827, Dec. 4, 2013; 80 FR 42746, July 20, 2015]