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)
A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, to the submitter's EPA contact for that notice, subject to paragraph (b)(3) of this section.
(i) Older notices.
Requests for suspension for premanufacture notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Newer notices.
For notices submitted on or after April 6, 2010, EPA will accept requests for suspension only if submitted in accordance with this paragraph:
(A)
Requests for suspension may be submitted on paper on or before April 6, 2011. All paper-based requests for suspension must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B)
Requests for suspension may be submitted as electronic files on optical disc on or before April 6, 2012. All requests for suspension submitted as electronic files on optical disc generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(C)
Requests for suspension may be submitted electronically to EPA via CDX. Such requests must be generated and completed using e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
(3)
An oral request for suspension may be granted by EPA for a maximum of 15 days only. Requests for a longer suspension must only be submitted in the manner set forth in this paragraph.
(4)
If the submitter has not made a previous oral request, the running of the notice review period is suspended as of the date of receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA.
(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.
(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.
(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)
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 of the written paper request, electronic request on optical disc, or CDX submission by EPA.
(i) Older notices.
Statements of withdrawal for premanufacture notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Newer notices.
For notices submitted on or after April 6, 2010, EPA will accept statements of withdrawal only if submitted in accordance with this paragraph:
(A)
Statements of withdrawal may be submitted on paper on or before April 6, 2011. All paper-based statements of withdrawal must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the statement of withdrawal for submission to EPA. Paper statements of withdrawal must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B)
Statements of withdrawal may be submitted as electronic files on optical disc on or before April 6, 2012. All statements of withdrawal submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic statements of withdrawal must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(C)
Statements of withdrawal may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such statements of withdrawal must be generated and completed using e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
(2)
If a manufacturer or importer which withdrew a notice later resubmits a notice for the same chemical substance, a new notice review period begins.