This subpart establishes procedures that EPA will follow in reviewing notices.

When EPA receives a notice, EPA will review it to determine whether the chemical substance is subject to the requirements of this part. If EPA determines that the chemical substance is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture or import of the substance and that the submission is not a notice under this part.

(a) Notification to the submitter. (1) 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 applicable review period begins as described in paragraph (a)(2) of this section.

(2) Before EPA sends an acknowledgement of receipt of a notice pursuant to paragraph (a)(1) of this section, EPA will conduct a pre-screen of the notice, typically taking 2-3 days and according to the criteria under paragraphs (b)(1) and (c)(1) of this section.

(i) If EPA concludes that the notice contains errors warranting remedy or is incomplete, EPA will notify the submitter according to paragraph (d)(3) of this section. The applicable review period will not begin. Once the submitter corrects the errors or incomplete submission according to the requirements provided by EPA and re-submits the notice to EPA, EPA will follow the procedures of paragraph (a)(2) of this section.

(ii) If EPA does not identify errors or determine the notice to be incomplete during screening, EPA will notify the submitter according to paragraph (a)(1) of this section. The applicable review period will begin on the date EPA received the complete notice.

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

(ii) Contradictory information.

(iii) Ambiguous statements or information.

(2) The applicable review period does not begin for notices containing errors that EPA asks the submitter to remedy until corrections are made following the procedures of paragraph (d) of this section.

(c) Incomplete submissions. (1) A submission is not complete, and the applicable review 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 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 § 703.5(c).

(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 § 700.45(e)(3).

(2) The submission may be declared incomplete if at any time during the applicable review period the submitter submits additional or revised information without demonstrating to EPA's satisfaction that the additional or revised information in the amended notice was not known to or reasonably ascertainable by the submitter at the time of initial notice submission (e.g., new information as described in § 720.40(f) or information from testing in progress at the time of the original submission, as described in § 720.50(a)(4)), unless it relates to administrative or non-substantive amendments (e.g., changing the technical point of contact) or amendments made at the request of EPA.

(d) Corrections to errors in the notice or incomplete submissions. (1) If EPA receives an incomplete submission or seeks remedy of errors identified in a notice, EPA will notify the submitter within 30 days of receipt that the submission contains errors or is incomplete and that the applicable review period will not begin until EPA receives a correct and complete notice.

(2) If EPA obtains additional information during the applicable review period that indicates the original submission was incomplete, EPA 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 contains errors or is incomplete under paragraph (d)(1) or (2) of this section will include:

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

(ii) The requirements for correcting the errors or incomplete submission.

(iii) Information on procedures under paragraph (d)(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 contains errors or 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) EPA will consider the objections filed by the submitter and determine:

(i) 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 EPA determines, in response to the objection, that the submission was complete, the applicable 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, EPA may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.

(iii) If EPA modifies the requirements for completing the submission or affirms its original determination that the submission contains errors or is incomplete, or if no objections are filed, the applicable review period will begin (or if previously begun, will restart at Day 1) when EPA receives a complete notice.

(e) Materially false or misleading statements. If EPA discovers at any time that a 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.

(a) Filing notice of receipt. In accordance with section 5(d)(2) of the Act, after EPA has received a complete notice, EPA will file a notice of receipt with the Office of the Federal Register including the information specified in paragraph (b) of this section.

(b) Contents of notice. (1) In the public interest, the specific chemical identity listed in the notice will be published in the Federal Register unless the submitter has claimed chemical identity confidential. If the submitter claims confidentiality, a generic name will be published in accordance with § 720.85(a)(3).

(2) The categories of use of the new chemical substance will be published as reported in the notice unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under § 720.87(b) will be published.

(3) For test data submitted in accordance with § 720.40(g), a summary of the data received will be published.

(4) The submitter's identity will be published, unless the submitter has claimed it confidential.

(a) Length of applicable review period. The applicable review period specified in section 5(a) of the Act runs for 90 days from the date EPA receives a complete notice, or the date EPA determines the notice is complete under § 720.65(d), unless the Agency extends the applicable review period under section 5(c) of the Act and paragraph (c) of this section.

(b) Suspension of the running of the applicable review period. (1) A submitter may voluntarily suspend the running of the applicable review period if EPA agrees. If EPA 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 applicable review period. The suspension must be for a specified period of time.

(2) Requests for suspensions. (i) A request for a suspension of 30 days or less may be made orally, including by telephone, or in writing, including by e-mail, to the submitter's EPA contact for that notice. Any request for a suspension exceeding 30 days must be submitted in the manner set forth in paragraph (b)(2)(ii) of this section. The running of the applicable review period will be suspended upon approval of the oral or written request by EPA.

(ii) Requests for suspensions exceeding 30 days must be submitted electronically to EPA via CDX using e-PMN software. Requests for suspensions of 30 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 applicable review period will be suspended upon approval of the request submitted electronically to EPA via CDX using e-PMN software by EPA.

(c) Extension of applicable review period. (1) At any time during the applicable review period, EPA may determine that good cause exists to extend the applicable 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 applicable 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 applicable 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 applicable 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 applicable review period, which was not known to or reasonably ascertainable by the submitter at the time of initial notice submission.

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

(d) Determinations. (1) Within the applicable review period, EPA will make one of the following five determinations, as set forth in section 5(a)(3) of the Act:

(i) The chemical substance presents an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(A) of the Act.

(ii) Information available to EPA is insufficient to permit a reasoned evaluation of the health and the environmental effects of the relevant chemical substance, as set forth in section 5(a)(3)(B)(i) of the Act.

(iii) In the absence of sufficient information to permit EPA to make such an evaluation, the chemical substance may present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(B)(ii)(I) of the Act.

(iv) The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.

(v) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(C) of the Act.

(2) EPA will take the following actions required in association with the determination:

(i) For determinations described in paragraph (d)(1)(i) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(f) of the Act, or will issue a proposed rule under section 6(a) of the Act, as set forth in section 5(f) of the Act.

(ii) For determinations described in paragraphs (d)(1)(ii), (iii), or (iv) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(e) of the Act. EPA may issue an order under section 5(e) of the Act that requires certain testing to be conducted and presented to EPA after the applicable review period has concluded.

(iii) For determinations described in paragraph (d)(1)(v) of this section, EPA will issue the submitter a document containing EPA's final determination and will submit for publication in the Federal Register a statement of the finding, as set forth in section 5(g) of the Act. Upon EPA's issuance of the determination document, the submitter may commence the manufacture of the chemical substance without waiting for the end of the applicable review period.

(3) EPA may modify or revoke the prohibitions and limitations in an order issued under paragraph (d)(2)(i) or (ii) of this section after the applicable review period has ended if EPA receives additional testing, studies, reports, or other information that EPA determines, upon review, demonstrate that such prohibitions or limitations are no longer necessary to protect against an unreasonable risk of injury to health or the environment. Where such information demonstrates that the prohibitions or limitations of the order are not sufficient to protect against an unreasonable risk of injury to health or the environment, EPA may modify the order or take other action, as appropriate, to the extent necessary to protect against such risk.

(4) No person submitting a notice in response to the requirements of this part may manufacture a chemical substance subject to this part until EPA has issued a determination in accordance with paragraph (d)(1) of this section and taken the associated action required under paragraph (d)(2) of this section.

(e) Withdrawal of a notice by the submitter. (1)(i) A submitter may withdraw a notice during the applicable 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 applicable review period begins.

(a) Any person who submits a notice under this part must retain documentation of information in the notice, including (1) other data, as defined in § 720.50(b), in the submitter's possession or control; and (2) records of production volume for the first three years of production or import, the date of commencement of manufacture or import, and documentation of this information. This information must be retained for five years from the date of commencement of manufacture of import.

(b)(1) Persons who manufacture a chemical substance under § 720.36 must retain the following records:

(i) Copies of, or citations to, information reviewed and evaluated under § 720.36(b)(1) to determine the need to make any notification of risk.

(ii) Documentation of the nature and method of notification under § 720.36(c)(1) including copies of any labels or written notices used.

(iii) Documentation of prudent laboratory practices used instead of notification and evaluation under § 720.36(b)(2).

(iv) The names and addresses of any persons other than the manufacturer or importer to whom the substance is distributed, the identity of the substance to the extent known, the amount distributed, and copies of the notifications required under § 720.36(c)(2). These records are not required when substances are distributed as impurities or incorporated into an article, in accordance with paragraph (d) of this section.

(2) A person who manufactures a chemical substance under § 720.36 and who manufactures the substance in quantities greater than 100 kilograms per year must retain records of the identity of the substance to the extent known, the production volume of the substance, and the person's disposition of the substance. The person is not required to maintain records of the disposition of products containing the substance as an impurity or of articles incorporating the substances.

(3) Records under this paragraph must be retained for 5 years after they are developed.

(c) Any person who obtains a test-marketing exemption under this part must retain documentation of information in the application and documentation of compliance with any restrictions imposed by EPA when it granted the application. This information must be retained for five years from the final date of manufacture under the exemption.