§720.40. General. — Inbound Citations

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

(2) If information is claimed as confidential pursuant to § 720.80, a person who submits a notice to EPA in the manner set forth in § 720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a sanitized copy.

(1) Any affected person may request modification or revocation of significant new use notification requirements for a chemical substance that has been added to subpart E of this part using the procedures described in § 721.160 or § 721.170 by submitting a request that is accompanied by information sufficient to support the request. Persons submitting a request to EPA under this part must submit the request to EPA using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain the e-PMN software. Support documents related to these requests must also be submitted to EPA in the manner set forth in 40 CFR 720.40(c).

(b) Persons submitting a request for a determination of equivalency to EPA under this part must submit the request to EPA via CDX using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must be submitted in the manner set forth in 40 CFR 720.40(c). A request for a determination of equivalency must contain:

(3) The citation for the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(5) The specifications of the alternative worker exposure control measures or environmental release control measures.

(6) An analysis justifying why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.

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

(2) To establish a bona fide intent to manufacture (including import) a chemical substance, the person who proposes to manufacture the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) must be generated and completed using e-PMN software. See § 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) must contain:

(i) Except as provided in paragraphs (b)(3)(i) and (ii) of this section, the specific chemical identity of the substance that the person intends to manufacture (including import), using the currently correct CA Index name for the substance and the other correct chemical identity information in accordance with § 720.45(a) (1), (2), and (3).

(ii) A signed statement that the person intends to manufacture (including import) that chemical substance for commercial purposes.

(A) A brief description of the research and development activities conducted to date related to the substance, including the year in which the person first started to conduct research or development activity on the substance, and the general types of research and development activities conducted thus far (e.g., synthesis, substance isolation/purification, formulating, product development, process development, end-use application, toxicity testing, etc.). The person must also indicate whether any pilot plant or production-scale plant evaluations have been conducted involving the manufacture or processing of the substance.

(B) If an importer is unable to provide the information requested in paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer or supplier, the following information shall be submitted:

(1) A brief statement indicating how long the substance has been in commercial use outside of the United States.

(2) The name of a country in which it has been commercially used.

(3) Whether the importer believes that the substance has already been used commercially, in any country, for the same purpose or application that the importer is intending.

(v) An infrared spectrum of the substance, or alternative spectra or other data which identify the substance if infrared analysis is not suitable for the substance or does not yield a reasonable amount of structural information. When using alternative spectra or instrumental analysis, the person must submit a spectrum or instrumental readout for the substance.

(vi) The estimated date (month/year) in which the person intends to submit a Premanufacture Notice (PMN) for this substance if EPA informs the notice submitter that the substance is not on the Inventory.

(vii) The address of the facility under the control of the submitter at which the manufacture or processing of the substance would most likely occur. For an imported substance, the facility under the control of the importer at which processing of the substance would likely occur, if any.

(A) For substances intended to be manufactured in the United States, a description of the most probable manufacturing process that would be used by the submitter to produce the substance for non-exempt commercial purposes.

(B) For substances intended to be imported, a brief description of how the submitter is most likely to process or use the substance for a commercial purpose. If the substance is not expected to be processed or used at any facility under the importer's control, a statement to this effect must be included along with a description of how the substance will be processed or used at sites controlled by others, if this information is known or reasonably ascertainable.

(2) If information is claimed as confidential pursuant to § 720.80, a person who submits a notice to EPA in the manner set forth in § 720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a sanitized copy.

(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.

(b) To establish a bona fide intent to manufacture (including import) or process a chemical substance, the person who proposes to manufacture (including import) or process the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) or process must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) or process must contain:

(1) The specific chemical identity of the chemical substance that the person intends to manufacture (including import) or process.

(2) A signed statement that the person intends to manufacture (including import) or process the chemical substance for commercial purposes.

(3) A description of the research and development activities conducted to date, and the purpose for which the person will manufacture (including import) or process the chemical substance.

(5) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum of the particular chemical substance, or, if such data do not resolve uncertainties with respect to the identity of the chemical substance, additional or alternative spectra or other data to identify the substance.

(1) Any affected person may request modification or revocation of significant new use notification requirements for a chemical substance that has been added to subpart E of this part using the procedures described in § 721.160 or § 721.170 by submitting a request that is accompanied by information sufficient to support the request. Persons submitting a request to EPA under this part must submit the request to EPA using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain the e-PMN software. Support documents related to these requests must also be submitted to EPA in the manner set forth in 40 CFR 720.40(c).

(b) Persons submitting a request for a determination of equivalency to EPA under this part must submit the request to EPA via CDX using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must be submitted in the manner set forth in 40 CFR 720.40(c). A request for a determination of equivalency must contain:

(3) The citation for the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(5) The specifications of the alternative worker exposure control measures or environmental release control measures.

(6) An analysis justifying why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.

(f) For substances exempt under paragraphs (e)(1) through (3) of this section a report of manufacture or import must be submitted by January 31 of the year subsequent to initial manufacture, except that for initial manufacture or import in 2023 the report must be submitted by March 31, 2024. The report and accompanying claims must be submitted via CDX (https://cdx.epa.gov/), using the TSCA Section 5 Notices and Supports—ePMN application. See § 720.40(a)(2)(ii) of this subchapter for information on how to access e-PMN software. The notice must include:

(1) This includes the name and address of the manufacturer and the name and telephone number of a technical contact.

(2) Number of substances manufactured. The manufacturer must identify the number of polymers manufactured under terms of the exemption for the first time in the year preceding the notice.

(1) A manufacturer applying for an exemption under either paragraph (c)(1) or (c)(2) of this section must submit an exemption notice to EPA at least 30 days before manufacture of the new chemical substance begins. Exemption notices and modifications must be submitted to EPA on EPA Form No. 7710-25 via CDX using e-PMN software in the manner set forth in this paragraph. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Notices and any related support documents, must be generated and completed (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(2) To establish a bona fide intent to manufacture (including import) or process a microorganism, the person who proposes to manufacture (including import) or process the microorganism must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) or process must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) or process must contain the following information:

(i) Taxonomic designations and supplemental information required by § 725.12.

(ii) A signed statement certifying that the submitter intends to manufacture (including import) or process the microorganism for commercial purposes.

(iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture (including import) or process the microorganism.

(iv) An indication of whether a related microorganism was previously reviewed by EPA to the extent known by the submitter.

(d) All notices of commencement must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(c) MCANs and exemption requests, and any support documents related to these submissions, may only be submitted in a manner set forth in this paragraph. MCANs and exemption requests, and any related support documents, must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(2) EPA will accept requests for suspension only if submitted in accordance with this paragraph. Requests for suspension, must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(2) 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 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(b) Persons submitting a request for a determination of equivalency to EPA under this part must submit the request to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software. A request for a determination of equivalency must contain:

(3) The citation for the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted.

(5) The specifications of the alternative worker exposure control measures or environmental release control measures.

(6) A detailed analysis explaining why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted.

(7) The data and information described in §§ 725.155 and 725.160. If such data and information have already been submitted to EPA's Office of Pollution Prevention and Toxics, the submitter need only document that it was previously submitted, to whom, and the date it was submitted.

(1) Any affected person may request modification or revocation of significant new use notification requirements for a microorganism that has been added to subpart M of this part using the procedures described in § 725.980. The request must be accompanied by information sufficient to support the request. Persons submitting a request to EPA under this part must submit the request to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software.

(2) If information is claimed as confidential pursuant to § 720.80, a person who submits a notice to EPA in the manner set forth in § 720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a sanitized copy.

(1) The notice must be submitted on EPA Form 7710-56, which is available as part of EPA's e-PMN software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software. The form must be signed and dated by an Authorized Official (AO). All information specified on the form must be provided. The notice must contain the following information:

(iv) The date of commencement for the submitter's manufacture for a non-exempt commercial purpose (indicating whether the substance was initially manufactured in the United States or imported). The date of commencement is the date of completion of non-exempt manufacture of the first amount (batch, drum, etc.) of new chemical substance identified in the submitter's PMN. For importers, the date of commencement is the date the new chemical substance clears United States customs.

(ix) Clear indications of whether the chemical identity, submitter identity, and/or other information are claimed as confidential by the submitter.

(1) Any affected person may request modification or revocation of significant new use notification requirements for a chemical substance that has been added to subpart E of this part using the procedures described in § 721.160 or § 721.170 by submitting a request that is accompanied by information sufficient to support the request. Persons submitting a request to EPA under this part must submit the request to EPA using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain the e-PMN software. Support documents related to these requests must also be submitted to EPA in the manner set forth in 40 CFR 720.40(c).

(b) Persons submitting a request for a determination of equivalency to EPA under this part must submit the request to EPA via CDX using e-PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must be submitted in the manner set forth in 40 CFR 720.40(c). A request for a determination of equivalency must contain:

(3) The citation for the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(5) The specifications of the alternative worker exposure control measures or environmental release control measures.

(6) An analysis justifying why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.

(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.

(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.

(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).

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

(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).