The following definitions also apply to subpart B of this part.

Active substance means any interim active substance, any naturally occurring chemical substance as defined by § 710.27(b), any chemical substance that was added to the Inventory on or after June 21, 2006 pursuant to a Notice of Commencement under § 720.102 received by the Agency on or after June 21, 2006, and any chemical substance subject to commercial activity designation that the Administrator designates as active based on the receipt of a notice under this subpart.

Central Data Exchange or CDX means EPA's centralized electronic document reporting portal, or its successors.

Chemical Information Submission System or CISS means EPA's web-based reporting tool for preparing and submitting a Notice of Activity.

Chemical substance subject to commercial activity designation means a chemical substance that requires a designation as either an active or an inactive substance. A chemical substance is subject to commercial activity designation if it is not an interim active substance, it was added to the Inventory before June 21, 2006, it is not a naturally occurring chemical substance as defined by § 710.27(b), and it has not yet been designated by the Administrator as either an active or an inactive substance.

e-NOA means EPA's software module within CISS for generating and completing Notice of Activity Forms A and B.

Existing claim for protection of specific chemical identity against disclosure is a claim for protection of the specific chemical identity of a chemical substance that is listed on the confidential portion of the Inventory, asserted prior to June 22, 2016.

Inactive substance means any chemical substance subject to commercial activity designation, that the Administrator designates as inactive based on the lack of receipt of a notice under this subpart, effective 90 days after the Administrator identifies the chemical substance for such designation.

Interim active substance means any chemical substance that was reported, pursuant to 40 CFR part 711, as having been manufactured in and of the calendar years: 2010, 2011, 2012, 2013, 2014, or 2015.

Known to or reasonably ascertainable by means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

Notice of Activity Form A means the form for supplying retrospective notification under TSCA section 8(b)(4), for which the submission obligation is described in § 710.25(a).

Notice of Activity Form B means the form for supplying forward-looking reporting under TSCA section 8(b)(5), for which the submission obligation is described in § 710.25(c).

Lookback period means the period beginning on June 21, 2006 and ending on June 21, 2016.

Possession or Control means in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the chemical substance in question. Information is in the possession or control of a person if it is:

(1) In the person's own files including files maintained by employees of the person in the course of their employment.

(2) In commercially available data bases to which the person has purchased access.

(3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question.

Reportable chemical substance means a chemical substance that is listed on the Inventory and that is either:

(1) A chemical substance subject to commercial activity designation for which notification is required or allowed under § 710.25(a) and § 710.25(b),

(2) A chemical substance that was added to the confidential portion of the Inventory before June 22, 2016, or (3) an inactive substance for which notification is required under § 710.25(c).

Submission period means the applicable period for submitting a Notice of Activity under § 710.25.

The following persons are subject to the requirements of this subpart.

(a) Who must submit the Notice of Activity Form A? Any person who manufactured (including imported) a chemical substance subject to commercial activity designation at any time during the lookback period, except as provided in § 710.27, must submit a Notice of Activity Form A as specified under §§ 710.29 and 710.30(a), unless such person has evidence in the form of a CDX receipt, documenting EPA's receipt of a Notice of Activity Form A from another person, for the same chemical substance, or unless the prior manufacturing of such a substance is not known to or reasonably ascertainable by the person. Evidence in the form of a CDX receipt for a Notice of Activity Form A is not a basis for exemption from the requirements of § 710.25(c) if the chemical substance is ultimately designated as inactive due to withdrawal of the Notice of Activity Form A.

(b) Who else may submit the Notice of Activity Form A? Any person not required to submit a Notice of Activity Form A under § 710.25(a), who manufactured (including imported) or processed a reportable chemical substance, at any time during the lookback period, may submit a Notice of Activity Form A as specified under §§ 710.29 and 710.30(a).

(c) Who must submit the Notice of Activity Form B? Any person who intends to manufacture (including import) or process an inactive substance, except as provided in § 710.27, after the effective date of the Administrator's designation of such chemical substance as an inactive substance, must submit a Notice of Activity Form B as specified under §§ 710.29 and 710.30(b), unless the presence of the inactive substance on the confidential portion of the Inventory is not known to or reasonably ascertainable by the person.

(a) In general. The following activities do not trigger notification requirements under this subpart:

(1) The manufacturing or processing of a chemical substance in small quantities solely for research and development.

(2) The import or processing of a chemical substance as part of an article.

(3) The manufacturing or processing of a chemical substance as described in § 720.30(g) or (h).

(4) The manufacturing or processing of a chemical substance solely for export from the United States as described in § 720.30(e) or § 721.3, except where the Administrator has made a finding described in TSCA section 12(a)(2).

(5) The manufacturing or processing of a chemical substance solely for test marketing purposes.

(b) Manufacturing or processing naturally occurring chemical substances. The following activities do not trigger notification requirements under this subpart:

(1) The manufacture of a naturally occurring chemical substance, as described in § 710.4(b). Some chemical substances can be manufactured both as described in § 710.4(b) and by means other than those described in § 710.4(b). If a person manufactures a chemical substance by means other than those described in § 710.4(b), this exemption is inapplicable, regardless of whether the chemical substance also could have been produced as described in § 710.4(b). This exemption does not cover the manufacture of a chemical substance from a naturally occurring chemical substance.

(2) The processing of a naturally occurring chemical substance only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water.

(a) Reporting information to EPA. A person who reports information to EPA under this subpart must do so using the e-NOA software module, the CISS reporting tool, and the CDX electronic reporting portal provided by EPA at the addresses set forth in § 710.39. For notices of activity under §§ 710.25(a) and 710.25(b), the submission must include all information described in paragraph (b) of this section. For a Notice of Activity under § 710.25(c), the submission must include all information described in paragraph (c) of this section. A person must submit a separate notice for each chemical substance that the person is required to report. Using e-NOA and CISS and registering in CDX are described in instructions available from EPA at the Web sites set forth in § 710.39.

(b) Information to be reported on the Notice of Activity Form A. A person submitting a Notice of Activity Form A under § 710.25(a) or § 710.25(b) must submit the information specified in § 710.29(d) for each reportable chemical substance. A person submitting information under § 710.25(a) or § 710.25(b) must report information to the extent that such information is known to or reasonably ascertainable by that person.

(c) Information to be reported on a Notice of Activity Form B. Any person submitting a Notice of Activity Form B under § 710.25(c) must provide the information described in this paragraph for each inactive substance intended to be manufactured or processed.

(1) Information specified in § 710.29(d).

(2) The anticipated date by which the inactive substance is to be manufactured or processed in the United States. If the Notice of Activity Form B is filed prior to the effective date of the chemical substance's inactive designation, the most recent date of manufacturing or processing may be provided in lieu of an anticipated date.

(d) Information to be reported on either the Notice of Activity Form A or Form B.

(1) Company. The name and address of the submitting company.

(2) Authorized official. The name and address of the authorized official for the submitting company.

(3) Technical contact. The name and telephone number of a person who will serve as technical contact for the submitting company and who will be able to answer questions about the information submitted by the company to EPA.

(4) Chemical-specific information. The system described under § 710.29(a) will provide a list of reportable chemical substances from which a person can select his or her chemical. The list will include the correct CASRN and CA Index name used to list a non-confidential chemical substance on the Inventory. For confidential substances on the Inventory, the list will include the TSCA Accession Number and generic name.

(i) If an importer submitting a notice cannot provide the information specified in § 710.29(d)(4) because it is unknown to the importer and claimed as confidential by the supplier of the chemical substance or mixture, the importer must ask the supplier to provide the specific chemical identity information directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must refer the supplier to EPA's instructions for submitting chemical identity information electronically, using e-NOA, CISS, and CDX (see § 710.39), and for clearly referencing the importer's submission. Contact information for the supplier, a trade name or other name for the chemical substance or mixture, and a copy of the request to the supplier must be included with the importer's submission.

(ii) If a manufacturer or processor submitting a notice cannot provide the information specified in § 710.29(d)(4) because the reportable chemical substance is manufactured or processed using a reactant having a specific chemical identity that is unknown to the manufacturer or processor and claimed as confidential by its supplier, the manufacturer or processor must ask the supplier of the confidential reactant to provide the specific chemical identity of the confidential reactant directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must refer the supplier to EPA's instructions for submitting chemical identity information electronically using e-NOA, CISS, and CDX (see § 710.39), and for clearly referencing the manufacturer's or processor's submission. Contact information for the supplier, a trade name or other name for the chemical substance, and a copy of the request to the supplier must be included with the manufacturer's or processor's submission with respect to the chemical substance.

(iii) Joint submissions must be submitted electronically using e-NOA, CISS, and CDX (see § 710.39).

(5) Certification statements. The authorized official must certify that the submitted information has been completed in compliance with the requirements of this part as described in this paragraph.

(i) The certification must be signed and dated by the authorized official for the submitting company.

(ii) The following is required certification language for an authorized official submitting a Notice of Activity Form A under § 710.25(a) or § 710.25(b): “I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge, is true, accurate, and complete. I also certify that I have manufactured, imported, or processed the above chemical between the dates of June 21, 2006 and June 21, 2016. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.”

(iii) The following is required certification language for an authorized official submitting a Notice of Activity Form B under § 710.25(c): “I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge, is true, accurate, and complete. I also certify that I have intent to manufacture, import, or process the above chemical within 90 days of submission. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.”

(a) When must a Notice of Activity Form A be submitted? The Notice of Activity Form A required to be submitted under § 710.25(a) must be submitted during the applicable submission period.

(1) Manufacturers. The submission period for manufacturers under §§ 710.25(a) and 710.25(b) begins on August 11, 2017 and ends on February 7, 2018.

(2) Processors. The submission period for processors under § 710.25(b) begins on August 11, 2017 and ends on October 5, 2018.

(3) Withdrawal of a Notice of Activity Form A. A Notice of Activity Form A submitted under § 710.30(a)(1) or § 710.30(a)(2) may be withdrawn by the submitter no later than October 5, 2018. If EPA receives a timely request to withdraw a previously submitted Notice of Activity Form A for a chemical substance subject to commercial activity designation, and EPA has not received a Notice of Activity Form A from another submitter for the same chemical substance, EPA will not designate the chemical substance as active. A Form A withdrawn under this paragraph will not satisfy the obligation under this rule to submit a Form A.

(b) When must a Notice of Activity Form B be submitted?—(1) Manufacturers and processors. The Notice of Activity Form B required to be submitted under § 710.25(c) must be submitted before a person manufactures or processes the inactive substance, but not more than 90 days prior to the anticipated date of manufacturing or processing.

(2) When else may a Notice of Activity Form B be submitted? A Notice of Activity Form B that will later be required to be submitted under § 710.25(c) may be submitted during the 90-day period between EPA's identification of a chemical substance for inactive designation and the effective date for such designation, by a person who is currently manufacturing or processing such chemical substance or who anticipates manufacturing or processing such chemical substance within 90 days following submission.

(3) When may EPA execute a request to withdraw a Notice of Activity Form B? If EPA receives a request to withdraw a previously submitted Notice of Activity Form B from the submitter of the Notice of Activity Form B and EPA has neither yet moved the subject chemical substance from the inactive to the active Inventory nor yet moved the subject chemical substance from the confidential portion of the Inventory to the public portion of the Inventory as a result of the original submission, then EPA may execute the request.

(a) Notice of Activity submitted by co-manufacturers. When, in a single instance of manufacturing or importing a particular volume of a chemical substance during the lookback period, two or more persons qualify as the manufacturer or importer of that volume, they may determine among themselves who should make the required submission under § 710.25(a). If no notice is submitted as required under this subpart, EPA will hold each such person liable for failure to submit a notice.

(b) Notice of Activity by prospective co-manufacturers or co-processors. If two or more persons intend to manufacture, import, or process a particular volume of an inactive substance, such that multiple persons would qualify as the manufacturer, importer, or processor of that volume, they may determine among themselves who will submit the required notice under § 710.25(c). If no notice is submitted as required under this subpart, all of the persons remain subject to the reporting requirements, and EPA will hold each such person liable for a failure to submit a notice prior to the date of manufacturing, importing, or processing.

Each person who is subject to the notification requirements of this part must retain records that document any information reported to EPA. Records relevant to a Notice of Activity under §§ 710.25(a) and 710.25(b) must be retained for a period of 5 years beginning on the last day of the submission period. Records relevant to a Notice of Activity under § 710.25(c) must be retained for a period of 5 years beginning on the day that the notice was submitted.

(a) Chemical identity. A person submitting information under this part may request to maintain an existing claim of confidentiality for the specific chemical identity of a reportable chemical substance, but may do so only if the identity of the chemical substance is listed on the confidential portion of the Inventory as of the time the notice is submitted for that chemical substance under this part. A request to maintain an existing claim of confidentiality must be made at the time the information is submitted. If no person submitting the information specified in § 710.29(d)(4) for a particular chemical substance requests that the claim be maintained, EPA will treat the specific chemical identity of that chemical substance as not subject to a confidentiality claim and will move the chemical substance to the public portion of the Inventory. Except as set forth in this subsection, information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2, subpart B.

(1) Notice of Activity Form A. A person requesting to maintain an existing claim of confidentiality for specific chemical identity may submit with the notice answers to the questions in paragraphs (c)(1) and(c)(2) of this section, signed and dated by an authorized official. If these answers are submitted less than five years before the date on which substantiation is due pursuant to TSCA section 8(b)(4)(D)(i), the answers will be deemed to be substantiations made under TSCA section (8)(b)(4)(D)(i) and the person will be exempt from further substantiation requirements under TSCA section (8)(b)(4)(D)(i). Answers that do not include the answers to all applicable questions in paragraph (c) of this section will not be deemed to be substantiations made under the TSCA section (8)(b)(4)(D)(i) requirement.

(2) Notice of Activity Form B. A person requesting to maintain an existing claim of confidentiality for specific chemical identity must submit answers to the questions in paragraphs (c)(1) and (c)(2) of this section within 30 days of submitting the notice, signed and dated by an authorized official. If this information is not submitted within 30 days of submitting the notice, EPA will consider the confidentiality claim as deficient, so that the specific chemical identity is not subject to a confidentiality claim, and may make the information public without further notice.

(i) Persons who submitted the information described in paragraph (a)(2) of this section before May 5, 2020 must submit answers to the questions in paragraphs (c)(2)(ii) and (iii) of this section not later than June 4, 2020.

(ii) [Reserved]

(b) Information other than specific chemical identity. A person submitting information under this part may assert a claim of confidentiality for information other than specific chemical identity. Any such confidentiality claim must be made at the time the information is submitted. Except as set forth in this section, information claimed as confidential in accordance with this subsection will be treated and disclosed in accordance with 40 CFR part 2, subpart B. A person asserting a claim of confidentiality under this subsection must submit with the notice answers to the questions in paragraph (c)(1) of this section, signed and dated by an authorized official. If no claim is asserted at the time the information is submitted, or if the answers to the questions in paragraph (c)(1) of this section are not provided, EPA will consider the information as not subject to a confidentiality claim and may make the information public without further notice.

(c) Substantiation questions. Persons asserting that information is exempt from substantiation pursuant to TSCA section 14(c)(2) must answer only the question in paragraph (c)(1)(i) of this section.

(1) Substantiation questions for any confidentiality claim. For any information with a confidentiality claim that you assert is exempt from substantiation pursuant to TSCA section 14(c)(2), answer only the question in paragraph (c)(1)(i) of this section. For all other information with a confidentiality claim, answer the questions in paragraphs (c)(1)(ii) through (vi) of this section. If more than one data element on Form A or Form B is claimed as confidential, you must answer the applicable questions individually for each data element. If the answer to a question applies for all confidentiality claims on the form, indicate this in your substantiation response.

(i) Do you believe that the information is exempt from substantiation pursuant to TSCA section 14(c)(2)? If you answered yes, you must individually identify the specific information claimed as confidential and specify the applicable exemption(s).

(ii) Will disclosure of the information likely result in substantial harm to your business's competitive position? If you answered yes, describe with specificity the substantial harmful effects that would likely result to your competitive position if the information is made available to the public.

(iii) To the extent your business has disclosed the information to others (both internally and externally), what precautions has your business taken? Identify the measures or internal controls your business has taken to protect the information claimed as confidential: Non-disclosure agreement required prior to access; access is limited to individuals with a need-to-know; information is physically secured; other internal control measure(s). If yes, explain.

(iv) Does the information appear in any public documents, including (but not limited to) safety data sheets, advertising or promotional material, professional or trade publication, or any other media or publications available to the general public? If you answered yes, explain why the information should be treated as confidential.

(v) Is the claim of confidentiality intended to last less than 10 years? If so, indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn.

(vi) Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If you answered yes, explain the outcome of that determination and provide a copy of the previous confidentiality determination or any other information that will assist in identifying the prior determination.

(2) Substantiation for confidentiality claims for specific chemical identity. (i) Is the confidential chemical substance publicly known to have ever been offered for commercial distribution in the United States? If you answered yes, explain why the information should be treated as confidential.

(ii) Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain what measures have been taken, if any, to guard against the discovery of its identity.

(iii) If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

(d) Confidentiality of substantiation. If any of the information contained in the answers to the questions listed in paragraph (c)(1) or (c)(2) of this section is claimed as confidential business information, the submitter must clearly indicate such by marking the substantiation as confidential business information as provided in a Notice of Activity Form A or Form B.

(e) Certification statement for claims. An authorized official of a person submitting or substantiating a claim of confidentiality or a request to maintain an existing claim of confidentiality for specific chemical identity must certify that the submission complies with the requirements of this part by signing and dating the following certification statement: “I certify that all claims for confidentiality made or sought to be maintained with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001.” I further certify that it is true and correct that:

(1) My company has taken reasonable measures to protect the confidentiality of the information;

(2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;

(3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and

(4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

(a) EPA will accept information submitted under this subpart only if submitted in accordance with this section. All information must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, Notices of Activity and any associated information must be generated and completed using the e-NOA software module.

(b) Obtain instructions for registering in CDX as follows:

(1) Web site. The CDX Registration User Guide is available at https://www.epa.gov/sites/production/files/documents/cdx__registration__guide__v0__02.pdf. To register in CDX, go to https://cdx.epa.gov and follow the appropriate links.

(2) Telephone. Contact the EPA CDX Help Desk at 1-888-890-1995.

(3) Email. Email the EPA CDX Help Desk at [email protected].

(c) Obtain instructions for using CISS and the e-NOA software module as follows:

(1) Web site. Go to the EPA New Chemicals under the Toxic Substances Control Act Web site at https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn and follow the appropriate links.

(2) Telephone. Contact the EPA TSCA Hotline at 1-202-554-1404.

(3) Email. Email the EPA TSCA Hotline at [email protected].