PART 710—COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY Authority: 15 U.S.C. 2607(a) and (b). Subpart A—General Provisions § 710.1 Scope and compliance. (a) This part establishes regulations governing reporting and recordkeeping by certain persons who manufacture, import, or process chemical substances for commercial purposes under section 8(a) of the Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a) authorizes the Administrator to require reporting of information necessary for administration of the Act and requires EPA to issue regulations for the purpose of compiling and keeping current an inventory of chemical substances manufactured or processed for a commercial purpose, as required by section 8(b) of the Act. Following an initial reporting period, EPA published an initial inventory of chemical substances manufactured, processed, or imported for commercial purposes. In accordance with section 8(b), EPA periodically amends the inventory to include new chemical substances which are manufactured or imported for a commercial purpose and reported under section 5(a)(1) of the Act. EPA also revises the categories of chemical substances and makes other amendments as appropriate. (b) This part applies to the activities associated with the compilation of the TSCA Chemical Substance Inventory (Inventory) and the designation of chemical substances on the TSCA Inventory as active or inactive in U.S. commerce. (c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under these reporting regulations. In addition, section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by these regulations. Section 16 provides that any person who violates a provision of section 15 is liable to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, the Government may seek judicial relief to compel submission of section 8(a) information and to otherwise restrain any violation of section 15. (EPA does not intend to concentrate its enforcement efforts on insignificant clerical errors in reporting.) (d) Each person who reports under these regulations must maintain records that document information reported under these regulations and, in accordance with the Act, permit access to, and the copying of, such records by EPA officials. [68 FR 887, Jan. 7, 2003, as amended at 76 FR 50859, Aug. 16, 2011; 76 FR 54933, Sept. 6, 2011; 82 FR 37539, Aug. 11, 2017] § 710.3 Definitions. For purposes of this part: (a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., Cosmetic, device, drug, food, food additive. food et seq.; et seq.; et seq. (b) The term pesticide et seq. (c) The following terms will have the meaning contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq. Byproduct material, source material, special nuclear material. (d) The following definitions also apply to this part: Act et seq. Administrator Article (1) Which is formed to a specific shape or design during manufacture, (2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design. Byproduct CASRN Chemical substance not (1) Any mixture; (2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide; (3) Tobacco or any tobacco product, but not including any derivative products; (4) Any source material, special nuclear material, or byproduct material; (5) Any pistol, firearm, revolver, shells, and cartridges; and (6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. Commerce (1) Between a place in a State and any place outside of such State or (2) Which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State. Customs territory of the United States Distribute in commerce distribution in commerce Domestic EPA Importer (1) The consignee, (2) The importer of record, (3) the actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20, or (4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144. Impurity Intermediate Inventory Manufacture Manufacture for commercial purposes Manufacturer Mixture New chemical substance Person Process Process for commercial purposes Processor Site (1) For chemical substances manufactured under contract, i.e., (2) The site for an importer who imports a chemical substance described in § 710.25 is the U.S. site of the operating unit within the person's organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer. Small quantities solely for research and development (or small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product”) State Technically qualified individual (1) Who because of his/her education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision, (2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and (3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition. Test marketing United States, [68 FR 888, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 76 FR 50859, Aug. 16, 2011; 76 FR 54933, Sept. 6, 2011; 82 FR 37539, Aug. 11, 2017] § 710.4 Scope of the inventory. (a) Chemical substances subject to these regulations. (b) Naturally occurring chemical substances automatically included. (1) Which is (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or (2) Which is extracted from air by any means, will automatically be included in the inventory under the category “Naturally Occurring Chemical Substances.” Examples of such substances are: raw agricultural commodities; water, air, natural gas, and crude oil; and rocks, ores, and minerals. (c) Substances excluded by definition or section 8(b) of TSCA. (1) Any substance which is not considered a “chemical substance” as provided in subsection 3(2)(B) of the Act and in the definition of “chemical substance” in § 710.3(d); (2) Any mixture as defined in § 710.3(d); Note: A chemical substance that is manufactured as part of a mixture is subject to these reporting regulations. This exclusion applies only to the mixture and not to the chemical substances of which the mixture is comprised. The term “mixture” includes alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement. (3) Any chemical substance which is manufactured, imported, or processed solely in small quantities for research and development, as defined in § 710.3(d); and (4) Any chemical substance not manufactured, processed or imported for a commercial purpose since January 1, 1975. (d) Chemical substances excluded from the inventory. per se Note: In addition, chemical substances excluded here will not be subject to premanufacture notification under section 5 of the Act. (1) Any impurity. (2) Any byproduct which has no commercial purpose. Note: A byproduct which has commercial value only to municipal or private organizations who (i) burn it as a fuel, (ii) dispose of it as a waste, including in a landfill or for enriching soil, or (iii) extract component chemical substances which have commercial value, may be reported for the inventory, but will not be subject to premanufacture notification under section 5 of the Act if not included. (3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight. (4) Any chemical substance which results from a chemical reaction that occurs incidental to storage of another chemical substance, mixture, or article. (5) Any chemical substance which results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleansers or other housekeeping products, fuels and fuel additives, water softening and treatment agents, photographic films, batteries, matches, and safety flares, and which is not itself manufactured for distribution in commerce or for use as an intermediate. (6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints; or other chemical substances formed during manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that may occur as described elsewhere in this § 710.4(d). (7) Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or de-foamer, dispersant, precipitation inhibitor, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended or (ii) a chemical substance, solely intended to impart a specific physicochemical characteristic, functions as intended. (8) Chemical substances which are not intentionally removed from the equipment in which they were manufactured. Note: See note to definition of “intermediate” at § 710.3(d) for explanation of “equipment in which it was manufactured.” [42 FR 64572, Dec. 23, 1977, as amended at 68 FR 889, Jan. 7, 2003] Subpart B—Commercial Activity Notification Source: 82 FR 37540, Aug. 11, 2017, unless otherwise noted. § 710.23 Definitions. The following definitions also apply to subpart B of this part. Active substance Central Data Exchange or CDX Chemical Information Submission System or CISS Chemical substance subject to commercial activity designation e-NOA Existing claim for protection of specific chemical identity against disclosure Inactive substance Interim active substance Known to or reasonably ascertainable by Notice of Activity Form A Notice of Activity Form B Lookback period Possession Control (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 (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 § 710.25 Persons subject to the notification requirement. The following persons are subject to the requirements of this subpart. (a) Who must submit the Notice of Activity Form A? (b) Who else may submit the Notice of Activity Form A? (c) Who must submit the Notice of Activity Form B? § 710.27 Activities for which notification is not required. (a) In general. (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. (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. § 710.29 Information required in the notification. (a) Reporting information to EPA. (b) Information to be reported on the Notice of Activity Form A. (c) Information to be reported on a Notice of Activity Form B. (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. (2) Authorized official. (3) Technical contact. (4) Chemical-specific information. (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. (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.” § 710.30 When to submit notifications. (a) When must a Notice of Activity Form A be submitted? (1) Manufacturers. (2) Processors. (3) Withdrawal of a Notice of Activity Form A. (b) When must a Notice of Activity Form B be submitted?— Manufacturers and processors. (2) When else may a Notice of Activity Form B be submitted? (3) When may EPA execute a request to withdraw a Notice of Activity Form B? § 710.33 Co-manufacturers and co-processors. (a) Notice of Activity submitted by co-manufacturers. (b) Notice of Activity by prospective co-manufacturers or co-processors. § 710.35 Recordkeeping requirements. 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. § 710.37 Confidentiality claims. (a) Chemical identity. (1) Notice of Activity Form A. (2) Notice of Activity Form B. (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. (c) Substantiation questions. (1) Substantiation questions for any confidentiality claim. (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. (ii) Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., (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., (d) Confidentiality of substantiation. (e) Certification statement for claims. (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. [82 FR 37540, Aug. 11, 2017, as amended at 85 FR 13067, Mar. 6, 2020] § 710.39 Electronic filing. (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. https://www.epa.gov/sites/production/files/documents/cdx__registration__guide__v0__02.pdf. https://cdx.epa.gov (2) Telephone. (3) Email. [email protected]. (c) Obtain instructions for using CISS and the e-NOA software module as follows: (1) Web site. https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn (2) Telephone. (3) Email. [email protected]. Subpart C—Review Plan Source: 85 FR 13068, Mar. 6, 2020, unless otherwise noted. § 710.41 Scope. This subpart applies to the substantiation and review of claims of confidentiality asserted in Notices of Activity Form A to protect the specific chemical identities of chemical substances. § 710.43 Persons subject to substantiation requirement. (a) Who must substantiate. (b) Exemptions. (2) A person who has previously substantiated the confidentiality claim for a specific chemical identity that the person requested to maintain in a Notice of Activity Form A, by submitting information that is responsive to all questions in § 710.45, is exempt from the substantiation requirement of this subpart if both of the following conditions are met: (i) The previous substantiation was submitted to EPA on or after November 1, 2015; and (ii) The person reports to EPA the submission date, submission type, and case number, transaction ID, or equivalent identifier for the previous submission that contained the substantiation, not later than the deadline specified in § 710.47. § 710.45 Contents of substantiation. (a) The submission. (b) Substantiation questions. (2) To the extent your business has disclosed the information to others (both internally and externally), has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures, including but not limited to internal controls, that your business has taken to protect the information claimed as confidential. (3)(i) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain. (ii) Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to) safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files; or any other media or publications available to the general public? If yes, please explain why the information should be treated as confidential. (iii) Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential. (4) Is the claim of confidentiality intended to last less than 10 years? If yes, please indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn. (5) Has EPA, another Federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination. (6) Is the confidential chemical substance publicly known (including by your competitors) to have ever been offered for commercial distribution in the United States? If yes, please explain why the specific chemical identity should still be afforded confidential status ( e.g., (7) Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., (8) 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., § 710.47 When to submit substantiation or information on previous substantiation. (a) All persons required to substantiate a confidentiality claim pursuant to § 710.43(a) or (b)(1) must submit their substantiation not later than November 1, 2020. (b) All persons who seek an exemption under § 710.43(b)(2) must submit the information specified in § 710.43(b)(2)(ii) not later than November 1, 2020. § 710.49 Failure to report. If neither the substantiation required under § 710.43(a) or (b)(1), nor the information specified in § 710.43(b)(2)(ii), is submitted to EPA in accordance with the provisions of this subpart, then EPA will deny the confidentiality claim in accordance with the procedures set forth in TSCA section 14(g)(2) and 40 CFR part 2, subpart B. § 710.51 Electronic filing. EPA will accept information submitted under this subpart only if submitted in accordance with § 710.39. § 710.53 Recordkeeping requirements. Each person who is subject to this part must retain records that document any information reported to EPA. Records must be retained for a period of 5 years beginning on the last day of the submission period. § 710.55 Claim review, duration of protection, TSCA Inventory maintenance, posting results, and extension. (a) Review criteria and procedures. (b) Duration of protection from disclosure. (c) Updating the TSCA Inventory. (d) Posting of annual goals and numbers of reviews completed. (e) Extension. Federal Register