Tsca Chemical Data Reporting Requirements

§ 711.1 — Scope, compliance, and enforcement.

(a) This subpart specifies reporting and recordkeeping procedures under section 8(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain manufacturers (including importers) of chemical substances. TSCA section 8(a) authorizes the EPA Administrator to require reporting of information necessary for the administration of TSCA.

(b) This part applies to the activities associated with the periodic update of information on a subset of the chemical substances included on the TSCA Inventory.

(c) TSCA section 15(3) makes it unlawful for any person to fail or refuse to submit information required under this part. In addition, TSCA section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by this part. Section 16 of TSCA provides that any person who violates a provision of TSCA section 15 is liable to the United States for a civil penalty and may be criminally prosecuted. Pursuant to TSCA section 17, the Federal Government may seek judicial relief to compel submission of TSCA section 8(a) information and to otherwise restrain any violation of TSCA section 15. (EPA does not intend to concentrate its enforcement efforts on insignificant clerical errors in reporting.) TSCA section 11 allows for inspections to assure compliance, and the Administrator may by subpoena require the attendance and testimony of witnesses and the production of reports, papers, documents, answers to questions, and other information that the Administrator deems necessary.

(d) Each person who reports under this part must maintain records that document information reported under this part and, in accordance with TSCA, permit access to, and the copying of, such records by EPA officials.

§ 711.3 — Definitions.

The definitions in this section and the definitions in TSCA section 3 apply to this part. In addition, the definitions in 40 CFR 704.3 also apply to this part, except the definitions manufacture and manufacturer in 40 CFR 704.3.

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

Commercial use means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services.

Consumer use means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) when sold to or made available to consumers for their use.

e-CDRweb means the electronic, web-based tool provided by EPA for the completion of Form U and submission of the CDR data.

Highest-level parent company means the highest-level company of the site's ownership hierarchy as of the start of the submission period during which data are being reported according to the following instructions. The highest-level U.S. parent company is located within the United States while the highest-level foreign parent company is located outside the United States. The following rules govern how to identify the highest-level U.S. parent company and highest-level foreign parent company (if applicable):

(1) If the site is entirely owned by a single U.S. company that is not owned by another company, that single company is the U.S. parent company.

(2) If the site is entirely owned by a single U.S. company that is, itself, owned by another U.S.-based company (e.g., it is a division or subsidiary of a higher-level company), the highest-level domestic company in the ownership hierarchy is the United States parent company. If there is a higher-level parent company that is outside of the United States, the highest-level foreign company in the ownership hierarchy is the foreign parent company.

(3) If the site is owned by more than one company (e.g., company A owns 40 percent, company B owns 35 percent, and company C owns 25 percent), the company with the largest ownership interest in the site is the parent company. If a higher-level company in the ownership hierarchy owns more than one ownership company, then determine the entity with the largest ownership by considering the lower-level ownerships in combination (e.g., corporation x owns companies B and C, for a total ownership of 60 percent for the site).

(i) If the parent company is a U.S. company owned by another U.S. company, then the highest-level domestic company in the ownership hierarchy is the U.S. parent company. If the U.S. parent company has a higher-level foreign company in the ownership hierarchy, then the highest-level foreign company in the ownership hierarchy is the foreign parent company.

(ii) If the parent company is a foreign company, then the site is its own U.S. parent company and the foreign parent company is the highest-level foreign company in the ownership hierarchy.

(4) If the site is owned by a 50:50 joint venture or a cooperative, the joint venture or cooperative is its own parent company. If the site is owned by a U.S. joint venture or cooperative, the highest level of the joint venture or cooperative is the U.S. parent company. If the site is owned by a joint venture or cooperative outside the United States, the highest level of the joint venture or cooperative outside the United States is the foreign parent company.

(5) If the site is entirely owned by a foreign company (i.e., without a U.S.-based subsidiary within the site's ownership hierarchy), the highest-level foreign company in the ownership hierarchy is the site's foreign parent company.

(6) If the site is federally owned, the highest-level federal agency or department is the U.S. parent company.

(7) If the site is owned by a non-federal public entity, that entity (such as a municipality, State, or tribe) is the U.S. parent company.

Industrial function means the intended physical or chemical characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged; or used.

Industrial use means use at a site at which one or more chemical substances or mixtures are manufactured (including imported) or processed.

Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers “yes” to at least one of the following questions for the product into which the submitter's chemical substance or mixture is incorporated:

(1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger?

(2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger?

(3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger?

Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances. A chemical substance is co-manufactured by the person who physically performs the manufacturing and the person contracting for such production when that chemical substance, manufactured other than by import, is:

(1) Produced exclusively for another person who contracts for such production, and

(2) That other person dictates the specific chemical identity of the chemical substance and controls the total amount produced and the basic technology for the manufacturing process.

Manufacturer means a person who manufactures a chemical substance.

Master Inventory File means EPA's comprehensive list of chemical substances which constitutes the TSCA Inventory compiled under TSCA section 8(b). It includes chemical substances reported under 40 CFR part 710 and substances reported under 40 CFR part 720 for which a Notice of Commencement of Manufacture or Import has been received under 40 CFR 720.120.

Principal reporting year means the latest complete calendar year preceding the submission period.

Reasonably likely to be exposed means an exposure to a chemical substance which, under foreseeable conditions of manufacture (including import), processing, distribution in commerce, or use of the chemical substance, is more likely to occur than not to occur. Such exposures would normally include, but would not be limited to, activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and transfers, and analytical operations. Covered exposures include exposures through any route of entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical exposures.

Repackaging means the physical transfer of a chemical substance or mixture, as is, from one container to another container or containers in preparation for distribution of the chemical substance or mixture in commerce.

Reportable chemical substance means a chemical substance described in § 711.5.

Site means a contiguous property unit. Property divided only by a public right-of-way shall be considered one site. More than one manufacturing plant may be located on a single site.

(1) For chemical substances manufactured under contract, i.e., by a co-manufacturer, the site is the location where the chemical substance is physically manufactured.

(2) The site for an importer who imports a chemical substance described in § 711.5 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.

(3) For portable manufacturing units sent to different locations from a single distribution center, the distribution center shall be considered the site.

Site-limited means a chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as a chemical substance or as part of a mixture or article outside the site. Imported chemical substances are never site-limited. Although a site-limited chemical substance is not distributed for commercial purposes outside the site at which it is manufactured and processed, the chemical substance is considered to have been manufactured and processed for commercial purposes.

Submission period means the period in which the manufacturing, processing, and use data are submitted to EPA.

Use means any utilization of a chemical substance or mixture that is not otherwise covered by the terms manufacture or process. Relabeling or redistributing a container holding a chemical substance or mixture where no repackaging of the chemical substance or mixture occurs does not constitute use or processing of the chemical substance or mixture.

§ 711.5 — Chemical substances for which information must be reported.

Any chemical substance that is in the Master Inventory File at the beginning of a submission period described in § 711.20, unless the chemical substance is specifically excluded by § 711.6.

§ 711.6 — Chemical substances for which information is not required.

The following groups or categories of chemical substances are exempted from some or all of the reporting requirements of this part, with the following exception: A chemical substance described in paragraph (a)(1), (2), or (4), or (b) of this section is not exempted from any of the reporting requirements of this part if that chemical substance is the subject of a rule proposed or promulgated under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an enforceable consent agreement (ECA) developed under the procedures of 40 CFR part 790, or is the subject of an order issued under TSCA sections 4, 5(e), or 5(f), or is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7.

(a) Full exemptions. The following categories of chemical substances are exempted from the reporting requirements of this part.

(1) Polymers. (i) Any chemical substance described with the word fragments “*polym,” “*alkyd,” or “oxylated” in the Chemical Abstracts (CA) Index Name in the Master Inventory File, where the asterisk () in the listed word fragments indicates that any sets of characters may precede, or follow, the character string defined.

(ii) Any chemical substance that is identified in the Master Inventory File as an enzyme, lignin, a polysaccharide (cellulose, gum, starch), a protein (albumin, casein, gelatin, gluten, hemoglobin), rubber, siloxane and silicone, or silsesquioxane.

(iii) This exclusion does not apply to a polymeric substance that has been depolymerized, hydrolyzed, or otherwise chemically modified, except in cases where the intended product of this reaction is totally polymeric in structure.

(2) Microorganisms. Any combination of chemical substances that is a living organism, and that meets the definition of microorganism at 40 CFR 725.3. Any chemical substance produced from a living microorganism is reportable under this part unless otherwise excluded.

(3) Naturally occurring chemical substances. Any naturally occurring chemical substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is determined in each case by the specific activities of the person who manufactures the chemical substance in question. Some chemical substances can be manufactured both as described in 40 CFR 710.4(b) and by means other than those described in 40 CFR 710.4(b). If a person described in § 711.8 manufactures a chemical substance by means other than those described in 40 CFR 710.4(b), the person must report regardless of whether the chemical substance also could have been produced as described in 40 CFR 710.4(b). Any chemical substance that is produced from such a naturally occurring chemical substance described in 40 CFR 710.4(b) is reportable unless otherwise excluded.

(4) Water and certain forms of natural gas. Chemical substances with the following Chemical Abstracts Service Registry Number (CASRN): CASRN 7732-18-5, water; CASRN 8006-14-2, natural gas; CASRN 8006-61-9, gasoline, natural; CASRN 64741-48-6, natural gas (petroleum), raw liq. mix; CASRN 68410-63-9, natural gas, dried; CASRN 68425-31-0, gasoline (natural gas), natural; and CASRN 68919-39-1, natural gas condensates.

(b) Partial exemptions. The following groups of chemical substances are partially exempted from the reporting requirements of this part (i.e., the information described in § 711.15(b)(4) need not be reported for these chemical substances). Such chemical substances are not excluded from the other reporting requirements under this part.

(1) Petroleum process streams. EPA has designated the chemical substances listed in Table 1 of this paragraph by CASRN, as partially exempt from reporting under the CDR.

(2) Specific exempted chemical substances—(i) Exemption. EPA has determined that, at this time, the information in § 711.15(b)(4) associated with the chemical substances listed in paragraph (b)(2)(iv) of this section is of low current interest.

(ii) Considerations. In making its determination of whether this partial exemption should apply to a particular chemical substance, EPA will consider the totality of information available for the chemical substance in question, including but not limited to, one or more of the following considerations:

(A) Whether the chemical substance qualifies or has qualified in past IUR or CDR collections for the reporting of the information described in § 711.15(b)(4).

(B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).

(C) The information needs of EPA, other Federal agencies, Tribes, States, and local governments, as well as members of the public.

(D) The availability of other complementary risk screening information.

(E) The availability of comparable processing and use information.

(F) Whether the potential risks of the chemical substance are adequately managed.

(iii) Amendments. EPA may amend the chemical substance list in paragraph (b)(2)(iv) of this section on its own initiative or in response to a request from the public based on EPA's determination of whether the information in § 711.15(b)(4) is of low interest.

(A) Any person may request that EPA amend the chemical substance list in Table 2 in paragraph (b)(2)(iv) of this section. Your request must be in writing and must be submitted to the address provided in 40 CFR 700.17(a). Please label your request as follows: Attention: TSCA Chemical Data Reporting—Partial Exemption Request. Requests must identify the chemical substance in question, as well as its CASRN or other chemical identification number as identified in § 711.15(b)(3)(i), and must contain a written rationale for the request that provides sufficient specific information, addressing the considerations listed in § 711.6(b)(2)(ii), including cites and relevant documents, to demonstrate to EPA that the collection of the information in § 711.15(b)(4) for the chemical substance in question either is or is not of low current interest. If a request related to a particular chemical substance is resubmitted, any subsequent request must clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA will issue a written response to each request within 120 days of receipt of the request, and will maintain copies of these responses in a docket that will be established for each reporting cycle.

(B) As needed, the Agency will initiate rulemaking to make revisions to Table 2 in paragraph (b)(2)(iv) of this section.

(C) To assist EPA in reaching a decision regarding a particular request prior to a given principal reporting year, requests must be submitted to EPA no later than 12 months prior to the start of the next principal reporting year.

(iv) List of chemical substances. EPA has designated the chemical substances listed in Table 2 of this paragraph by CASRN, as partially exempt from reporting under the CDR.

§ 711.8 — Persons who must report.

Except as provided in §§ 711.9 and 711.10, the following persons are subject to the requirements of this part. Persons must determine whether they must report under this section for each chemical substance that they manufacture (including import) at an individual site.

(a) Persons subject to recurring reporting. Any person who manufactured (including imported) for commercial purposes 25,000 lb (11,340 kg) or more of a chemical substance described in § 711.5 at any single site owned or controlled by that person during any calendar year since the last principal reporting year.

(b) Exceptions. Any person who manufactured (including imported) for commercial purposes any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 4, 5(e) or 5(f), or is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7 is subject to reporting as described in § 711.8(a), except that the applicable production volume threshold is 2,500 lb (1,134 kg).

§ 711.9 — Persons not subject to this part.

A person described in § 711.8 is not subject to the requirements of this part if that person qualifies as a small manufacturer or small government as those terms are defined in 40 CFR 704.3. Notwithstanding this exclusion, a person who qualifies as a small manufacturer or small government is subject to this part with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 4 or 5(e), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 7.

§ 711.10 — Activities for which reporting is not required.

A person described in § 711.8 is not subject to the requirements of this part with respect to any chemical substance described in § 711.5, when:

(a) The person manufactured or imported the chemical substance solely in small quantities for research and development.

(b) The person imported the chemical substance as part of an article.

(c) The person manufactured the chemical substance in a manner described in 40 CFR 720.30(g) or (h).

(d) The person manufactured the chemical substance in any of the following manners:

(1) Byproduct substances listed in paragraph (i) of this section for the following manufacturing processes, when recycled or otherwise used within a site-limited, physically enclosed system that is part of the same overall manufacturing process from which the byproduct substance was generated, and when the site is reporting the byproduct or a different chemical substance that was manufactured from the recycled byproduct or manufactured in the same overall manufacturing process:

(i) List of processes and certain related byproduct substances. (A) Portland Cement Manufacturing (i.e., CASRN 68475-76-3, Flue dust, portland cement).

(B) Kraft Pulping Process (i.e., CASRN 66071-92-9, Sulfite liquors and Cooking liquors, spent; CASRN 68514-09-0, Sulfite liquors and Cooking liquors, spent, oxidized; and CASRN 471-34-1, Carbonic acid calcium salt (1:1)).

(ii) Amendments. EPA may amend the exemptions list in paragraph (d)(1)(i) of this section on its own initiative or in response to a request from the public based on EPA's determination of whether the byproduct substance and process described meet the criteria explained in this paragraph (d)(1), based on the requirements and considerations listed in paragraphs (d)(1)(ii)(B) and (C) of this section.

(A) Any person may request that EPA amend the chemical substance list in paragraph (d)(1)(i) of this section. Your request must be in writing and must be submitted to the address provided in 40 CFR 700.17(a). Please label your request as follows: Attention: TSCA Chemical Data Reporting—Byproduct Exemption Request. Requests must identify the manufacturing process and byproduct chemical substance in question, as well as its CASRN or other chemical identification number as identified in 40 CFR 711.15(b)(3)(i), and must contain a written rationale for the request that provides sufficient specific information, addressing the requirements and considerations listed in paragraphs (d)(1)(ii)(B) and (C) of this section, including citations and relevant documents, to demonstrate to EPA that the byproduct substance and process in question either does or does not meet the criteria explained in this paragraph (d)(1). If a request related to a particular byproduct substance and process is resubmitted, any subsequent request must clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA will issue a written response to each request within 120 days of receipt of the request and will maintain copies of these responses in a docket that will be established for each reporting cycle.

(B) In making its determination whether this exemption should apply to a particular manufacturing process and related byproduct substance, the following two requirements must be met:

(1) The byproduct substance is recycled or otherwise used to manufacture another chemical substance within an enclosed system, within the same overall manufacturing process, and on the same site as that byproduct was originally manufactured.

(2) The site is reporting under CDR other chemical substances, in particular a chemical substance other than the byproduct substance that was manufactured from the byproduct or manufactured in the same overall manufacturing process.

(C) In addition to the requirements in paragraph (d)(1)(ii)(B) of this section, EPA will consider the totality of information available for the process and related byproduct substance in question, including but not limited to, one or both of the following considerations:

(1) Whether EPA has a current interest in the byproduct substance.

(2) Whether the byproduct substance must have already been reported under CDR, or would be expected to be reported if not exempted by this exemption.

(D) After granting a petition, the Agency will initiate rulemaking to make revisions to the list of substances in paragraph (d)(1)(i) of this section.

(E) To assist EPA in reaching a decision regarding a particular request prior to a given principal reporting year, requests must be submitted to EPA no later than 12 months prior to the start of the next principal reporting year.

(2) A quantity of the byproduct that is manufactured solely in the following equipment when it is not integral to the chemical manufacturing processes of the site:

(i) Pollution control equipment.

(ii) Boilers used to generate heat or electricity for that site.

§ 711.15 — Reporting information to EPA.

Any person who must report under this part, as described in § 711.8, must submit the information described in this section for each chemical substance described in § 711.5 that the person manufactured (including imported) for commercial purposes in an amount of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg) or more for chemical substances subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any calendar year since the last principal reporting year (e.g., for the 2020 submission period, consider calendar years 2016, 2017, 2018, and 2019, because 2015 was the last principal reporting year). The principal reporting year for each submission period is the previous calendar year (e.g., the principal reporting year for the 2020 submission period is calendar year 2019). For all submission periods, a separate report must be submitted for each chemical substance at each site for which the submitter is required to report. A submitter of information under this part must report information as described in this section to the extent that such information is known to or reasonably ascertainable by that person.

(a) Reporting information to EPA. Any person who reports information to EPA must complete a Form U using the e-CDRweb reporting tool provided by EPA at the address set forth in § 711.35. The submission must include all information described in paragraph (b) of this section. Persons must submit the chemical reports on a separate single Form U for each site for which the person is required to report. The e-CDRweb reporting tool is described in the instructions available from EPA at the website set forth in § 711.35.

(b) Information to be reported. The information described in paragraphs (b)(1) through (4) of this section must be reported for each chemical substance manufactured (including imported) in an amount of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg) or more for chemical substances subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any calendar year since the last principal reporting year. The requirement to report information described in paragraph (b)(4) of this section is subject to exemption as described in § 711.6.

(1) A certification statement signed and dated by an authorized official of the submitter company. The authorized official must certify that the submitted information has been completed in compliance with the requirements of this part and that the confidentiality claims made on the Form U are true and correct. The certification must be signed and dated by the authorized official for the submitter company, and provide that person's name, official title, and email address.

(2) Company and site information. The following currently correct parent company and site information at the date of CDR submission must be reported for each site at which a reportable chemical substance is manufactured (including imported) above the applicable production volume threshold, as described in this section (see § 711.3 for the “site” for importers and special situations).

(i) The legal name, address, and Dun and Bradstreet D-U-N-S® (D&B) number for the highest-level parent company located in the United States and, if one exists, for the highest-level foreign-based parent company. A submitter under this part must obtain a D&B number for the parent company if none exists and must report using the standardized conventions for the naming of a parent company as provided in the CDR Instructions for Reporting identified in § 711.35.

(ii) The name of a person who will serve as technical contact for the submitter company who will be able to answer questions about the information submitted by the company to EPA, and that technical contact person's full mailing address, telephone number, and email address.

(iii) The legal name and full street address of each site. A submitter under this part must include the appropriate D&B number for each site reported, and the county or parish (or other jurisdictional indicator) in which the site is located. A submitter under this part must obtain a D&B number for the site reported if none exists. For a co-manufacturing situation in which the contracting company initiates the report, the contracting company must report both the site controlling the contract and the producing company's site information.

(iv) The six-digit NAICS code for the site. A submitter under this part must include the appropriate six-digit NAICS code for each site reported.

(3) Chemical-specific information. The following chemical-specific information must be reported for each reportable chemical substance manufactured (including imported) above the applicable production volume threshold, as described in paragraph (b) of this section:

(i) The specific, currently correct CA Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding CASRN for each reportable chemical substance at each site. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using the corresponding TSCA Accession Number that is listed on the public portion of the Inventory. In addition to reporting the chemical identifying number itself, submitters must specify the type of number they are reporting by selecting from among the codes in Table 1 to paragraph (b)(3)(i).

(A) If an importer submitting a report cannot provide the information specified in this paragraph (b)(3)(i) because it is unknown to the importer and claimed as confidential by the supplier of the chemical substance or mixture, the importer must use e-CDRweb to ask the supplier to provide the correct chemical identity and, in the case of a mixture, the percentage of formulation and chemical function information directly to EPA in a joint submission. Such request must include instructions for submitting chemical identity information electronically, using e-CDRweb and CDX (see § 711.35), and for clearly referencing the importer's submission. Contact information for the supplier, a trade name or other designation for the chemical substance or mixture, and a copy of the request to the supplier must be included with the importer's submission.

(B) If a manufacturer submitting a report cannot provide the information specified in this paragraph (b)(3)(i) because the reportable chemical substance is manufactured using a reactant having a specific chemical identity that is unknown to the manufacturer and claimed as confidential by its supplier, the manufacturer must use e-CDRweb to ask the supplier of the confidential reactant to provide the correct chemical identity of the confidential reactant directly to EPA in a joint submission. Such request must include instructions for submitting chemical identity information electronically using e-CDRweb and CDX (see § 711.35), and for clearly referencing the manufacturer's submission. Contact information for the supplier, a trade name or other designation for the chemical substance, and a copy of the request to the supplier must be included with the importer's submission.

(C) EPA will accept only joint submissions that are submitted electronically using e-CDRweb and CDX (see § 711.35) and that clearly reference the primary submission to which they refer.

(ii) For the principal reporting year only, a statement indicating, for each reportable chemical substance at each site, whether the chemical substance is manufactured in the United States, imported into the United States, or both manufactured in the United States and imported into the United States.

(iii) For the principal reporting year only, the total annual volume (in pounds) of each reportable chemical substance domestically manufactured or imported at each site. The total annual domestically manufactured volume (not including imported volume) and the total annual imported volume must be separately reported. These amounts must be reported to two significant figures of accuracy. In addition, the total annual volume (domestically manufactured plus imported volumes in pounds) of each reportable chemical substance at each site for each complete calendar year since the last principal reporting year.

(iv) For the principal reporting year only, the volume used on site and the volume directly exported of each reportable chemical substance domestically manufactured or imported at each site. These amounts must be reported to two significant figures of accuracy.

(v) For the principal reporting year only, a designation indicating, for each imported reportable chemical substance at each site, whether the imported chemical substance is physically present at the reporting site.

(vi) For the principal reporting year only, a designation indicating, for each reportable chemical substance at each site, whether the chemical substance is being recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream.

(vii) For the principal reporting year only, the total number of workers reasonably likely to be exposed to each reportable chemical substance at each site. For each reportable chemical substance at each site, the submitter must select from among the ranges of workers listed in Table 2 to paragraph (b)(3)(vii) and report the corresponding code (i.e., W1 through W8):

(viii) For the principal reporting year only, the maximum concentration, measured by percentage of weight, of each reportable chemical substance at the time it is sent off-site from each site. If the chemical substance is site-limited, you must report the maximum concentration, measured by percentage of weight of the reportable chemical substance at the time it is reacted on-site to produce a different chemical substance. This information must be reported regardless of the physical form(s) in which the chemical substance is sent off-site/reacted on-site. For each chemical substance at each site, select the maximum concentration of the chemical substance from among the ranges listed in Table 3 to paragraph (b)(3)(viii) and report the corresponding code (i.e., M1 through M5):

(ix) For the principal reporting year only, the physical form(s) of the reportable chemical substance as it is sent off-site from each site. If the chemical substance is site-limited, you must report the physical form(s) of the reportable chemical substance at the time it is reacted on-site to produce a different chemical substance. For each chemical substance at each site, the submitter must report as many physical forms as applicable from among the physical forms listed in this Unit:

(A) Dry powder.

(B) Pellets or large crystals.

(C) Water- or solvent-wet solid.

(D) Other solid.

(E) Gas or vapor.

(F) Liquid.

(x) For the principal reporting year only, submitters must report the percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance, reported in response to paragraph (b)(3)(iii) of this section, that is associated with each physical form reported under paragraph (b)(3)(ix) of this section.

(4) Chemical-specific information related to processing and use. The following chemical-specific information must be reported for each reportable chemical substance manufactured (including imported) above the applicable production volume threshold, as described in this section. Persons subject to paragraph (b)(4) of this section must report the information described in paragraphs (b)(4)(i) and (ii) of this section for each reportable chemical substance at sites under their control and at sites that receive a reportable chemical substance from the submitter directly or indirectly (including through a broker/distributor, from a customer of the submitter, etc.). Information reported in response to this paragraph must be reported for the principal reporting year only and only to the extent that it is known to or reasonably ascertainable by the submitter. Information required to be reported under this paragraph is limited to domestic (i.e., within the customs territory of the United States) processing and use activities. If information responsive to a given data requirement under this paragraph, including information in the form of an estimate, is not known or reasonably ascertainable, the submitter is not required to respond to the requirement.

(i) Industrial processing and use information. (A) A designation indicating the type of industrial processing or use operation(s) at each site that receives a reportable chemical substance from the submitter site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). For each chemical substance, report the letters which correspond to the appropriate processing or use operation(s) listed in Table 4 to paragraph (b)(4)(i)(A). A particular designation may need to be reported more than once, to the extent that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that applies to a given designation under this paragraph.

(B) A code indicating the sector(s) that best describe the industrial activities associated with each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this section. For each chemical substance, report the code that corresponds to the appropriate sector(s) listed in Table 5 to paragraph (b)(4)(i)(B). A particular sector code may need to be reported more than once, to the extent that a submitter reports more than one function code (under paragraph (b)(4)(i)(C) of this section) that applies to a given sector code under this paragraph.

(C) For each sector reported under paragraph (b)(4)(i)(B) of this section, the applicable code(s) from Table 6 to paragraph (b)(4)(i)(C) must be selected to designate the function category(ies) that best represents the specific manner in which the chemical substance is used. For the 2020 submission period:

(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical substances designated in 2019 as high priority for risk evaluation (those chemicals listed in Table 7 to paragraph (b)(4)(i)(C)); and

(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C) for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C). For the 2024 and future submission periods, use only column A in Table 6 to paragraph (b)(4)(i)(C). A particular function category may need to be reported more than once, to the extent that a submitter reports more than one industrial processing or use operation/sector combination (under paragraphs (b)(4)(i)(A) and (B) of this section) that applies to a given function category under this paragraph. If more than 10 unique combinations of industrial processing or use operations/sector/function categories apply to a chemical substance, submitters need only report the 10 unique combinations for the chemical substance that cumulatively represent the largest percentage of the submitter's production volume for that chemical substance, measured by weight. If none of the listed function categories accurately describes a use of a chemical substance, the category “Other” may be used, and must include a description of the use.

(D) The estimated percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, sector, and function category. Where a particular combination of industrial processing or use operation, sector, and function category accounts for less than 5 percent of the submitter's site's total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent if the production volume attributable to that industrial processing or use operation, sector, and function category combination is 25,000 lb (11,340 kg) or more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular combination of industrial processing or use operation, sector, and function category.

(E) For each combination of industrial processing or use operation, sector, and function category, the submitter must estimate the number of sites at which each reportable chemical substance is processed or used. For each combination associated with each chemical substance, the submitter must select from among the ranges of sites listed in Table 8 to paragraph (b)(4)(i)(E) and report the corresponding code (i.e., S1 through S7):

(F) For each combination of industrial processing or use operation, sector, and function category, the submitter must estimate the number of workers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each chemical substance, the submitter must select from among the worker ranges listed in paragraph (b)(3)(vii) of this section and report the corresponding code (i.e., W1 though W8).

(ii) Consumer and commercial use information. (A) Using the applicable codes listed in Table 9 to paragraph (b)(4)(ii)(A), submitters must designate the consumer and commercial product category(ies) that best describe the consumer and commercial products in which each reportable chemical substance is used (whether the recipient site(s) are controlled by the submitter site or not). For the 2020 submission period:

(1) Use column A in Table 9 to paragraph (b)(4)(ii)(A) for chemical substances designated in 2019 as high priority for risk evaluation (those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and

(2) Use either column A or B in Table 9 to paragraph (b)(4)(ii)(A) for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C). For the 2024 and future submission periods, use only column A in Table 9 to paragraph (b)(4)(ii)(A). If more than 10 codes apply to a chemical substance, submitters need only report the 10 codes for the chemical substance that cumulatively represent the largest percentage of the submitter's production volume for that chemical, measured by weight. If none of the listed consumer and commercial product categories accurately describes the consumer and commercial products in which each reportable chemical substance is used, the category “Other” may be used, and must include a description of the use.

(B) For each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, the applicable code(s) described in paragraph (b)(4)(i)(C) of this section must be selected to designate the function category(ies) that best represents the specific manner in which the chemical substance is used. For the 2020 submission period:

(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical substances designated in 2019 as high priority for risk evaluation (those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and

(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C) for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C). For the 2024 and future submission periods, use only column A in Table 6 to paragraph (b)(4)(i)(C). A particular function category may need to be reported more than once, to the extent that a submitter reports more than one consumer or commercial product category (under paragraph (b)(4)(ii)(A) of this section) that applies to a given function category under this paragraph. If none of the listed function categories accurately describes a use of a chemical substance, the category “Other” may be used, and must include a description of the use.

(C) An indication, within each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use.

(D) Submitters must determine, within each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical substance manufactured (including imported) by the submitter is present in (for example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children age 14 or younger, regardless of the concentration of the chemical substance remaining in or on the product. Submitters must select from the following options: The chemical substance is used in or on any consumer products intended for use by children; the chemical substance is not used in or on any consumer products intended for use by children; or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not known to or reasonably ascertainable by the submitter.

(E) The estimated percentage, rounded off to the closest 10 percent, of the submitter's site's total production volume of the reportable chemical substance associated with each consumer and commercial product category. Where a particular consumer and commercial product category accounts for less than 5 percent of the total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent if the production volume attributable to that commercial and consumer product category is 25,000 lb (11,340 kg) or more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular consumer and commercial product category.

(F) Where the reportable chemical substance is used in consumer or commercial products, the estimated typical maximum concentration, measured by weight, of the chemical substance in each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section. For each chemical substance in each commercial and consumer product category reported under paragraph (b)(4)(ii)(A) of this section, submitters must select from among the ranges of concentrations listed in Table 3 to paragraph (b)(3)(viii) of this section and report the corresponding code (i.e., M1 through M5).

(G) Where the reportable chemical substance is used in a commercial product, the submitter must estimate the number of commercial workers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each substance, the submitter must select from among the worker ranges listed in Table 2 to paragraph (b)(3)(vii) of this section and report the corresponding code (i.e., W1 though W8).

§ 711.20 — When to report.

All information reported to EPA in response to the requirements of this part must be submitted during an applicable submission period. The 2024 CDR submission period is from June 1, 2024, to November 22, 2024. Subsequent recurring submission periods are from June 1 to September 30 at 4-year intervals, beginning in 2028. In each submission period, any person described in § 711.8 must report as described in this part.

§ 711.22 — Duplicative reporting.

(a) With regard to TSCA section 8(a) rules. Any person subject to the requirements of this part who previously has complied with reporting requirements of a rule under TSCA section 8(a) by submitting the information described in § 711.15 for a chemical substance described in § 711.5 to EPA, and has done so within 1 year of the start of a submission period described in § 711.20, is not required to report again on the manufacture of that chemical substance at that site during that submission period.

(b) With regard to importers. This part requires that only one report be submitted on each import transaction involving a chemical substance described in § 711.5. When two or more persons are involved in a particular import transaction and each person meets the Agency's definition of “importer” as set forth in 40 CFR 704.3, they may determine among themselves who should submit the required report; if no report is submitted as required under this part, EPA will hold each such person liable for failure to report.

(c) Co-manufactured chemicals. This part requires that only one report per site be submitted on each chemical substance described in § 711.5. However, both the contracting company and producing company are liable if no report is made. When a company contracts with a producing company to manufacture a chemical substance, and each party meets the definition of “manufacturer” as set forth in § 711.3, reporting of the co-manufactured chemical can be performed by one of the following methods:

(1) The contracting company initiates the required report for that site as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in § 711.15(b)(3) and processing and use information set forth in § 711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.

(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.

§ 711.25 — Recordkeeping requirements.

Each person who is subject to the reporting requirements of this part must retain records that document any information reported to EPA. Records relevant to reporting during a submission period must be retained for a period of 5 years beginning on the last day of the submission period. Submitters are encouraged to retain their records longer than 5 years to ensure that past records are available as a reference when new submissions are being generated.

§ 711.30 — Confidentiality claims.

(a) Making confidentiality claims—(1) Generally. Any person submitting information under this part may assert a confidentiality claim for that information at the time it is submitted, except for information described in paragraph (a)(2). Any such confidentiality claims must be asserted at the time the information is submitted. These claims will apply only to the information submitted with the claim. Instructions for asserting confidentiality claims are provided in the document identified in § 711.35. Information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2 and section 14 of TSCA.

(2) Exceptions. Confidentiality claims cannot be asserted:

(i) For chemical identities listed on the public portion of the TSCA Inventory;

(ii) For processing and use data elements required by § 711.15(b)(4)(i)(A), (B), and (C) and § 711.15(b)(4)(ii)(A), (B), (C), and (D); or

(iii) When a response is left blank or designated as “not known or reasonably ascertainable.”

(3) Substantiations. All confidentiality claims must be substantiated at time of submission, in accordance with the requirements in paragraphs (b), (c), and (d)(1) of this section, and must be signed and dated by an authorized official. Confidentiality claims for the following data elements are exempt from this substantiation requirement:

(i) Production volume information required pursuant to § 711.15(b)(3)(iii).

(ii) Joint submission information from the primary submitter, consisting of trade name and supplier identification required pursuant to § 711.15(b)(3)(i)(A) and (B).

(iii) Joint submission information from the secondary submitter, consisting of the percentage of formulation required pursuant to § 711.15(b)(3)(i)(A) and (B).

(iv) Information that is supplied in a petition submitted under § 711.6(b)(2)(iii) or § 711.10(d)(1)(ii) and that is described in section 14(c)(2) of TSCA.

(4) Marking information claimed as confidential in confidentiality substantiation documentation. If any of the information contained in the answers to the questions listed in paragraphs (b) and (c) of this section is asserted to contain information that itself is considered to be confidential, you must clearly identify the information that is claimed confidential.

(5) Certification statement for claims. An authorized official representing a person asserting a claim of confidentiality must certify that the submission complies with the requirements of this part by signing and dating the following certification statement:

(6) Company, site, and technical contact identity information. A submitter may assert a claim of confidentiality for a site, company, or technical contact identity to protect the link between that information and the reported chemical substance. Such claim may be asserted only when the linkage of that information to a reportable chemical substance is confidential and not publicly available.

(7) Processing and use information. A submitter may assert a claim of confidentiality for each data element required by § 711.15(b)(4)(i)(D), (E) and (F) and § 711.15(b)(4)(ii)(E), (F), and (G) to protect the link between that information and the reported chemical substance. Such claim may be asserted only when the linkage of that information to a reportable chemical substance is confidential and not publicly available.

(b) All confidentiality claims requiring substantiation at time of submission. For each data element (or information supplied in a petition submitted under § 711.6(b)(2)(iii)(A) or § 711.10(d)(1)(ii)(A)) that is claimed as confidential, you must submit with your report detailed written answers to the following questions:

(1) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information, and the causal relationship between the disclosure and the harmful effects.

(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) Does any of the information that you are claiming as confidential constitute a trade secret? If yes, please explain how the information you are claiming as confidential constitutes a trade secret.

(5) Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number of years (between 1-10 years) or the specific date after which the claim is withdrawn.

(6) 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.

(c) Additional requirements for specific chemical identity. A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 711.15(b)(3) of this part only if the identity of that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance. Generic chemical identities and accession numbers may not be claimed as confidential. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must submit with the report detailed written answers to the questions from paragraph (b) of this section and to the following questions.

(1) Is this chemical substance publicly known (including by your competitors) to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status (e.g., the chemical substance is publicly known only as being distributed in commerce for research and development purposes, but no other information about the current commercial distribution of the chemical substance in the United States is publicly available). If no, please complete the certification statement:

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

(3) 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, emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

(4) Would disclosure of the specific chemical name release confidential process information? If yes, please explain.

(d) Special situations—(1) Joint submissions. If a primary submitter asks a secondary submitter to provide information directly to EPA in a joint submission under § 711.15(b)(3)(i)(A) and (B), only the primary submitter may assert a confidentiality claim for the data elements that it directly submits to EPA. The primary submitter must substantiate those claims that are not exempt under paragraph (a)(3)(ii) of this section. The secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims that are not exempt under paragraph (a)(3)(iii) of this section.

(2) Petitions. If a petition submitted under § 711.6(b)(2)(iii)(A) or § 711.10(d)(1)(ii)(A) includes any information claimed as confidential, the petitioner must provide a version of the petition that redacts the information claimed as confidential.

(e) No claim of confidentiality. Information not claimed as confidential in accordance with the requirements of this section may be made public without further notice to the submitter.

§ 711.35 — Electronic filing.

(a) You must use e-CDRweb to complete and submit Form U (EPA Form 7740-8). Submissions may only be made as set forth in this section.

(b) Submissions must be sent electronically to EPA via CDX.

(c) Access e-CDRweb and instructions, as follows:

(1) By website. Go to the EPA Chemical Data Reporting internet homepage at http://www.epa.gov/cdr and follow the appropriate links.

(2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554-1404 or [email protected] for a CD-ROM containing the instructions.