(a) Definitions. For purposes of this section the terms below are defined as follows:

An agglomerate is a collection of weakly bound particles or aggregates or mixtures of the two where the resulting external surface area is similar to the sum of the surface areas of the individual components.

An aggregate is a particle comprising strongly bonded or fused particles where the resulting external surface area may be significantly smaller than the sum of calculated surface areas of the individual components.

Central Data Exchange or CDX means EPA's centralized electronic submission receiving system.

CISS tool means the Chemical Information Submission System, EPA's electronic, web-based reporting tool for the completion and submission of data, reports, and other information, or its successors.

Discrete form of a reportable chemical substance differs from another form of the same reportable chemical substance in one or more of the following 3 characteristics:

(i) The change in the reportable chemical substance is due to all of the following:

(A) There is a change in process to effect a change in size, a change in one or more of the properties of the reportable chemical substances identified in paragraph (i)(C) of this definition, or both;

(B) There is a size variation in the mean particle size that is greater than 7 times the standard deviation of the mean particle size (± 7 times the standard deviation); and

(C) There is a change in at least one of the following properties: Zeta potential, specific surface area, dispersion stability, or surface reactivity, that is greater than 7 times the standard deviation of the measured value (± 7 times the standard deviation).

(ii) The reportable chemical substance has a different morphology. Examples of morphologies include but are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, torus, cone, and sheet.

(iii) A reportable chemical substance that is coated with another chemical substance or mixture at the end of manufacturing or processing has a coating that consists of a different chemical substance or mixture.

Nanoscale Materials Stewardship Program was a program conducted by EPA from January 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily provided EPA available information on engineered nanoscale materials that were manufactured, processed or used.

Particle is a minute piece of matter with defined physical boundaries.

Primary particles are particles or droplets that form during manufacture of a chemical substance before aggregation or agglomerization occurs.

Reportable chemical substance is a chemical substance as defined in section 3 of TSCA that is solid at 25 °C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nm in at least one dimension, and that is manufactured or processed to exhibit unique and novel properties because of its size. A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1-100 nm.

Small manufacturer or processor means any manufacturer or processor whose total annual sales, when combined with those of its parent company (if any), are less than $11 million. The definition of small manufacturer in section 704.3 of this title does not apply to reporting under this section (40 CFR 704.20).

Specific surface area means the ratio of the area of the surface of the reportable chemical substance to its mass or volume. Specific surface area by mass is the ratio of the area of the surface of a nanoscale material divided by the mass (m 2/kg) and the specific surface area by volume is the area of the surface of the reportable chemical substance divided by its volume m 2/m 3.

Surface reactivity means the reactivity at the surface of a reportable chemical substance. It is dependent upon factors such as redox potential, which is a measure of the tendency of a substance to lose or acquire electrons, photocatalytic activity, including the potential to generate free radicals.

Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.

Zeta potential is the electrostatic potential near the particle surface.

(b) Persons who must report. (1) Persons who can reasonably ascertain that they are manufacturers and processors of a discrete form of a reportable chemical substance during the three years prior to the final effective date of the rule must report except as provided in paragraph (c) of this section.

(2) Persons who can reasonably ascertain that they propose to manufacture or process a discrete form of a reportable chemical substance after the final effective date of the rule which was not reported under paragraph (b)(1) of this section must report except as provided in paragraph (c) of this section.

(c) When reporting is not required. (1) The following chemical substances are not subject to reporting under this section:

(i) Chemical substances formed at the nanoscale as part of a film on a surface.

(ii) DNA.

(iii) RNA.

(iv) Proteins.

(v) Enzymes.

(vi) Lipids.

(vii) Carbohydrates.

(viii) Peptides.

(ix) Liposomes.

(x) Antibodies.

(xi) Viruses.

(xii) Microorganisms.

(xiii) Chemical substances which dissociate completely in water to form ions that are smaller than 1 nanometer.

(xiv) Chemical substances that are not on the TSCA Chemical Substance Inventory at the time reporting would otherwise be required under this section.

(2) Persons who submitted a notice under 40 CFR parts 720, 721, or 723 for a reportable chemical substance on or after January 1, 2005 are not required to submit a report for the reportable chemical substance submitted except where the person manufactures or processes a discrete form of the reportable chemical substance.

(3) Section 704.5(a) through (e) apply to reporting under this section. Small manufacturers and processors as defined in paragraph (a) of this section are exempt from reporting under this section.

(4) Persons who submitted some or all of the required information for a reportable chemical substance as part of the Nanoscale Materials Stewardship Program are not required to report the information previously submitted except where the person manufactures or processes a discrete form of the reportable chemical substance.

(d) What information to report. The following information must be reported for each discrete form of a reportable chemical substance to the extent that it is known to or reasonably ascertainable by the person reporting:

(1) The common or trade name, the specific chemical identity including the correct Chemical Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the molecular structure of each chemical substance or mixture. Information must be reported as specified in § 720.45.

(2) Material characteristics including particle size, morphology, and surface modifications.

(3) Physical/chemical properties.

(4) The maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance.

(5)(i) Persons described in paragraph (b)(1) of this section must report the annual production volume for the previous three years before the effective date of the final rule and an estimate of the maximum production volume for any consecutive 12-month period during the next two years of production after the final effective date of this rule.

(ii) Persons described in paragraph (b)(2) of this section must report the estimated maximum 12 month production volume and the estimated maximum production volume for any consecutive 12 month period during the first three years of production.

(iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section must be on 100% chemical basis of the discrete form of the solid nanoscale material.

(6) Use information describing the category of each use by function and application, estimates of the amount manufactured or processed for each category of use, and estimates of the percentage in the formulation for each use.

(7) Detailed information on methods of manufacturing or processing.

(8) Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions and estimates of any general population or consumer exposures.

(9) Release information with estimates of the amounts released, descriptions and duration of the activities that cause such releases, and whether releases are directly to the environment or to control technology.

(10) Risk management practices describing protective equipment for individuals, engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, or other information which is provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, or disposal of the substance.

(11) Existing information concerning the environmental and health effects.

(e) How to report. You must use CDX and the CISS tool to complete and submit the information required under this part to EPA electronically.

(1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA § 8(a) Reporting for Nanoscale Materials: Information Submission Form.

(2) Electronic submission. You must submit the required information to EPA electronically via CDX and using the CISS tool.

(i) To access the CDX portal, go to https://cdx.epa.gov.

(ii) The CISS tool is accessible in CDX.

(f) When to report. (1) Persons specified in paragraph (b)(1) of this section must report the information specified in paragraph (d) of this section within one year after the final effective date of the rule.

(2) Persons specified in paragraph (b)(2) of this section must report the information specified in paragraph (d) of this section at least 135 days before commencing manufacture or processing of a discrete form of the reportable chemical substance, except where the person has not formed an intent to manufacture or process that discrete form at least 135 days before commencing such manufacture or processing, in which case the information must be filed within 30 days of the formation of such an intent.

(g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to the recordkeeping requirements in § 704.11(a) and (b).

(h) Confidential business information. (1) Persons submitting a notice under this rule are subject to the requirements for confidential business information claims in § 704.7(a) through (c).

(2) In submitting a claim of confidentiality, a person attests to the truth of the following four statements concerning all information which is claimed confidential:

(i) My company has taken measures to protect the confidentiality of the information,

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

(iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person.

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

[82 FR 3653, Jan. 12, 2017]

(a) Definitions—(1) 11-AA means the chemical substance 11-aminoundecanoic acid, CAS Number 2432-99-7.

(2) Enclosed process means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to an environmental contamination from the releases.

(3) Internal subunit means a subunit that is covalently linked to at least two other subunits. Internal subunits of polymer molecules are chemically derived from monomer molecules that have formed covalent links between two or more other molecules.

(4) Monomer means a chemical substance that has the capacity to form links between two or more other molecules.

(5) Polymer means a chemical substance that consists of at least a simple weight majority of polymer molecules but consists of less than a simple weight majority of molecules with the same molecular weight. Collectively, such polymer molecules must be distributed over a range of molecular weights wherein differences in molecular weight are primarily attributable to differences in the number of internal subunits.

(6) Polymer molecule means a molecule which includes at least four covalently linked subunits, at least two of which are internal subunits.

(7) Small processor means a processor that meets either the standard in paragraph (a)(7)(i) of this section or the standard in paragraph (a)(7)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms (100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph (a)(7)(ii) of this section.

(ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance processed by that company.

(iii) Inflation index. EPA will use the Inflation Index described in the definition of small manufacturer set forth in § 704.3, for purposes of adjusting the total annual sales values of this small processor definition. EPA will provide notice in the Federal Register when changing the total annual sales values of this definition.

(8) Subunit means an atom or group of associated atoms chemically derived from corresponding reactants.

(b) Persons who must report. Except as provided in paragraph (c) of this section, the following persons are subject to this section:

(1) Persons who manufacture or propose to manufacture 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(2) Persons who import or propose to import 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(3) Persons who process or propose to process 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(c) Persons not subject to this section. The following persons are not subject to this section:

(1) Small manufacturers (includes importers) as described in § 704.3.

(2) Small processors.

(3) Persons described in § 704.5.

(4) Persons who, at any time during the 3-year period ending July 22, 1986, manufactured, imported, or processed 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(d) What information to report. Persons identified in paragraph (b) of this section must submit a Premanufacture Notice Form (EPA Form 7710-25).

(e) When to report. (1) Persons who intend to manufacture, import, or process 11-AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process or for use as a component in photoprocessing solutions must notify EPA within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of 11-AA.

(2) Persons who initiated manufacturing, importing, or processing of 11-AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or for use as a component in photoprocessing solutions during the time period between July 22, 1986 and July 13, 1987 must notify EPA by August 10, 1987.

(f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of submission of the report.

(g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: 11-AA Notification.

[52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60 FR 34463, July 3, 1995; 71 FR 33641, June 12, 2006]

(a) Definitions—(1) P-TBBA means the substance p-tert-butylbenzoic acid, also identified as 4-(1,1-dimethylethyl)benzoic acid, CAS No. 98-73-7.

(2) P-TBT means the substance p-tert-butyltoluene, also identified as 1-(1,1-dimethylethyl)-4-methylbenzene, CAS No. 98-51-1.

(3) P-TBB means the substance p-tert-butylbenzaldehyde, also identified as 4-(1,1-dimethylethyl)benzaldehyde, CAS No. 939-97-9.

(4) Small processor means a processor that meets either the standard in paragraph (a)(4)(i) of this section or the standard in paragraph (a)(4)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms (100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph (a)(1)(ii) of this section.

(ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance processed by that company.

(iii) Inflation index. EPA shall use the Inflation Index described in the definition of small manufacturer that is set forth in § 704.3, for purposes of adjusting the total annual sales values of this small processor definition. EPA shall provide Federal Register notification when changing the total annual sales values of this definition.

(b) Persons who must report. Except as provided in paragraph (c) of this section, the following persons are subject to the reporting requirements of this rule; a person may become subject to this rule more than once, for more than one substance or under more than one of the criteria listed in this paragraph (b).

(1) Persons who manufactured, imported, or processed P-TBBA, P-TBT, and/or P-TBB for commercial purposes during the person's latest complete corporate fiscal year prior to June 25, 1986. For purposes of this provision, processors of P-TBBA, P-TBT, and/or P-TBB shall include only those persons who processed the substances other than as non-isolated intermediates.

(2) Persons who commence manufacture or importation of P-TBBA, P-TBT, and/or P-TBB for commercial purposes after June 25, 1986. This provision is applicable to persons who cease manufacture or importation of P-TBBA, P-TBT, and/or P-TBB after June 25, 1986 and then subsequently resume manufacture or importation of the substance(s).

(3) Persons who process P-TBBA, P-TBT, and/or P-TBB for commercial purposes in any way other than as a non-isolated intermediate after June 25, 1986.

(c) Persons not subject to this rule. In addition to the persons described in § 704.5, small processors, as defined in paragraph (a)(4) of this section, are not subject to this rule.

(d) Information to report. Persons subject to this rule as described in paragraph (b) of this section shall report information to EPA as specified in this paragraph (d). Respondents to this rule shall report all information that is known to or reasonably ascertainable by the person reporting. For purposes of importer reporting under this paragraph, a site is the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction. The import site may in some cases be the organization's headquarters office in the United States.

(1) All manufacturers, importers, and processors specified in paragraph (b) of this section shall report their name and headquarters address.

(2) All manufacturers, importers, and processors specified in paragraph (b) of this section shall report the name, address, and office telephone number (including area code) of their principal technical contact.

(3) All manufacturers, importers, and processors specified in paragraph (b) of this section shall report the name and address of each site where P-TBBA, P-TBT, and/or P-TBB is manufactured, imported, or processed.

(4) All manufacturers, importers, and processors specified in paragraph (b)(1) of this section only shall report the information described in this paragraph (d)(4). Respondents to this paragraph (d)(4) shall report separately for each substance that they manufacture, import, or process, and for each site at which they do so. However, if the information to be reported in response to this paragraph (d)(4) is the same for different sites, the respondent need not report separately for each site but need only notify EPA that the information is the same for each site. The information to be reported under this paragraph (d)(4) shall cover the respondent's latest complete corporate fiscal year prior to June 25, 1986. Respondents to this paragraph (d)(4) shall report the following information:

(i) The total quantity (by weight) of P-TBBA, P-TBT, or P-TBB manufactured, imported, or processed for commercial purposes per site.

(ii) A narrative description of the manufacturing, importing, or processing operation(s) involving P-TBBA, P-TBT, or P-TBB at each site.

(iii) A narrative description of worker activities involving P-TBBA, P-TBT, or P-TBB at each site, including the number of workers potentially exposed to each substance and, if applicable, the number of workers potentially exposed to more than one substance.

(iv) The potential routes of worker exposure to P-TBBA, P-TBT, or P-TBB at each site (e.g., inhalation, ingestion, dermal absorption).

(v) Available monitoring data from employee breathing zones with potential exposure to P-TBBA, P-TBT, or P-TBB at each site, including a description of the method of monitoring, the number of samples taken, and the potential number of workers similarly exposed for each worker job category. Respondents to this paragraph (d)(4)(v) shall submit data showing a range of 8-hour time weighted averages (TWAs), provided that the data are available in that form. Respondents also shall submit a calculated geometric mean of these data, with an explanation of the method by which the mean was derived. However, if the monitoring data are not available in the form of 8-hour TWAs, respondents shall submit raw sample data results and the duration time of sampling for each job category.

(vi) A narrative description of any personal protective equipment and/or engineering controls used to prevent exposure to P-TBBA, P-TBT, or P-TBB at each site.

(vii) A listing of the estimated quantities of P-TBBA, P-TBT, or P-TBB released directly into air, water, or land from each site.

(viii) A narrative description of the times during the manufacturing, importing, or processing operations involving P-TBBA, P-TBT, or P-TBB when environmental release occurs at each site.

(ix) A narrative description of any engineering controls used to prevent environmental release of P-TBBA, P-TBT, or P-TBB at each site.

(x) A narrative description of all known end uses of any P-TBBA, P-TBT, or P-TBB that is manufactured, imported, or processed by the respondent. The narrative need not include customer identity.

(xi) A narrative description of the methods used at each site for disposing of wastes generated during the manufacture, importation, or processing of P-TBBA, P-TBT, or P-TBB, including the quantity and content of such wastes (per site), the method of disposal, and an identification of the disposal site(s).

(5) All manufactureres, importers, and processors specified in paragraph (b) of this section shall report the information described in this paragraph (d)(5). Respondents to this paragraph (d)(5) shall report separately for each substance that they intend to manufacture, import, or process during the first 2 years following the date on which they become subject to this rule. The data reported under this paragraph (d)(5) shall cover that 2-year period. Respondents to this paragraph (d)(5) shall report separately for each site at which they intend to manufacture, import, or process each substance. Respondents need not comply with this paragraph (d)(5) if the information to be reported is identical to that reported by the respondent under paragraph (d)(4) of this section, provided that the respondent makes note of that fact to EPA. Respondents to this paragraph (d)(5) shall report the following information:

(i) An estimate of the total quantity (by weight) of P-TBBA, P-TBT, or P-TBB that the respondent intends to manufacture, import, or process for commercial purposes per site during each of the first 2 years following the date on which the respondent becomes subject to this rule.

(ii) A narrative description of the intended manufacturing, importing, or processing activities involving P-TBBA, P-TBT, or P-TBB at each site during the first 2 years following the date on which the respondent becomes subject to this rule. The description shall include a summary of the intended manufacturing, importing, or processing operation(s); a summary of intended worker activities involving the substances, including an estimate of the number of persons anticipated to be exposed annually to P-TBBA, P-TBT, or P-TBB (per site) during the 2-year period, the anticipated routes of worker exposure to the substances (e.g., inhalation, ingestion, dermal absorption); and a summary of any personal protective equipment and/or engineering controls that the respondent intends to use to prevent exposure to the substances.

(iii) A narrative description of anticipated environmental releases of P-TBBA, P-TBT, or P-TBB at each site from the manufacture, importation, or processing of these substances during the first 2 years following the date on which the respondent becomes subject to this rule. The narrative shall include the anticipated quantities of each substance released directly into air, water, or land, the anticipated routes of environmental release, and any intended engineering controls to be used to prevent environmental release of the substances.

(iv) A narrative description of all anticipated end uses or P-TBBA, P-TBT, or P-TBB resulting from the respondent's manufacture, importation, or processing of the substances during the first 2 years following the date on which the respondent becomes subject to this rule. The summary need not include customer identity.

(v) A narrative summary of the anticipated disposal of wastes generated from the manufacture, importation, or processing of P-TBBA, P-TBT, or P-TBB during the first 2 years following the date on which the respondent becomes subject to this rule. The summary shall include the anticipated quantity and content of such wastes (per site), the intended method of disposal, and an identification of intended disposal site(s).

(e) When to report. Persons subject to this rule must submit the requisite information to EPA within 60 days of becoming subject to the rule under the standards set forth in paragraph (b) of this section.

(f) Certification. Persons subject to this rule must attach the following statement to any information submitted to EPA in response to this rule: “I hereby certify that, to the best of my knowledge and belief, all of the attached information is complete and accurate.” This statement shall be signed and dated by the company's principal technical contact.

(g) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of the submission of the report.

[51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52 FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]

(a) Definitions—(1) Extent of chlorination means the percent by weight of chlorine.

(2) Import means to import in bulk form or as part of a mixture.

(3) Isomeric ratio means the relative amounts of each isomeric chlorinated naphthalene that composes the chemical substance; and for each isomer the relative amounts of each chlorinated naphthalene designated by the position of the chlorine atom(s) on the naphthalene.

(4) Polychlorinated biphenyl means any chemical substance that is limited to the biphenyl molecule and that has been chlorinated to varying degrees.

(5) Small manufacturer means a manufacturer (including importers) who meets either paragraph (a)(5) (i) or (ii) of this section:

(i) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production volume of a particular chemical substance at any individual site owned or controlled by the manufacturer is greater than 45,400 kilograms (100,000 pounds), the manufacturer shall not qualify as small for purposes of reporting on the production of that chemical substance at that site, unless the manufacturer qualifies as small under paragraph (a)(5)(ii) of this section.

(ii) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance produced by that manufacturer.

(iii) For imported mixtures containing a chemical substance identified in paragraph (b) of this section, the 45,400 kilograms (100,000 pounds) standard in paragraph (a)(5)(i) of this section applies only to the amount of the chemical substance in a mixture and not the other components of the mixture.

(6) Waste means any solid liquid, semisolid, or contained gaseous material that results from the production of a chemical substance identified in paragraph (b) of this section and which is to be disposed.

(b) Substances for which reports must be submitted.

(c) Persons who must report. (1) Persons who are manufacturing or importing a chemical substance identified in paragraph (b) of this section on October 8, 1984.

(2) Persons who propose to import a chemical substance identified in paragraph (b) of this section on or after October 8, 1984.

(3) Persons who manufacture a chemical substance identified in paragraph (b) of this section after October 8, 1984.

(4) A person is required to report only once for each chemical substance identified in paragraph (b) of this section.

(d) Persons exempt from reporting. (1) Small manufacturers.

(2) Persons described in § 704.5.

(e) What information to report. Persons described in paragraph (c) of this section must notify EPA of current or prospective manufacture or import. The notice must include, to the extent that it is known to or reasonably ascertainable by the person making the report, the following information:

(1) Company name and address.

(2) Name, address, and telephone number of the principal technical contact.

(3) For chemical substances proposed to be imported, the proposed date of import.

(4) A description of the use(s) or intended use(s) for the chemical substance.

(5) A description of the isomeric ratio and extent of chlorination of the chemical substance and the impurity level of polychlorinated biphenyls.

(6) The quantity (by weight) manufactured or imported within 12 months prior to October 8, 1984, if any, and the estimated quantity (by weight) to be manufactured or imported for the first 3 years following the date of the report or the date of the intended start of import whichever occurs later.

(7) The number of persons exposed to the chemical substance during manufacture, import, processing, distribution in commerce, use, and disposal.

(8) If a manufacturer's waste contains one or more of the chemical substances identified in paragraph (b) of this section, the manufacturer must:

(i) Provide the quantity (by weight) of the chemical substances identified in paragraph (b) of this section present in the waste.

(ii) Identify the constituents of the waste and their concentrations,

(iii) State the rate of waste generation as a percentage of production volume,

(iv) Describe where in the manufacturing process the waste is generated, and

(v) Describe the method for disposal of the waste.

(f) When to report. (1) Persons who are manufacturing or importing a chemical substance identified in paragraph (b) of this section on October 8, 1984 must notify EPA by November 6, 1984.

(2) Persons who propose to import a chemical substance identified in paragraph (b) of this section on or after October 8, 1984 must notify EPA by November 6, 1984, or 15 days after making the management decision described in § 704.3, whichever is later in time.

(3) Persons who manufacture a chemical substance identified in paragraph (b) of this section after October 8, 1984 must notify EPA within 30 days after the initial date of manufacture.

[49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. 15, 1984; 50 FR 1215, Jan. 10, 1985; 51 FR 19839, June 3, 1986; 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988]

(a) Definitions—(1) Chlorinated terphenyl means a chemical substance, CAS No. 61788-33-6, comprised of chlorinated ortho-, meta-, and paraterphenyl.

(2) Extent of chlorination means the percent by weight of chlorine for each isomer (ortho, meta, and para).

(3) Isomeric ratio means the ratios of ortho-, meta-, and parachlorinated terphenyls.

(4) Polychlorinated biphenyl means any chemical substance that is limited to the biphenyl molecule that has been chlorinated to varying degrees.

(5) Small manufacturer means a manufacturer (importers are defined as manufacturers under TSCA) who meets either of the following standards under this rule:

(i) First standard. A manufacturer of an existing chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production volume of a particular chemical substance at any individual site owned or controlled by the manufacturer is greater than 45,400 kilograms (100,000 pounds), the manufacturer shall not qualify as small for purposes of reporting on the production of that chemical substance at the site, unless the manufacturer qualified as small under paragraph (a)(5)(ii) of this section.

(ii) Second standard. A manufacturer of an existing chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of chemicals produced by that manufacturer.

(b) Persons who must report. Except for small manufacturers and as provided in § 704.5, the following persons are subject to the rule:

(1) Persons who manufacture or propose to manufacture chlorinated terphenyl.

(2) Persons who import (importers) or propose to import chlorinated terphenyl as a chemical substance in bulk or as part of a mixture.

(c) What information to report. Persons subject to this rule as described in paragraph (b) of this section must notify EPA of current or proposed manufacture or import of chlorinated terphenyl. The notice must include, to the extent that it is known to the person making the report or is reasonably ascertainable, the following information:

(1) Company name and address.

(2) Name, address, and telephone number of principal technical contact.

(3) A description of the use(s) or intended use(s) for chlorinated terphenyl.

(4) A description of the isomeric ratio and extent of chlorination of the chlorinated terphenyl and the impurity level of polychlorinated biphenyls.

(5) The quantity (by weight) manufactured or imported within 12 months prior to the effective date of the rule, if any, and the estimated quantity (by weight) to be manufactured or imported for the first three years following the date of the report or the date of the intended start of production, whichever occurs later.

(6) The proposed date for the initiation of manufacturing or importation of chlorinated terphenyl, if appropriate.

(d) When to report. Persons who are manufacturing or importing chlorinated terphenyl on the effective date of the rule must notify EPA within 30 days of the effective date of the rule. Persons who propose to manufacture or import chlorinated terphenyl must notify EPA within 15 days after making the management decision described in § 704.3 “Proposed to manufacture or import”.

[49 FR 11184, Mar. 26, 1984, as amended at 49 FR 32068, Aug. 10, 1984; 50 FR 2048, Jan. 15, 1985; 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

(a) Substances for which reporting is required. The chemical substances for which reporting is required under this section are:

(b) Persons who must report. Unless exempt as provided in § 704.5, reports must be submitted by:

(1) Persons who manufacture or import any of the substances identified in paragraph (a) of this section.

(2) Persons who propose to manufacture or propose to import any of the substances identified in paragraph (a) of this section. For the purposes of importer reporting under this section, an import site is the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction; the import site may in some cases be the organization's headquarters office in the United States.

(c) What information to report. Persons identified in paragraph (b) of this section must report to EPA, for each of the substances identified in paragraph (a) of this section, the following information to the extent known to or reasonably ascertainable by them.

(1) Initial Report:

(i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted.

(ii) Company name and headquarters address.

(iii) Name, address, and telephone number of the principal technical contact.

(iv) The total quantity (by weight in pounds) of the substance manufactured or imported for the person's most recently completed corporate fiscal year.

(v) A description of the commercial uses of the substance during the person's most recently completed corporate fiscal year, including the production volume for each use.

(vi) The estimated quantity (by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year.

(vii) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use.

(2) Follow-up Report:

(i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted.

(ii) Company name and headquarters address.

(iii) Name, address, and telephone number of the principal technical contact.

(iv) The estimated quantity (by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year.

(v) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use.

(d) When to report. (1) Persons specified in paragraph (b)(1) of this section who are manufacturing or importing the substance as of December 5, 1988 must submit an initial report described in paragraph (c)(1) of this section by January 3, 1989.

(2) Persons specified in paragraph (b)(2) of this section must submit an initial report within 30 days after making the management decision described in § 704.3 or by January 3, 1989, whichever is later.

(3) Persons specified in paragraph (b) of this section, who submitted a report described in paragraph (c)(1) of this section, must submit a follow-up report described in paragraph (c)(2) of this section within 30 days of making the management decision, described at § 704.3, to do either of the following events:

(i) Manufacture or import the substance in a quantity 50 percent greater than the quantity reported in the most recently submitted report.

(ii) Manufacture or import the substance for a use not reported for that substance in any previous report.

(e) Certification. Persons subject to this section must attach the following statement to any information submitted to EPA in response to this section: “I hereby certify that, to the best of my knowledge and belief, all of the attached information is complete and accurate.” This statement must be signed and dated by the company's principal technical contact.

(f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of the submission of the report.

[53 FR 41337, Oct. 21, 1988, as amended at 58 FR 34204, June 23, 1993]

(a) Definitions—(1) Endrin means the pesticide 2,7:3,6-Dimethanonaphth[2,3-b]oxirene,3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-, (1aalpha, 2beta, 2abeta, 3alpha, 6alpha, 6abeta, 7beta, 7aalpha)-, CAS Number 72-20-8.

(2) HEX-BCH means the chemical substance 1,2,3,4,7,7-hexachloronorbornadiene, CAS Number 3389-71-7.

(3) Isodrin means the pesticide 1,4:5,8-Dimethanonaphthalene,1,2,3,4,10,10-hexacholoro-1,4,4a,5,8,8a-hexahydro-, (1alpha, 4alpha, 4abeta, 5beta, 8beta, 8abeta)-, CAS Number 465-73-6.

(4) Small business means any manufacturer, importer, or processor who meets either paragraph (a)(4)(i) or (ii) of this section:

(i) A business is small if its total annual sales, when combined with those of its parent (if any), are less than $40 million. However, if the annual manufacture, importation, or processing volume of a particular chemical substance at any individual site owned or controlled by the business is greater than 45,400 kilograms (100,000 pounds), the business shall not qualify as small for purposes of reporting on the manufacture, importation, or processing of that chemical substance at that site, unless the business qualifies as small under paragraph (a)(4)(ii) of this section.

(ii) A business is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance manufactured, imported, or processed by that business.

(iii) For imported and processed mixtures containing HEX-BCH, the 45,400 kilograms (100,000 pounds) standard in paragraph (a)(4)(i) of this section applies only to the amount of HEX-BCH in a mixture and not the other components of the mixture.

(5) 8-hour time weighted average means the cumulative exposure for an 8-hour work shift computed as follows:

$$ Where: E is the equivalent exposure for the working shift. Ci is the concentration (i.e., parts per million) during any period of time (Ti) where the concentration remains constant. Ti is the duration in hours of the exposure at the concentration Ci.

(6) Year means corporate fiscal year.

(b) Persons who must report. (1) Reports must be submitted by:

(i) Persons who are manufacturing, importing, or processing HEX-BCH for use as an intermediate in the production or isodrin or endrin on or after January 2, 1986; and

(ii) Persons who propose to manufacture, import, or process HEX-BCH for use as an intermediate in the production of isodrin or endrin, on or after January 2, 1986.

(2) Persons described in paragraph (b)(1) of this section who engage or propose to engage in more than one activity (i.e., manufacture and processing) must report the information required in paragraph (d) separately for each activity.

(c) Persons exempt from reporting. (1) Small businesses.

(2) Persons described in § 704.5(a) and (c).

(d) Information to report. (1) Initial reports must include, to the extent that it is known to or reasonably ascertainable by the person reporting, the following information:

(i) Company name and address.

(ii) Name, address, and telephone number of the principal contact.

(iii) Name and address of plant sites where HEX-BCH is or is proposed to be manufactured, imported, or processed, noting for each plant site which activity takes or would take place at each site.

(iv) If applicable, the intended date for initiating the manufacture, import, or processing of HEX-BCH.

(v) If applicable, the actual quantity (by weight) of HEX-BCH manufactured, imported, or processed during the most recently concluded year.

(vi) The estimated quantity (by weight) of HEX-BCH to be manufactured, imported, or processed each year during the first 3 years following the date of the report or the date of the intended start of manufacture, import, or processing, whichever occurs later.

(vii) For each year described in paragraphs (d)(1) (v) and (vi) of this section: the number or expected number of employees exposed to HEX-BCH during the manufacture, import, processing, distribution in commerce, use, and disposal; the routes of exposure; and the 8-hour time weighted average of exposure.

(viii) If employees are exposed or expected to be exposed to HEX-BCH, state for each reported route of exposure, whether personal protective equipment is used or expected to be used, and a description of the personal protective equipment.

(ix) The actual or anticipated quantity, content, method of disposal, and disposal site of any wastes generated or expected to be generated during the manufacture, importation, or processing of HEX-BCH.

(2) Subsequent reports must provide, to the extent known to or reasonably ascertainable by the person reporting, the information in paragraph (d)(1) of this section and a statement explaining why the subsequent report is required.

(e) When to report. (1) Persons who are manufacturing, importing, or processing HEX-BCH on January 2, 1986, must submit an initial report to EPA by February 3, 1986.

(2) Persons who propose to manufacture, import, or process HEX-BCH on or after January 2, 1986, must submit an initial report to EPA by February 3, 1986, or 30 days after making the management decision described in § 704.3 “Propose to manufacture, import, or process,” whichever is later in time.

(3) Persons described in paragraph (b) of this section, who have submitted a report described in paragraph (d) of this section, must submit a subsequent report within 30 days of any of the following events. Based on the most recently submitted report:

(i) The manufacture, importation, or processing of HEX-BCH begins at a plant site different than that reported pursuant to paragraph (d)(1)(iii) of this section.

(ii) The actual quantity (by weight) of HEX-BCH manufactured, imported, or processed in a given year is greater than or equal to 200 percent of the estimated value for that year reported pursuant to paragraph (d)(1)(vi) of this section.

(iii) The total number of employees exposed to HEX-BCH is greater than 130 percent of the projected value reported pursuant to paragraph (d)(1)(vii) of this section.

(iv) The route of exposures to HEX-BCH differs from that reported pursuant to paragraph (d)(1)(vii) of this section.

(v) The actual 8-hour time weighted average exposure for any activity exceeds the projection reported pursuant to paragraph (d)(1)(vii) of this section by more than 100 percent.

(vi) The method of disposal or disposal site reported pursuant to paragraph (d)(1)(ix) of this section has changed.

(vii) Three years have passed since the most recent submission of a report and the person is still engaged in the manufacture, importation, or processing of HEX-BCH.

(f) Certification of review. Each person who submits a report under this section must for 3 years following the submission date of the most recent submission, review their activities at the end of each year to determine whether any reportable event specified in paragraph (e)(3) of this section has occurred. If a review shows that none of these events has occurred, the person is required to certify this fact in writing.

(g) Recordkeeping. Any person subject to the reporting requirements of this section must:

(1) Retain documentation of information contained in their reports. This documentation must be maintained for a period of 3 years from the date of the submission of the report; and

(2) Retain the certification required by paragraph (f) of this section for 3 years from the date of its creation.

[50 FR 47536, Nov. 19, 1985, as amended at 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

(a) Definitions. (1) “HFPO” means the chemical substance hexafluoropropylene oxide, CAS Number 428-59-1. [Listed in TSCA Inventory as oxirane, trifluoro(trifluoromethyl)-]

(2) “Enclosed process” means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases.

(3) “Small processor” means a processor that meets either the standard in paragraph (a)(3)(i) of this section or the standard in paragraph (a)(3)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms (100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph (a)(3)(ii) of this section.

(ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance processed by that company.

(iii) Inflation index. EPA will use the Inflation Index described in the definition of “small manufacturer” that is set forth in § 704.3 for purposes of adjusting the total annual sales values of this small processor definition. EPA will provide Federal Register notification when changing the total annual sales values of this definition.

(b) Persons who must report. Except as provided in paragraph (c) of this section, the following persons are subject to this section:

(1) Persons who manufacture or propose to manufacture HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process.

(2) Persons who import or propose to import HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process.

(3) Persons who process or propose to process HFPO as an intermediate in the manufacture of fluorinated substances in an enclosed process.

(c) Persons not subject to this rule. The following persons are not subject to this rule:

(1) Small processors.

(2) Persons described in § 704.5(a) through (f).

(3) Persons who have already submitted to EPA a completed copy of the Preliminary Assessment Information Manufacturer's Report (EPA Form 7710-35, as described at § 712.28 of this chapter) for HFPO are not required to report under this section with respect to activities previously reported on.

(d) What information to report. Persons identified in paragraph (b) of this section must submit a Premanufacture Notice Form (EPA Form 7710-25).

(e) When to report. (1) Persons who are manufacturing, importing, or processing, or who propose to manufacture, import, or process HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process as of December 10, 1987, must report by February 8, 1988.

(2) Persons who propose to manufacture, import, or process HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process after December 10, 1987, must report within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of HFPO.

(f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of submission of the reports.

(g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: HFPO Reporting.

[52 FR 41299, Oct. 27, 1987, as amended at 58 FR 34204, June 23, 1993; 60 FR 16308, Mar. 29, 1995; 60 FR 31920, June 19, 1995; 60 FR 34463, July 3, 1995; 71 FR 33641, June 12, 2006; 85 FR 31995, May 28, 2020]

(a) Substance subject to reporting. The chemical substance 4,4′-methylenebis(2-chloroaniline) (CAS No. 101-14-4) is subject to reporting under this section. The substance also is identified as 4,4′-methylenebis(2-chlorobenzenamine) and MBOCA.

(b) Persons who must report. Except as provided in paragraph (c) of this section, the following persons are subject to this rule.

(1) Persons who propose to manufacture MBOCA in the United States on or after June 2, 1986.

(2) Persons who are manufacturing MBOCA in the United States as of June 2, 1986.

(3) Persons manufacturing MBOCA in the United States on or after June 2, 1986 who propose to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section.

(c) Persons not subject to this rule. The following persons are exempt from the reporting requirements of this section:

(1) Persons who import MBOCA into the customs territory of the United States and do not otherwise manufacture the substance in the United States.

(2) Persons who complied with the requirements of this section prior to June 2, 1986 and received written notification of compliance from EPA.

(d) What information to report. Persons who are subject to this rule as described in paragraph (b) of this section must report information to EPA by completing the following parts of the notice form contained in appendix A to part 720 of this chapter: Parts I.A., I.B., I.C.1., I.C.3., and II.A.; also, part III as appropriate. Persons subject to the requirements of this section also must submit a narrative description of any processing and packaging of MBOCA that occurs at the manufacturing plant site, including the number of workers potentially exposed to MBOCA during on-site processing and packaging of MBOCA and a description of any personal protective equipment and/or engineering controls that would be used to prevent release of and exposure to MBOCA during on-site processing and packaging. Persons subject to the requirements of this section are not required to submit information on processing or use of MBOCA away from the manufacturing plant site. Respondents to this rule shall report all information that is known to or reasonably ascertainable by the person reporting.

(e) When to report. (1) Persons specified in paragraph (b)(1) of this section must report by July 2, 1986 or within 30 days after making a firm management decision to commit financial resources for the manufacture of MBOCA, whichever is later in time.

(2) Persons specified in paragraph (b)(2) of this section must report by July 2, 1986.

(3) Persons specified in paragraph (b)(3) of this section must report within 30 days of making a firm management decision to commit financial resources to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section.

[51 FR 13223, Apr. 18, 1986, as amended at 52 FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]

(a) Definitions. The definitions in subpart A of this part apply to § 704.180 unless otherwise specified in this section.

Asbestos is a collective term meaning any of the substances listed in Table 1 of this paragraph (a).

Bulk asbestos means any quantity of asbestos fiber of any type or grade, or combination of types or grades, that is mined or milled with the purpose of obtaining asbestos. This term does not include asbestos that is produced or processed as a contaminant or an impurity.

Bulk materials containing asbestos means bulk materials in which asbestos is being mined or milled as an impurity.

Chemical Information Submission System or CISS means EPA's electronic, web-based reporting tool for the completion and submission of CDR data, reports, and other information, or its successors.

Form A means an abbreviated form for persons who know or can reasonably ascertain that they manufactured (including imported) or processed asbestos, including as an impurity, during the reporting period described in paragraph (f) of this section but do not know and cannot reasonably ascertain the amount of asbestos manufactured (including imported) or processed by them.

Form B means the standard form to be used by persons who know or can reasonably ascertain that they manufactured (including imported) or processed asbestos, including as an impurity, during the reporting period described in paragraph (f) of this section and know or can reasonably ascertain how much asbestos they manufactured (including imported) or produced.

Primary processor means a person who starts with bulk asbestos or bulk materials containing asbestos, and makes a mixture that contains asbestos as a component.

Secondary processor means a person who further processes asbestos, after primary processing of asbestos is completed, including as a component of a mixture, or an article containing asbestos.

Small processor means any processor whose total annual sales, when combined with those of its parent company (if any), are less than $12 million.

(b) Substance for which reports must be submitted. The requirements of this section apply to asbestos, including asbestos in bulk form, in an article and/or product, as an impurity, or as a component of a mixture.

(c) Persons who must report. Persons (i.e., plant sites) who have manufactured (including imported), or processed asbestos, including asbestos as a component of a mixture, asbestos in articles, or asbestos as an impurity in the four full calendar years prior to the effective date of this rule, and with annual sales greater than or equal to $500,000, in any calendar year from 2019 to 2022, when combined with those of their ultimate parent company (if any), must report under this subpart.

(d) Persons exempt from reporting. A person who is subject to reporting requirements pursuant to paragraph (c) of this section is exempt from the requirements in this subpart to the extent that the person and that person's use of asbestos is described in this paragraph (d).

(1) Non-isolated intermediate. A person who manufactures or proposes to manufacture asbestos, as described in paragraph (c) of this section, solely as a non-isolated intermediate is exempt from the reporting requirements of this subpart.

(2) Research and development. A person who manufactures (including imports), processes, or proposes to manufacture (including import), or process asbestos, as described in paragraph (c) of this section, only in small quantities solely for research and development is exempt from the reporting requirements of this subpart.

(3) Small manufacturers (including importers) and processors. Small manufacturers (including importers) and processors are exempt from the reporting requirements of this subpart for Libby amphibole asbestos only.

(4) Byproducts. A person who manufactures (including imports) or proposes to manufacture (including import) asbestos solely as a byproduct is exempt from the reporting requirements of this subpart.

(e) Reporting information to EPA. Persons described in paragraph (c) of this section and not described and exempted in paragraph (d) of this section must report to EPA the following information, to the extent known to or reasonably ascertainable by them. In the event that specific numeric data are not known or are not reasonably ascertainable by the submitter, then reasonable estimates may be submitted.

(1) Required forms. Report using the appropriate Form, based on whether you know or can reasonably ascertain a quantity for asbestos.

(i) Form A. Report using Form A if you know or can reasonably ascertain that asbestos, including as a component of a mixture or article, or as an impurity, but are unable to determine the asbestos quantity by weight.

(ii) Form B. Report using Form B if you know or can reasonably ascertain a quantity for asbestos, including as a component of a mixture or article, or as an impurity.

(2) 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 Form A or Form B 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.

(3) Company and plant site information. The following currently correct company and plant site information must be reported for each site at which a reportable chemical substance is manufactured (including imported) or processed (see § 704.3 for the definition of “site,” which includes what “site” means for importers):

(i) Company name. The highest-level U.S. parent company name, address, and Dun and Bradstreet D-U-N-S® (D&B) number. A submitter under this part must obtain a D&B number for the U.S. parent company if none exists.

(ii) Authorized official. The name of a person who will serve as Authorized Official for the submitter company, and who will be able to sign the certification statement as described in paragraph (e)(2) of this section, the Authorized Official's full mailing address, telephone number, and email address.

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

(iv) Site information. The site name, full street address, including the county or parish (or other jurisdictional indicator) in which the plant site is located. Also report the following:

(A) The appropriate D&B number for the plant site. If none exists, you must obtain a D&B number for the reported site.

(B) Other site identification numbers, including the Facility Registry Service (FRS) identification number, if they exist.

(v) Applicable NAICS code. The six-digit North American Industry Classification System (NAICS) code(s) of the site.

(vi) Number of employees. The total number of employees at the site. Select from among the ranges of employees listed in Table 2 of this paragraph (e) and report the corresponding code (i.e., W1 through W8):

(4) Activity information. The following activity information must be reported.

(i) Type of activity at reporting site. Report all that apply.

(A) Mining of bulk asbestos or bulk materials containing asbestos, including as an impurity.

(B) Milling of bulk asbestos or bulk materials containing asbestos, including as an impurity.

(C) Importing of bulk asbestos or bulk materials containing asbestos, including as an impurity.

(1) For importing only. For importing only, if the imported bulk material was never physically present at the reporting site.

(2) [Reserved]

(D) Primary processing of bulk asbestos or bulk materials containing asbestos, including as an impurity.

(E) Secondary processing of asbestos, including as a component of a mixture, or an article containing asbestos.

(F) Importing of asbestos, including as a component of a mixture, or an article containing asbestos.

(ii) For importing only. For importing only, if the imported bulk material was never physically present at the reporting site.

(iii) Form B only. For mining, milling, or importing of bulk asbestos reported under activity in paragraphs (e)(4)(i)(A) through (C) of this section, report by year:

(A) The most specific asbestos type that applies. Select from among the asbestos types listed in Table 1 of paragraph (a) in this section. If the specific asbestos type is not known or reasonably ascertainable, report the general listing, “asbestos CASRN 1332-21-4”.

(B) Report. For each asbestos type, report the following:

(1) Quantity of asbestos, in pounds.

(2) Disposition of asbestos (see Table 3 to this paragraph (e)).

(iv) Reporting information for mining, milling, or importing of bulk materials containing asbestos, including as an impurity. For mining, milling, or importing of bulk materials containing asbestos reported under the activity identified in paragraphs (e)(4)(i)(A) through (C) of this section, report by year:

(A) Bulk material type manufactured or processed.

(B) For Form B only, for each bulk material type:

(1) Quantity of bulk material manufactured or processed.

(2) Percent asbestos impurity by weight in bulk material.

(3) The most specific asbestos type that applies. Select from among the asbestos types listed in Table 1 to paragraph (a) of this section. If the specific asbestos type is not known or reasonably ascertainable, report the general listing, asbestos CASRN 1332-21-4.

(4) Any testing of or test results assessing the asbestos content of your bulk material in the applicable reporting years.

(i) If testing was conducted, specify how often testing was conducted on the presence of asbestos in your bulk material and what method and type of test was used for determining asbestos content, and provide the test results.

(ii) If testing was not conducted, explain how you knew or reasonably ascertained the presence and amount of asbestos in the bulk materials.

(C) For each bulk material type, the disposition of bulk material (see Table 3 of this paragraph (e)).

(D) For importing only, if the imported bulk material was never physically present at the reporting site.

(v) Reporting information for primary processors. For primary processing reported under activity identified in paragraph (e)(4)(i)(D) of this section, report by year:

(A) For Form B only, the total quantity of asbestos processed.

(B) End product type, selecting from products listed in Table 4 of this paragraph (e). If your end product is not listed, report “other” and provide a brief description. For each end product type, report:

(1) For Form B only, the most specific asbestos types that apply. Select from among the asbestos types listed in Table 1 in paragraph (a) of this section. If the specific asbestos types are not known or reasonably ascertainable, report the general listing, “asbestos CASRN 1332-21-4”. Report also the total annual quantity of each of the asbestos types processed.

(2) The total annual production quantity of end products produced, using the associated unit of measure listed in Table 4 of this paragraph (e). If a unit of measure is not listed, provide the unit of measure associated with the quantity reported.

(3) For Form B only, the percentage of asbestos in the end product.

(4) For Form B only, the disposition of the end product (see Table 3 of this paragraph (e)).

(5) For Form B only, explain if you tested or received test results assessing the asbestos content of your end product in the applicable reporting years.

(i) If testing was conducted, specify how often testing was conducted on the presence of asbestos in your end product and what method and type of test was used for determining asbestos content, and provide the test results.

(ii) If testing was not conducted, explain how you knew or reasonably ascertain the presence and amount of asbestos in the end product.

(vi) Reporting information for secondary processors. For secondary processing reported under the activity identified in paragraph (e)(4)(i)(E) of this section, report by year:

(A) For Form B only, the estimated total quantity of asbestos processed.

(B) End product type listed in Table 4 of this paragraph (e). For each product type, report:

(1) For Form B only, the most specific asbestos types that apply. Select from among the asbestos types listed in Table 1 in paragraph (a) of this section. If the specific asbestos type is not known or reasonably ascertainable, report the general listing, asbestos CASRN 1332-21-4. Also report the quantity of each type of asbestos.

(2) The total annual production quantity of the end products produced, using the associated unit of measure listed in Table 4 of this paragraph (e).

(3) For Form B only, the percentage of asbestos in the end product.

(i) If testing was conducted, specify how often testing was conducted on the presence of asbestos in your products and what method and type of test was used for determining asbestos content, and provide the test results.

(ii) If testing was not conducted, explain how you knew or reasonably ascertained the presence and amount of asbestos in the end product.

(4) For Form B only, the disposition of the end product (see Table 3 of this paragraph (e)).

(vii) Reporting information for importers. For importing reported under an activity identified in paragraph (e)(4)(i)(F) of this section, report by year:

(A) For Form B only, the estimated total quantity of asbestos imported.

(B) Imported product type (Table 4 of this paragraph (e)). For each imported product type, report:

(1) Whether the imported product is a mixture or an article.

(2) For Form B only, the most specific asbestos types that apply. Select from among the asbestos types listed in Table 1 in paragraph (a) of this section. If a specific asbestos type is not known or reasonably ascertainable, report the general listing, “asbestos CASRN 1332-21-4”. Also report the quantity of each asbestos type.

(3) The total annual import quantity of the imported product, using the associated unit of measure listed in Table 4 of this paragraph (e).

(4) Whether the imported asbestos was never physically present at the reporting site.

(5) For Form B only, the percentage of asbestos in the product.

(6) For Form B only, explain if you tested or received test results assessing the asbestos content of your imported product in the applicable reporting years.

(i) If testing was conducted, specify how often testing was conducted on the presence of asbestos in your imported product and what method and type of test was used for determining asbestos content, and provide the test results.

(ii) If testing was not conducted, explain how you knew or reasonably ascertained the presence and amount of asbestos in the imported product.

(7) For Form B only, the disposition of the imported product (see Table 3 of this paragraph (e)).

(5) Employee information. For each activity reported, report the following information about employees at the associated site:

(i) Number of employees involved with activity. Select from among the ranges of employees listed in Table 2 of this paragraph (e) and report the corresponding code (i.e., W1 through W8).

(ii) Is personal protective equipment used? If yes, identify the type(s) of personal protective equipment used.

(iii) For Form B only, submit any workplace exposure measurement assessments and data (e.g., monitoring).

(f) When to report. All information reported to EPA under this section must be submitted during the applicable submission period. The submission period shall begin six months following the effective date of this rule and last for three months.

(g) Recordkeeping requirements. 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. Relevant records must be retained for a period of five years beginning on the last day of the submission period.

(h) Confidentiality claims—(1) Assertion of confidentiality claims—(i) Generally. Any person submitting information under this part may assert a confidentiality claim for that information, except for information described in paragraph (h)(1)(ii) of this section. Any such confidentiality claims must be asserted electronically, pursuant to § 704.180(i), at the time the information is submitted. 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.

(ii) Exceptions. Confidentiality claims may not be asserted with respect to the following:

(A) Site NAICS code required by § 704.180(e)(3)(v);

(B) For chemical identities and bulk material forms required by §§ 704.180(e)(4)(iii)(A), (iv)(A), (iv)(B)(3), (v)(B)(1), (vi)(B)(1), and (vii)(B)(2);

(C) Any data element that is left blank or designated as “not known or reasonably ascertainable;” or

(D) Health and safety data required by § 704.180(e)(5)(iii), except that the following information may be claimed as confidential:

(1) Information that would reveal processes used in the manufacturing, importing, or processing of the substance or mixture, or the portion of a mixture comprised by any of the substances in the mixture, provided that the information is expressly identified as revealing processing information or portion of a mixture;

(2) Company name or address, financial statistics, and product codes used by a company and contained in a study; and

(3) Information other than company name or address, financial statistics, and product codes used by a company, which is contained in a study, the disclosure of which would clearly be an unwarranted invasion of personal privacy (such as individual medical records).

(iii) 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:

“I certify that all claims for confidentiality asserted 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: I have taken reasonable measures to protect the confidentiality of the information; I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; 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 I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.”

(2) Substantiation—(i) Requirement to substantiate. Confidentiality claims must be substantiated at the time of submission to EPA, unless exempt under paragraph (h)(2)(iv) of this section.

(ii) Information in substantiations may be claimed as confidential. Such claims must be accompanied by the certification described in paragraph (h)(1)(iii) of this section, but need not be themselves substantiated.

(iii) Substantiation questions for all claims. Answers to the following questions must be provided for each confidentiality claim in a TSCA submission:

(A) Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential. How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable) to be caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential (e.g., site information, exposure information, environmental release information), explain how disclosure of each type of information would be likely to cause substantial harm to the competitive position of your business.

(B) 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. If the same or similar information was previously reported to EPA as non-confidential (such as in an earlier version of this submission), please explain the circumstances of that prior submission and reasons for believing the information is nonetheless still confidential.

(C)(1) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.

(2) 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.

(3) 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.

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

(E) 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.

(iv) Exemptions from the substantiation requirement. Confidentiality claims are exempt from the requirement to substantiate the claim at the time of submission for the data elements required pursuant to paragraphs (e)(4)(iii)(B)(1), (iv)(B)(1), (v)(A), (v)(B)(2), (vi)(A), (vi)(B)(2), (vii)(A), and (vii)(B)(3) of this section.

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

(vi) Public copies. Submissions and their accompanying attachments that include a confidentiality claim must be accompanied, at the time of submission, by a public version of the submission and any attachments, with all information that is claimed as confidential removed. Only information that is claimed as confidential may be redacted or removed. Generally, a public copy that removes all or substantially all of the information would not meet the requirements of this paragraph.

(A) Where the electronic reporting tool contains a checkbox or other means of designating with specificity what information is claimed as confidential, no further action by the submitter is required to satisfy this requirement.

(B) For all other information claimed as confidential, including but not limited to information in attachments and in substantiations required under paragraph (h) of this section, the submitter must prepare and attach a public copy. Submissions with public or sanitized copies that are entirely blank or that are substantially reduced in length as compared to the CBI version will not meet the requirements of this paragraph (h)(2)(vi) of this section.

(i) Electronic reporting. You must use the EPA Central Data Exchange (CDX) to complete and submit the information required under this section. Submissions may only be made as set forth in this paragraph. Submissions must be sent electronically to EPA using the asbestos reporting tool in CDX. The information submitted and all attachments (unless the attachment appears in scientific literature) must be in English. All information must be true and correct. Access the asbestos reporting tool and instructions, as follows:

(1) By website. Access the asbestos reporting tool via the CDX homepage at https://cdx.epa.gov/ and follow the applicable instructions.

(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-1404 or [email protected].

[88 FR 47800, July 25, 2023; 88 FR 84242, Dec. 5, 2023]