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Title 40: Protection of Environment

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PART 710—TSCA CHEMICAL INVENTORY REGULATIONS

Authority:   15 U.S.C. 2607(a).

Subpart A—General Provisions

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(a) This part establishes regulations governing reporting and recordkeeping by certain persons who manufacture, import, or process chemical substances for commercial purposes under section 8(a) of the Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a) authorizes the Administrator to require reporting of information necessary for administration of the Act and requires EPA to issue regulations for the purpose of compiling and keeping current an inventory of chemical substances manufactured or processed for a commercial purpose, as required by section 8(b) of the Act. Following an initial reporting period, EPA published an initial inventory of chemical substances manufactured, processed, or imported for commercial purposes. In accordance with section 8(b), EPA periodically amends the inventory to include new chemical substances which are manufactured or imported for a commercial purpose and reported under section 5(a)(1) of the Act. EPA also revises the categories of chemical substances and makes other amendments as appropriate.

(b) The regulations in this part apply to the activities associated with the compilation of the TSCA Chemical Inventory and the update of information on a subset of the chemical substances included on the Inventory. The Inventory Update regulations were amended in 2002; however, these amendments apply to updates after 2002, not to the 2002 update. In order to prevent confusion as to which regulations apply to which update, EPA has preserved the provisions that apply to the 2002 update in subpart B. The new and revised requirements that apply to updates after 2002 appear in subpart C. Prior to January 1, 2003, the regulations in subpart B of this part are effective for purposes of Inventory update activities. As of January 1, 2003, subpart C is effective for purposes of Inventory update activities. The Agency intends to remove subpart B from the CFR once the 2002 update is complete.

(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under these reporting regulations. In addition, section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by these regulations. Section 16 provides that any person who violates a provision of section 15 is liable to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, the Government may seek judicial relief to compel submission of section 8(a) information and to otherwise restrain any violation of section 15. (EPA does not intend to concentrate its enforcement efforts on insignificant clerical errors in reporting.)

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

[68 FR 887, Jan. 7, 2003]

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In addition to the definitions in §704.3 of this chapter, the following definitions apply to this part:

(a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued under such Act: Cosmetic, device, drug, food, and food additive. In addition, the term food includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 et seq. ; meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 et seq. ; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.

(b) The term pesticide will have the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq ., and the regulations issued thereunder.

(c) The following terms will have the meaning contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq ., and the regulations issued thereunder: Byproduct material, source material, and special nuclear material.

(d) The following definitions also apply to this part:

Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq .

Administrator means the Administrator of the U.S. Environmental Protection Agency, any employee or authorized representative of the Agency to whom the Administrator may either herein or by order delegate his/her authority to carry out his/her functions, or any other person who will by operation of law be authorized to carry out such functions.

An article is a manufactured item:

(1) Which is formed to a specific shape or design during manufacture,

(2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use, and

(3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in §710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design.

Byproduct means a chemical substance produced without separate commercial intent during the manufacture or processing of another chemical substance(s) or mixture(s).

Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that “chemical substance” does not include:

(1) Any mixture,

(2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide,

(3) Tobacco or any tobacco product, but not including any derivative products,

(4) Any source material, special nuclear material, or byproduct material,

(5) Any pistol, firearm, revolver, shells, and cartridges, and

(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

Commerce means trade, traffic, transportation, or other commerce:

(1) Between a place in a State and any place outside of such State, or

(2) Which affects trade, traffic, transportation, or commerce described in paragraph (1) of this definition.

Distribute in commerce and distribution in commerce, when used to describe an action taken with respect to a chemical substance or mixture or article containing a substance or mixture, mean to sell or the sale of the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of the substance, mixture, or article; or to hold or the holding of the substance, mixture, or article after its introduction into commerce.

EPA means the U.S. Environmental Protection Agency.

Importer means any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the U.S. and includes:

(1) The person primarily liable for the payment of any duties on the merchandise, or

(2) An authorized agent acting on his/her behalf (as defined in 19 CFR 1.11).

Impurity means a chemical substance which is unintentionally present with another chemical substance.

Intermediate means any chemical substance:

(1) Which is intentionally removed from the equipment in which it is manufactured, and

(2) Which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s).

Note: The equipment in which it was manufactured includes the reaction vessel in which the chemical substance was manufactured and other equipment which is strictly ancillary to the reaction vessel, and any other equipment through which the chemical substance may flow during a continuous flow process, but does not include tanks or other vessels in which the chemical substance is stored after its manufacture.

Manufacture means to manufacture, produce, or import for commercial purposes.

Manufacture or import “for commercial purposes” means to manufacture, produce, or import with the purpose of obtaining an immediate or eventual commercial advantage, and includes, for example, the manufacture or import of any amount of a chemical substance or mixture:

(1) For commercial distribution, including for test marketing, or

(2) For use by the manufacturer, including use for product research and development, or as an intermediate.

Mixture means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that “mixture” does include:

(1) Any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined and if, after the effective date or premanufacture notification requirements, none of the chemical substances comprising the combination is a new chemical substance, and

(2) Hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water.

New chemical substance means any chemical substance which is not included in the inventory compiled and published under section 8(b) of the Act.

Non-isolated intermediate means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture.

Person means any natural or juridical person including any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality, any interstate body and any department, agency, or instrumentality of the Federal Government.

Process means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce:

(1) In the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or

(2) As part of a mixture or article containing the chemical substance or mixture.

Process “for commercial purposes” means to process:

(1) For distribution in commerce, including for test marketing purposes, or

(2) For use as an intermediate.

Processor means any person who processes a chemical substance or mixture.

Site means a contiguous property unit. Property divided only by a public right-of-way will be considered one site. There may be more than one manufacturing plant on a single site. For the purposes of imported chemical substances, the site will be the business address of the importer.

Small quantities for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product (hereinafter sometimes shortened to small quantities for research and development ) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed that:

(1) Are no greater than reasonably necessary for such purposes, and

(2) After the publication of the revised inventory, are used by, or directly under the supervision of, a technically qualified individual(s).

Note: Any chemical substances manufactured, imported, or processed in quantities less than 1,000 lbs. (454 kg) annually will be presumed to be manufactured, imported, or processed for research and development purposes. No person may report for the inventory any chemical substance in such quantities unless that person can certify that the substance was not manufactured, imported, or processed solely in small quantities for research and development, as defined in this section.

State means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States.

Technically qualified individual means a person:

(1) Who because of his/her education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision,

(2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and

(3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition.

Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce.

United States, when used in the geographic sense, means all of the States, territories, and possessions of the United States.

[68 FR 888, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004]

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(a) Chemical substances subject to these regulations. Only chemical substances which are manufactured, imported, or processed “for a commercial purpose,” as defined in §710.3(d), are subject to these regulations.

(b) Naturally occurring chemical substances automatically included. Any chemical substance which is naturally occurring and:

(1) Which is (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or

(2) Which is extracted from air by any means, will automatically be included in the inventory under the category “Naturally Occurring Chemical Substances.” Examples of such substances are: raw agricultural commodities; water, air, natural gas, and crude oil; and rocks, ores, and minerals.

(c) Substances excluded by definition or section 8(b) of TSCA. The following substances are excluded from the inventory:

(1) Any substance which is not considered a “chemical substance” as provided in subsection 3(2)(B) of the Act and in the definition of “chemical substance” in §710.3(d);

(2) Any mixture as defined in §710.3(d);

Note: A chemical substance that is manufactured as part of a mixture is subject to these reporting regulations. This exclusion applies only to the mixture and not to the chemical substances of which the mixture is comprised. The term “mixture” includes alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement.

(3) Any chemical substance which is manufactured, imported, or processed solely in small quantities for research and development, as defined in §710.3(d); and

(4) Any chemical substance not manufactured, processed or imported for a commercial purpose since January 1, 1975.

(d) Chemical substances excluded from the inventory. The following chemical substances are excluded from the inventory. Although they are considered to be manufactured or processed for a commercial purpose for the purpose of section 8 of the Act, they are not manufactured or processed for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they may be a part.

Note: In addition, chemical substances excluded here will not be subject to premanufacture notification under section 5 of the Act.

(1) Any impurity.

(2) Any byproduct which has no commercial purpose.

Note: A byproduct which has commercial value only to municipal or private organizations who (i) burn it as a fuel, (ii) dispose of it as a waste, including in a landfill or for enriching soil, or (iii) extract component chemical substances which have commercial value, may be reported for the inventory, but will not be subject to premanufacture notification under section 5 of the Act if not included.

(3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.

(4) Any chemical substance which results from a chemical reaction that occurs incidental to storage of another chemical substance, mixture, or article.

(5) Any chemical substance which results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleansers or other housekeeping products, fuels and fuel additives, water softening and treatment agents, photographic films, batteries, matches, and safety flares, and which is not itself manufactured for distribution in commerce or for use as an intermediate.

(6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints; or other chemical substances formed during manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that may occur as described elsewhere in this §710.4(d).

(7) Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or de-foamer, dispersant, precipitation inhibitor, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended or (ii) a chemical substance, solely intended to impart a specific physicochemical characteristic, functions as intended.

(8) Chemical substances which are not intentionally removed from the equipment in which they were manufactured.

Note: See note to definition of “intermediate” at §710.3(d) for explanation of “equipment in which it was manufactured.”

[42 FR 64572, Dec. 23, 1977, as amended at 68 FR 889, Jan. 7, 2003]

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In addition to the definitions in §704.3 of this chapter and §710.3, the following definitions also apply to subpart B of this part.

Master Inventory File means EPA's comprehensive list of chemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes substances reported under subpart A of this part and substances reported under part 720 of this chapter for which a Notice of Commencement of Manufacture or Import has been received under §720.120 of this chapter.

Non-isolated intermediate means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture.

Site-limited means a chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as a substance or as part of a mixture or article outside the site. Imported substances are never site-limited.

[68 FR 889, Jan. 7, 2003]

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Any chemical substance which is in the Master Inventory File at the beginning of a reporting period described in §710.33, unless the chemical substance is specifically excluded by §710.26.

[51 FR 21447, June 12, 1986]

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The following categories of chemical substances are excluded from the reporting requirements of this subpart. However, a chemical substance described in paragraphs (a), (b), or (c) of this section is not excluded from the reporting requirements of this subpart if that substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.

(a) Inorganic chemical substances. Any chemical substance which does not contain carbon or contains carbon only in the form of carbonato [=CO₃], cyano [−CN], cyanato [−OCN], isocyano [−NC], or isocyanato [−NCO] groups, or the chalcogen analogues of such groups.

(b) Polymers. (1) Any chemical substance described with the word fragments “*polym*”, “*alkyd”, or “*oxylated” in the Chemical Abstracts Service Index or Preferred Nomenclature in the Chemical Substance Identities section of the 1985 edition of the Inventory or in the Master Inventory File, where the asterisk (*) indicates that any sets of characters may precede, or follow, the character string defined.

(2) Any chemical substance which is identified in the 1985 edition of the Inventory or the Master Inventory File as siloxane and silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), rubber, or lignin. This exclusion, however, does not apply to a chemical substance which has been hydrolyzed, depolymerized, or chemically modified to the extent that the final product is no longer polymeric in structure.

(c) Microorganisms. Any combination of chemical substances that is a living organism, such as bacteria, eimeria, fungi, and yeasts. Any chemical substance produced from such a living organism is reportable unless otherwise excluded.

(d) Naturally occurring chemical substances. Any naturally occurring chemical substance, as described in §710.4(b). The applicability of this exclusion is determined in each case by the specific activities of the person who manufactures the substance in question. Some chemical substances can be manufactured both as described in §710.4(b) and by means other than those described in §710.4(b). If a person described in §710.28 manufactures a chemical substance by means other than those described in §710.4(b), the person must report regardless of whether the substance also could have been produced as described in §710.4(b). Any chemical substance that is produced from such a naturally occurring chemical substance described in §710.4(b) is reportable unless otherwise excluded.

[51 FR 21447, June 12, 1986]

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Except as provided in §§710.29 and 710.30, the following persons are subject to the requirements of this subpart. Persons must determine whether they must report under this §710.28 for each chemical substance that they manufacture at an individual site.

(a) Persons subject to initial reportinq. Any person who manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or more of a chemical substance described in §710.25 at any single site owned or controlled by that person at any time during the person's latest complete corporate fiscal year before August 25, 1986.

(b) Persons subject to recurring reporting. Any person who manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or more of a chemical substance described in §710.25 at any single site owned or controlled by that person at any time during the person's latest complete corporate fiscal year before August 25, 1990, or before August 25 at four-year intervals thereafter.

(c) Special provisions for importers. For purposes of paragraphs (a) and (b) of this section, the site for a person who imports a chemical substance described in §710.25 is the site of 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 in the U.S. (See also §710.35(b).)

[51 FR 21447, June 12, 1986]

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A person described in §710.28 is not subject to the requirements of this subpart if that person qualifies as a small manufacturer as that term is defined in §704.3 of this chapter. Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject of a rule proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.

[51 FR 21447, June 12, 1986]

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A person described in §710.28 is not subject to the requirements of this subpart with respect to any chemical substance described in §710.25 that the person manufactured or imported under the following circumstances:

(a) The person manufactured or imported the chemical substance described in §710.25 solely in small quantities for research and development,

(b) The person imported the chemical substance described in §710.25 as part of an article,

(c) The person manufactured the chemical substance described in §710.25 in a manner described in §720.30(g) or (h) of this chapter.

[51 FR 21447, June 12, 1986]

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Any person who must report under this part must submit the information prescribed in this section for each chemical substance described in §710.25 that the person manufactured for commercial purposes in an amount of 10,000 pounds (4,540 kilograms) or more at a single site during a corporate fiscal year described in §710.28. (The site for a person who imports a chemical substance is the site of the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction, and may in some cases be the organization's headquarters office in the U.S.). A respondent to this subpart must report information in writing or by magnetic media as prescribed in this section, to the extent that such information is known to or reasonably ascertainable by that person. A respondent to this subpart must report information that applies to the specific corporate fiscal year for which the person is required to report.

(a) Reporting in writing. Any person who chooses to report information to EPA in writing must do so by completing the reporting form available from EPA at the address set forth in §710.39(b). The form must include all information prescribed in paragraph (c) of this section. Persons reporting in writing must submit a separate form for each site for which the person is required to report.

(b) Reporting by magnetic media. Any person who chooses to report information to EPA by means of magnetic media must submit the information prescribed in paragraph (c) of this section. Magnetic media submitted in response to this subpart must meet EPA specifications, as described in the instruction booklet available from EPA at the address set forth in §710.39(b).

(c) Information to be reported. Persons reporting information under this subpart must report the following:

(1) The name, company, address, city, State, Zip code, and telephone number of a person who will serve as technical contact for the respondent company, and will be able to answer questions about the information submitted by the company to EPA. Persons reporting by means of magnetic media must submit this information on the reporting form available from EPA at the address set forth in §710.39.

(2) A certification statement signed and dated by an authorized official of the respondent company. Persons reporting by means of magnetic media must submit this information on the reporting form available from EPA at the address set forth in §710.39.

(3) The specific chemical name and Chemical Abstracts Service (CAS) Registry Number of each chemical substance for which reporting is required under this subpart. A respondent to this subpart may use other chemical identification numbers in lieu of CAS Registry Numbers when a CAS Registry Number is not known to the respondent as provided in the instruction booklet identified in §710.39(b), including EPA-designated Accession Numbers for confidential substances, EPA-assigned numbers for bona fide or Premanufacture Notification submissions, or Test Market Exemption Applications, or original Inventory form numbers.

(4) The name, street address, city, State, and Zip code of each site at which 10,000 pounds (4,540 kilograms) or more of a chemical substance for which reporting is required under this subpart is manufactured or imported. (The site for a person who imports a chemical substance is the site of the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction, and may in some cases be the organization's headquarters office in the U.S.) A respondent to this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported.

(5) A statement for each substance for which information is being submitted indicating whether the substance is manufactured in the United States or imported into the United States.

(6) A statement for each substance for which information is being submitted indicating whether the substance is site-limited.

(7) The total volume (in pounds) of each subject chemical substance manufactured or imported at each site. This amount must be reported to two significant figures of accuracy provided that the reported figures are within ±10 percent of the actual volume.

[55 FR 39587, Sept. 27, 1990, as amended at 60 FR 31921, June 19, 1995]

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All information reported to EPA in response to the requirements of this subpart must be submitted during an applicable reporting period. The following reporting periods are prescribed for this subpart.

(a) Initial reporting period. The first reporting period is from August 25, 1986 to December 23, 1986. Any person described in §710.28(a) must report during this period for each chemical substance described in §710.25 that the person manufactured during the corporate fiscal year described in §710.28(a).

(b) Recurring reporting periods. The first recurring reporting period is from August 25, 1990 to December 23, 1990. Subsequent reporting periods, except as provided in paragraph (c) of this section, are from August 25 to December 23 at 4-year intervals thereafter. Any person described in §710.28(b) must report during the appropriate reporting period for each chemical substance described in §710.25 that the person manufactured during the applicable corporate fiscal year described in §710.28(b).

(c) Reporting in 1998. The 1998 reporting period is from August 25, 1998 until January 31, 1999. Any person described in §710.28(b) must report during this reporting period for each chemical substance described in §710.25 that the person manufactured during the applicable corporate fiscal year described in §710.28(b). This reporting period is applicable to 1998 reporting only.

[51 FR 21447, June 12, 1986: 51 FR 22521, June 20, 1986, as amended at 63 FR 71600, Dec. 29, 1998]

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(a) With regard to section 8(a) rules. Any person subject to the requirements of this part who previously has complied with reporting requirements of a rule under section 8(a) of the Act by submitting the information described in §710.32 for a chemical substance described in §710.25 to EPA, and has done so within one year of the start of a reporting period described in §710.33, is not required to report again on the manufacture of that substance at that site during that reporting 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 §710.25. 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 §§710.2(l) and 704.3 of this chapter, 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.

[51 FR 21447, June 12, 1986, as amended at 60 FR 31921, June 19, 1995]

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Each person who is subject to the reporting requirements of this part must maintain records that document any information reported to EPA. For substances that are manufactured or imported at less than 10,000 pounds annually, volume records must be maintained as evidence to support a decision not to submit a report. Records relevant to reporting during a reporting period described in §710.33 must be retained for a period of four years beginning with the effective date of that reporting period.

[51 FR 21447, June 12, 1986, as amended at 58 FR 34204, June 23, 1993; 60 FR 31921, June 19, 1995]

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(a) Any person submitting information under this part may assert a business confidentiality claim for the information. The procedures for asserting confidentiality claims are described in the instruction booklet identified in §710.39. Information claimed as confidential in accordance with this section and those instructions will be treated and disclosed in accordance with the procedures in part 2 of this chapter.

(b) A person may assert a claim of confidentiality for the chemical identity of a specific chemical substance only if the identity of that substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that substance under this part.

(c) To assert a claim of confidentiality for the chemical identity of a specific chemical substance, the person must take the following steps:

(1) The person must submit with the report detailed written answers to the following questions signed and dated by an authorized official.

(i) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?

(iv) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?

(v) Is the fact that the chemical substance is being manufactured or imported for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?

(vi) What measures have you taken to prevent undesired disclosure of the fact that this chemical substance is being manufactured or imported for a commercial purpose?

(vii) To what extent has the fact that this chemical substance is manufactured or imported for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

(viii) Does this particular chemical substance leave the site of manufacture in any form, as product, effluent, emission, etc.? If so, what measures have you taken to guard against discovery of its identity?

(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?

(x) For what purpose do you manufacture or import the substance?

(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

(2) If any of the information contained in the answers to the questions is asserted to contain confidential business information, the person must mark that information as “trade secret,” “confidential,” or other appropriate designation.

(d) If no claim of confidentiality accompanies information at the time it is submitted to EPA under this part or if substantiation required under paragraph (c) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.

[51 FR 21447, June 12, 1986, as amended at 55 FR 39588, Sept. 27, 1990; 60 FR 31921, June 19, 1995]

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(a) Use the proper EPA form. You must use the EPA form identified as “Form U” to submit written information in response to the requirements of this subpart. Copies of the Form U are available from EPA at the address set forth in paragraph (c) of this section and from the EPA Internet Home Page at http://www.epa.gov/oppt/iur/iur02/index.htm.

(b) Follow the reporting instructions. You should follow the detailed instructions for completing the reporting form and preparing a magnetic media report, which are given in the EPA publication entitled “Instructions for Reporting for Partial Updating of the TSCA Chemical Inventory Data Base,” via the Internet or the TSCA Hotline.

(c) Obtain the reporting package and copies of the form. EPA is mailing the reporting package to those companies that reported in 1998. Failure to receive a reporting package does not obviate or otherwise affect the requirement to submit a timely report. If you did not receive a reporting package, but are required to report, you may obtain a copy of the reporting package and the reporting form from EPA by submitting a request for this information as follows:

(1) By phone. Call the EPA TSCA Hotline at (202) 554–1404.

(2) By e-mail. Send an e-mail request for this information to the EPA TSCA Hotline at TSCA-Hotline@epamail.epa.gov.

(3) By mail. Send a written request for this information to the following address: TSCA Hotline, Mail Code 7408M, ATTN: Inventory Update Rule, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

(d) Submit the completed reports. You must submit your completed reporting form(s) and/or magnetic media to EPA at the following address: OPPT Document Control Officer, Mail Code 7407M, ATTN: Inventory Update Rule, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[63 FR 45953, Aug. 28, 1998, as amended at 68 FR 890, Jan. 7, 2003]

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Source:   68 FR 890, Jan. 7, 2003, unless otherwise noted.

§ 710.43   Definitions.

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In addition to the definitions in §704.3 of this chapter and §710.3, the following definitions also apply to subpart C of this part:

Commercial use means the use of a chemical substance or mixture in a commercial enterprise providing saleable goods or services (e.g., dry cleaning establishment, painting contractor).

Consumer use means the use of a chemical substance that is directly, or as part of a mixture, sold to or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in or around recreational areas.

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?

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

Master Inventory File means EPA's comprehensive list of chemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes substances reported under subpart A of this part and substances reported under part 720 of this chapter for which a Notice of Commencement of Manufacture or Import has been received under §720.120 of this chapter.

Readily obtainable information means information which is known by management and supervisory employees of the submitter company who are responsible for manufacturing, processing, distributing, technical services, and marketing of the reportable chemical substance. Extensive file searches are not required.

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 §710.45.

Reporting year means the calendar year in which information to be reported to EPA during an IUR submission period is generated, i.e., calendar year 2005 and the calendar year at 5–year intervals thereafter.

Site-limited means a chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as a substance or as part of a mixture or article outside the site. Imported 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 substance is considered to have been manufactured and processed for commercial purposes.

Submission period means the period in which the information generated during the reporting year is 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.

[68 FR 890, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 70 FR 75068, Dec. 19, 2005]

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Any chemical substance which is in the Master Inventory File at the beginning of a submission period described in §710.53, unless the chemical substance is specifically excluded by §710.46.

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

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

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

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

(iii) This exclusion does not apply to a polymeric substance that has been hydrolyzed, depolymerized, 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 §725.3 of this chapter. Any chemical substance produced from a living microorganism is reportable under this subpart unless otherwise excluded.

(3) Naturally occurring chemical substances. Any naturally occurring chemical substance, as described in §710.4(b). The applicability of this exclusion is determined in each case by the specific activities of the person who manufactures the substance in question. Some chemical substances can be manufactured both as described in §710.4(b) and by means other than those described in §710.4(b). If a person described in §710.48 manufactures a chemical substance by means other than those described in §710.4(b), the person must report regardless of whether the substance also could have been produced as described in §710.4(b). Any chemical substance that is produced from such a naturally occurring chemical substance described in §710.4(b) is reportable unless otherwise excluded.

(4) Certain forms of natural gas. Chemical substances with the following Chemical Abstract Service (CAS) Registry Numbers: CAS No. 64741–48–6, Natural gas (petroleum), raw liquid mix; CAS No. 68919–39–1, Natural gas condensates; CAS No. 8006–61–9, Gasoline natural; CAS No. 68425–31–0, Gasoline (natural gas), natural; CAS No. 8006–14–2, Natural gas; and CAS No. 68410–63–9, Natural gas, dried.

(b) Partial exemptions. The following groups of chemical substances are partially exempted from the reporting requirements of this subpart (i.e., the information described in §710.52(c)(4) need not be reported for these substances). Such chemical substances are not excluded from the other reporting requirements under this subpart. A chemical substance described in paragraph (b)(3) of this section qualifies for a partial reporting exemption during the 2006 submission period; in subsequent submission periods, the chemical substances described in paragraph (b)(3) of this section will be subject to full reporting under this subpart (i.e., all of the information described in this subpart must be reported), unless otherwise exempted.

(1) Petroleum process streams. EPA has designated the following chemical substances, listed by CAS Number, as partially exempt from reporting under the IUR.

(2) Specific exempted chemical substances —(i) Exemption. EPA has determined that, at this time, the information in §710.52(c)(4) associated with the chemicals 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 qualifies or has qualified in past IUR collections for the reporting of the information described in §710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or more of the chemical).

(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 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 §710.52(c)(4) is of low interest.

(A) Any person may request that EPA amend the chemical list in paragraph (b)(2)(iv) of this section. Your request must be in writing and must be submitted to the address provided in §710.59(d). Requests must identify the chemical in question, as well as its CAS number or other chemical identification number as identified in §710.52(c)(3)(i), and must contain a written rationale for the request that provides sufficient specific information, addressing the considerations listed in §710.46(b)(2)(ii), including cites and relevant documents, to demonstrate to EPA that the collection of the information in §710.52(c)(4) for the chemical in question either is or is not of low current interest. If a request related to a particular chemical 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 public docket that will be established for each reporting cycle.

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

(C) To assist EPA in reaching a decision regarding a particular request prior to a given reporting year, requests must be submitted to EPA no later than 12 months prior to the start of the reporting year, i.e., by January 1, 2004, or by each January 1 at 5–year intervals thereafter.

(iv) List of chemical substances. EPA has designated the following chemical substances, listed by CAS Number, as partially exempt from reporting under the IUR.

(3) Inorganic chemical substances. For purposes of this subpart, an inorganic chemical substance is any chemical substance which does not contain carbon or contains carbon only in the form of carbonato [=CO3], cyano [--CN], cyanato [--OCN], isocyano [--NC], or isocyanato [--NCO] groups or the chalcogen analogues of such groups. During the 2006 submission period, manufacturers are excluded only from the reporting requirements under §710.52(c)(4) for inorganic chemical substances. During the 2006 submission period, manufacturers of inorganic chemical substances are not excluded from the other reporting requirements under this part. During submission periods following the 2006 submission period, manufacturers of inorganic chemical substances are subject to all of the reporting requirements in this subpart.

[68 FR 890, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 70 FR 60221, Oct. 17, 2005; 70 FR 74700, Dec. 16, 2005; 70 FR 75068, Dec. 19, 2005; 71 FR 8470, Feb. 17, 2006]

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Except as provided in §§710.49 and 710.50, the following persons are subject to the requirements of this subpart. 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 lbs. (11,340 kg) or more of a chemical substance described in §710.45 at any single site owned or controlled by that person at any time during calendar year 2005 or during the calendar year at 5–year intervals thereafter is subject to reporting.

(b) Special provisions for importers. For purposes of this section, the site for a person who imports a chemical substance described in §710.45 is the site of 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 in the United States (see also §710.55(b)).

[68 FR 890, Jan. 7, 2003, as amended at 70 FR 75069, Dec. 19, 2005]

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A person described in §710.48 is not subject to the requirements of this subpart if that person qualifies as a small manufacturer as that term is defined in §704.3 of this chapter. Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject of a rule proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.

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A person described in §710.48 is not subject to the requirements of this subpart with respect to any chemical substance described in §710.45 that the person solely manufactured or imported under the following circumstances:

(a) The person manufactured or imported the chemical substance described in §710.45 solely in small quantities for research and development.

(b) The person imported the chemical substance described in §710.45 as part of an article.

(c) The person manufactured the chemical substance described in §710.45 in a manner described in §720.30(g) or (h) of this chapter.

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Any person who must report under this subpart, as described in §710.48, must submit the information described in this section for each chemical substance described in §710.45 that the person manufactured (including imported) for commercial purposes in an amount of 25,000 lbs. (11,340 kg) or more at any one site during calendar year 2005 or during the calendar year at 5–year intervals thereafter. (See §710.48(b) for the “site” for importers). A separate form must be submitted for each chemical substance at each site for which the submitter is required to report. A submitter of information under this subpart must report information as described in paragraphs (c)(1), (c)(2), and (c)(3) of this section to the extent that such information is known to or reasonably ascertainable by that person whereas a submitter must report information as described in paragraph (c)(4) of this section only to the extent that such information is readily obtainable by that person. A submitter under this subpart must report information that applies to the calendar year for which the person is required to report (i.e., calendar year 2005 and the calendar year at 5–year intervals thereafter).

(a) Reporting in writing. Any person who chooses to report information to EPA in writing must do so by completing the reporting form available from EPA at the address set forth in §710.59. The form must include all information described in paragraph (c) of this section. Persons reporting in writing must submit a separate form for each site for which the person is required to report.

(b) Reporting by magnetic media. Any person who chooses to report information to EPA by means of magnetic media must submit the information described in paragraph (c) of this section. Magnetic media submitted in response to this subpart must meet EPA specifications, as described in the instruction booklet available from EPA at the address set forth in §710.59.

(c) Information to be reported. Manufacturers (including importers) of a reportable chemical substance in an amount of 25,000 lbs. (11,340 kg) or more at a site during a reporting year must report the information described in paragraphs (c)(1), (c)(2), and (c)(3) of this section. Manufacturers (including importers) of a reportable chemical substance in an amount of 300,000 lbs. (136,077 kg) or more at a site during a reporting year must report the information described in paragraph (c)(4) of this section in addition to the information described in paragraphs (c)(1), (c)(2), and (c)(3) of this section. As described in §710.46(b)(3), manufacturers of certain inorganic chemical substances are not required to report the information described in paragraph (c)(4) of this section during the 2006 submission period, but are required to report this information during subsequent submission periods. As described in §710.46(b)(1) and (b)(2), manufacturers of certain chemicals are not required to report the information described in paragraph (c)(4) of this section.

(1) A certification statement signed and dated by an authorized official of the submitter company. Persons reporting by means of magnetic media must submit this information on the reporting form available as described in §710.59.

(2) Company and plant site information. The following company and plant site information must be reported for each site at which at least 25,000 lbs. (11,340 kg) of a reportable chemical substance is manufactured (including imported) during calendar year 2005 or during the calendar year at 5–year intervals thereafter (see §710.48(b) for the “site” for importers):

(i) 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 company name and Dun and Bradstreet Number, the contact person's full mailing address, the contact person's telephone number and the contact person's e-mail address.

(ii) The name and full street address of each site. A submitter under this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish (or other jurisdictional indicator) in which the plant site is located.

(3) Specific information for chemicals manufactured in amounts of 25,000 lbs. or more. The following chemical-specific information must be reported for each reportable chemical substance manufactured at (including imported into) each site in amounts of 25,000 lbs. (11,340 kg) or more during calendar year 2005 or during the calendar year at 5–year intervals thereafter:

(i) The specific chemical name and CAS Number of each reportable chemical substance at each site. A submitter under this subpart may use an EPA-designated Accession Number for confidential substances, or a premanufacture notice (PMN) case number (see §720.65 of this chapter) in lieu of a CAS Number when a CAS Number is not known to or reasonably ascertainable by the submitter. In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the following codes:

(ii) A statement indicating, for each reportable chemical substance at each site, whether the 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) A designation indicating, for each reportable chemical substance at each site, whether the substance is site-limited.

(iv) The total volume (in pounds) of each reportable chemical substance manufactured and imported at each site. The total manufactured volume (not including imported volume) and the total imported volume must be separately reported. This amount must be reported to two significant figures of accuracy provided that the reported figures are within ±10% of the actual volume.

(v) The total number of workers reasonably likely to be exposed to each reportable chemical substance at each site. For each reportable substance at each site, the submitter must select from among the ranges of workers listed in the following table and report the corresponding code (i.e., W1 through W8):

(vi) 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 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 substance is sent off-site/reacted on-site. For each substance at each site, select the maximum concentration of the substance from among the ranges listed in the following table and report the corresponding code (i.e., M1 through M5):

(vii) The physical form(s) of the reportable chemical substance as it is sent off-site from each site. If the chemical 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 substance at each site, the submitter must report as many physical forms as apply from among the physical forms listed below:

(A) Dry powder.

(B) Pellets or large crystals.

(C) Water- or solvent-wet solid.

(D) Other solid.

(E) Gas or vapor.

(F) Liquid.

(viii) Submitters must report the percentage, rounded off to the closest 10%, of total production volume of the reportable chemical substance, reported in response to paragraph (c)(3)(iv) of this section, that is associated with each physical form reported under paragraph (c)(3)(vii) of this section.

(4) Specific information for chemical substances manufactured in amounts of 300,000 lbs. or more . In addition to the information required under paragraphs (c)(1), (c)(2), and (c)(3) of this section, the following information must be reported for each reportable chemical substance manufactured (including imported) in an amount of 300,000 lbs. (136,077 kg) or more at any one site during calendar year 2005 or during the calendar year at 5–year intervals thereafter. Persons subject to paragraph (c)(4) of this section must report the information described in paragraphs (c)(4)(i) and (c)(4)(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 only to the extent that it is readily obtainable by the submitter. Information required to be reported under this paragraph is limited to domestic (i.e., within the custom 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 readily obtainable, 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 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). A particular designation may need to be reported more than once, to the extent that a submitter reports more than one NAICS code (under paragraph (c)(4)(i)(B) of this section) that applies to a given designation under this paragraph.

(B) The five-digit North American Industrial Classification System (NAICS) codes which best describe the industrial activities associated with each industrial processing or use operation reported under paragraph (c)(4)(i)(A) of this section. Information about how to find these codes is provided in the instruction booklet available from EPA at the address set forth in §710.59. A particular NAICS code may need to be reported more than once, to the extent that a submitter reports more than one industrial function code (under paragraph (c)(4)(i)(C) of this section) that applies to a given NAICS code under this paragraph.

(C) For each NAICS code reported under paragraph (c)(4)(i)(B) of this section, code(s) from the following list must be selected to designate the industrial function category(ies) that best represents the specific manner in which the chemical substance is used. A particular industrial 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/NAICS code combination (under paragraphs (c)(4)(i)(A) and (c)(4)(i)(B) of this section) that applies to a given industrial function category under this paragraph. If more than 10 unique combinations of industrial processing or use operations/NAICS codes/industrial 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, measured by weight.

(D) The estimated percentage, rounded off to the closest 10%, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, NAICS code and industrial function category. Where a particular combination of industrial processing or use operation, NAICS code and industrial function category accounts for 5% or less of the submitter's site's total production volume of a reportable chemical substance, the percentage must not be rounded off to zero % if the production volume attributable to that industrial processing or use operation, NAICS code and industrial function category combination is 300,000 lbs. (136,077 kg) or more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1%, 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, NAICS code and industrial function category.

(E) For each combination of industrial processing or use operation, NAICS code and industrial 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 substance, the submitter must select from among the ranges of sites listed in the following table and report the corresponding code (i.e., S1 through S7):

(F) For each combination of industrial processing or use operation, NAICS code and industrial 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 substance, the submitter must select from among the worker ranges listed in paragraph (c)(3)(v) of this section and report the corresponding code (i.e., W1 though W8).

(ii) Commercial and consumer use information. (A) Using the codes listed in this paragraph, submitters must designate the commercial and consumer product category or categories that best describe the commercial and consumer products in which each reportable chemical substance is used (whether the recipient site(s) are controlled by the submitter site or not). 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:

(B) Submitters must determine, within each commercial and consumer product category reported under paragraph (c)(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 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 up to the age of 14, regardless of the concentration of the 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 readily obtainable.

(C) The estimated percentage, rounded off to the closest 10%, of the submitter's site's total production volume of the reportable chemical substance associated with each commercial and consumer product category. Where a particular commercial and consumer product category accounts for 5% or less of the total production volume of a reportable chemical substance, the percentage must not be rounded off to zero % if the production volume attributable to that commercial and consumer product category is 300,000 lbs. (136,077 kg) or more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the reportable chemical substance associated with the particular commercial and consumer product category.

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

[68 FR 890, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 70 FR 75069, Dec. 19, 2005; 71 FR 52498, Sept. 6, 2006]

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All information reported to EPA in response to the requirements of this subpart must be submitted during an applicable submission period. The first submission period is from August 25, 2006, to March 23, 2007. Subsequent recurring submission periods are from June 1 to September 30 at 5–year intervals after the first submission period. Any person described in §710.48(a) must report during each submission period for each chemical substance described in §710.45 that the person manufactured (including imported) during the preceding calendar year (i.e., the “reporting year”).

[70 FR 75069, Dec. 19, 2005, as amended at 71 FR 76206, Dec. 20, 2006]

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(a) With regard to section 8(a) rules. Any person subject to the requirements of this part who previously has complied with reporting requirements of a rule under section 8(a) of the Act by submitting the information described in §710.52 for a chemical substance described in §710.45 to EPA, and has done so within 1 year of the start of a submission period described in §710.53, is not required to report again on the manufacture of that 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 §710.45. 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 §§710.3 and 704.3 of this chapter, 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.

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Each person who is subject to the reporting requirements of this subpart 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.

[70 FR 75070, Dec. 19, 2005]

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(a) Any person submitting information under this subpart may assert a business confidentiality claim for the information at the time it is submitted. These claims will apply only to the information submitted with the claim. New confidentiality claims, if necessary, must be asserted with regard to information submitted during the next submission period. Guidance for asserting confidentiality claims is provided in the instruction booklet identified in §710.59. Information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in part 2 of this chapter.

(b) Chemical identity . A person may assert a claim of confidentiality for the chemical identity of a specific chemical substance only if the identity of that substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that substance under this subpart. The following steps must be taken to assert a claim of confidentiality for the identity of a reportable chemical substance:

(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official.

(i) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?

(iv) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?

(v) Is the fact that the chemical substance is being manufactured (including imported) for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?

(vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured (including imported) for a commercial purpose?

(vii) To what extent has the fact that this chemical substance is manufactured (including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

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

(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?

(x) For what purpose do you manufacture (including import) the substance?

(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

(2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”

(c) Site identity . A submitter may assert a claim of confidentiality for a site only if the linkage of the site with a reportable chemical is confidential and not publicly available. The following steps must be taken to assert a claim of confidentiality for a site identity:

(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official:

(i) Has site information been linked with a chemical identity in any other Federal, state or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed as confidential in any of these instances?

(ii) What harmful effect, if any, to your competitive position do you think would result from the identity of the site and the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

(2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”

(d) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this subpart, or if confidentiality claim substantiation required under paragraphs (b) and (c) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.

[68 FR 890, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004]

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(a) Use the proper EPA form . You must use the EPA form identified as “Form U” to submit written information in response to the requirements of this subpart. Instructions for obtaining copies of Form U are in paragraph (c) of this section.

(b) Follow the reporting instructions . You should follow the detailed instructions for completing and submitting an electronic or hard copy report. Instructions given in the EPA publication titled, “Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory Database,” are available as described in paragraph (c) of this section. EPA encourages reporting sites subject to this part to submit the required information to EPA electronically.

(c) Obtain the reporting package and copies of the form . You can obtain the reporting form or software, reporting instructions, and other associated documents as follows:

(1) By website . Go to the EPA Inventory Update Reporting Internet home page at http://www.epa.gov/oppt/iur and follow the appropriate links. EPA encourages reporting sites subject to this subpart to visit this home page.

(2) By phone . Call the EPA TSCA Hotline at (202) 554–1404.

(3) By e-mail . Send an e-mail request for this information to the EPA TSCA Hotline at TSCA-Hotline@epa.gov .

(4) By mail . Send a written request for this information to the following address: TSCA Hotline, Mail Code 7408M, ATTN: Inventory Update Reporting, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001.

[71 FR 52498, Sept. 6, 2006]

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