Title 40—Protection of Environment--Volume 1
PART 712—CHEMICAL INFORMATION RULES
§ 712.1   Scope and compliance.
(a) This part establishes procedures for chemical manufacturers and processors to report production, use, and exposure-related information on listed chemical substances. Subpart A establishes requirements that apply to all reporting under this part. Subpart B covers manufacturers' and processors' reporting.
(b) Chemical substances, mixtures, and categories of substances or mixtures which have been recommended by the Interagency Testing Committee for testing consideration by the Agency but not designated for Agency response within 12 months, will be added to § 712.30 using the procedure specified in § 712.30(c) only to the extent that the total number of designated and recommended chemicals has not exceeded 50 in any 1 year. Additional recommended but not designated chemicals may be added after proposal, and consideration of public comment.
§ 712.3   Definitions.
The definitions in section 3 of TSCA, 15 U.S.C. 2602, apply for this part. In addition, the following definitions apply:
(a) Byproduct means any chemical substance or mixture produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.
(b) EPA means the U.S. Environmental Protection Agency.
(c) Import in bulk form means to import a chemical substance (other than as part of a mixture or article) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers used for purposes of transportation or containment, if the chemical substance has an end use or commercial purpose separate from the container.
(d) Importer means anyone who imports a chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the U.S. and includes the person liable for the payment of any duties on the merchandise, or an authorized agent on his behalf. Importer also includes, as appropriate:
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to withdraw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purposes of this definition, the customs territory of the U.S. consists of the 50 states, Puerto Rico, and the District of Columbia.
(e) Impurity means a chemical substance unintentionally present with another chemical substance or mixture.
(f) Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of other chemical substances or mixtures, or that is intentionally present for the purpose of altering the rates of such chemical reactions. (See also paragraph (j) of this section.)
(g) 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, or could obtain without unreasonable burden.
(h) Manufacture for commercial purposes means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer and includes, among other things, such “manufacture” of any amount of a chemical substance or mixture:
(1) For commercial distribution, including for test marketing.
(2) For use by the manufacturer, including use for product research and development, or as an intermediate. Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and coproducts that are separated from that other substance or mixture, and impurities that remain in that substance or mixture. Byproducts and impurities may not in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical produced for a commercial purpose.
(i) 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 all of the chemical substances comprising the combination are included in the EPA, TSCA Chemical Substance Inventory after the effective date of the premanufacture notification requirement under 40 CFR part 720, and (2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water. The term mixture includes alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement.
(j) 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. (See also paragraph (f) of this section.)
(k) Owned or controlled by the parent company means the parent owns or controls 50 percent or more of the other company's voting stock or other equity rights, or has the power to control the management and policies of the other company.
(l) Person means any natural person, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body, and any department, agency, or instrumentality of the Federal government.
(m) Process for commercial purposes means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.
(n) Site means a contiguous property unit. Property divided only by a public right-of-way shall be considered one site. There may be more than one manufacturing plant on a single site.
(o) Test marketing means distributing in commerce a limited amount of a chemical substance or mixture, or article containing such substance or mixture, to a defined number of potential customers, during a predetermined testing period, to explore market capability prior to broader distribution in commerce.
(p) TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
(q) Central Data Exchange or CDX means EPA's centralized electronic submission receiving system.
(r) Chemical Information Submission System or CISS means EPA's electronic, web-based reporting tool for the completion and submission of data, reports, and other information, or its successors.
§ 712.5   Method of identification of substances for reporting purposes.
(a) Report on TSCA-regulable quantities. Unless specifically otherwise required, respondents must report only about quantities of a chemical that is defined as a chemical substance under TSCA section 3(2).
(b) Chemicals from natural sources. A manufacturer of a chemical substance which is extracted from an ore, from oil, or from any other natural source must report only about the manufacturing steps for, and the uses of, that chemical, not about production of the natural source material or other crude precursors derived from the natural source material.
For example, persons who manufacture a chemical substance such as “sweetened naphtha, 64741-87-3,” but do not refine the naphtha to produce “hexane, 110-54-3” would not report on hexane. Only the production of “hexane” as an isolated product must be reported—not previous production of more crude, complex substances such as naphtha from which hexane is extracted. Thus, persons who produce crude oil, ores, and other crude natural materials, but do not carry them through further manufacturing steps that produce a listed chemical have no reporting responsibilities under this Part. Note, however, that any method of extraction, refinement, or purification of a listed chemical substance is considered to be manufacturing for the purposes of this rule.
(c) Chemical substances as marketed. This part requires reporting about chemical substances as they are marketed or used in practice. The following preparations of a chemical substance must be reported as the substance itself, not as a mixture, since these preparations are regarded as the substance in practice.
(1) The chemical substance in aqueous solution.
(2) The chemical substance containing an additive (such as a stabilizer or other chemical) to maintain the integrity or physical form of the substance.
(3) The chemical substance in any grade of purity.
§ 712.7   Report of readily obtainable information for subparts B and C.
TSCA section 8(a) authorizes EPA to require persons to report information that is known to or reasonably ascertainable by them. For purposes of subpart B, however, a lesser standard applies. Companies must report information that is readily obtainable by management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing. Extensive file searches are not required.
§ 712.15   Confidentiality.
(a) Any person submitting information under this part may assert business confidentiality claims for the information as described in the pertinent reporting form and its instructions. Any information covered by a claim will be disclosed by EPA only as provided in the procedures set forth at 40 CFR part 2.
(b) Persons must certify to the validity of a claim of confidentiality they make for information reported under this part, as specified on the reporting form.
(c) If no claim accompanies the information at the time it is submitted to EPA or if certification as to the claim is not made on the reporting form, EPA may place the information in an open file available to the public without further notice to the submitter.
§ 712.20   Manufacturers and importers who must report.
Except as described in § 712.25, at the time a chemical substance is listed in § 712.3, the following persons must submit the “Manufacturer's Report—Preliminary Assessment Information” (as described in § 712.28) for each plant site at which they manufactured or imported the chemical substance during the reporting period specified in § 712.30:
(a) Persons who manufactured one or more of the chemical substances listed in § 712.30 for commercial purposes.
(b) Persons who imported in bulk form one or more of the chemical substances listed in § 712.30 for commercial purposes.
§ 712.25   Exempt manufacturers and importers.
(a) Persons who manufactured or imported the chemical substance during the reporting period, solely for purposes of scientific experimentation, analysis, or research, including research or analysis for product development, are not subject to reporting under § 712.20.
(b) Persons who, during the reporting period, manufactured or imported fewer than 500 kilograms (1100 pounds) of the chemical substance at a single plant site are not subject to reporting for that site under § 712.20.
(c) Persons who qualify as small manufacturers (including importers) in respect to a specific chemical substance listed in § 712.30 are exempt. However, the exemption in this paragraph (c) does not apply with respect to any chemical in § 712.30 designated by an asterisk. A manufacturer is qualified as small and is exempt from submitting a report under this subpart for a chemical substance manufactured at a particular plant site if it meets the definition for small manufacturer in § 704.3 of this chapter.
(d) Persons are not subject to reporting under § 712.20 if they manufactured or imported the chemical substance during the reporting period only in the following forms:
(1) As a byproduct that was not used or sold or that was formed as described in 40 CFR 710.4(d) (3) through (7).
(2) As a non-isolated intermediate.
(3) As an impurity.
§ 712.28   Form and instructions.
(a) Manufacturers and importers subject to this subpart must submit a single EPA Form No. 7710-35, “Manufacturer's Report—Preliminary Assessment Information,” for each plant site manufacturing or importing a chemical substance listed in § 712.30.
(b) Reporting companies may submit their reports through individual plant sites or company headquarters as they choose. A separate form must be submitted for each plant site manufacturing the chemical substance.
(c) Persons authorized to report information under this subpart must include the following information on Form 7710-35, Manufacturer's Report—Preliminary Assessment Information (Manufacturer's Report):
(1) A certification as to the truth and accuracy of the information reported signed and dated by an authorized person located at the plant site or corporate headquarters of the respondent company.
(2) A confidentiality statement signed and dated by an authorized person located at the plant site or corporate headquarters of the respondent company.
(3) The specific chemical name and Chemical Abstracts Service (CAS) Registry Number listed in 40 CFR 712.30.
(4) The name, company, address, city, State, ZIP code, and telephone number of a person who is submitting the form, which may be a person located at a plant site or corporate headquarters that will serve as the respondent, and will be able to answer questions about the information submitted by the company to EPA. A respondent to this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported.
(5) The plant site activities, such as the manufacturing of a chemical substance, including the total quantity of the chemical substance (in kilograms) imported in bulk during the reporting period.
(6) The total number of workers and total worker-hours in each process category, which includes enclosed process, controlled release process, and open process.
(7) The information related to chemical substance processing by customers, including customers' use in industrial and consumer products, the market names under which the chemical substance is manufactured or imported, and the customer's process categories that are sold to customers for further processing.
(d) Persons must use the CISS tool to complete and submit Form 7710-35, Manufacturer's Report, and accompanying letters, via CDX. Submission requires registration with CDX, and must be made only as set forth in this section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links, and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
§ 712.30   Chemical lists and reporting periods.
(a)(1) Persons subject to this subpart B must submit a Preliminary Assessment Information Manufacturer's Report for each chemical substance or mixture that is listed or designated in this section.
(2) Unless a respondent has already prepared a Manufacturer's Report in conformity with conditions set forth in paragraph (a)(3) of this section, the information in each Manufacturer's Report must cover the respondent's latest complete corporate fiscal year as of the effective date. The effective date will be 30 days after the Federal Register publishes a rule amendment making the substance or mixture subject to this subpart B.
(3) Persons subject to this subpart B need not comply with the requirements of paragraph (a)(2) of this section if they meet either one of the following conditions:
(i)(A) The respondent has previously and voluntarily provided EPA with a Manufacturer's Report on a chemical substance or mixture subject to subpart B of this part, which contains data for a 1-year period ending no more than 3 years prior to the effective date described in paragraph (a)(2) of this section. Respondents meeting this condition must notify EPA by letter of their desire to have the voluntary submission used in lieu of a current data submission and must verify the completeness and current accuracy of the voluntarily submitted data. Such letters, sent in accordance with the method specified in § 712.28(d) to EPA, must contain the following language:
I hereby certify that, to the best of my knowledge and belief, all information entered on this form is complete and accurate. I agree to permit access to, and the copying of records by, a duly authorized representative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported on the form.
(B) Notification letters must be submitted in accordance with the method specified in § 712.28(d) prior to the reporting deadline.
(ii)(A) The respondent has previously submitted a Manufacturer's Report on a chemical substance or mixture subject to subpart B of this part to the Interagency Testing Committee, but not to EPA, and that Manufacturer's Report contained data for a 1-year period ending less than 3 years prior to the effective date described in paragraph (a)(2) of this section. Respondents meeting this condition must submit a copy of the Manufacture's Report, in accordance with the method specified in § 712.28(d) to EPA, and must submit an accompanying letter, also in accordance with the methods specified in § 712.28(d), notifying EPA of the respondent's intent that the submission be used in lieu of a current Manufacturer's Report. The notification letter must verify the completeness and current accuracy of the voluntarily submitted data. Such a letter must contain the following language:
I hereby certify that, to the best of my knowledge and belief, all information entered on this form is complete and accurate. I agree to permit access to, and the copying of records by, a duly authorized representative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported on the form.
(B) The submission must be made prior to the reporting deadline.
(b) Except as provided in paragraph (c) of this section, chemical substances and designated mixtures will be added after a notice of proposed amendment of this subpart is published in the Federal Register. There will be a 30 day public comment period on each notice; after consideration of the comments, a final amendment will identify the substances and mixtures added.
(c)(1) Chemical substances, mixtures, and categories of substances or mixtures that have been added by the Interagency Testing Committee, established under section 4(e) of TSCA, to the section 4(e) Priority List, for testing consideration by the Agency, will be added to this section 30 days after EPA issues for publication in the Federal Register a rule amendment listing these chemical substances, mixtures and categories. A Preliminary Assessment Information—Manufacturer's Report must be submitted for each chemical substance and mixture within 60 days after the effective date of the listing. At the discretion of the Assistant Administrator for Chemical Safety and Pollution Prevention, a listed substance, mixture or category may be withdrawn, for good cause, from the rule's reporting requirements prior to the effective date. Any information submitted showing why a substance, mixture or category should be removed from the rule must be received by EPA within 14 days after the date of publication of the notice under this paragraph. If a substance, mixture or category is removed, a Federal Register notice announcing this decision will be published no later than the effective date of the amendment.
(2) You must submit the information using the method specified in § 712.28(d).
(d) Manufacturers and importers of the substances listed below must submit a Preliminary Assessment Information Manufacturer's Report for each site at which they manufacture or import each substance by the reporting date shown in the table below. The substances are listed in Chemical Abstracts Service Registry Number order. Typically EPA lists the trivial or common name first, then, following the symbol “- -”, EPA lists the substance by its TSCA Chemical Substance Inventory name. Whenever EPA lists a single name, the name may be either the TSCA Chemical Substance Inventory name, a trivial name, or a common name. Generally, when a single name is listed, it is the TSCA Chemical Substances Inventory name.
(e) Manufacturers and importers of the substances listed below by category must submit a Preliminary Assessment Information Manufacturers Report for each site at which they manufacture or import each substance by the reporting date shown in the table below. The categories are listed in alphabetic order with the chemical substances within each category listed by ascending numerical CAS number.