(a) Purpose. The purpose of this subpart is to collect fees from manufacturers, importers, and processors who submit notices and applications to EPA under section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) to defray part of EPA's cost of administering the Act.

(b) Applicability. This subpart applies to all manufacturers, importers, and processors who submit certain notices and applications to EPA under section 5 of the Act.

User fees relating to radon proficiency programs authorized under the Toxic Substances Control Act appear at 40 CFR part 195.

Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, and 725.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:

Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.

Consolidated premanufacture notice or consolidated PMN means any PMN submitted to EPA that covers more than one chemical substance (each being assigned a separate PMN number by EPA) as a result of a prenotice agreement with EPA (See 48 FR 21734).

Exemption application means any application submitted to EPA under section 5(h)(2) of the Act.

Exemption notice means any notice submitted to EPA under § 723.175 of this chapter.

Final product means a new chemical substance (as “new chemical substance” is defined in § 720.3 of this chapter) that is manufactured by a person for distribution in commerce, or for use by the person other than as an intermediate.

Intermediate premanufacture notice or intermediate PMN means any PMN submitted to EPA for a chemical substance which is an intermediate (as “intermediate” is defined in § 720.3 of this chapter) in the production of a final product, provided that the PMN for the intermediate is submitted to EPA at the same time as, and together with, the PMN for the final product and that the PMN for the intermediate identifies the final product and describes the chemical reactions leading from the intermediate to the final product. If PMNs are submitted to EPA at the same time for several intermediates used in the production of a final product, each of those is an intermediate PMN if they all identify the final product and every other associated intermediate PMN and are submitted to EPA at the same time as, and together with, the PMN for the final product.

Joint submitters means two or more persons who submit a section 5 notice together.

Microbial commercial activity notice or MCAN means any notice for microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of part 725 of this chapter.

Person means a manufacturer, importer, or processor.

Premanufacture notice or PMN means any notice submitted to EPA pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of this chapter or § 723.250 of this chapter.

Section 5 notice means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN or consolidated MCAN submitted under section 5 of the Act.

Significant new use notice means any notice submitted to EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter.

Small business concern means any person whose total annual sales in the person's fiscal year preceding the date of the submission of the applicable section 5 notice, when combined with those of the parent company (if any), are less than $40 million.

(a) Persons who must pay fees. Persons submitting a section 5 notice to EPA shall remit for each such notice the appropriate fee identified in paragraph (b) of this section in accordance with the procedures in paragraph (e) of this section.

(b) Fees. Persons shall remit fee payments to EPA as follows:

(1) Small business concerns. Small business concerns shall remit a fee of $100 for each section 5 notice submitted.

(2) Others. Persons other than small business concerns shall remit fees according to the type of section 5 notice as follows:

(i) Premanufacture notices and consolidated premanufacture notices. Persons shall remit a fee of $2,500 for each PMN or consolidated PMN submitted.

(ii) Intermediate premanufacture notices. Persons shall remit a fee of $1,000 for each intermediate PMN. However, for the PMN for the final product the person shall submit the fee in paragraph (b)(2)(i) of this section.

(iii) Significant new use notices. Persons shall remit a fee of $2,500 for each significant new use notice submitted.

(iv) Exemption applications. Persons shall remit a fee of $2,500 for each exemption application submitted under section 5(h)(2) of the Act.

(v) Exemption notices. Persons shall remit a fee of $2,500 for each exemption notice submitted under § 723.175 of this chapter.

(vi) MCAN and consolidated MCAN. Persons shall remit a fee of $2,500 for each MCAN or consolidated MCAN submitted.

(c) No fee required. Persons are exempt from remitting any fee for submissions under §§ 720.38, 723.50, and subparts E, F, and G of part 725 of this chapter.

(d) Joint submitters. Joint submitters of a section 5 notice are required to remit the appropriate fee identified in paragraph (b) of this section for each section 5 notice regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph (b)(1) of this section, each joint submitter of a section 5 notice must qualify as a small business concern under § 700.43.

(e) Remittance procedure. (1) Each remittance under this section shall be in United States currency and shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency.

(2) Each remittance shall be sent to the Environmental Protection Agency, HQ Accounting Operations Branch (PM-226), P.O. 360399M, Pittsburgh, PA 15251-6399, ATTN: TSCA User Fee.

(3) Persons who submit a section 5 notice shall place a unique identifying number, which must include the letters “TS” followed by a combination of 6 numbers (letters may be substituted for some numbers), on the front page of each section 5 notice submitted. The same identifying number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one section 5 notice, the person shall include the name of the submitter, the identifying number for each section 5 notice to which the remittance applies, and the amount of the remittance which applies to each notice. Any remittance not having the identifying name and number described above will be returned to the remitter.

(4)(i) Each person who remits the fee identified in paragraph (b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” under “CERTIFICATION” on Page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).

(ii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption application under section 5(h)(2) of the Act shall include the words, “Each company identified in this application is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the exemption application.

(iii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “Each company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the certification required in § 723.175(i)(1)(x) of this chapter.

(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall include the words, “The company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(d),” in the certification required in § 725.25(b) of this chapter.

(5)(i) Each person who remits a fee identified in paragraph (b)(2) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, “The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b).” under “CERTIFICATION” on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).

(ii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption application under section (5)(h)(2) of the Act shall include the words, “Each company identified in this application has remitted a fee of $2,500 in accordance with 40 CFR 700.45(b).” in the exemption application.

(iii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “Each company identified in this notice has remitted a fee of $2,500 in accordance with 40 CFR 700.45(b).” in the certification required in § 723.175(i)(1)(x) of this chapter.

(iv) Each person who remits a fee identified in paragraph (b)(2) of this section for a MCAN for a microorganism shall include the words, “The company identified in this notice has remitted the fee specified in 40 CFR 700.45(b),” in the certification required in § 725.25(b) of this chapter.

(f) Fee refunds. EPA will refund any fee paid for a section 5 notice whenever the Agency determines:

(1) That the chemical substance that is the subject of a PMN, intermediate PMN, exemption application, or exemption notice is not a new chemical substance as of the date of submission of the notice.

(2) In the case of a significant new use notice, that the notice was not required.

(3) The notice is incomplete under either § 720.65(c) or 725.33, of this chapter.

(4) That as of the date of submission of the notice: the microorganism that is the subject of a MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use.

EPA will not consider a section 5 notice to be complete unless the appropriate certification under § 700.45(e) is included and until the appropriate remittance under § 700.45(b) has been sent to EPA as provided in § 700.45(e) and received by EPA. EPA will notify the submitter that the section 5 notice is incomplete in accordance with §§ 720.65(c) and 725.33 of this chapter.

(a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic Substances Control Act (TSCA) for manufacturers, importers, and processors of chemical substances and mixtures (hereafter collectively referred to as substances) that are identified in subpart B of this part. The reporting and recordkeeping provisions in subpart A of this part apply throughout this part unless revised in any other subpart.

(b) Subpart B of this part sets out chemical-specific reporting and recordkeeping requirements under section 8(a) of TSCA.

All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following definitions are provided for the purposes of this part.

Annual means the corporate fiscal year.

Article means 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 result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.

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

CAS Number means Chemical Abstracts Service Registry Number.

Coproduct means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal of another chemical substance or mixture.

Customer means any person to whom a manufacturer, importer, or processor directly distributes any quantity of a chemical substance, mixture, mixture containing the substance or mixture, or article containing the substance or mixture, whether or not a sale is involved.

Domestic means within the geographical boundaries of the 50 United States, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.

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

EPA means the United States Environmental Protection Agency.

Import means to import for commercial purposes.

Import for commercial purposes means to import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities also are imported for commercial purposes.

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, if the chemical substance is intended to be removed from the container and the substance has an end use or commercial purpose separate from the container.

Importer means (1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes:

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

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

(2) Importer also includes, as appropriate:

(i) The consignee.

(ii) The importer of record.

(iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20.

(iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.

(3) For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.

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

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.

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.

Manufacture means to manufacture for commercial purposes.

Manufacture for commercial purposes means: (1) 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:

(i) For commercial distribution, including for test marketing.

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

(2) 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 both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or 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 product for a commercial purpose.

Manufacturer means a person who imports, produces, or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance.

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. Mechanical or gravity transfer through a closed system is not considered to be intentional removal, but storage or transfer to shipping containers “isolates” the substance by removing it from process equipment in which it is manufactured.

Own or control means ownership of 50 percent or more of a company's voting stock or other equity rights, or the power to control the management and policies of that company. A company may own or control one or more sites. A company may be owned or controlled by a foreign or domestic parent company.

Parent company is a company that owns or controls another company.

Person includes any individual, 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.

Possession or control means in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the substance in question. Information is in the possession or control of a person if it is:

(1) In the person's own files including files maintained by employees of the person in the course of their employment.

(2) In commercially available data bases to which the person has purchased access.

(3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question.

Process means to process for commercial purposes.

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 in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes.

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

Production volume means the quantity of a substance which is produced by a manufacturer, as measured in kilograms or pounds.

Propose to manufacture, import, or process means that a person has made a firm management decision to commit financial resources for the manufacture, import, or processing of a specified chemical substance or mixture.

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 plant on a single site. The site for a person who imports a 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 United States.

Small manufacturer or importer means a manufacturer or importer that meets either of the following standards:

(1) First standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 pounds), the manufacturer or importer shall not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer or importer qualifies as small under standard (2) of this definition.

(2) Second standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of substances produced or imported by that manufacturer or importer.

(3) Inflation index. EPA shall make use of the Producer Price Index for Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor Statistics, for purposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made. EPA may adjust the total annual sales values whenever the Agency deems it necessary to do so, provided that the Producer Price Index for Chemicals and Allied Products has changed more than 20 percent since either the most recent previous change in sales values or the date of promulgation of this rule, whichever is later. EPA shall provide Federal Register notification when changing the total annual sales values.

Small quantities solely for research and development (or “small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product”) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.

Substance means either a chemical substance or mixture unless otherwise indicated.

Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, article containing that chemical substance or mixture, or a mixture containing that substance, 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.

Total annual sales means the total annual revenue (in dollars) generated by the sale of all products of a company. Total annual sales must include the total annual sales revenue of all sites owned or controlled by that company and the total annual sales revenue of that company's subsidiaries and foreign or domestic parent company, if any.

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

(a) Any person submitting a notice under this rule may assert a business confidentiality claim covering all or any part of the notice. Any information covered by a claim will be disclosed by EPA only to the extent and by means of the procedures set forth in part 2 of this title.

(b) If no claim accompanies the notice at the time it is submitted to EPA, the notice will be placed in an open file available to the public without further notice to the respondent.

(c) To assert a claim of confidentiality for data contained in a notice, the respondent must submit two copies of the notice.

(1) One copy of the notice must be complete. In that copy the respondent must indicate what data, if any, are claimed as confidential by marking the specific information on each page with a label such as “confidential”, “proprietary”, or “trade secret”.

(2) If some data in the notice are claimed as confidential, the respondent must submit a second copy. The second copy must be complete except that all information claimed as confidential in the first copy must be deleted.

(3) The first copy of the notice will be for internal use by EPA. The second copy will be placed in an open file to be available to the public.

(4) Failure to furnish a second copy of the notice when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent has 15 days from the date of receipt of notification to submit the required second copy. Failure to submit the second copy will cause EPA to place the first copy in the public file.

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

(1) My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures.

(2) The information is not, and has not been, reasonably obtainable without our consent by other persons (other than government bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding).

(3) The information is not publicly available elsewhere.

(4) Disclosure of the information would cause substantial harm to our competitive position.

Reports must be submitted by certified mail to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATT: 8(a) Reporting.

Each person who is subject to the reporting requirements of this part must retain the following records for 3 years following the creation or compilation of the record.

(a) A copy of each report submitted by the person in response to the requirements of this part.

(b) Materials and documentation sufficient to verify or reconstruct the values submitted in the report.

(c) A copy of each notice sent by the person, return receipt requested, to that person's customers for the purpose of notifying their customers of the customer's reporting obligations under this part.

(d) All return receipts signed by the person's customers who received the notice described in paragraph (c) of this section.

Violators of the requirements of this part may be subject to civil administrative penalties up to $25,000 per day of violation or criminal prosecution, as provided in sections 15 and 16 of TSCA. In addition, under section 17, EPA may seek judicial relief to compel submission of required information.

(a) Definitions. (1) 11-AA means the chemical substance 11-ami-no-un-de-ca-no-ic acid, CAS Number 2432-99-7.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(2) Small processors.

(3) Persons described in § 704.5.

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

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

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

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

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

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

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

(g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATT: 11-AA Notification.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(a) Definitions. (1) Extent of chlor-i-na-tion means the percent by weight of chlorine.

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

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

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

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

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

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

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

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

(b) Substances for which reports must be submitted.

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

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

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

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

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

(2) Persons described in § 704.5.

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

(1) Company name and address.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(a) Definitions. (1) Chlorinated ter-phenyl means a chemical substance, CAS No. 61788-33-6, comprised of chlor-inated ortho-, meta-, and paraterphenyl.

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

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

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

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

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

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

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

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

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

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

(1) Company name and address.

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

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

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

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

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

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

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

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

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

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

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

(1) Initial Report:

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

(ii) Company name and headquarters address.

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

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

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

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

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

(2) Follow-up Report:

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

(ii) Company name and headquarters address.

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

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

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

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

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

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

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

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

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

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

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

(2) HEX-BCH means the chemical substance 1,2,3,4,7,7-hex-a-chlor-onor-born-a-diene, CAS Number 3389-71-7.

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

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

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

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

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

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

(6) Year means corporate fiscal year.

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

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

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

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

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

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

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

(i) Company name and address.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(1) Small processors.

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

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

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

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

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

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

(g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: HFPO Reporting.

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

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

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

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

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

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

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

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

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

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

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

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

(a) Scope. (1) This statement addresses the policy of the Environmental Protection Agency (EPA) on importation of chemical substances, mixtures, and articles under section 13 of the Toxic Substances Control Act (TSCA; 15 U.S.C. 2601 et seq.). In particular, it addresses aspects of the regulation promulgated by the United States Customs Service (Customs), Department of the Treasury (19 CFR 12.118 through 12.127, and 127.28 [amended]) to implement section 13 of TSCA, 15 U.S.C. 2612. Section 13 requires the Secretary of the Treasury to refuse entry into the Customs territory of the United States of a chemical substance, mixture, or article if it does not comply with rules in effect under TSCA, or if it is offered for entry in violation of TSCA or rules or orders under TSCA.

(2) In addition to this statement of policy, EPA will continue, as necessary, to address problems associated with imports in rulemaking and other actions under individual sections of TSCA, i.e., sections 4, 5, 6, 7, 8, and 12. Sections 5, 6, and 7 apply directly to imports subject to the section 13 requirements. Section 12 may apply to export of a shipment that is refused entry under section 13. Importers may have obligations under sections 4 and 8; section 4 and 8 requirements for importers would not apply to individual chemical shipments and thus are not included under section 13 requirements. Interested persons should refer to the records of these individual rulemaking actions for specific information and guidance.

(b) Objectives. (1) TSCA is intended to be comprehensive, and assure protection of health and the environment from unreasonable risks associated with chemicals whether the chemicals are imported or produced domestically. This intent is manifested by the inclusion of importation in the Act's definition of the term “manufacture”: “[M]anufacture means to import * * *, produce, or manufacture” (15 U.S.C. 2602(7)). Thus, importers are responsible for insuring that chemical importation complies with TSCA just as domestic manufacturers are responsible for insuring that chemical manufacture complies with TSCA.

(2)(i) The section 13 rule requires importers to sign the following statement for each import of chemical substances subject to TSCA: “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” The certification will document that, in accordance with TSCA, the importer has taken the necessary steps to insure compliance.

(ii) The section 13 rule requires importers of chemicals not subject to TSCA (e.g., pesticides) to certify that compliance with TSCA is not required. Importers must certify this by signing the statement: “I certify that all chemicals in this shipment are not subject to TSCA.” This is appropriate when a chemical import is not clearly identified as a pesticide or other chemical not subject to TSCA.

(3) The United States is involved in a major effort toward international harmonization in the control of chemicals. At such time as international agreement is reached on this issue, EPA would be prepared to modify its policy if necessary. EPA believes that its international harmonization efforts in the control of chemicals will protect health and the environment while fulfilling its obligations under the Trade Agreements Act of 1979.

(c) The section 13 rule—(1) General certification. (i) The rule promulgated under section 13 of TSCA by Customs, in consultation with EPA, implements the requirement of section 13 that chemical substances, mixtures, or articles not in compliance with TSCA, or whose importation is not in compliance with TSCA, shall be denied entry into the customs territory of the United States. The rule requires that importers certify by a statement, on the entry document or invoice, that any shipment of a chemical substance subject to TSCA, imported in bulk or as part of a mixture, complies with TSCA, and that it is not offered for entry in violation of TSCA or any rule or order under TSCA, or that the chemicals imported are not subject to TSCA.

(ii) The certification applies to TSCA sections 5, 6, and 7.

(iii) EPA expects that this certification will be based upon actual knowledge of the importer in most cases. However, EPA realizes that sometimes importers may not have actual knowledge of the chemical composition of imported mixtures. In these cases, the importer should attempt to discover the chemical constituents of the shipment by contacting another party to the transaction (e.g., his principal or the foreign manufacturer). This person may be able to identify the components of the mixture, or at least state that the substances comply with TSCA. The greater the effort an importer makes to learn the identities of the imported substances and their compliance with TSCA, the smaller his chance of committing a violation by importing a noncomplying shipment. If a shipment is ultimately determined to have violated TSCA, the good faith efforts of the importer to verify compliance, as evidenced by documents contained in his files, may obviate or mitigate the assessment of a civil penalty under section 16 of TSCA.

(2) EPA enforcement. (i) EPA and Customs will monitor chemical imports to determine if shipments and their import comply with the certification requirements and the substantive mandates of TSCA. Customs will refuse entry to any shipment until such time as the certification is properly submitted. Customs will also detain a shipment if there are reasonable grounds to believe that such shipment or its import violates TSCA or regulations or orders thereunder. A violative shipment must either be brought into compliance, exported, destroyed, or voluntarily abandoned within the time periods prescribed in 19 CFR 12.124 of the section 13 rule.

(ii) When EPA determines that a shipment should be detained, EPA will identify the reasons for the detention and the necessary actions for an importer to bring the shipment into compliance with TSCA. If EPA has given this information to Customs before the district director issues the detention notice, the information will become part of the detention notice. The importer should contact one of the following EPA regional offices for guidance as to the proper procedures to correct any deficiencies in the shipment.

(iii) If Customs detains or refuses entry of a shipment (other than for failure to make the general certification) and the importer takes measures necessary to bring the shipment into conformity with the requirements of TSCA, EPA officials will reassess the shipment to determine its current compliance status. When a shipment is no longer in violation, EPA will notify the district director and the importer. The district director will then release the shipment. This notice will also serve as a determination to permit entry under 19 CFR 12.123(c) if a shipment is brought into compliance before the 19 CFR 12.123(c) decisionmaking process has been completed. If compliance is achieved after a 19 CFR 12.123(c) determination (adverse to the importer) has been made, the EPA notice to the district director will serve as a reversal of the decision to refuse entry.

(3) EPA assistance. Assistance in determining whether a chemical shipment is in compliance with TSCA can be obtained from the Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room E-543B, 401 M St., SW., Washington, DC, 20460, Telephone: (202) 554-1404, TDD: (202) 544-0551.

(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.

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.

(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.

(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.

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.

(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.

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.

(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 or importers in respect to a specific chemical substance listed in § 712.30 are exempt. However, this exemption 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 both of the following criteria are met:

(1) Total annual sales taken together of all sites owned or controlled by the foreign or domestic parent company were below $30 million for the reporting period;

(2) Total production of the listed substance for the reporting period was below 45,400 kilograms (100,000 pounds) at the plant site.

(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.

(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) Forms must be sent (preferably by certified mail) to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(a) PAIR Reporting.

(d) Form 7710-35, Manufacturer's Report--Preliminary Assessment Information or PAIR form and instructions may be obtained by telephoning or writing the Environmental Assistance Division. The telephone number and the address of the Environmental Assistance Division is: Phone Number (202) 554-1404, TDD (202) 554-0551. Address: Environmental Assistance Division (7406), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

(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) The respondent has previously and voluntarily provided EPA with a Manufacturer's Report on a chemical substance or mixture subject to this subpart B, which contains data for a one-year period ending no more than three 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 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.” Notification letters must be submitted prior to the reporting deadline.

(ii) The respondent has previously submitted a Manufacturer's Report on a chemical substance or mixture subject to this subpart B to the Interagency Testing Committee, but not to EPA, and that Report contained data for a one-year period ending less than three years prior to the effective date described in paragraph (a)(2) of this section. Respondents meeting this condition must submit a copy of the Manufacturer's Report to EPA, and must submit an accompanying letter 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.” 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) 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 Prevention, Pesticides and Toxic Substances, 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. Any information submitted must be addressed to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(a) Auto-ITC.

(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.

(a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical substances and mixtures selected for priority consideration for testing rules under section 4(a) of the Toxic Substances Control Act (TSCA) and on other chemical substances and mixtures for which EPA requires health and safety information in fulfilling the purposes of TSCA.

(b) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under this subpart. Section 16 provides that a violation of section 15 renders a person liable to the United States for a civil penalty and possible criminal prosecution. Under section 17, the district courts of the United States have jurisdiction to restrain any violation of section 15.

The definitions in section 3 of TSCA apply to this subpart. In addition, the following definitions are provided for the purposes of this subpart:

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

Co-product means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).

Copy of study means the written presentation of the purpose and methodology of a study and its results.

EPA means the United States Environmental Protection Agency.

Health and safety study or study means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA.

(1) It is intended that the term health and safety study be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included. Chemical identity is part of, or underlying data to, a health and safety study.

(2) Examples are:

(i) Long- and short-term tests of mutagenicity, carcinogenicity, or tera-togen-i-city; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.

(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.

(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; bio-mag-ni-fi-ca-tion and bio-con-cen-tra-tion; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.

(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.

Import means to import for commercial purposes.

Import for commercial purposes means to import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities are also imported for commercial purposes.

Importer means any person who imports a chemical substance, including a chemical substance as a part of a mixture or article, into the customs territory of the United States and includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his behalf (as defined in 19 CFR 1.11). 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 draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purpose of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.

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

Listed mixture means any mixture listed in § 716.120.

Manufacture means to manufacture for commercial purposes.

Manufacture for commercial purposes means: (1) To produce, 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:

(i) For commercial distribution, including for test marketing.

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

(2) 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 impurities. Such byproducts and impurities may, or 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 product for a commercial purpose.

Manufacturer means a person who produces or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance.

Person includes any individual, 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.

Process means to process for commercial purposes.

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 substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.

Propose to manufacture, import, or process means that a person has made a management decision to commit financial resources toward the manufacture, importation, or processing of a substance or mixture.

Substance means chemical substance as defined at section 3(2)(A) of TSCA, 15 U.S.C. 2602(2)(A).

TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).

(a) Except as provided in paragraphs (b) and (c) of this section, only those persons described in this section are required to report under this part. Persons who must report include manufacturers (including importers) who fall within the North American Industry Classification System (NAICS) (in effect as of January 1, 1997) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries), who:

(1) In the 10 years preceding the effective date on which a substance or mixture is added to § 716.120, either had proposed to manufacture (including import), or had manufactured (including imported) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.

(2) As of the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import), or who are manufacturing (including importing) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.

(3) After the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.

(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may require that any person who does not fall within NAICS (in effect as of January 1, 1997) Subsector 325 or Industry Group 32411, and who had proposed to manufacture (including import) or process, had manufactured (including imported) or processed, proposes to manufacture (including import) or process, or is manufacturing (including importing) or processing a substance or mixture listed in § 716.120 must report under this part.

(c) Processors and persons who propose to process a substance or mixture otherwise subject to the reporting requirements imposed by this part are not subject to this part unless EPA specifically states otherwise in a particular notice or rule promulgated under the authority of 15 U.S.C. 2607(d).

(a) In general, health and safety studies, as defined in § 716.3, on any substance or listed mixture listed in § 716.120, that are unpublished are reportable, i.e., must be submitted or listed. However, this requirement has limitations according to the nature of the material studied, so that:

(1) All studies of substances and listed mixtures are reportable. However, in the case of physical and chemical properties, only those studies listed in § 716.50 must be submitted.

(2) Studies of mixtures known to contain substances or listed mixtures listed in § 716.120 are reportable except for studies of physical and chemical properties and the studies exempted at § 716.20(a)(6) (i) through (vi).

(3) Studies of substances or listed mixtures that a person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as impurities are not generally reportable under § 716.20(a)(9).

(4) Underlying data, such as medical or health records, individual files, lab notebooks, and daily monitoring records supporting studies do not have to be submitted initially. EPA may request underlying data later under § 716.40.

(b) [Reserved]

(a) Excluding paragraph (a)(3) of this section, the following types of studies are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.

(1) Studies which have been published in the scientific literature.

(2) Studies previously submitted to the EPA Office of Pollution Prevention and Toxics. These studies are limited to section 8(e) submissions, studies submitted during section 4 proceedings, studies submitted with premanufacture notices or significant new use notices, and studies submitted “for your information” (FYI submissions) in support of EPA's TSCA Existing Chemicals Program. Studies which have been initiated pursuant to a TSCA section 4(a) test rule, for which the person has submitted a letter of intent to conduct testing in accordance with the provisions of § 790.25 of part 790 of this chapter, are exempt from the list submission requirements of § 716.35.

(3) Except for those studies described in paragraph (a)(2) of this section, studies previously submitted to any Federal agency with no claims of confidentiality are exempt only from the copy submission requirements of § 716.30, and must be listed in accordance with the provisions of § 716.35.

(4) Studies conducted or initiated by or for another person who is subject to, and who will report the studies under §§ 716.30 and 716.35.

(5) Studies of chemical substances which are not on the TSCA Chemical Substances Inventory. This exemption applies only to those substances within categories listed under § 716.120(c).

(6) The following types of studies when the subject of the study is a mixture known to contain a substance or listed mixture listed under § 716.120.

(i) Acute oral toxicity studies.

(ii) Acute dermal toxicity studies.

(iii) Acute inhalation toxicity studies.

(iv) Primary eye irritation studies.

(v) Primary dermal irritation studies.

(vi) Dermal sensitization studies.

(vii) Physical and chemical properties.

(7) Analyzed aggregations of monitoring data based on monitoring data acquired more than 5 years preceding the date the substance or listed mixture was added to the list under § 716.120.

(8) Analyzed aggregations of monitoring data on mixtures known to contain one or more substances or listed mixtures listed in § 716.120, when the monitoring data are not analyzed to determine the exposure or concentration levels of the substances or listed mixture listed under § 716.120.

(9) Studies on a substance or listed mixture listed under § 716.120 that the person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as an impurity. When reporting of such studies is to be required, that reporting will be separately proposed in the Federal Register.

(10) Studies of chemical substances or listed mixtures previously submitted by trade associations in accordance with the provisions of § 716.30.

(b) The following types of studies on substances or listed mixtures listed under § 716.120 are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.

(1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and 68611-64-3), studies on agronomic plant growth or damage which demonstrate only that the resins stimulate plant growth or cause plant damage when applied as a fertilizer.

(2) For the specified chemicals in § 716.120(d) under the category “Siloxanes,” acute oral, dermal, and inhalation toxicity studies and primary eye and dermal irritation studies.

(3) For the listed chemicals under § 716.120(d) in the category “OSHA Chemicals in Need of Dermal Absorption Testing,” studies on ecological effects.

(4) For the chemicals listed at § 716.120 with a special exemption referencing this paragraph, studies on mixtures containing the listed substance at levels below 1 percent of the mixture, except when a purpose of the study includes the investigation of the effects of the listed substance at levels below 1 percent.

(5) Rulemaking proceedings that add substances and mixtures to § 716.120 will specify the types of health and/or environmental effects studies that must be reported and will specify the chemical grade/purity requirements that must be met or exceeded in individual studies. Chemical grade/purity requirements will be specified on a per chemical basis or for a category of chemicals for which reporting is required.

The scope of a person's responsibility to search records is limited to records in the location(s) where the required information is typically kept, and to records kept by the person or the person's individual employee(s) who is/are responsible for keeping such records or advising the person on the health and environmental effects of chemicals. Persons are not required to search for reportable information dated before January 1, 1977, to comply with this subpart unless specifically required to do so in a rule.

(a)(1) Except as provided in §§ 716.5, 716.20, and 716.50, persons must send to EPA copies of any health and safety studies in their possession for the substances or mixtures listed in § 716.120. Persons are responsible for submitting copies on only the substances or listed mixtures which they: Have manufactured, imported, or processed or proposed to manufacture, import, or process (including as known byproducts) within the 10 years preceding the effective date for reporting on the substances or listed mixtures; manufacture, import, or process on the effective date for reporting on the substances or listed mixtures; and propose to manufacture, import, or process following the effective date for reporting on the substances or listed mixtures. Persons who list studies as ongoing or initiated under § 716.35(a) (1) and (2) must submit them when they are completed.

(2) [Reserved]

(b) Submissions under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone number of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made. In the cover letter, submitters must identify any impurity or additive known to have been present in the substance or listed mixtures as studied unless its presence is specifically noted in the study itself. The cover letter accompanying a study submitted by a trade association must also state that the submission is to satisfy reporting requirements under this part.

(c) Copies of health and safety studies and the accompanying cover letters must be submitted, preferably by certified mail, to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(d) Health and Safety Reporting Rule (Notification/Reporting).

(a) Except as provided in §§ 716.5, 716.20, and 716.50, persons subject to this rule must send lists of studies to EPA for each of the listed substances or listed mixtures (including as a known byproduct) in § 716.120 which they are manufacturing, importing, or processing, or which they propose to manufacture (including import) or process.

(1) Ongoing studies. As of the date a person becomes subject to this part, a list of ongoing health and safety studies being conducted by or initiated for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.

(2) Initiated studies. After the date a person becomes subject to this part, a list of studies initiated by or for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.

(3) Studies which are known but without possession of copies. As of the date a person becomes subject to this part, a list of unpublished health and safety studies known to them of which they do not have copies. The name and address of any person known to them to possess a copy of the unpublished study must accompany each entry on the list. For purposes of this section only, an unpublished study will be considered to be “known to” a person, if the study can be discovered by a file search in accordance with § 716.25.

(4) Studies previously sent to Federal agencies without confidentiality claims. A list of unpublished studies which have been sent to a Federal Agency with no claims of confidentiality. The submission must for each study: Identify the study by title, state the name and address to whom the study was sent, and the month and year in which the study was submitted. Any study identified will be treated as if it were submitted under section 8(d) and will be available for public disclosure under section 14(b) of TSCA. Persons subject to this requirement may submit either a list of unpublished health and safety studies previously submitted to any Federal agency without claims of confidentiality in accordance with § 716.35(a)(4), or copies of each such study in accordance with § 716.30.

(b) Submission under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone numbers of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made.

(c) Lists of health and safety studies should be submitted, preferably by certified mail, to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(d) Health and Safety Reporting Rule (Notification Reporting).

EPA may, by letter, request a person to submit or make available for review the following information after the initial reporting under §§ 716.30 and 716.35. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.

(a) Submission of underlying data of the kind described in § 716.10(a)(4) by persons who submit copies of studies under § 716.30 or list studies under § 716.35(a)(1) or § 716.35(a)(2).

(b) Submission of preliminary reports of ongoing studies by persons who list the studies under § 716.35(a)(1) or § 716.35(a)(2).

(c) Submission of copies of studies by persons listed under § 716.35(a)(3) as possessing them.

Section 716.120 lists substances and mixtures, in order by Chemical Abstract Service Registry Number and by alphabetical order. Studies of listed substances and listed mixtures shall be reported as follows:

(a) When a substance is individually listed under § 716.120(a), studies of the substance and studies of mixtures known to contain the substance must be reported as studies of that substance.

(b) When two or more substances are listed as a mixture under § 716.120(b), studies of the listed mixture and studies of any mixture known to contain the listed mixture must be reported as studies of the listed mixture.

(c) Studies of the following preparations of a substance must be reported as studies of the substance itself, not as studies of mixtures known to contain the substance.

(1) The substance in aqueous solution.

(2) The substance containing a small amount of an additive, such as a stabilizer, emulsifier, or other chemical added for purposes of maintaining the integrity or physical form of the substance.

(3) The substance of the grade/purity specified in each rule promulgated under 15 U.S.C. 2607(d).

Studies of physical and chemical properties must be reported under this subpart if performed for the purpose of determining the environmental or biological fate of a substance, and only if they investigated one or more of the following properties:

(a) Water solubility.

(b) Adsorption/desorption on particulate surfaces, e.g., soil.

(c) Vapor pressure.

(d) Octanol/water partition coefficient.

(e) Density/relative density (specific gravity).

(f) Particle size distribution for insoluble solids.

(g) Dissociation constant.

(h) Degradation by photochemical mechanisms—aquatic and atmospheric.

(i) Degradation by chemical mechanisms—hydrolytic, reductive, and oxidative.

(j) Degradation by biological mechanisms—aerobic and anaerobic.

(a) General requirements. Except as provided in § 716.5 and paragraphs (b) and (c) of this section, submissions under §§ 716.30 and 716.35 must be postmarked on or before 60 days after the effective date of the listing of a substance or mixture in § 716.120 or within 60 days of proposing to manufacture (including import) or process a listed substance or listed mixture (including as a known byproduct) if first done after the effective date of the substance or mixture being listed in § 716.120.

(b)(1) Submission of lists of initiated studies. Persons subject to the listing requirements of § 716.35(a)(2) must inform EPA of the initiated study within 30 days of its initiation.

(2) Submission of copies of completed studies. Persons must submit copies of studies listed as ongoing or initiated under § 716.35(a) (1) and (2) within 30 days of completing the study.

(c) Requests for extensions of time. Respondents who cannot meet a deadline under this section may apply for a reasonable extension of time. Requests for extensions must be in writing and addressed to the Director, Office of Pollution Prevention and Toxics (7401), U.S. Environmental Protection Agency, Room E-539, 401 M St., SW., Washington, DC, 20460, ATTN: Section 8(d) extension. Extension requests must be postmarked on or before 40 days after the effective date of the listing of a substance or mixture in § 716.120. The Director of EPA's Office of Pollution Prevention and Toxics will grant or deny extension requests.

Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d) relating to a listed chemical substance or listed mixture [hereinafter “rule”], the reporting period for a listed chemical substance or listed mixture will terminate 60 days after the effective date on which the listed chemical substance or listed mixture is added to 40 CFR 716.120. EPA may require reporting for a listed chemical substance or listed mixture beyond the 60 day period in a rule promulgated under 15 U.S.C. 2607(d), however EPA will not extend any reporting period later than 2 years after the effective date on which a listed chemical substance or listed mixture is added to 40 CFR 716.120. After the applicable reporting period terminates, any person subject to the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a copy of any such study within 30 days after its completion, regardless of the study's completion date.

The requirements of this subpart will be extended periodically to cover additional substances and mixtures. Two procedures will be used to add substances and mixtures.

(a) Except as provided in paragraph (b) of this section, substances and mixtures will be added to § 716.120 after publication in the Federal Register of a notice of proposed amendment to this subpart. There will be at least a 30-day public comment period on the notice. After consideration of the comments, EPA will amend § 716.120 by final rule to add the substances and listed mixtures.

(b) Except as provided in paragraph (c) of this section, chemical substances, mixtures, and categories of chemical substances that have been added to the TSCA section 4(e) Priority List by the Interagency Testing Committee, established under section 4 of TSCA, will be added to § 716.120 but only to the extent that the total number of designated and recommended substances, mixtures and categories of chemical substances has not exceeded 50 in any 1 year. The addition of such chemical substances, mixtures, and categories of chemical substances to § 716.120 will be effective 30 days after publication of a notice to that effect in the Federal Register.

(c) Prior to the effective date of an amendment under paragraph (b) of this section, the Assistant Administrator for Prevention, Pesticides and Toxic Substances may for good cause withdraw a chemical substance, mixture, or category of chemical substances from § 716.120. Any information submitted showing why a chemical substance, mixture, or category of chemical substances should be withdrawn from the amendment must be received by EPA within 14 days after the date of publication of the notice under paragraph (b) of this section. If a chemical substance, mixture, or category of chemical substances is withdrawn, a Federal Register notice announcing this decision will be published no later than the effective date of the amendment under paragraph (b) of this section. Persons who wish to submit information that shows why a chemical should be withdrawn must address their comments, in writing to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(d) Auto-ITC.

Substances listed in this section appear in order by Chemical Abstract Service Registry Number. Chemical mixtures and categories are listed separately and by alphabetical order. Chemical substances listed within a category are provided only as examples of the category, and are not included on the list of substances. When a chemical substance in the substance or category list had been listed previously by a trivial (or common) name, it appears first, followed by the Chemical Abstract Service (CAS) name appearing in the TSCA Chemical Substance Inventory.

(a) List of substances. The following chemical substances are subject to all the provisions of part 716. Manufacturers, importers, and processors of a listed substance are subject to the reporting requirements of subpart A for that substance.

(b) [Reserved]

(c) By category. The following categories are listed in alphabetical order. Chemical substances listed within a category are provided only as examples of the category. All chemical substances within a category are subject to all the provisions of part 716 for the time period from the effective date of the category until the sunset date. Manufacturers, importers, and processors of any chemical substance within a category are subject to the reporting requirements of subpart A for that category, except when the sunset date for the particular substance predates the sunset date for the category, or when the exemption of § 716.20(b) of this part applies.