25 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment A Toxic Substances Control Act ( TSCA) Section 8( a) ( 15 USC 2607a) 26 TITLE 15  COMMERCE AND TRADE CHAPTER 53  TOXIC SUBSTANCES CONTROL SUBCHAPTER I  CONTROL OF TOXIC SUBSTANCES Sec. 2607. Reporting and retention of information ( a) Reports ( 1) The Administrator shall promulgate rules under which

( A) each person ( other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process a chemical substance ( other than a chemical substance described in subparagraph ( B)( ii)) shall maintain such records, and shall submit to the Administrator such reports, as the Administrator may reasonably require, and ( B) each person ( other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process

( i) a mixture, or ( ii) a chemical substance in small quantities ( as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product,

shall maintain records and submit to the Administrator reports but only to the extent the Administrator determines the maintenance of records or submission of reports, or both, is necessary for the effective enforcement of this chapter.

The Administrator may not require in a rule promulgated under this paragraph the maintenance of records or the submission of reports with respect to changes in the proportions of the components of a mixture unless the Administrator finds that the maintenance of such records or the submission of such reports, or both, is necessary for the effective enforcement of this chapter. For purposes of the compilation of the list of chemical substances required under subsection ( b) of this section, the Administrator shall promulgate rules pursuant to this subsection not later than 180 days after January 1, 1977.

( 2) The Administrator may require under paragraph ( 1) maintenance of records and reporting with respect to the following insofar as known to the person making the report or insofar as reasonably ascertainable: 27 ( A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required. ( B) The categories or proposed categories of use of each such substance or mixture.

( C) The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.

( D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture.

( E) All existing data concerning the environmental and health effects of such substance or mixture.

( F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure.

( G) In the initial report under paragraph ( 1) on such substance or mixture, the manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.

To the extent feasible, the Administrator shall not require under paragraph ( 1), any reporting which is unnecessary or duplicative.

( 3)( A)( i) The Administrator may by rule require a small manufacturer or processor of a chemical substance to submit to the Administrator such information respecting the chemical substance as the Administrator may require for publication of the first list of chemical substances required by subsection ( b) of this section.

( ii) The Administrator may by rule require a small manufacturer or processor of a chemical substance or mixture

( I) subject to a rule proposed or promulgated under section 2603, 2604( b)( 4), or 2605 of this title, or an order in effect under section 2604( e) of this title, or ( II) with respect to which relief has been granted pursuant to a civil action brought under section 2604 or 2606 of this title,

to maintain such records on such substance or mixture, and to submit to the Administrator such reports on such substance or mixture, as the Administrator may reasonably require. A rule under 28 this clause requiring reporting may require reporting with respect to the matters referred to in paragraph ( 2).

( B) The Administrator, after consultation with the Administrator of the Small Business Administration, shall by rule prescribe standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of this paragraph and paragraph ( 1). OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment B Display Related to OMB Control # 2070 0054  Listings of Related Regulations in 40 CFR 9.1. 30 Display Related to OMB Control # 2070 0054  Listings of Related Regulations in 40 CFR 9.1 As of May 10, 1993, the OMB approval numbers for EPA regulations in Chapter I of Title 40 of the Code of Federal Regulations ( CFR) appear in a listing in 40 CFR 9.1 ( 58 FR 27472). This listing fulfills the display requirements in section 3507( f) of the Paperwork Reduction Act ( PRA) for EPA regulations. The listing at 40 CFR 9.1 displays this OMB Control number for the following regulations:

Program Title 40 CFR citation Chemical Information Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 712.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 712.7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 712.20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 712.28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 712.30 Dibenzo para dioxin/ Dibenzofurans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.35( b)( 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.35( b)( 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.35( b)( 4)( iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.35( c)( 1)( i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.35( c)( 1)( ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766.38 Good Laboratory Practice Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Part 792 31 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment C 40 CFR Part 712 This attachment can also be accessed online via Internet at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr712_ 00. html. 32 TITLE 40 PROTECTION OF ENVIRONMENT CHAPTER I ENVIRONMENTAL PROTECTION AGENCY PART 712 CHEMICAL INFORMATION RULES Table of Contents Subpart A General Provisions Sec. 712.1 Scope and compliance. 712.3 Definitions. 712.5 Method of identification of substances for reporting purposes. 712.7 Report of readily obtainable information for subparts B and C. 712.15 Confidentiality.

Subpart B  Manufacturers Reporting  Preliminary Assessment Information 712.20 Manufacturers and importers who must report. 712.25 Exempt manufacturers and importers. 712.28 Form and instructions. 712.30 Chemical lists and reporting periods.

Authority: 15 U. S. C. 2607( a).

Source: 47 FR 26998, June 22, 1982, unless otherwise noted.

SUBPART A  GENERAL PROVISIONS § 712.1 Scope and compliance.

( a) This part establishes procedures for chemical manufacturers and processors to report production, use, and exposure related information on listed chemical substances. Subpart A establishes requirements that apply to all reporting under this part. Subpart B covers manufacturers' and processors' reporting.

( b) Chemical substances, mixtures, and categories of substances or mixtures which have been recommended by the Interagency Testing Committee for testing consideration by the Agency but not designated for Agency response within 12 months, will be added to § 712.30 using the procedure specified in § 712.30( c) only to the extent that the total number of designated and recommended chemicals has not exceeded 50 in any 1 year. Additional recommended but not designated chemicals may be added after proposal, and consideration of public comment. 33 [ 47 FR 26998, June 22, 1982, as amended at 50 FR 34809, Aug. 28, 1985; 60 FR 31921, June 19, 1995] § 712.3 Definitions.

The definitions in section 3 of TSCA, 15 U. S. C. 2602, apply for this part. In addition, the following definitions apply:

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

( b) EPA means the U. S. Environmental Protection Agency.

( c) Import in bulk form means to import a chemical substance ( other than as part of a mixture or article) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers used for purposes of transportation or containment, if the chemical substance has an end use or commercial purpose separate from the container.

( d) Importer means anyone who imports a chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the U. S. and includes the person liable for the payment of any duties on the merchandise, or an authorized agent on his behalf. Importer also includes, as appropriate:

( 1) The consignee.

( 2) The importer of record.

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

( 4) The transferee, if the right to withdraw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purposes of this definition, the customs territory of the U. S. consists of the 50 states, Puerto Rico, and the District of Columbia.

( e) Impurity means a chemical substance unintentionally present with another chemical substance or mixture.

( f) Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of other chemical substances or mixtures, or that is intentionally present for the purpose of altering the rates of such chemical reactions. ( See also paragraph ( j) of this section.) 34 ( 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 35 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.

§ 712.5 Method of identification of substances for reporting purposes.

( a) Report on TSCA regulable quantities. Unless specifically otherwise required, respondents must report only about quantities of a chemical that is defined as a chemical substance under TSCA section 3( 2).

( b) Chemicals from natural sources. A manufacturer of a chemical substance which is extracted from an ore, from oil, or from any other natural source must report only about the manufacturing steps for, and the uses of, that chemical, not about production of the natural source material or other crude precursors derived from the natural source material.

For example, persons who manufacture a chemical substance such as " sweetened naphtha, 64741 87 3," but do not refine the naphtha to produce " hexane, 110 54 3" would not report on hexane. Only the production of " hexane" as an isolated product must be reported  not previous production of more crude, complex substances such as naphtha from which hexane is extracted. Thus, persons who produce crude oil, ores, and other crude natural materials, but do not carry them through further manufacturing steps that produce a listed chemical have no reporting responsibilities under this Part. Note, however, that any method of extraction, refinement, or purification of a listed chemical substance is considered to be manufacturing for the purposes of this rule.

( c) Chemical substances as marketed. This part requires reporting about chemical substances as they are marketed or used in practice. The following preparations of a chemical substance must be reported as the substance itself, not as a mixture, since these preparations are regarded as the 36 substance in practice.

( 1) The chemical substance in aqueous solution.

( 2) The chemical substance containing an additive ( such as a stabilizer or other chemical) to maintain the integrity or physical form of the substance.

( 3) The chemical substance in any grade of purity.

§ 712.7 Report of readily obtainable information for subparts B and C.

TSCA section 8( a) authorizes EPA to require persons to report information that is known to or reasonably ascertainable by them. For purposes of subpart B, however, a lesser standard applies. Companies must report information that is readily obtainable by management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing. Extensive file searches are not required.

[ 47 FR 26998, June 22, 1982, as amended at 60 FR 31921, June 19, 1995]

§ 712.15 Confidentiality.

( a) Any person submitting information under this part may assert business confidentiality claims for the information as described in the pertinent reporting form and its instructions. Any information covered by a claim will be disclosed by EPA only as provided in the procedures set forth at 40 CFR part 2.

( b) Persons must certify to the validity of a claim of confidentiality they make for information reported under this part, as specified on the reporting form.

( c) If no claim accompanies the information at the time it is submitted to EPA or if certification as to the claim is not made on the reporting form, EPA may place the information in an open file available to the public without further notice to the submitter.

SUBPART B  MANUFACTURERS REPORTING  PRELIMINARY ASSESSMENT INFORMATION § 712.20 Manufacturers and importers who must report.

Except as described in § 712.25, at the time a chemical substance is listed in § 712.3, the following persons must submit the " Manufacturer's Report  Preliminary Assessment Information" ( as described in § 712.28) for each plant site at which they manufactured or imported the chemical substance during the reporting period specified in § 712.30: 37 ( a) Persons who manufactured one or more of the chemical substances listed in § 712.30 for commercial purposes.

( b) Persons who imported in bulk form one or more of the chemical substances listed in § 712.30 for commercial purposes.

§ 712.25 Exempt manufacturers and importers.

( a) Persons who manufactured or imported the chemical substance during the reporting period, solely for purposes of scientific experimentation, analysis, or research, including research or analysis for product development, are not subject to reporting under § 712.20.

( b) Persons who, during the reporting period, manufactured or imported fewer than 500 kilograms ( 1100 pounds) of the chemical substance at a single plant site are not subject to reporting for that site under § 712.20.

( c) Persons who qualify as small manufacturers 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.

[ 47 FR 26998, June 22, 1982; 47 FR 28382, June 30, 1982]

§ 712.28 Form and instructions.

( a) Manufacturers and importers subject to this subpart must submit a single EPA Form No. 38 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, 1200 Pennsylvania Ave., NW., 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, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[ 47 FR 26998, June 22, 1982, as amended at 52 FR 20083, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 31921, June 19, 1995; 60 FR 34463, July 3, 1995]

§ 712.30 Chemical lists and reporting periods.

( a)( 1) Persons subject to this subpart B must submit a Preliminary Assessment Information Manufacturer's Report for each chemical substance or mixture that is listed or designated in this section.

( 2) Unless a respondent has already prepared a Manufacturer's Report in conformity with conditions set forth in paragraph ( a)( 3) of this section, the information in each Manufacturer's Report must cover the respondent's latest complete corporate fiscal year as of the effective date. The effective date will be 30 days after the FEDERAL REGISTER publishes a rule amendment making the substance or mixture subject to this subpart B.

( 3) Persons subject to this subpart B need not comply with the requirements of paragraph ( a)( 2) of this section if they meet either one of the following conditions:

( i) 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 39 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, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 8( a) Auto ITC.

( d) Manufacturers and importers of the substances listed below must submit a Preliminary 40 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.

 Effective Reporting CAS No. Substance date date  90 30 2 N Phenyl 1 naphthylamine...................... 9/ 30/ 91 11/ 27/ 91 100 40 3 4 Vinylcyclohexene.............................. 1/ 11/ 90 3/ 12/ 90 108 95 5 Thiophenol........................................... 1/ 26/ 94 3/ 28/ 94 118 79 6 2,4,6 tribromophenol................................ 1/ 11/ 90 3/ 12/ 90 143 33 9 Sodium cyanide...................................... 10/ 29/ 90 12/ 27/ 90 632 79 1 Tetrabromophthalic anhydride................. 1/ 11/ 90 3/ 12/ 90 637 92 3 Ethyl tert butyl ether............................... 12/ 28/ 94 2/ 27/ 95 994 05 8 Tert amyl methyl ether............................ 12/ 28/ 94 2/ 27/ 95 1163 19 5 Decabromodiphenyl ether........................ 1/ 11/ 90 3/ 12/ 90 3194 55 6 Hexabromocyclododecane....................... 1/ 11/ 90 3/ 12/ 90 3296 90 0 Dibromoneopentyl glycol......................... 1/ 11/ 90 3/ 12/ 90 12185 10 3 White phosphorus.................................... 1/ 26/ 94 3/ 28/ 94 32534 81 9 Pentabromodiphenyl ether....................... 1/ 11/ 90 3/ 12/ 90 32536 52 0 Octabromodiphenyl ether......................... 1/ 11/ 90 3/ 12/ 90 32588 76 4 Ethylene Bis( tetrabromophthalimide)... 1/ 11/ 90 3/ 12/ 90 37853 59 1 1,2 Bis( tribromophenoxy) ethane........... 1/ 11/ 90 3/ 12/ 90 41291 34 3 Ethylene( 5,6 dibromonorbornane 2,3 dicarboximide) 1/ 11/ 90 3/ 12/ 90 52907 07 0 Ethylene bis( 5,6 dibromonorbornane 2,3 dicarboximide) 1/ 26/ 94 3/ 28/ 94 57137 10 7 Tribrominated polystyrene...................... 1/ 11/ 90 3/ 12/ 90 61262 53 1 Ethylene bis( pentabromophenoxide)...... 1/ 11/ 90 3/ 12/ 90

( 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.

 41 Effective Reporting CAS No. Substance date date  Aldehydes: 66 77 3..................... 1 Naphthalenecarboxaldehyde................... 9/ 30/ 91 11/ 27/ 91 75 07 0..................... Acetaldehyde.......................................... 9/ 30/ 91 11/ 27/ 91 75 87 6..................... Acetaldehyde, trichloro............................ 9/ 30/ 91 11/ 27/ 91 78 84 2..................... Propanal, 2 methyl................................... 9/ 30/ 91 11/ 27/ 91 78 85 3..................... 2 Propenal, 2 methyl................................. 9/ 30/ 91 11/ 27/ 91 80 54 6..................... Benzenepropanal, 4( 1,1 dimethylethyl). alpha. methyl. 9/ 30/ 91 11/ 27/ 91 84 83 3..................... Acetaldehyde, ( 1,3 dihydro 1,3, 3 trimethyl 2H indol 2 ylidene) 89 98 5..................... Benzaldehyde, 2 chloro............................ 9/ 30/ 91 11/ 27/ 91 90 02 8..................... Benzaldehyde, 2 hydroxy......................... 9/ 30/ 91 11/ 27/ 91 93 02 7..................... Benzaldehyde, 2,5 dimethoxy................... 9/ 30/ 91 11/ 27/ 91 93 53 8..................... Benzeneacetaldehyde, . alpha. methyl........ 9/ 30/ 91 11/ 27/ 91 95 01 2..................... Benzaldehyde, 2,4 dihydroxy................... 9/ 30/ 91 11/ 27/ 91 97 51 8..................... Benzaldehyde, 2 hydroxy 5 nitro............. 9/ 30/ 91 11/ 27/ 91 98 01 1..................... 2 Furancarboxaldehyde............................. 9/ 30/ 91 11/ 27/ 91 98 03 3..................... 2 Thiophenecarboxaldehyde...................... 9/ 30/ 91 11/ 27/ 91 100 10 7.................... Benzaldehyde, 4( dimethylamino)............ 9/ 30/ 91 11/ 27/ 91 100 50 5.................... 3 Cyclohexene 1 carboxaldehyde............. 9/ 30/ 91 11/ 27/ 91 100 52 7.................... Benzaldehyde.......................................... 9/ 30/ 91 11/ 27/ 91 101 39 3.................... 2 Propenal, 2 methyl 3 phenyl............... 9/ 30/ 91 11/ 27/ 91 101 86 0.................... Octanal, 2( phenylmethylene)................. 9/ 30/ 91 11/ 27/ 91 103 95 7.................... Benzenepropanal, . alpha. methyl 4( 1 methylethyl) 9/ 30/ 91 11/ 27/ 91 104 09 6.................... Benzeneacetaldehyde, 4 methyl............... 9/ 30/ 91 11/ 27/ 91 104 55 2.................... 2 Propenal, 3 phenyl............................... 9/ 30/ 91 11/ 27/ 91 104 87 0.................... Benzaldehyde, 4 methyl.......................... 9/ 30/ 91 11/ 27/ 91 104 88 1.................... Benzaldehyde, 4 chloro........................... 9/ 30/ 91 11/ 27/ 91 106 23 0.................... 6 Octenal, 3,7 dimethyl........................... 9/ 30/ 91 11/ 27/ 91 106 26 3.................... 2,6 Octadienal, 3,7 dimethyl, ( Z)........... 9/ 30/ 91 11/ 27/ 91 106 72 9.................... 5 Heptenal, 2,6 dimethyl......................... 9/ 30/ 91 11/ 27/ 91 107 02 8.................... 2 Propenal............................................ 9/ 30/ 91 11/ 27/ 91 107 20 0.................... Acetaldehyde, chloro................................ 9/ 30/ 91 11/ 27/ 91 107 22 2.................... Ethanedial............................................ 9/ 30/ 91 11/ 27/ 91 107 75 5.................... Octanal, 7 hydroxy 3,7 dimethyl............. 9/ 30/ 91 11/ 27/ 91 110 41 8.................... Undecanal, 2 methyl............................... 9/ 30/ 91 11/ 27/ 91 110 62 3.................... Pentanal.............................................. 9/ 30/ 91 11/ 27/ 91 111 30 8.................... Pentanedial........................................... 9/ 30/ 91 11/ 27/ 91 111 71 7.................... Heptanal.............................................. 9/ 30/ 91 11/ 27/ 91 112 31 2.................... Decanal............................................... 9/ 30/ 91 11/ 27/ 91 42 112 44 7.................... Undecanal............................................. 9/ 30/ 91 11/ 27/ 91 112 45 8.................... 10 Undecenal.......................................... 9/ 30/ 91 11/ 27/ 91 112 54 9.................... Dodecanal............................................. 9/ 30/ 91 11/ 27/ 91 120 14 9.................... Benzaldehyde, 3,4 dimethoxy................ 9/ 30/ 91 11/ 27/ 91 120 21 8.................... Benzaldehyde, 4( diethylamino)............. 9/ 30/ 91 11/ 27/ 91 120 57 0.................... 1,3 Benzodioxole 5 carboxaldehyde........ 9/ 30/ 91 11/ 27/ 91 121 32 4.................... Benzaldehyde, 3 ethoxy 4 hydroxy....... 9/ 30/ 91 11/ 27/ 91 121 33 5.................... Benzaldehyde, 4 hydroxy 3 methoxy...... 9/ 30/ 91 11/ 27/ 91 122 40 7.................... Heptanal, 2( phenylmethylene)................ 9/ 30/ 91 11/ 27/ 91 122 78 1.................... Benzeneacetaldehyde................................. 9/ 30/ 91 11/ 27/ 91 123 05 7.................... Hexanal, 2 ethyl..................................... 9/ 30/ 91 11/ 27/ 91 123 08 0.................... Benzaldehyde, 4 hydroxy........................ 9/ 30/ 91 11/ 27/ 91 123 11 5.................... Benzaldehyde, 4 methoxy....................... 9/ 30/ 91 11/ 27/ 91 123 38 6.................... Propanal.............................................. 9/ 30/ 91 11/ 27/ 91 124 13 0.................... Octanal............................................... 9/ 30/ 91 11/ 27/ 91 124 19 6.................... Nonanal............................................... 9/ 30/ 91 11/ 27/ 91 126 15 8.................... 4a( 4H) Dibenzofurancarboxaldehyde, 1,5a, 6,9,9a, 9b hexahydro 9/ 30/ 91 11/ 27/ 91 135 02 4.................... Benzaldehyde, 2 methoxy....................... 9/ 30/ 91 11/ 27/ 91 141 27 5.................... 2,6 Octadienal, 3,7 dimethyl, ( E).......... 9/ 30/ 91 11/ 27/ 91 143 14 6.................... 9 Undecenal........................................... 9/ 30/ 91 11/ 27/ 91 455 19 6.................... Benzaldehyde, 4( trifluoromethyl)........... 9/ 30/ 91 11/ 27/ 91 505 57 7.................... 02 Hexenal............................................ 9/ 30/ 91 11/ 27/ 91 552 89 6.................... Benzaldehyde, 2 nitro............................. 9/ 30/ 91 11/ 27/ 91 590 86 3.................... Butanal, 3 methyl.................................... 9/ 30/ 91 11/ 27/ 91 597 31 9.................... Propanal, 3 hydroxy 2,2 dimethyl........... 9/ 30/ 91 11/ 27/ 91 939 97 9.................... Benzaldehyde, 4( 1,1 dimethylethyl)....... 9/ 30/ 91 11/ 27/ 91 1121 60 4................... 2 Pyridinecarboxaldehyde......................... 9/ 30/ 91 11/ 27/ 91 1200 14 2................... Benzaldehyde, 4 butyl............................... 9/ 30/ 91 11/ 27/ 91 1331 92 6................... 2 Propenal, 3 phenyl, monopentyl deriv.. 9/ 30/ 91 11/ 27/ 91 1334 78 7................... Benzaldehyde, methyl.............................. 9/ 30/ 91 11/ 27/ 91 1423 46 7................... 3 Cyclohexene 1 carboxaldehyde, 2,4,6 trimethyl 9/ 30/ 91 11/ 27/ 91 1504 74 1................... 2 Propenal, 3( 2 methoxyphenyl)............ 9/ 30/ 91 11/ 27/ 91 2591 86 8................... 1 Piperidinecarboxaldehyde...................... 9/ 30/ 91 11/ 27/ 91 3132 99 8................... Benzaldehyde, 3 bromo........................... 9/ 30/ 91 11/ 27/ 91 3268 49 3................... Propanal, 3( methylthio).......................... 9/ 30/ 91 11/ 27/ 91 3613 30 7................... Octanal, 7 methoxy 3,7 dimethyl............ 9/ 30/ 91 11/ 27/ 91 4501 58 0................... 3 Cyclopentene 1 acetaldehyde, 2,2,3 trimethyl 9/ 30/ 91 11/ 27/ 91 5435 64 3................... Hexanal, 3,5,5 trimethyl.......................... 9/ 30/ 91 11/ 27/ 91 5780 07 4................... 1,3 Benzodioxole 5 carboxaldehyde, 7 methoxy 9/ 30/ 91 11/ 27/ 91 43 5949 05 3................... 6 Octenal, 3,7 dimethyl, ( S)................... 9/ 30/ 91 11/ 27/ 91 5988 91 0................... Octanal, 3,7 dimethyl............................... 9/ 30/ 91 11/ 27/ 91 10031 82 0................. Benzaldehyde, 4 ethoxy.......................... 9/ 30/ 91 11/ 27/ 91 13586 68 0................. 2 Propenal, 3 4( 1,1 dimethylethyl) phenyl 2 methyl 9/ 30/ 91 11/ 27/ 91 17754 90 4................. Benzaldehyde, 4( diethylamino) 2 hydroxy 9/ 30/ 91 11/ 27/ 91 26266 68 2................. Hexenal, 2 ethyl..................................... 9/ 30/ 91 11/ 27/ 91 27939 60 2................. 3 Cyclohexene 1 carboxaldehyde, dimethyl 9/ 30/ 91 11/ 27/ 91 28602 27 9................. Benzaldehyde, ( dimethylamino)............. 9/ 30/ 91 11/ 27/ 91 31906 04 4................. 3 Cyclohexene 1 carboxaldehyde, 4( 4 hydroxy 4 methylpentyl) 9/ 30/ 91 11/ 27/ 91 37677 14 8................. 3 Cyclohexene 1 carboxaldehyde, 4( 4 methyl 3 pentenyl). 9/ 30/ 91 11/ 27/ 91 39515 51 0................. Benzaldehyde, 3 phenoxy....................... 9/ 30/ 91 11/ 27/ 91 52475 86 2................. 3 Cyclohexene 1 carboxaldehyde, 1 methyl 4( 4 methyl 3 pentenyl) 9/ 30/ 91 11/ 27/ 91 66327 54 6................. 3 Cyclohexene 1 carboxaldehyde, 1 methyl 4( 4 methylpentyl) 9/ 30/ 91 11/ 27/ 91 Alkyl, Chloro, and Hydroxymethyl Diaryl Ethers. 3061 36 7................... 1,4 Diphenoxybenzene.............................. 04/ 12/ 93 06/ 10/ 93 3586 14 9................... Benzene, 1 methyl 3 phenoxy................. 04/ 12/ 93 06/ 10/ 93 13826 35 2................. Benzenemethanol, 3 phenoxy,................ 04/ 12/ 93 06/ 10/ 93 28299 41 4................. Benzene, 1,1, oxybis[ methyl................... 04/ 12/ 93 06/ 10/ 93 28984 89 6................. 1,1 Biphenyl, phenoxy............................ 04/ 12/ 93 06/ 10/ 93 42874 96 4................. 2 Chloro 1( 3 methylphenoxy) 4( trifluoromethyl) benzene 04/ 12/ 93 06/ 10/ 93 50594 77 9................. Phenol, 3[ 2 chloro 4( trifluoromethyl) phenoxy], acetate 04/ 12/ 93 06/ 10/ 93 50789 44 1................. Benzenemethanol, 3 phenoxy, acetate.... 04/ 12/ 93 06/ 10/ 93 51632 16 7................. Benzene, 1( bromomethyl) 3 phenoxy.. 04/ 12/ 93 06/ 10/ 93 61702 88 3................. Benzene, 1,1 oxybis[( 1,1,3,3 tetramethylbutyl). 04/ 12/ 93 06/ 10/ 93 63734 62 3................. Benzoic acid, 3[ 2 chloro 4( trifluoromethyl) phenoxy] 04/ 12/ 93 06/ 10/ 93 69834 19 1................. Benzene, 1,1 oxybis[ dodecyl................ 04/ 12/ 93 06/ 10/ 93 72252 48 3................. Benzoic acid, 3[ 2 chloro 4( trifluoromethyl) phenoxy], potassium salt 04/ 12/ 93 06/ 10/ 93 Alkylphenols and Alkylphenol Ethoxylates:. 80 46 6..................... 4 tert Pentylphenol................................... 3/ 29/ 96 5/ 29/ 96 88 18 6..................... 2 tert Butylphenol.................................... 3/ 29/ 96 5/ 29/ 96 94 06 4..................... 4( 1 Methylbutyl) phenol.......................... 3/ 29/ 96 5/ 29/ 96 98 54 4..................... 4 tert Butylphenol.................................... 3/ 29/ 96 5/ 29/ 96 99 71 8..................... 4 sec Butylphenol..................................... 3/ 29/ 96 5/ 29/ 96 44 104 40 5.................... 4 Nonylphenol......................................... 3/ 29/ 96 5/ 29/ 96 104 43 8.................... 4 Dodecylphenol...................................... 3/ 29/ 96 5/ 29/ 96 949 13 3.................... 2 Octylphenol......................................... 3/ 29/ 96 5/ 29/ 96 1300 16 9................... Nonylphenol ( mixed isomers).................. 3/ 29/ 96 5/ 29/ 96 1322 69 6...................( 1,1,3,3 Tetramethylbutyl) phenol ( mixed isomers) 3/ 29/ 96 5/ 29/ 96 1331 57 3................... Dodecylphenol ( mixed isomers)............... 3/ 29/ 96 5/ 29/ 96 1638 22 8................... 4 n Butylphenol....................................... 3/ 29/ 96 5/ 29/ 96 1806 26 4................... 4 Octylphenol......................................... 3/ 29/ 96 5/ 29/ 96 2315 66 4................... Decaethylene glycol 4 isooctylphenyl ether 3/ 29/ 96 5/ 29/ 96 2497 58 7................... Hexaethylene glycol 4 isooctylphenyl ether 3/ 29/ 96 5/ 29/ 96 3180 09 4................... 2 Butylphenol......................................... 3/ 29/ 96 5/ 29/ 96 3884 95 5................... 2( 1,1,3,3 Tetramethylbutyl) phenol.......... 3/ 29/ 96 5/ 29/ 96 9002 93 1................... Polyethylene glycol 4( tert octyl) phenyl ether5/ 29/ 96 9036 19 5................... Polyethylene glycol mono( octyl) phenyl ether 3/ 29/ 96 5/ 29/ 96 11066 49 2................. Isononylphenol ( mixed isomers)............. 3/ 29/ 96 5/ 29/ 96 14938 35 3................. 4 Pentylphenol........................................ 3/ 29/ 96 5/ 29/ 96 17404 66 9................. 4( 1 Methyloctyl) phenol.......................... 3/ 29/ 96 5/ 29/ 96 25154 52 3................. Nonylphenol ( mixed isomers).................. 3/ 29/ 96 5/ 29/ 96 27178 34 3................. tert Butylphenol ( mixed isomers)............ 3/ 29/ 96 5/ 29/ 96 27193 28 8.................( 1,1,3,3 Tetramethylbutyl) phenol ( mixed isomers)...... 3/ 29/ 96 5/ 29/ 96 27193 86 8................. Dodecylphenol ( mixed isomers).............. 3/ 29/ 96 5/ 29/ 96 27985 70 2.................( 1 Methylheptyl) phenol ( mixed isomers) 3/ 29/ 96 5/ 29/ 96 29932 96 5.................( 1,1,3,3 Tetramethylbutyl) phenol ( mixed isomers)...... 3/ 29/ 96 5/ 29/ 96 30105 54 5.................( 1,1,3,3 Tetramethylbutyl) phenol ( mixed isomers)...... 3/ 29/ 96 5/ 29/ 96 31195 95 6................. Isobutylphenol ( mixed isomers).............. 3/ 29/ 96 5/ 29/ 96 54932 78 4................. 4( 2,2,3,3 Tetramethylbutyl) phenol......... 3/ 29/ 96 5/ 29/ 96 62744 41 6.................( 1,1,3,3 Tetramethylbutyl) phenol ( mixed isomers) 3/ 29/ 96 5/ 29/ 96 68987 90 6................. Poly( oxy 1,2 ethanediyl), < greek a>( octylphenyl)< greek oh> hydroxy, branched. 3/ 29/ 96 5/ 29/ 96 84852 15 3................. Branched 4 nonylphenol ( mixed isomers) 3/ 29/ 96 5/ 29/ 96 Alkyl phosphates: 78 40 0..................... Phosphoric acid, triethyl ester................... 10/ 29/ 90 12/ 27/ 90 78 42 2..................... Phosphoric acid, tris( 2 ethylhexyl) ester.... 10/ 29/ 90 12/ 27/ 90 78 51 3..................... Ethanol, 2 butoxy, phosphate ( 3: 1)......... 10/ 29/ 90 12/ 27/ 90 107 66 4.................... Phosphoric acid, dibutyl ester.................. 10/ 29/ 90 12/ 27/ 90 126 71 6.................... Phosphoric acid, tris( 2 methylpropyl) ester 10/ 29/ 90 12/ 27/ 90 126 73 8.................... Phosphoric acid tributyl ester.................... 10/ 29/ 90 12/ 27/ 90 298 07 7.................... Phosphoric acid, bis( 2 ethylhexyl) ester..... 10/ 29/ 90 12/ 27/ 90 45 812 00 0.................... Phosphoric acid, monomethyl ester........... 10/ 29/ 90 12/ 27/ 90 1070 03 7................... Phosphoric acid, mono( 2 ethylhexyl) ester 10/ 29/ 90 12/ 27/ 90 1498 51 7................... Phosphorodichloridic acid, ethylester..... 10/ 29/ 90 12/ 27/ 90 1623 15 0................... Phosphoric acid, monobutyl ester............. 10/ 29/ 90 12/ 27/ 90 1623 24 1................... Phosphoric acid, mono( 1 methylethyl) ester10/ 29/ 90 12/ 27/ 90 2958 09 0................... Phosphoric acid, monooctadecyl ester...... 10/ 29/ 90 12/ 27/ 90 3900 04 7................... Phosphoric acid, monohexyl ester............. 10/ 29/ 90 12/ 27/ 90 3991 73 9................... Phosphoric acid, monooctyl ester.............. 10/ 29/ 90 12/ 27/ 90 7057 92 3................... Phosphoric acid, didodecyl ester............... 10/ 29/ 90 12/ 27/ 90 7332 46 9................... Ethanol, 2( 2 butoxyethoxy), phosphate ( 3: 1) 10/ 29/ 90 12/ 27/ 90 12645 31 7................. Phosphoric acid, 2 ethylhexyl ester.......... 10/ 29/ 90 12/ 27/ 90 12751 23 4................. Phosphoric acid, dodecyl ester................. 10/ 29/ 90 12/ 27/ 90 27215 10 7................. Phosphoric acid, diisooctyl ester.............. 10/ 29/ 90 12/ 27/ 90 Brominated flame retardants: 74 97 5..................... Methane, bromochloro............................. 10/ 29/ 90 12/ 27/ 90 87 10 5..................... Benzamide, 3,5 dibromo N( 4 bromophenyl) 2 hydroxy 10/ 29/ 90 12/ 27/ 90 87 83 2..................... Benzene, pentabromomethyl.................... 10/ 29/ 90 12/ 27/ 90 87 84 3..................... Cyclohexane, 1,2,3,4,5 pentabromo 6 chloro............ 10/ 29/ 90 12/ 27/ 90 96 13 9..................... 1 Propanol, 2,3 dibromo......................... 10/ 29/ 90 12/ 27/ 90 593 60 2.................... Ethene, bromo........................................ 10/ 29/ 90 12/ 27/ 90 615 58 7.................... Phenol, 2,4 dibromo............................... 10/ 29/ 90 12/ 27/ 90 4162 45 2................... Ethanol, 2,2'(( 1 methylethylidene) bis(( 2,6 dibromo 4,1 phenylene) oxy)) bis 10/ 29/ 90 12/ 27/ 90 25327 89 3................. Benzene, 1,1'( 1 methylethylidene) bis( 3,5 dibromo 4( 2 propenyloxy) 10/ 29/ 90 12/ 27/ 90 30554 72 4................. Cyclohexane, tetrabromodichloro........... 10/ 29/ 90 12/ 27/ 90 30554 73 5................. Cyclohexane, tribromotrichloro.............. 10/ 29/ 90 12/ 27/ 90 36483 57 5................. 1 Propanol, 2,2 dimethyl, tribromo deriv 10/ 29/ 90 12/ 27/ 90 55205 38 4................. 2 Propenoic acid, ( 1 methylethylidene) bis( 2,6 dibromo 4,1 phenylene) ester 10/ 29/ 90 12/ 27/ 90 68955 41 9................. Alkanes, C10 18, bromochloro............. 10/ 29/ 90 12/ 27/ 90 69882 11 7................. Phenol, 2,4( or 2,6) dibromo, homopolymer10/ 29/ 90 12/ 27/ 90 88497 56 7................. Benzene, ethenyl, homopolymer, brominated 10/ 29/ 90 12/ 27/ 90 Chloralkyl phosphates 34621 99 3................. 1,2 Ethanediyltetrakis( 2 chloro 1 methylethylene) phosphate 6/ 14/ 93 8/ 12/ 93 38051 10 4................. 2,2 Bis( chloromethyl) 1,3 propanediyltetrakis( 2 chloroethyl) phosphate 6/ 14/ 93 8/ 12/ 93 53461 82 8................. Oxydi 2,1 ethanediyltetrakis( 2 chloroethyl) phosphate 6/ 14/ 93 8/ 12/ 93 46 76649 15 5................. 2 Chloro 1 methylethylbis( 2 chloropropyl) phosphate Cyanoacrylates: 137 05 3.................... 2 Propenoic acid, 2 cyano, methyl ester. 1/ 26/ 94 3/ 28/ 94 1069 55 2................... 2 Propenoic acid, 2 cyano, isobutyl ester 1/ 26/ 94 3/ 28/ 94 6197 30 4................... 2 Propenoic acid, 2 cyano 3,3 diphenyl, 2 ethylhexyl ester 1/ 26/ 94 3/ 28/ 94 6606 65 1................... 2 Propenoic acid, 2 cyano, butyl ester..... 1/ 26/ 94 3/ 28/ 94 7085 85 0................... 2 Propenoic acid, 2 cyano, ethyl ester.... 1/ 26/ 94 3/ 28/ 94 7324 02 9................... 2 Propenoic acid, 2 cyano, 2 propenyl ester1/ 26/ 94 3/ 28/ 94 10586 17 1................. 2 Propenoic acid, 2 cyano, 1 methylethyl ester 1/ 26/ 94 3/ 28/ 94 21982 43 4................. 2 Propenoic acid, 2 cyano, ethoxyethyl ester 1/ 26/ 94 3/ 28/ 94 23023 91 8................. 2 Propenoic acid, 2 cyano, 2,2,2 trifluoromethyl ester 1/ 26/ 94 3/ 28/ 94 27816 23 5................. 2 Propenoic acid, 2 cyano, 2 methoxyethyl ester 1/ 26/ 94 3/ 28/ 94 64992 16 1................. Ethanaminium, 2[[ 2 cyano 3[ 4( diethylamino) phenyl] 1 oxo 2 propenyl] oxy] N, N, N trimethyl, chloride 1/ 26/ 94 3/ 28/ 94 IRIS Chemicals: 51 28 5..................... 2,4 Dinitrophenol..................................... 9/ 30/ 91 11/ 27/ 91 95 65 8..................... 3,4 Dinethylphenol.................................... 9/ 30/ 91 11/ 27/ 91 Isocyanates: 91 97 4..................... 1,1' Biphenyl, 4,4' diisocyanato 3,3' dimethyl 10/ 29/ 90 12/ 27/ 90 100 28 7.................... Benzene, 1 isocyanato 4 nitro................ 10/ 29/ 90 12/ 27/ 90 101 68 8.................... Benzene, 1,1' methylenebis( 4 isocyanato 10/ 29/ 90 12/ 27/ 90 102 36 3.................... Benzene, 1,2 dichloro 4 isocyanato....... 10/ 29/ 90 12/ 27/ 90 103 71 9.................... Benzene, isocyanato............................... 10/ 29/ 90 12/ 27/ 90 104 12 1.................... Benzene, 1 chloro 4 isocyanato.............. 10/ 29/ 90 12/ 27/ 90 104 49 4.................... Benzene, 1,4 diisocyanato...................... 10/ 29/ 90 12/ 27/ 90 109 90 0.................... Ethane, isocyanato................................. 10/ 29/ 90 12/ 27/ 90 110 78 1.................... Propane, 1 isocyanato............................ 10/ 29/ 90 12/ 27/ 90 111 36 4.................... Butane, 1 isocyanato.............................. 10/ 29/ 90 12/ 27/ 90 112 96 9.................... Octadecane, 1 isocyanato....................... 10/ 29/ 90 12/ 27/ 90 123 61 5.................... Benzene, 1,3 diisocyanato...................... 10/ 29/ 90 12/ 27/ 90 329 01 1.................... Benzene, 1 isocyanato 3( trifluoromethyl) 10/ 29/ 90 12/ 27/ 90 614 68 6.................... Benzene, 1 isocyanato 2 methyl............. 10/ 29/ 90 12/ 27/ 90 622 58 2.................... Benzene, 1 isocyanato 4 methyl............. 10/ 29/ 90 12/ 27/ 90 624 83 9.................... Methane, isocyanato............................... 10/ 29/ 90 12/ 27/ 90 1476 23 9................... 1 Propene, 3 isocyanato........................... 10/ 29/ 90 12/ 27/ 90 2422 91 5................... Benzene, 1,1', 1'' methylidynetris( 4 isocyanato 10/ 29/ 90 12/ 27/ 90 47 2493 02 9................... Benzene, 1 bromo 4 isocyanato.............. 10/ 29/ 90 12/ 27/ 90 2909 38 8................... Benzene, 1 chloro 3 isocyanato............... 10/ 29/ 90 12/ 27/ 90 2949 22 6................... Acetic acid, isocyanato, ethyl ester.......... 10/ 29/ 90 12/ 27/ 90 3173 53 3................... Cyclohexane, isocyanato.......................... 10/ 29/ 90 12/ 27/ 90 4035 89 6................... Imidodicarbonic diamide, N, N', 2 tris( 6 isocyanatohexyl) 10/ 29/ 90 12/ 27/ 90 4098 71 9................... Cyclohexane, 5 isocyanato 1( isocyanatomethyl) 1,3,3 trimethyl 10/ 29/ 90 12/ 27/ 90 4151 51 3................... Phenol, 4 isocyanato, phosphorothioate ( 3: 1) ( ester) 10/ 29/ 90 12/ 27/ 90 5124 30 1................... Cyclohexane, 1,1' methylenebis( 4 isocyanato.......... 10/ 29/ 90 12/ 27/ 90 5873 54 1................... Benzene, 1 isocyanato 2(( 4 isocyanatophenyl) methyl) 10/ 29/ 90 12/ 27/ 90 10031 75 1................. Benzene, 1,1'( diisocyanatomethylene) bis 10/ 29/ 90 12/ 27/ 90 15646 96 5................. Hexane, 1,6 diisocyanato 2,4,4 trimethyl 10/ 29/ 90 12/ 27/ 90 16938 22 0................. Hexane, 1,6 diisocyanato 2,2,4 trimethyl 10/ 29/ 90 12/ 27/ 90 25854 16 4................. Benzene, bis( isocyanatomethyl).............. 10/ 29/ 90 12/ 27/ 90 26447 40 5................. Benzene, 1,1' methylenebis( isocyanato.. 10/ 29/ 90 12/ 27/ 90 26603 40 7................. 1,3,5, Triazine 2,4,6( 1H. 3H, 5H trione, 1,3,5 tris( 3 isocyanatomethyl phenyl) 10/ 29/ 90 12/ 27/ 90 26747 90 0................. 1,3 Diazetidine 2,4 dione, 1,3 bis( 3 isocyanatomethylphenyl) 10/ 29/ 90 12/ 27/ 90 28178 42 9................. Benzene, 2 isocyanato 1,3 bis( 1 methylethyl) 10/ 29/ 90 12/ 27/ 90 28556 81 2................. Benzene, 2 isocyanato 1,3 dimethyl....... 10/ 29/ 90 12/ 27/ 90 30674 80 7................. 2 Propenoic acid, 2 methyl, 2 isocyanatoethyl ester 10/ 29/ 90 12/ 27/ 90 34893 92 0................. Benzene, 1,3 dichloro 5 isocyanato.... 10/ 29/ 90 12/ 27/ 90 68239 06 5................. Cyclohexane, 2 heptyl 3,4 bis( 9 isocyanatononyl) 1 pentyl 10/ 29/ 90 12/ 27/ 90 73597 26 9................. 2 Propenoic acid, 2 methyl, 2((((( 5 isocyanato 1,3,3 trimethylcyclo hexyl) methyl) amino) carbonyl) oxy) ethyl ester 10/ 29/ 90 12/ 27/ 90 Methyl ethylene glycol ethers and esters: 3121 61 7................... Ethylene glycol monomethyl ether acrylate 1/ 26/ 94 3/ 28/ 94 23783 42 8................. Tetraethylene glycol monomethyl ether 1/ 26/ 94 3/ 28/ 94 Nonylphenol ethoxylates 07311 27 5................. Ethanol, 2[ 2[ 2[ 2( p nonylphenoxy) ethoxy] ethoxy] ethoxy] 11/ 29/ 96 1/ 27/ 97 09016 45 9 and 20636 48 0... Nonylphenol polyethylene glycol ether 11/ 29/ 96 1/ 27/ 97 20427 84 3................. Ethanol, 2[ 2( p nonylphenoxy) ethoxy] 11/ 29/ 96 1/ 27/ 97 26027 38 3 and 26064 02 8... p Nonylphenol polyethylene glycol ether 48 11/ 29/ 96 1/ 27/ 97 26571 11 9................. Nonylphenol octa( oxyethylene) ethanol 11/ 29/ 96 1/ 27/ 97 27176 93 8 and 27177 01 1... Nonylphenoxydiglycol 11/ 29/ 96 1/ 27/ 97 27177 05 5................. Nonylphenol hepta( oxyethylene) ethanol 11/ 29/ 96 1/ 27/ 97 27177 08 8................. Nonylphenolnona( oxyethylene) ethanol 11/ 29/ 96 1/ 27/ 97 27986 36 3................. Nonylphenoxy ethanol 11/ 29/ 96 1/ 27/ 97 37205 87 1................. Poly( oxy 1,2 ethanediyl), alpha( isononylphenyl) omega hydroxy 11/ 29/ 96 1/ 27/ 97 OSHA Chemicals in Need of Dermal Absorption Testing: 60 29 7..................... Ethyl ether........................................... 1/ 26/ 94 3/ 28/ 94 61 82 5..................... Amitrole.............................................. 3/ 11/ 94 5/ 10/ 94 74 96 4..................... Ethyl bromide......................................... 3/ 11/ 94 5/ 10/ 94 75 05 8..................... Acetonitrile.......................................... 8/ 4/ 95 10/ 3/ 95 75 12 7..................... Formamide............................................. 8/ 4/ 95 10/ 3/ 95 75 15 0..................... Carbon disulfide...................................... 3/ 11/ 94 5/ 10/ 94 75 25 2..................... Bromoform............................................. 3/ 11/ 94 5/ 10/ 94 75 34 3..................... 1,1 Dichloroethane................................... 3/ 11/ 94 5/ 10/ 94 75 35 4..................... Vinylidene chloride................................... 8/ 4/ 95 10/ 3/ 95 75 65 0..................... tert Butyl alcohol.................................... 1/ 26/ 94 3/ 28/ 94 76 22 2..................... Camphor............................................... 1/ 26/ 94 3/ 28/ 94 77 73 6..................... Dicyclopentadiene..................................... 8/ 4/ 95 10/ 3/ 95 77 78 1..................... Dimethyl sulfate...................................... 3/ 11/ 94 5/ 10/ 94 78 59 1..................... Isophorone............................................ 8/ 4/ 95 10/ 3/ 95 78 87 5..................... Propylene dichloride................................. 8/ 4/ 95 10/ 3/ 95 78 92 2..................... sec Butyl alcohol..................................... 1/ 26/ 94 3/ 28/ 94 79 20 9..................... Methyl acetate........................................ 1/ 26/ 94 3/ 28/ 94 79 46 9..................... 2 Nitropropane........................................ 3/ 11/ 94 5/ 10/ 94 88 72 2..................... o Nitrotoluene........................................ 3/ 11/ 94 5/ 10/ 94 89 72 5..................... o sec Butylphenol.................................... 3/ 11/ 94 5/ 10/ 94 90 04 0..................... o Anisidine........................................... 3/ 11/ 94 5/ 10/ 94 91 20 3..................... Naphthalene........................................... 8/ 4/ 95 10/ 3/ 95 92 52 4..................... Biphenyl.............................................. 8/ 4/ 95 10/ 3/ 95 95 13 6..................... Indene................................................ 3/ 11/ 94 5/ 10/ 94 95 49 8..................... o Chlorotoluene....................................... 3/ 11/ 94 5/ 10/ 94 95 50 1..................... o Dichlorobenzene.................................... 8/ 4/ 95 10/ 3/ 95 96 18 4..................... 1,2,3 Trichloropropane............................ 8/ 4/ 95 10/ 3/ 95 97 77 8..................... Disulfiram............................................ 1/ 26/ 94 3/ 28/ 94 98 29 3..................... t Butylcatechol....................................... 8/ 4/ 95 10/ 3/ 95 99 08 1..................... m Nitrotoluene........................................ 8/ 4/ 95 10/ 3/ 95 99 65 0..................... m Dinitrobenzene.................................... 3/ 11/ 94 5/ 10/ 94 99 99 0..................... p Nitrotoluene........................................ 8/ 4/ 95 10/ 3/ 95 100 00 5.................... p Nitrochlorobenzene.............................. 3/ 11/ 94 5/ 10/ 94 100 01 6.................... p Nitroaniline........................................ 3/ 11/ 94 5/ 10/ 94 49 100 44 7.................... Benzyl chloride....................................... 3/ 11/ 94 5/ 10/ 94 100 25 4.................... p Dinitrobenzene..................................... 1/ 26/ 94 3/ 28/ 94 100 63 0.................... Phenylhydrazine....................................... 3/ 11/ 94 5/ 10/ 94 105 46 4.................... sec Butyl acetate..................................... 1/ 26/ 94 3/ 28/ 94 106 42 3.................... p Xylene.............................................. 1/ 26/ 94 3/ 28/ 94 106 46 7.................... p Dichlorobenzene.................................. 8/ 4/ 95 10/ 3/ 95 106 49 0.................... p Toluidine........................................... 3/ 11/ 94 5/ 10/ 94 107 06 2.................... Ethylene dichloride.................................. 8/ 4/ 95 10/ 3/ 95 107 31 3.................... Methyl formate........................................ 1/ 26/ 94 3/ 28/ 94 107 66 4.................... Dibutyl phosphate.................................... 1/ 26/ 94 3/ 28/ 94 108 03 2.................... 1 Nitropropane........................................ 1/ 26/ 94 3/ 28/ 94 108 44 1.................... m Toluidine........................................... 3/ 11/ 94 5/ 10/ 94 108 87 2.................... Methylcyclohexane.................................. 1/ 26/ 94 3/ 28/ 94 108 90 7.................... Chlorobenzene......................................... 3/ 11/ 94 5/ 10/ 94 108 93 0.................... Cyclohexanol.......................................... 8/ 4/ 95 10/ 3/ 95 109 66 0.................... Pentane............................................... 1/ 26/ 94 3/ 28/ 94 109 99 9.................... Tetrahydrofuran....................................... 3/ 11/ 94 5/ 10/ 94 110 12 3.................... Methyl isoamyl ketone............................. 8/ 4/ 95 10/ 3/ 95 110 83 8.................... Cyclohexene........................................... 1/ 26/ 94 3/ 28/ 94 111 84 2.................... Nonane................................................ 1/ 26/ 94 3/ 28/ 94 120 80 9.................... Catechol.............................................. 8/ 4/ 95 10/ 3/ 95 121 14 2.................... 2,4 Dinitrotoluene................................... 3/ 11/ 94 5/ 10/ 94 121 69 7.................... Dimethylaniline....................................... 8/ 4/ 95 10/ 3/ 95 122 39 4.................... Diphenylamine......................................... 3/ 11/ 94 5/ 10/ 94 123 42 2.................... Diacetone alcohol..................................... 8/ 4/ 95 10/ 3/ 95 123 92 2.................... Isoamyl acetate....................................... 1/ 26/ 94 3/ 28/ 94 126 99 8.................... beta Chloroprene...................................... 3/ 11/ 94 5/ 10/ 94 127 19 5.................... Dimethyl acetamide.................................. 8/ 4/ 95 10/ 3/ 95 142 82 5.................... Heptane ( n Heptane)............................... 1/ 26/ 94 3/ 28/ 94 150 76 5.................... p Methoxyphenol.................................... 3/ 11/ 94 5/ 10/ 94 287 92 3.................... Cyclopentane.......................................... 1/ 26/ 94 3/ 28/ 94 528 29 0.................... o Dinitrobenzene..................................... 3/ 11/ 94 5/ 10/ 94 532 27 4.................... a Chloroacetophenone............................. 1/ 26/ 94 3/ 28/ 94 540 59 0.................... 1,2 Dichloroethylene............................... 3/ 11/ 94 5/ 10/ 94 540 88 5.................... tert Butyl acetate.................................... 1/ 26/ 94 3/ 28/ 94 542 92 7.................... Cyclopentadiene...................................... 8/ 4/ 95 10/ 3/ 95 626 17 5.................... m Phthalodinitrile.................................... 3/ 11/ 94 5/ 10/ 94 628 63 7.................... n Amyl acetate........................................ 1/ 26/ 94 3/ 28/ 94 768 52 5.................... N Isopropylaniline................................... 3 / 11/ 94 5/ 10/ 94 1300 73 8................... Xylidine.............................................. 3/ 11/ 94 5/ 10/ 94 6423 43 4................... Propylene glycol dinitrate......................... 3/ 11/ 94 5/ 10/ 94 7631 90 5................... Sodium bisulfite...................................... 1/ 26/ 94 3/ 28/ 94 7681 57 4................... Sodium metabisulfite............................... 1/ 26/ 94 3/ 28/ 94 50 25013 15 4................. Vinyl toluene......................................... 3/ 11/ 94 5/ 10/ 94 34590 94 8................. Dipropylene glycol methyl ether............. 8/ 4/ 95 10/ 3/ 95 Propylene glycol ethers and esters: 108 65 6.................... Propylene glycol monomethyl ether acetate1/ 26/ 94 3/ 28/ 94 110 98 5.................... Dipropylene glycol................................... 1/ 26/ 94 3/ 28/ 94 770 35 4.................... 1 Phenoxy 2 propanol............................. 1/ 26/ 94 3/ 28/ 94 20324 32 7................. 1( 2 Methoxy 1 methylethoxy) 2 propanol 1/ 26/ 94 3/ 28/ 94 20324 33 8................. Tripropylene glycol methyl ether............. 1/ 26/ 94 3/ 28/ 94 28677 93 2................. Methoxy 1 propanol................................. 1/ 26/ 94 3/ 28/ 94 29387 86 8................. Propylene glycol monobutyl ether............ 1/ 26/ 94 3/ 28/ 94 29911 28 2................. Dipropylene glycol butyl ether................. 1/ 26/ 94 3/ 28/ 94 42978 66 5................. Tripropylene glycol diacrylate.................. 1/ 26/ 94 3/ 28/ 94 57018 52 7................. Propylene glycol mono tert butyl ether.... 1/ 26/ 94 3/ 28/ 94 88917 22 0................. Dipropylene glycol monomethyl ether acetate 1/ 26/ 94 3/ 28/ 94 Siloxanes: 107 46 0.................... Hexamethyldisiloxane.............................. 10/ 12/ 93 2/ 28/ 94 107 50 6.................... Tetradecamethylcycloheptasiloxane......... 10/ 12/ 93 2/ 28/ 94 107 51 7.................... Octamethyltrisiloxane.............................. 10/ 12/ 93 2/ 28/ 94 107 52 8.................... Tetradecamethylhexasiloxane.................. 10/ 12/ 93 2/ 28/ 94 107 53 9.................... Tetracosamethylundecasiloxane............... 10/ 12/ 93 2/ 28/ 94 141 62 8.................... Decamethyltetrasiloxane.......................... 10/ 12/ 93 2/ 28/ 94 141 63 9.................... Dodecamethylpentasiloxane....................... 10/ 12/ 93 2/ 28/ 94 540 97 6.................... Dodecamethylcyclohexasiloxane............... 10/ 12/ 93 2/ 28/ 94 541 01 5.................... Hexadecamethylheptasiloxane................. 10/ 12/ 93 2/ 28/ 94 541 02 6.................... Decamethylcyclopentasiloxane................ 10/ 12/ 93 2/ 28/ 94 541 05 9.................... Hexamethylcyclotrisiloxane..................... 10/ 12/ 93 2/ 28/ 94 546 56 5.................... Octaphenylcyclotetrasiloxane..................... 10/ 12/ 93 2/ 28/ 94 556 67 2.................... Octamethylcyclotetrasiloxane.................. 10/ 12/ 93 2/ 28/ 94 556 68 3.................... Hexadecamethylcyclooctasiloxane........... 10/ 12/ 93 2/ 28/ 94 556 69 4.................... Octadecamethyloctasiloxane.................... 10/ 12/ 93 2/ 28/ 94 556 70 7.................... Docosamethyldecasiloxane...................... 10/ 12/ 93 2/ 28/ 94 556 71 8.................... Octadecamethylcyclononasiloxane........... 10/ 12/ 93 2/ 28/ 94 999 97 3.................... Hexamethyldisilazane.............................. 10/ 12/ 93 2/ 28/ 94 2370 88 9................... Tetramethylcyclotetrasiloxane.................. 10/ 12/ 93 2/ 28/ 94 2374 14 3................... Trifluoropropylmethylcyclotrisiloxane..... 10/ 12/ 93 2/ 28/ 94 2471 08 1................... Hexacosamethyldodecasiloxane............... 10/ 12/ 93 2/ 28/ 94 2471 09 2................... Octacosamethyltridecasiloxane................ 10/ 12/ 93 2/ 28/ 94 2471 10 5................... Triacontamethyltetradecasiloxane............ 10/ 12/ 93 2/ 28/ 94 2471 11 6................... Dotriacontamethylpentadecasiloxane........ 10/ 12/ 93 2/ 28/ 94 2554 06 5................... Methylvinylcyclosiloxane......................... 10/ 12/ 93 2/ 28/ 94 2627 95 4................... Tetramethyldivinyldisiloxane................... 10/ 12/ 93 2/ 28/ 94 2652 13 3................... Eicosamethylnonasiloxane........................ 10/ 12/ 93 2/ 28/ 94 70131 67 8................. Siloxanes and silicones, di Me, hydroxy terminated 51 10/ 12/ 93 2/ 28/ 94 9004 73 3................... Methylpolysiloxane................................... 10/ 12/ 93 2/ 28/ 94 18766 38 6................. Docosamethylcycloundecasiloxane.......... 10/ 12/ 93 2/ 28/ 94 18772 36 6................. Eicosamethylcyclodecasiloxane............... 10/ 12/ 93 2/ 28/ 94 18844 04 7................. Hexatriacontamethylheptadecasiloxane... 10/ 12/ 93 2/ 28/ 94 18919 94 3................. Tetracosamethylcyclododecasiloxane...... 10/ 12/ 93 2/ 28/ 94 23523 12 8................. Hexatriacontamethylcyclooctadecasiloxane 10/ 12/ 93 2/ 28/ 94 23523 14 0................. Triacontamethylcyclopentadecasiloxane.. 10/ 12/ 93 2/ 28/ 94 23732 94 7................. Hexacosamethylcyclotridecasiloxane....... 10/ 12/ 93 2/ 28/ 94 36938 50 8................. Tetratriacontamethyl hexadecasiloxane... 10/ 12/ 93 2/ 28/ 94 36938 52 0................. Octatriacontamethyl octadecasiloxane..... 10/ 12/ 93 2/ 28/ 94 63148 62 9................. Dimethyl silicones and siloxanes............. 10/ 12/ 93 2/ 28/ 94 67762 90 7................. Dimethyl silicones and siloxane, reaction products with silica 0/ 12/ 93 2/ 28/ 94 67762 94 1................. Dimethylmethylvinylsiloxane.................. 10/ 12/ 93 2/ 28/ 94 68037 59 2................. Dimethylhydropolylsiloxane.................... 10/ 12/ 93 2/ 28/ 94 68037 74 1................. Dimethylpolysiloxanes............................. 10/ 12/ 93 2/ 28/ 94 68083 14 7................. Dimethyldiphenylsiloxane........................ 10/ 12/ 93 2/ 28/ 94 69430 24 6................. Cyclopolydimethylsiloxane...................... 10/ 12/ 93 2/ 28/ 94 115361 68 7............... Dimethylmethyl 3,3,3 trifluoropropyl siloxane 10/ 12/ 93 2/ 28/ 94 149050 40 8............... Octacosamethylcyclotetradecasiloxane... 10/ 12/ 93 2/ 28/ 94 150026 95 2............... Dotriacontamethylcyclohexadecasiloxane 10/ 12/ 93 2/ 28/ 94 150026 96 3............... Tetratriacontamethylcycloheptadecasiloxane 10/ 12/ 93 2/ 28/ 94 150026 97 4............... Octatriacontamethylcyclononadecasiloxane 10/ 12/ 93 2/ 28/ 94 150026 98 5............... Tetracontamethylcycloeicosasiloxane..... 10/ 12/ 93 2/ 28/ 94 150026 99 6............... Tetracontamethylnonadecasiloxane........ 10/ 12/ 93 2/ 28/ 94 150027 00 2............... Dotetracontamethyleicosasiloxane.......... 10/ 12/ 93 2/ 28/ 94 not available............... Polymethyloctadecylsiloxane.................... 10/ 12/ 93 2/ 28/ 94 Substantially produced chemicals in need of subchronic tests: 80 51 3..................... p, p' Oxybis( benzenesulfonylhydrazide).... 9/ 30/ 91 11/ 27/ 91 81 84 5..................... Naphthalenedicarboxylic anhydride............ 9/ 30/ 91 11/ 27/ 91 84 51 5..................... 2 Ethylanthraquinone................................ 9/ 30/ 91 11/ 27/ 91 87 02 5..................... 7 Amino 4 hydroxy 2 naphthalenesulfonic acid 9/ 30/ 91 11/ 27/ 91 90 15 3..................... 1 Naphthol............................................. 9/ 30/ 91 11/ 27/ 91 92 70 6..................... 3 Hydroxy 2 naphthoic acid..................... 9/ 30/ 91 11/ 27/ 91 94 28 0..................... Triethylene glycol bis( 2 ethylhexanoate)... 9/ 30/ 91 11/ 27/ 91 95 32 9..................... 2( 4 Morpholinyldithio) benzothiazole...... 9/ 30/ 91 11/ 27/ 91 97 88 1..................... N Butyl methacrylate............................... 9/ 30/ 91 11/ 27/ 91 98 48 6..................... 1,3 Benzenedisulfonic Acid....................... 9/ 30/ 91 11/ 27/ 91 99 54 7..................... 3,4 Dichloronitrobenzene......................... 9/ 30/ 91 11/ 27/ 91 99 63 8..................... Isophthaloyl chloride................................. 9/ 30/ 91 11/ 27/ 91 52 100 20 9.................... Terephthaloyl chloride............................. 9/ 30/ 91 11/ 27/ 91 100 29 8.................... 4 Ethoxynitrobenzene................................ 9/ 30/ 91 11/ 27/ 91 102 01 2.................... Acetoacetanilide...................................... 9/ 30/ 91 11/ 27/ 91 106 31 0.................... Butyric anhydride.................................... 9/ 30/ 91 11/ 27/ 91 106 63 8.................... Isobutyl acrylate..................................... 9/ 30/ 91 11/ 27/ 91 111 96 6.................... Diethylene glycol dimethyl ether.............. 9/ 30/ 91 11/ 27/ 91 112 15 2.................... Ethanol, 2( 2 ethoxyethoxy), acetate........ 9/ 30/ 91 11/ 27/ 91 116 81 4.................... Bromamine acid...................................... 9/ 30/ 91 11/ 27/ 91 119 33 5.................... 4 Methyl 2 nitro phenol.......................... 9/ 30/ 91 11/ 27/ 91 121 60 8.................... 4( Acetylamino) benzenesulfonyl chloride. 9/ 30/ 91 11/ 27/ 91 123 54 6.................... 2,4 Pentanedione...................................... 9/ 30/ 91 11/ 27/ 91 123 62 6.................... Propanoic anhydride................................ 9/ 30/ 91 11/ 27/ 91 142 16 5.................... Bis( 2 ethylhexyl) 2 butenedioate............. 9/ 30/ 91 11/ 27/ 91 311 89 7.................... Perfluorotributylamine............................. 9/ 30/ 91 11/ 27/ 91 355 42 0.................... Perfluoro N hexane................................. 9/ 30/ 91 11/ 27/ 91 594 42 3.................... Trichloromethanesulfenyl chloride............ 9/ 30/ 91 11/ 27/ 91 616 21 7.................... 1,2 Dichlorobutane.................................... 9/ 30/ 91 11/ 27/ 91 626 17 5.................... 1,3 Dicyanobenzene................................. 9/ 30/ 91 11/ 27/ 91 760 23 6.................... 3,4 Dichlorobutene.................................... 9/ 30/ 91 11/ 27/ 91 929 06 6.................... 2( 2 Aminoethoxy) ethanol..................... 6/ 30/ 92 9/ 28/ 92 1047 16 1................... Quinacridone.......................................... 9/ 30/ 91 11/ 27/ 91 1111 78 0................... Ammonium carbamate.............................. 9/ 30/ 91 11/ 27/ 91 3089 11 0................... Hexa( methoxymethyl) melamine.............. 9/ 30/ 91 11/ 27/ 91 Sulphones: 67 71 0..................... Dimethylsulfone....................................... 9/ 30/ 91 11/ 27/ 91 77 79 2..................... 3 Sulfolene........................................... 9/ 30/ 91 11/ 27/ 91 80 07 9..................... Sulfonyl bis( 4 chlorobenzene)................. 9/ 30/ 91 11/ 27/ 91 80 08 0..................... 4,4' Diaminodiphenyl sulfone..................... 9/ 30/ 91 11/ 27/ 91 80 09 1..................... Bisphenol S........................................... 9/ 30/ 91 11/ 27/ 91 98 30 6..................... 2 Amino 4( methylsulfonyl) phenol............ 9/ 30/ 91 11/ 27/ 91 126 33 0.................... Sulfolane............................................. 9/ 30/ 91 11/ 27/ 91 127 63 9.................... Diphenylsulfone....................................... 9/ 30/ 91 11/ 27/ 91 2580 77 0................... 2,2' Sulfonyl bis ethanol........................... 9/ 30/ 91 11/ 27/ 91 3278 22 6................... 1,1'[ Methylene bis( sulfonyl)] bisethene... 9/ 30/ 91 11/ 27/ 91 5246 57 1................... 2[( 3 Aminophenyl) sulfonyl] ethanol........ 9/ 30/ 91 11/ 27/ 91 16588 67 3................. 3[ N Ethyl 4[[ 6( methylsulfonyl) 2 benzothiazolyl] azo] m toluidino] propionitrile 9/ 30/ 91 11/ 27/ 91 17557 67 4................. 6( Methylsulfonyl) 2 benzothiazolamine 9/ 30/ 91 11/ 27/ 91 17601 96 6................. 2 Amino 4[( 2 hydroxyethyl) sulfonyl] phenol 9/ 30/ 91 11/ 27/ 91 17688 68 5................. 4 Phenylthiomorpholine, 1,1 dioxide...... 9/ 30/ 91 11/ 27/ 91 17741 62 7................. 4[ 4[( 2,6 Dichloro 4 nitrophenyl) azo] phenyl] thiomorpholine, 1,1 dioxide 9/ 30/ 91 11/ 27/ 91 53 18760 44 6................. 3( Decyloxy) tetrahydrothiophene 1,1 dioxide 9/ 30/ 91 11/ 27/ 91 20018 09 1................. 1( Diiodomethyl) sulfonyl 4 methyl benzene 9/ 30/ 91 11/ 27/ 91 26750 50 5................. 1,1'[ Oxybis( methylenesulfonyl)] bisethene 9/ 30/ 91 11/ 27/ 91 36724 43 3................. 2,2'[ Oxybis( methylenesulfonyl)] bisethanol 9/ 30/ 91 11/ 27/ 91 41123 59 5................. 1,1'[ Methylenebis( sulfonyl)] bis 2 chloroethane 9/ 30/ 91 11/ 27/ 91 41123 69 7................. 2,2'[ Methylenebis( sulfonyl)] bisethanol.. 9/ 30/ 91 11/ 27/ 91 41687 30 3................. 2[( 3 Nitrophenyl) sulfonyl] ethanol......... 9/ 30/ 91 11/ 27/ 91 52218 35 6................. 2[( 6 Amino 2 naphthalenyl) sulfonyl] ethanol 9/ 30/ 91 11/ 27/ 91 53061 10 2................. 1,1'[ Oxybis( methylenesulfonyl)] bis 2 chloroethane 9/ 30/ 91 11/ 27/ 91 63134 33 8................. 4[[ 4( Phenylmethoxy) phenyl] sulfonyl] phenol 9/ 30/ 91 11/ 27/ 91  ( Secs 8( a) and 8( d), 90 Stat. 2027, 2029; 15 U. S. C. 2607 ( a) and ( d))

[ 47 FR 26998, June 22, 1982] 54 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment D PAIR Reporting Form ( EPA Form 7710 35) and Instructions Available electronically in Portable Document Format via Internet at http:// www. epa. gov/ opptintr/ chemtest/ pairform. pdf Note: The Notice to Submitters contained in the electronic file will be amended to reflect the Agency's new estimated average burden per response. This notice is provided to submitters of EPA Form 7710 35, " Manufacturer's Report  Preliminary Assessment Information," in accordance with the Paperwork Reduction Act, to disclose public reporting burden information. In addition, EPA wishes to inform submitters that the reporting requirements on EPA Form 7710 35 have not changed with this notice. For further information on Preliminary Assessment Information reporting, refer to the Code of Federal Regulations  Title 40  Part 712. Upon OMB approval, the revised statement will read as follows:

OMB Control No. 2070 0054 PAPERWORK REDUCTION ACT NOTICE The public reporting and record keeping burden for this collection is estimated to average 28.45 hours per report, with 2.44 reports per respondent for a per respondent burden of 69.41 hours, including the time for reviewing the instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Director, Collection Strategies Division, U. S. Environmental Protection Agency ( Mail Code 2822), 1200 Pennsylvania Avenue N. W., Washington, D. C. 20460; or to: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, N. W., Washington, DC 20503. Include the OMB control number in any correspondence, but do not submit the form or report to this address. The actual information or form should be submitted in accordance with the instructions accompanying the information or form, specified in the corresponding regulation. 55 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment E 40 CFR 766 This attachment can also be accessed online via Internet at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr766_ 00. html 56 TITLE 40 PROTECTION OF ENVIRONMENT CHAPTER I ENVIRONMENTAL PROTECTION AGENCY PART 766 DIBENZO PARA DIOXINS/ DIBENZOFURANS Subpart A   General Provisions Sec. 766.1 Scope and Purpose. 766.2 Applicability and duration of this part. 766.3 Definitions. 766.5 Compliance. 766.7 Submission of information. 766.10 Test standards. 766.12 Testing guidelines. 766.14 Contents of protocols. 766.16 Developing the analytical test method. 766.18 Method sensitivity.

Subpart B   Specific Chemical Testing/ Reporting Requirements 766.20 Who must test. 766.25 Chemical substances for testing. 766.27 Congeners and LOQs for which quantitation is required. 766.28 Expert review of protocols. 766.32 Exclusions and waivers. 766.35 Reporting requirements. 766.38 Reporting on precursor chemical substances.

AUTHORITY: 15 U. S. C. 2603 and 2607 SOURCE: 52 FR 21437, June 5, 1987, unless otherwise noted.

SUBPART A   GENERAL PROVISIONS § 766.1 Scope and purpose.

( a) This part identifies requirements for testing under section 4 of the Toxic Substances Control Act ( TSCA), 15 U. S. C. 2603, to ascertain whether certain specified chemical substances may be contaminated with halogenated dibenzodioxins ( HDDs)/ dibenzofurans ( HDFs) as defined in § 766.3, and requirements for reporting under section 8 of TSCA, 15 U. S. C. 2607. 57 ( b) Section 766.35( b) requires manufacturers and processors of chemical substances identified in § 766.25 to submit to EPA: ( 1) Any existing test data showing analysis of the chemical substances for concentrations of HDDs/ HDFs, applicable protocols, and the results of the analysis for HDDs/ HDFs, ( 2) allegations of significant adverse reactions to HDDs/ HDFs, compiled in accordance with part 717 of this chapter, and ( 3) health and safety studies on the HDDs/ HDFs, in accordance with applicable provisions of part 716 of this chapter.

( c) Section 766.35( a) requires manufacturers and, under certain circumstances, processors of chemical substances identified in § 766.25 to submit letters of intent to test and protocols for the analysis of the chemical substances for the presence of HDDs/ HDFs. Section 766.20 requires these manufacturers and processors to test their chemical substances for the presence of HDDs/ HDFs. Any submissions must be in accordance with the EPA Procedures Governing Testing Consent Agreements and Test Rules contained in part 790 of this chapter and any modifications to such procedures contained in this part.

( d) Section 766.32 specifies conditions under which persons required to test may request an exclusion or waiver from testing.

( e) Deadlines for submission to EPA of protocols, reports, studies, and test results are specified in part 790, subpart C and § 766.35.

( f) Sections 766.10, 766.12, 766.14, 766.16, and 766.18 prescribe analytical methods required; § 766.27 prescribes target levels of quantitation ( LOQ) for each congener for which quantitation is required.

( g) If results of existing tests or tests performed under this part indicate the presence of HDDs/ HDFs in the identified chemical substance above the LOQ specified in § 766.27, § 766.35( c) requires the following additional reporting on the specified chemicals: production, process, use, exposure and disposal data under section 8( a) of TSCA; health and safety studies under section 8( d) of TSCA; and reports of allegations of significant adverse reactions under section 8( c) of TSCA. In some cases, additional reporting may be required of manufacturers reporting no contamination of the identified chemical substances under § 766.35( c)( 2).

( h) Section 766.38 requires manufacturers of chemical substances produced from chemical substances identified as possible precursors to HDD/ HDF formation, to report on chemical substances produced from such precursors.

§ 766.2 Applicability and duration of this part.

( a) Chemical substances subject to testing. ( 1) This part is applicable to each person who, at any time during the duration of this part, manufactures ( and/ or imports), or processes, a chemical substance identified under § 766.25. 58 ( 2) The duration of this part for any testing requirement for any chemical substance is the period commencing with the effective date of this part to the end of the reimbursement period, as defined in § 766.3, for each chemical substance. All reporting requirements for any chemical substance listed under § 766.25 shall be in effect for the same period as the testing requirement.

( b) Precursor chemical substances. ( 1) This part is applicable to each person who manufactures ( and/ or imports) a chemical substance from any precursor chemical substance identified in § 766.38.

( 2) The requirement for precursor reporting under § 766.38 shall be in effect until three years after the effective date of this part.

( 3) Small manufacturers are exempt from reporting process and reaction condition data on chemical substances made from precursor chemical substances listed under § 766.38.

§ 766.3 Definitions.

The definitions in section 3 of TSCA and the definitions of § § 704.3, 716.3, 717.3, and 790.3 of this chapter also apply to this part.

Congener means any one particular member of a class of chemical substances. A specific congener is denoted by unique chemical structure, for example 2,3,7,8 tetrachlorodibenzofuran.

Dibenzofuran means any of a family of compounds which has as a nucleus a triple ring structure consisting of two benzene rings connected through a pair of bridges between the benzene rings. The bridges are a carbon carbon bridge and a carbon oxygen carbon bridge at both substitution positions.

Dibenzo p dioxin or dioxin means any of a family of compounds which has as a nucleus a triple ring structure consisting of two benzene rings connected through a pair of oxygen atoms.

Guidelines means the Midwest Research Institute ( MRI) publication Guidelines for the Determination of Polyhalogenated Dioxins and Dibenzofurans in Commercial Products, EPA contract No. 68 02 3938; MRI Project No. 8201 A( 41), 1985.

HDD or 2,3,7,8 HDD means any of the dibenzo p dioxins totally chlorinated or totally brominated at the following positions on the molecular structure: 2,3,7,8; 1,2,3,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8; 1,2,3,7,8,9; and 1,2,3,4,7,8,9.

HDF or 2,3,7,8 HDF means any of the dibenzofurans totally chlorinated or totally brominated at the following positions on the molecular structure: 2,3,7,8; 1,2,3,7,8; 2,3,4,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8; 1,2,3,7,8,9; 2,3,4,6,7,8; 1,2,3,4,6,7,8; and 1,2,3,4,7,8,9. 59 Homolog means a group of isomers that have the same degree of halogenation. For example, the homologous class of tetrachlorodibenzo p dioxins consists of all dibenzo p dioxins containing four chlorine atoms. When the homologous classes discussed in this part are referred to, the following abbreviations for the prefix denoting the number of halogens are used: tetra, T ( 4 atoms) penta, Pe ( 5 atoms) hexa, Hx ( 6 atoms) hepta, Hp ( 7 atoms)

HRGC means high resolution gas chromatography.

HRMS means high resolution mass spectrometry.

Level of quantitation or LOQ means the lowest concentration at which HDDs/ HDFs can be reproducibly measured in a specific chemical substance within specified confidence limits, as described in this part.

Polybrominated dibenzofurans refers to any member of a class of dibenzofurans with two to eight bromine substituents.

Polybrominated dibenzo p dioxin or PBDD means to any member of a class of dibenzo p dioxins with two to eight bromine substituents.

Polychlorinated dibenzofuran means any member of a class of dibenzofurans with two to eight chlorine substituents.

Polychlorinated dibenzo p dioxin or PCDD means any member of a class of dibenzo p dioxins with two to eight chlorine substituents.

Polyhalogenated dibenzofuran or PHDF means any member of a class of dibenzofurans containing two to eight chlorine, bromine, or a combination of chlorine and bromine substituents.

Polyhalogenated dibenzo p dioxin or PHDD means any member of a class of dibenzo p dioxins containing two to eight chlorine substituents or two to eight bromine substituents.

Positive test result means: ( 1) Any resolvable gas chromatographic peak for any 2,3,7,8 HDD or HDF which exceeds the LOQ listed under § 766.27 for that congener, or ( 2) exceeds LOQs approved by EPA under § 766.28.

Precursor means a chemical substance which is not contaminated due to the process conditions under which it is manufactured, but because of its molecular structure, and under favorable process conditions, it may cause or aid the formation of HDDs/ HDFs in other chemicals in which it is used as a feedstock or intermediate. 60 QA means quality assurance.

QC means quality control.

Reimbursement period means the period that begins when the data from the last test to be completed under this part for a specific chemical substance listed in § 766.25 is submitted to EPA, and ends after an amount of time equal to that which had been required to develop that data or 5 years, whichever is later.

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

§ 766.5 Compliance.

Any person who fails or refuses to comply with any aspect of this part is in violation of section 15 of TSCA. Section 15( 1) makes it unlawful for any person to fail or refuse to comply with any rule or order issued under section 4. Section 15( 3) makes it unlawful for any person to fail or refuse to submit information required under this part. 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 of TSCA, the district courts of the United States have jurisdiction to restrain any violation of section 15.

§ 766.7 Submission of information.

All information ( including letters of intent, protocols, data, forms, studies, and allegations) submitted to EPA under this part must bear the applicable Code of Federal Regulations ( CFR) section number ( e. g., § 766.20) and must be addressed to: Document Control Office, ( 7407), Information Management Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Dioxin/ Furan Report.

[ 52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]

§ 766.10 Test standards.

Testing required under subpart B of this part must be performed using the protocols submitted to and reviewed by the EPA expert panel established under § 766.28. All new data, documentation, records, protocols, specimens, and reports generated as a result of testing under subpart B of this part must be fully developed and retained in accordance with part 792 of this chapter. These items must be made available during an inspection or submitted to EPA upon request by EPA or its authorized representative. Laboratories conducting testing for submission to EPA in response to a test rule promulgated under section 4 of TSCA must adhere to the TSCA Good Laboratory Practices ( GLPs) published in part 792 of this chapter. Sponsors must notify the laboratory that the testing is being conducted pursuant to TSCA section 4. Sponsors are also responsible for 61 ensuring that laboratories conducting the testing abide by the TSCA GLP standards. At the time test data are submitted, manufacturers must submit a certification to EPA that the laboratory performing the testing adhered to the TSCA GLPs.

§ 766.12 Testing guidelines. Analytical test methods must be developed using methods equivalent to those described or reviewed in Guidelines for the Determination of Polyhalogenated Dibenzo p dioxins and Dibenzofurans in Commercial Products. Copies are available from the Director, Environmental Assistance Division ( 7408), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room E 543B, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Telephone: ( 202) 554 1404, TDD: ( 202) 544 0551. Copies are also located in the public docket for this part ( Docket No. OPPTS 83002) and are available for inspection in the Non Confidential Information Center ( NCIC) ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room B 607 NEM, 401 M St., SW., Washington, DC 20460, between the hours of 12 p. m. and 4 p. m. weekdays excluding legal holidays.

[ 60 FR 34466, July 3, 1995]

§ 766.14 Contents of protocols.

Protocols should include all parts of the Quality Assurance Plan for Measurement of Brominated or Chlorinated Dibenzofurans and Dibenzodioxins, as stated in the Guidelines. For each chemical substance and each process, the manufacturer must submit a statement of how many grades of the chemical substance it produces, a justification for selection of the specific grade of chemical substance for testing, specific plans for collection of samples from the process stream, naming the point of collection, the method of collecting the sample, and an estimate of how well the samples will represent the material to be characterized; a description of how control samples ( blanks) and HDD/ HDF reinforced control samples, or isotopically labeled compounds ( standards) and duplicate samples will be handled; a description of the chemical extraction and clean up procedures to be used; how extraction efficiency and measurement efficiency will be established; and a description of instrument hardware and operating conditions, including type and source of columns, carrier gas and flow rate, operating temperature range, and ion source temperature.

§ 766.16 Developing the analytical test method.

Because of the matrix differences of the chemicals listed for testing, no one method for sample selection, preparation, extraction and clean up is prescribed. For analysis, High Resolution Gas Chromatography ( HRGC) with High Resolution Mass Spectrometry ( HRMS) is the method of choice, but other methods may be used if they can be demonstrated to reach the target LOQs as well as HRGC/ HRMS.

( a) Sample selection. The chemical product to be tested should be sampled so that the specimens collected for analysis are representative of the whole. Additional guidance for sample selection is 62 provided under § 766.12.

( b) Sample preparation. The sample must be mechanically homogenized and subsampled as necessary. Subsamples must be spiked or reinforced with surrogate compounds or with standard stock solutions, and the surrogates or standards must be thoroughly incorporated by mechanical agitation. Additional guidance is provided under § 766.12. ( c) Sample extraction and cleanup. The spiked samples must be treated to separate the HDDs/ HDFs from the sample matrix. Methods are reviewed in the Guidelines under § 766.12, but the final method or methods are left to the discretion of the analyst, provided the instrumental response of the surrogates meets the criteria listed in the Quality Assurance Plan for Measurement of Brominated or Chlorinated Dibenzofurans and Dibenzodioxins, Appendixes B and C of the Guidelines. Cleanup techniques are described in the Guidelines. These are chosen at the discretion of the analyst to meet the requirements of the chemical matrix.

( d) Analysis. The method of choice is High Resolution Gas Chromatographic/ High Resolution Mass Spectrometric Determination, ( HRGC/ HRMS) but alternate methods may be used if the manufacturer can demonstrate that the method will reach the target LOQs as well as HRGC/ HRMS. Specific operating requirements are found in the Guidelines.

§ 766.18 Method sensitivity.

The target level of quantitation required under § 766.27 for each HDD/ HDF congener is the level which must be attempted for each resolved HRGC peak for that congener. For at least one product sample, at least two analyses of the same isotopically labeled HDD/ HDF internal calibration standards spiked to a final product concentration equal to the LOQ for that congener must be reproducibly extracted, cleaned up, and quantified to within ± 20 percent of each other. For each spiked product sample, the signal to noise ratio for the calibration standard peaks after complete extraction and cleanup must be 10: 1 or greater. The recovery of the internal calibration standards in the extracted and cleaned up product samples must be within 50 to 150 percent of the amount spiked, and the results must be corrected for recovery.

SUBPART B  SPECIFIC CHEMICAL TESTING/ REPORTING REQUIREMENTS § 766.20 Who must test.

( a) Any person who manufactures, imports, or processes a chemical substance listed in § 766.25 must test that chemical substance and must submit appropriate information to EPA according to the schedules described in § 766.35. Chemical substances manufactured, imported or processed between January 1, 1984 and the date of promulgation of this part are subject to testing upon the effective date of this part. All other chemical substances are subject to testing immediately upon manufacture, import or processing. EPA expects that only manufacturers and importers will perform testing, and that the cost of testing will be passed on to processors through the pricing mechanism, thereby enabling them to share in the cost of testing. However, processors will be 63 called upon to sponsor testing should manufacturers and importers fail to do so. A processor may apply for an exemption from testing upon certification to EPA that a manufacturer or importer is testing the chemical substance which that person processes.

( b) If no manufacturer or importer described in § 766.20 submits a letter of intent to perform testing within the period described under § 766.35( a), or an exemption application under § 790.45( a), or a request for an exclusion or waiver under § 766.32, EPA will issue a notice in the FEDERAL REGISTER to notify all processors of that chemical substance. The notice will state that EPA has not received any of the documents described in the previous sentence, and that current processors will have 30 days to submit either a letter of intent to perform the test or submit an exemption application.

( c) If no manufacturer, importer or processor submits a letter of intent to perform testing of a specific chemical substance produced by a specific process, EPA will notify all manufacturers, importers, and processors, either by notice in the FEDERAL REGISTER or by letter, that all exemption applications will be denied and that within 30 days all manufacturers, importers, and processors will be in violation of this part until a proposed study plan is submitted for required testing.

( d) Manufacturers, importers, and processors who are subject to this part must comply with the test rule development and exemption procedures in part 790 of this chapter, except as modified in this part.

§ 766.25 Chemical substances for testing.

( a) Listing of chemical substances. Chemical substances required to be tested for HDDs/ HDFs under this rule are listed in this section. The listing is by Chemical Abstracts Service ( CAS) Number and common name.

Note: For purposes of guidance only, EPA lists the chemical substances subject to testing under this part in two classes  those known to be manufactured or imported between January 1, 1984, and promulgation of this part, and those not known to be manufactured or imported at the time of promulgation of this part.

( 1) Chemicals substances known to be manufactured between January 1, 1984 and date of promulgation of this part.

 CAS No. Chemical name  79 94 7 Tetrabromobisphenol A. 118 75 2 2,3,5,6 Tetrachloro 2,5 cyclohexadiene 1,4 dione. 118 79 6 2,4,6 Tribromophenol. 64 120 83 2 2,4 Dichlorophenol. 1163 19 5 Decabromodiphenyloxide. 4162 45 2 Tetrabromobisphenol A bisethoxylate. 21850 44 2 Tetrabromobisphenol A bis 2,3 dibromopropyl ether. 25327 89 3 Allyl ether of tetrabromobisphenol A. 32534 81 9 Pentabromodiphenyloxide. 32536 52 0 Octabromodiphenyloxide. 37853 59 1 1,2 Bis( tribromophenoxy) ethane. 55205 38 4 Tetrabromobisphenol A diacrylate.

( 2) Chemicals not known to be manufactured between January 1, 1984 and the date of promulgation of this part.  CAS No. Chemical name  79 95 8 Tetrachlorobisphenol A. 87 10 5 3,4', 5 Tribromosalicylanilide. 87 65 0 2,6 Dichlorophenol. 95 77 2 3,4 Dichlorophenol. 95 95 4 2,4,5 Trichlorophenol. 99 28 5 2,6 Dibromo 4 nitrophenol. 120 36 5 2[ 2,4( Dichlorophenoxy)] propionic acid. 320 72 9 3,5 Dichlorosalicyclic acid. 488 47 1 Tetrabromocatechol. 576 24 9 2,3 Dichlorophenol. 583 78 8 2,5 Dichlorophenol. 608 71 9 Pentabromophenol. 615 58 7 2,4 Dibromophenol. 933 75 5 2,3,6 Trichlorophenol. 1940 42 7 4 Bromo 2,5 dichlorophenol. 2577 72 2 3,5 Dibromosalicylanilide. 3772 94 9 Pentachlorophenyl laurate. 37853 61 5 Bismethylether of tetrabromobisphenol A. Alkylamine tetrachlorophenate. Tetrabromobisphenol B.

( b) Grade to be tested. If the same process is used to manufacture all grades of the same chemical substance, only one grade need be tested. The grade to be tested must be the grade subject to the most intense heat and alkalinity for the longest duration of time, manufactured under each different process. If the heat, alkalinity and duration of reaction do not differ for various grades, the test substance must be the grade of chemical substance with the highest volume of sales. 65 § 766.27 Congeners and LOQs for which quantitation is required.

Quantitation at the target LOQ shown for each of the following HDDs/ HDFs which may be present in the chemical substances is required for the chemical substances listed under § 766.25. Analysis must take place for either chlorinated or brominated dibenzodioxins or dibenzofurans, whichever is predominantly expected to occur in the chemical substance to be tested. Only chlorinated and brominated congeners need be quantified; for chemical substances containing predominantly chlorine atoms, only congeners totally chlorinated at the numbered positions need be quantified; for chemical substances containing predominantly bromine atoms, only congeners totally brominated at the numbered positions need be quantified.

 Chlorinated dioxins Brominated dioxins LOQ  2,3,7,8 TCDD.......................... 2,3,7,8 TBDD............ 0.1 ppb. 1,2,3,7,8 PeCDD..................... 1,2,3,7,8 PeBDD........ 0.5 ppb. 1,2,3,4,7.8 HxCDD................. 1,2,3,4,7,8 HxBDD.... 2.5 ppb. 1,2,3,6,7,8 HxCDD................. 1,2,3,6,7,8 HxBDD.... 2.5 ppb. 1,2,3,7,8,9 HxCDD................. 1,2,3,7,8,9 HxBDD.... 2.5 ppb. 1,2,3,4,6,7,8 HpCDD.............. 1,2,3,4,6,7,8 HpBDD. 100 ppb. 2,3,7,8 TCDF.......................... 2,3,7,8 TBDF............ 1 ppb. 1,2,3,7,8 PeCDF...................... 1,2,3,7,8 PeBDF........ 5 ppb. 2,3,4,7,8 PeCDF...................... 2,3,4,7,8 PeBDF........ 5 ppb. 1,2,3,4,7,8 HxCDF.................. 1,2,3,4,7,8 HxBDF.... 25 ppb. 1,2,3,6,7,8 HxCDF.................. 1,2,3,6,7,8 HxBDF.... 25 ppb. 1,2,3,7,8,9 HxCDF.................. 1,2,3,7,8,9 HxBDF.... 25 ppb. 2,3,4,6,7,8 HxCDF.................. 2,3,4,6,7,8 HxBDF.... 25 ppb. 1,2,3,4,6,7,8 HpCDF............... 1,2,3,4,6,7,8 HpBDF. 1 ppm. 1,2,3,4,7,8,9 HpCDF............... 1,2,3,4,7,8,9 HpBDF. 1 ppm.

§ 766.28 Expert review of protocols.

EPA will gather a panel of experts in analysis of chemical matrices for HDDs/ HDFs to review the protocols for testing submitted to EPA. The panel members will be employees of EPA and/ or of other U. S. Government agencies who have had experience in analysis of chemical matrices and/ or chemical wastes for HDDs/ HDFs. The panel will recommend to the Director, EPA Office of Pollution Prevention and Toxics, whether the protocol submitted is likely to allow analysis down to the target LOQs, or if not, whether the protocol represents a good faith effort on the part of the tester to achieve the lowest possible LOQs. The final determination to accept or reject the protocol will be made by the Director, Office of Pollution Prevention and Toxics. EPA will review the submitted protocols as rapidly as possible and will complete the review within 90 days after receipt. EPA may require submission of revised protocols. Comments and 66 recommendations will be transmitted to the submitter, and if revisions are required, a final protocol must be submitted to EPA within 90 days after EPA transmits such recommendations.

§ 766.32 Exclusions and waivers.

( a) Reasons for exclusions and waivers. Any person subject to the testing requirements of this part may request an exclusion or waiver from testing for any one of the following reasons:

( 1) Exclusions may be granted if. ( i) Testing of the appropriate grade of the chemical substance has already been carried out, either analytical testing at the lowest LOQ possible, with appropriate QA/ QC, or a well designed bioassay with appropriate QA/ QC or;

( ii) Process and reaction conditions of the chemical substance such that no HDDs/ HDFs could be produced under those conditions;

( 2) Waivers may be granted if. ( i) A responsible company official certifies that the chemical substance is produced only in quantities of 100 kilograms or less per year, only for research and development purposes; or ( ii) In the judgement of EPA, the cost of testing would drive the chemical substance off the market, or prevent resumption of manufacture or import of the chemical substance, if it is not currently manufactured, and the chemical substance will be produced so that no unreasonable risk will occur due to its manufacture, import, processing, distribution, use, or disposal. ( In this case, the manufacturer must submit to EPA all data supporting the determination.)

( iii) Waivers may be appropriately conditioned with respect to such factors as time and conditions of manufacture or use. The grade of decabromodiphenyl oxide produced by Dow Chemical Company ( Dow) for the National Toxicology Program ( NTP) bioassay on that chemical is excluded from the testing requirement under this part. Provided, however, that this exclusion will not apply if Dow fails to supply to EPA within 60 days of the effective date of this section evidence showing which grade was used for the NTP bioassay.

( b) Timing. Exclusion or waiver requests and detailed supporting data must be submitted to EPA within 60 days from the effective date of this part for persons manufacturing, importing or processing a chemical substance as of the date of promulgation, or 60 days prior to the date of resumption of manufacture or import for a chemical substance produced by a specific process if the chemical substance is not manufactured, imported or processed as of the date of promulgation.

( c) Publication. Within 10 days of receipt of any exclusion or waiver request, EPA will issue in the FEDERAL REGISTER a notice of such receipt. EPA will also issue a notice of its decision on each exclusion or waiver request within 60 days of receipt. 67 ( d) Decision. The EPA Director of the Office of Pollution Prevention and Toxics will make the decision to grant or deny waivers or exclusions.

§ 766.35 Reporting requirements.

( a) Letters of intent, exemption applications, and protocols  ( 1) Letters of Intent. ( i) Persons who have manufactured or imported chemical substances listed under § 766.25 between January 1, 1984, and the effective date of this part are required to submit under § 790.45 of this chapter a letter of intent to test or an exemption application. These letters must be submitted no later than September 3, 1987.

( ii) Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 that has not been manufactured, imported or processed between January 1, 1984 and the effective date of this part must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import, or processing of the chemical substance, a letter of intent to test or an exemption application.

( iii) Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 between the effective date of this part and the end of the reimbursement period for that particular chemical substance produced by a specific process must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import or processing of the chemical substance, a letter of intent to test or an exemption application.

( 2) Protocols. ( i) Each person who is manufacturing or processing a chemical substance listed in § 766.25 as of the effective date of this part who submits a notice of intent to test under § 766.35( a)( 1) must submit a protocol for the test as follows:

( A) The protocols for each chlorinated chemical substance produced by each process to be tested must be submitted to EPA no later than 12 months after the effective date of this part.

( B) The protocol for each brominated chemical substance produced by each process to be tested must be submitted to EPA no later than 24 months after the effective date of this part except for the following chemicals.

( 1) The deadline for submitting the protocols for tetrabromobisphenol A ( CAS No. 79 94 7); 2,4,6 tribromophenol ( CAS No. 118 79 6); decabromodiphenyloxide ( CAS No. 1163 19 5); and 1,2 bis( tribromophenoxy) ethane ( CAS No. 37853 59 1) is January 31, 1991.

( 2) The deadline for submitting protocols for octabromodiphenyloxide ( CAS No. 32536 52 0) and allyl ether of tetrabromobisphenol A ( CAS No. 25327 89 3) is January 31, 1991.

( 3) The deadline for submitting protocols for pentabromodiphenyloxide ( CAS No. 32534 81 9) is February 6, 1995. The deadline for submitting tetrabromobisphenol A bisethoxylate ( CAS No. 68 4126 45 2) is January 31, 1991.

( 4) The deadline for submitting protocols for 3,4', 5 tribromosalicylanilide ( CAS No. 87 10 5) is September 5, 1990.

( ii) For chemical substances produced by a specific process not manufactured or processed as of the effective date of this part, a person who begins manufacture and submits a notice of intent to test must submit protocols for the test as follows:

( A) Except as noted for the submitter and substance specified in the following table, protocols for testing must be submitted 12 months after manufacture or importation begins for chlorinated chemical substances.

 CAS No. Submitter Chemical Due date  118 75 2 Rhone Poulenc.......... 2,3,5,6 tetrachloro 2,5 cyclohexaniene March 4, 1994 1,4 dione.

( B) Protocols for testing must be submitted 24 months after manufacture begins for brominated chemical substances.

( iii) For persons who have been granted exemptions, waivers or exclusions from testing, protocols must be submitted 12 months after expiration of the exemption, waiver or exclusion for chlorinated chemical substances, and 24 months after expiration of the exemption, waiver or exclusion for brominated chemical substances.

( b) Information that must be submitted to EPA. ( 1) Persons who manufacture or import a chemical substance listed under § 766.25 must report no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later, the results of all existing test data which show that chemical substance has been tested for the presence of HDDs/ HDFs.

( 2) Any manufacturer or importer of a chemical substance listed in § 766.25 in possession of unpublished health and safety studies on HDDs/ HDFs is required to submit copies of such studies to EPA no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later. The following provisions of part 716 of this chapter apply to submission of these studies: § § 716.3, 716.10( a) ( 1) and ( 4); 716.20( a) ( 1), ( 2), ( 3), ( 4), ( 7), ( 8) and ( 10); 716.25; 716.30; 716.35( a) ( 1), ( 2), and ( 4) [ if applicable]; 716.35 ( b) and ( c); 716.40 ( a) and ( b); 716.50; 716.55; and 716.60( a)( 2). 69 ( 3) No later than October 5, 1987 or 90 days after the person first manufactures or imports the substance listed in § 766.25, any manufacturer or importer of a chemical substance listed in § 766.25 must submit records required to be held under part 717 of this chapter on any HDDs/ HDFs.

( 4) Test results. ( i) Test results must be submitted to EPA not later than 270 days after EPA's transmission of comments or 180 days after a final protocol is submitted to EPA, whichever is shorter, except as noted for the submitters and substances specified in the following table:

 CAS No. Submitter Chemical Due Date Effective Date  79 94 7 Great Lakes Tetrabromobisphenol A May 26, 1992 May 28, 1993 79 94 7 Ethyl Tetrabromobisphenol A August 10, 1992 May 28, 1993 79 94 7 Ameribrom Tetrabromobisphenol A April 15, 1994 September 29, 1995 87 10 5 Pfister 3,4', 5 tribromosalicylanilide 45 days after protocol May 28, 1993 approval 118 75 2 Rhone Poulenc. 2,3,5,6 tetrachloro 2,5 July 5, 1996 June 30, 1997 Inc. cyclohexadiene 1,4 dione 118 79 6 Great Lakes 2,4,6 Tribromophenol May 26, 1992 May 28, 1993 1163 19 5 Ameribrom Decabromodiphenyloxide April 15, 1994 September 29, 1995 1163 19 5 Ethyl Decabromodiphenyloxide May 26, 1992 May 28, 1993 1163 19 5 Great Lakes Decabromodiphenyloxide May 26, 1992 May 28, 1993 4162 45 2 Great Lakes Tetrabromobisphenol A June 2, 1993 September 8, 1994 bisethoxylate 25327 89 3 Great Lakes Allyl Ether of August 10, 1992 May 28, 1993 Tetrabromobisphenol A 32534 81 9 Great Lakes Pentabromodiphenyloxide March 22, 1993 September 8, 1994 32534 81 9 Akzo Chemicals Pentabromodiphenyloxide February 6, 1995 September 29, 1995 Inc.

32534 81 9 Ameribrom Pentabromodiphenyloxide March 22, 1993 September 8, 1994 32536 52 0 Ameribrom Octabromodiphenyloxide January 8, 1993 September 29, 1995 32536 52 0 Ethyl Octabromodiphenyloxide May 15, 1994 May 28, 1993 32536 52 0 Great Lakes Octabromodiphenyloxide May 26, 1992 May 28, 1993 70 37853 59 1 Great Lakes 1,2 bis( tribromo January 24, 1995 September 29, 1995 phenoxy) ethane

( ii) For purposes of reporting test results to EPA, and for further reporting triggered by a positive test result under § 766.35( c), a positive test result is defined at § 766.3.

( iii) Reporting of test results must follow procedures set out in part 790 of this chapter, except as modified in this part.

( c) Information required to be submitted to EPA after submission of a positive test result. ( 1) Any person who submits a positive test result for a specific chemical substance listed under § 766.25 must submit to EPA no later than 90 days after the date of submission of the positive test result the following:

( i) A completed form ( EPA 7710 51) for that chemical substance. The form and instructions are available from the Environmental Assistance Division ( 7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. One form must be submitted for each chemical substance for which a positive test result has been submitted.

( ii) Health and safety studies for the chemical substance for which a positive test result has been reported. The following provisions of part 716 of this chapter apply to submission of these studies: § § 716.3; 716.10 ( a) ( 1), ( 2), ( 3) and ( 4); 716.20; 716.25; 716.30; 716.35( a) ( 1), ( 2), and ( 4), [ if applicable]; 716.35 ( b) and ( c); 716.40 ( a) and ( b); 716.50; 716.55; 716.60( a)( 2).

( iii) Copies of records on the chemical substances required to be held under part 717 of this chapter.

( 2) If a positive test result on a chemical substance is received from one person but not from others, EPA may issue a notice in the FEDERAL REGISTER listing that chemical substance and requiring any person manufacturing, importing or processing that chemical substance who has not submitted a positive test result to submit the information required in Part II of EPA Form 7710 51. Such a notice will be published only if EPA needs additional process data to make a determination of unreasonable risk.

( d)( e) [ Reserved]

( f) Effective date. ( 1) The effective date of this final rule is July 6, 1987, except for paragraphs ( a)( 2)( i)( B) introductory text, ( a)( 2)( i)( B)( 1), ( a)( 2)( i)( B)( 2), ( a)( 2)( i)( B)( 3), ( a)( 2)( i)( B)( 4), the table in paragraph ( a)( 2)( ii)( A), and the table in paragraph ( b)( 4)( i) of this section.

( 2) The effective date for paragraph ( a)( 2)( i)( B) introductory text, ( a)( 2)( i)( B)( 1), ( a)( 2)( i)( B)( 2), and ( a)( 2)( i)( B)( 4), is May 21, 1991. The effective date of paragraphs ( a)( 2)( i)( B)( 3), and the 71 table in paragraph ( a)( 2)( ii)( A) is September 29, 1995. The effective date of paragraph ( b)( 4)( i) introductory text is May 28, 1993, and the effective date of the entries in the table in paragraph ( b)( 4)( i) is shown in the effective dates column of the table.

( 3) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.

[ 52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57 FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June 23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 31922, June 19, 1995; 60 FR 50433, Sept. 29, 1995; 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 30, 1997]

§ 766.38 Reporting on precursor chemical substances.

( a) Identification of precursor chemical substances. Precursor chemical substances are produced under conditions that will not yield HDDs and HDFs, but their molecular structure is conducive to HDD/ HDF formation under favorable reaction conditions when they are used to produce other chemicals or products. The following precursor chemical substances are identified by Chemical Abstract Service ( CAS) number and name.

 CAS No. Chemical name  85 22 3.......................... Pentabromoethylbenzene. 87 61 6.......................... 1,2,3 Trichlorobenzene. 87 84 3.......................... 1,2,3,4,5 Pentabromo 6 chloro cyclohexane. 89 61 2.......................... 1,4 Dichloro 2 nitrobenzene. 89 64 5.......................... 4 Chloro 2 nitrophenol. 89 69 0.......................... 2,4,5 Trichloronitrobenzene. 92 04 6.......................... 2 Chloro 4 phenylphenol. 94 74 6.......................... 4 Chloro o toloxy acetic acid. 94 81 5.......................... 4( 2 Methyl 4 chlorophenoxy) butyric acid. 95 50 1.......................... o Dichlorobenzene. 95 56 7.......................... o Bromophenol. 95 57 8.......................... o Chlorophenol. 95 88 5.......................... 4 Chlororesorcinol. 95 94 3.......................... 1,2,4,5 Tetrachlorobenzene. 97 50 7.......................... 5 Chloro 2,4 dimethoxyaniline. 99 30 9.......................... 2,6 Dichloro 4 nitroaniline. 99 54 7.......................... 1,2 Dichloro 4 nitrobenzene. 106 46 7......................... p Dichlorobenzene. 108 70 3......................... 1,3,5 Trichlorobenzene. 108 86 1......................... Bromobenzene. 72 108 90 7......................... Chlorobenzene. 117 18 0......................... 1,2,4,5 Tetrachloro 3 nitrobenzene. 120 82 1......................... 1,2,4 Trichlorobenzene. 348 51 6......................... o Chorofluorobenzene. 350 30 1......................... 3 Chloro 4 fluoronitrobenzene. 615 67 8......................... Chlorohydroquinone. 626 39 1......................... 1,3,5 Tribromobenzene. 827 94 1......................... 2,6 Dibromo 4 nitroaniline.

( b) Persons required to report. All persons who manufacture or import a chemical product produced using any of the chemical substances listed in paragraph ( a) of this section as feedstocks or intermediates must report no later than September 29, 1987. Small manufacturers and those manufacturers and importers who produce the precursor chemical substances in quantities of 100 kilograms or less per year only for research and development purposes are not required to report under this section ( c) Data to be reported. Manufacturers and importers of chemical products made from precursor chemical substances identified in paragraph ( a) of this section must report process and reaction condition data on Part II of EPA Form 7710 51 for each chemical product. A separate EPA Form 7710 51 must be submitted for each chemical product reported, and the precursor chemical substance used must be identified. All forms must be submitted to EPA no later than September 29, 1987.

[ 52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995] 73 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment F Dioxin/ Furan Report ( EPA Form 7710 51)

[ Note: An electronic copy of this attachment is not available. Please contact the Environmental Protection Agency at the address noted in the Federal Register notice for a complete copy of this ICR.] 74 OMB Control No. 2070 0054; EPA ICR No. 0586.10 Attachment G 40 CFR 792 This attachment can also be accessed online via Internet at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr792_ 00. html 75 TITLE 40 PROTECTION OF ENVIRONMENT CHAPTER I ENVIRONMENTAL PROTECTION AGENCY PART 792  GOOD LABORATORY PRACTICE STANDARDS Subpart A  General Provisions Sec. 792.1 Scope. 792.3 Definitions. 792.10 Applicability to studies performed under grants and contracts. 792.12 Statement of compliance or non compliance. 792.15 Inspection of a testing facility. 792.17 Effects of non compliance.

Subpart B  Organization and Personnel 792.29 Personnel. 792.31 Testing facility management. 792.33 Study director. 792.35 Quality assurance unit.

Subpart C  Facilities 792.41 General. 792.43 Test system care facilities. 792.45 Test system supply facilities. 792.47 Facilities for handling test, control, and reference substances. 792.49 Laboratory operation areas. 792.51 Specimen and data storage facilities.

Subpart D  Equipment 792.61 Equipment design. 792.63 Maintenance and calibration of equipment.

Subpart E  Testing Facilities Operation 76 792.81 Standard operating procedures. 792.83 Reagents and solutions. 792.90 Animal and other test system care.

Subpart F  Test, Control, and Reference Substances 792.105 Test, control, and reference substance characterization. 792.107 Test, control, and reference substance handling. 792.113 Mixtures of substances with carriers.

Subpart G  Protocol for and Conduct of A Study 792.120 Protocol. 792.130 Conduct of a study. 792.135 Physical and chemical characterization studies.

Subparts H I [ Reserved]

Subpart J  Records and Reports 792.185 Reporting of study results. 792.190 Storage and retrieval of records and data. 792.195 Retention of records.

Authority: 15 U. S. C. 2603.

Source: 54 FR 34043, Aug. 17, 1989, unless otherwise noted.

SUBPART A  GENERAL PROVISIONS § 792.1 Scope.

( a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing. This part is intended to ensure the quality and integrity of data submitted pursuant to testing consent agreements and test rules issued under section 4 of the Toxic Substances Control Act ( TSCA) ( Pub. L. 94 469, 90 Stat. 2006, 15 U. S. C. 2603 et seq.).

( b) This part applies to any study described by paragraph ( a) of this section which any person 77 conducts, initiates, or supports on or after September 18, 1989.

( c) It is EPA's policy that all data developed under section 5 of TSCA be in accordance with provisions of this part. If data are not developed in accordance with the provisions of this part, EPA will consider such data insufficient to evaluate the health and environmental effects of the chemical substances unless the submitter provides additional information demonstrating that the data are reliable and adequate.

§ 792.3 Definitions.

As used in this part the following terms shall have the meanings specified:

Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to § 792.105( a).

Carrier means any material, including but not limited to, feed, water, soil, and nutrient media, with which the test substance is combined for administration to a test system.

Control substance means any chemical substance or mixture, or any other material other than a test substance, feed, or water, that is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test substance for chemical or biological measurements.

EPA means the U. S. Environmental Protection Agency.

Experimental start date means the first date the test substance is applied to the test system.

Experimental termination date means the last date on which data are collected directly from the study.

FDA means the U. S. Food and Drug Administration.

Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.

Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies.

Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared ( e. g., tapes which have been transcribed verbatim, dated, and 78 verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. " Raw data" may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurements.