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PART 766—DIBENZO-PARA-DIOXINS/DIBENZOFURANS 

Section Contents

Subpart A—General Provisions 

§ 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. 

(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 
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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. 

(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. 

Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, or its 

successors. 

Chemical Information Submission System or CISS means EPA’s electronic, web-based reporting tool for the 

completion and submission of data, reports, and other information.
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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 carboncarbon 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. 

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. 
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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. 

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. 

(a) 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 must be submitted using the method specified in paragraph (b) of this section.

(b) You must use CISS to complete and submit all data, reports, and other information required under this 

part. 

(c) Submissions must be submitted to EPA via CDX. 

(d) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the 

appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. 

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 Polution 
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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 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) 
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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 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 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 
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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. 

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. 
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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. 

§ 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. 
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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 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. 
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(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. 

(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. 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. 
Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) 

Demonstration of Proposed Revisions to Existing Rules – 40 CFR 766

(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-1,4-dione March 4, 1994 

(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). 

(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 

approval May 28, 1993 

118–75–2 Rhone-Poulenc 

Inc. 

2,3,5,6-tetrachloro-2,5-cyclohexadiene-1,4-

dione July 5, 1996 June 30, 1997 

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 
Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) 

Demonstration of Proposed Revisions to Existing Rules – 40 CFR 766

1163–19–5 Great Lakes Decabromodiphenyloxide May 26, 1992 May 28, 1993 

4162–45–2 Great Lakes Tetrabromobisphenol-A-bisethoxylate June 2, 1993 September 8, 

1994 

25327–89–3 Great Lakes Allyl Ether of Tetrabromobisphenol-A August 10, 1992 May 28, 1993 

32534–81–9 Great Lakes Pentabromodiphenyloxide March 22, 1993 September 8, 

1994 

32534–81–9 Akzo Chemicals 

Inc. Pentabromodiphenyloxide February 6, 1995 September 29, 1995 

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 

37853–59–1 Great Lakes 1,2-bis(tribromophenoxy)ethane January 24, 1995 September 29, 

1995 

(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. 
Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) 

Demonstration of Proposed Revisions to Existing Rules – 40 CFR 766

(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 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. 

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. 
Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) 

Demonstration of Proposed Revisions to Existing Rules – 40 CFR 766

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]