933 

Environmental Protection Agency Pt. 766 

information being claimed as CBI. The 

second copy must contain only information not claimed as CBI. The Agency will place the second copy of the 

submission in a public file. Failure to 

furnish a second copy of the submission 

when information is claimed as CBI in 

the first copy will be considered a presumptive waiver of the claim of confidentiality. The Agency will notify the 

applicant by certified mail that a finding of a presumptive waiver of the 

claim of confidentiality has been made. 

The applicant has 30 days from the 

date of receipt of notification to submit the required second copy. Failure 

to submit the second copy will cause 

the Agency to place the first copy in a 

public file. 

(d) Applicants must substantiate all 

claims of CBI at the time the applicant 

asserts the claim, i.e., when the exemption application or supplement is submitted, by responding to the questions 

in paragraph (e) of this section. Failure 

to provide substantiation of a claim at 

the time the applicant submits the application will result in a waiver of the 

CBI claim, and the information may be 

disclosed to the public without further 

notice to the applicant. 

(e) Applicants who assert any CBI 

claims must substantiate all claims by 

providing detailed responses to the following: 

(1) Is this information subject to a 

patent or patent application in the 

United States or elsewhere? If so, why 

is confidentiality necessary? 

(2) For what period do you assert a 

claim of confidentiality? If the claim is 

to extend until a certain event or point 

in time, please indicate that event or 

time period. Explain why such information should remain confidential until 

such point. 

(3) Has the information that you are 

claiming as confidential been disclosed 

to persons outside of your company? 

Will it be disclosed to such persons in 

the future? If so, what restrictions, if 

any, apply to use or further disclosure 

of the information? 

(4) Briefly describe measures taken 

by your company to guard against 

undesired disclosure of the information 

you are claiming as confidential to 

others. 

(5) Does the information claimed as 

confidential appear or is it referred to 

in advertising or promotional materials for the product or the resulting 

end product, safety data sheets or 

other similar materials for the product 

or the resulting end product, professional or trade publications, or any 

other media available to the public or 

to your competitors? If you answered 

yes, indicate where the information appears. 

(6) If the Agency disclosed the information you are claiming as confidential to the public, how difficult would 

it be for the competitor to enter the 

market for your product? Consider in 

your answer such constraints as capital and marketing cost, specialized 

technical expertise, or unusual processes. 

(7) Has the Agency, another Federal 

agency, or a Federal court made any 

confidentiality determination regarding this information? If so, provide copies of such determinations. 

(8) How would your company’s competitive position be harmed if the 

Agency disclosed this information? 

Why should such harm be considered 

substantial? Describe the causal relationship between the disclosure and 

harm. 

(9) In light of section 14(b) of TSCA, 

if you have claimed information from a 

health and safety study as confidential, 

do you assert that disclosure of this information would disclose a process 

used in the manufacturing or processing of a product or information unrelated to the effects of asbestos on 

human health and the environment? If 

your answer is yes, explain. 

PART 766—DIBENZO-PARADIOXINS/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. 

934 

§ 766.1 40 CFR Ch. I (7–1–10 Edition) 

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 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 

935 

Environmental Protection Agency § 766.3 

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. 

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. 

936 

§ 766.5 40 CFR Ch. I (7–1–10 Edition) 

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. 

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 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] 

937 

Environmental Protection Agency § 766.18 

§ 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 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. 

938 

§ 766.20 40 CFR Ch. I (7–1–10 Edition) 

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 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. 

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. 

939 

Environmental Protection Agency § 766.32 

CAS No. Chemical name 

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. 

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 

940 

§ 766.35 40 CFR Ch. I (7–1–10 Edition) 

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. 

(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 

941 

Environmental Protection Agency § 766.35 

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. 

(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 

942 

§ 766.35 40 CFR Ch. I (7–1–10 Edition) 

CAS No. Submitter Chemical Due Date Effective Date 

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

4162–45–2 Great Lakes Tetrabromobisphenol-Abisethoxylate 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. 

(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. 

943 

Environmental Protection Agency § 766.38 

(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. 

CAS No. Chemical name 

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. 

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] 

PARTS 767–789 [RESERVED]