### 933 Environmental Protection Agency Pt. 766

information being claimed as CBI. Thesecond 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 inthe first copy will be considered a presumptive waiver of the claim of confidentiality. The Agency will notify theapplicant by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The applicant has 30 days from thedate 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 applicantasserts 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 atthe 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 byproviding 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 ortime 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 toin advertising or promotional materials for the product or the resulting end product, safety data sheets or other similar materials for the productor the resulting end product, professional or trade publications, or any other media available to the public or to your competitors? If you answeredyes, 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 inyour answer such constraints as capital and marketing cost, specializedtechnical expertise, or unusual processes.

(7) Has the Agency, another Federal agency, or a Federal court made anyconfidentiality 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 consideredsubstantial? 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 processused 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 40 CFR Ch. I (7–1–10 Edition) § 766.1

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.

S OURCE : 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), 15U.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 chemicalsubstances identified in §766.25 to submit to EPA:

(1) Any existing test data showing analysis of the chemical substances forconcentrations 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 chemicalsubstances 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 testtheir 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 anymodifications 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 testresults 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 thepresence 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) ofTSCA; and reports of allegations of significant adverse reactions under section 8(c) of TSCA. In some cases, additional reporting may be required ofmanufacturers 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 aspossible 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 eachperson 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 substancesmade 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 denotedby 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 asa 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 ortotally 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 isomersthat have the same degree of halogenation. For example, the homologous class of tetrachlorodibenzo-p-dioxinsconsists of all dibenzo-p-dioxins containing four chlorine atoms. When the homologous classes discussed in thispart 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 whichHDDs/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 40 CFR Ch. I (7–1–10 Edition) § 766.5

Precursor means a chemical substance which is not contaminated due to the process conditions under which it is manufactured, but because of itsmolecular 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 equalto 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 EPAunder 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 befully developed and retained in accordance with part 792 of this chapter.
These items must be made available during an inspection or submitted toEPA upon request by EPA or its authorized representative. Laboratories conducting testing for submission toEPA 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 thetesting 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 Preventionand 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 forinspection 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 gradeof chemical substance for testing, specific plans for collection of samples from the process stream, naming thepoint of collection, the method of collecting the sample, and an estimate of how well the samples will represent thematerial to be characterized; a description of how control samples (blanks)and HDD/HDF-reinforced control samples, or isotopically labeled compounds (standards) and duplicate samples willbe handled; a description of the chemical extraction and clean up procedures to be used; how extraction efficiencyand 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 onemethod 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 homogenizedand subsampled as necessary. Subsamples must be spiked or reinforced with surrogate compounds or with standard stock solutions, and the surrogates orstandards must be thoroughly incorporated by mechanical agitation. Additional guidance is provided under §766.12.

(c) Sample extraction and cleanup. Thespiked 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 SpectrometricDetermination, (HRGC/HRMS) but alternate methods may be used if the
manufacturer can demonstrate that the method will reach the target LOQsas 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/HDFcongener 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 andcleanup 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 40 CFR Ch. I (7–1–10 Edition) § 766.20



### 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 submitappropriate information to EPA according to the schedules described in§766.35. Chemical substances manufactured, imported or processed betweenJanuary 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 processormay apply for an exemption from testing upon certification to EPA that a manufacturer or importer is testingthe 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 F EDERAL REGISTER to notify all processors of that chemical substance.
The notice will state that EPA has notreceived any of the documents described in the previous sentence, and that current processors will have 30 days to submit either a letter of intentto 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 chemicalsubstance produced by a specific process, EPA will notify all manufacturers, importers, and processors, either by
notice in the F EDERAL REGISTER or by letter, that all exemption applications will be denied and that within 30 daysall 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 partmust 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.

N OTE : For purposes of guidance only, EPAlists the chemical substances subject to testing under this part in two classes—thoseknown to be manufactured or imported between January 1, 1984, and promulgation ofthis 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 oftime, manufactured under each different process. If the heat, alkalinity
and duration of reaction do not differ for various grades, the test substancemust 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 andbrominated congeners need be quantified; for chemical substances containing predominantly chlorine atoms, only congeners totally chlorinated atthe numbered positions need be quantified; for chemical substances containing predominantly bromine atoms, only congeners totally brominated atthe 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 EPAand/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 thetarget LOQs, or if not, whether the protocol represents a good faith effort on the part of the tester to achieve thelowest 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 daysafter receipt. EPA may require submission of revised protocols. Commentsand recommendations will be transmitted to the submitter, and if revisions are required, a final protocol must be submitted to EPA within 90days 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 atthe 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 certifiesthat 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 40 CFR Ch. I (7–1–10 Edition) § 766.35

resumption of manufacture or import of the chemical substance, if it is notcurrently 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 toEPA all data supporting the determination.)

(iii) Waivers may be appropriatelyconditioned 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 tosupply 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 thispart 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 achemical substance produced by a specific process if the chemical substanceis 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 F EDERAL 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 lettersmust 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 partand the end of the reimbursement period for that particular chemical substance produced by a specific processmust 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 ismanufacturing 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 eachchlorinated 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 submitterand 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 manufacturebegins for brominated chemical substances.

(iii) For persons who have beengranted 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 thanOctober 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 andsafety studies on HDDs/HDFs is required to submit copies of such studies to EPA no later than October 5, 1987 or90 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 90days 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 270days after EPA’s transmission of comments or 180 days after a final protocol is submitted to EPA, whichever isshorter, 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 40 CFR Ch. I (7–1–10 Edition) § 766.35

CAS No. Submitter Chemical Due Date Effective Date

1163–19–5 Great Lakes Decabromodiphenyloxide May 26, 1992 May 28, 19934162–45–2 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 apositive 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 thechemical 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 F EDERAL REGISTERlisting that chemical substance and requiring any person manufacturing, importing or processing that chemical
substance who has not submitted apositive 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 effectivedate 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 effectivedate 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 usedto 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 inparagraph (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 yearonly for research and development purposes are not required to report under
this section

(c) Data to be reported. Manufacturers and importers of chemical productsmade 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]