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Title 40Chapter ISubchapter RPart 766 → Subpart A


Title 40: Protection of Environment
PART 766—DIBENZO-PARA-DIOXINS/DIBENZOFURANS


Subpart A—General Provisions


Contents
§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.

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§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.

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§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.

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§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 submission receiving system.

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, or its successors.

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.

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.

[52 FR 21437, June 5, 1987, as amended at 78 FR 72828, Dec. 4, 2013]

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§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.

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§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).

(b) You must use the CISS tool to complete and submit all data, reports, and other information required under this part except for records and reports of allegations of significant adverse reactions, which must be submitted in accordance with paragraph (c) of this section.

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

(2) To access the CISS tool 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.

(c) You must submit records and reports of allegations of significant adverse reactions and the accompanying cover letters by one of the following methods:

(1) Mail, preferably certified, to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001, ATTN: Dioxin/Furan report part 766, Allegations of significant adverse reactions.

(2) Hand delivery to OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC, ATTN: Dioxin/Furan report part 766, Allegations of significant adverse reactions. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation.

[78 FR 72828, Dec. 4, 2013]

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§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.

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§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. Publicly available docket materials are available at the addresses in §700.17(b)(1) and (2) of this chapter.

[60 FR 34466, July 3, 1995, as amended at 77 FR 46292, Aug. 3, 2012]

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§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.

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§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.

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§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.

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