Attachment E - 40 CFR 766 - Dibenzo-Paradioxins/Dibenzofurans

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.

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§ 766.1
766.18

40 CFR Ch. I (7–1–10 Edition)

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

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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.

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§ 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]

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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 incor-

porated 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.

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§ 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
118–75–2
118–79–6
120–83–2
1163–19–5
4162–45–2
21850–44–2
25327–89–3
32534–81–9
32536–52–0
37853–59–1
55205–38–4

Tetrabromobisphenol-A.
2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4dione.
2,4,6-Tribromophenol.
2,4-Dichlorophenol.
Decabromodiphenyloxide.
Tetrabromobisphenol-A-bisethoxylate.
Tetrabromobisphenol-A-bis-2,3-dibromopropyl
ether.
Allyl ether of tetrabromobisphenol-A.
Pentabromodiphenyloxide.
Octabromodiphenyloxide.
1,2-Bis(tribromophenoxy)-ethane.
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
87–10–5
87–65–0
95–77–2
95–95–4
99–28–5
120–36–5
320–72–9
488–47–1
576–24–9
583–78–8
608–71–9
615–58–7
933–75–5
1940–42–7
2577–72–2

Tetrachlorobisphenol-A.
3,4′,5-Tribromosalicylanilide.
2,6-Dichlorophenol.
3,4-Dichlorophenol.
2,4,5-Trichlorophenol.
2,6-Dibromo-4-nitrophenol.
2[2,4-(Dichlorophenoxy)]-propionic acid.
3,5-Dichlorosalicyclic acid.
Tetrabromocatechol.
2,3-Dichlorophenol.
2,5-Dichlorophenol.
Pentabromophenol.
2,4-Dibromophenol.
2,3,6-Trichlorophenol.
4-Bromo-2,5-dichlorophenol.
3,5-Dibromosalicylanilide.

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Environmental Protection Agency
CAS No.

§ 766.32

Chemical name

3772–94–9
37853–61–5

Pentachlorophenyl laurate.
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
which quantitation is required.

for

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

2,3,7,8-TCDD ..............
1,2,3,7,8-PeCDD .........
1,2,3,4,7.8-HxCDD ......
1,2,3,6,7,8-HxCDD ......
1,2,3,7,8,9-HxCDD ......
1,2,3,4,6,7,8-HpCDD ...
2,3,7,8-TCDF ...............
1,2,3,7,8-PeCDF .........
2,3,4,7,8-PeCDF .........
1,2,3,4,7,8-HxCDF ......
1,2,3,6,7,8-HxCDF ......
1,2,3,7,8,9-HxCDF ......
2,3,4,6,7,8-HxCDF ......
1,2,3,4,6,7,8-HpCDF ...
1,2,3,4,7,8,9-HpCDF ...

2,3,7,8-TBDD ..............
1,2,3,7,8-PeBDD .........
1,2,3,4,7,8-HxBDD ......
1,2,3,6,7,8-HxBDD ......
1,2,3,7,8,9-HxBDD ......
1,2,3,4,6,7,8-HpBDD ...
2,3,7,8-TBDF ...............
1,2,3,7,8-PeBDF .........
2,3,4,7,8-PeBDF .........
1,2,3,4,7,8-HxBDF ......
1,2,3,6,7,8-HxBDF ......
1,2,3,7,8,9-HxBDF ......
2,3,4,6,7,8-HxBDF ......
1,2,3,4,6,7,8-HpBDF ...
1,2,3,4,7,8,9-HpBDF ...

LOQ
0.1 ppb.
0.5 ppb.
2.5 ppb.
2.5 ppb.
2.5 ppb.
100 ppb.
1 ppb.
5 ppb.
5 ppb.
25 ppb.
25 ppb.
25 ppb.
25 ppb.
1 ppm.
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

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§ 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
1,2bis(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

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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 manuCAS No.
118–75–2

factured 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.

Submitter

Chemical

Due date

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 reCAS No.

Submitter

quired 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:

Chemical

Due Date

Effective Date

79–94–7
79–94–7
79–94–7

Great Lakes
Ethyl
Ameribrom

Tetrabromobisphenol-A
Tetrabromobisphenol-A
Tetrabromobisphenol-A

May 26, 1992
August 10, 1992
April 15, 1994

87–10–5

Pfister

3,4′,5-tribromosalicylanilide

Rhone-Poulenc Inc.

45 days after protocol approval
July 5, 1996
May 26, 1992
April 15, 1994
May 26, 1992

118–75–2
118–79–6
1163–19–5

Great Lakes
Ameribrom

2,3,5,6-tetrachloro-2,5cyclohexadiene-1,4-dione
2,4,6-Tribromophenol
Decabromodiphenyloxide

1163–19–5

Ethyl

Decabromodiphenyloxide

May 28, 1993
May 28, 1993
September 29,
1995
May 28, 1993
June 30, 1997
May 28, 1993
September 29,
1995
May 28, 1993

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§ 766.35

40 CFR Ch. I (7–1–10 Edition)

CAS No.

Submitter

1163–19–5
4162–45–2

Great Lakes
Great Lakes

25327–89–3

Great Lakes

32534–81–9
32534–81–9
32534–81–9
32536–52–0

Great Lakes
Akzo Chemicals
Inc.
Ameribrom
Ameribrom

32536–52–0
32536–52–0
37853–59–1

Ethyl
Great Lakes
Great Lakes

Chemical

Due Date

Decabromodiphenyloxide
Tetrabromobisphenol-Abisethoxylate
Allyl
Ether
Tetrabromobisphenol-A
Pentabromodiphenyloxide
Pentabromodiphenyloxide

of

May 28, 1993
September 8, 1994

August 10, 1992

May 28, 1993

March 22, 1993
February 6, 1995

September 8, 1994
September 29,
1995
September 8, 1994
September 29,
1995
May 28, 1993
May 28, 1993
September 29,
1995

Pentabromodiphenyloxide
Octabromodiphenyloxide

March 22, 1993
January 8, 1993

Octabromodiphenyloxide
Octabromodiphenyloxide
1,2-bis(tribromophenoxy)ethane

May 15, 1994
May 26, 1992
January 24, 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 per-

Effective Date

May 26, 1992
June 2, 1993

son 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.

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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.
85–22–3 ...
87–61–6 ...
87–84–3 ...
89–61–2 ...
89–64–5 ...
89–69–0 ...
92–04–6 ...
94–74–6 ...
94–81–5 ...
95–50–1 ...
95–56–7 ...
95–57–8 ...
95–88–5 ...
95–94–3 ...
97–50–7 ...
99–30–9 ...
99–54–7 ...
106–46–7

Chemical name
Pentabromoethylbenzene.
1,2,3-Trichlorobenzene.
1,2,3,4,5-Pentabromo-6-chloro-cyclohexane.
1,4-Dichloro-2-nitrobenzene.
4-Chloro-2-nitrophenol.
2,4,5-Trichloronitrobenzene.
2-Chloro-4-phenylphenol.
4-Chloro-o-toloxy acetic acid.
4-(2-Methyl-4-chlorophenoxy) butyric acid.
o-Dichlorobenzene.
o-Bromophenol.
o-Chlorophenol.
4-Chlororesorcinol.
1,2,4,5-Tetrachlorobenzene.
5-Chloro-2,4-dimethoxyaniline.
2,6-Dichloro-4-nitroaniline.
1,2-Dichloro-4-nitrobenzene.
p-Dichlorobenzene.

CAS No.
108–70–3
108–86–1
108–90–7
117–18–0
120–82–1
348–51–6
350–30–1
615–67–8
626–39–1
827–94–1

Chemical name
1,3,5-Trichlorobenzene.
Bromobenzene.
Chlorobenzene.
1,2,4,5-Tetrachloro-3-nitrobenzene.
1,2,4-Trichlorobenzene.
o-Chorofluorobenzene.
3-Chloro-4-fluoronitrobenzene.
Chlorohydroquinone.
1,3,5-Tribromobenzene.
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]

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