Document ID: EPA-HQ-OPPT-2007-0670-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-21T05:00Z

OMB Control No. 2070-0054; EPA ICR No. 0586.11

Attachment E

40 CFR 766

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TITLE 40--PROTECTION OF ENVIRONMENT 

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY 

PART 766--DIBENZO-PARA-DIOXINS/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.  

766.18  Method sensitivity.  

Subpart B—Specific Chemical Testing/Reporting Requirements

766.20  Who must test.  

766.25  Chemical substances for testing.

766.27  Congeners and LOQs for which quantitation is required.  

766.28  Expert review of protocols.

766.32  Exclusions and waivers.

766.35  Reporting requirements.

766.38  Reporting on precursor chemical substances.

   AUTHORITY: 15 U.S.C. 2603 and 2607

   SOURCE: 52 FR 21437, June 5, 1987, unless otherwise noted.

SUBPART A— GENERAL PROVISIONS

§ 766.1  Scope and purpose.  

(a) This part identifies requirements for testing under section 4 of the
Toxic Substances Control Act (TSCA), 15 U.S.C. 2603, to ascertain
whether certain specified chemical substances may be contaminated with
halogenated dibenzodioxins (HDDs)/dibenzofurans (HDFs) as defined in
§766.3, and requirements for reporting under section 8 of TSCA, 15
U.S.C. 2607.  

(b) Section 766.35(b) requires manufacturers and processors of chemical
substances identified in §766.25 to submit to EPA: 

(1) Any existing test data showing analysis of the chemical substances
for concentrations of HDDs/HDFs, applicable protocols, and the results
of the analysis for HDDs/HDFs, (2) allegations of significant adverse
reactions to HDDs/HDFs, compiled in accordance with part 717 of this
chapter, and (3) health and safety studies on the HDDs/HDFs, in
accordance with applicable provisions of part 716 of this chapter.  

(c) Section 766.35(a) requires manufacturers and, under certain
circumstances, processors of chemical substances identified in §766.25
to submit letters of intent to test and protocols for the analysis of
the chemical substances for the presence of HDDs/HDFs.  Section 766.20
requires these manufacturers and processors to test their chemical
substances for the presence of HDDs/HDFs.  Any submissions must be in
accordance with the EPA Procedures Governing Testing Consent Agreements
and Test Rules contained in part 790 of this chapter and any
modifications to such procedures contained in this part.  

(d) Section 766.32 specifies conditions under which persons required to
test may request an exclusion or waiver from testing.  

(e) Deadlines for submission to EPA of protocols, reports, studies, and
test results are specified in part 790, subpart C and §766.35.  

(f) Sections 766.10, 766.12, 766.14, 766.16, and 766.18 prescribe
analytical methods required; §766.27 prescribes target levels of
quantitation (LOQ) for each congener for which quantitation is required.
 

(g) If results of existing tests or tests performed under this part
indicate the presence of HDDs/HDFs in the identified chemical substance
above the LOQ specified in §766.27, §766.35(c) requires the following
additional reporting on the specified chemicals: production, process,
use, exposure and disposal data under section 8(a) of TSCA; health and
safety studies under section 8(d) of TSCA; and reports of allegations of
significant adverse reactions under section 8(c) of TSCA.  In some
cases, additional reporting may be required of manufacturers reporting
no contamination of the identified chemical substances under
§766.35(c)(2).

(h) Section 766.38 requires manufacturers of chemical substances
produced from chemical substances identified as possible precursors to
HDD/HDF formation, to report on chemical substances produced from such
precursors.

§ 766.2  Applicability and duration of this part.  

(a) Chemical substances subject to testing.  (1) This part is applicable
to each person who, at any time during the duration of this part,
manufactures (and/or imports), or processes, a chemical substance
identified under §766.25.  

(2) The duration of this part for any testing requirement for any
chemical substance is the period commencing with the effective date of
this part to the end of the reimbursement period, as defined in §766.3,
for each chemical substance.  All reporting requirements for any
chemical substance listed under §766.25 shall be in effect for the 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.  

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 Pollution Prevention and
Toxics, Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460,
ATTN: Dioxin/Furan Report.  

[52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]

§766.10   Test standards.  

Testing required under subpart B of this part must be performed using
the protocols submitted to and reviewed by the EPA expert panel
established under §766.28.  All new data, documentation, records,
protocols, specimens, and reports generated as a result of testing under
subpart B of this part must be fully developed and retained in
accordance with part 792 of this chapter.  These items must be made
available during an inspection or submitted to EPA upon request by EPA
or its authorized representative.  Laboratories conducting testing for
submission to EPA in response to a test rule promulgated under section 4
of TSCA must adhere to the TSCA Good Laboratory Practices (GLPs)
published in part 792 of this chapter.  Sponsors must notify the
laboratory that the testing is being conducted pursuant to TSCA section
4.  Sponsors are also responsible for ensuring that laboratories
conducting the testing abide by the TSCA GLP standards.  At the time
test data are submitted, manufacturers must submit a certification to
EPA that the laboratory performing the testing adhered to the TSCA GLPs.
 

§766.12   Testing guidelines.

Analytical test methods must be developed using methods equivalent to
those described or reviewed in Guidelines for the Determination of
Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans in Commercial
Products.  Copies are available from the Director, Environmental
Assistance Division (7408), Office of Pollution Prevention and Toxics,
U.S.Environmental

Protection Agency, Room E-543B, 1200 Pennsylvania Ave., NW., Washington,
DC 20460, Telephone: (202) 554-1404, TDD: (202) 544-0551.  Copies are
also located in the public docket for this part (Docket No. OPPTS-83002)
and are available for inspection in the Non-Confidential Information
Center (NCIC) (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room B-607 NEM, 401 M St., SW.,
Washington, DC 20460, between the hours of 12 p.m.  and 4 p.m. weekdays
excluding legal holidays.  

[60 FR 34466, July 3, 1995]

§766.14   Contents of protocols.  

Protocols should include all parts of the Quality Assurance Plan for
Measurement of Brominated or Chlorinated Dibenzofurans and
Dibenzodioxins, as stated in the Guidelines.  For each chemical
substance and each process, the manufacturer must submit a statement of
how many grades of the chemical substance it produces, a justification
for selection of the specific grade of chemical substance for testing,
specific plans for collection of samples from the process stream, naming
the point of collection, the method of collecting the sample, and an
estimate of how well the samples will represent the material to be
characterized; a description of how control samples (blanks) and
HDD/HDF-reinforced control samples, or isotopically labeled compounds
(standards) and duplicate samples will be handled; a description of the
chemical extraction and clean up procedures to be used; how extraction
efficiency and measurement efficiency will be established; and a
description of instrument hardware and operating conditions, including
type and source of columns, carrier gas and flow rate, operating
temperature range, and ion source temperature.  

§766.16   Developing the analytical test method.  

Because of the matrix differences of the chemicals listed for testing,
no one method for sample selection, preparation, extraction and clean up
is prescribed.  For analysis, High Resolution Gas Chromatography (HRGC)
with High Resolution Mass Spectrometry (HRMS) is the method of choice,
but other methods may be used if they can be demonstrated to reach the
target

LOQs as well as HRGC/HRMS.  

(a) Sample selection.  The chemical product to be tested should be
sampled so that the specimens collected for analysis are representative
of the whole.  Additional guidance for sample selection is provided
under §766.12.  

(b) Sample preparation.  The sample must be mechanically homogenized and
subsampled as necessary.  Subsamples must be spiked or reinforced with
surrogate compounds or with standard stock solutions, and the surrogates
or standards must be thoroughly incorporated by mechanical agitation. 
Additional guidance is provided under §766.12. 

 

(c) Sample extraction and cleanup.  The spiked samples must be treated
to separate the HDDs/HDFs from the sample matrix.  Methods are reviewed
in the Guidelines under §766.12, but the final method or methods are
left to the discretion of the analyst, provided the instrumental
response of the surrogates meets the criteria listed in the Quality
Assurance Plan for

Measurement of Brominated or Chlorinated Dibenzofurans and
Dibenzodioxins, Appendixes B and C of the Guidelines.  Cleanup
techniques are described in the Guidelines.  These are chosen at the
discretion of the analyst to meet the requirements of the chemical
matrix.  

(d) Analysis.  The method of choice is High Resolution Gas
Chromatographic/High Resolution Mass Spectrometric Determination,
(HRGC/HRMS) but alternate methods may be used if the manufacturer can
demonstrate that the method will reach the target LOQs as well as
HRGC/HRMS.  Specific operating requirements are found in the Guidelines.
 

§766.18   Method sensitivity.  

The target level of quantitation required under §766.27 for each
HDD/HDF congener is the level which must be attempted for each resolved
HRGC peak for that congener.  For at least one product sample, at least
two analyses of the same isotopically labeled HDD/HDF internal
calibration standards spiked to a final product concentration equal to
the LOQ for that congener

must be reproducibly extracted, cleaned up, and quantified to within
±20 percent of each other.  For each spiked product sample, the signal
to noise ratio for the calibration standard peaks after complete
extraction and cleanup must be 10:1 or greater.  The recovery of the
internal calibration standards in the extracted and cleaned up product
samples must be within 50 to 150 percent of the amount spiked, and the
results must be corrected for recovery.  

SUBPART B -- SPECIFIC CHEMICAL TESTING/REPORTING REQUIREMENTS 

§766.20   Who must test.  

(a) Any person who manufactures, imports, or processes a chemical
substance listed in §766.25 must test that chemical substance and must
submit appropriate information to EPA according to the schedules
described in §766.35.  Chemical substances manufactured, imported or
processed between January 1, 1984 and the date of promulgation of this
part are subject to testing upon the effective date of this part.  All
other chemical substances are subject to testing immediately upon

manufacture, import or processing.  EPA expects that only manufacturers
and importers will perform testing, and that the cost of testing will be
passed on to processors through the pricing mechanism, thereby enabling
them to share in the cost of testing.  However, processors will be
called upon to sponsor testing should manufacturers and importers fail
to do so.  A processor may apply for an exemption from testing upon
certification to EPA that a manufacturer or importer is testing the
chemical substance which that person processes.  

(b) If no manufacturer or importer described in §766.20 submits a
letter of intent to perform testing within the period described under
§766.35(a), or an exemption application under §790.45(a), or a request
for an exclusion or waiver under §766.32, EPA will issue a notice in
the FEDERAL REGISTER to notify all processors of that chemical
substance.  The notice will state that EPA has not received any of the
documents described in the previous sentence, and that current
processors will have 30 days to submit either a letter of intent to
perform the test or submit an exemption application.  

(c) If no manufacturer, importer or processor submits a letter of intent
to perform testing of a specific chemical substance produced by a
specific process, EPA will notify all manufacturers, importers, and
processors, either by notice in the FEDERAL REGISTER or by letter, that
all exemption applications will be denied and that within 30 days all
manufacturers, importers, and

processors will be in violation of this part until a proposed study plan
is submitted for required testing.  

(d) Manufacturers, importers, and processors who are subject to this
part must comply with the test rule development and exemption procedures
in part 790 of this chapter, except as modified in this part.  

§766.25   Chemical substances for testing.  

(a) Listing of chemical substances.  Chemical substances required to be
tested for HDDs/HDFs under this rule are listed in this section.  The
listing is by Chemical Abstracts Service (CAS) Number and common name.  

Note: For purposes of guidance only, EPA lists the chemical substances
subject to testing under this part in two classes -- those known to be
manufactured or imported between January 1, 1984, and promulgation of
this part, and those not known to be manufactured or imported at the
time of promulgation of this part.

(1) Chemicals substances known to be manufactured between January 1,
1984 and date of promulgation of this part.  

------------------------------------------------------------------------

   CAS No.                          Chemical name

------------------------------------------------------------------------

  79-94-7  	Tetrabromobisphenol-A.

  118-75-2  	2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4-dione.

  118-79-6  	2,4,6-Tribromophenol.

  120-83-2  	2,4-Dichlorophenol.

  1163-19-5  	Decabromodiphenyloxide.

  4162-45-2  	Tetrabromobisphenol-A-bisethoxylate.

  21850-44-2  	Tetrabromobisphenol-A-bis-2,3-dibromopropyl ether.

  25327-89-3  	Allyl ether of tetrabromobisphenol-A.

  32534-81-9  	Pentabromodiphenyloxide.

  32536-52-0  	Octabromodiphenyloxide.

  37853-59-1  	1,2-Bis(tribromophenoxy)-ethane.

  55205-38-4  	Tetrabromobisphenol-A diacrylate.

------------------------------------------------------------------------

(2) Chemicals not known to be manufactured between January 1, 1984 and
the date of promulgation of this part.  

------------------------------------------------------------------------

   CAS No.                          Chemical name

------------------------------------------------------------------------

     79-95-8  	Tetrachlorobisphenol-A.

     87-10-5  	3,4',5-Tribromosalicylanilide.

     87-65-0  	2,6-Dichlorophenol.

     95-77-2  	3,4-Dichlorophenol.

     95-95-4  	2,4,5-Trichlorophenol.

     99-28-5  	2,6-Dibromo-4-nitrophenol.

    120-36-5  	2[2,4-(Dichlorophenoxy)]-propionic acid.

    320-72-9  	3,5-Dichlorosalicyclic acid.

    488-47-1  	Tetrabromocatechol.

    576-24-9  	2,3-Dichlorophenol.

    583-78-8  	2,5-Dichlorophenol.

    608-71-9  	Pentabromophenol.

    615-58-7  	2,4-Dibromophenol.

    933-75-5  	2,3,6-Trichlorophenol.

   1940-42-7  	4-Bromo-2,5-dichlorophenol.

   2577-72-2  	3,5-Dibromosalicylanilide.

   3772-94-9  	Pentachlorophenyl laurate.

  37853-61-5  	Bismethylether of tetrabromobisphenol-A.

              	Alkylamine tetrachlorophenate.

             	Tetrabromobisphenol-B.

------------------------------------------------------------------------

(b) Grade to be tested.  If the same process is used to manufacture all
grades of the same chemical substance, only one grade need be tested. 
The grade to be tested must be the grade subject to the most intense
heat and alkalinity for the longest duration of time, manufactured under
each different process.  If the heat, alkalinity and duration of
reaction do not differ for various grades, the test substance must be
the grade of chemical substance with the highest volume of sales.  

§766.27   Congeners and LOQs for which quantitation is required.  

Quantitation at the target LOQ shown for each of the following HDDs/HDFs
which may be present in the chemical substances is required for the
chemical substances listed under §766.25.  Analysis must take place for
either chlorinated or brominated dibenzodioxins or dibenzofurans,
whichever is predominantly expected to occur in the chemical substance
to be tested.  Only

chlorinated and brominated congeners need be quantified; for chemical
substances containing predominantly chlorine atoms, only congeners
totally chlorinated at the numbered positions need be quantified; for
chemical substances containing predominantly bromine atoms, only
congeners totally brominated at the numbered positions need be
quantified.  

------------------------------------------------------------------------

        Chlorinated dioxins          Brominated dioxins         LOQ

------------------------------------------------------------------------

2,3,7,8-TCDD..........................  2,3,7,8-TBDD............  0.1
ppb.

1,2,3,7,8-PeCDD.....................  1,2,3,7,8-PeBDD........  0.5 ppb.

1,2,3,4,7.8-HxCDD.................  1,2,3,4,7,8-HxBDD....  2.5 ppb.

1,2,3,6,7,8-HxCDD.................  1,2,3,6,7,8-HxBDD....  2.5 ppb.

1,2,3,7,8,9-HxCDD.................  1,2,3,7,8,9-HxBDD....  2.5 ppb.

1,2,3,4,6,7,8-HpCDD..............  1,2,3,4,6,7,8-HpBDD.  100 ppb.

2,3,7,8-TCDF..........................   2,3,7,8-TBDF............      1
ppb.

1,2,3,7,8-PeCDF......................  1,2,3,7,8-PeBDF........      5
ppb.

2,3,4,7,8-PeCDF......................  2,3,4,7,8-PeBDF........      5
ppb.

1,2,3,4,7,8-HxCDF..................  1,2,3,4,7,8-HxBDF....    25 ppb.

1,2,3,6,7,8-HxCDF..................  1,2,3,6,7,8-HxBDF....    25 ppb.

1,2,3,7,8,9-HxCDF..................  1,2,3,7,8,9-HxBDF....    25 ppb.

2,3,4,6,7,8-HxCDF..................  2,3,4,6,7,8-HxBDF....    25 ppb.

1,2,3,4,6,7,8-HpCDF...............  1,2,3,4,6,7,8-HpBDF.      1 ppm.

1,2,3,4,7,8,9-HpCDF...............  1,2,3,4,7,8,9-HpBDF.      1 ppm.

------------------------------------------------------------------------

§766.28   Expert review of protocols.  

EPA will gather a panel of experts in analysis of chemical matrices for
HDDs/HDFs to review the protocols for testing submitted to EPA.  The
panel members will be employees of EPA and/or of other U.S. Government
agencies who have had experience in analysis of chemical matrices and/or
chemical wastes for HDDs/HDFs.  The panel will recommend to the
Director, EPA Office of Pollution Prevention and Toxics, whether the
protocol submitted is likely to allow analysis down to the target LOQs,
or if not, whether the protocol represents a good faith effort on the
part of the tester to achieve the lowest possible LOQs.  The final
determination to accept or reject the protocol will be made by the
Director, Office of Pollution Prevention and Toxics.  EPA will review
the submitted protocols as rapidly as possible and will complete the
review within 90

days after receipt.  EPA may require submission of revised protocols. 
Comments and recommendations will be transmitted to the submitter, and
if revisions are required, a final protocol must be submitted to EPA
within 90 days after EPA transmits such recommendations.  

§766.32   Exclusions and waivers.  

(a) Reasons for exclusions and waivers.  Any person subject to the
testing requirements of this part may request an exclusion or waiver
from testing for any one of the following reasons: 

(1) Exclusions may be granted if.  (i) Testing of the appropriate grade
of the chemical substance has already been carried out, either
analytical testing at the lowest LOQ possible, with appropriate QA/QC,
or a well-designed bioassay with appropriate QA/QC or; 

(ii) Process and reaction conditions of the chemical substance such that
no HDDs/HDFs could be produced under those conditions; 

(2) Waivers may be granted if.  (i) A responsible company official
certifies that the chemical substance is produced only in quantities of
100 kilograms or less per year, only for research and development
purposes; or  

(ii) In the judgement of EPA, the cost of testing would drive the
chemical substance off the market, or prevent resumption of manufacture
or import of the chemical substance, if it is not currently
manufactured, and the chemical substance will be produced so that no
unreasonable risk will occur due to its manufacture, import, processing,
distribution, use, or disposal.  (In this case, the manufacturer must
submit to EPA all data supporting the determination.) 

(iii) Waivers may be appropriately conditioned with respect to such
factors as time and conditions of manufacture or use.  The grade of
decabromodiphenyl oxide produced by Dow Chemical Company (Dow) for the
National Toxicology Program (NTP) bioassay on that chemical is excluded
from the testing requirement under this part.  Provided, however, that
this exclusion will not apply if Dow fails to supply to EPA within 60
days of the effective date of this section evidence showing which grade
was used for the NTP bioassay.  

(b) Timing.  Exclusion or waiver requests and detailed supporting data
must be submitted to EPA within 60 days from the effective date of this
part for persons manufacturing, importing or processing a chemical
substance as of the date of promulgation, or 60 days prior to the date
of resumption of manufacture or import for a chemical substance produced
by a specific process if the chemical substance is not manufactured,
imported or processed as of the date of promulgation.  

(c) Publication.  Within 10 days of receipt of any exclusion or waiver
request, EPA will issue in the FEDERAL REGISTER a notice of such
receipt.  EPA will also issue a notice of its decision on each exclusion
or waiver request within 60 days of receipt.

(d) Decision.  The EPA Director of the Office of Pollution Prevention
and Toxics will make the decision to grant or deny waivers or
exclusions.  

§766.35   Reporting requirements.  

(a) Letters of intent, exemption applications, and protocols -- (1)
Letters of Intent.  (i) Persons who have manufactured or imported
chemical substances listed under §766.25 between January 1, 1984, and
the effective date of this part are required to submit under §790.45 of
this chapter a letter of intent to test or an exemption application. 
These letters must be submitted no later than September 3, 1987.  

(ii) Persons who commence manufacture, import or processing of a
chemical substance listed under §766.25 that has not been manufactured,
imported or processed between January 1, 1984 and the effective date of
this part must submit under §790.45 of this chapter, within 60 days
after the commencement of manufacture, import, or processing of the
chemical substance, a letter of intent to test or an exemption
application.  

(iii) Persons who commence manufacture, import or processing of a
chemical substance listed under §766.25 between the effective date of
this part and the end of the reimbursement period for that particular
chemical substance produced by a specific process must submit under
§790.45 of this chapter, within 60 days after the commencement of
manufacture, import or processing of the chemical substance, a letter of
intent to test or an exemption application.  

(2) Protocols.  (i) Each person who is manufacturing or processing a
chemical substance listed in §766.25 as of the effective date of this
part who submits a notice of intent to test under §766.35(a)(1) must
submit a protocol for the test as follows:  

(A) The protocols for each chlorinated chemical substance produced by
each process to be tested must be submitted to EPA no later than 12
months after the effective date of this part.  

(B) The protocol for each brominated chemical substance produced by each
process to be tested must be submitted to EPA no later than 24 months
after the effective date of this part except for the following
chemicals.  

(1) The deadline for submitting the protocols for tetrabromobisphenol-A
(CAS No. 79-94-7); 2,4,6 tribromophenol (CAS No. 118-79-6);
decabromodiphenyloxide (CAS No. 1163-19-5); and
1,2-bis(tribromophenoxy)-ethane (CAS No. 37853-59-1) is January 31,
1991.  

(2) The deadline for submitting protocols for octabromodiphenyloxide
(CAS No. 32536-52-0) and allyl ether of tetrabromobisphenol-A (CAS No.
25327-89-3) is January 31, 1991.  

(3) The deadline for submitting protocols for pentabromodiphenyloxide
(CAS No. 32534-81-9) is February 6, 1995.  The deadline for submitting
tetrabromobisphenol-A-bisethoxylate (CAS No. 4126-45-2) is January 31,
1991.  

(4) The deadline for submitting protocols for
3,4',5-tribromosalicylanilide (CAS No. 87-10-5) is September 5, 1990.  

(ii) For chemical substances produced by a specific process not
manufactured or processed as of the effective date of this part, a
person who begins manufacture and submits a notice of intent to test
must submit protocols for the test as follows: 

(A) Except as noted for the submitter and substance specified in the
following table, protocols for testing must be submitted 12 months after
manufacture or importation begins for chlorinated chemical substances.  

------------------------------------------------------------------------
----------------------------------------

 CAS No.       Submitter                                       Chemical 
                            Due date

------------------------------------------------------------------------
----------------------------------------

 118-75-2     Rhone-Poulenc.......... 
2,3,5,6-tetrachloro-2,5-cyclohexaniene-   March 4, 1994

                                                           1,4-dione.

------------------------------------------------------------------------
----------------------------------------

(B) Protocols for testing must be submitted 24 months after manufacture
begins for brominated chemical substances.  

(iii) For persons who have been granted exemptions, waivers or
exclusions from testing, protocols must be submitted 12 months after
expiration of the exemption, waiver or exclusion for chlorinated
chemical substances, and 24 months after expiration of the exemption,
waiver or exclusion for brominated chemical substances.  

(b) Information that must be submitted to EPA.  (1) Persons who
manufacture or import a chemical substance listed under §766.25 must
report no later than October 5, 1987 or 90 days after the person first
manufactures or imports the chemical substance, whichever is later, the
results of all existing test data which show that chemical substance has
been tested for the

presence of HDDs/HDFs.  

(2) Any manufacturer or importer of a chemical substance listed in
§766.25 in possession of unpublished health and safety studies on
HDDs/HDFs is required to submit copies of such studies to EPA no later
than October 5, 1987 or 90 days after the person first manufactures or
imports the chemical substance, whichever is later.  The following
provisions of part 716 of this

chapter apply to submission of these studies: §§716.3, 716.10(a) (1)
and (4); 716.20(a) (1), (2), (3), (4), (7), (8) and (10); 716.25;
716.30; 716.35(a) (1), (2), and (4) [if applicable]; 716.35 (b) and (c);
716.40 (a) and (b); 716.50; 716.55; and 716.60(a)(2).  

(3) No later than October 5, 1987 or 90 days after the person first
manufactures or imports the substance listed in §766.25, any
manufacturer or importer of a chemical substance listed in §766.25 must
submit records required to be held under part 717 of this chapter on any
HDDs/HDFs.  

(4) Test results.  (i) Test results must be submitted to EPA not later
than 270 days after EPA’s transmission of comments or 180 days after a
final protocol is submitted to EPA, whichever is shorter, except as
noted for the submitters and substances specified in the following
table: 

------------------------------------------------------------------------
----------------------------------------

     CAS No.     Submitter                 Chemical                    
Due Date                    Effective Date

------------------------------------------------------------------------
----------------------------------------

   79-94-7      Great Lakes     Tetrabromobisphenol-A           May 26,
1992               May 28, 1993

   79-94-7      Ethyl                Tetrabromobisphenol-A          
August 10, 1992          May 28, 1993

   79-94-7      Ameribrom      Tetrabromobisphenol-A           April 15,
1994             September 29, 1995

   87-10-5      Pfister             3,4',5-tribromosalicylanilide    45
days after protocol    May 28, 1993

                                                                        
                      approval

 118-75-2      Rhone-Poulenc.  2,3,5,6-tetrachloro-2,5-         July 5,
1996                  June 30, 1997

                        Inc.                    
cyclohexadiene-1,4-dione

 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

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

 4162-45-2    Great Lakes       Tetrabromobisphenol-A-      	June 2,
1993              September 8, 1994

                                                    bisethoxylate

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

                                                   Tetrabromobisphenol-A

32534-81-9   Great Lakes      Pentabromodiphenyloxide     	March 22,
1993         September 8, 1994

32534-81-9   Akzo Chemicals  Pentabromodiphenyloxide  February 6, 1995  
         September 29, 1995

                        Inc.

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(tribromo- 	         January 24,
1995           September 29, 1995

                                                     phenoxy)ethane

------------------------------------------------------------------------
----------------------------------------

(ii) For purposes of reporting test results to EPA, and for further
reporting triggered by a positive test result under §766.35(c), a
positive test result is defined at §766.3.  

(iii) Reporting of test results must follow procedures set out in part
790 of this chapter, except as modified in this part.  

(c) Information required to be submitted to EPA after submission of a
positive test result.  (1) Any person who submits a positive test result
for a specific chemical substance listed under §766.25 must submit to
EPA no later than 90 days after the date of submission of the positive
test result the following: 

(i) A completed form (EPA 7710-51) for that chemical substance.  The
form and instructions are available from the Environmental Assistance
Division (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.  One form must be submitted for each chemical
substance for which a positive test result has been submitted.  

(ii) Health and safety studies for the chemical substance for which a
positive test result has been reported.  The following provisions of
part 716 of this chapter apply to submission of these studies:
§§716.3; 716.10 (a) (1), (2), (3) and (4); 716.20; 716.25; 716.30;
716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and (c); 716.40
(a) and (b); 716.50; 716.55; 716.60(a)(2).  

(iii) Copies of records on the chemical substances required to be held
under part 717 of this chapter.  

(2) If a positive test result on a chemical substance is received from
one person but not from others, EPA may issue a notice in the FEDERAL
REGISTER listing that chemical substance and requiring any person
manufacturing, importing or processing that chemical substance who has
not submitted a positive test result to submit the information required
in Part II of EPA Form

7710-51.  Such a notice will be published only if EPA needs additional
process data to make a determination of unreasonable risk.  

(d)-(e)      [Reserved] 

(f) Effective date.  (1) The effective date of this final rule is July
6, 1987, except for paragraphs (a)(2)(i)(B) introductory text,
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), (a)(2)(i)(B)(3), (a)(2)(i)(B)(4), the
table in paragraph (a)(2)(ii)(A), and the table in paragraph (b)(4)(i)
of this section.  

(2) The effective date for paragraph (a)(2)(i)(B) introductory text,
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and (a)(2)(i)(B)(4), is May 21, 1991. 
The effective date of paragraphs (a)(2)(i)(B)(3), and the table in
paragraph (a)(2)(ii)(A) is September 29, 1995.  The effective date of
paragraph (b)(4)(i) introductory text is May 28, 1993, and the effective
date of the entries in the table in paragraph (b)(4)(i) is shown in the
effective dates column of the table.  

(3) The guidelines and other test methods cited in this rule are
referenced as they exist on the effective date of the final rule.  

[52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57
FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June
23, 1993; 59 FR 46356, Sept.  8, 1994; 60 FR 31922, June 19, 1995; 60 FR
50433, Sept.  29, 1995; 60 FR 56955, Nov.  13, 1995; 62 FR 35105, June
30, 1997]

§766.38   Reporting on precursor chemical substances.  

(a) Identification of precursor chemical substances.  Precursor chemical
substances are produced under conditions that will not yield HDDs and
HDFs, but their molecular structure is conducive to HDD/HDF formation
under favorable reaction conditions when they are used to produce other
chemicals or products.  The following precursor chemical substances are
identified by Chemical Abstract Service (CAS) number and name.  

------------------------------------------------------------------------

             CAS No.                          Chemical name

------------------------------------------------------------------------

85-22-3..........................  Pentabromoethylbenzene.

87-61-6..........................  1,2,3-Trichlorobenzene.

87-84-3.......................... 
1,2,3,4,5-Pentabromo-6-chloro-cyclohexane.

89-61-2..........................  1,4-Dichloro-2-nitrobenzene.

89-64-5..........................  4-Chloro-2-nitrophenol.

89-69-0..........................  2,4,5-Trichloronitrobenzene.

92-04-6..........................  2-Chloro-4-phenylphenol.

94-74-6..........................  4-Chloro-o-toloxy acetic acid.

94-81-5..........................  4-(2-Methyl-4-chlorophenoxy) butyric
acid.

95-50-1..........................  o-Dichlorobenzene.

95-56-7..........................  o-Bromophenol.

95-57-8..........................  o-Chlorophenol.

95-88-5..........................  4-Chlororesorcinol.

95-94-3..........................  1,2,4,5-Tetrachlorobenzene.

97-50-7..........................  5-Chloro-2,4-dimethoxyaniline.

99-30-9..........................  2,6-Dichloro-4-nitroaniline.

99-54-7..........................  1,2-Dichloro-4-nitrobenzene.

106-46-7.........................  p-Dichlorobenzene.

108-70-3.........................  1,3,5-Trichlorobenzene.

108-86-1.........................  Bromobenzene.

108-90-7.........................  Chlorobenzene.

117-18-0.........................  1,2,4,5-Tetrachloro-3-nitrobenzene.

120-82-1.........................  1,2,4-Trichlorobenzene.

348-51-6.........................  o-Chorofluorobenzene.

350-30-1.........................  3-Chloro-4-fluoronitrobenzene.

615-67-8.........................  Chlorohydroquinone.

626-39-1.........................  1,3,5-Tribromobenzene.

827-94-1.........................  2,6-Dibromo-4-nitroaniline.

------------------------------------------------------------------------

(b) Persons required to report.  All persons who manufacture or import a
chemical product produced using any of the chemical substances listed in
paragraph (a) of this section as feedstocks or intermediates must report
no later than September 29, 1987.  Small manufacturers and those
manufacturers and importers who produce the precursor chemical
substances in

quantities of 100 kilograms or less per year only for research and
development purposes are not required to report under this section 

(c) Data to be reported.  Manufacturers and importers of chemical
products made from precursor chemical substances identified in paragraph
(a) of this section must report process and reaction condition data on
Part II of EPA Form 7710-51 for each chemical product.  A separate EPA
Form 7710-51 must be submitted for each chemical product reported, and
the precursor chemical substance used must be identified.  All forms
must be submitted to EPA no later than September 29, 1987.  

[52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]

OMB Control No. 2070-0054; EPA ICR No. 0586.11

Attachment F

Dioxin/Furan Report (EPA Form 7710-51)

[Note: An electronic copy of this attachment is not available.  Please
contact the Environmental Protection Agency at the address noted in the
Federal Register notice for a complete copy of this ICR.]

OMB Control No. 2070-0054; EPA ICR No. 0586.11

Attachment G

40 CFR 792

This attachment can also be accessed online via Internet at     
HYPERLINK
"http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr792_00.html
" 
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr792_00.html 

TITLE 40--PROTECTION OF ENVIRONMENT 

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY

PART 792 -- GOOD LABORATORY PRACTICE STANDARDS

Subpart A -- General Provisions

Sec.

792.1   Scope.

792.3   Definitions.

792.10   Applicability to studies performed under grants and contracts.

792.12   Statement of compliance or non-compliance.

792.15   Inspection of a testing facility.

792.17   Effects of non-compliance.

Subpart B -- Organization and Personnel

792.29   Personnel.  

792.31   Testing facility management.

792.33   Study director.

792.35   Quality assurance unit.

Subpart C -- Facilities

792.41   General.

792.43   Test system care facilities.

792.45   Test system supply facilities.

792.47   Facilities for handling test, control, and reference
substances.

792.49   Laboratory operation areas.

792.51   Specimen and data storage facilities.

Subpart D -- Equipment

792.61   Equipment design.

792.63   Maintenance and calibration of equipment.

Subpart E -- Testing Facilities Operation

792.81   Standard operating procedures.

792.83   Reagents and solutions.

792.90   Animal and other test system care.

Subpart F -- Test, Control, and Reference Substances

792.105   Test, control, and reference substance characterization.

792.107   Test, control, and reference substance handling.

792.113   Mixtures of substances with carriers.

Subpart G -- Protocol for and Conduct of A Study

792.120   Protocol.

792.130   Conduct of a study.

792.135   Physical and chemical characterization studies.

Subparts H-I      [Reserved]

Subpart J -- Records and Reports

792.185   Reporting of study results.

792.190   Storage and retrieval of records and data.

792.195   Retention of records.

Authority: 15 U.S.C. 2603.

Source: 54 FR 34043, Aug.  17, 1989, unless otherwise noted.

SUBPART A -- GENERAL PROVISIONS

§792.1   Scope.

(a) This part prescribes good laboratory practices for conducting
studies relating to health effects, environmental effects, and chemical
fate testing.  This part is intended to ensure the quality and integrity
of data submitted pursuant to testing consent agreements and test rules
issued under section 4 of the Toxic Substances Control Act (TSCA) (Pub. 
L.  94-469, 90 Stat. 2006, 15 U.S.C. 2603 et seq.).  

(b) This part applies to any study described by paragraph (a) of this
section which any person conducts, initiates, or supports on or after
September 18, 1989. 

(c) It is EPA’s policy that all data developed under section 5 of TSCA
be in accordance with provisions of this part.  If data are not
developed in accordance with the provisions of this part, EPA will
consider such data insufficient to evaluate the health and environmental
effects of the chemical substances unless the submitter provides
additional information demonstrating that the

data are reliable and adequate.  

§792.3   Definitions.

As used in this part the following terms shall have the meanings
specified: 

Batch means a specific quantity or lot of a test, control, or reference
substance that has been characterized according to §792.105(a).  

Carrier means any material, including but not limited to, feed, water,
soil, and nutrient media, with which the test substance is combined for
administration to a test system.  

Control substance means any chemical substance or mixture, or any other
material other than a test substance, feed, or water, that is
administered to the test system in the course of a study for the purpose
of establishing a basis for comparison with the test substance for
chemical or biological measurements.  

EPA means the U.S.  Environmental Protection Agency.  

Experimental start date means the first date the test substance is
applied to the test system.  

Experimental termination date means the last date on which data are
collected directly from the study.  

FDA means the U.S.  Food and Drug Administration.  

Person includes an individual, partnership, corporation, association,
scientific or academic establishment, government agency, or
organizational unit thereof, and any other legal entity.  

Quality assurance unit means any person or organizational element,
except the study director, designated by testing facility management to
perform the duties relating to quality assurance of the studies.  

Raw data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and
evaluation of the report of that study.  In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original
source as raw data.  “Raw data” may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated instruments.  

Reference substance means any chemical substance or mixture, or
analytical standard, or material other than a test substance, feed, or
water, that is administered to or used in analyzing the test system in
the course of a study for the purposes of establishing a basis for
comparison with the test substance for known chemical or biological
measurements.  

Specimen means any material derived from a test system for examination
or analysis.  

Sponsor means: 

(1) A person who initiates and supports, by provision of financial or
other resources, a study; 

(2) A person who submits a study to the EPA in response to a TSCA
section 4(a) test rule and/or a person who submits a study under a TSCA
section 4 testing consent agreement or a TSCA section 5 rule or order to
the extent the agreement, rule or order references this part; or 

(3) A testing facility, if it both initiates and actually conducts the
study.  

Study means any experiment at one or more test sites, in which a test
substance is studied in a test system under laboratory conditions or in
the environment to determine or help predict its effects, metabolism,
environmental and chemical fate, persistence, or other characteristics
in humans, other living organisms, or media.  The term “study” does
not include basic exploratory studies carried out to determine whether a
test substance or a test method has any potential utility.  

Study completion date means the date the final report is signed by the
study director.  

Study director means the individual responsible for the overall conduct
of a study.  

Study initiation date means the date the protocol is signed by the study
director.  

Test substance means a substance or mixture administered or added to a
test system in a study, which substance or mixture is used to develop
data to meet the requirements of a TSCA section 4(a) test rule and/or is
developed under a TSCA section 4 testing consent agreement or section 5
rule or order to the extent the agreement, rule or order references this
part.  

Test system means any animal, plant, microorganism, chemical or physical
matrix, including but not limited to, soil or water, or components
thereof, to which the test, control, or reference substance is
administered or added for study.  “Test system” also includes
appropriate groups or components of the system not treated with the
test, control, or reference substance.  

Testing facility means a person who actually conducts a study, i.e.,
actually uses the test substance in a test system.  “Testing
facility” encompasses only those operational units that are being or
have been used to conduct studies.  

TSCA means the Toxic Substances Control Act (15 U.S.C, 2601 et seq.) 

Vehicle means any agent which facilitates the mixture, dispersion, or
solubilization of a test substance with a carrier.  

§792.10   Applicability to studies performed under grants and
contracts.

When a sponsor or other person utilizes the services of a consulting
laboratory, contractor, or grantee to perform all or a part of a study
to which this part applies, it shall notify the consulting laboratory,
contractor, or grantee that the service is, or is part of, a study that
must be conducted in compliance with the provisions of this part.  

§792.12   Statement of compliance or non-compliance.

Any person who submits to EPA a test required by a testing consent
agreement or a test rule issued under section 4 of TSCA shall include in
the submission a true and correct statement, signed by the sponsor and
the study director, of one of the following types: 

(a) A statement that the study was conducted in accordance with this
part; or 

(b) A statement describing in detail all differences between the
practices used in the study and those required by this part; or 

(c) A statement that the person was not a sponsor of the study, did not
conduct the study, and does not know whether the study was conducted in
accordance with this part.  

§792.15   Inspection of a testing facility.

(a) A testing facility shall permit an authorized employee or duly
designated representative of EPA or FDA, at reasonable times and in a
reasonable manner, to inspect the facility and to inspect (and in the
case of records also to copy) all records and specimens required to be
maintained regarding studies to which this part applies.  The records
inspection and copying

requirements shall not apply to quality assurance unit records of
findings and problems, or to actions recommended and taken, except the
EPA may seek production of these records in litigation or formal
adjudicatory hearings.  

(b) EPA will not consider reliable for purposes of showing that a
chemical substance or mixture does not present a risk of injury to
health or the environment any data developed by a testing facility or
sponsor that refuses to permit inspection in accordance with this part. 
The determination that a study will not be considered reliable does not,
however, relieve the sponsor of a required test of any obligation under
any applicable statute or regulation to submit the results of the study
to EPA.  

(c) Since a testing facility is a place where chemicals are stored or
held, it is subject to inspection under section 11 of TSCA.  

 

§792.17   Effects of non-compliance.

(a) The sponsor or any other person who is conducting or has conducted a
test to fulfill the requirements of a testing consent agreement or a
test rule issued under section 4 of TSCA will be in violation of section
15 of TSCA if: 

(1) The test is not being or was not conducted in accordance with any
requirement of this part; 

(2) Data or information submitted to EPA under this part (including the
statement required by §792.12) include information or data that are
false or misleading, contain significant omissions, or otherwise do not
fulfill the requirements of this part; or 

(3) Entry in accordance with §792.15 for the purpose of auditing test
data or inspecting test facilities is denied.  Persons who violate the
provisions of this part may be subject to civil or criminal penalties
under section 16 of TSCA, legal action in United States district court
under section 17 of TSCA, or criminal prosecution under 18 U.S.C. 2 or
1001.  

(b) EPA, at its discretion, may not consider reliable for purposes of
showing that a chemical substance or mixture does not present a risk of
injury to health or the environment any study which was not conducted in
accordance with this part.  EPA, at its discretion, may rely upon such
studies for purposes of showing adverse effects.  The determination that
a study will not be

considered reliable does not, however, relieve the sponsor of a required
test of the obligation under any applicable statute or regulation to
submit the results of the study to EPA.  

(c) If data submitted to fulfill a requirement of a testing consent
agreement or a test rule issued under section 4 of TSCA are not
developed in accordance with this part, EPA may determine that the
sponsor has not fulfilled its obligations under section 4 of TSCA and
may require the sponsor to develop data in accordance with the
requirements of this part in order to satisfy such

obligations.  

SUBPART B -- ORGANIZATION AND PERSONNEL

§792.29   Personnel.

(a) Each individual engaged in the conduct of or responsible for the
supervision of a study shall have education, training, and experience,
or combination thereof, to enable that individual to perform the
assigned functions.  

(b) Each testing facility shall maintain a current summary of training
and experience and job description for each individual engaged in or
supervising the conduct of a study.  

(c) There shall be a sufficient number of personnel for the timely and
proper conduct of the study according to the protocol.  

(d) Personnel shall take necessary personal sanitation and health
precautions designed to avoid contamination of test, control, and
reference substances and test systems.  

(e) Personnel engaged in a study shall wear clothing appropriate for the
duties they perform.  Such clothing shall be changed as often as
necessary to prevent microbiological, radiological, or chemical
contamination of test systems and test, control, and reference
substances.  

(f) Any individual found at any time to have an illness that may
adversely affect the quality and integrity of the study shall be
excluded from direct contact with test systems, test, control, and
reference substances and any other operation or function that may
adversely affect the study until the condition is corrected.  All
personnel shall be instructed to report to their immediate

supervisors any health or medical conditions that may reasonably be
considered to have an adverse effect on a study.  

§792.31   Testing facility management.

For each study, testing facility management shall: 

(a) Designate a study director as described in §792.33 before the study
is initiated.  

(b) Replace the study director promptly if it becomes necessary to do so
during the conduct of a study.  

(c) Assure that there is a quality assurance unit as described in
§792.35.  

(d) Assure that test, control, and reference substances or mixtures have
been appropriately tested for identity, strength, purity, stability, and
uniformity, as applicable.  

(e) Assure that personnel, resources, facilities, equipment, materials
and methodologies are available as scheduled.  

(f) Assure that personnel clearly understand the functions they are to
perform.  

(g) Assure that any deviations from these regulations reported by the
quality assurance unit are communicated to the study director and
corrective actions are taken and documented.  

§792.33   Study director.

For each study, a scientist or other professional of appropriate
education, training, and experience, or combination thereof, shall be
identified as the study director.  The study director has overall
responsibility for the technical conduct of the study, as well as for
the interpretation, analysis, documentation, and reporting of results,
and represents the single point of study control.  The study director
shall assure that: 

(a) The protocol, including any change, is approved as provided by
§792.120 and is followed.  

(b) All experimental data, including observations of unanticipated
responses of the test system are accurately recorded and verified.  

(c) Unforeseen circumstances that may affect the quality and integrity
of the study are noted when they occur, and corrective action is taken
and documented.  

(d) Test systems are as specified in the protocol.  

(e) All applicable good laboratory practice regulations are followed.  

(f) All raw data, documentation, protocols, specimens, and final reports
are transferred to the archives during or at the close of the study.  

§792.35   Quality assurance unit.

(a) A testing facility shall have a quality assurance unit which shall
be responsible for monitoring each study to assure management that the
facilities, equipment, personnel, methods, practices, records, and
controls are in conformance with the regulations in this part.  For any
given study, the quality assurance unit shall be entirely separate from
and independent of the personnel engaged in the direction and conduct of
that study.  The quality assurance unit shall conduct inspections and
maintain records appropriate to the study.  

(b) The quality assurance unit shall: 

(1) Maintain a copy of a master schedule sheet of all studies conducted
at the testing facility indexed by test substance and containing the
test system, nature of study, date study was initiated, current status
of each study, identity of the sponsor, and name of the study director. 

(2) Maintain copies of all protocols pertaining to all studies for which
the unit is responsible.  

(3) Inspect each study at intervals adequate to ensure the integrity of
the study and maintain written and properly signed records of each
periodic inspection showing the date of the inspection, the study
inspected, the phase or segment of the study inspected, the person
performing the inspection, findings and problems, action recommended and
taken to resolve existing problems, and any scheduled date for
re-inspection.  Any problems which are likely to affect study integrity
found during the course of an inspection shall be brought to the
attention of the study director and management immediately.  

(4) Periodically submit to management and the study director written
status reports on each study, noting any problems and the corrective
actions taken.  

(5) Determine that no deviations from approved protocols or standard
operating procedures were made without proper authorization and
documentation.  

(6) Review the final study report to assure that such report accurately
describes the methods and standard operating procedures, and that the
reported results accurately reflect the raw data of the study.  

(7) Prepare and sign a statement to be included with the final study
report which shall specify the dates inspections were made and findings
reported to management and to the study director.  

(c) The responsibilities and procedures applicable to the quality
assurance unit, the records maintained by the quality assurance unit,
and the method of indexing such records shall be in writing and shall be
maintained.  These items including inspection dates, the study
inspected, the phase or segment of the study inspected, and the name of
the individual performing the inspection shall be made available for
inspection to authorized employees or duly designated representatives of
EPA or FDA.  

(d) An authorized employee or a duly designated representative of EPA or
FDA shall have access to the written procedures established for the
inspection and may request testing facility management to certify that
inspections are being implemented, performed, documented, and followed
up in accordance with this paragraph.  

SUBPART C -- FACILITIES

§792.41   General.

Each testing facility shall be of suitable size and construction to
facilitate the proper conduct of studies.  Testing facilities which are
not located within an indoor controlled environment shall be of suitable
location to facilitate the proper conduct of studies.  Testing
facilities shall be designed so that there is a degree of separation
that will prevent any function or activity from having an

adverse effect on the study.  

§792.43   Test system care facilities.

(a) A testing facility shall have a sufficient number of animal rooms or
other test system areas, as needed, to ensure: proper separation of
species or test systems, isolation of individual projects, quarantine or
isolation of animals or other test systems, and routine or specialized
housing of animals or other test systems.  

(1) In tests with plants or aquatic animals, proper separation of
species can be accomplished within a room or area by housing them
separately in different chambers or aquaria.  Separation of species is
unnecessary where the protocol specifies the simultaneous exposure of
two or more species in the same chamber, aquarium, or housing unit.  

(2) Aquatic toxicity tests for individual projects shall be isolated to
the extent necessary to prevent cross-contamination of different
chemicals used in different tests.  

(b) A testing facility shall have a number of animal rooms or other test
system areas separate from those described in paragraph(a) of this
section to ensure isolation of studies being done with test systems or
test, control, and reference substances known to be biohazardous,
including volatile substances, aerosols, radioactive materials, and
infectious agents.  

(c) Separate areas shall be provided, as appropriate, for the diagnosis,
treatment, and control of laboratory test system diseases.  These areas
shall provide effective isolation for the housing of test systems either
known or suspected of being diseased, or of being carriers of disease,
from other test systems.  

(d) Facilities shall have proper provisions for collection and disposal
of contaminated water, soil, or other spent materials.  When animals are
housed, facilities shall exist for the collection and disposal of all
animal waste and refuse or for safe sanitary storage of waste before
removal from the testing facility.  Disposal facilities shall be so
provided and operated as to minimize vermin infestation, odors, disease
hazards, and environmental contamination.  

(e) Facilities shall have provisions to regulate environmental
conditions (e.g., temperature, humidity, photoperiod) as specified in
the protocol.  

(f) For marine test organisms, an adequate supply of clean sea water or
artificial sea water (prepared from deionized or distilled water and sea
salt mixture) shall be available.  The ranges of composition shall be as
specified in the protocol.  

(g) For freshwater organisms, an adequate supply of clean water of the
appropriate hardness, pH, and temperature, and which is free of
contaminants capable of interfering with the study shall be available as
specified in the protocol.  

(h) For plants, an adequate supply of soil of the appropriate
composition, as specified in the protocol, shall be available as needed.
 

§792.45   Test system supply facilities.

(a) There shall be storage areas, as needed, for feed, nutrients, soils,
bedding, supplies, and equipment.  Storage areas for feed, nutrients,
soils, and bedding shall be separated from areas where the test systems
are located and shall be protected against infestation or contamination.
 Perishable supplies shall be preserved by appropriate means.  

(b) When appropriate, plant supply facilities shall be provided.  These
include: 

(1) Facilities, as specified in the protocol, for holding, culturing,
and maintaining algae and aquatic plants.  

(2) Facilities, as specified in the protocol, for plant growth,
including but not limited to, greenhouses, growth chambers, light banks,
and fields.  

(c) When appropriate, facilities for aquatic animal tests shall be
provided.  These include but are not limited to aquaria, holding tanks,
ponds, and ancillary equipment, as specified in the protocol.  

§792.47   Facilities for handling test, control, and reference
substances.

(a) As necessary to prevent contamination or mixups, there shall be
separate areas for: 

(1) Receipt and storage of the test, control, and reference substances. 

(2) Mixing of the test, control, and reference substances with a
carrier, e.g., feed.  

(3) Storage of the test, control, and reference substance mixtures.  

(b) Storage areas for test, control, and/or reference substance and for
test, control, and/or reference mixtures shall be separate from areas
housing the test systems and shall be adequate to preserve the identity,
strength, purity, and stability of the substances and mixtures.  

§792.49   Laboratory operation areas.

Separate laboratory space and other space shall be provided, as needed,
for the performance of the routine and specialized procedures required
by studies.  

§792.51   Specimen and data storage facilities.

Space shall be provided for archives, limited to access by authorized
personnel only, for the storage and retrieval of all raw data and
specimens from completed studies.  

SUBPART D -- EQUIPMENT

§792.61   Equipment design.

Equipment used in the generation, measurement, or assessment of data and
equipment used for facility environmental control shall be of
appropriate design and adequate capacity to function according to the
protocol and shall be suitably located for operation, inspection,
cleaning, and maintenance.  

§792.63   Maintenance and calibration of equipment.

(a) Equipment shall be adequately inspected, cleaned, and maintained. 
Equipment used for the generation, measurement, or assessment of data
shall be adequately tested, calibrated, and/or standardized.  

(b) The written standard operating procedures required under
§792.81(b)(11) shall set forth in sufficient detail the methods,
materials, and schedules to be used in the routine inspection, cleaning,
maintenance, testing, calibration, and/or standardization of equipment,
and shall specify, when appropriate, remedial action to be taken in the
event of failure or malfunction of

equipment.  The written standard operating procedures shall designate
the person responsible for the performance of each operation.  

(c) Written records shall be maintained of all inspection, maintenance,
testing, calibrating, and/or standardizing operations.  These records,
containing the date of the operation, shall describe whether the
maintenance operations were routine and followed the written standard
operating procedures.  Written records shall be kept of nonroutine
repairs performed on equipment as a result of failure and malfunction. 
Such records shall document the nature of the defect, how and when the
defect was discovered, and any remedial action taken in response to the
defect.  

SUBPART E -- TESTING FACILITIES OPERATION

§792.81   Standard operating procedures.

(a) A testing facility shall have standard operating procedures in
writing, setting forth study methods that management is satisfied are
adequate to insure the quality and integrity of the data generated in
the course of a study.  All deviations in a study from standard
operating procedures shall be authorized by the study director and shall
be documented in the raw data.  Significant

changes in established standard operating procedures shall be properly
authorized in writing by management.  

(b) Standard operating procedures shall be established for, but not
limited to, the following: 

(1) Test system room preparation.  

(2) Test system care.  

(3) Receipt, identification, storage, handling, mixing, and method of
sampling of the test, control, and reference substances.  

(4) Test system observations.  

(5) Laboratory or other tests.  

(6) Handling of test systems found moribund or dead during study.  

(7) Necropsy of test systems or postmortem examination of test systems. 

(8) Collection and identification of specimens.  

(9) Histopathology.  

(10) Data handling, storage and retrieval.  

(11) Maintenance and calibration of equipment.  

(12) Transfer, proper placement, and identification of test systems.  

(c) Each laboratory or other study area shall have immediately available
manuals and standard operating procedures relative to the laboratory or
field procedures being performed.  Published literature may be used as a
supplement to standard operating procedures.  

(d) A historical file of standard operating procedures, and all
revisions thereof, including the dates of such revisions, shall be
maintained.  

§792.83   Reagents and solutions.

All reagents and solutions in the laboratory areas shall be labeled to
indicate identity, titer or concentration, storage requirements, and
expiration date.  Deteriorated or outdated reagents and solutions shall
not be used.  

§792.90   Animal and other test system care.

(a) There shall be standard operating procedures for the housing,
feeding, handling, and care of animals and other test systems.  

(b) All newly received test systems from outside sources shall be
isolated and their health status or appropriateness for the study shall
be evaluated.  This evaluation shall be in accordance with acceptable
veterinary medical practice or scientific methods.  

(c) At the initiation of a study, test systems shall be free of any
disease or condition that might interfere with the purpose or conduct of
the study.  If during the course of the study, the test systems contract
such a disease or condition, the diseased test systems should be
isolated, if necessary.  These test systems may be treated for disease
or signs of disease provided that such

treatment does not interfere with the study.  The diagnosis,
authorization of treatment, description of treatment, and each date of
treatment shall be documented and shall be retained.  

(d) Warm-blooded animals, adult reptiles, and adult terrestrial
amphibians used in laboratory procedures that require manipulations and
observations over an extended period of time, or in studies that require
these test systems to be removed from and returned to their test
system-housing units for any reason (e.g., cage cleaning, treatment,
etc.), shall receive appropriate identification (e.g., tattoo, color
code, ear tag, ear punch, etc.).  All information needed to specifically
identify each test system within the test system-housing unit shall
appear on the outside of that unit.  Suckling mammals and juvenile birds
are excluded from the requirement of individual identification unless
otherwise specified in the protocol.  

(e) Except as specified in paragraph (e)(1) of this section, test
systems of different species shall be housed in separate rooms when
necessary.  Test systems of the same species, but used in different
studies, should not ordinarily be housed in the same room when
inadvertent exposure to test, control, or reference substances or test
system mixup could affect the outcome of either study.  If such mixed
housing is necessary, adequate differentiation by space and
identification shall be made.  

(1) Plants, invertebrate animals, aquatic vertebrate animals, and
organisms that may be used in multispecies tests need not be housed in
separate rooms, provided that they are adequately segregated to avoid
mixup and cross contamination.  

(2) [Reserved] 

(f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds,
growth chambers, and other holding, rearing, and breeding areas, and
accessory equipment, shall be cleaned and sanitized at appropriate
intervals.  

(g) Feed, soil, and water used for the test systems shall be analyzed
periodically to ensure that contaminants known to be capable of
interfering with the study and reasonably expected to be present in such
feed, soil, or water are not present at levels above those specified in
the protocol.  Documentation of such analyses shall be maintained as raw
data.  

(h) Bedding used in animal cages or pens shall not interfere with the
purpose or conduct of the study and shall be changed as often as
necessary to keep the animals dry and clean.  

(i) If any pest control materials are used, the use shall be documented.
 Cleaning and pest control materials that interfere with the study shall
not be used.  

(j) All plant and animal test systems shall be acclimatized to the
environmental conditions of the test, prior to their use in a study.

SUBPART F -- TEST, CONTROL, AND REFERENCE SUBSTANCES

§792.105   Test, control, and reference substance characterization.

(a) The identity, strength, purity, and composition, or other
characteristics which will appropriately define the test, control, or
reference substance shall be determined for each batch and shall be
documented before its use in a study.  Methods of synthesis,
fabrication, or derivation of the test, control, or reference substance
shall be documented by the sponsor or the testing facility, and such
location of documentation shall be specified.  

(b) When relevant to the conduct of the study the solubility of each
test, control, or reference substance shall be determined by the testing
facility or the sponsor before the experimental start date.  The
stability of the test, control or reference substance shall be
determined before the experimental start date or concomitantly according
to written standard operating procedures, which provide for periodic
analysis of each batch.  

(c) Each storage container for a test, control, or reference substance
shall be labeled by name, chemical abstracts service number (CAS) or
code number, batch number, expiration date, if any, and, where
appropriate, storage conditions necessary to maintain the identity,
strength, purity, and composition of the test, control, or reference
substance.  Storage containers shall be assigned to a particular test
substance for the duration of the study.  

(d) For studies of more than 4 weeks experimental duration, reserve
samples from each batch of test, control, and reference substances shall
be retained for the period of time provided by §792.195.  

(e) The stability of test, control, and reference substances under
storage conditions at the test site shall be known for all studies.

§792.107   Test, control, and reference substance handling.

Procedures shall be established for a system for the handling of the
test, control, and reference substances to ensure that: 

(a) There is proper storage.  

(b) Distribution is made in a manner designed to preclude the
possibility of contamination, deterioration, or damage.  

(c) Proper identification is maintained throughout the distribution
process.  

(d) The receipt and distribution of each batch is documented.  Such
documentation shall include the date and quantity of each batch
distributed or returned.  

§792.113   Mixtures of substances with carriers.

(a) For each test, control, or reference substance that is mixed with a
carrier, tests by appropriate analytical methods shall be conducted: 

(1) To determine the uniformity of the mixture and to determine,
periodically, the concentration of the test, control, or reference
substance in the mixture.  

(2) When relevant to the conduct of the experiment, to determine the
solubility of each test, control, or reference substance in the mixture
by the testing facility or the sponsor before the experimental start
date. 

 

(3) To determine the stability of the test, control or reference
substance in the mixture before the experimental start date or
concomitantly according to written standard operating procedures, which
provide for periodic analysis of each batch.  

(b) Where any of the components of the test, control, or reference
substance carrier mixture has an expiration date, that date shall be
clearly shown on the container.  If more than one component has an
expiration date, the earliest date shall be shown.  

(c) If a vehicle is used to facilitate the mixing of a test substance
with a carrier, assurance shall be provided that the vehicle does not
interfere with the integrity of the test.  

SUBPART G -- PROTOCOL FOR AND CONDUCT OF A STUDY

§792.120   Protocol.

(a) Each study shall have an approved written protocol that clearly
indicates the objectives and all methods for the conduct of the study. 
The protocol shall contain but shall not necessarily be limited to the
following information: 

(1) A descriptive title and statement of the purpose of the study.  

(2) Identification of the test, control, and reference substance by
name, chemical abstracts service (CAS) number or code number.  

(3) The name and address of the sponsor and the name and address of the
testing facility at which the study is being conducted.

(4) The proposed experimental start and termination dates.  

(5) Justification for selection of the test system.  

(6) Where applicable, the number, body weight, sex, source of supply,
species, strain, substrain, and age of the test system.  

(7) The procedure for identification of the test system.  

(8) A description of the experimental design, including methods for the
control of bias.  

(9) Where applicable, a description and/or identification of the diet
used in the study as well as solvents, emulsifiers and/or other
materials used to solubilize or suspend the test, control, or reference
substances before mixing with the carrier.  The description shall
include specifications for acceptable levels of contaminants that are
reasonably expected to be present in the dietary materials and are known
to be capable of interfering with the purpose or conduct of the study if
present at levels greater than established by the specifications.  

(10) The route of administration and the reason for its choice.  

(11) Each dosage level, expressed in milligrams per kilogram of body or
test system weight or other appropriate units, of the test, control, or
reference substance to be administered and the method and frequency of
administration.  

(12) The type and frequency of tests, analyses, and measurements to be
made.  

(13) The records to be maintained.  

(14) The date of approval of the protocol by the sponsor and the dated
signature of the study director.  

(15) A statement of the proposed statistical method.  

(b) All changes in or revisions of an approved protocol and the reasons
therefor shall be documented, signed by the study director, dated, and
maintained with the protocol.  

§792.130   Conduct of a study.

(a) The study shall be conducted in accordance with the protocol.  

(b) The test systems shall be monitored in conformity with the protocol.
 

(c) Specimens shall be identified by test system, study, nature, and
date of collection.  This information shall be located on the specimen
container or shall accompany the specimen in a manner that precludes
error in the recording and storage of data.  

(d) In animal studies where histopathology is required, records of gross
findings for a specimen from postmortem observations shall be available
to a pathologist when examining that specimen histopathologically.  

(e) All data generated during the conduct of a study, except those that
are generated by automated data collection systems, shall be recorded
directly, promptly, and legibly in ink.  All data entries shall be dated
on the day of entry and signed or initialed by the person entering the
data.  Any change in entries shall be made so as not to obscure the
original entry, shall indicate the reason for such change, and shall be
dated and signed or identified at the time of the change.  In automated
data collection systems, the individual responsible for direct data
input shall be identified at the time of data input.  Any change in
automated data entries shall be made so as not to obscure the original
entry, shall indicate the reason for change, shall be dated, and the

responsible individual shall be identified.  

§792.135   Physical and chemical characterization studies.

(a) All provisions of the GLPs shall apply to physical and chemical
characterization studies designed to determine stability, solubility,
octanol water partition coefficient, volatility, and persistence (such
as biodegradation, photodegradation, and chemical degradation studies). 

(b) The following GLP standards shall not apply to studies designed to
determine physical and chemical characteristics of a test, control, or
reference substance: 

Section 792.31 (c), (d), and (g) 

Section 792.35 (b) and (c) 

Section 792.43 

Section 792.45 

Section 792.47 

Section 792.49 

Section 792.81(b) (1), (2), (6) through (9), and (12) 

Section 792.90 

Section 792.105 (a) through (d) 

Section 792.113 

Section 792.120(a) (5) through (12), and (15) 

												

Section 792.185(a) (5) through (8), (10), (12), and (14) 

Section 792.195 (c) and (d)

SUBPARTS H-I      [RESERVED]

SUBPART J -- RECORDS AND REPORTS

§792.185   Reporting of study results.

(a) A final report shall be prepared for each study and shall include,
but not necessarily be limited to, the following: 

(1) Name and address of the facility performing the study and the dates
on which the study was initiated and was completed, terminated, or
discontinued.  

(2) Objectives and procedures stated in the approved protocol, including
any changes in the original protocol.  

(3) Statistical methods employed for analyzing the data.  

(4) The test, control, and reference substances identified by name,
chemical abstracts service (CAS) number or code number, strength,
purity, and composition, or other appropriate characteristics.  

(5) Stability, and when relevant to the conduct of the study, the
solubility of the test, control, and reference substances under the
conditions of administration.  

(6) A description of the methods used.  

(7) A description of the test system used.  Where applicable, the final
report shall include the number of animals or other test organisms used,
sex, body weight range, source of supply, species, strain and substrain,
age, and procedure used for identification.  

(8) A description of the dosage, dosage regimen, route of
administration, and duration.  

(9) A description of all circumstances that may have affected the
quality or integrity of the data.  

(10) The name of the study director, the names of other scientists or
professionals and the names of all supervisory personnel, involved in
the study.  

(11) A description of the transformations, calculations, or operations
performed on the data, a summary and analysis of the data, and a
statement of the conclusions drawn from the analysis.  

(12) The signed and dated reports of each of the individual scientists
or other professionals involved in the study, including each person who,
at the request or direction of the testing facility or sponsor,
conducted an analysis or evaluation of data or specimens from the study
after data generation was completed.  

(13) The locations where all specimens, raw data, and the final report
are to be stored.  

(14) The statement prepared and signed by the quality assurance unit as
described in §792.35(b)(7).  

(b) The final report shall be signed and dated by the study director.  

(c) Corrections or additions to a final report shall be in the form of
an amendment by the study director.  The amendment shall clearly
identify that part of the final report that is being added to or
corrected and the reasons for the correction or addition, and shall be
signed and dated by the person responsible.  Modification of a final
report to comply with the submission requirements

of EPA does not constitute a correction, addition, or amendment to a
final report.  

(d) A copy of the final report and of any amendment to it shall be
maintained by the sponsor and the test facility.  

§792.190   Storage and retrieval of records and data.

(a) All raw data, documentation, records, protocols, specimens, and
final reports generated as a result of a study shall be retained. 
Specimens obtained from mutagenicity tests, specimens of soil, water,
and plants, and wet specimens of blood, urine, feces, and biological
fluids, do not need to be retained after quality assurance verification.
 Correspondence and other documents relating to interpretation and
evaluation of data, other than those documents contained in the final
report, also shall be retained.  

(b) There shall be archives for orderly storage and expedient retrieval
of all raw data, documentation, protocols, specimens, and interim and
final reports.  Conditions of storage shall minimize deterioration of
the documents or specimens in accordance with the requirements for the
time period of their retention and the nature of the documents of
specimens.  A testing facility may contract with commercial archives to
provide a repository for all material to be retained.  Raw data and
specimens may be retained elsewhere provided that the archives have
specific reference to those other locations.  

(c) An individual shall be identified as responsible for the archives.  

(d) Only authorized personnel shall enter the archives.  

(e) Material retained or referred to in the archives shall be indexed to
permit expedient retrieval.  

§792.195   Retention of records.

(a) Record retention requirements set forth in this section do not
supersede the record retention requirements of any other regulations in
this subchapter.  

(b)(1) Except as provided in paragraph (c) of this section,
documentation records, raw data, and specimens pertaining to a study and
required to be retained by this part shall be retained in the archive(s)
for a period of at least ten years following the effective date of the
applicable final test rule.  

(2) In the case of negotiated testing agreements, each agreement will
contain a provision that, except as provided in paragraph (c) of this
section, documentation records, raw data, and specimens pertaining to a
study and required to be retained by this part shall be retained in the
archive(s) for a period of at least ten years following the publication
date of the acceptance of a

negotiated test agreement.  

(3) In the case of testing submitted under section 5, except for those
items listed in paragraph (c) of this section, documentation records,
raw data, and specimens pertaining to a study and required to be
retained by this part shall be retained in the archive(s) for a period
of at least five years following the date on which the results of the
study are submitted to the agency.  

(c) Wet specimens, samples of test, control, or reference substances,
and specially prepared material which are relatively fragile and differ
markedly in stability and quality during storage, shall be retained only
as long as the quality of the preparation affords evaluation.  Specimens
obtained from mutagenicity tests, specimens of soil, water, and plants,
and wet specimens of blood, urine, feces, biological fluids, do not need
to be retained after quality assurance verification.  In no case shall
retention be required for longer periods than those set forth in
paragraph (b) of this section.  

(d) The master schedule sheet, copies of protocols, and records of
quality assurance inspections, as required by §792.35(c) shall be
maintained by the quality assurance unit as an easily accessible system
of records for the period of time specified in paragraph (b) of this
section.  

(e) Summaries of training and experience and job descriptions required
to be maintained by §792.29(b) may be retained along with all other
testing facility employment records for the length of time specified in
paragraph (b) of this section.  

(f) Records and reports of the maintenance and calibration and
inspection of equipment, as required by §792.63 (b) and (c), shall be
retained for the length of time specified in paragraph (b) of this
section.  

(g) If a facility conducting testing or an archive contracting facility
goes out of business, all raw data, documentation, and other material
specified in this section shall be transferred to the archives of the
sponsor of the study.  The EPA shall be notified in writing of such a
transfer.  

(h) Specimens, samples, or other non-documentary materials need not be
retained after EPA has notified in writing the sponsor or testing
facility holding the materials that retention is no longer required by
EPA.  Such notification normally will be furnished upon request after
EPA or FDA has completed an audit of the particular study to which the
materials relate and EPA has concluded that the study was conducted in
accordance with this part.  

(i) Records required by this part may be retained either as original
records or as true copies such as photocopies, microfilm, microfiche, or
other accurate reproductions of the original records.