33 

Environmental Protection Agency Pt. 792 

(c) Amounts of the test chemical 

manufactured for export will not be included unless covered by a finding 

under TSCA section 12(a)(2). 

(d) Chemicals excluded from the jurisdiction of TSCA by section 3(2)(B) 

need not be included in the computation of production volume. (Chemicals 

used as intermediates to produce pesticides are covered by TSCA.) 

(e) The burden of establishing the 

fact that particular amounts of the 

test chemical are produced for exempt 

purposes lies with the party seeking to 

exclude those amounts from the calculation of his production volume. 

§ 791.50 Costs. 

(a) All costs reasonable and necessary to comply with the test rule, 

taking into account the practices of 

other laboratories in conducting similar tests, are eligible for reimbursement. Necessary costs include: 

(1) Direct and indirect costs of planning, conducting, analyzing and submitting the test results to EPA. 

(2) A reasonable profit, and a reasonable rate of interest and depreciation 

on the tester’s initial capital investment. 

(3) The cost of repeating or repairing 

tests where failure was demonstrably 

due to some cause other than negligence of the tester. 

(b) Costs attributable to tests beyond 

those specified by EPA shall not be eligible for reimbursement under this 

rule. 

§ 791.52 Multiple tests. 

When more than one of a particular 

kind of test required by the test rule is 

performed, the additional costs will be 

shared among all those holding exemptions. The costs of all the tests will be 

added together and each exemption 

holder shall be responsible for a share 

of the total which is equal to its share 

of the total production of the test 

chemical. The exemption holders shall 

divide their shares between test sponsors in proportion to the costs of their 

respective tests. Those sponsoring a 

particular test do not have to obtain 

exemptions for that test and therefore 

do not have reimbursement responsibilities for the same tests done by others. 

Subpart D—Review 

§ 791.60 Review. 

(a) The hearing officer’s proposed 

order shall become the final Agency 

order 30 days after issuance unless 

within the 30-day period one of the parties requests Agency review or the Administrator of his own initiative decides to review the proposed order. 

(b) The proposed order may be reviewed upon the record of the hearing 

and the petitions for review. If 

necesary, the Administrator may order 

the transcription of the stenographic 

record of the hearing, written briefs, 

oral arguments or any other reasonable 

aids to making an equitable decision. 

(c) The final Agency order may be reviewed in federal court as provided by 

26 U.S.C. 2603(c). 

Subpart E—Final Order 

§ 791.85 Availablity of final Agency 

order. 

The final Agency order shall be available to the public for inspection and 

copying pursuant to 5 U.S.C. 552(a)(2), 

subject to necessary confidentiality restrictions. 

Subpart F—Prohibited Acts 

§ 791.105 Prohibited acts. 

Failure to provide information required by the Agency or to pay the 

amounts awarded under this rule within time alloted in the final order shall 

constitute a violation of 15 U.S.C. 

2614(1) or 2614(3). 

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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
34 

§ 792.1 40 CFR Ch. I (7–1–09 Edition) 

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 biologicaI 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 


cprice-sewell on DSKDVH8Z91PROD with CFR
35 

Environmental Protection Agency § 792.10 

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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
36 

§ 792.12 40 CFR Ch. I (7–1–09 Edition) 

§ 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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
37 

Environmental Protection Agency § 792.35 

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 


cprice-sewell on DSKDVH8Z91PROD with CFR
38 

§ 792.41 40 CFR Ch. I (7–1–09 Edition) 

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 


cprice-sewell on DSKDVH8Z91PROD with CFR
39 

Environmental Protection Agency § 792.49 

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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
40 

§ 792.51 40 CFR Ch. I (7–1–09 Edition) 

§ 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, 


cprice-sewell on DSKDVH8Z91PROD with CFR
41 

Environmental Protection Agency § 792.105 

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 systemhousing 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, 


cprice-sewell on DSKDVH8Z91PROD with CFR
42 

§ 792.107 40 CFR Ch. I (7–1–09 Edition) 

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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
43 

Environmental Protection Agency § 792.135 

(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) 


cprice-sewell on DSKDVH8Z91PROD with CFR
44 

§ 792.185 40 CFR Ch. I (7–1–09 Edition) 

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 


cprice-sewell on DSKDVH8Z91PROD with CFR
45 

Environmental Protection Agency § 792.195 

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 nondocumentary 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. 


cprice-sewell on DSKDVH8Z91PROD with CFR
46 

Pt. 795 40 CFR Ch. I (7–1–09 Edition) 

PART 795—PROVISIONAL TEST 

GUIDELINES 

Subpart A [Reserved] 

Subpart B—Provisional Chemical Fate 

Guidelines 

Sec. 

795.70 Indirect photolysis screening test: 

Sunlight photolysis in waters containing 

dissolved humic substances. 

Subpart C—Provisional Environmental 

Effects Guidelines 

795.120 Gammarid acute toxicity test. 

Subpart D—Provisional Health Effects 

Guidelines 

795.225 Dermal pharmacokinetics of DGBE 

and DGBA. 

795.228 Oral/dermal pharmacokinetics. 

795.231 Pharmacokinetics of isopropanal. 

795.232 Inhalation and dermal pharmacokinetics of commercial hexane. 

795.250 Developmental neurotoxicity screen. 

AUTHORITY: 15 U.S.C. 2603. 

Subpart A [Reserved] 

Subpart B—Provisional Chemical 

Fate Guidelines 

§ 795.70 Indirect photolysis screening 

test: Sunlight photolysis in waters 

containing dissolved humic substances. 

(a) Introduction. (1) Chemicals dissolved in natural waters are subject to 

two types of photoreaction. In the first 

case, the chemical of interest absorbs 

sunlight directly and is transformed to 

products when unstable excited states 

of the molecule decompose. In the second case, reaction of dissolved chemical is the result of chemical or electronic excitation transfer from lightabsorbing humic species in the natural 

water. In contrast to direct photolysis, 

this photoreaction is governed initially 

by the spectroscopic properties of the 

natural water. 

(2) In general, both indirect and direct processes can proceed simultaneously. Under favorable conditions 

the measurement of a photoreaction 

rate constant in sunlight (KpE) in a natural water body will yield a net value 

that is the sum of two first-order reaction rate constants for the direct (kDE) 

and indirect (kIE) pathways which can 

be expressed by the relationship 

Equation 1 

kpE=kDE+kIE. 

This relationship is obtained when the 

reaction volume is optically thin so 

that a negligible fraction of the incident light is absorbed and is sufficiently dilute in test chemical; thus 

the direct and indirect photoreaction 

processes become first-order. 

(3) In pure water only, direct 

photoreaction is possible, although hydrolysis, biotransformation, sorption, 

and volatilization also can decrease the 

concentraton of a test chemical. By 

measuring kpE in a natural water and 

kDE in pure water, kIE can be calculated. 

(4) Two protocols have been written 

that measure kDE in sunlight or predict 

kDE in sunlight from laboratory measurements with monochromatic light 

(USEPA (1984) under paragraph (f)(14) 

and (15) of this section; Mill et al. (1981) 

under paragraph (f)(9) of this section; 

Mill et al. (1982) under paragraph (f)(10) 

of this section; Mill et al. (1983) under 

paragraphs (f)(11) of this section). As a 

preface to the use of the present protocol, it is not necessary to know kDE; 

it will be determined under conditions 

that definitively establish whether kIE

is significant with respect to kDE. 

(5) This protocol provides a cost effective test method for measuring kIE

for test chemicals in a natural water 

(synthetic humic water, SHW) derived 

from commercial humic material. It 

describes the preparation and standardization of SHW. To implement the 

method, a test chemical is exposed to 

sunlight in round tubes containing 

SHW and tubes containing pure water 

for defined periods of time based on a 

screening test. 

(6) To correct for variations in solar 

irradiance during the reaction period, 

an actinometer is simultaneously insolated. From these data, an indirect 

photoreaction rate constant is calculated that is applicable to clear-sky, 

near-surface, conditions in fresh water 

bodies. 


cprice-sewell on DSKDVH8Z91PROD with CFR