[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR792.3]



[Page 34-35]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  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 Sec.  

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



[[Page 35]]



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.