As used in this part the following terms shall have the meanings specified:
Application for research or marketing permit means any of the following:
Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to § 160.105(a) .
Carrier means any material, including but not limited to feed, water, soil, 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 known 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.
FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 321 et seq).
FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act as amended (7 U.S.C. 136 et seq).
Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit thereof, or 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:
Study means any experiment at one of 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, product performance (efficacy studies only as required by 40 CFR 158.400 or 161.640 , as applicable), environmental and chemical fate, persistence and residue, 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:
Test system means any animal, plant, microorganism, chemical or physical matrix, including but not limited to soil or water, or subparts 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.
Vehicle means any agent which facilitates the mixture, dispersion, or solubilization of a test substance with a carrier.
40 C.F.R. §160.3