Attachment II - Page 53 
Federal Register / 
Pesticide: (a) any substance or 
mixture of substances intended for 
preventing, destroying, repelling or 
mitigating any pest, and (b) any 
substance or mixture of substances 
intended for use as a plant regulator, 
defoliant, or desiccant (FIFRA, section 
2(U)J. 
Pharmaceuticals: Products intended 
for use in humans, as well as in vitro 
applications to humans, including drugs, 
vaccines, diagnostics, and biological 
response modifiers. 
Phenotype: The appearance or other 
characteristics of an organism resulting 
from the interaction of its genetic 
constitution with the environment. 
Physical containment: Procedures or 
structures designed to restrict the 
release of viable organisms, degree of 
containment varies. 
Plant: Multicellular organism 
characterised by eukaryotic cells 
surrounded by rigid cell walls, 
photosynthetic ability, and embryonic 
development; members include mosses, 
liverworts, and vascular plants 
(including most terrestrial crop plants). 
Prokaryotes: A cell or organism 
lacking mebrane-bound, structurally 
discrete nuclei and organelles. 
Prokaryotes include bacteria and blue- 
green algae. 
Protist: Unicellular, colonial, or 
multicellular eukaryotic organism 
lacking embyronic development; plant- 
like protists include euglena, 
dinoflagellates, diatoms, algae (except 
blue-green); animal-like protists include 
protozoa such as amoeba and 
paramecia. 
Recombinant DNA: The hybrid DNA 
produced by joining pieces of DNA from 
different organisms or synthetic DNA 
together in vitro. 
Vol. 49, No. 252 / Monday, December 
Recombinant DNA techniques: Those 
techniques used to develop recombinant 
DNA molecules. 
Recombinant RNA: Hybrid RNA 
molecules constructed in vitro by joining 
RNA segments from different organisms 
(or synthetic RNA); techniques used to 
produce rRNA molecules. 
Recombination: Formation of a new 
association of genes or DNA sequences 
from different parental origins. 
Somatic cell: One of the cells 
composing parts of the body (e.g., 
tissues, organs) other than a germ cell. 
Species: A taxonomic subdivision of a 
genus. A group of closely related, 
miorphologically similar individuals 
which actually or potentially interbreed. 
Spontaneous mutation-. Mutation of 
unknown causes that occurs as a result 
of normal cellular operations or 
interactions with the environment and 
without direct human intervention. 
Transduction : The transfer of 
bacterial genes from one bacterium to 
another by a bacteriophage particle. 
Transfection : Transformation of 
eukaryotic and prokaryotic cells or 
uptake of free viral nucleic acids by 
cells with the subsequent formation of 
infective particles. 
Transformation: The acquisition of 
new genetic markers by incorporation of 
added DNA. 
Trqnsgenic. An animal which had a 
foreign gene transplant is a transgenic 
animal. 
Transposab/e element: Segment of 
DNA which moves from one location to 
another among and within chromosomes 
in possibly a predetermined fashion, 
causing genetic change; may be useful 
as a vector for manipulating DNA. 
Undirected mutagenesis: Use of 
chemical or physical agents to change 
the sequence of nucleotides in a DNA or 
31. 1984 / Notices 50907 
RNA in a random, nonspecific manner, 
examples of mutagens arc ethyl 
methane sulfonate, nitrosoguanidine. 
and ultraviolet light. 
Vector. DNA molecule used to 
introduce DNA into host cells. Vectors 
include plasmids, bacteriophage (virus) 
and other forms of DNA. A vector must 
be capable of replicating autonomously 
and must have cloning sites for the 
introduction of foreign DNA. 
Virus: Any of large group of 
submicroscopic agents infecting plants, 
animals and bacteria and unable to 
reproduce outside the tissues of the host. 
A fully formed virus consists of nucleic 
acid (DNA or RNA) surrounded by a 
protein or protein and lipid coat. (For 
FDA’s regulatory definition, see 21 CFR 
(500.3(h)(1).) 
Sources 
President’s Commission for the Study 
of Ethical Problems in Medicine and 
Biomedical and Behavioral Research; 
"Splicing Life. The Social and Ethical 
Issues of Genetic Engineering with 
Human Beings"; Washington. D.C.. 
November 1982. 
Office of Technology Assessment; 
U.S. Congress; “Commercial 
Biotechnology: A International 
Analysis"; Washington. D.C.; January 
1984. 
U.S. Department of Commerce; 
International Trade Administration: 
"High Technology Industries: Profiles 
and Outlook: Biotechnology": 
Washington, D.C.; July 1984. 
Dorland’s Illustrated Medical 
Dictionary; 24th Edition. 
U.S. Food and Drug Administration. 
U.S. Department of Agriculture, the 
Environmental Protection Agency. 
[FR Doc. 84-33638 Filed 12-28-64: 8.45 am| 
•ILUNO coot SM0-40-M 
[407] 
