14 
TITLE I— INTERIM REGULATION OF RECOMBINANT 
DNA ACTIVITIES 
Section 101. Definitions 
(1) DNA 
DNA is used throughout the proposed legislation as the abbreviation 
for deoxyribonucleic acid, the molecular entity which is the primary 
site of genetic information for all living organisms and a large frac- 
tion of viruses. 
(2) Recombinant DNA 
Subparagia*.^ (A) contains an operational definition of recom- 
binant DNA, designed to be consistent with that in the proposed revi- 
sions to the NIH Guidelines. In order to be considered recombinant 
DNA, a DNA molecule must consist of two or more DNA segments 
which are joined together outside of living cells and must have the ca- 
pacity to enter ana propagate within a living cell, either autono- 
mously or after integration with the cell’s genome. This definition is 
intended primarily to cover those molecules formed by the site spe- 
cific recombination of double stranded DNA segments obtained as 
products of restriction endonuclease digestion of larger DNA mole- 
cules. However, this definition also includes recombinant DNA mole- 
cules which contain chemically synthesized segments or which are 
formed using enzymes other than restriction endonucleases and DNA 
ligase. 
Because replication products of recombinant DNA molecules are 
presumably identical to the parent molecules, but formed inside liv- 
ing cells, they are also to be considered recombinant DNA for the pur- 
poses of legislation, as specified in subparagraph (B). That is, all of 
the cells in a bacterial clone resulting from a single cell containing re- 
combinant plasmid DNA, are considered to be cells containing recom- 
binant DNA. 
It is recognized that some recombinant DNA molecules may not 
represent a unique or unusual set of genes to be propagated in a partic- 
ular host cell, and thus not create a potentially hazardous organism. 
However, it is the Committee’s intent that any exclusions for obvi- 
ously safe host- vector combinations be included under section III of 
the NIH Guidelines, or by exemptions from the requirements of this 
title granted under section 102(b). 
(3) Recombinant DNA activity 
The phrase “recombinant DNA activity” is used throughout the 
recombinant DNA Act to denote all uses of recombinant DNA, includ- 
ing research, transportation, possession or production. 
(4) Public entity 
An important clause in definition (3), “recombinant DNA activity”, 
defines as included in this Act any activity “undertaken in a state by 
any individual or public or private entity”. The term “public entity” is 
defined here as any Federal, state or local government entity. This 
[Appendix B — 144] 
