33100 
NOTICES 
• International scientific represen 
tatives present at the hearing reported 
on guidelines prevailing in the United 
Kingdom and Western Europe and on 
their interpretation by Genetic Manip- 
ulation Advisory Groups. It was point- 
ed out that some experiments are per- 
mitted in Europe which are not per- 
mitted in America. More importantly. 
It was noted that there is no factual 
basis upon which to defend the great- 
er stringency of the U S. (NIH) guide- 
lines. 
• There was special emphasis by 
public commentators on the need for 
procedures at the local and national 
level to insure public participation and 
oversight. The public and scientific 
commentators were especially con- 
cerned that there should be a commit- 
ment at the local and national levels 
to the training of all laboratory per- 
sonnel. and to health surveillance, 
when feasible, to Insure occupational 
health and safety. Concern was also 
expressed for local community partici- 
pation to Insure that practices In the 
laboratory meet public and environ- 
mental safety requirements. 
• Several representatives from the 
private sector urged that NIH consider 
introducing mechanisms into the pro- 
posed revisions to allow private-sector 
participation through the guidelines. 
They urged that NIH provide for their 
voluntary registration, certification of 
their host-vector ays ems. and provi- 
sion for the protection of proprietary 
information and patent rights. 
• Strong support came from both 
the scientific community and the 
public for clear enunciation of the 
benefits and potential risks of this re- 
search. In addition, several of the 
public commentators urged that the 
rationale for the classification of per- 
missible experiments be staled more 
clearly. 
• Finally, a number of commenta- 
tors In the scientific community and 
representatives from institutional bio- 
hazards committees advocated more 
flexible implementation of the NIH 
guidelines. Specifically, the locus of re- 
sponsibility for the use of the guide- 
lines must shift further toward the in- 
st it it ions conducting the research. 
Present requirements for NIH approv 
al before an experiment may proceed 
have caused delays unjustified by 
proof that safety has been enhanced. 
All of the issues raised by the com- 
mentators w'ere carefully analyzed. A 
number of possible revisions were de- 
veloped and referred to the Recombin- 
ant Advisory Committee for review 
The following items were among those 
on the agenda of the Recombinant Ad 
visory Committee at its April 1978 
meeting: 
• To redefine the scope of the 
guidelines, including construction of a 
first list of ' exempted exchangers 
• To review selected issues on the 
guidelines raised by the public com- 
mentators; 
• To review the containment levels 
for experiments with viral DNA or 
viral vectors and with plant pathogens 
or viruses. 
On the basis of the issues raised and 
the response of the Recombinant Ad- 
visory Committee, a decision and envi- 
ronmental impact assessment on pro- 
posed revisions is offered for public 
comment. The assessment that follows 
explains the present guidelines, the 
RAC’s alternatives, the alternatives 
posed by the public and scientific com- 
mentators at the public hearing and in 
correspondence, the RAC's views on 
the issues raised at the April 1978 
meeting, and the assessment of the re- 
DNA plays to two roles: (1) provides 
Information for the reproduction, 
growth, and functions of the cell, and 
(2) preserves and directs replication of 
this information and transfers it to 
the offspring. These two roles of DNA 
are common to animals, plants, single- 
cell organisms, and many viruses. The 
DNA of cells is mainly found In orga- 
nized structures called ’’chromo- 
somes.” 
Intracellular DNA also occurs out- 
visions as proposed by the Director. 
NIH. 
The Recombinant DNA Experimental 
Process 
All living things, from subcellular 
particles to higher organisms, contain 
the specific information needed for 
their reproduction and functions. The 
basic source of this information is 
deoxyribonucleic acid (DNA), which is 
the principal substance of the genes— 
the units of heredity. Genes determine 
the characteristics of the species as 
well as individual traits such as size 
and eye color. 
Each cell of an organism is com- 
posed of various organized structures, 
several of which contain DNA. Figure 
1 illustrates a typical eukaryotic, or 
nucleated, cell. Bacterial cells (prokar- 
yotic) are much less complex, showing 
fewer organelles and no organized nu- 
cleus. 
side of the chromosomes as separately 
replicating molecules. Such DNA mol- 
ecules include the plasmids, found in 
bacteria; the DNA of chloroplasts, 
common to green plants; and the DN A 
of mitochondria, the energy-producing 
units of the cells of complex organ- 
isms. These DNA's. while not strictly 
part of the inherent genetic make-up 
of a cell, help define the cell’s func- 
tional capability Another type of 
DNA commonly found in cells is the 
DNA of infecting viruses. 
FEO'AAl REGISTER, VOL 43, NO. 146— FRIDAY, JULY 28, 1978 
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