204 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
only be demonstrated that harmful events are level of uncertainty it is willing to accept. 
unlikely. Hence, society must determine what 
Other concerns 
Concerns raised by industrial 
applications 
Originally concerns involved hazards that 
might arise in the laboratory. Now that there 
are industrial applications of genetic engineer- 
ing, the concerns include: 
• risks associated with the laboratory con- 
struction of new strains of organisms, 
• risks associated with industrial production 
or consumer use of the new strains, and 
• risks associated with the products obtained 
from the new strains. 
Many similar considerations apply to the as- 
sessment of the first two kinds of risks. Unless 
the organisms used in an industrial production 
scheme are thoroughly characterized, conjec- 
tured fears about their ability to cause disease 
will continue. Even with a recombinant orga- 
nism that has a well-defined sequence of DNA, a 
break in containment would leave its behavior 
in the environment questionable. Experience 
with substances such as asbestos gives rise to 
fears that exposure to the new biological sys- 
tems might also cause unforseen pathological 
conditions at some future time. 
Hazards associated with products raise dif- 
ferent questions. The growing consensus in 
Federal regulatory agencies appears to be that 
these products should be assessed like all 
others— e.g., human growth hormone (hGH) 
produced by genetically engineered bacteria 
should be tested for purity, chemical identity, 
and biological activity just like hGH from human 
pituitary glands. The possibility of product 
variation due to mutation of the bacteria, 
however, suggests that batch testing and certifi- 
cation might be warranted as well. (For further 
discussion see ch. 11.) 
Concerns raised by the implications of 
the rDNA controversy for general 
microbiology 
Questions about the |)Otential hai'in from 
genetically engineered micro-organisms have 
led to questions about the efforts curixMitly 
employed to protect the public fi'om work being 
done with micro-organisms known to he hazard- 
ous. These viruses, bacteria, and fungi are 
handled daily in laboratory expei’iments, in the 
routine isolation of infectious agents from |)a- 
tients, and in the production of \ accines in the 
pharmaceutical industry. 
Questions have been raised about the efficacy 
of regulations established for these xai'ious 
potentially hazardous agents. A full-s('ale as.sess- 
ment is not within the scope ot this study, hut it 
is clear that the (|uestions are* piM tiniMit. I wo 
conclusions have been reaclKul. 
First, there is a growing h(‘li('f that the mere 
existence of a classification scheme for ha/.aid- 
ous agents by the Clenter for Disease (l)nlrol 
(GDC) is not enough to ensure their .safe han- 
dling. The Subcommittee on .\rho\ irus Labora- 
tory Safety was formed I'ecently because of con- 
cerns expressed in academic ('ircles. Ke|)ia‘senl- 
atives from unixersities, the I’uhlic Health Serv- 
ice, the U. S. DepartiiHMit of .Agriculture, and 
the military, who constitutc'd the suhcommit- 
tee, are prej)aring a report based on an interna- 
tional survey of laboratory practices and inlec 
tions. They found wide' vaiiation in the wavs 
different agents vv(M'(> liandled Most ol their 
recommendations are idcMitical with those ,i|)- 
plicahle to rDNA— that appropriate cont.iinment 
levels he used with diffeicnt viiuses that the 
health of workers lu' monitored, and th.it .in In 
stitutional Biosafety (l)mmittee he appointed to 
serve each institution. 
