Federal Register / Vol. 46, No. 233 / Friday, December 4, 1981 / Notices 
59391 
guidelines, or (2) totally abolishing the 
guidelines. The route recommended by 
the subcommittee will then be 
discussed. 
1. Maintain the Status Quo. 
a. Advantages. The status quo is not 
static, since the 1978 major revision of 
the guidelines recognized the need for 
constant evolution of the guidelines and 
provided procedures for changes which 
have been applied frequently in the last 
three years. The guidelines have been 
useful; their existence raised the 
awareness of investigators and 
institutions as to the importance of 
considering and avoiding hazards in the 
laboratory. If there are significant 
dangers associated with recombinant 
DNA research, the safety of this 
research thus for may have been due to 
the existence of the guidelines. Time 
will permit accumulation of more 
experience and data relevant to risk 
assessment so that reductions in 
restrictions can be derived from a 
greater factual base. A carefully 
thought-through simplification of the 
guidelines could be one immediate aim, 
while preserving the current guideline 
structure. 
Gradual evolution of the guidelines 
would permit exploration of the means 
of dealing with possible laboratory- 
created biohazards so that tracking 
systems for such hazards in general — 
inclusive, but not limited to, those that 
might arise from recombinant DNA 
technology — might be established. To 
monitor biohazards, an expanded role 
for a body similar in concept to RAC 
might also be explored, as well as that 
body’s relation to the IBCs. Current 
guidelines for good laboratory practices 
could be examined and possibly 
adapted to include recombinant DNA 
experiments. 
b. Disadvantages. The current 
guidelines are long, cumbersome, and 
detailed. They are, in practice, 
regulations rather than guidelines. 
Because no guidelines or regulations can 
hope to anticipate, in detail, all 
experiments or circumstances, 
particularly in such a rapidly growing 
field, much time and effort are expended 
by investigators, RAC, and ORDA with 
requests to alter containment 
requirements or be granted exemptions 
from guidelines. The record shows that 
more often than not, after careful 
deliberation, the requests are granted. 
Most scientists now conclude, after 
almost a decade of experience, 
deliberate risk assessment 
experimentation and theorizing, that the 
potential risks of recombinant DNA 
research have not materialized and most 
probably will not. While it is not 
possible to exclude with certainty risks 
to man or the ecosystem from 
application of recombinant DNA 
technology, at present these risks now 
appear to be much smaller than they 
appeared to be a few years ago. 
In view of this conclusion, the current 
guidelines are too complex and 
restrictive of development of useful 
knowledge with direct health, 
agricultural, and economic benefits. 
They require a bureaucratic apparatus 
and an amount of paperwork that is 
viewed as excessive and excessively 
costly in terms of dollars and 
professionals’ time. 
2. Abolish the Guidelines. 
a. Advantages. In the absence of 
known or suspected hazards, it appears 
unjustified to single out certain classes 
of experiments as requiring elevated 
levels or physical containment. Similarly 
unjustified is the expenditure of time 
and money required to maintain a 
regulatory apparatus that has been 
developed to protect society firom 
hazards that may be non-existent. What 
residual uncertainties exist about such 
hazards can be handled more flexibly 
and more efficiently at the level of the 
individual scientist, with consultation 
with others as he sees fit. In some 
universities, the procedures for 
monitoring laboratory hazards will 
remain in force and provide a backup 
system for checking on the individual 
scientist. Other kinds of laboratory 
guidelines (e.g., those for working with 
human and animal pathogens) will still 
exist and will provide guidance for 
proper use of such organisms when 
recombinant DNA technology is used. 
Since many of the residual concerns are 
centered around changing the host range 
and pathogenicity of already existing 
pathogens, such appropriate 
containment procedures should be 
adequate and in line with the existing 
dangers. 
b. Disadvantages. There remain some 
areas in which specific risks may exist. 
It would seem appropriate to have some 
mechanism for ensuring that scientists 
consider these risks before and during 
their experimentation, and that they 
seek some outside advice on how 
serious the risk may be. The current IBC 
structure, with ORDA and RAC as 
backup, provides such a structure. Its 
abolition will also leave the regulatory 
aspects of the field in chaos, and may 
encourage local jurisdictions, which may 
come to different conclusions about the 
degree of certainty concerning special 
risks, to enact less informed and less 
flexible guidelines and regulations for 
control of this field. In any case, 
individual determinations in many areas 
of the country will possibly require more 
time and effort of more scientists than if 
the same determination was made once 
centrally. The results will also be less 
uniform, encouraging pressure on local 
groups to keep containment low. 
In the absence of a working procedure 
for monitoring other laboratory hazards, 
it seems foolhardy to abandon this 
mechanism even if one concludes that 
recombinant DNA risks are not 
qualitatively different from other 
research risks. It may be more 
appropriate to refine the mechanisms for 
tracking recombinant DNA experiments 
such that this mechanism can be used as 
a model for watching and preventing 
other research risks. 
C. Recommendation 
The Working Group on Revision of the 
Guidelines has proposed changes in the 
guidelines which (1) would significantly 
reduce required containment for a large 
class of experiments, (2) would employ 
other guidelines to set appropriate 
containment for working with pathogens 
containing recombinant DNA, and (3) 
would eliminate the prohibited class of 
experiments, including the large volume 
growth of recombinant DNA containing 
organisms, relegating them to the same 
status as other experiments. The 
proposal does retain, however, the 
requirement for IBC prereview of non- i 
exempt experiments, and suggests that ' 
in specific cases where additional risk ' 
might be expected due to the nature of 
the recombinant DNA experiment itself, [ 
the containment should be adjusted [ 
accordingly. Thus, this procedure would | 
have the effect of ii 
(1) Supporting the notion that, for the jj 
vast majority of recombinant DNA ^ 
experiments, the risks are those ^ 
associated with the organisms involved. ^ 
The appropriate containment for ij 
pathogens such as that specified by the (ti 
proposed GDC Biosafety Guidelines for )i| 
Microbiological and Biomedical ^ 
Laboratories would continue to be j 
enforced for experiments utilizing 
recombinant DNA. gi 
(2) Simplifying the containment levels - 
for the vast majority of experiments, and y 
in most cases decreasing the required ' 
containment. 
(3) Retaining flexibility in allowing _ 
change in containment in particular r 
experiments where circumstances ij 
permit. Flexibility would reside |j 
primarily with the IBC, and, if !' 
necessary, questions could be referred 
to RAC. 
(4) Maintaining the class of "exempt” 
experiments, which covers the majority 
of recombinant DNA experiments; new 
additions could be made to this class as 
justified. 
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