August 2, 1977 CONGRESSIONAL RECORD — SENATE S 13317 
or to make any requirements applicable to 
recombinant DNA activities. 
■‘(b)(1) Upon application by a Federal 
agency, and after consultation with euch 
agency, the Secretary may exempt euch 
agency from subsection (a) . 
"(2) An application for an exemption shall 
be accompanied by the proposed require- 
ment and the reasons therefor. 
“(3) If the Secretary grants an exemption, 
the proposed requirement shall be promul- 
gated in accordance with section 553 of title 
5 of the United States Code. 
"(4) The Secretary may limit, alter, or 
withdraw such exemption. 
“EFFECT OH STATE AND LOCAL. REQUIREMENTS 
“Sec. 484. (a) Except as provided in sub- 
section (b), no State or political subdivision 
of a State may establish or continue in ef- 
fect any requirement for the regulation of 
recombinant DNA activities. 
“(b) Upon application of a State or po- 
litical subdivision o* a State, the Secretary 
may allow, by order promulgated after pro- 
viding (in accordance with this subsection) 
notice and opportunity for an oral hear- 
ing on such application and after consider- 
ing local conditions, exempt from subsec- 
tion (a), under such conditions as may be 
prescribed In such order, a requirement of 
such State or political subdivision applica- 
ble to recombinant DNA activities if — 
"(1) the requirement is more stringent 
than a requirement under this part which 
would be applicable to such activities if an 
exemption were not In effect under this sub- 
section; and 
“(2) the requirement is necessary to pro- 
tect health or the environment and Is re- 
quired by compelling local conditions. 
A State or political subdivision which sub- 
mits an application under this subsection 
6hall be given an opportunity for an oral 
hearing on such application to be commenced 
not later than sixty days from the date the 
application is submitted. The presiding offi- 
cer at such a hearing shall upon conclusion 
of the hearing make a written recommenda- 
tion to the Secretary respecting approval of 
the application upon which the hearing was 
held. 
“(c) Within— 
“(1) sixty days of the conclusion of a hear- 
ing held on an application submitted under 
subsection (b) , or 
"(2) one hundred and twenty days of the 
date the application was submitted, 
whichever occurs later, the Secretary shall 
either approve or disapprove such applica- 
tion. The decision of the Secretary shall be 
In writing, shall, if a hearing was held on 
the application, contain the recommendation 
made by the presiding officer at such hearing, 
and shall Include a statement of the reasons 
for the decision of the Secretary. 
“training and studies 
“Sec. 485. (a) The Secretary may conduct 
and support training in the safe handling of 
recombinant DNA. 
“(b) The Secretary shall conduct or sup- 
port on a continuing basis studies designed 
to assess the risks to health and the envi- 
ronment which may be presented by recom- 
binant DNA activities.”. 
expiration of act 
Sec. 4. This Act expires five years after Its 
enactment. 
XT Supplemental Views or 
Senator Nelson 
S. 1217, a bill to regulate deoxyribonucleic 
acid (DNA) activities has a laudable goal: 
the protection of public health and safety 
by requiring that uniform national guide- 
lines be met by scientists conducting recom- 
binant DNA research, both in publicly sup- 
ported and private Industry research labora- 
tories. 
However, I am concerned that 8. 1217 Is 
unnecessarily burdensome and detrimental 
to the future of this Important biomedical 
research. 
Scientists all agree that the Joining to- 
gether of different segments of deoxyribo- 
nucleic acid (DNA) is a potent tool for the 
conquest of disease and other beneficial 
scientific advances. The recently announced 
discovery that recombined genes facilitate 
the production of insulin by bacteria is an 
example of such an important breakthrough. 
Recombining fragments of DNA occurs con- 
tinually in nature. Four years ago, however, 
at a 1973 Gordon Conference on Nucleic 
Acids, scientists involved in developing re- 
combinant DNA research drew attention to 
the possible hazards of manmade recom- 
binants. 
Because scientists and laboratory techni- 
cians are at greatest risk of direct contact 
with the organisms involved, they have been 
most concerned with clearly defining the haz- 
ards. To date, despite many thousands of 
recombinant DNA experiments, no known 
hazards have occurred. 
Nevertheless, as a result of concerns ex- 
pressed in the 1973 Gordon Conference, and 
a 1975 Asilomar Conference, guidelines were 
promulgated by the National Institutes of 
Health (NIH) in 1976, which are required to 
be met by any researchers having Federal fi- 
nancial support. The guidelines, however, 
cannot be enforced In the private sector 
without enabling legislation. 
Therefore, legislation to simply extend the 
NIH Guidelines to all sectors engaged in re- 
combinant DNA activities seems appropriate. ' 
NIH guidelines 
The NIH guidelines prohibit certain kinds 
of recombinant DNA experiments and the 
release of recombinant molecules into the en- 
vironment. Permissible experiments are out- 
lined and are assigned both a physical and 
biological containment level, depending on 
assessment of potential blohazards.- 
iPhyslcal containment refers to methods 
used to prevent release of organisms con- 
taining recombinant DNA molecules from 
the lab. Relying on proven methods that 
have been developed for handling known 
pathogenic organisms in clinical and research 
laboratories, physical containment Is ap- 
proached in two ways: (1) standard micro- 
biological practices and training are pre- 
scribed by the guidelines; (2) special kinds 
of equipment and facilities are used. Four 
levels of physical containment are described, 
progressing from least to most strict; P-1, 
P-2, P-3, P-4. 
Biological containment refers to methods 
whereby organisms are weakened, so that, in 
the event of their escape from the laboratory, 
their survival is extremely improbable. The 
guidelines characterize three levels of im- 
pairment of a weakened laboratory strain 
known as E-coll K-12. 
The guidelines also provide an administra- 
tive framework for their implementation and 
a compendium of safety information. 
The guidelines require establishment of 
Institutional bio-hazard committees for local 
review of recombinant DNA activities. 
A Recombinant DNA Advisory Committee, 
under the auspices of the' National Institutes 
of Health, meets regularly to review and up- 
date the guidelines. At their May 15, 1977, 
meeting, the Advisory Committee issued the 
following statement: 
During this period the committee has be- 
come better Informed abou/t the general ecol- 
ogy and epidemiology of infectious micro- 
organisms. Experiments have been reported 
showing that the incqrporation of foreign 
DNA does not Increase but rather tends to 
decrease the growth rate of microorganisms, 
and this further contributes to the unlikeli- 
hood that cells carrying recombinant DNA 
will survive in nature and produce harmful 
effects. Indeed, everything that we have 
[ 809 ] 
learned has tended to diminish our estimate 
of risk. Nevertheless, the revised guidelines 
continue to represent a deliberately conserva- 
tive approach, with the intent of erring on 
the side of caution. 
Uniform guidelines 
The Federal Inter-Agency Committee Re- 
combinant DNA Research in 1976 proposed 
that a single set of national standards be 
applied to all recombinant DNA activities. 
HEW and representatives of private indus- 
try testified before the Health Subcommittee 
that all laboratories receiving Federal grants 
now comply with the NIH guidelines, and 
private laboratories voluntarily impose the 
same guidelines on themselves. However, the 
extent to which the guidelines are enforced 
in the private sector, cannot be determined 
without Federal law. 
Therefore, the administration proposed a 
bill, largely based on the committee's recom- 
mendations, which provided HEW with the 
responsibility for regulation and specified 
that the NIH guidelines be promulgated as 
Initial standards. The scope of the regulation 
was directed to the use and production of 
recombinant DNA molecules. The Depart- 
ment was to exercise its regulatory authority 
In close consultation with other appropriate 
agencies. 
Scientists’ concerns - 
A 1977 Gordon Research Conference on 
Nucleic Acids expressed serious reservations 
about pending legislation. An open letter to 
Congress, June 18, 1977, signed by 137 mem- 
bers of the conference states: 
We are concerned that the benefits of re- 
combinant DNA research will be denied to 
society by unnecessarily restrictive legisla- 
tion. 
Four years ago, the members of the 1973 
Gordon Conference on Nucleic Acids were 
the first to draw public attention to possible 
hazards of recombinant DNA research. The 
discussions which'started at that meeting re- 
sulted in the Issuance in 1976 of the NIH 
guidelines for the conduct of this research. 
We, members of the 1977 Gordon Research 
Conference on Nucleic Acids, are now con- 
cerned that legislative measures now under 
consideration by congressional, State and 
local authorities will set up additional reg- 
ulatory machinery so unwieldy and unpre- 
dictable as to inhibit severely the further 
development of this field of research. We feel 
that much of the stimulus for this legisla- 
tive activity derives from exaggerations of 
the hypothetical hazards of recombinant 
DNA research that go far beyond any rea- 
soned assessment. 
This meeting made apparent the dramatic 
emergence of new fundamental knowledge 
as a result of application of recombinant 
DNA methods. On the other hand, the ex- 
perience of the last 4 years has not given any 
Indication of actual hazard. Under these cir- 
cumstances, an unprecedented Introduction 
of prior restraints on scientific inquiry seema 
unwarranted. 
We urge that Congress consider these views. 
Should legislation nevertheless be deemed 
necessary, it ought to prescribe uniform 
standards throuhgout the country .and be 
carefully framed so as not to impede scien- 
tific progress. 
The 137 undersigned are members of the 
1977 Nucleic Acids Gordon Conference. _ 
In addition, a number of other scientists 
and scientific organizations have expressed 
similar concerns, Including the Inter-Society 
Council for Biology and Medicine, compris- 
ing officers of seven professional organiza- 
tions; the American Institute of Biological 
Sciences, the American Society for Medical 
Technology, the American Society for Micro- 
biology. the American Society of Allied 
Health Professions, the Association of Amer- 
ican Medical Colleges, the Federation of 
American Societies for Experimental Biology 
