60080 
[4110-08 M] 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
Notional Inttitvtot of Hoalih 
RECOMBINANT ONA RESEARCH 
Rovitod Cuidolinot 
I am announcing today several ac- 
tions affecting the conduct of recom- 
binant DNA research In this country. 
In taking these steps. I have been 
guided by my responsibility to allow 
the maximum freedom of scientific in- 
quiry consistent with the protection of 
the public health and the environment 
and with respect for the important 
ethical concerns surrounding genetic 
research In general. 
The research techniques used to pro- 
duce recombined molecules of deoxyri- 
bonucleic acid, the complex chemical 
that codes genetic information for all 
living cells, hold great promise for sig- 
nificantly advancing our understand- 
ing of fundamental biological process- 
es. Moreover, this research may also 
hold potential for the commercial pro- 
duction of needed biological materials 
and agricultural products. 
From the pioneering days of this re- 
search. many of this nation's leading 
scientists expressed concern that the 
insertion of foreign genes Into micro- 
organisms could carry the potential 
for harm by yielding new disease-pro- 
ducing organisms. Although no harm 
has resulted from recombinant DNA 
research to date, there has been wide- 
spread uncertainty as to the degree of 
risk involved. 
We must always recognize that sci- 
entific knowledge is not immutable: It 
Is constantly changing as research 
generates additional Information and 
understanding. Public policy in the 
field of science must therefore be 
flexible— to allow change as knowledge 
and understanding Increase. The re- 
quirements that we Impose must con- 
stantly be revised and updated to re- 
flect new knowledge. Today the expe- 
rience and insights that we have 
gained provide the basis for relaxing 
some of the restrictions the National 
Institutes of Health first Imposed in 
1976 on recombinant DNA research it 
funds. 
The actions I am Announcing today 
strive to allow the greatest freedom of 
scientific Inquiry possible. At the same 
time, they provide the protections nec- 
essary to safeguard the public health 
and environment and also provide the 
opportunity for those concerned to 
raise any ethical Issues posed by re- 
combinant DNA research. 
Specifically. I am today: 
• Approving final guidelines pre- 
pared by the National Institutes of 
Health that significantly revise the 
NOTICES 
safety requirements for conducting re- 
combinant DNA research: 
• Taking immediate steps to require 
that research conducted by private 
companies complies with the NIH 
guidelines, primarily through use of 
the regulatory authority of the Food 
and Drug Administration (at Appendix 
A): 
• Requesting the Environmental 
Protection Agency to review its au- 
thority and to take all action it can to 
require compliance with the NIH 
guidelines by companies that carry out 
DNA research but whose products are 
not regulated by the Food and Drug 
Administration: 
• Directing NIH to increase Its re- 
search designed to determine the 
extent of risk associated with recom- 
binant DNA research (at Appendix B); 
• Broadening substantially the 
public representation on the HEW ad- 
visory committee that will assist NIH 
In administering the revised guide- 
lines: 
• Increasing significantly public 
access to information about recombin- 
ant DNA research activities and in- 
creasing public participation in the ad- 
ministration of the guidelines in local 
communities. 
Revises Guidelines 
The revised final guidelines that 
NIH has developed and that I am ap- 
proving today set new directions for 
regulation of future recombinant DNA 
research. These final guidelines retain 
much of the guidelines that NIH pub- 
lished in proposed form last July. But 
NIH has made many revisions based 
on public comment and on the review 
conducted by a Departmental commit- 
tee. The Director. NIH. has prepared a 
Decision Document responding to the 
public comments and explaining the 
reasons for the revision. 
The final guidelines relax some of 
the restrictions under which recom- 
binant DNA research ha' been con- 
ducted since 1976. and <it the same 
time increase the role c. the public In 
approving and monitoring recombin- 
ant DNA experiments. 
In particular, these final guidelines 
relax in two major respects the guide- 
lines that were placed in effect in 
1976. 
• The revisions exempt altogether 
five categories of experiments from the 
guidelines' restrictions. NIH has con- 
cluded that these experiments present 
no known health risk. Approximately 
one-third of research covered under 
the existing guidelines would be 
exempted under the revised standards. 
The revised guidelines continue to 
ban all six categories of potentially 
hazardous research that the 1976 
guidelines prohibited. They will now. 
however, permit the Director of NIH 
to grant— following public notice and 
comment— case-by-case exceptions to 
these prohibitions with appropriate 
safeguards. 
• The revised guidelines will ease re- 
strictions on other permissible experi- 
ments. Depending on the potential 
risk of an experiment, both the 1976 
guidelines and today's revised guide- 
lines require a researcher to comply 
with one of four levels of protective 
laboratory procedures and one of 
three levels of restrictions on the type 
of organism that may be used in the 
research. The revised guidelines assign 
almost all categories of research physi- 
cal containment and/or biological con- 
tainment levels at least one step lower 
than in the 1976 guidelines. Since the 
likelihood of harm now appears more 
remote than was once anticipated, the 
scientific community has now conclud- 
ed that this downgrading is appropri- 
ate. The four levels of physical con- 
tainment and three levels of "biologi- 
cal containment"— the. use of weak- 
ened organisms that cannot survive 
outside the laboratory— set by the 
1976 guidelines would remain the 
same. 
Based on the review and public hear- 
ing conducted by a Departmental com- 
mittee, the guidelines have been sig- 
nificantly rewritten from the July ver- 
sion to increase public participation at 
both the local and national level: 
• Twenty percent of the members of 
local Institutional Biosafety Commit- 
tees (IBC's) must represent the general 
public, and /lave no connection to the 
institution. The 1976 guidelines had 
no such requirements for public par- 
ticipation. 
• Important records must be made 
public. The bulk of IBC records must 
be made available to the public and 
problems, violations, illnesses and acci- 
dents must be reported to NIH. 
• At the national level, major ac- 
tions cannot be taken without advice 
of the Recombinant DNA Advisory 
Committee (RAC) with public and Fed- 
eral agency comment Major actions 
include decisions to approve on a case- 
by-case basis experiments that are 
generally prohibited, to exempt addi- 
tional categories of research from the 
guidelines, to permit the insertion of 
genes in new types of bacteria, and to 
approve changes in the guidelines 
themselves. 
Finally, today’s revised guidelines 
provide more explicit guidance both 
for local Institutions and for NIH to 
follow in implementing the guidelines. 
• Institutions must develop emer- 
gency plans covering accidental spills 
and personnel contamination; health 
surveillance programs for projects 
needing such safeguards; and training 
programs for IBC members, research- 
ers, and other laboratory staff. 
• Under the revised guidelines, the 
NIH Director cannot approve pro- 
FEDERAl REGISTER, VOL 43, NO. 147 — FRIDAY, DECEMBER n, 1778 
