33096 
NOTICES 
National In s t i tut es or Health. Exvi- 
bonmextal Impact Assessment or a 
Proposal To Release Revised NIH 
Guidelines roe Research Involtinc 
Recomxinant DNA Molecules 
rr ERASED BY THE OFT1CX or THE D I REC- 
TO*. NATIONAL IN S T I T U T ES OT 
health— July ibtb 
Summary 
Mature of Document Emironmental 
Impact Assessment. 
Agency: National Institutes of 
Health. Public Health Service. U S. 
Department of Health. Educat.cn. and 
Welfare. 
7>?e of Action : (X) Administrative. 
( ) LefisiaUre. 
Description of Action: Publication 
for public comment of proposed re- 
vised Etude lines for research involving 
recombinant DNA molecules. 
Organization of Material: Back- 
ground information is presented on 
the recombinant DNA process and on 
the presumed risks and demonstrable 
benefit* of this basic research tech- 
nique. Next the proposed revised 
guidelines are analyzed according to 
their four main parts; scope, principles 
of containment of possibly hazardous 
agents, proposed changes In the con- 
tainment for experiments to be cov- 
ered by the revised guidelines, and 
roles and responsibilities of investiga- 
tors and institutions. 
Analysis of Alternatives. For each of 
these four main parts, the assessment 
is presented under four sections: anal- 
ysis of the current Guidelines (in 
effect since June 23. 1979 r. alterna- 
tives (revisions) proposed by the .VI H 
Recombinant DNA Advisory Commit- 
tee ' RAC) ! Federal Register. Septem- 
ber 27. 1977); alternatives proposed by 
the Director J67H. after full considera- 
tion of scientific evidence, public com- 
ments. and the testimony taken in 1 1 
day meeting of the Director's Advisory 
Committee (DAC) at which scientists 
of various disciplines, representatives 
of environmental groups, and other 
witnesses discussed the RAC propos- 
als: and finally, the projected environ- 
mental impact of research to be con- 
ducted under the NTH Director's pro- 
posed guide lines. Appendix A wHJ aid 
in comparing the conts nment levels 
under the current guidelines with 
those under the two alternatives. Ap- 
pend ix B shows how those alternatives 
would have affected all NTH-funded 
recombinant DNA experiments active 
m December 1977. 
f snron’neelcf Impact of the Pro- 
posed Action: As can best be deter- 
mined from all evidence compiled to 
date and analyzed in numerous scien- 
tific and public forums, there will be 
no adverse environmental impact from 
recombinant DNA research conducted 
under the Director's proposed revi- 
sions. The Z-vironmeniol Impact 
Statement cn N1H Guidelines for Re- 
search Involving Recombinant DMA 
MolecvJes. issued in October 1977. pre- 
dicted that the environmental impact 
of research conducted under the 1976 
NIH Guidelines would be the contin- 
ued prelection of the laboratory 
worker, the general public, and the en- 
vironment from conjectural hazards. 
So far. this prediction has been con- 
firmed; We know of no scientists con- 
ducting recombinant DNA research in 
the United States or other countries 
who are not following the NIH or com- 
parable guidelines, and ro untoward 
effect of the research has re* n report- 
ed. Meanwhile, new scientiftc evidence 
as well as extern. vc experience to oper- 
ating under the NIH Guidelines indi- 
cate that revisions are in croer. The 
predictable effect of continued use of 
reccmb'nant DNA techniques under 
the Directors proproed revisions 
would be a greater realization of the 
benefits of this valuable tool without 
compromise of safety. 
Contents 
Po reward 
The Recombinant DNA Experimental 
Process 
Risks and Benefits of Recombinant 
DNA Research. 
Analysis of Alternatives and Impact of 
Proposed Guidelines. 
I. Scope of the Guidelines. 
Analysis of Current Guidelines. 
Alternatives RAC-Proposed Re- 
visions. 
AitemaHves Public Commenta- 
tors 
Proposed Action; Environmental 
Impact Assessment 
II. Containment 
Analysts of Current Guidelines. 
Alternatives; RAC-Proposed Re- 
visions. 
Alternatives; Public Commenta- 
tors. 
Proposed Action Environmental 
Impact Assessment. 
III. Containment Guidelines for 
Covered Experiments. 
Analysis of Current Guidelines. 
Alternatives; RAC-Proposed Re- 
visions. 
Alternatives; Public Commenta- 
ti n 
Proposed Action; Environmental 
Impact Assessment. 
IV. Roles and Responsibilities. 
Analyse of Current Guidelines. 
Alternatives: RAC-Proposed Re- 
visions. 
Alternatives: Public Commenta- 
tors. 
Prc posed Action: Environmental 
Impact Assessment. 
Appendices 
A Comparison of Containment Levels. 
B Class; float on cf NIH-Funded Ex- 
periments as of December 1977. 
C. Comments and Responses cn the 
EIS. from the DAC Meeting of De- 
cember 15-16. 1977. 
D D.scusuion of the List of Exchang- 
ers Constituting Appendix A to the 
Guidelines. 
El Report of C.S EMSO Workshop to 
Assess Risks for Recombinant DNA 
Experiments Involving the Genomes 
of Animal. Plant, and Insect Viruses 
F Report of the Virus Working Group 
Sporuored by the Recombinant DNA 
Advisory Committee. 
G Report of the Recombinant DNA 
Advisory Committee Workshop on 
Risk Assessment of Agricultural 
Patnogens. 
PosrwcsD 
In June 1976 the National Institutes 
cf Health, with the concurrence of the 
Secretary of Health. Education, and 
Welfare and the Ass>stan: Secretary 
for Health, issued guidelines to govern 
the conduct of NTH -supported re- 
search involving recombinant DNA 
molecules. These guidelines stated 
that they would be subjected to peri- 
odic review (at least annually) and 
modified to reflect improvements In 
our knowledge of the potential bioha- 
zards and of the available safeguards." 
Since that time, a number of scientific, 
administrative, and legislative events 
have occurred that should be summa- 
rized at the outset, for they are re- 
flected in the revisions of the NIH 
guidelines as proposed, first by the Re- 
combinant Advisory Committee and 
currently by the Dtreetor. NIH 
Recombinant DNA experiments 
have proceeded in htmdreds of labora- 
tories throughout the world. The sub- 
ject has been discussed and debated in 
countless meetings, and the public has 
been consulted as well as the scientific 
community. NTH has taken into ac- 
count public comments in preparing 
the original guidelines, an environ- 
mental impact statement .EIS). and 
the proposed Director's revision. 
One of the mas: important recent 
developments has been the careful 
scrutiny, from a very broad point of 
view, of the premises upon which the 
original guidelines were based. Thus, 
the molecular biologists, who Hrst 
raised questions about the safety of re- 
combinant research, have new had 
greater opportunity to consider their 
concerns m the company of many ex- 
perts on infectious disease, epicemio- 
lory. viruses, plants, laboratory safety 
practices, ecology, and other relevant 
disciplines. 
Prom all of these activities have 
emerged certain important facts. For 
one. no evidence has come to light 
that any of the thousands of individu- 
al recombinant DNA denes construe t- 
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