NOTICES 
60101 
and S.L. Adhya (editors), DNA Insertion 
Elements, Plasmids and Episome, pp. 521— 
530, Cold Spring Harbor Laboratory. Cold 
Spring Harbor, N.Y. 
18. Goldberg. R. B„ R. A. Bender, and S. 
L. Streicher (1974). Direct Selection for PI- 
Sensitive Mutants of Enteric Bacteria. J. 
Bact, 778:810-814. 
19. Hedges, R. W., A. E. Jacob, and I. P. 
Crawford (1977). Wide Ranging Plasmid 
Bearing the Pseudomonas Aeruginosa Tryp- 
tophan Synthetase Genes. Nature 267:283- 
284. 
20. Johnson. E. M.. B. P. Placek, N. J. 
Snellings, and L. S. Baron (1975) Conserva- 
tion of Salmonella Typhimurium Deoxyri- 
bonucleic Acid By Chromosomal Inserttion 
in a Partially Diploid Escherichia Coli 
Hybrid. J. Bact. 723:1-6. 
21. Nagahari. K„ Y. Sano, and K. Sakagu- 
chi (1977). Derepression of E. Coli trp 
Operon on Interfamilial Transfer. Nature 
266.^45-746. 
22. Signer, E. R.. a. Torriani, and C. Le- 
vinthal (1961). Gene Expression in Intergen- 
eric Merozygoles. Cold Spring Harbor 
Symp.. Quant. Biol. 26:31-34. 
Appendix 3 
(Director's Decision concerning Appendix B 
of the Guidelines) 
Three correspondents correctly point out 
that since the publication in 1974 of the 
“CDC Classification of Etiologic Agents on 
the Basis of Hazard" (which is repeated ver- 
batim as Appendix B to the Guidelines). Ac- 
tinomycetes have been reclassified. Former- 
ly considered to be fungal agents, they are 
now considered bacterial agents. An ex- 
planatory footnote has been added to the 
table. 
Appendix I — Environmental Impact 
Assessment 
ENVIRONMENTAL IMPACT OF THE FINAL 
GUIDELINES 
An Environmental Impact Assessment of 
the NIH-Proposed Revised Guidelines (ELA) 
was published with the Guidelines in the 
Federal Register of July 28, 1978. The as- 
sessment was based on an intensive analysis 
of the Guidelines then in effect, the Guide- 
lines as proposed by the Recombinant DNA 
Advisory Committee in September 1977, and 
the Guidelines as proposed by NIH in July 
1978. The conclusion of the assessment was 
that there would be no adverse impact of 
the NIH-proposed changes upon the envi- 
ronment. 
The issues raised by the commentators in 
correspondence and by the witnesses of the 
September 15 hearing on the NIH-proposed 
revised Guidelines are reviewed in detail in 
the accompanying Decision document. It is 
the conclusion, based on that review of the 
alternatives proposed in July 1978 and the 
decisions reflected in the final Guidelines, 
that there will be no adverse impact of the 
Federal actions upon the environment. 
Indeed, in the extensive revision of part IV. 
these final Guidelines enhance public par- ■ 
ticipation and accessibility at the national 
and local levels, with increased emphasis on 
health surveillance and safety training. The 
final Guidelines provide an even stronger 
framework to ensure that no significant risk 
is presented to the public health or the en- 
vironment. 
Consideration now follows of certain 
issues relating to the EIA of July 28, 
1978, which were raised in correspond- 
ence and by witnesses at the Septem- 
ber 15 hearing. 
NEPA Considerations 
A witness at the September 15 hear- 
ing cited the EIA as being inadequate 
and held that a full Environmental 
Impact Statement (EIS) should be 
prepared. The witness stated that an 
EIS is clearly required by the law. In 
addition, the witness found the EIA 
inadequate in its analysis of the revi- 
sions in such areas as exemptions and 
the use of E. Coli. K-12 and other 
host-vector systems. 
In our view, the EIA prepared by 
NIH on the proposed revisions to the 
NIH Guidelines fully satisfies the re- 
quirements of the National Environ- 
mental Policy Act of 1969 (NEPA). 
The current Guidelines on Recom- 
binant DNA Research were issued on 
June 23; 1976, and published in the 
Federal Register on July 7, 1976 (41 
F.R. 27902). They were developed by 
NIH after opportunity for public com- 
ment and an open meeting at which 
members of the public were invited to 
testify (41 F.R. 2105). 
In the Decision of the Director, NIH, 
which accompanied the 1976 Guide- 
lines, it was indicated that NIH would 
prepare a draft EIS on the Guidelines 
in order to give the public further op- 
portunity to comment. The draft EIS 
was published in the Federal Register 
on September 9, 1976, with a preamble 
soliciting public comment (41 F.R. 
38426). After the close of the comment 
period, a final ~EIS was prepared, 
taking into account the comments re- 
ceived and scientific developments up 
to that time. The EIS actually became 
final on November 28, 1977, when 
notice of its receipt was published in 
the Federal Register by the Council 
on Environmental Quality (42 F.R. 
60588). 
During this period, scientific evi- 
dence has been accumulating that the 
risks presented by recombinant DNA 
research, which has always been 
purely speculative, were indeed 
remote. As a result, it became appar- 
ent that the restrictions in the Guide- 
lines were more stringent than neces- 
sary and that the Guidelines needed 
to be revised. The process of revision 
was first undertaken by NIH's Recom- 
binant DNA Advisory Committee 
(RAC), which referred a proposal for 
revision to the Director, NIH, in Sep- 
tember 1977. On. September 27, 1977, 
the Director published the RAC's pro- 
posal in the Federal Register for 
public comment (42 F.R. 49596). At 
the same time, and in a subsequent 
Federal Register notice (42 F.R. 
59918), the Director announced a two- 
day meeting to secure public testimo- 
ny on the RAC proposal. This meeting 
was held on December 15-16, 1977, and 
witnesses appeared from environmen- 
tal groups, the scientific community, 
and industry. 
Based on the comments received and 
the testimony at the December meet- 
ing, the Director developed an NIH- 
proposed revision of the Guidelines 
(referred to herein as the PRG), rely- 
ing in part on the RAC proposal. The 
PRG was issued by the Director, as a 
proposal, with the approval of the Sec- 
retary, on July 19, 1978, and published 
in the Federal Register on July 28, 
1978 (43 FR 33042), the preamble to 
the PRG requested public comment, 
announced that a further hearing on 
the PRG would be conducted on Sep- 
tember 15, 1978, before an HEW panel 
chaired by the General Counsel, and 
indicated that final action on the PRG 
would be taken after the panel had re- 
viewed both the written comments and 
those provided at the hearing.* 
When the PRG was published on 
July 28, it was accompanied by a de- 
tailed EIA, which included a discus- 
sion of the risks and benefits of recom- 
binant DNA research and an analysis 
of the current Guidelines, of alterna- 
tives to the Guidelines, and of NIH’s 
PRG. In addition to an overall assess- 
ment of the environmental impact of 
the PRG, sepaate environmental 
impact analyses were made of each 
section. The conclusions reached were 
summarized at the beginning of the 
EIA as follows: 
As can best be determined from all evi- 
dence compiled to date and analyzed in nu- 
merous scientific and public forums, there 
will be no adverse environmental impact 
from recombinant DNA research conducted 
under the Director's proposed revisions. The 
Environmental Impact Statement on NIH 
Guidelines for Research Involving Recom- 
binant DNA Molecules, issued in October 
1977, predicted that the environmental 
impact of research conducted under the 
1976 NIH Guidelines would be the contin- 
ued protection of the laboratory worker, the 
general public, and the environment from 
conjectural hazards. So far, this prediction 
has been confirmed: We know of no scien- 
tists conducting recombinant DNA research 
in the United States or other countries who 
are not following the NIH or comparable 
guidelines, and no untoward effect of the re- 
search has been reported. Meanwhile, new 
scientific evidence as well as extensive expe- 
rience in operating under the NIH Guide- 
lines indicate that revisions are in order. 
The predictable effect of continued use of 
recombinant DNA techniques under the Di- 
rector's proposed revisions would be a great- 
er realization of the benefits of this valua- 
ble tool without compromise of safety. (43 
FR 33096). 
The EIA prepared by NIH on the 
PRG discusses in detail scientific de- 
velopments regarding recombinant 
DNA research. It justifies the changes 
proposed by NIH, explains why some 
RAC and public proposals were not ac- 
* More than 30 persons from environmen- 
tal groups and the scientific community tes- 
tified at the September 15 hearing. 
FEDERAL REGISTER, VOL. 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
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