33042 
NOTICES 
[4110-08] 
DEPARTMENT OF HEALTH. 
EDUCATION, AND WELFARE 
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IKOMUNANT DMA RESEARCH 
Propo n g Iniud G v»4» l i w « 
Statement by Joseph A. Califano. Jr.. 
Secretary or Health. Education. 
and Welfare 
The Director of the National Insti- 
tutes of Health Is publishing proposed 
revisions to the NIH guidelines on re- 
search involving recombinant DNA 
molecules. 
The original guidelines are being up- 
dated in light of NIHs experience op- 
erating under them and in light of our 
increasing knowledge about the poten- 
tial risks and benefits of this research 
technique. As experience accumulates, 
we should review and evaluate the evi- 
dence to assure that the restrictions 
imposed are appropriate to potential 
risks— strengthening restrictions 
where needed, relaxing regulation 
where Justified. 
In publishing these proposals for 
public comment. I recognise the ex- 
traordinarily difficult challenge that 
developing sensitive but effective regu- 
lations in this field poses for NIH. for 
the research community, and for the 
concerned public. 
Necessarily, this task poses difficult 
questions that we will never be able to 
answer with complete certainty. I 
hope that those concerned will ana- 
lyse the p-oposed revisions with care 
and give us their views on the strength 
of the evidence that supports the pro- 
posed revisions, the specif c scientific 
and research containment procedures 
that the proposed revisions require, 
and the procedures and the standards 
they establish for future changes in 
the guidelines and for the exercise of 
discretion under them. 
We particularly seek comment on 
the sections in the proposed revisions 
that establish the mechan<sms for ad- 
ministering and revising the guide- 
lines. For example, do the proposed re- 
visions strike the proper balance in es- 
tablishing: 
The procedures for permitting oth- 
erwise prohibited experiments and for 
exempting classes of research from 
the guidelines: 
The standards for the exercise of ad- 
ministrative discretion under the 
guidelines: 
The composition of the Depart- 
ment's Recombinant DNA Advisory 
Committee and of the institutional 
biohazard committees. 
To review the comments on the pro- 
posed revisions. I am establishing a de- 
partmental renew committee consist- 
ing of Mr. Feter Libassi. the Depart- 
ment's General Counsel (Chairper- 
son); Dr. Donald Fredrickson, the Di- 
rector of NIH (Vice-Chairperson): Dr. 
Julius Richmond. Assistant Secretary 
for Health; and Dr. Henry Aaron. As- 
sistant Secretary for Planning and 
Evaluation. 
I have asked this committee to hold 
a public hearing to insure full and 
complete opportunity for comment. In 
order to hold this hearing and to issue 
the revised guidelines on a reasonably 
prompt schedule, no extension of the 
60-day period for public comment will 
be possible. 
In preparing these revisions, the Na- 
tional Institutes of Health have al- 
ready held 19 hours of public hearings 
and have received continual advice 
from the scientific community and 
from the public. I want this open proc- 
ess to continue. I urge those concerned 
to help us fmd the proper balance by 
providing us with their comments on 
NIH's proposed revisions. 
Dated July 19. 1978. 
Joseph A. Califano. Jr.. 
Secretary. 
Department of Health. Education, 
and Welfare 
NATIONAL INST ! I TIE S OF HEALTH 
Recombinant DNA Research 
PROPOSED REVISES GUIDELINES — NTH 
This will introduce three related 
documents that the National Insti- 
tutes of Health (NIH> is p'.blishing for 
public comment; (l)a Dc irion of the 
Director. NIH. to publish revised NIH 
guidelines for research involving re- 
combinant DNA molecules. »2> the 
Proposed flensed Guuieiinet—NIH. 
and (3) an fartronTienfaf Impact As- 
sessment of the proposed action. The 
Secretary of Health. Educa’ion. and 
Welfare has approved the release of 
these documents for public comment. 
As stated in the Secretary's preface, 
we are particularly concerned that 
public comment be invited on the sci- 
entific ar.d procedural aspects of the 
proposed guidelines. A pubuc hearing 
on these pro cos* d revisions wul be 
held in late September at the Hubert 
H. Humphrey Building. Washington. 
D.C. All comments received on or 
before September 25. 1978. will be con- 
sidered. and no extension of the com- 
ment period will be granted. Within 45 
days after the comment period final 
guidelines will be promo' gated with a 
notice in the Federal Register 
The events leading to the proposed 
revisions are described in the "Intro- 
duction and Overview '* to the Decision 
and in the ' Foreword" to the Assess- 
ment This preface will orient the 
reader to other NIH documents that 
are directly related to the present pub- 
lications. One is the current Recom- 
binant DNA Research Guidelines, ef- 
fective since June 23. 1976 (published 
in the Federal Register. July 7. 1976). 
Another is the Environmental Impact 
Statement (EIS) on those guidelines, 
published in 1977. The EIS. which 
contains a copy of the guidelines, is 
available from the Government Print- 
ing Office (stock No. 017-640-00413-3) 
and in GPO depository libraries 
throughout the country. A third relat- 
ed document is Proposed Revised 
Guidelines on Recombinant DNA Re- 
search. which the NIH Recombinant 
DNA Advisory Committee (RAC) rec- 
ommended to the NIH Director on 
September 1. 1977. The RAC proposal 
was published in the Federal Regis- 
ter. September 27. 1977. for public 
comment 
The RAC-proposed revisions were 
discussed at a public meeting of the 
Advisory Committee to the Director 
(DAC). held at NIH on December 13- 
16. 1977. The DAC and special consul- 
tants heard witnesses from environ- 
mental groups, the scientific communi- 
ty. industry, etc. All correspondence 
from the public in response in the Fed- 
eral Register publication was availa- 
ble to those present and will be pub 
lished. with the transcript of the meet- 
ing and other documents, as part of a 
continuing public record of NIH activi- 
ties concerning recombinant DNA. 
The Director. NIH. acting in light of 
the 2 day discussion, all commentaries, 
and the DACs recommendations, has 
arrived at the present proposal— the 
Proposed Revised Guidelines < NIH > — 
and offers it for public review. 
The current (1976) guidelines con- 
tain an appendix entitled "Supplemen- 
tary Information on Physical Contain- 
ment." This has been omitted from 
the present proposed guidelines but. in 
revised ar.d expanded form, will be 
available on request as Laboratory- 
Safety Monograph— A Supplement to 
the NIH Guidelines for Recombinant 
DNA Research." For a copy, write to 
the Offire of Reccrr.binan? DNA Activ- 
ities. Building 31. Room 4A52. Nation- 
al Institutes of Health. Bethesda. Mi. 
20014. 
The Environmental Impact Assess- 
ment is based on an intensive analysis 
of the current guidelines, the RAC- 
proposed alternative, and the present 
NIH alternative. The conclusion of 
this analysis is that there would be no 
adverse impact of the NIH-proposed 
changes upyr. the environment. 
The guidelines as presently proposed 
are designed to discharge the continu- 
ing obligation of NTH to insure that 
recombinant DNA research goes for- 
ward under standards of safety reflect- 
ing the latest scientific knowledge, so 
that the public and the environment 
are protected from any hazards while 
deriving the full benefits of the recom- 
binant DNA technique. 
F€D€* Al REGISTER VOL 43. MO. 144 — FRIDAY. RAY 2*. 1971 
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