1 
®j>e tUasliington |Jost 
THURSDAY. MARCH 2 4, 1977 
Controlling Genetic Research 
T HERE ARE FEW areu of Kientific research 
that hold as much hope, and danger, as genetic 
experimentation. In the future may lie such develop- 
ments as the creation of oil-eating bacterid’ that 
would eliminate much of the damage caused by oil 
spills, and such spectacular developments as break- 
throughs in the cure and prevention of many dis- 
eases and human disabilities. But also in the future 
may lie the possibility that organisms may be created 
which man cannot control. It is even conceivable that 
some scientists might choose to tinker malevolently 
with the genetic makeup of human beings. 
These various possibilities led many prominent sci- 
entists in 1974 to call for a moratorium on such re- 
search. They also led to the guidelines issued last 
summer by the National Institutes of Health on how 
federally-funded projects in this field must conduct 
their work. Now. a high-level government committee 
has recommended that those guidelines, with some 
modification, form the base of a new federal law, 
which would control tightly the production and use 
of the molecules that are the focus and product of ge- 
netic research. 
The committee, on which all federal agencies con- 
cerned with this research were represented, has 
taken the right approach. It believes that research 
Into genetic materials must be allowed to go on: the 
potential benefits to mankind are so great that it 
would be foolish to deny ourselves their discovery, 
and the research Is so challenging that some scien- 
tists would continue with it illegally even if it were 
barred by law. But the committee also believes that 
the dangers are too great to permit the research to 
proceed unregulated and that the federal govern- 
ment is the proper source of that regulation. 
Drafting of the legislation has begun at the Depart- 
ment of Health, Education and Welfare, and will no 
doubt be difficult We have bad precious little experi- 
ence in limiting what research scientists can and can- 
not do. And we have not had much more experience 
in requiring Industrial scientists to keep the govern- 
ment Informed of the kind of products they are at- 
tempting to develop for their employers. But the 
need is clear for requiring that the federal govern- 
ment be told what kind of genetic research is under 
way and that it have the power to ensure that the re- 
search is conducted in facilities that meet safety 
standards sufficiently high to minimize the possibil- 
ity of, say, loosing new creatures in the world. Devel- 
oping rules that accomplish those ends without sti- 
fling scientific inquiry may be difficult, particularly 
for a department noted for its ability to complicate 
enormously the administration of even simple pro- 
grams, but it must be done, and done quickly. 
Genetic research Is more than an American prob- 
lem, and concerns about its promise and its dangers 
are widely shared. Substantial work is under way, on 
both the research itself and the ways In which it 
should be regulated, in other countries: these include 
the United Kingdom and most of Western Europe 
and Canada Once Congress determines how research 
is to proceed in this country, the groundwork for an 
international agreement will have been laid. The 
need for such an agreement is as clear as the need for 
domestic regulation. A tragic mistake in this kind of 
research anywhere in the world could endanger all 
of us, just as a brilliant discovery in any country 
could benefit all mankind. 
Copyright © 1977 
by The Washington 
Post . 
Reprinted with 
permission of 
The Wall Street 
Journal © 1977 
Dow Jones & Co . , 
Inc. All Rights 
Reserved. 
Copyright © 
1976/77 by The 
New York Times 
Company. Re- 
printed by 
permission. 
HEW to Propose 
Laws to Regulate 
Genetic Research 
WStJrnl 3-17-77 
By a Wall Stmut Journal Staff Reporter 
WASHINGTON - The Department of 
Health. Education and Welfare said It plans 
to propose legislation to regulate laboratory 
experimentation with new life forms. 
The government controls would be de- 
signed to permit necesaary scientific re- 
search but to protect the public against dan- 
ge sms experiments and the fabrication of 
disease-causing organisms. 
"We aren't saying that research should 
be halted." explained HEW Secretary Jo- 
seph Calftano. "We are urging that It should 
proceed under careful safeguards unless and 
until we have a better understanding of the 
risks and benefits posed by use of recombl- 
nant DNA techniques (genetic engineering) 
without government regulation." 
The new legislation would be based on 
recommendations by a federal Interagency 
committee that, reported yesterday to Mr. 
Callfano. The committee called for a law re- 
quiring any person engaged In genetic-engi- 
neering research to register with the HEW 
Secretary and to work only In facilities li- 
censed by the Secretary. The HEW Secre- 
tary would have authority to Inspect the fa- 
cilities and to take other steps to protect the 
public. 
Agencies Ask Law to Curb 
Research on Gene-Splicing 
NYTIMES 3-17-77 
WASHINGTON, March 16— Legislation 
that would closely regulate a controver- 
sial area of genetics experimentation was 
proposed today by a high-level committee 
representing all Federal agencies con- 
cerned with the research. 
The Department of Health, Education 
and Welfare, which would be the main 
regulating agency in the proposal, an- 
nounced today that efforts to draft legis- 
lation would begin immediately. Congress 
already has before it several bills to regu- 
late the experiments, which are generally 
known as recombinant DNA research. 
The experiments, often described as 
gene-splicing, involve newly developed 
techniques that give scientists the ability 
to take genetic material from one organ- 
ism and incorporate it into living cells 
representing an entirely different form 
of life — for example, animal genes into 
bacteria. 
The research is believed to hold great 
promise but also to involve potentially 
great hazards through the production of 
novel forms of life. DNA, the short name 
for deoxyribonucleic acid, is the funda- 
mental genetic material in all living 
things. It is the key material of the genes 
and chromosomes. 
Joseph A. Califano Jr.. Secretary of 
Health, Education and Welfare, accepted 
the interagency report today and an- 
nounced that his department would begin 
drafting legislation at once. 
By HAROLD M. SCHMECK Jr. 
Sptdal lo The New York Times 
Potential Hazards Cited 
“I recognize that legislation in this area 
.would represent an unusual regulation of 
(activities affecting basic science,” he said 
I in the announcement, "but the potential 
|hczards posed by recombinant DNA tech- 
niques warrant such a step. ’ 
He described legislation as necessary 
to afeguard the public while assuring 
that basic research would continue in 
"this vital scientific area." r 
The interagency report recommended 
that all facilities engaged in recombinant 
DNA research be licensed, and that all 
research projects in this field be regis- 
tered before the work began. 
The report said that the primary re- 
sponsibility for regulating the research 
should rest with the Department of 
Health, Education and Welfare, and that 
the Secretary should have authority to 
inspect facilities where the research was 
being done. 
Guidelines for conduct of the research 
have been developed by the National In- 
stitute of Health, an agency of H.E.W. 
All other Government agencies concerned 
with this type of research have adopted 
the guidelines, but they arc not at present 
binding on industry. A major reason for 
the widespread interest in Federal legisla- 
tion is the desire to bring industry’s re- 
search efforts in this field under regula- 
tion. 
The Federal interagency committee 
recommended that the Secretary of 
H.E.W. be authorized to set standards 
for the research and to sue to halt 
production or use of recombinant DNA 
materials if they appeared to constitute 
a hazard to health or environment. 
‘Sunset’ Provision Urged 
The committee proposed that the 
Federal legislation be drafted to pre-empt 
state and local laws on the same subject 
and that the Federal law have a iife of 
only five years. This so-cal!e -! "sunset” 
provision was recommended on the 
ground that recombinant DNA research 
was advancing so fast that major revi- 
sions in regulation cf the field were likely 
to be needed within five years. 
Hearings on recombinant DNA research 
are in progress before the Health and 
Environmental Subcommittee of the 
House Commerce Committee. In opening 
the hearings yesterday. Representative 
Paul G. Rogers, Democrat of Florida, the 
subcommittee chairman, said that the re- 
search held great promise but that the 
threat of its potential hazards required 
a uniform set of safety procedures. 
The Federal interagency committee is 
made up of representatives of the Depart- 
ments of Agriculture. Commerce. De- 
fense, Interior, Justice. Labor. State, 
Transportation and of Health. Education 
and Welfare. 
Also, the Center for Disease Control, 
the Food and Drug Administration, the 
Energy Research and Development Ad- 
ministration, the Er.’. iror.mcntal Protec- 
tion Agency, the Exccuv.ve Off-cc of the 
President, the Nation?: Aeronautics and 
Space Administration, the National 
Science Foundation, the Nuclear Regula- 
tory Commission, the Arms Control and 
Disarmament Agency and the Veterans 
Administration. 
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