Washington Post 4-12-77 
How To Regulate Basic Research 
T HE FEDERAL government is in the process o. 
writing legislation to control research on DNA 
molecules— the material that determines the heredi- 
tary characteristics of all known cells. This is a par- 
ticularly delicate undertaking, because Congress has 
no experience with regulating basic, scientific re- 
search and because the kind of research under scru- 
tiny has the potential not only of bringing great good 
to mankind but also of threatening it with untold 
harm. So we would like to underline the plea of Dr. 
Norton Zinder of Rockefeller University to the Sen- 
ate Health Subcommittee last week that “this be done 
with extreme care and without haste." 
With that in mind, it seems to us that the licensing 
proposal presented by Secretary of Health. Education 
and Welfare Califano is a useful starting point. Mr. 
Califano has followed the general outline proposed 
by an inter-agency committee which urged that fed- 
eral safety standards be set for the laboratories in 
which this research is conducted. But he rejected the 
committee's key recommendation that the federal 
standards override state and local safety legis- 
lation In this field. This, it seems to u* is a serious 
mistake. 
It is not good enough for the federal government to 
say, as Mr. Califano recommends, that it is setting 
minimum standards and letting states and local gov- 
ernments set higher ones, if they want to. The federal 
standards must be sufficiently high to provide ade- 
quate safety for all the country if anything should go 
wrong in the experimental process; the potential for 
harm is that great. But if federal standards are that 
high, there Is no sound reason for local governments 
to drive them higher. When the federal government 
talks about minimum standards, it almost invites ad- 
ditional regulation by local governments. 
There are, as we see it, seveial dangers in such an 
invitation. One is that some local governments would 
create unrealistic standards; the expertise available 
to the federal government in drafting regulations of 
this kind is not so readily available to state and local 
governments. Another is that local governments 
might erect standards so stringent that scientists 
could not meet them. Either possibility would drive 
this kind of research out of institutions located in cer- 
tain communities and cause a reshuffling of scien- 
tists between institutions as they sought more con- 
genial regulations. Indeed, it is conceivable that fear 
of DNA research could produce a series of local regu- 
lations that would drive this research out of the in- 
stitutions best equipped to conduct it and force this 
work into less qualified institutions or, in the worst 
possible case, underground. 
It seems quite remarkable that the federal govern- 
ment would consider giving local governments so 
much leeway in handling so delicate a subject when 
it has denied local option in such matters as regulat- 
ing the amount of meat in a package of bacon. This is 
one area where Congress must exercise that "ex- 
treme care” of which Dr. Zinder spoke— extreme 
care that citizens not only are protected against the 
harm that DNA research might do but are also as- 
sured that this research ran mntinue under the best 
possible conditions. 
Washington Post/4-26 
‘Minimum Standards’ for DNA Research 
Your editorial “How to Regulate 
Basic Research” raises the valid issue of 
“minimum" federal standards for DNA 
(deoxyribonucleic acid) research. ' At 
the same time, however, it erroneously 
c. includes that communities should not 
have the opUon of setting higher stan- 
dards for genetic research. Such ac- 
. ions would ostensibly lead to unrealis- 
tically high standards or force 
researchers to seek a more conducive 
(i.e., less regulated) climate for study. 
Much the same controversy surroun- 
ded passage of the Clean Air Act when 
Congress called for nationwide air 
quality standards but permitted states 
to set higher standards. California sub- 
sequently developed auto emission st- 
andards that reflected the state's belief 
that federal “minimum" standards 
would not adequately meet local and 
statewide environmental and public 
health goals. 
If the elected officials in a commu- 
nity believe that a federal standard— 
be it for occupational safety, nuclear 
power, clean air or genetic research- 
does not adequately protect the health 
and welfare of its citizens, it should bo 
the right and, indeed, the duty of those 
officials to act to ensure such protec- 
tion. While local standard-setting will 
obviously be a delicate and highly tech- 
nical endeavor, its sheer complexity 
should not be the justification for pro 
hibiting active local involvement. Fur 
thermore, it is improbable that com- 
munities with sophisticated research 
institutions in their midst will pass laws 
that drive those institutions away. And, 
finally, the spectre of forcing DNA re- 
search underground will remain even 
if the federal government is the sole 
standard-setter. 
The debate over stringent local stan- 
lifano Urges Strict Safeguards 
Control Research on DNA? 
W. Star, 3/18/77 
Sought 
jlslative controls 
on the search tor new life forms through genetic 
research, HEW Secretary Joseph Califano said 
yesterday. 
"I recognize that legislation in this area would 
represent an unusual regulation of activities af- 
fecting basic science," Califano said, “but the 
potential hazards posed by recombinant DNA tech- 
niques warrant such a step at this time." 
Copyright 
Post. 
© by The Washington 
Reprinted by permission of The 
Washington Star . 
.ards for genetic research will be mini- 
mized if federal standards are suffi- 
ciently rigorous and encompassing. Un- 
fortunately, the word “minimum" con- 
notes a lack of stringency, but for the 
federal government to set “maximum" 
standards will clearly undercut the 
right of a community to decide what is 
needed to protect the health and safety 
of its citizens. 
DIANA H. WAHL 
Washington 
Wcisii S pm, 4-7-77 
The Carter administration has 
asked Congress to impose unprece- 
dented federal controls on research 
into the manipulation of genes to 
create new forms of life. 
The legislation, proposed yester- 
day, would allow the controversial 
recombinant DNA research to con- 
tinue but only under federally ap- 
proved standards and safeguards. 
Joseph A. Califano Jr., secretary 
of health, education and welfare, told 
a Senate health subcommittee that 
the potential but still unidentified 
hazards posed by such research lead 
to the conclusion that "there is no 
reasonable alternative to regulation 
under law." 
"Only continued research, pro- 
ceeding under strict safeguards, will 
tell us whether these restrictions 
must continue in force or whether 
they can be relaxed at some time in 
the future," Califano said. 
"I understand that legislation in 
this area constitutes unusual govern- 
ment involvement in the workings of 
basic science," Califano said. "But 
the potential risks inherent in present 
recombinant DNA techniques justify 
such a measure at this time. " 
Califano called recombinant DNA 
"a scientific tool of enormous poten- 
tial.” reciting the possibilities that 
the technique it represents could be 
of significant help in the fields of 
medicine, agriculture and industry 
as well as providing the means of 
gaining a far greater insight into 
basic biological processes than ever 
befer- 
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