16 
ment, and the research proliferates. New and more ingenious hinds of 
experiments are proposed.” And Paul Berg agreed that a 2-year evalu- 
ation is not sufficient. In view of the likelihood that considerable uncer- 
tainty will remain, particularly about newly developed techniques and 
host-vector systems, there is broad support for continuing to prohibit 
certain recombinant DNA experiments and control others, provided 
that there is opportunity to relax or remove restictions on research that 
is shown to pose no significant risk. Marshall Shapo suggested, 
u* * * Where present foresight of some possible risks remains dim, reg- 
ulation is justified to a level that corresponds with the uncertainty, 
though not a more stringent one.” 
DEFICIENCIES OF THE GUIDELINES 
Coverage, 
Although Federal sponsors of research with recombinant DNA other 
than NIH have adopted its guidelines, there appears to be great varia- 
tion among their respective review procedures; initial evidence sug- 
gests a very superficial approach by some Federal agencies. The sub- 
committee is inquiring further about the activities of the National 
Science Foundation, the Department of Agriculture, the Veterans’ 
Administration, and the Department of Energy, and will report its 
findings at a later date. Thus far the principal concern of Government 
officials, public interest groups, private industry, and State and local 
officials has been that privately supported research activities in uni- 
versities and industry are not subject to the NIFI standards or external 
review except on a voluntary basis. 
In issuing the 1976 regulations. Donald Fredrickson, Director of 
NIH, urged all Government agencies and “all who support or conduct 
such research throughout the United States” to adhere to the guide- 
lines voluntarily. In November 1976, the Environmental Defense Fund 
and the Natural Resources Defense Council petitioned the Secretary 
of HEW to promulgate regulations governing all recombinant DNA 
activities in the United States under the authority granted by section 
361 — Control of Communicable Diseases — of the Public Health 
Service Act (42 U.S.C. 264). Members of the Pharmaceutical Manu- 
facturers Association and other industrial firms which have agreed to 
observe the guidelines urge that their coverage be formalized. 
The concern is not merely about compliance by unregulated sponsors 
and performers of research. As the president of the PMA and the 
president of Cetus Corp. observed to the subcommittee, the present 
guidelines are written for Federal grantees. Commercial firms have 
had ample opportunity to comment on the standards and the proposed 
revisions, and have consulted NIH officials on their interpretation, but 
they have no representation on the Recombinant Advisory Committee 
nor on the Advisorv Committee to the Director of NIH which reviews 
changes in the guidelines. Private laboratories mav be prevented from 
receiving recombinant DNA materials from an NIH grantee for lack 
of certification or may be handicapped in their research and 
development efforts bv the 10-liter limit. At present, theTe is no formal 
mechanism for resolving issues that concern the private sector. As more 
private firms enter recombinant DNA research and as the research 
becomes more sophisticated, the private sector is likely to experience 
[Appendix B — 276] 
