316 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animals 
invited confronted the scientists with some of these 
questions.® The conference report concluded that al- 
though a moratorium should continue on some ex- 
periments, most work involving rDNA could con- 
tinue with appropriate safeguards in the form of 
physical and biological containment. 
In Phase II, the debate widened to encompass 
broader social and ethical issues, such as the re- 
lationship between scientific freedom of inquiry and 
the protection of society’s interests, in whatever 
manner those were defined. Such issues led natural- 
ly to questions about who makes the decisions and 
the role of the public in that process. Finally, deci- 
sionmaking mechanisms were developed. Issues 
raised and actions taken during this phase in many 
respects controlled the subsequent development of 
the Federal response to the debate, and created 
problems that continue to the present. At this stage, 
participation in the debate went beyond the scien- 
tific community. 
Questions of ethics and public policy had been 
raised earlier, but they now received much wider at- 
tention. On April 22, 1975, Sen. Edward M. Kennedy, 
Chairman of the Subcommittee on Health of the 
Senate Committee on Labor and Public Welfare, held 
a half-day hearing on science policy issues arising 
from rDNA research. In May 1975, a 2-day con- 
ference on "Ethical and Scientific Issues Posed by 
Human Uses of Molecular Genetics" was held under 
the joint sponsorship of the New York Academy of 
Sciences and the Institute of Society, Ethics, and the 
Life Sciences. In addition to molecular biologists, par- 
ticipants included lawyers, sociologists, psychiatrists, 
and philosophers. 
The issue of public participation arose as decision- 
making mechanisms were developed. RAC was orig- 
inally composed of 12 members from "the fields of 
molecular biology, virology, genetics and microbiol- 
ogy. ’® Critics first noted the need for more expertise 
in the fields of epidemiology and infectious diseases, 
since most molecular biologists were trained as 
chemists.* * RAC’s membership was increased to 16 
and the range of expertise was widened to include 
the fields of epidemiology, infectious diseases, and 
the biology of enteric organisms, by amendment to 
the charter on April 25, 1975. 
Since some members were conducting the re- 
search in question, critics claimed that a conflict of 
interests existed. They also noted that the Committee 
“Swazey, et al., op. cit., p, 1,034. 
^The charter of the Recombinant DNA Molecule Program Ad- 
visory Committee, Oct. 7, 1974, op. cit. 
*One of the members of the original RAC (Stanley Falkovv) did 
have substantial expertise with enteric organisms and £. coli in 
particular. 
advised the Director of NIH, an agency whose mis- 
sion was to foster biomedical research, not to stop or 
otherwise regulate it. These issues were brought out 
in a petition to NIH signed by 48 biologists in August 
1975. Criticizing a proposed draft of the guidelines as 
setting substantially lower safety standards than 
those accepted at Asilomar, the petition argued for 
broader representation on RAC from other fields of 
scientific expertise and from the puhlic-at-large. RAC 
itself had been sensitive to these limitations: in the 
summer of 1975, an attempt was made to recruit 
nonscientists.'® One nonscientist was added in 
January 1976, and another was added in .August 
1976. 
In December 1975, RAC submitted revised dratt 
guidelines to the Director of NIH, Dr. Donald 
Fredrickson. Although they were stricter than tho.se 
drafted at Asilomar, some criticized them as being 
"tailored to fit particular experiments that are al- 
ready on the drawing hoards."” I he con.sensus of 
RAC, on the other hand, was that the guidelines were 
excessiv'ely strict, hut that it was in*cessary to lie 
overly cautious because of its limited exfiertise in 
public health,'^ In any event. Dr. Fri'derick.son ar- 
ranged for public hearings on the proposed guide- 
lines at a 2-day meeting in February 1976 of the .Ad- 
visory Committee to the Dii-ector, a diviM se group ol 
scientists, physicians, lawyers, philsopliers, and 
others. A similarly diver.se group of scientists and 
public interest advocates wei'e invited to attend 
Some modifications to the Guide-lines [iroposed hv 
Dr. Fredrickson as a result of that nu-eting were 
adopted and others were rejecte-d hv It At in .\pnl 
1976.'® 
The final major issue arising during this period 
concerned NIH's lack of authority to set condition.s 
on research funded by other Federal agencies or hv 
the private sector. In a June 2. 1976, mi-eting Im-- 
tween Dr. Fredrickson and .some JO re[)iesent.itiv es 
of industry, including pharmaci-utical and < hemical 
companies, it became clear that some rl).\ A rese.iri h 
was being done; however, the lepresent.itives ap- 
peared hesitant to (aimmit themselves to voluntai v 
compliance with the |)ro|)o.s(‘d guidelines '* I he jiri 
'“tJr. hlizahclh Kiitirr ,i liirmcr H V( iiii-inlM'i imii 
munication. Sept II I9H(1 
"N. Wade, "Recombinant l),\ V Mil s<•^^ sine i Hull s in l.miu h 
New I echnologv'," .S<(e/icf, \ (il 19(1.197'. pp II". 1179 
‘'Kulter, op. cit 
'Mhid. 
''Subcommittee on Science HcmmuIi .ind I r. Iim .1. ,.l lln- 
Hou.se Committee on Scii‘nce and lei lmuli.K\ i-rnrln iti^^nrr’nn 
llumun Cptwiics, and ( rll Hiulnti\ l).\ t lln nmhin.inl ulr Hr 
search ISupp Repoi't III 94th ( on^ 3d m-ss ftri. p l 
