Appendix III A — History of the Recombinant DNA Debate *317 
mary it'a-son was their concern over protection of 
pi-oprietarv information 
Phase II culminated with the pi'onuilgation on 
June 23. 1976. of the (Guidelines for Research InvoK - 
in^( Recombinant I).\ \ .Molecules (1976 (Guidelines ") 
covering institutions and individuals receiving MM 
funils for this research 
Phase III was characterized hv attempts to remedy 
the limited applicability of the (Guidelines. Soon after 
their publication. S«>nators Kennedy and Ja\ its sent a 
letter to President Ford, calling his attention to the 
(Guidelines. They noted that any risk was not limited 
to fetleralK funded research, and urged him to 
take neces.sar\ steps to implement the (Guidelines 
throughout the research community. In October 
1976. the S«*cretary ol lIF.W with the appro\ al of the 
President formed the Federal Interagency .Advisory 
Cornmittw under the chairmanship of the Director 
of MM to determine the extent to which the (Guide- 
lines could he applied to all research and to rec- 
ommend necessary executive or legislati\ e actions to 
ensure compliance '• In .March 1977. the Committee 
concluded that existing Federal law would not per- 
mit the regulation of all rO.VA research in the United 
States to the extent deemed necessary: it further 
recommendetl new legislation, specifying the ele- 
ments of that legislation.'* 
During 1977 se\eral bills to deal with this and 
other problems were introduced in Congress. They 
addressed in different ways the issues of the extent 
of regulatory coverage, the mechanisms for regula- 
tion and Federal preemption of State and local regu- 
lation The major bills were those of Rep. Paul 
Rogers. M R. 7897 (and its substitute, H R. 11192) and 
of Sen. Edw ard Kennedy, S. 1217.* 
While hearings were being held, three devel- 
opments occurred which, by the end of 1977, had 
dissipated much of the impetus for legislation. The 
first was the expanded role of R.AC. On September 
24. 1976. its charter had been amended once more to 
provide for additional expertise in the areas of 
botany, plant pathologx', and tissue culture. More- 
over. its membership was increased from 16 to 20 so 
that four members would be "from other disciplines 
or representatives of the general public.” This was 
the first official provision for public representation 
’’Ibid., pp. 52. 
'^Interim Report of the Federal Interagency Committee on Recom- 
binant D\A Research: Suggested Elements for Legislation, Mar. 15, 
1977. pp 3-4. 
'Mbid,. pp. 9-10. 
'•Ibid., pp. 11-15. 
'For a more complete discussion of the legislation, see footnote 
19. 
‘•. Recombinant DN.A .Molecule Research, " Congressional Re- 
search Service, issue brief ,\o. IB 77024. update of Jan. 2, 1979. 
although two nonscientists vv^ere already members. 
The number of nonscientists remained the same 
until December 1978.^° Also, RAC's responsibilities 
were defined in greater detail, including the respon- 
sibility tor reviewing large-scale experiments. Never- 
theless, RAC continued formally at least to be "a tech- 
nical committee, established to look at a specific 
problem.” 
The second development was a growing belief 
among scientists that the risks of the research were 
less than originally feared. This was based on the fol- 
lowing: 1) a letter from Roy Curtiss at the University 
of Alabama to the Director of NIH, explaining risk 
assessment experiments using Escherichia coli, from 
which he concluded that the use of E. coli K-12 host- 
vectors posed no danger to humans; 2) the conclu- 
sions of a committee of experts in infectious diseases 
'' assembled by NIH in June 1977 in Falmouth, Mass., 
that the alleged hazards of the research were un- 
substantiated: and 3) a prepublication report on ex- 
periments showing that genetic recombination oc- 
curs naturally between lower and higher life forms, 
and suggesting that the rDNA technique was not as 
novel as presumed. 
The third dev'elopment affecting the legislation 
was a concerted lobbying effort by scientists against 
what they considered to be some of the overly 
restrictive provisions of the bills, especially S. 
1217.^' -phe efforts included wide circulation of 
reports (including some in draft form) as soon as 
available, which supported the conclusion that 
the research was less hazardous than originally 
supposed. 
By the end of 1977, the legislation was in limbo. 
This situation continued in early 1978, although 
some hearings were held. On June 1, 1978, Senators 
Kennedy, Javits, Nelson, Stevenson, Williams, and 
Schweiker addressed a letter to HEW Secretary 
Joseph Califano, which acknowledged the likelihood 
that legislation would not pass and urged that defi- 
ciencies in the regulatory system be addressed 
through executive action based on existing authority, 
if that w'ere to be the case. 
During Phase IV, NIH and its parent organization, 
HEW (now DHHS), have attempted to operate in the 
regulatory vacuum left by the lack of legislation. In 
response to the consensus that developed in 1977 on 
“William Gartland, Director of the Office of Recombinant DNA 
■Activities, NIH, personal communication, June 19, 1980. 
•‘B. Culliton, " Recombinant DNA Bills Derailed: Congress Still 
Trying to Pass Law,” Science, vol. 199, Jan. 20, 1978. pp. 274-277. 
^^D. Dickson, "Friends of DNA Fight Back,” Nature, vol. 272, 
April 1978, pp. 664-665. 
“R. Lewin, "Recombinant DNA as a Political Pawn,” New Scien- 
tist, vol. 79, Sept. 7, 1978, pp. 672-674. 
