Federal Register / Vol. 47. No. 77 / Wednesday. April 21. 1962 / Notices 
17167 
OROA and NIH staff prepared a 
document rununarizing the two 
proposals (i.e.. the September 1981 RAC 
proposal published for comment in the 
December 4. 1961. Federal Register, and 
the Cottesman proposal published for 
comment in the December 7. 1961. 
Federal Register) including a table 
comparing them with the July 1961 
Guidelines. ORDA distribute the 
summary and copies of the Federal 
Register of December 4. 1961, and 
December 7. 1961, to over 4.300 
individuals and organizatiofu that had 
expressed Interest in being Informed 
about developments affecting the 
Guidelines and recombinant DNA 
research. The document invited 
comments on the two proposais. in 
addition, notices appeared in a number 
of periodicals inviting comments on the 
proposals. 
Q. February 6-9, 1962. Meeting of 
Recorabinant DNA Advisory Committee 
On February S-9. 1962. the RAC 
reviewed the proposals for changing the 
Guidelines. They had been sent in 
advance: The December 4. 1961. Federal 
Register containing the September 1961 
RAC proposal: the December 7. 1961. 
Federal Register containing the 
Cottesman proposal the summary of the 
two proposals including the table 
comparing them with the July 1961 
Culdelinea; and all letters of comment 
on the proposals (a total of 86 letters) 
receiv^ by NIH by February 5, 1962 
Part U-A of this announcement contains 
the draft minutes of the relevant 
portions of the February 8-9. 1962. RAC 
meeting Part D-B of this announcement 
fives the response of the Acting 
Director. National Insbtute of Allergy 
and Infectious Diseases (N1A1D). to the 
RAC recommendations. 
D-A Draft Minutes of Relav ant Portions 
of February 8 - 6 , 1962. RAC Meeting 
Mr. Thornton called the alienlion of 
the RAC to the major topic of the 
February 8-9. 1962 meeting, a discussion 
of two proposals (tabs 1060. lOSdA. 
1066B. 1056C/1, 1066C/7, 1(1660. 1056E. 
1066F. 1060C) to modify the current NIH 
Guidelines for Research Involving 
Rccombinsnt DNA molecules 
Mr. Thornton ssid he would take a 
moment to give his personal perspective 
pnor to resuming the role as committee 
chairman. He said former NIH Director. 
Donald Fredrickson summarized the 
purposes of the Guidelines at (1) to 
establish s rapid, complete means of 
oommunicstion. (2) to assure that the 
Guidelines are conservative yet allow 
research to proceed, and (3) to permit 
public participation in the formulation of 
public policy. Mr. Thornton noted the 
difficulty of establishing and 
maintaining communication between 
public policy decision makers and 
experta in a sdentillc field. NIH has 
devised a mechanism which 
successfuHy maintains this 
communication, and he would not wish 
to abandon it. 
Mr. Thornton then described the 
Guidelines from a lawyer's perspective. 
He noted that the Guidebnes are not 
laws: he thought this is good since laws 
are difncult to formulate and difTicult to 
change. Neither are they regulatioiu: 
regulationa are subject to formal 
revision procedures much more rigid 
than those RAC and the NIH follow In 
modifying the Guidelinea. Neither are 
the Guidelinea simply statements of 
good practice. The RAC and the NIH 
have been responsive to change, not as 
quickly perhaps as some would have 
preferred, but quickly enough that the 
advance of science has not been 
significantly impeded. 
Mr. Thornton then recognized Dr. 
Baltimore who referred to the December 
4. 1961. proposel which RAC had 
recommended for publication In the 
Federal Registsr (46 FR 59366). Dr. 
Baltimore said that the proposal had 
elicited tremendous response. He said 
that conversion to a voluntary code of 
standard practice, as described in the 
December 4. 1961. Federal Register, is 
appropriate. Although the current NIH 
Guidelines are not formal regulations, 
they have instituted an informal 
regulatory process. He expressed hope 
that the philosophy of voluntary 
compliance expressed in the December 
4. 1961. propos^ would be accepted. 
Dr Baltimore suggested that some of 
the concerns expressed about the 
December 4. 1961. propoMl by 
correspondents could be addressed and 
met by modifications. Some 
correspondents had expressed concern 
that the IBCs would be dismantled. Dr. 
Baltimore assumed that with the 
language of the December 4. 1961. 
proposal the IBCs would remain in 
place He said he had. however, 
prepared an amendment which might 
be added during the discussion, 
specifying a continuing role for IBCs. 
Dr. Baltimore said that in setting Pi 
containment conditions, the December 4. 
1961, proposal implies there could not be 
deliberate release of recombinant 
organisms into the environment. It is 
clear from the letters received in 
response to the proposal, however, that 
some people would prefer an explicit 
statement to that effect. Dr Baltimore 
said that if RAC felt it was necessary, he 
would support an amendment to the 
December 4, 1981, proposal to 
accomplish that aim. 
Finally, Dr. Baltimore suggested the 
language of Section I-A might be 
modified to include a strong statement 
that although voluntary, adherence to 
the Guidelines is strongly recommended. 
He said the December 4. 1981, proposal 
with these amendments would be 
responsive to comments received. He 
then moved the proposal appearing in 
the December 4. 1981, Federal Register 
(46 FR 59368] as an item for discussion. 
The motion was seconded by Dr. 
McGarrity. 
Dr. Baltimore made an additional 
statement in response to certain written 
comments received. He said that he has 
never hidden his affiliation with the 
company. Collaborative Research, of 
Waltham. Massachusetts. He stressed, 
however, that if he were acting for the 
company, he would not be supporting 
the December 4, 1981, proposal because 
he said it is not in the interests of any 
institution in the Boston area, as it might 
lead to more stringent regulation at the 
local level. He said he supported the 
December 4, 1961. proposal becaue he 
believes it is correct. 
Dr. Nightingale said that letters 
commenting on the proposals indicate 
many remaining concerns in both the 
scientific and public sectors. In her 
view, these concerns are not adequately 
addressed by the December 4. 1981, 
proposal even if that proposal were 
modified as Just suggested by Dr. 
Baltimore. 
Dr. Nightingale said that there is not a 
clear consensus for eliminating the 
mandatory nature of the Guidelines or 
eliminating the requirement for IBCs. 
She said the issue of scale-up needs 
further discussion. She expressed the 
belief that removing the mandatory 
nature of the Guidelines would stimulate 
a variety of legislative actions across 
the country, possibly resulting in 
regulatory variation from location to 
location. She also suggested that 
although the probability of an event 
with disastrous consequences is very 
small one must acknowledge that gaps 
in scientific knowledge exist: if such a 
very rare event should occur, there 
could be tremendous backlash against 
the scientific community. 
Dr. Nightingale said the December 7, 
1981 (46 FR 59734. Part 7. "Cottesman"), 
proposal would simplify the Guidelines 
and remove many restrictions. Dr. 
Nightingale said she had a list of at least 
six ways in which the Cottesman 
proposal could be further simplified, and 
restrictions further removed, by the next 
RAC meeting. Dr. Nightingale then 
moved acceptance of the December 7, 
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