18 
Dr. Clowes said Dr a. Giles and Vhitehead apparently believe the/ created a 
pathogen through gene transfer. Many people have hypothesized that creation 
of pathogens through such manipulations is possible. He said that Congress- 
man Gore should be informed that RAC was created to assess and monitor 
such potential hazard. 
Dr. Fedoroff said she did not wish to imply by her comments that creation 
of pathogens is not a concern. However, the observation reported by 
Drs. Giles and Whitehead has not demonstrated the creation of a pathogen. 
[Executive Secretary's Note: When these minutes were approved at the 
dune 1, 1984, meeting, a motion was passed unanimously that the March 30, 
1984, letter from Drs. Pramer and Halvorson concerning the Giles and 
Whitehead paper be attached to the February 6, 1984, minutes. That letter 
accordingly has been added as Attachment IV. Mr. Robert Nicholas, Chief 
Counsel/Staff Director of the Subcommittee on Investigations and Oversight 
of the Carmittee on Science and Technology of the U.S. House of Representa- 
tives, requested that his reply of April 27, 1984, to Dr. Pramer also be 
attached to these minutes. That letter accordingly has been added as 
Attachment V.] 
Mr. Rifkin noted that RAC had addressed only one of the issues redeed in 
Congressman Gore's letter. Dr. Fedoroff responded that she had been asked 
specifically to review the Giles /Whitehead paper forwarded by Mr. Gore. 
Dr. McKinney said that all of the points raised in Mr. Gore's letter had 
been addressed in a reply letter from Dr. wyngaanden (tab 1126); in his 
letter, Dr. Wyngaarden specifically stated that he was asking RAC to review 
the paper by Drs. Giles and Whitehead. Dr. Gottesman said seme of the 
issues raised by Mr. Gore will be discussed later in the meeting (Item X. 
Questions Concerning Boundaries for NIH and RAC Oversight ) when RAC considers 
NIH's appropriate role in overseeing recombinant DNA activities. 
Dr. Alexander referred to the statement by Mr. Gore: 
"...that the RAC does not seem to employ a formal procedure for adequ- 
ately evaluating the potential risk presented by a particular deliberate 
release . " 
Dr. Alexander said the procedure followed by the NIH cited in Er. wyngaarden ' s 
reply (i.e. , notice is placed in the Federal Register at least 30 days prior 
to the RAC meeting inviting public comment, the proposal is discussed in 
open session at the RAC meeting, advice is sought from the USDA, and approval 
is given by notice in the Federal Register explaining the request and the 
reasons for granting approval) does not in his view constitute a formal 
procedure but rather is a series of administrative actions. Mr. Mitchell 
replied that RAC has considered each proposal on a case-by-case basis as 
these proposals do not fall into a pattern as do other types of experiments 
that are covered in the Guidelines. 
[263] 
