"Page 3, footnote 1: Revise and add to RNA. 'Section III-A-4 applies both to 
recombinant DNA and to DNA or RNA derived from recombinant DNA.' 
"Page 4, footnote 2: Update Federal Register reference, ’...please see the Federal Register . 
Volume 51. p. 23309-23313. 1986.’ 
"Page 10, part (b): Revise list of contaminating materials, '...eliminate any 
contaminating materials (for example, VL30 RNA, other nucleic acids, or 
proteins) or.„' 
"Page 10, part (c): Revise new point, so that it does not ask investigators to demonstrate 
the absence of something, '(c) If co-cultivation is employed, what kinds of cells 
are being used for co-cultivation? What steps are being taken (and assays used 
with their sensitivity) to detect and eliminate any contaminating materials? 
Specifically, what tests are being done to assess the material to be returned to the 
patient for the presence of live or killed donor cells or other non-vector materials 
(for example, VL30 sequences) originating from those cells?' 
"Page 10. part (d): Revise new point, so that it does not ask investigators to demonstrate 
absence, '(d) If methods other than those covered by a-c are used to introduce new 
genetic information into target cells, what steps are being taken to detect and 
eliminate any contaminating materials? What are...?* 
"Page 12, part b, third line: Add a word for clarification. In what percentage of cells does 
expression from ihs added DNA occur?” 
Dr. Walters moved that the RAC accept the revised "Points to Consider” at tab 1272 with the further technical 
amendments just discussed reflecting the recommendations of the Human Gene Therapy Subcommittee and its 
consultants. Dr. Epstein seconded the motion. 
Dr. Epstein noted that tab 1276 contains a number of suggestions from Dr. Howard Temin of McArdle Laboratory, 
University of Wisconsin, most of which were accepted, but one of which (page 6, line 1) was not. Dr. Temin had 
pointed out that it is possible that cells other than bone marrow cells might be used. Dr. Epstein stated Dr. Temin’s 
suggestion could be accomplished by eliminating the words "bone marrow" from this sentence which currently reads, 
"...e.g., by inserting a properly functioning gene into a patient's cells in vitro ..." 
Dr. Johnson and Dr. Pirone both noted that the language begins with "e.g." and is meant only as an example. Dr. 
Walters stated that if there were no qualifier on the phrase "into a patient's cells," it could be interpreted that this new 
gene could go into any cells including possibly germline cells or reproductive cells which is not the intention. Dr. 
Epstein agreed to drop this issue for now but requested the next time the subcommittee meets they consider changing 
this sentence to something like, "The purpose of somatic-cell gene therapy is to treat an individual patient's somatic 
cells," and then add examples if appropriate. 
Dr. Rapp asked the meaning of the term "contamination" in the new text which had been added as page 10, pan (d); Dr. 
Epstein replied it presumably meant the same as in pan (b) on the same page which had been previously defined. Dr. 
Neiman noted that in pan (c) on the same page the clarifying text, "(e.g., VL30 sequences)" appears. 
The motion was put to a vote by the Chair and was passed unanimously, by a vote of 19 in favor, none opposed, and 
no abstentions. 
Mr. Mitchell then called for any other business that any member desired to bring before the committee. Dr. Johnson 
asked about the committee appointed by the NIH Director to review the Pseudorabies vaccine field test and wondered 
if the panel had concluded their report. Dr. Talbot replied that the committee had not finished their work but that it 
was anticipated to be concluded within the next few weeks. 
Recombinant DNA Research, Volume 1 1 
[ 103 ] 
