P.O. Box 232 
Kerr vi lie, Texas 78029 
August 4, 1986 
Director, Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes o-f Health 
Bethesda, Maryland 20892 
Dear sir: 
I am writing in response to the proposal to ammend section III-A-4 [Federal 
Register, Vol 51 ( 122) : 23210-2321 1 , June 25, 19861 o-f the NIH Guidelines on 
Recombinant DNA Molecules. Although I do not doubt the good intentions o-f 
this ammendment, the specific wording does present some potentially serious 
problems that should be considered prior to acceptance of the ammendment, 
since in practice, the "Guidelines" essentially set precedence and have 
the force of law. 
III-A-4. "The RAC will not review and the NIH will not approve any 
human genetic therapy:..." 
This statement allows no discretion by the RAC on review of proposed 
research if it falls under either of the categories listed below, even if 
such research may prove to be greatly beneficial to the public welfare. 
Since development of research technology involving DNA manipulation as well 
as advances in knowledge regarding DNA structure and function are rapidly 
progressing, it is not possible to predict the safety nor benefit of future 
research proposals. This aspect becomes very important if you consider the 
intent of certain individuals or groups to impede such research without 
regard to potential benefit, and that these individuals or groups could 
cite the specific wording of the guidelines (if ammended) and use judicial 
intervention to prevent consi der ati on of such proposals, even if 
circumstances have substantially changed the percieved ethical or 
biological risks involved. I strongly urge alteration of the wording of 
the proposed ammendment to preserve d i scr et i onar y authority of the RAC to 
review any recombinant DNA research proposals or topics that the committee 
believes to be wi thing reasonable bounds of its di screti onsry authority to 
regulate or to provide a public forum. 
III-A-4. "... 1. That is not aimed sol el v at the relief of a 
life-threatening or severely disabling condition; or 
2. That could alter germ line cells. 
Furthermore, the RAC wll not review and the NIH will 
not approve any in vitro recombinant DNA experiments that 
alter human germ line cells or early human embryos." 
Secondly, the words " sol el v " and "or" under condition 1 of the proposed 
ammendment are unreasonably restrictive of the discretion of the committee 
in that: 
(a) a proposed therapy could not be considered even for relief of 
1 l f e-threateni ng conditions if the therapy could conceivably alter germ 
line cells (even in non-r eproduct i vel y active or sterilised individuals) 
due to the word "or" in condition 1 of the proposed ammendment. 
Recombinant DNA Research, Volume 1 1 
[ 217 ] 
