Dr. Donald S. Fredrickson 
September 23, 1978 
Page 3 
reconsideration of all experiments now prohibited under Sections I-D-l and I-D-2. 
4. Section I-D-3. (p. 33070). I do not understand why this prohibition is restricted 
to the "deliberate creation ....of a plant pathogen with increased virulence and 
host range" and does not also include such amnipulations concerned with animal 
pathogens. 
5. Section I-E. Exemptions (p. 33070, Col. 2). This entire Section is a very neces- 
sary and worthwhile addition to the Guidelines and Section I-E-5 certainly pro- 
vides flexibility for making exemptions other than those now allowed pending adequate 
review and public input on potential recombinant DNA experiments or uses that pose 
little or no risk to public health or the environment. On the other hand, as men- 
tioned below, I have specific criticisms about Section I-E-4 as now proposed which 
constitute one of the two major criticisms I have about the Proposed Revised Guide- 
1 ines. 
6. I will consider together my criticisms of Section I-E-4 (p. 33070, Col. 2), Sec- 
tion I I I-A-l-b- (1 ) (p. 33077, Col. 2), Section V-footnote 35 (p. 33088, Col. 2), 
Appendix A (p. 33089) and Appendix D to the Proposed Environmental Impact Statement 
(p. 33158-33159) . 
The information provided to you by the RAC and others that led to the listing of 
organisms in Appendix A seems to have been misleading, inaccurate and incomplete 
and thus the statement on page 33044 "a list of donor-host pairs to be exempted... 
is a conservative one, restricted to pairs of organisms for which there is docu- 
mented evidence of natural exchange" is false. In reviewing the information which 
is now in Appendix A to the Revised Guidelines and Appendix D to the Proposed 
Environmental Impact Statement (p.33158-33159) this past July, I wrote a lengthy 
letter to Drs. John Spizizen and Donald Hel inski raising numerous issues pertaining 
to these lists. A copy of my letter to Drs. Spizizen and Hel inski which was not dealt 
with in a substantial way at the August, 1978 Meeting of the RAC is attached to 
this letter as Appendix B. I will enumerate the problems as follows: 
a. The first problem concerns the absence of the specific criteria used to 
include or exclude groups of organisms from Appendix A. In footnote 35, 
Section V (p. 33088, Col. 2), it defines genetic exchange "as observable 
under optimal laboratory conditions by transformation, transduction, 
phage infection, and/or conjugation with transfer of phage, plasmid, and/ 
or chromosomal genetic information." and then goes on to state, "Note 
that this definition of exchange may be less stringent than that applied 
to exempt organisms under Section I-E-4." The difficulty arises in that 
nowhere in the Guidelines, whether in Section I-E-4 (p. 33070, Col. 2) or 
in Appendix A (p. 33089) or in Appendix D of the Proposed Environmental 
Impact Statement (p.33158-33159), are these more stringent standards for 
demonstration of exchange by natural physiological processes given. It is 
evident from the list of microorganisms in Appendix A and the existence of 
Section 1 1 I-A-l-b- (1 ) (p. 33077, Col. 2) that a more stringent set of 
standards for demonstrating exchange by natural physiological processes 
was sometimes but not always used. I should note that if the definition 
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