8 
modify Appendix L of the Guidelines. Dr. Tolin described the process by 
which this proposal was developed. The RAC Working Group on Revision of 
the Guidelines at its January 21, 1983, meeting recommended that guidelines 
for field experimentation involving plants modified by recombinant DNA 
techniques be developed for consideration at the April 11, 1983, RAC meeting. 
A proposal specifying conditions under which field testing of plants could 
be performed was subsequently developed by the Plant Working Group. The 
NIH Guidelines for Research Involving Recombinant DNA Molecules in force 
at that time required RAC review and NIH approval as well as IBC approval 
for the "deliberate release into the environment of any organism containing 
recombinant DNA." The proposal developed by the working group would have 
changed this so that provided experiments met certain criteria, growing of 
plants containing recombinant DNA in the field would have been able to 
proceed without RAC review and NIH approval. IBC approval would have been 
required as would notification of ORDA. 
At its April 11, 1983, meeting, the RAC considered the Plant Working Group 
proposal and discussed it extensively. RAC made several modifications in 
the specified criteria and modified the procedural aspects of the proposal. 
The RAC recommended that the modified language be incorporated into a new 
appendix (Appendix L) which would require review and approval of experiments 
both by the Institutional Biosafety Committee (IBC) and by the Plant 
Working Group. 
The exact language of Appendix L was subsequently developed by NIH staff 
based on the recommendations made at the RAC meeting. Ihe U.S. Department 
of Agriculture Recombinant DNA Committee then reviewed the RAC recommendation 
including the proposed wording for Appendix L and endorsed adoption of this 
language. 
The NIH accepted the proposed language and incorporated it into the Guidelines 
as Appendix L on June 1, 1983 (48 FR 24548 and 24580). 
Dr. Tolin said that in consultation with other members of the RAC Plant 
Working Group, she was now proposing several amendments to Appendix L-II-C. 
This section specifies some of the criteria which allow the RAC Plant 
Working Group to review certain proposals without the requirement for full 
RAC review. Dr. Tolin noted that Appendix L-II-C currently reads as follows: 
"Appendix L-II-C. The vector consists of DNA: (i) from exempt 
host-vector systems (Appendix C); (ii) from plants of the same 
or closely related species; (iii) from nonpathogenic prokaryotes 
or nonpathogenic lower eukaryotic plants; (iv) from plant pathogens 
only if sequences causing disease have been deleted; or (v) chimeric 
vectors constructed from sequences defined in (i) to (iv) above. 
The DNA may be introduced by any suitable method." 
[ 192 ] 
