12 
of the proposed language of items two and three as published in the April 24, 
1984, Federal Register announcement. Dr. McKinney seconded the motion. 
The RAC approved the motion to accept items two ard three as published in 
the April 24, 1984, Federal Register by a vote of twenty-one in favor, none 
opposed, and no abstentions. 
Dr. Landy said he wished to comment for the record; he felt IBC review and 
approval should not be required for large-scale experiments involving the 
organisms listed in Appendix C. 
V. PROPOSED GUIDELINES FOR SUBMISSION UNDER APPENDIX L 
Dr. McGarrity offered seme background information on the preposed guidelines 
(tabs 1156/III, 1164, 1168) for submissions under Appendix L of the NIH 
Guidelines. Appendix L, Release into the Envi raiment of Certain Plants , 
specifies conditions under which certain plants may be approved for release 
into the environment. 
Dr. McGarrity said prcposals involving release into the environment of 
plants not covered by Appendix L would be reviewed under Section III-A-2 
of the NIH Guidelines. These prcposals would be subject to review and 
approval by the IBC, the full RAC, and NIH. 
Dr. McGarrity said RAC recognized the need for some standardized format for 
submission of "relevant information under Appendix L. " The Plant Working 
Group, therefore, developed a draft guidance document for investigators 
submitting proposals under Appendix L. The draft document was submitted 
to the RAC for its consideration at the February 6, 1984, meeting and 
ccrrments at that meeting suggested the document should specify additional 
information requirements . In response, the RAC Working Group on Release 
into the Environment met on April 9, 1984, to consider further information 
requirements for submission under Appendix L. The working group modified 
the draft document Vthich was then published for public carmen t in the 
April 24, 1984, Federal Register (49 FR 17672). The document was again 
reviewed and modified by the Working Group on Release into the Environment 
at its May 31, 1984, meeting. 
Dr. McGarrity said this modified document entitled Preposed Guidelines for 
Submissions under Appendix L (distributed at the RAC meeting) deeds only 
with plants covered by Appendix L. The document does not address other 
plants or microorganisms. A similar document addressing field testing of 
microorganisms will be drafted in the future. 
Dr. McGarrity said data requirements in the document are divided into 
three major informational areas: (1) a description of the plant materials; 
(2) information regarding the vector and the method of introduction into 
the plant; ard (3) characteristics and monitoring of the plants in the 
greenhouse and grewth chamber and under field conditions. 
[465] 
