10 
(3) A paragraph would be added following the second paragraph of 
Appendix C-II, Appendix C-III, and Appendix C-IV. That paragraph 
would read as follows: 
"For large-scale fermentation experiments Pl-LS physical contain- 
ment conditions are recommended. However, following review by 
the IBC of appropriate data for a particular host-vector system, 
seme latitude in the application of Pl-LS requirements as out- 
lined in Appendix K-II^A through K-II-F is permitted." 
(4) A reference to Appendix C would be added to the fourth sentence of 
Appendix K-I, Selection of Physical Containment Levels . That 
sentence would read as follows: 
"The Pl-LS level of physical containment is required for large- 
scale research or production of viable organisms containing 
recombinant ENA molecules which require PI containment at the 
laboratory scale (See Appendix C)." 
As a possible substitute, NIH staff proposed an alternate modification of 
Appendix K-I, Selection of Physical Containment Levels ; the NIH staff alter- 
native was published for comment m the April 24, 1984, Federal Register 
notice with the working group recarmendations . In the NIH staff alternate 
modification the following sentence would be added following the fourth 
sentence of Appendix K-I , Selection of Physical Containment Levels : 
"(The Pl-LS level of physical containment is recommended for large-scale 
research or production of viable organisms for which PI is reccrrmended 
at the laboratory scale such as those described in Appendix C. ) " 
Dr. McKinney said the working group proposal offers seme flexibility in 
application while requiring Institutional Biosafety Committee (IBC) 
oversight. 
Dr. McGarrity concurred with Dr. McKinney's remarks. He said that while he 
had not supported Dr. Johnson's original proposal, he was comfortable with 
the language and intent of the working group proposal . He noted that 
although the guidelines on laboratory scale experiments have been revised 
several times, the large-scale procedures in Appendix K have experienced no 
major revisions. 
Dr. Wens ink said he preferred the alternative language offered by NIH staff 
to the working group language offered in item four. He suggested seme other 
word be substituted for the word "experiments" in the third item of the 
working group proposal as these modifications refer not only to experiments 
but also to production procedures. 
In addition. Dr. Wens ink suggested the language of the third item of the 
proposal be modified as follows: 
[463] 
