13 
Dr. Nightingale then reviewed the proposed changes in Secticai III. She 
noted that a "caution" had been added to Section III-B-3. That caution 
is as follows: 
"CAOTIca^; Special care should be used in the evaluation 
of containment levels for experiments which are likely 
to either enhance the pathogenicity (e.g., insertion of 
a host oncogene) or to extend the host range (e.g., 
introduction of ncvel control elements) of viral vectors 
under conditions which permit a productive infection. 
In such cases, serious consideration should be given to 
raising physical containment by at least one level." 
Dr. Nightingale said this is one instance where new information suggested 
that a caution be added. Dr. Ahmed asked to \^om the caution was addressed. 
Dr. Bems relied that the caution is addressed primarily to the IBC. 
Dr. Ahmed asked if the phrase "consideration by the IBC" should be added. 
He felt the caution as proposed speared parenthetical; the IBC should be 
cited more explicitly. Dr. Bems did not accept Er. Ahmed's suggestion as 
he felt responsibility should be incumbent on both the investigator and 
the IBC. Dr. Ahmed withdrew the proposal. 
Dr. Nightingale asked if Er. Ahmed, as the maker of the motion, would 
agree to strike the work "viral" in Section III-B-2-a. The language 
reads in part; 
"Recon±»inant ENA experiments in which ENA from Class 4 agents 
is transferred into nonpathogenic prokaryotes or lower eukaryotes 
can be performed at P2 containment after demonstration that only a 
totally and irreversibly defective fraction of the agent's viral 
genone is present in a given recombinant." 
Er. Berns explained that currently all Class 4 agents classified in 
Appendix B are viruses, lhat situation might, however, change in the 
future, and deleting the word "viral" in Secticai III-B-2-a would provide 
greater flexibility. Dr. Ahmed agreed to delete the word "viral." 
Dr. Gottesman noted that language from Sections III-B-2-a and III-B-2-b of 
the ;^ril 21, 1982, Guidelines had been combined by the workir^ group into 
a new Section III-B-2-a. In so doing, the working group had moved experi- 
ments involving a totally and irreversibly defective fraction of Class 4 
agents into Section III-B-2-a and delegated authority to the IBC to lower 
containment on experiments involving these agents. 
Er. Nightingale mentioned the inadvertent omission in Secticxi III-B-4-ia of 
language dealing with IBEA permits for working with Class 5 agents and sug- 
gested suitable language be inserted analogous to that found at the end of 
Section III-B-2-b. Mr. Thornton asked if Er. Ahmed would agree to insertion 
of such language in Secticxi III-B-4-a. Er. Ahmed agreed as did Er. Bems. 
[472] 
