Dr. McKinney asked about the distinction between the terms 
"considered" or "treated" as etiologic organisms. Dr. Atlas 
suggested the substitution of "shipped as" in place of 
"considered," and edited his proposed language accordingly. He 
mentioned that this substitute may still be questioned by the RAC 
as too inclusive or stringent. 
Dr. McVicar asked if the proposed language brought the NIH 
Guidelines back to their original form. Class 1 agents in Appendix 
B include all microorganisms not found in Classes 2, 3, and 4. Dr. 
McKinney suggested that the NIH Guidelines might become "too tight" 
and should focus on potential for causing disease rather than on 
classes of organisms. Dr. Atlas added that the proposed language 
would revise Appendix H to apply to Class 2 or higher agents and 
would add HIV virus with the "G-III-2" reference. The HIV 
reference might also be treated as a separate motion at the next 
RAC meeting. Dr. McVicar argued that the addition of the reference 
to HIV could set a procedural precedent for updating the lists in 
the NIH Guidelines. 
Subcommittee members returned to the problem of a mechanism for 
updating Appendix B. Dr. McKinney suggested that HIV could be 
added to the list of Class 2 agents by means of a footnote. 
Dr. McVicar asked whether, if Class 1 agents are exempt from the 
NIH Guidelines for shipping purposes, organisms that require BL1 
containment could also be exempt. Dr. Stevenson said that if a 
recombinant DNA product requires more than BL1 containment, then it 
is an etiologic agent and case-by-case approval would be necessary. 
Dr. McKinney believed that BL1 containment was included in the 
proposal . 
Dr. Atlas, noting that the diagram must still be changed, read the 
motion as amended: 
"Preamble: 
Recombinant DNA molecules contained in an organism or in a viral 
genome shall be shipped under the appropriate requirements of the 
U.S. Public Health Service (42 CFR, Section 72), U.S. Department 
of Agriculture (9 CFR, subchapters D&E; 7 CFR, part 340), and/or 
the U.S. Department of Transportation (49 CFR, Section 173). For 
purposes of these Guidelines the following recombinant DNA 
molecules contained in an organism or in a viral genome shall be 
shipped as etiologic agents: (1) those listed as Class 2, 3, or 
4 agents in Appendix B; or (2) those contained in reference G- 
III-2’; and/or (3) those regulated as animal or plant pathogens 
or pests under titles 7 and 9 CFR; or (4) host organisms 
containing recombinant DNA derived from those organisms or viral 
genomes . 
"Appendix H-I: 
Recombinant DNA Research, Volume 13 
[297] 
