bring it before the RAC on short notice. He underlined that this 
was an excellent example of two Federal agencies working closely 
together and coming up with something beneficial and productive. 
Dr. McGarrity said the proposal as written in tab 1290 appeared 
to be very confusing and legalistic. He stressed that this was 
really not the case. Much of the submission in tab 1290 is 
merely housekeeping to realign paragraph numbering and shift some 
paragraphs to more closely align them with the sections of the 
NIH Guidelines to which they refer. He explained that the 
proposal deals with two sections of the NIH Guidelines, Section 
II, "Containment," and Section III, "Guidelines for Covered 
Experiments . " 
He said the containment section explains the concepts in terms of 
both physical and biological containment. Most of what the 
proposal deals with on the animal side is physical containment, 
while the plant portion of the proposal deals more with the 
biological containment issues. Dr. McGarrity noted that the 
problem with the current biosafety levels is that they do not 
really deal with large animals or plants. The working group 
developed two new appendices: Appendix P for plants and 
experiments in greenhouses, and Appendix Q for large animals, 
which describes biosafety levels for these categories of 
experiments . 
Section III, "Guidelines for Covered Experiments," as currently 
structured classifies types of experiments into four categories: 
(1) those that are exempt from the NIH Guidelines, (2) those 
requiring only notification but not prior approval of local 
Institutional Biosafety Committees (IBCs), (3) those requiring 
prior notification and approval of IBCs, and (4) those requiring 
IBC approval, RAC review, and NIH approval. 
Dr. McGarrity said that traditionally in laboratory studies a key 
item in determining containment levels for an experiment has been 
Appendix B of the NIH Guidelines, "Classification of Micro- 
organisms on the Basis of Hazard." This classification system 
has developed from the principle that an organism that has 
relatively low risk would require BL1 or minimal containment and 
something with a greater biohazard potential a higher degree of 
containment: BL2 , BL3 , or BL4 . However, the working group 
recognized that many organisms used in conjunction with animals 
and especially with plants had no similar list; and there was no 
classification system whereby an investigator could readily 
determine assignment of biosafety levels. He noted that the 
working group thought such a list should be developed. However, 
they felt it was not within the scope of their objectives at this 
point. 
Several members of the working group had expressed their desire 
that someone, either NIH, USDA, or the National Academy of 
[58] 
Recombinant DNA Research, Volume 13 
