Recombinant DMA Advisory Committee - 2/4/91 
created some confusion. She said the subcommittee suggested the following changes to 
the grid appearing on page 9 of tab 1412: 
1. The wording for Criterion 20 should read "Access to the workplace." and 
under the colunrn marked "GLSF' should read "NR" (not required); under 
the column marked "BLl-LS" it should read "G-H-A-l-a"; under the column 
marked "BL2-LS" it should read "G-II-B-l-a"; and the column marked 
"BL3-LS" would remain the same, "K-III-L." 
2. Items 21 through 42 would be eliminated from the grid because they do 
not pertain to a controlled access area for the categories of GLSP, BLl-LS 
and BL2-LS. 
3. In lieu of items 21 through 42 in the grid, these will be a text statement 
that the requirements and characteristics of a controlled access area are 
elaborated in Appendix K, Part V. 
Dr. Schaechter cautioned that the wording of "not required" for some of the criteria 
between 21 and 42 was incorrect. Dr. Riley suggested that a statement be made that 
"requirements and characteristics of a controlled access area are elaborated in Appendix 
K, Part V." Dr. Hirano said this would make the grid clear. 
Dr. Post noted that the whole issue of good large scale practice was delegated by the 
RAC to the Institutional Biosafety Committees (IBCs) in 1988 and that some IBCs have, 
in fact, been doing the review, llius, this proposal is merely to make it official and 
define the conditions at the level of the RAC rather than to leave it for the IBCs to do 
this on an hoc basis. 
Dr. Miller noted that Item Number 33, referring to the use of the Universal Biohazard 
Sign, was useful enough and misinterpreted enough that it should be left in to be explicit. 
Dr. McGarrity asked if Dr. Miller if he meant that it should be left in to say that it was 
not required. Dr. Riley said she did not agree, and that to be consistent there should be 
no emphasis placed on one criterion versus another. 
Dr. Miller added that there were frequently references to a "closed system," and that 
oftentimes the FDA deals with fermentations which are used for producing yogurt and 
wine which are not closed fermentations, and he wondered if this was going to be 
misinterpreted. 
Dr. Atlas asked how the subcommittee thought about responses received from Merck as 
to the handwashing and HEPA filtration. Dr. Riley said that is what caused Dr. Hirano 
to find the inconsistencies which resulted in her comments as to the changes in the grid. 
Recombinant DNA Research, Volume 14 
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