Corporate Quality Assurance 
Abbott Laboratories — 
Abbott Park 
North Chicago, Illinois 60064, U.S.A. 
May 23, 1984 
Director, Office of Recombinant DNA Activities 
Building 31 , Room 3B10 
National Institutes of Health 
Bethesda, MD 20205 
Dear Sir: 
In response to the request In the Fed. Reg. Vol . 49, No. 80, Tuesday, 
April 24, 1984, we would like to make the following comments on the 
"Proposal to Amend Appendix G of the Guidelines, Physical Containment", 
page 17675. 
We feel the acceptance of these proposed amendments will serve to unify 
the concepts of potential biohazards with regard to both recombinant and 
nonrecombinant organisms. Since RDNA experimentation In many Instances 
Involves the use of microorganisms, the proposed changes In the 
terminology of containment levels will result In a consistency of 
language which Is extremely Important. 
It Is also Important to recognize that with the advent of new and more 
efficient Host Vector systems and the exemption of certain recombinant 
experiments from the guidelines (particular Section III-D) It may be 
necessary to contain work with certain host or recombinant organisms 
based not only on the potential hazard of recombinant procedure but also 
on the biosafety (biohazard) level classification of the ultimate 
recombinant organisms. Although PI (BL1) containment Is recommended for 
exempt experiments listed In Appendix C In the present guidelines, there 
are no recommendations with regard to containment of those exempt 
experiments Involving organisms listed In Appendix A. There may be some 
confusion as to the Interpretation of the guidelines with respect to the 
containment levels recommended for these (Appendix A) exempt 
experiments. Since some of these organisms fall Into Class II 
("Biosafety In Microbiological and Biomedical Laboratories"), PI (BL1) 
containment for these organisms Is not appropriate. We believe It would 
be advisable, therefore, to recommend that appropriate biosafety levels 
be considered for those recombinant procedures which are exempt for the 
RDNA guidelines . 
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