g ABBOTT 
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, we would like 
to make the following comments concerning the proposed changes In the 
Recombinant DNA Guidelines regarding the "Proposed Amendment of 
Procedures for Scale-Up of Organisms Listed In Appendix C," page 17672. 
The risk assessments have been done with the exempt organisms for which 
the proposed amendments apply. There Is no evidence we are aware of to 
Indicate that there Is any Increased risk to personnel or public health 
by experimentation with these organisms at low volumes and no reason that 
the production of large volumes will lead to any greater risk to 
personnel or the environment. 
As a Health Care Company, Abbott Laboratories Is committed to Improved 
health care world wide, and believe that It Is Imperative that reasonable 
guidelines for the large scale production of RDNA organisms at the Pl-LS 
level be available. 
We believe that the proposed amendments are well conceived and recommend 
their acceptance by NIH for Incorporation Into the guidelines. We 
suggest, however, that the placement of the paragraph under modifi- 
cation #3 found on page 17672 be reconsidered. Adding the proposed 
paragraph after the second paragraph would, In effect, place this para- 
graph dealing with large-scale fermentation experiments under the 
exemption experiments. Since large scale experiments are not exempted 
but rather are listed as exceptions to the exemptions, we recommend the 
proposed paragraph be added to the third paragraph under the Exceptions 
section of Appendix C — 1 1 , Appendix C-III and Appendix C-IV. 
We appreciate the opportunity to comment on these proposed amendments to 
the Guidelines. 
Sincerely, 
John H. Keene, Dr. P.H. 
Corporate Biohazard Control Officer 
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