SCHERINC CORPORATION 
60 ORANCE STREET ^n'o BLOOMFIELD, N. J. 07003 
& 
TELEPHONE: (201)429-4000 
TELEX: 138183 
CABLES: SCHERING BLOOMFIELD, N.J. 
January 27, 1983 
William J. Gartland, Jr., Ph.D., Director 
Office of Recombinant DNA Activities 
National Institutes of Health 
Building 31, Room 4A52 
Bethesda, Maryland 20205 
Dear Dr. Gartland: 
On behalf of our chairman, John Galat, I am conveying the responses of 
Schering Corporation's IBCs at Bloomfield and Union, New Jersey to your recent 
questionnaire regarding IBC activities. 
• What are the problems with the revised Guidelines? 
In general, Schering has no problem with the Guidelines as they 
currently exist. In fact, we have found them to be both a reasonable 
and workable code of prudent practices and controls. 
A major revision we would like to see is the formalization of the 
Recommendations for Physical Containment for Large Scale Uses of Viable 
Organisms Containing Recombinant DNA Molecules (45 FR 24968-24971) as 
an Appendix K to the Guidelines. This topic was addressed in a 
presentation by Dr. J. Allan Waitz to the Large Scale Review Working 
Group on October 26, 1982. A copy is attached for your reference. 
The RAC has long been recognized as the authority on biosafety issues 
relating to work with recombinant DNA. We strongly support a 
continuation of this function and hope that NIH will continue its 
active role in providing direction in this area. If not, the 
reasonable approach we have become accustomed to may be supplanted by 
conflicting regulatory requirements which will not be in the best 
interest of further scientific development. 
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