MEMORANDUM 
DEPARTMENT OF HEmlTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
CENTER FOR DISEASE CONTROL 
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 
TO 
Dr. William J. Gartland 
Office of Recombinant DNA Activities 
National Institutes of Health 
DATE: January 25, 1980 
THRU: Melvin Myers, Director OPPE 
FROM : Health Scientist, OPPE/PAB 
SUBJECT: NIOSH comments on the NIH Draft Part VII, Physical Containment Guidelines 
for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules. 
We have examined, the Draft Part VII, Physical Containment Guidelines for 
Large-Scale Uses of Organisms Containing Recombinant DNA Molecules and 
are pleased to comment upon them. Our comments will be confined at the 
present time to four areas of concern. 
1. Research Guidelines vs Guidelines for Commercial Applications 
2. Assessment of Increased Risk 
3. Format and Language 
4. Occupational Safety and Health 
Research Guidelines vs Guidelines for Commercial applications 
The draft guidelines for large-scale uses appear to be developed from 
the perspective of merely expanding the scale of a laboratory research 
operation. They do not address the different circumstances, procedures, 
and equipment found in commercial operations. The draft of Part VII does 
not reflect an appreciation of the fact that laboratory technicians and 
operators are WORKERS; they do not address the fact that the laboratory or 
production site is an occupational work setting. 
In a letter to Dr. Emmett Barkley from Dr. Robert McKinney (RAC consultant) 
dated July 26, 1979, various concerns over the safety of fermentors for 
the propagation of potentially hazardous microorganisms were raised. In 
this letter. Dr. McKinney addressed several phases of large-scale fermentor 
operations where increased hazard may exist such as: 1) charging or 
inoculating the fermentors, 2) collection of in-process samples, 3) 
harvesting of the raw product, and 4) processing of the product. Discussion 
of these concerns are absent from Part VII. Dr. McKinney felt management 
of potential hazards associated with fermentors could be accomplished 
with "existing equipment, methods, and technology", but these controls were 
not delineated or recommended in Part VII. 
Similar attention should be focused on other aspects of large-scale 
production which would differ from those of laboratory research. Such 
concerns pertain to equipment, size, design, and the interface with other 
process; they also may include possible differences in employee training, 
education, and motivation. 
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