I 
MEMORANDUM 
Pane 1 of Attachment C 
DEPARTMENT OF HEALTH. EDUCATION. .AND WELFARE 
PUBLIC HEALTH SERVICE 
CENTER FOR DISEASE CONTROL 
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 
TO 
Dr. Gilbert S. Omenn 
Chairman, Industrial Practices Sub-Committee 
ot tha Faderal Intaragancy Advisory Committaa 
on Recombinant DNA Research 
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FROM : Anthony Robbins, M.D/ ' 
Director, NIOSH ^ 
SUBJECT: MIOSH.' s Proposed Program for Addressing Potential Hazards to Workers Related 
to Commercial Recombinant DNA Applications 
This memorandum outlines NIOSH' s program for addressing potential hazards 
to workers related to commercial recombinant DNA applications. It is 
important to consider how NIOSR concerns fit into the concerns of other 
representatives on this committee and of the Recombinant DNA Advisory 
Committee for potential health hazards. 
NIOSH is focusing its evaluations of potential hazards in the recombinant 
DNA area of the biotechnology industry for a variety of reasons. First, 
the number of workers involved in recombinant DNA applications is 
potentially higher than any other segment of the biotechnology industry 
(e.g., in vaccine or antibiotic production). Industries outside the 
pharmaceutical sector are also applying recombinant DNA techniques. These 
industries which are involved in such areas as energy development and 
chemical production have far less experience in handling biological 
agents and may be less aware of potential or actual biohazards. 
Also, recombinant DNA applications are in the preliminary stages of 
capitalization. Recommendations for safeguarding health can be most 
cost-effective if installed now, avoiding expensive retrofit. Rarely do 
we have such opportunities for active prevention in the early stages of 
development of potentially hazardous processes. 
NIOSH is initiating a program to help define the potential for health 
hazards to workers participating in commercial recombinant DNA applica- 
tions. We will continue to advise OSHA of our findings and recommendations. 
As part of this program we will continue the on-site surveys of companies 
moving into scale-up or pilot production phases of operation, in order to 
assess the control measures and reduce human exposures. We are including 
evaluation of the following areas as appropriate: 
1) physical containment design (e-g., fermenters) 
2) engineering controls (e.g., ventilation, filter of exhaust gases) 
3) work practices Ce.g., operational protocols, clothing and hygiene 
requirements) 
4) validation procedures (e.g., sterilization and fermenter containment) 
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