MEMORA^fBtWJ 
TO 
FROM 
•tachment B DEPaRTMENT 0 F HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
CENTER FOR DISEASE CONTROL 
■NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 
Dr. Gilbert S'. Ome-nn 
Chairman, Industrial Practices Sub— Commie tee 
oi the Federal Interagency Advisory Committee 
on Recombinant DMA. Research. 
Anthony Robbins, M 
Director, MIOSH / 
DATE: 
1 'V 
IS80 
SUBJECT: MIOSH.' s Proposed Program for Addressing Potential Hazards to Workers Related 
to Commercial Recombinant DMA Applications 
This memorandum outlines MIOSH' s program for addressing potential hazards 
to workers related to commercial, recombinant' DMA applications. It is 
important to consider how NIQSK concerns fit into the concerns of ocher 
representatives, on this committee and of the Recombinant DNA Advisory 
Committee for potential health hazards. 
MIOSH 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 DMA applications is 
potentially higher chan any other segment of the biotechnology industry 
(e.g., in vaccine or antibiotic production). Industries outside the 
pharmaceutical sector are also applying recombinant. DMA 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 DMA 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. 
MIOSH is initiating a program to help define the potential for health 
hazards Co workers participating in commercial recombinant DNA applica- 
tions. We will continue to advise OSHA of our findings and recommendations. 
As part of chis 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 (e.g., operational protocols, clothing and hygiene 
requirements) 
4) validation procedures (e.g., sterilization and fermenter containment) 
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