Page 4 of Attachment B 
INTRODUCTION 
The public debate over genetic engineering has focused on the possible 
hazards of genetically modified microorganisms, potential health hazards 
to workers involved with industrial application of recombinant DNA tech- 
niques, and the utilitarian prospects of such technology. Several risks 
assessment programs designed to investigate some of the characteristics 
of proposed host vector systems which might affect hazard potential have 
been conducted by interested scientists. Likewise the benefits from 
recombinant DNA technology are being as vigorously promoted. The National 
Institute for Occupational Safety and Health (NIOSH) is responsible for 
conducting research, recommending occupational safety and health standards, 
providing technical assistance to workers and employers, and conducting 
training and educational programs. NIOSH 1 s responsibility extends to 
both existing and emerging technology which might impact on worker health 
and safety. Thus, NIOSH is evaluating the potential occupational hazards 
involved with recombinant DNA technology. 
This research effort was prompted by the anticipated surge of recombinant 
DNA techniques in various industrial processes. Genetic engineering 
technology may be utilized in various manufacturing processes in the areas 
of agriculture, organic chemicals, energy, food processing, and pharma- 
ceuticals. This potential growth and the possibility of uncharacterized 
occupational exposures indicate the necessity for careful evaluation of 
health risks. NIOSH is accustomed to examining new technologies for 
potential occupational hazards and developing recommendations for safe- 
guarding the workers health. Implementation of safeguards and protective 
engineering controls early in the growth of an industry can only minimize 
human suffering and avoid expensive retrofitting of production systems. 
Under the Occupational Safety and Health Act of 1970, Public Law 9 1 — 596 , 
the National Institute for Occupational Safety and Health (NIOSH) was man- 
dated and authorized to conduct research and health studies. Specifically, 
Section 20(a)7 states that NIOSH shall conduct and publish industrywide 
studies of the effect of chronic or low level exposure to industrial 
materials, processes, and stresses on the potential for illness, disease, 
or loss of functional capacity. Thus, this research is pursuant to the 
development of health standards applicable to a broad range of occupational 
environments. In compliance with this mandate, the Industry-wide Studies 
Branch of the Division of Surveillance, Hazard Evaluations and Field Studies 
is conducting a study to assess the potential occupational hazards in 
research and the commercial application of recombinant DNA technology. 
In order to analyze the current technology for potential occupational 
hazards, NIOSH plans to conduct several walk through surveys of recombinant 
DNA processes and associated industries. Identification of potential hazards, 
with recommendations to minimize worker exposure, will be derived from the 
information gained during these surveys. This report contains recommen- 
dations relevant to operations at Eli Lilly and Company. Recommendations 
applicable to the entire industry employing recombinant DNA technology will 
be made after NIOSH completes a thorough assessment. An assessment of the 
following areas will be made: 
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