2 
of E^iarmaceuticals and feed stock chemicals. The report examines three 
areas of potential hazard; (1) exposure to recombinant ENA containing 
microbes (2) exposure to the products of recombinant organisms and 
(3) exposure to reagents used in production processes. He said the study 
does not focus on microbial hazards as, under current applications, the 
likelihood of colonization or infection of workers is very smll. Rather, 
hazardous exposure to recombinant technology products, particularly contact 
with biologically active molecules, is far more likely and is examined in 
greater detail. He cited as an example the gynecomastia developed by male 
workers exposed to oral contraceptives. The quantity of biologically 
active product that elicits a response is so minute that men wearing 
spacesuits have been affected. Dr. Landrigan said that in many biotech- 
nological procedures, exposure hazard will be present throughout the process 
from fermentation of the organisms to packaging of the products. Indeed, 
packaging may be the most hazardous activity as packaging workers frequently 
underestimate the hazards and often do not exercise adequate caution. Allergic 
reactions to polypeptide products or iiyproducts are also considered in the 
report. The OX:/NIOSH document does not examine the problem of worker 
exposure to reagents as that concern in adequately covered in other documents. 
Dr. Landrigan said NI06H does not view the report as guidelines but as sug- 
gestions of prudent practice for the reccmbinant IXIA industry. He said the 
document suggests companies using recombinant DQA technology should consider 
(1) a preexamination physical of workers with collection of baseline serum, 
(2) a periodic follow-up, (3) illness surveillance, and (4) epidemiological 
studies. He said the primary means of protecting worker health is careful 
I^ysical containment of organisms and products. The second line of defense 
[ 370 ] 
