Ch. 10 — The Question of Risk • 205 
Second, little is known ahoiit the health 
record ot v\orkers in\ oKed iti the fermentation 
and vaccine industries. Foi' most industrial 
operations the e\ idence of harm is almost en- 
tirely anecdotal. .Most industrial fermentations 
are regarded as hai mless: representativ es of in- 
dustry characterize it as a "non-pmhlem” that 
has never merited monitoring. Conifirehensive 
information on the potential harmful effects 
associated w ith research using rn\.\-carrying 
micro-organisms w ill not he available because 
the (iuidelines consider it the responsibility of 
each institution or companv to "determine, in 
connection with each project, the necessitv for 
medical sui'v eillance of recomhinant-l),\,\ re- 
search personnel." Hence some institutions 
might decide to keep records of some or all ac- 
tiv ities; others might not. 
To he sin e, some companies have e.xceeded 
the minimal medical standards set by \'1H for 
fermentation using rDN.A-carrv ing micro-orga- 
nisms— eg., Kli l.illy &. Co. requires that all 
illnesses he reported to supervisors and that any 
employees who are ill for more than 5 days 
must report to a phvsician before being allowed 
to return to work. .Any employee taking antibi- 
otics (vv hich might make it easier for bacteria to 
colonize) is restricted from areas where rDN.A 
research is being done until 5 days after the dis- 
continuance of the antibiotic. .At .Abbott Labora- 
tories. a physician checks into the illness of any 
recombinant worker who is off more than 1 
dav— a precaution taken onlv after 5 days off 
for workers in other areas. Lilly maintains a 
computer listing of all workers involved in 
rD.VA activities. Lilly, the Upjohn Co., and 
Merck, Sharp and Dohme have been in the 
process of computerizing the health records of 
all their employees over the past several years. 
Work with rD\A has focused attention on 
biohazards and medical surveillance— an aware- 
ness that had arisen in the past but had not been 
sustained.* Consequently, several documents 
on the subject either have been or will be pub- 
lished: 
■.As of Sepiember 1980, the .National Institutes of Occupational 
Safety and Health and the environmental Protection Agency were 
planning to fund a.ssessnients of the adequacy of current medical 
surv eillance technologv-. 
• CDC is preparing a complete revision of its 
laboratory safety manual, wdiich is widely 
used as a starting point by other labora- 
tories. 
• The Classification of Etiologic Agents on the 
Basis of Hazard, which was last revised in 
1974, has been expanded by CDC in collab- 
oration with NIH into a Proposed Biosafety 
Guidelines for Microbiological and Biomedi- 
cal Laboratories. These guidelines serve the 
purpose tultilled by the Dangerous Patho- 
gens Advisory Group (DRAG) in the United 
Kingdom, although they lack any regula- 
tory strength. 
• A comprehensive program in safety, 
health, and environmental protection was 
developed in 1979 by and for NIH. It is ad- 
ministered by the Division of Safety, which 
includes programs in radiation safety, oc- 
cupational safety and health, environmen- 
tal protection, and occupational medicine. 
• The Office of Biohazard Safety, National 
Cancer Institute has just completed a 3- 
year study of the medical surveillance pro- 
grams of its contractors; a report is being 
drafted. 
Although the academic, governmental, and 
industrial communities have shown growing in- 
terest in biosafety,* no Federal agency regulates 
the possession or use of micro-organisms except 
for those highly pathogenic to animals and for 
interstate transport.** Whether such regula- 
tions are necessary is an issue that extends be- 
yond the scope of this study. Nevertheless, 
other countries— for instance the United King- 
dom, with its DPAG— have acted on the issue. 
This organization functions specifically to guard 
against hazardous micro-organisms, by moni- 
toring and licensing university and industrial 
laboratories and meting out penalties when 
necessary. 
•Curiously, there is no formal society or journal, but there has 
been an annual Biological Safety Cionference since 1955, con- 
ducted on a round-robin basis primarily by close associates of the 
late Arnold VV'edum, M.D.— former Director of Industrial Health 
and Safetvat the I'.S, Army Biological Research Laboratories, Fort 
Detrick, Md.. who is regarded as the "Father of Microbiological 
Safety." 
*”ln some States and cities, licensing is required for all facilities 
handling pathogenic micro-organisms. 
