M. Kucuii Cl .il ■ Sale l'»>lci‘lii»«ili*j:y 
The German DECHEMA report. Sichcrc Hid- 
technologic (2| mentioned above, also describes four 
Risk Classes. In this classification. Risk Class 1 is 
further divided: Class la contains organisms that long 
industrial experience has shown to be innocuous; 
Gass lb includes organisms that can be regarded as 
nonpathogcnic only as a result of laboratory expe- 
rience. The German report recommends the devel- 
opment of "non-pathogenicity” tests which may be 
used to justify the transfer of organisms from Gass lb 
(o Gass la. 
In the guidelines of the Netherlands Microbio- 
logical Society [3] three classes of pathogens arc 
described and it is considered that all microorganisms 
not listed in these may be handled without any special 
precautions as experience and history has shown 
them to be safe. These include bakers’ yeast and 
organisms used in the manufacture of beer, wine, 
vinegar, enzymes, antibiotics, etc. and compare with 
the DECHEMA Risk Gass la. 
As indicated above, these classifications lack 
complete unanimity in their descriptions of the 
Tabl« 1- Proposed EFB dxuificatioa of frucroorgtnomi according 
to pathogentdiy 
EFB Class I 
This dia contains those microorganisms that have never been 
identified as causative agents of dries sc in man and (hit offer no 
threat to the environment. They are not listed in higher dsew-s or 
In Croup E. 
EFB Class 2 
This dan contains those microorganisms that may cause disease in 
man and which might therefore ofTer a hazard to laboratory 
workers. They are unlikely to spread in the environment. 
■ Prophylactics are available and treatment is effective. 
EFB doss 3 
This dass contains those microor g anisms that ofTer i severe threat 
to the health of laboratory workers but a comparatively small risk 
• to the population at large. Prophylactics are available and 
treatment is e f fe c tive. 
EFB Class 4 
This data contains those microorganisms that cause severe illness 
In man sod offer a serious hazard to laboratory workers and to 
people at targe. In general effective prophylactics ire not available 
and no effective treatment is known. 
EFB Croup E (erivirorsnauat risk) 
This group contains microorganisms that offer • more seve r e threat 
to the v iv ’ r>rl,T ' cn t than to man. They may be responsible for 
heavy economic Ictses. Nttional aod International tlsa'snd 
regulations concerning these microorginismi are already in 
cars i -■ooe In contexts other than b* *o technology (e g., for phyto- 
taaiiary purposes). 
These EFB descriptions differe slightly from those in existing 
European arid American daxsiCicaiioos. The proposed aod existing 
dcufoikyu are compared la the Annex. 
various risk classes Therefore, in an attempt to 
harmonise these differing national descriptions the 
European Federation of Biotechnology proposes the 
following classification which contains four classes. 
1-4, with a fifth. Group E. containing those which 
offer a risk only to the environment, especially to 
animals and plants. 
The microorganisms placed in Group E present 
no. or only a very small risk to man. Nevertheless 
they may cause severe economic losses. This group is 
considered separately only in the Netherlands and not 
in Germany or the United Kingdom. It seems 
desirable to mention this group separately with a view 
to encouraging discussion about the appropriate level 
of containment (Classes 1-4) for individual cases. 
This classification is shown in Table 1. 
For practical purposes it is desirable to correlate 
the four classes with four agreed levels of contain- 
ment. 
During recent years there has been a great deal of 
discussion about the genetic manipulation of mi- 
croorganisms by means of recombinant DNA. Con- 
trols over this work, now mostly less restrictive than 
in the past, have been established. It is now widely 
understood, however, that the hazards associated 
with recombinant DNA microorganisms may be 
assessed in the same way as those associated with 
other organisms. Once the relevant informality 
about the pathogenicity of a candidate industrial 
strain has been assembled, it is possible to determine 
the appropriate level of containment. The history of 
the manufacture of vaccines has shown that even the 
most dangerous pathogens may be grown in 
safety. 
5.2 Problems associated 
with biologically active microbial products 
AM biotechnology industries encounter biologically 
active microbial products in the course of their 
day-to-day activities: intentionally, e.g., when they 
are producing toxins for vaccine manufacture or 
antibiotics for use in medicine and agriculture; and 
adventitiously when certain contaminant microorgan- 
isms invade their processes. Furthermore, some 
products released after cell disruption may cause 
allergic reactions in man. Other biologically active 
microbial products sire also encountered elscwhe ree- 
fer example, farmers cannot prevent common toxi- 
genic fungi from invading and rpoiling certain crops 
during adverse growing conditions, and those who 
prepare food must always guard against bacterial 
contamination that may result in food poisoning, 
especially in processed meat and fish products. 
Recombinant DNA Research, Volume 13 
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