Apf>J Microbiol Hmtcchruil ( t V?< 5 ) 21: I— (* 
Review 
Applied 
w Microbiology 
Biotechnology 
© Springcr-VcrUp I9K5 
Safe biotechnology 
General considerations* 
M. Kuenzi (Chairman), F. Assi, A. Chmicl, C. H. Collins (Secretary), 
M. Donikian, J. B. Dominguez, L. Financsek, L. M. Fogarty, W. Frommer, 
F. Hasko, J. Hodand, E. H. Houwink, J. L. Mahler, A. Sandkvist, K. Sargeant, 
C. Sloover, and G. Tuijnenburg Msijs (Co-opted for the preparation of this Report) 
Contents 
1 . 
Introduction 
2. 
Definition of biotechnology 
3. 
The fields covered 
4. 
The objects of safety assessment 
5. 
Problems specific to biotechnology 
5.1. 
The pathogenicity of seme microorganisms, 
i.e., their ability to produce disease in higher 
life forms 
5.2. 
Problems associated with biologically active 
microbial products 
S3. 
Problems associated with handling bulk 
quantities of microorganisms 
5.4. 
The stability and purity of process strains 
6. 
Conclusions and recommendations • 
7. 
Bibliography 
Annex. 
Comparison of EFB dasses with other 
national dasses 
L Introduction 
This document has been prepared by the European 
Federation of Biotechnology (EFB) Working Parry 
on Safety in Biotechnology to cocourage the devel- 
opment of safe biotechnology by drawing attention to 
the current Kate of the art and to existing guidelines, 
etc. It attempts to summarise the safety problems that 
are encountered in biotechnology, to show how they 
may be overcome, to highlight fields where further 
progress can lead to less costly solutions and to 
catalogue the regulations, guidelines and codes of 
practice that apply to biotechnology in Europe. 
The Working Party intends to maintain a watch- 
ing brief on safety developments, periodically to 
* A Report prepared by tbe Safety In Biotech oology Working 
Parry of the E nr op ea a Fedcraiioa of Biotechnology 
Offprint rr y Me re r loc DEOtEMA, r. H. Fran Schubd, Tbco- 
dor-Heuw-AOeo 25, D-6000 Frankfort atn Stain 97 
collate what is new in this field, and to promote 
collaboration between experts at European level in 
jointly solving perceived problems. 
A recent WHO report (lj concludes that “bio- 
technology in general is regarded as a safe industry” 
and assumes that many countries will develop 
adequate guidelines to ensure that future develop- 
ments will be equally safe. ■Germany has already 
taken this course in the form of a report Sichene 
Bio technologic (Safe Biotechnology) [2], prepared by 
a Working Party of the Deutsche Gesellschaft fur 
Chemisches Apparatewesen (DECHEMA) on Bio- 
technology and in 1984 the Netherlands Microbio- 
logical Society published Guidelines for Safe Biotech- 
nological Work (3] 
There are very few regulations that relate solely to 
safety in biotechnology, but a large number that 
govern either particular sectors of industry (e.g., food 
and drink), or more general matters (e.g., protection 
of the environment) and these must be respected. by 
-biotech no togiscs. Many of these regulations are 
rather broadly drawn because it is undesirable for 
them to be changed frequently. Guidelines are 
different; they must be changed to govern, new, and 
perhaps transient techniques and to encourage- the 
rapid adoption of improvements that have been 
generally recognised. Regulations concern the whole 
of society but safety guidelines and codes of practice 
are primarily the concern of workers in industry. 
Some of the most relevant literature is mentioned In 
the bibliography appended to this report. 
2. Definition of biotechnology 
For the purpose* of this document the following EFB 
definition will be used: 
“Biotechnology is the integrated use of biochem- 
istry, microbiology, and engineering sciences in order 
to achieve the technological findustrial) application 
Recombinant DNA Research, Volume 13 
[361] 
