Appendix lll-C Information on International Guidelines for Recombinent DNA • 323 
VII. \ations in which guidelines are legally en- 
forceable: 
Hungary 
L'.S.S.R.' 
Finland '.At present, the guidelines are 
entirely voluntary, but in the near 
tuture, the intention is to include 
them in the law of infectious dis- 
eases w hen they u ill become legally 
enforceable." 
South Atrica , At present the guidelines are not 
legally enforceable. They will only 
become so if regulations under the 
existing Health Act of 1977 and the 
Animal Diseases and F'arasites .Act of 
1956 are promulgated: and none are 
intended at present." 
United Kingdom The regulation to notify GM.AG 
does not strictly mean that the 
Williams Guidelines themselves are 
legally enforceable. But, under the 
Health and Safety at Work ,Act 
(w ithin w hich the Regulations were 
introduced), it is e.xpected that ac- 
count w ill be taken of the relevant 
Codes of Practice and the advice 
given by GM.AG.” 
Mil. \ations in w hich observance of the guidelines is 
monitored by a nationally-directed mechanism: 
.Australia 
Czechoslo\ akia 
German Democratic 
Republic 
France 
Hungary 
Japan 
Norway 
South .Africa 
Sweden 
United Kingdom 
United States 
U.S.S.R. 
Vugosla\ia 
IX. Xations in which a license or other authorization 
for recombinant DXA activity is granted: 
—to an institution: U.S.S.R. 
—to an indixdual laboratory: Hungary, Czechoslo- 
vakia 
—to an indix'idual scientist: .Australia, Canada, Ger- 
man Democratic Republic, Federal Republic of 
Germany, Finland, France, Japan, Norway, South 
.Africa, Sweden, United Kingdom®, United States 
and U.S.S.R. 
Netherlands: ‘There are gentlemen’s agreements, 
signed by the indix idual scientist, the institution 
and the Committee.” The reports of the Committee 
also recommend legislation that w'ill require regis- 
tration of research projects in this field and make 
binding the guidelines and supervision of their 
observance. (Report of the Committee in Charge of 
the Control on Genetic Manipulation, Amsterdam, 
March 1977, p. 54.) 
Bulgaria, Switzerland: None of the above. 
Taiwan: No response. 
“The Group advises on proposals from individual workers, but considers 
them in the conte.xt of information about tbe centre’ in which the work is to 
go on.” 
X. Xations in which special provisions for agriculture 
and/or industrial research and applications have 
been made: 
Czechoslovakia. "10 liter maximum volume of the 
culture containing recombinant 
DNA” 
German 
Democratic 
Republic "The GDR Guidelines will be com- 
pulsory for industrial and agricul- 
tural applications. 10-liter maximum 
deviations may be allowed by the 
Minister of Health if suggested by 
the Committee.” 
Federal Republic 
of Germany . . "Specification of containment of 
plants” 
France “Industry, maximum volume of cell 
culture is set at 10 liters” 
Norway "The Guidelines cover both agri- 
culture and industry. Application of 
recombinant DNA research outside 
an approved laboratory is prohib- 
ited. Otherwise the Committee fol- 
lows the NIH Guidelines.” 
United Kingdom "Agriculture, industry; see Williams 
Report, paragraphs 1.3, 2.7, 5.13 
and appendix II, section 34.” 
United States . . "Agriculture. NIH Guidelines pro- 
vide containment levels for cloning 
total plant DNA, plant virus DNA 
and plant organelle DNA in E. coli 
K-12, and provide general guidance 
for the use of plant host-vector sys- 
tems. 10 liter maximum. A proposed 
Supplement to the Guidelines for 
voluntary compliance by the private 
sector is under consideration by 
RAC. Development of a monograph 
for large-scale applications has been 
proposed.” 
U.S.S.R "Guidelines are compulsory for in- 
dustrial and agricultural applica- 
tions. 10 liter maximum. Deviation 
is allowed by the Recombinant DNA 
Commission.” 
Other 
respondents . . No 
