Ordinance
on the Handling of Organisms in the Environment
(Release Ordinance, RO)

¹ The ap­plic­a­tion for au­thor­isa­tion for an ex­per­i­ment­al re­lease of patho­gen­ic or­gan­isms must con­tain all the re­quired in­form­a­tion to prove that the ex­per­i­ment­al re­lease can­not con­tra­vene the re­quire­ments of Art­icles 12–14.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

de­tails of the ob­ject­ive and con­text of the ex­per­i­ment;

b.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nex 3.1;

c.

the res­ults of pre­vi­ous ex­per­i­ments, in par­tic­u­lar:

1.

res­ults of pre­lim­in­ary ex­per­i­ments in con­tained sys­tems to de­term­ine bio­lo­gic­al safety,

2.

data, res­ults and eval­u­ations of ex­per­i­ment­al re­leases car­ried out with the same or­gan­isms un­der com­par­able cli­mat­ic con­di­tions and with com­par­able fauna and flora;

d.

the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the re­quire­ments of Art­icles 12 and 13 are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

de­tails of wheth­er the pub­lic will be in­formed about the planned ex­per­i­ment­al re­lease;

g.

proof that the li­ab­il­ity guar­an­tee has been ful­filled.

³ The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter c sub­sec­tion 2 may refer to data or res­ults from an­oth­er ap­plic­ant if this per­son has giv­en writ­ten per­mis­sion.

⁴ The FOEN may waive cer­tain de­tails of the tech­nic­al dossier in ac­cord­ance with para­graph 2 let­ter b if the ap­plic­ant can prove that these de­tails are not ne­ces­sary for an eval­u­ation of the ap­plic­a­tion.

⁵ A single ap­plic­a­tion may be sub­mit­ted if an ex­per­i­ment­al re­lease is be­ing car­ried out for the same pur­pose and with­in a lim­ited peri­od:

a.

with a single patho­gen­ic or­gan­ism at dif­fer­ent places;

b.

with a com­bin­a­tion of patho­gen­ic or­gan­isms at the same place or in dif­fer­ent places.