Ordinance
on Handling Organisms in Contained Systems
(Containment Ordinance, ContainO)

This Or­din­ance is in­ten­ded to pro­tect hu­man be­ings, an­im­als and the en­vir­on­ment, as well as bio­lo­gic­al di­versity and its sus­tain­able use, from haz­ards or harm caused by hand­ling or­gan­isms, their meta­bol­ic products and wastes in con­tained sys­tems.

¹ This Or­din­ance reg­u­lates the hand­ling of or­gan­isms, in par­tic­u­lar ge­net­ic­ally mod­i­fied, patho­gen­ic or ali­en or­gan­isms, in con­tained sys­tems.

² The trans­port of or­gan­isms in­ten­ded for hand­ling in con­tained sys­tems is gov­erned by Art­icles 4, 15 and 25 only.

³ Hand­ling or­gan­isms in the en­vir­on­ment is gov­erned by the Re­lease Or­din­ance of 10 Septem­ber 2008⁶.

⁴ The pro­tec­tion of people and the en­vir­on­ment against ser­i­ous dam­age res­ult­ing from ma­jor ac­ci­dents in­volving mi­croor­gan­isms is reg­u­lated by the Ma­jor Ac­ci­dents Or­din­ance of 27 Feb­ru­ary 1991⁷.⁸

⁵ The pro­tec­tion of em­ploy­ees when hand­ling mi­croor­gan­isms is gov­erned by the Or­din­ance of 25 Au­gust 1999⁹ on the Pro­tec­tion of Em­ploy­ees from Dan­ger­ous Mi­croor­gan­isms.

⁶ This Or­din­ance does not ap­ply to the hand­ling of or­gan­isms:

a.

in ac­cord­ance with the Or­din­ance of 20 Septem­ber 2013¹⁰ on Clin­ic­al Tri­als in Hu­man Re­search;

b.

in the case of per­son­al use of med­ic­al devices for the pur­poses of in-vitro dia­gnostics, the dis­pens­ing of which is au­thor­ised in ac­cord­ance with Art­icle 17 para­graph 3 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001¹¹.¹²

In this Or­din­ance:

a.

or­gan­isms means cel­lu­lar or non-cel­lu­lar bio­lo­gic­al en­tit­ies cap­able of rep­lic­a­tion or of trans­fer­ring ge­net­ic ma­ter­i­al, and in par­tic­u­lar an­im­als, plants and mi­croor­gan­isms. Mix­tures, art­icles and products con­tain­ing such en­tit­ies are also re­garded as or­gan­isms;

b.

mi­croor­gan­isms means mi­cro­bi­o­lo­gic­al en­tit­ies, in par­tic­u­lar bac­teria, al­gae, fungi, pro­to­zoa, vir­uses and viroids; cell cul­tures, para­sites, pri­ons and bio­lo­gic­ally act­ive ge­net­ic ma­ter­i­al are also re­garded as mi­croor­gan­isms;

c.

small in­ver­teb­rates meansarth­ro­pods, an­nelids, nem­at­odes and flat­worms;

d.

ge­net­ic­ally mod­i­fied or­gan­isms means or­gan­isms in which the ge­net­ic ma­ter­i­al has been altered by meth­ods of gene tech­no­logy in ac­cord­ance with An­nex 1 in a way that does not oc­cur un­der nat­ur­al con­di­tions by cross­ing or nat­ur­al re­com­bin­a­tion, as well as patho­gen­ic or ali­en or­gan­isms that have also been ge­net­ic­ally mod­i­fied;

e.

patho­gen­ic or­gan­isms means or­gan­isms that can cause dis­eases in hu­man be­ings, do­mest­ic­ated an­im­als and plants, in wild flora or fauna or oth­er or­gan­isms, as well as ali­en or­gan­isms that are also patho­gen­ic;

f.

ali­en or­gan­isms means or­gan­isms of a spe­cies, sub-spe­cies or lower taxo­nom­ic level that:

1.

do not nat­ur­ally oc­cur in Switzer­land or in oth­er EFTA and EU mem­ber states (not in­clud­ing over­seas areas),

2.

have not un­der­gone se­lec­tion for use in ag­ri­cul­ture or hor­ti­cul­tur­al pro­duc­tion to such an ex­tent that their vi­ab­il­ity in the wild is re­duced;

g.

in­vas­ive ali­en or­gan­isms means ali­en or­gan­isms of which it is known or must be as­sumed that they will spread in Switzer­land and could achieve such a high pop­u­la­tion dens­ity that bio­lo­gic­al di­versity or its sus­tain­able use could be harmed or hu­man be­ings, an­im­als and the en­vir­on­ment could be en­dangered;

h.

con­tained sys­tem means a sys­tem that uses phys­ic­al bar­ri­ers or a com­bin­a­tion of phys­ic­al and chem­ic­al or bio­lo­gic­al bar­ri­ers to lim­it or pre­vent con­tact between or­gan­isms and people or the en­vir­on­ment;

i.

hand­ling means any de­lib­er­ate activ­ity in­volving or­gan­isms, and in par­tic­u­lar use, pro­cessing, propaga­tion, modi­fic­a­tion, de­tec­tion, trans­port, stor­age or dis­pos­al;

j.¹³

im­prop­er use means the hand­ling of or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion which il­leg­ally and in­ten­tion­ally en­dangers or harms hu­mans, an­im­als, the en­vir­on­ment or bio­lo­gic­al di­versity and their sus­tain­able use.

¹ Any per­son hand­ling or­gan­isms in con­tained sys­tems must take all due care to en­sure that or­gan­isms, their meta­bol­ic products or wastes:

a.

can­not en­danger people, an­im­als or the en­vir­on­ment;

b.

do not harm bio­lo­gic­al di­versity or its sus­tain­able use.

² The rel­ev­ant reg­u­la­tions and the dis­trib­ut­or's in­struc­tions and re­com­mend­a­tions must be ob­served.

³ Com­pli­ance with the duty of care must be clearly doc­u­mented. The doc­u­ment­a­tion must be re­tained for ten years fol­low­ing the con­clu­sion of the activ­ity and must be made avail­able on re­quest to the en­force­ment au­thor­it­ies.

¹ The fol­low­ing or­gan­isms must be handled only in con­tained sys­tems un­less they may be handled in the en­vir­on­ment in ac­cord­ance with the Re­lease Or­din­ance of 10 Septem­ber 2008,¹⁴ the Plant Pro­tec­tion Products Or­din­ance of 12 May 2010¹⁵ or the Biocid­al Products Or­din­ance of 18 May 2005¹⁶:

a.

ge­net­ic­ally mod­i­fied or­gan­isms;

b.

patho­gen­ic or­gan­isms;

c.¹⁷

or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion:

1.

ali­en small in­ver­teb­rates,

2.

in­vas­ive ali­en or­gan­isms as defined in An­nex 2 of the Re­lease Or­din­ance, and

3.

harm­ful or­gan­isms that are con­sidered par­tic­u­larly dan­ger­ous in ac­cord­ance with the Or­din­ance is­sued by the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search and the Fed­er­al De­part­ment of the En­vir­on­ment, Trans­port, En­ergy and Com­mu­nic­a­tions based on Art­icles 4 para­graph 3, 24 para­graph 2 and 29 para­graph 2 of the Plant Health Or­din­ance of 31 Oc­to­ber 2018¹⁸, and or­gan­isms that are con­sidered po­ten­tial quar­ant­ine or­gan­isms in ac­cord­ance with the Or­din­ance is­sued by the Fed­er­al Of­fice for Ag­ri­cul­ture (FO­AG) and the Fed­er­al Of­fice for the En­vir­on­ment (FOEN) based on Art­icle 5 para­graph 2 of the Plant Health Or­din­ance.

² Any per­son who handles or­gan­isms in con­tained sys­tems must first de­term­ine and as­sess the risk of the oc­cur­rence of the or­gan­isms (al­loc­ate the or­gan­isms to a group) and there­after de­term­ine and as­sess the risk due to the planned activ­it­ies with the or­gan­isms (clas­si­fy the activ­it­ies).

³ Any per­son who handles ge­net­ic­ally mod­i­fied an­im­als and plants in con­tained sys­tems must first en­sure by weigh­ing the in­terests in ac­cord­ance with Art­icle 8 GTA that the dig­nity of liv­ing be­ings is re­spec­ted.

¹ Where a patho­gen­ic or­gan­ism with the po­ten­tial to do con­sid­er­able harm nat­ur­ally oc­curs on a fre­quent basis, is re­leased in­ten­tion­ally or un­in­ten­tion­ally or if it is sus­pec­ted that it has been re­leased, its primary de­tec­tion may take place ex­cep­tion­ally out­side of con­tained sys­tems if:

a.

there is no threat to hu­mans, an­im­als, the en­vir­on­ment or bio­lo­gic­al di­versity;

b.

the ana­lyses are car­ried out in or­der help an as­sess­ment of the situ­ation;

c.

ap­pro­pri­ate se­cur­ity meas­ures are re­spec­ted; and

d.

the rap­id de­tec­tion sys­tems used can be shown to be re­li­able.

² De­tec­tion as defined in para­graph 1 is only per­miss­ible if car­ried out by em­ploy­ees of the fol­low­ing com­pet­ent au­thor­it­ies who pos­sess the re­quis­ite spe­cial­ist ex­pert­ise:

a.

the can­ton­al emer­gency ser­vices for B-in­cid­ents in ac­cord­ance with Art­icle 3 let­ter e of the Or­din­ance of 29 April²⁰ on Mi­cro­bi­o­lo­gic­al Labor­at­or­ies;

b.

the com­pet­ent veter­in­ary au­thor­it­ies re­spons­ible for meas­ures to com­bat dis­ease in ac­cord­ance with Art­icle 63 of the Epi­zo­ot­ic Dis­eases Or­din­ance of 27 June 1995²¹;

c.

the fed­er­al or can­ton­al plant pro­tec­tion ser­vices re­spons­ible for pre­vent­ive meas­ures in ac­cord­ance with Art­icle 10, for mon­it­or­ing in ac­cord­ance with Art­icle 18 and for sur­vey­ing in ac­cord­ance with Art­icle 19 of the Plant Health Or­din­ance of 31 Oc­to­ber 2018²² (PHO);

d.

the es­tab­lish­ments au­thor­ised in ac­cord­ance with Art­icle 76 PHO to con­duct as­sess­ments in ac­cord­ance with Art­icle 84 PHO.

¹ In or­der to de­term­ine the risk of an oc­cur­rence of or­gan­isms, the ex­tent and prob­ab­il­ity of harm­ful ef­fects to hu­man be­ings, an­im­als or the en­vir­on­ment and to bio­lo­gic­al di­versity and its sus­tain­able use must be es­tim­ated. In do­ing so, the cri­ter­ia in An­nex 2.1 num­ber 1 must be taken in­to ac­count.

² In or­der to as­sess the risks de­term­ined, the or­gan­isms must be al­loc­ated to one of the fol­low­ing groups ac­cord­ing to the cri­ter­ia in An­nex 2.1 num­ber 2:

a.

Group 1: or­gan­isms whose oc­cur­rence presents no risk or a neg­li­gible risk;

b.

Group 2: or­gan­isms whose oc­cur­rence presents a low risk;

c.

Group 3: or­gan­isms whose oc­cur­rence presents a mod­er­ate risk;

d.

Group 4: or­gan­isms whose oc­cur­rence presents a high risk.

³ If cer­tain or­gan­isms have already been grouped ac­cord­ing to the list in Art­icle 26, no new risk de­term­in­a­tion and as­sess­ment need be car­ried out un­less there are in­dic­a­tions of an in­creased or re­duced risk in an oc­cur­rence of these or­gan­isms. In the event of sig­ni­fic­ant new find­ings, the risk must be de­term­ined and as­sessed again.

¹ In or­der to de­term­ine the risk of a planned activ­ity with or­gan­isms in the con­tained sys­tem, the ex­tent and prob­ab­il­ity of harm­ful ef­fects to hu­man be­ings, an­im­als or the en­vir­on­ment, bio­lo­gic­al di­versity and its sus­tain­able use must be es­tim­ated. In do­ing so, the group of or­gan­isms con­cerned, the nature of the planned activ­ity and the en­vir­on­ment­al con­di­tions ac­cord­ing to the cri­ter­ia in An­nex 2.2 num­ber 1 must be taken in­to ac­count.

² In or­der to as­sess the risks de­term­ined, the planned activ­ity must be al­loc­ated to one of the fol­low­ing classes ac­cord­ing to the cri­ter­ia in An­nex 2.2 num­ber 2:

a.

Class 1: activ­it­ies with no risk or a neg­li­gible risk;

b.

Class 2: activ­it­ies with a low risk;

c.

Class 3: activ­it­ies with a mod­er­ate risk;

d.

Class 4: activ­it­ies with a high risk.

³ The risk must be de­term­ined and as­sessed again if the activ­ity is mod­i­fied or sig­ni­fic­ant new find­ings are made.

⁴ In activ­it­ies where em­ploy­ees may be ex­posed to mi­croor­gan­isms, the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with this Or­din­ance may be com­bined with the risk as­sess­ment in ac­cord­ance with Art­icles 5–7 of the Or­din­ance of 25 Au­gust 1999²³ on the Pro­tec­tion of Em­ploy­ees from Dan­ger­ous Or­gan­isms.

¹ Any per­son who wishes to carry out Class 1 activ­it­ies with ge­net­ic­ally mod­i­fied or­gan­isms must no­ti­fy this glob­ally, at the latest when be­gin­ning the activ­it­ies.

² Any change in the glob­ally no­ti­fied activ­it­ies or their ter­min­a­tion must be no­ti­fied.

¹ Any per­son who wishes to carry out a Class 2 activ­ity with ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms or ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion must no­ti­fy this at the latest when be­gin­ning the activ­ity.

² Any tech­nic­al or ad­min­is­trat­ive change in the no­ti­fied activ­ity or its ter­min­a­tion must be no­ti­fied.

³ If an au­thor­isa­tion is re­quired un­der Art­icle 49 para­graph 2 of the Epi­zo­ot­ic Dis­eases Or­din­ance of 27 June 1995²⁴ (EzDO), this must be ob­tained be­fore start­ing the activ­ity.

¹ Any per­son who wishes to carry out a Class 3 or a Class 4 activ­ity with ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms or ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion re­quires au­thor­isa­tion.

² Any tech­nic­al change in the au­thor­ised activ­ity re­quires fur­ther au­thor­isa­tion.

³ Any ad­min­is­trat­ive change must be no­ti­fied.

¹ No­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions must be sub­mit­ted to the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

² No­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions must in­clude the in­form­a­tion lis­ted in An­nex 3. In the in­form­a­tion, pro­ced­ures and meth­ods re­lated in their nature, ex­tent and pur­pose may be sum­mar­ised.

³ The in­form­a­tion must be entered dir­ectly in­to the ECO­GEN elec­tron­ic data­base (Art. 27a).²⁵

¹ Any per­son in­volved in the con­tained hand­ling of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms or ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion must:

a.

en­sure in the case of activ­it­ies in Classes 1 and 2 that any es­cape by these or­gan­isms is lim­ited to the ex­tent that hu­man be­ings, an­im­als and the en­vir­on­ment as well as bio­lo­gic­al di­versity and its sus­tain­able use can­not be en­dangered;

b.

en­sure in the case of activ­it­ies in Classes 3 and 4 that these or­gan­isms can­not es­cape.

² The gen­er­al safety meas­ures lis­ted in An­nex 4 and the spe­cial safety meas­ures re­quired ac­cord­ing to the type and class of activ­ity must be taken, and an op­er­a­tion­al safety concept must be de­vised which takes ap­pro­pri­ate ac­count of wheth­er or­gan­isms could po­ten­tially be put to im­prop­er use. The safety meas­ures taken must take ac­count of the risk de­term­ined in the in­di­vidu­al case and the state of the art of safety tech­no­logy.²⁶

³ The com­pet­ent fed­er­al of­fice may or­der in spe­cif­ic cases that:

a.

in­di­vidu­al spe­cial safety meas­ures ac­cord­ingly spe­cified in An­nex 4 may be mod­i­fied, re­placed or omit­ted if the Ap­plic­ant has proven that the pro­tec­tion of hu­man be­ings, an­im­als and the en­vir­on­ment as well as bio­lo­gic­al di­versity and its sus­tain­able use is nev­er­the­less guar­an­teed;

b.

fur­ther spe­cial safety meas­ures not lis­ted in An­nex 4 for the rel­ev­ant type and class of activ­ity must be taken if such meas­ures have been re­com­men­ded by in­ter­na­tion­al or­gan­isa­tions or the Swiss Ex­pert Com­mit­tee for Biosafety (SECB) and are re­garded as ne­ces­sary by the com­pet­ent fed­er­al of­fice.

¹ Any per­son who car­ries out an activ­ity in con­tained sys­tems with ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms of Classes 3 or 4 must guar­an­tee leg­al li­ab­il­ity:

a.

of 20 mil­lion francs to cov­er dam­age to per­sons and prop­erty (Art. 30 GTA, Art. 59a^bis para. 1 EPA); and

b.

of 2 mil­lion francs to cov­er dam­age to the en­vir­on­ment (Art. 31 GTA, Art. 59a^bis para. 9 EPA).

² The ob­lig­a­tion to guar­an­tee li­ab­il­ity may be ful­filled:

a.

by ob­tain­ing li­ab­il­ity in­sur­ance from an in­sur­ance com­pany that is au­thor­ised to do busi­ness in Switzer­land;

b.

by provid­ing se­cur­ity of equi­val­ent value.

³ The fol­low­ing are ex­empt from this guar­an­tee of li­ab­il­ity:

a.

the Con­fed­er­a­tion, its pub­lic cor­por­a­tions and in­sti­tu­tions;

b.

the can­tons and their pub­lic cor­por­a­tions and in­sti­tu­tions, provided the can­tons cov­er their li­ab­il­it­ies.

¹ The per­son who guar­an­tees li­ab­il­ity must no­ti­fy the spe­cial­ist agency ap­poin­ted by the can­ton of the start, sus­pen­sion and ter­min­a­tion of the guar­an­tee.

² The sus­pen­sion and ter­min­a­tion of the guar­an­tee, un­less pre­vi­ously re­placed by a dif­fer­ent guar­an­tee, be­come ef­fect­ive 60 days after re­ceipt of no­ti­fic­a­tion by the spe­cial­ist agency ap­poin­ted by the can­ton.

¹ Any per­son trans­port­ing ge­net­ic­ally mod­i­fied or patho­gen­ic mi­croor­gan­isms must ob­serve the ap­plic­able na­tion­al and in­ter­na­tion­al trans­port reg­u­la­tions, in par­tic­u­lar with re­gard to la­belling and pack­aging.

² In the case of trans­port in a man­ner not covered by para­graph 1 of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms or ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion, it must be en­sured that any es­cape of or­gan­isms is either lim­ited or pre­ven­ted, de­pend­ing on the risk.

³ The dis­trib­ut­or must in­form the re­cip­i­ent of:

a.

the iden­tity and the quant­ity of the or­gan­isms;

b.

the prop­er­ties of the or­gan­isms, and in par­tic­u­lar wheth­er they are ge­net­ic­ally mod­i­fied, patho­gen­ic or ali­en or­gan­isms;

c.

that the or­gan­isms must be handled in con­tained sys­tems.

¹ The spe­cial­ist agency ap­poin­ted by the can­ton must be in­formed im­me­di­ately in the event that, when hand­ling or­gan­isms in con­tained sys­tems:

a.

or­gan­isms that should have been pre­ven­ted from es­cap­ing in­to the en­vir­on­ment un­der Art­icle 12 para­graph 1 have done so;

b.

there was a genu­ine risk of or­gan­isms be­ing re­leased in­to the en­vir­on­ment in the course of activ­it­ies in Classes 3 and 4; or

c.²⁷

there is a strong sus­pi­cion of im­prop­er use.

² The can­tons shall in­form the com­pet­ent fed­er­al of­fice of any re­por­ted in­cid­ents.

¹ The Con­fed­er­a­tion op­er­ates a Co­ordin­a­tion Centre for Bi­o­tech­no­logy with­in the Fed­er­al Of­fice for the En­vir­on­ment (FOEN).

² The Co­ordin­a­tion Centre has the fol­low­ing ad­min­is­trat­ive du­ties:

a.

it ac­cepts no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions un­der Art­icles 8–12 as well as no­ti­fic­a­tions un­der the Or­din­ance of 25 Au­gust 1999²⁸ on the Pro­tec­tion of Em­ploy­ees from Dan­ger­ous Or­gan­isms;

b.

it ex­am­ines the no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions, re­quests any miss­ing in­form­a­tion with­in 20 days and con­firms to the per­son fil­ing the no­ti­fic­a­tion or ap­plic­a­tion that the doc­u­ment is com­plete;

c.

it for­wards com­plete no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions to the com­pet­ent fed­er­al of­fice (Art. 18 para. 1) for a de­cision and to the spe­cial­ist agen­cies (Art. 18 para. 2) for an opin­ion;

d.

it gives no­tice of re­ceipt of no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions in the Of­fi­cial Fed­er­al Gaz­ette and makes these no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions avail­able for pub­lic in­spec­tion un­less they are con­fid­en­tial;

e.

it mon­it­ors pro­gress in pro­cessing the no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions re­ceived;

f.²⁹

it main­tains the ECO­GEN elec­tron­ic data­base (Art. 27a);

g.

it main­tains a re­gister of no­ti­fied and au­thor­ised activ­it­ies and makes this in­form­a­tion, and the res­ults of sur­veys un­der Art­icle 27, pub­licly ac­cess­ible via auto­mated in­form­a­tion and com­mu­nic­a­tions ser­vices un­less they con­cern con­fid­en­tial in­form­a­tion;

h.

it is the in­form­a­tion and ad­vice centre for en­quir­ies about:

1.

pro­ced­ures and the status of no­ti­fic­a­tion pro­ced­ures and au­thor­isa­tion ap­plic­a­tions,

2.

forms, guidelines and for­eign stand­ards as well as con­tact ad­dresses with­in the Fed­er­al Ad­min­is­tra­tion,

3.

the list of clas­si­fied or­gan­isms;

i.

it may run courses and train­ing ses­sions in its ca­pa­city as an in­form­a­tion and ad­vice centre;

j.

it re­ceives in­form­a­tion and re­ports from the can­tons on their su­per­vis­ory activ­it­ies un­der Art­icle 23, for­wards them im­me­di­ately to the re­spons­ible fed­er­al of­fices and is­sues an an­nu­al re­port on su­per­vis­ory activ­it­ies un­der this Or­din­ance.

¹ The fol­low­ing of­fices are com­pet­ent to take the de­cisions re­quired in con­nec­tion with activ­it­ies sub­ject to no­ti­fic­a­tion or au­thor­isa­tion:

a.

the Fed­er­al Of­fice of Pub­lic Health (FOPH) where the main risk of an activ­ity con­cerns hu­man be­ings;

b.

the FOEN for all oth­er activ­it­ies.

² The fol­low­ing are the spe­cial­ist agen­cies:

a.

for all activ­it­ies, the FOPH, the FOEN, the Fed­er­al Eth­ics Com­mit­tee on Non-Hu­man Bi­o­tech­no­logy (ECNH), the spe­cial­ist agency ap­poin­ted by the can­ton, and, at its re­quest, the State Sec­ret­ari­at for Eco­nom­ic Af­fairs (SECO);

b.

for activ­it­ies in Classes 2‒4, the Swiss Na­tion­al Ac­ci­dent In­sur­ance Fund (SUVA);

c.

for activ­it­ies in Classes 3 and 4 and ap­plic­a­tions un­der Art­icle 12 para­graph 3 let­ter a, the SECB;

d.

for activ­it­ies with or­gan­isms patho­gen­ic to an­im­als, the Fed­er­al Food Safety and Veter­in­ary Of­fice (FS­VO)³⁰;

e.

for activ­it­ies with or­gan­isms patho­gen­ic to plants and ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion, the Fed­er­al Of­fice for Ag­ri­cul­ture (FO­AG).

³ If the FOPH, the FOEN, the FO­AG or the FS­VO are the spe­cial­ist agen­cies, the com­pet­ent fed­er­al of­fice de­cides with their con­sent in cases where the mat­ter in ques­tion relates to com­pli­ance with the le­gis­la­tion en­forced by these agen­cies.

⁴ In the case of activ­it­ies with highly con­ta­gious epi­zo­ot­ic dis­eases un­der Art­icle 2 EzDO³¹ that are in­ten­ded to be car­ried out out­side the In­sti­tute for Vir­o­logy and Im­mun­o­logy (IVI) ³², the com­pet­ent fed­er­al of­fice co­ordin­ates its de­cision with that of the FS­VO un­der Art­icle 49 para­graph 2 EzDO.

¹ The com­pet­ent fed­er­al of­fice veri­fies wheth­er the re­quire­ments of Art­icles 4–7 have been met. In do­ing so, it takes ac­count of any opin­ions from the spe­cial­ist agen­cies.

² The com­pet­ent fed­er­al of­fice may pro­hib­it the activ­ity en­tirely or in part if there is reas­on to as­sume that the re­quire­ments of Art­icles 4–7 have not been met. It com­mu­nic­ates its de­cision with­in 90 days of con­firm­a­tion of its com­plete­ness to the no­ti­fy­ing per­son, the spe­cial­ist agen­cies, and the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

³ If the com­pet­ent fed­er­al of­fice fails to is­sue a de­cision with­in the said peri­od, Class 1 activ­it­ies sub­ject to no­ti­fic­a­tion and changes to Class 2 activ­it­ies of which the of­fice has already been no­ti­fied are deemed to be in com­pli­ance with this Or­din­ance, un­less this is con­tra­dicted by sub­stan­tial new find­ings.³³

¹ The com­pet­ent fed­er­al of­fice veri­fies wheth­er the re­quire­ments of Art­icles 4–7 and 13 have been met. In do­ing so, it takes ac­count of the opin­ions re­ceived from the spe­cial­ist agen­cies.

² The com­pet­ent fed­er­al of­fice de­cides on the au­thor­isa­tion ap­plic­a­tion with­in 90 days of con­firm­a­tion of its com­plete­ness. Au­thor­isa­tion is val­id for a max­im­um of five years.

³ If there is a risk in delay, and in par­tic­u­lar if a rap­id dia­gnos­is of new mi­croor­gan­isms is re­quired, the com­pet­ent fed­er­al of­fice may, fol­low­ing a pro­vi­sion­al ex­am­in­a­tion of the risk de­term­in­a­tion and as­sess­ment and hav­ing in­formed the spe­cial­ist agen­cies, grant au­thor­isa­tion lim­ited un­til the con­clu­sion of the or­din­ary pro­ced­ure.

⁴ The com­pet­ent fed­er­al of­fice com­mu­nic­ates its de­cision to the ap­plic­ant, the spe­cial­ist agen­cies and the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

¹ With­in 90 days of con­firm­a­tion that the ap­plic­a­tion is com­plete, the com­pet­ent fed­er­al of­fice au­thor­ises re­ques­ted de­vi­ations from spe­cial safety meas­ures provided the re­quire­ments (Art. 12 para. 3 let. a) are met. In do­ing so, it takes ac­count of the opin­ions re­ceived from the spe­cial­ist agen­cies.

² The com­pet­ent fed­er­al of­fice com­mu­nic­ates its de­cision the ap­plic­ant, the spe­cial­ist agen­cies and the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

¹ If ad­di­tion­al in­form­a­tion must be sub­mit­ted in or­der to con­sider no­ti­fic­a­tions and au­thor­isa­tion ap­plic­a­tions, the stand­ard dead­lines in this Sec­tion are ex­ten­ded ac­cord­ingly.

² If the com­pet­ent fed­er­al of­fice is un­able to com­ply with the dead­line for is­su­ing a de­cision un­der this Sec­tion, it no­ti­fies the no­ti­fy­ing per­son or ap­plic­ant and the spe­cial­ist agen­cies be­fore ex­piry of the dead­line and in­forms them when the de­cision is to be ex­pec­ted.

¹ The can­tons mon­it­or shall com­pli­ance with the duty of care, the con­tain­ment ob­lig­a­tion and the safety meas­ures.

² They also veri­fy by means of spot checks wheth­er:

a.

the doc­u­ment­a­tion re­quired by Art­icle 4 para­graph 3 has been pre­pared and pre­served;

b.

no­ti­fic­a­tion has been giv­en or au­thor­isa­tion gran­ted, if re­quired, for an activ­ity that has been car­ried out;

c.

the in­form­a­tion on the or­gan­isms to be used and the activ­ity giv­en in the no­ti­fic­a­tion or au­thor­isa­tion ap­plic­a­tion cor­res­ponds with the or­gan­isms ac­tu­ally used and the activ­ity car­ried out;

d.

a sig­ni­fic­ant change in the pro­posed activ­ity has been made such that the risk de­term­in­a­tion and as­sess­ment un­der Art­icle 7 para­graph 3 must be re­peated;

e.

pub­lic li­ab­il­ity is guar­an­teed.

³ The samples, de­tec­tion meth­ods and ma­ter­i­als re­quired for mon­it­or­ing are made avail­able to the can­tons.

⁴ If the mon­it­or­ing shows cause for com­plaint, the can­ton in ques­tion or­ders the re­quired meas­ures to be taken and in­form the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

⁵ If there is jus­ti­fied doubt wheth­er an activ­ity that has only been doc­u­mented is not sub­ject to a no­ti­fic­a­tion or au­thor­isa­tion ob­lig­a­tion, the can­ton in­forms the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy.

⁶ The can­tons wherever pos­sible co­ordin­ate mon­it­or­ing un­der this and oth­er le­gis­la­tion.

⁷ The can­tons sub­mit an an­nu­al re­port to the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy on their mon­it­or­ing activ­it­ies. To do so, they use the tem­plate provided by the Co­ordin­a­tion Centre.

¹ If the re­quire­ments for a no­ti­fied activ­ity or an au­thor­isa­tion are not met des­pite a com­plaint from the can­ton, the com­pet­ent fed­er­al of­fice, hav­ing con­sul­ted the can­ton, shall pro­hib­it the con­tinu­ation of the no­ti­fied activ­ity or re­voke au­thor­isa­tion.

² The com­pet­ent fed­er­al of­fice de­cides based on in­form­a­tion provided by the can­ton wheth­er an activ­ity that is only doc­u­mented is sub­ject to the no­ti­fic­a­tion or au­thor­isa­tion ob­lig­a­tion or not.

The re­spons­ib­il­ity for mon­it­or­ing the trans­port of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms or ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion and for or­der­ing any meas­ures is gov­erned by the rel­ev­ant trans­port reg­u­la­tions.

¹ The FOEN main­tains with con­sent of the FOPH, SECO, FS­VO, FO­AG and SUVA and after con­sult­ing the SECB a pub­licly ac­cess­ible, non-con­clus­ive list in which or­gan­isms are clas­si­fied in one of the four groups ac­cord­ing to the cri­ter­ia in An­nex 2.1.

² The FOPH main­tains with the con­sent of the FOEN and after con­sult­ing SECO, the FS­VO, the FO­AG, the Fed­er­al Of­fice for Civil Pro­tec­tion, SUVA and the SECB, a pub­licly ac­cess­ible, non-con­clus­ive list of or­gan­isms with a high po­ten­tial for im­prop­er use.

³ The FOEN and the FOPH shall take ac­count of ex­ist­ing lists, in par­tic­u­lar those of the European Uni­on and its mem­ber states and of in­ter­na­tion­al or­gan­isa­tions.

The FOEN and the FOPH may carry out sur­veys of all activ­it­ies in­volving ge­net­ic­ally mod­i­fied, patho­gen­ic and ali­en or­gan­isms in con­tained sys­tems, in par­tic­u­lar as to the type and num­ber of and time sched­ule for these activ­it­ies.

¹ Data re­quired to con­duct the fol­low­ing tasks are re­cor­ded and pro­cessed in the ECO­GEN elec­tron­ic data­base:

a.

the no­ti­fic­a­tion and au­thor­isa­tion pro­ced­ures spe­cified in Art­icles 19 and 20;

b.

re­port­ing in­cid­ents un­der Art­icle 16 para­graph 2;

c.

re­ceiv­ing in­form­a­tion and re­ports on su­per­vis­ory activ­it­ies un­der Art­icle 17 para­graph 2 let­ter j;

d.

provid­ing in­form­a­tion and ad­vice un­der Art­icle 17 para­graph 2 let­ter h;

e.

con­duct­ing oth­er tasks re­lat­ing to the im­ple­ment­a­tion of this Or­din­ance.

² The fol­low­ing per­sons have ac­cess to ECO­GEN and may pro­cess the data it con­tains:

a.

em­ploy­ees of the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy and of the of­fices and agen­cies re­spons­ible lis­ted in Art­icle 18 para­graphs 1 and 2: in ac­cord­ance with their ap­poin­ted tasks;

b.

per­sons mak­ing a no­ti­fic­a­tion or ap­plic­a­tion: to the ex­tent that the data con­cerns them.

¹ The au­thor­it­ies re­spons­ible for the en­force­ment of this Or­din­ance shall treat in­form­a­tion as con­fid­en­tial where there is a le­git­im­ate and over­rid­ing in­terest in do­ing so. They clas­si­fy this in­form­a­tion as such when for­ward­ing it to oth­er au­thor­it­ies.

² There is a le­git­im­ate in­terest in par­tic­u­lar in pre­serving trade and man­u­fac­tur­ing secrecy.

³ Any per­son sub­mit­ting doc­u­ments to the au­thor­it­ies must:

a.

in­dic­ate the in­form­a­tion which is to be treated as con­fid­en­tial; and

b.

jus­ti­fy the need for con­fid­en­ti­al­ity.

⁴ An au­thor­ity that does not wish to ac­cede to a re­quest for con­fid­en­ti­al­ity shall in­vest­ig­ate wheth­er the grounds giv­en for con­fid­en­ti­al­ity are jus­ti­fi­able. If its as­sess­ment dif­fers from the pro­pos­al of the per­sons sup­ply­ing the in­form­a­tion, the au­thor­ity, after hear­ing these per­sons, shall in­form them in a rul­ing which in­form­a­tion they do not find worthy of pro­tec­tion.

⁵ The fol­low­ing in­form­a­tion shall al­ways be ac­cess­ible to the pub­lic:

a.

the name of the per­sons re­spons­ible for the activ­ity and for mon­it­or­ing bio­lo­gic­al safety;

b.

ad­dress of the es­tab­lish­ment and the in­stall­a­tion (loc­a­tion of the activ­ity);

c.

the type of in­stall­a­tion, safety meas­ures and waste dis­pos­al;

d.

a gen­er­al de­scrip­tion of the or­gan­isms and of their prop­er­ties;

e.

a gen­er­al de­scrip­tion of the activ­ity, and in par­tic­u­lar its pur­pose and its ap­prox­im­ate size (e.g. cul­ture volume);

f.

a sum­mary of the risk as­sess­ment;

g.

the class of the activ­ity.

¹ Any per­son who causes the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy, the FOEN or the FOPH to provide a ser­vice or the of­fices to is­sue a rul­ing un­der this Or­din­ance must pay a fee.

² Un­less this Or­din­ance con­tains spe­cial reg­u­la­tions, the pro­vi­sions of the Gen­er­al Fees Or­din­ance of 8 Septem­ber 2004³⁶ap­ply.

¹ The fees are as fol­lows:

² The fee is as­sessed on a time and ma­ter­i­al basis. If the work in­volved is un­usu­ally high, the fee may be in­creased by up to 50 per cent.

³ When ex­amin­ing ap­plic­a­tions for a re-as­sess­ment, fees of up to 50 per cent of the rates fixed may be charged.

⁴ For ser­vices without a fee rate, the fee amounts to 130–190 francs per hour.

Out­lays are the costs ad­di­tion­ally in­curred for an in­di­vidu­al ser­vice, and in par­tic­u­lar:

a.

re­mu­ner­a­tion for mem­bers of ex­tra-par­lia­ment­ary com­mit­tees un­der the Gov­ern­ment and Ad­min­is­tra­tion Or­gan­isa­tion Or­din­ance of 25 Novem­ber 1998³⁷;

b.

costs in­curred in gath­er­ing evid­ence, con­duct­ing sci­entif­ic in­vest­ig­a­tions or spe­cial ex­am­in­a­tions or ob­tain­ing doc­u­ments;

c.

costs of work that the Fed­er­al Co­ordin­a­tion Centre for Bi­o­tech­no­logy, the FOEN or the FOPH ar­ranges to be car­ried out by third parties.

¹ The FOEN and the FOPH may is­sue joint guidelines on the im­ple­ment­a­tion of this Or­din­ance, in par­tic­u­lar on the de­term­in­a­tion and as­sess­ment of the risks posed by the oc­cur­rence of or­gan­isms or activ­it­ies with or­gan­isms, trans­port of or­gan­isms, safety meas­ures and re­lated qual­ity con­trols. They con­sult the spe­cial­ist agen­cies (Art. 18 para. 2) be­fore­hand.

² The FOEN and the FOPH jointly en­sure, in con­sulta­tion in par­tic­u­lar with the SECB, that ba­sic and con­tinu­ing pro­fes­sion­al edu­ca­tion events are held reg­u­larly for per­sons who carry out du­ties un­der this Or­din­ance.

The fol­low­ing or­din­ances are re­pealed:

1.

Con­tain­ment Or­din­ance of 25 Au­gust 1999³⁸;

2.

Or­din­ance of 15 Oc­to­ber 2001³⁹ on Fees for Ser­vices un­der the Con­tain­ment Or­din­ance.

The amend­ment of cur­rent le­gis­la­tion is reg­u­lated in An­nex 5.

¹ Activ­it­ies that are au­thor­ised in the prop­er man­ner when this Or­din­ance comes in­to force may be con­tin­ued un­til ex­piry of au­thor­isa­tion in ac­cord­ance with the pre­vi­ous law.

² Activ­it­ies that have been prop­erly no­ti­fied be­fore this Or­din­ance comes in­to force must with­in five years of this Or­din­ance com­ing in­to force be re­viewed by the no­ti­fy­ing per­son to veri­fy com­pli­ance here­with. If changes to the activ­ity or the safety meas­ures are re­quired due to this Or­din­ance, they must be no­ti­fied with­in the same five-year dead­line.

³ No­ti­fic­a­tion of pre­vi­ous activ­it­ies with ge­net­ic­ally mod­i­fied or­gan­isms in Class 1 must be re­placed with­in one year of this Or­din­ance com­ing in­to force by a glob­al no­ti­fic­a­tion un­der Art­icle 8.

⁴ Activ­it­ies with ali­en or­gan­isms sub­ject to a con­tain­ment ob­lig­a­tion may only be car­ried out without a no­ti­fic­a­tion or an au­thor­isa­tion ap­plic­a­tion for one year from the date on which this Or­din­ance comes in­to force.

The duty to con­tain par­tic­u­larly dan­ger­ous plants as lis­ted in An­nex 6 of the Plant Pro­tec­tion Or­din­ance of 27 Oc­to­ber 2010⁴¹ in ac­cord­ance with Art­icle 5 para­graph 1 let­ter c ap­plies un­til 31 Decem­ber 2023.

This Or­din­ance comes in­to force on 1 June 2012.