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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 9 May 2012 (Status as of 1 January 2020)

The Swiss Federal Council,

on the basis of Articles 29b paragraphs 2 and 3, 29f, 38 paragraph 3, 39 paragraph 1,
41 paragraphs 2 and 3, 44 paragraph 3, 46 paragraphs 2 and 3, 48 paragraph 2 and 59bof the Environmental Protection Act of 7 October 19831 (EPA),
and Articles 10 paragraph 2, 14, 19, 20, 24 paragraphs 2 and 3, 25 and 34 of the Gene Technology Act of 21 March 20032 (GTA),
on Articles 26 paragraphs 2 and 3, 29 and 78 paragraph 1 of the Epidemics Act of 28 September 20123

and in implementation of Article 8 letters g, h and l and Article 19 paragraph 4
of the Convention of 5 June 19924 on Biological Diversity,5

ordains:

1 SR 814.01

2 SR 814.91

3 SR 818.101

4 SR 0.451.43

5 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

Chapter 1 General Provisions

Art. 1 Aim  

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.
Art. 2 Subject matter and scope of application  

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

6 SR 814.911

7 SR 814.012

8 Amended by No III 2 of the O of 29 April 2015, in force since 1 June 2015 (AS 2015 1337).

9 SR 832.321

10 SR 810.305

11 SR 812.213

12 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 3 Definitions  

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.

13 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

Chapter 2 Requirements for Handling Organisms in Contained Systems

Section 1 General Requirements

Art. 4 Duty of care  

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.
Art. 5 Containment obligation and prior assessments  

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.

14 SR 814.911

15 SR 916.161

16 SR 813.12

17 Amended by An­nex 8 No 4 of the Plant Health Or­din­ance of 31 Oc­to­ber 2018, in force since 1 Jan. 2020 (AS 2018 4209).

18 SR 916.20
Art. 5a Primary detection outside contained systems 19  

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.

19 In­ser­ted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

20 SR 818.101.32

21 SR 916.401

22 SR 916.20
Art. 6 Grouping of organisms  

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.
Art. 7 Classification of activities  

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.

23 SR 832.321

Section 2 Requirements for Handling Genetically Modified or Pathogenic Organisms or Alien Organisms subject to a Containment Obligation

Art. 8 Notification of Class 1 activities  

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.
Art. 9 Notification of Class 2 activities  

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.

24 SR 916.401
Art. 10 Authorisation of activities in Classes 3 and 4  

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.
Art. 11 Submission to the authorities  

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

25 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 12 Safety measures  

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.

26 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 13 Guarantee of liability  

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. 59abis para. 1 EPA); and
b.
of 2 mil­lion francs to cov­er dam­age to the en­vir­on­ment (Art. 31 GTA, Art. 59abis 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.
Art. 14 Start, suspension and termination of the guarantee  

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.
Art. 15 Transport  

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.
Art. 16 Reporting incidents  

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.

27 In­ser­ted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

Chapter 3 Duties of the Authorities

Section 1 Examination of Notifications and Authorisation Applications

Art. 17 Federal Coordination Centre for Biotechnology  

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.

28 SR 832.321

29 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 18 Competent federal office and specialist agencies  

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.

30 The name of the fed­er­al of­fice was changed on 1 Jan. 2014 in ac­cord­ance with Art. 16 para. 3 of the Pub­lic­a­tions Or­din­ance of 17 Nov. 2004 (AS 2004 4937). The change has been made throughout the text.

31 SR 916.401

32 The name of this ad­min­is­trat­ive unit was mod­i­fied in ap­plic­a­tion of Art. 16 para. 3 of the Pub­lic­a­tions Or­din­ance of 17 Nov. 2004 (SR 170.512.1) on 1 May 2013.
Art. 19 Notification procedure  

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

33 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 20 Authorisation procedure  

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.
Art. 21 Authorisation to modify, replace or omit certain special safety measures  

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.
Art. 22 Standard deadlines  

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.

Section 2 Monitoring in Establishments

Art. 23 Duties of the cantons  

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.
Art. 24 Duties of the Confederation  

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.

Section 3 Monitoring Transport

Art. 25  

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.

Section 4 Obtaining, Processing and Confidentiality of Data

Art. 26 Lists of classified organisms 34  

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.

34 Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 27 Surveys  

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.
Art. 27a ECOGEN electronic database 35  

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.

35 In­ser­ted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 28 Confidentiality of information  

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.

Section 5 Fees

Art. 29 Obligation to pay a fee  

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.

36 SR 172.041.1
Art. 30 Level of fees  

1 The fees are as fol­lows:

Francs

a.
Ex­am­in­a­tion of no­ti­fic­a­tions un­der Art­icle 19

100–2000

b.
Ex­am­in­a­tion of au­thor­isa­tion ap­plic­a­tions un­der Art­icle 20

300–4000

c.
Ex­am­in­a­tion of au­thor­isa­tion ap­plic­a­tions un­der Art­icle 21

100–4000

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.
Art. 31 Outlays  

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.

37 SR 172.010.1

Section 6 Guidelines, Basic and Continuing Professional Education

Art. 32  

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.

Chapter 4 Final Provisions

Art. 33 Repeal of current legislation  

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.

38 [AS 1999 2783, 2003 4793No I 3, 2006 4705No II 82, 2007 4477No IV 35, 2008 4377An­nex 5 No 6]

39 [AS 2001 2878]
Art. 34 Amendment of Current Legislation  

The amend­ment of cur­rent le­gis­la­tion is reg­u­lated in An­nex 5.
Art. 35 Transitional provisions  

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.
Art. 35a Transitional provision to the Amendment of 31 October 2018 40  

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.

40 In­ser­ted by An­nex 8 No 4 of the Plant Health Or­din­ance of 31 Oct. 2018, in force since 1 Jan. 2020 (AS 2018 4209).

41 AS 2010 6167, 2011 3331, 2012 6385, 2014 4009, 2015 4567, 2016 24453215, 2017 6141, 2018 2041
Art. 36 Commencement  

This Or­din­ance comes in­to force on 1 June 2012.

Annex 1

(Art. 3 let. d)

Definition of Gene Technology Methods

1 Gene technology methods means, in particular:

a.
recombinant nucleic acid techniques, in which nucleic acid molecules synthesised outside an organism are inserted into viruses, bacterial plasmids or other vector systems to produce novel combinations of genetic material, which are then transferred to a recipient organism in which they do not naturally occur but are capable of continued propagation;
b.
techniques in which genetic material produced outside the organism is inserted directly into an organism, in particular by microinjection, macroinjection and microencapsulation, electroporation or on microprojectiles;
c.
cell fusion or hybridisation techniques in which cells with novel combinations of genetic material are produced by the fusion of two or more cells through processes that do not occur under natural conditions.

2 Self-cloning of pathogenic organisms is regarded as a gene technology method. This consists of the removal of nucleic acid sequences from one cell of an organism and the complete or partial insertion of this nucleic acid or a synthetic equivalent (possibly after a previous enzymatic or mechanical treatment) into cells of the same species or cells which are closely related phylogenetically and which can exchange genetic material by natural physiological processes.

3 Self-cloning of non-pathogenic organisms and the following methods are not regarded as gene technology methods as long as they are not used in association with recombinant nucleic acid molecules or genetically modified organisms:

a.
mutagenesis;
b.
cell and protoplast fusion of prokaryotic microorganisms that exchange genetic material by natural physiological processes;
c.
cell and protoplast fusion of eukaryotic cells, including the production of hybridoma cell lines and the fusion of plant cells;
d.
in vitro fertilisation;
e.
natural processes such as conjugation, transduction and transformation;
f.
changes in ploidy level, including aneuploidy and the elimination of chromosomes.

Annex 2

Determination and Assessment of Risk

Annex 2.1 42

42 Corrected by No 2 of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

(Arts 6 and 26)

Assigning organisms to groups

1 Risk determination

1 In order to determine the risk due to the occurrence of an organism for human beings, animals or the environment as well as biological diversity and its sustainable use, the following criteria in particular must be taken into account:

a.
pathogenicity and lethality;
b.
virulence or attenuation;
c.
mode of infection, effective infection dose and the infection routes;
d.
production of non-cellular components such as toxins and allergens;
e.
the reproductive cycle and survival structures;
f.
host range;
g.
the degree of natural or acquired immunity of the host;
h.
pattern of resistance or sensitivity to antibiotics and other specific agents;
i.
availability of appropriate prophylaxis and therapy;
j.
the presence of oncogenic nucleic acid sequences;
k.
mutagenicity;
l.
virus production and viral shedding in cell lines;
m.
parasitic properties;
n.
potential contamination with pathogenic microorganisms;
o.
environmental aspects;
p.
experience with the spread of closely related types of organism in Switzerland or in other countries (invasive potential);
q.
the availability of suitable techniques to record, detect, identify, monitor and combat these organisms;
r.
potential for improper use.

2 In order to determine the risk arising when a genetically modified organism occurs, both donor and receptor organisms, introduced genetic material (inserts), the vector or the vector-receptor system and the genetically modified organism itself must be taken into account, in particular according to the following criteria:

a.
function of the genetic changes;
b.
degree of purity and characterisation of the genetic material used in recombination;
c.
properties of vectors, in particular relating to replication capacity, host range, host specificity, existence of a transfer system, mobilisation and independent infectivity;
d.
properties of affected nucleic acid sequences, in particular regulatory effects on cell growth, cell cycle and immune system;
e.
production and supply of organisms and active pharmaceutical substances, allergens or toxins via the genetically modified organism;
f.
stability and expression of recombinant genetic material;
g.
mobilisation potential of recombinant genetic material;
h.
selection pressure for recombinant genetic material.

3 In order to determine the risk due to the occurrence of an alien organism for human beings, animals or the environment as well as biological diversity and its sustainable use, the following criteria in particular must be taken into account:

a.
life cycle and reproduction, in particular with regard to asexual reproduction, generation time and the number of offspring;
b.
presence of host organisms in the environment;
c.
environmental aspects and viability, in particular cold tolerance and diapause;
d.
potential contamination with microorganisms that may be pathogenic for humans, animals and plants;
e.
invasiveness and ability to suppress native species;
f.
threat to human, animal and plant health by the organism due to its allergicity, pathogenicity, toxicity or property as a vector;
g.
harm to other organisms, in particular through competition and hybridisation;
h.
harm to resource cycles;
i.
effects on the functioning of the ecosystem;
j.
resistance or sensitivity to pesticides, herbicides and other agents;
k.
availability of suitable techniques to detect the organism in the environment and to combat it.

2 Risk assessment

1 When making a risk assessment, the effects of the organisms on healthy people, animals and plants must generally be considered.

2 The risk is considered inexistent or negligible (Group 1) if:

a.
it is unlikely that an organism will cause illness in people, animals or plants or some other damage to the environment or to biological diversity and its sustainable use; and
b.
such damage is not severe.

3 The risk is considered low (Group 2) if:

a.
an organism may cause illness in people, animals or plants or some other damage to the environment or to biological diversity and its sustainable use;
b.
such illness or damage is rarely severe;
c.
the organism is unlikely to spread; and
d.
normally effective preventive or therapeutic measures to combat the illness or damage are available.

4 The risk is considered moderate (Group 3), if:

a.
an organism may cause severe illness in people, animals or plants or other severe damage to the environment or to biological diversity and its sustainable use;
b.
the organism is likely to spread; and
c.
normally, effective preventive or therapeutic measures to combat the illness or damage are available.

5 The risk is considered high (Group 4), if:

a.
an organism may cause severe illness in people, animals or plants or other severe damage to the environment or to biological diversity and its sustainable use;
b.
the organism is likely to spread; and
c.
normally, no effective preventive or therapeutic measures to combat the illness or damage are available.

6 If, in an individual case, it is unclear to which of two groups an organism belongs, the risk must be assessed by weighing the seriousness of the illness and damage, and the probability that the organism will spread, against the availability of effective preventive or therapeutic measures. In the event of any doubt, an organism must be assigned to the higher of two groups.

Annex 2.2 43

43 Corrected by No 2 of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

(Art. 7)

Classification of activities

1 Risk determination

In order to determine the risk arising from planned activities with organisms in a contained system, the following criteria in particular should be taken into account while considering the group to which the organisms concerned have been assigned:

a.
the nature, extent and purpose of the activity, such as diagnosis, research, production or storage;
b.
the known or suspected geographical distribution and frequency in Switzerland of the organisms concerned or of their hosts and vectors and if applicable of the recombinant genetic material involved endemically, by natural occurrence, immigration, reproduction or genetic transfer;
c.
the potential for survival, replication and dissemination of the organisms in Switzerland, in particular the formation of long-lasting forms;
d.
the interaction of the organisms concerned with other organisms or involvement in biogeochemical processes;
e.
host or vector occurrence in Switzerland;
f.
the impact of the activity on pathogenicity, detectability and transmissibility, ability to survive and disseminate, virulence, host spectrum or tropism of the organisms used;
g.
the influence of the activity on the effectiveness of vaccines, antibiotics, antivirals or other agents with a medical or agricultural use against pathogenic organisms;
h.
the purpose of the activity in producing novel pathogenic organisms or restoring extinct or extinct pathogenic organisms;
i.
the potential of the pathogenic organisms for improper use.

2 Risk assessment

2.1 In general

1 The class of an activity normally corresponds to the group to which the organisms have been assigned. However, the class differs from the group of organisms if the risk assessment indicates, based on the activity and environmental conditions, a considerably increased or reduced risk compared with the group to which the organisms have been assigned.

2 An activity is assigned to Class 1 if it presents no risk or a negligible risk to people, animals, the environment and biological diversity and its sustainable use, in particular if no impact or a negligible impact on these targets can be expected should organisms escape from the contained system.

3 An activity is assigned to Class 2 if it presents a low risk to people, animals, the environment and biological diversity and its sustainable use, in particular if a limited, reversible impact on these targets can be expected should organisms escape from the contained system.

4 An activity is assigned to Class 3 if it presents a moderate risk to people, animals, the environment and biological diversity and its sustainable use, in particular if an irreversible but limited impact on these targets can be expected should organisms escape from the contained system.

5 An activity is assigned to Class 4 if it presents a high risk to people, animals, the environment and biological diversity and its sustainable use, in particular if an irreversible impact on these targets can be expected or epidemics with serious consequences may possibly occur should organisms escape from the contained system.

6 If, in an individual case, it is unclear to which of two classes an organism belongs, it must be assigned to the higher of two classes.

2.2 In particular

1 The following activities are normally assigned to Class 1:

a.
analyses of soil, water, air or food samples, provided it can be assumed that the samples are not so contaminated that they pose an increased risk to human beings, animals, the environment and biological diversity and its sustainable use;
b.
analyses of organisms in Groups 1 and 2 from clinical and other biological material for diagnostic purposes, if organisms can be shown to be present by direct or indirect methods without propagation, or if organisms can be shown to be present following slight enrichment carried out exclusively in closed containers;
c.
activities with certain strains of Group 2 organisms, provided such strains have proved in experiments or over many years of experience to be as safe as Group 1 organisms.

2 Analyses of organisms from clinical and other biological material for diagnostic purposes with exception of analyses under paragraph 1 must normally be assigned to Class 2.

3 Where Group 3 pathogenic organisms have been enriched for diagnostic purposes and if this results in an increased risk to human beings, animals or the environment as well as biological diversity and its sustainable use, this activity must be assigned to Class 3.

4 When Group 4 organisms are processed, the activity should in most cases be assigned to Class 4. However, if a primary diagnostics of Group 4 organisms from non-inactivated clinical material is performed by direct or indirect methods without replication, this activity may be assigned to Class 3. Where further testing is carried out using the same source material containing Group 4 organisms, this activity must in all cases be assigned to Class 4.

5 Primary diagnosis of Group 3 organisms that are pathogenic to animals may in exceptional cases and in accordance with Article 49 para. 2 EzDO44 be assigned to Class 2 if it can be assumed that there is a high probability that no pathogen organisms are present in the samples.

44 SR 916.401

Annex 3

(Art. 11 para. 2)

Information for the Notification and Authorisation of Activities

Annex 3.1

Information for the global notification of activities with Class 1 genetically modified organisms

The global notification under Article 8 includes the following information:

a.
the names and postal addresses of the establishment, of the persons responsible for the activities and the persons responsible for monitoring biological safety;
b.
the location and type of the installations where the activities are carried out;
c.
confirmation that in these installations Class 1 activities with genetically modified organisms are carried out;
d.
confirmation that a weighing of interests under Article 8 GTA has been carried out for activities with genetically modified animals covered by the Animal Protection Ordinance of 23 April 200845.

45 SR 455.1

Annex 3.2 46

46 Corrected by No 2 of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

Information for the notification and authorisation of activities in Classes 2–4

1 Principles

1 The extent and the level of detail of the technical information required depend on the risk of the activity. In the case of Class 2 activities, the technical information for one organism may be used for other organisms with similar properties, provided the activities concerned carry similar risks.

2 The documents must indicate what information must be treated as confidential. The need for confidentiality must be justified (Art. 28).

2 Administrative information

a.
The names and postal addresses of the establishment, the persons responsible for the activities and persons responsible for monitoring biological safety;
b.
A description of the activities;
c.
The duration the activities;
d.
The location and type of the installation;
e.
Confirmation of the guarantee of liability for activities with genetically modified and pathogenic organisms of Classes 3 and 4 (Art. 13);
f.
Confirmation that a weighing of interests under Article 8 GTA has been carried out for activities with genetically modified animals covered by the Animal Protection Ordinance of 23 April 200847.

47 SR 455.1

3 Technical information

a.
A description and the group of the organisms and genetic materials to be used or analysed, and in particular of the reference organisms;
b.
A description of the activities, and in particular of their purpose and the methods to be used;
c.
The maximum volume of culture media for the organisms to be used;
d.
A verifiable record of the procedure under Article 7 for determining and assessing the risks of the activities;
e.
The type of waste and method of disposal;
f.
The planned safety levels and safety measures for the activities and, if applicable, the individual procedures;
g.
Information on the time and place that the human pathogens in Groups 3 and 4 are brought into the country.

Annex 4 48

48 Corrected by No 2 of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

(Art. 12)

Safety Measures

1 General safety measures

The following safety measures apply to all species and classes of activity:

a.
Compliance with the generally recognised codes of building practice in the construction and maintenance of buildings and installations, in particular with a view to their stability, the safety of persons and property and fire prevention;
b.
Compliance with the operational safety concept and the related operating instructions and codes of conduct;
c.
Employment of at least one person to monitor biological safety and prevent the improper use of organisms; the person must have sufficient knowledge of and competence in both technical matters and safety issues to carry out his or her duties; the tasks include in particular preparing, updating and implementing the safety concept, informing, advising and training staff, verifying compliance with biosafety rules and communicating with the authorities in relation to notifications, authorisation applications, safety measures and the safety concept;
d.
Employment of a sufficient number of staff adequately trained on security issues;
e.
Compliance with the principles of good microbiological practice in accordance with Annex 3 number 1 paragraph 1 of the Ordinance of 25 August 199949 on the Protection of Employees from Dangerous Organisms, including the provision of washing and decontamination facilities for the staff;
f.
Appropriate inspections and maintenance of the monitoring measures and the equipment;
g.
If required, testing for the occurrence of viable forms of the organisms used outside the primary physical barriers;
h.
Use of suitable storage facilities for equipment and materials that could be contaminated;
i.
Provision of effective decontaminants and disinfectants and procedures in case of a release of organisms;
j.
Measures against any pests and vermin;
k.
Appropriate measures to minimise any previously identified risk of improper use of the organisms, such as restricting access to premises and recording the identity of persons with access to the organisms used.

49 SR 832.321

2 Special safety measures

2.1 Activities with genetically modified or pathogenic organisms

Depending on the nature and class of the activity, special safety measures that go beyond the general safety measures must be taken which:

a.
must take account of the risk determined in the specific case;
b.
must correspond to the state of the art in safety technology;
bbis.
take account of the possibility of improper use of organisms;
c.
are listed according to the safety levels in specific installations in the following table, whereby the information under Safety Levels 1–4 corresponds to the requirements for the conduct of activities in Classes 1–4;
d.
apply mutatis mutandis to the storage and the transport within the installation of organisms.

Table

Key

P means that the measure is required for production activities.

L means that the measure is required for all other laboratory activities.

G means that the measure is required for activities in greenhouses.

V means that the measure is required for activities in installations with animals.

[ ] means that the measure is required for the field of activity in brackets, but may be modified, replaced or omitted with the authorisation of the competent federal office.

– means that the relevant measure is not required.

MSC II/III means the Class II/III microbiological safety cabinet.

HEPA filter means High Efficiency Particulate Air Filter

No

Safety measures

Safety level

1

2

3

4

Building

1

Separate work area

– –

–

–

P –

–

–

P L

G

V

P L

G

V

2

Restricted access to the work area

– –

–

–

P L

G

V

P L

G

V

P L

G

V

3

Animal rooms separated by lockable doors

– –

–

V

Only in installations with vertebrates

– –

–

V

Only in installations with vertebrates

– –

–

V

– –

–

V

4

Access to work area via airlock (separate room).

The inside of the airlock must be separated from the outside by changing facilities, and preferably by lockable doors.

– –

–

–

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

Airlock doors lockable on both sides

5

Shower area in airlock

– –

–

–

– –

–

–

P L

G

V

Depending on the risk this measure may be omitted without authorisation from the competent federal offices.

[P] [L]

[G]

[V]

6

Facilities for personal decontamination in the work area

– –

–

–

P L

G

V

P L

G

V

P L

G

V

7

Observation window or other means of monitoring the work area

– –

–

–

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

8

Biohazard warning sign

– –

–

–

P L

G

V

P L

G

V

P L

G

V

9

Rooms with easily cleanable floors

P L

–

V

P L

G

V

P L

G

V

P L

G

V

10

Rooms with easily cleanable walls

– –

–

–

– –

–

–

P L

G

V

P L

G

V

11

Work area sealed so that fumigation is possible

– –

–

–

[P] –

–

–

[P] [L]

[G]

[V]

P L

G

V

12

Work area under negative air pressure with respect to the immediate surroundings

– –

–

–

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

13

Air supply to the work area
via HEPA filter

– –

–

–

– –

–

–

[P] –

–

–

[P] [L]

[G]

[V]

14

Exhaust air outlet from the work area via HEPA filter

– –

–

–

– –

–

–

P [L]

[G]

[V]

P L

G

V

For viruses that are not retained by HEPA filters, additional measures are required.

15

Microorganisms must be held in a primary contained system that physically separates the process from the rest of the work area. This primary contained system must be entirely within the work area.

– –

–

–

P –

–

–

P –

–

–

P –

–

–

16

The work area must be constructed so that a release of the entire contents of the primary contained system can be captured and retained.

P –

–

–

P –

–

–

P –

–

–

P –

–

–

17

Requirements for the air outlet from the primary contained system

– –

–

–

P –

–

–

Minimise any escape of organisms

P –

–

–

Prevent any escape of organisms

P –

–

–

Prevent any escape of organisms

18

The work area must be ventilated so as to minimise the contamination of the air with organisms.

– –

–

–

[P] –

–

–

[P] –

–

–

P –

–

–

Equipment

19

Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontaminants

P L

G

V

Work bench

P L

G

V

Work bench

P L

G

V

Work bench and floor

P L

G

V

Work bench, floor, ceiling and walls

20

Work area with complete, independent equipment

– –

–

–

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

21

Microbiological safety cabinet (MSC) when working with microorganisms

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

P L

G

V

MSC III including airlock entry and exit system or MSC II with full protection; full protection may be omitted for activities with animal and plant pathogens if authorised by the competent federal office

22

Measures against aerosol formation and dissemination

– –

–

–

P L

G

V

Minimise

aerosol dissemination

P L

G

V

Prevent aerosol dissemination

P L

G

V

Prevent aerosol dissemination

23

...

24

For the animal species concerned, suitable systems for keeping animals (e.g. cages), that are easily decontaminated

– –

–

V

Washable

– –

–

V

Decontaminable

– –

–

V

Decontaminable

– –

–

V

Decontaminable

25

Filter on isolation chambers (Isolation chamber = transparent container in which the animal is kept when inside or outside a cage) or isolation rooms (for large animals)

– –

–

–

– –

–

[V]

– –

–

V

– –

–

V

26

Requirements for seals on primary contained systems

– –

–

–

P –

–

–

Minimise any escape of organisms

P –

–

–

Prevent any escape of organisms

P –

–

–

Prevent any escape of organisms

Work Organisation

27

Suitable clothing for the work area

P L

G

V

For laboratory activities: laboratory clothing

P L

G

V

For laboratory activities: laboratory clothing

P L

G

V

Suitable protective clothing and, if applicable, shoes

P L

G

V

Change all clothing and shoes before entering or leaving

28

Personal safety equipment

Personal safety measures must be adapted to the activity and the organisms used.

P L

G

V

P L

G

V

P L

G

V

P L

G

V

29

Regular disinfection
of the workplaces

– –

–

–

P L

G

V

P L

G

V

P L

G

V

30

Inactivation of microorganisms in the outflow of sinks, pipes and showers

– –

–

–

– –

–

–

[P] [L]

[G]

[V]

P L

G

V

31

Escape of contaminated waste water

– –

[G]

–

Minimise

– –

[G]

–

Minimise

– –

G

–

Prevent

– –

G

–

Prevent

32

Escape of reproductive plant parts in the air or via vectors

– –

[G]

–

Minimise

– –

[G]

–

Minimise

– –

G

–

Prevent

– –

G

–

Prevent

33

...

34

Inactivation of large volumes of culture medium prior to its removal from the primary contained system

– –

–

–

P –

–

–

P –

–

–

P –

–

–

35

Minimise or prevent the escape of organisms during internal transport between various work areas

P L

G

V

Minimise

P L

G

V

Minimise

P L

G

V

Prevent

P L

G

V

Prevent

36

Inactivation of the microorganisms in contaminated material, in waste and on contaminated apparatus, from animals, plants and process fluid in production activities ‘P’.

P L

G

V

Harmless disposal; inactivation of genetically modified microorganisms on site or disposal as hazardous waste;

Deactivation methods are permissible if their effectiveness is proven.

[P] [L]

[G]

[V]

Autoclaving in the building, may take place outside the building if approval given by the federal office responsible;

other equivalent deactivation methods are permissible if their effectiveness is proven;

may be disposed of as hazardous waste:

a. contaminated material, animal cadavers, diagnostic samples;

b. solid cultures, if approval given by the federal office responsible

[P] [L]

[G]

[V]

Autoclaving in the work area, may take place elsewhere in the building if approval given by the federal office responsible;

other equivalent deactivation methods are permissible if validated;

the autoclave may be omitted if approval given by the federal office responsible.

P L

G

V

Deactivation and pass-through autoclave in work area

2.2 Activities with alien organisms subject to a containment obligation

1 For activities with alien organisms subject to a containment obligation, all potential escape paths must be secured by appropriate special safety measures so as to ensure that any escape of alien organisms subject to a containment obligation:

a.
is so limited in the case of Class 1 and 2 activities that human beings, animals and the environment cannot be endangered and biological diversity and its sustainable use cannot be harmed;
b.
is prevented in the case of Class 3 and 4 activities.

2 The special safety measures in Annex 4 number 2.1 apply mutatis mutandis.

Annex 5

(Art. 34)

Amendment of Current Legislation

...50

50 These amendments may be consulted under AS 2012 2777.

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