Radiological Protection Ordinance
(RPO)

¹ For the pro­tec­tion of people and the en­vir­on­ment against ion­ising ra­di­ation, this Or­din­ance reg­u­lates:

for planned ex­pos­ure situ­ations:

li­cences,

pub­lic ex­pos­ure,

un­jus­ti­fied activ­it­ies,

med­ic­al ex­pos­ure,

oc­cu­pa­tion­al ex­pos­ure,

hand­ling of ra­di­ation sources,

hand­ling of ra­dio­act­ive waste,

pre­ven­tion and man­age­ment of fail­ures;

for emer­gency ex­pos­ure situ­ations: pre­pared­ness and man­age­ment;

for ex­ist­ing ex­pos­ure situ­ations: man­age­ment of ra­di­olo­gic­al legacies, radon, nat­ur­ally oc­cur­ring ra­dio­act­ive ma­ter­i­al and long‑term con­tam­in­a­tion fol­low­ing an emer­gency;

train­ing and con­tinu­ing edu­ca­tion of per­sons hand­ling ion­ising ra­di­ation or ra­dio­activ­ity;

su­per­vi­sion and en­force­ment;

ad­vis­ory activ­it­ies of the Fed­er­al Com­mis­sion for Ra­di­olo­gic­al Pro­tec­tion (KSR).

² It ap­plies to all ex­pos­ure situ­ations for ar­ti­fi­cial and for nat­ur­al ion­ising ra­di­ation.

³It does not ap­ply to:

a.

ex­pos­ures to ra­di­o­nuc­lides nat­ur­ally present in the hu­man body;

b.

ex­pos­ures to cos­mic ra­di­ation; it does, however, ap­ply to ex­pos­ures of air­crew to cos­mic ra­di­ation;

c.

above­ground ex­pos­ures to ra­di­o­nuc­lides present in the un­dis­turbed earth’s crust.

1 In this Or­din­ance:

planned ex­pos­ure situ­ation means an ex­pos­ure situ­ation which arises from the planned op­er­a­tion of a ra­di­ation source or from a hu­man activ­ity which al­ters ex­pos­ure path­ways, so as to cause the ex­pos­ure or po­ten­tial ex­pos­ure of people or the en­vir­on­ment;

emer­gency ex­pos­ure situ­ation means an ex­pos­ure situ­ation due to an emer­gency, as defined in Art­icle 132;

c.

ex­ist­ing ex­pos­ure situ­ation means an ex­pos­ure situ­ation that already ex­ists when a de­cision on its con­trol has to be taken and which does not call or no longer calls for ur­gent meas­ures to be taken; this in­volves, in par­tic­u­lar, ra­di­olo­gic­al legacies, radon, nat­ur­ally oc­cur­ring ra­dio­act­ive ma­ter­i­al and long‑term con­tam­in­a­tion fol­low­ing an emer­gency;

d.

oc­cu­pa­tion­al ex­pos­ure means ex­pos­ure due to oc­cu­pa­tion­al activ­it­ies; oc­cu­pa­tion­al ex­pos­ure may in­volve em­ploy­ees, self-em­ployed per­sons, ap­pren­tices and stu­dents;

e.

med­ic­al ex­pos­ure means the ex­pos­ure of pa­tients or asymp­to­mat­ic in­di­vidu­als for dia­gnost­ic or thera­peut­ic pur­poses, with the aim of im­prov­ing their health, and ex­pos­ure of carers and com­fort­ers in medi­cine and of par­ti­cipants in hu­man re­search;

f.

pub­lic ex­pos­ure means any ex­pos­ure of per­sons, ex­clud­ing oc­cu­pa­tion­al and med­ic­al ex­pos­ures;

g.

ra­di­olo­gic­al pro­tec­tion ex­perts means ex­perts, as spe­cified in Art­icle 16 of the RPA, who have the know­ledge, train­ing and ex­per­i­ence in ra­di­olo­gic­al pro­tec­tion needed to en­sure the ef­fect­ive pro­tec­tion of people and the en­vir­on­ment; ex­perts are re­spons­ible for im­ple­ment­a­tion of the leg­al re­quire­ments in in­tern­al ra­di­olo­gic­al pro­tec­tion dir­ect­ives and for mon­it­or­ing com­pli­ance with­in the en­ter­prise;

h.

nat­ur­ally oc­cur­ring ra­dio­act­ive ma­ter­i­al (NORM³) means ma­ter­i­al with nat­ur­ally oc­cur­ring ra­di­o­nuc­lides which does not con­tain ar­ti­fi­cial ra­dio­act­ive sub­stances; ma­ter­i­al in which the activ­ity con­cen­tra­tions of nat­ur­ally oc­cur­ring ra­di­o­nuc­lides have been un­in­ten­tion­ally changed by some pro­cess is also NORM; if con­cen­tra­tions of nat­ur­ally oc­cur­ring ra­di­o­nuc­lides are de­lib­er­ately en­hanced, in par­tic­u­lar to util­ise their ra­dio­act­ive prop­er­ties, then they are no longer con­sidered to be NORM;

i.

ion­ising ra­di­ation means en­ergy trans­mit­ted in the form of particles or elec­tro­mag­net­ic waves of a wavelength of 100 nm or less cap­able of ion­ising an atom or mo­lecule dir­ectly or in­dir­ectly;

j.

clear­ance lim­it (LL) means the value cor­res­pond­ing to the spe­cif­ic activ­ity level of a ma­ter­i­al be­low which hand­ling of this ma­ter­i­al is no longer sub­ject to man­dat­ory li­cens­ing or, ac­cord­ingly, su­per­vi­sion; the val­ues are spe­cified in An­nex 3 Column 9;

k.

NORM clear­ance lim­it (LLM) means the value cor­res­pond­ing to the spe­cif­ic activ­ity level of nat­ur­al ra­di­o­nuc­lides in NORM be­low which this ma­ter­i­al may be freely dis­charged in­to the en­vir­on­ment; the val­ues are spe­cified in An­nex 2;

l.

li­cens­ing lim­it (LA) means the value cor­res­pond­ing to the ab­so­lute activ­ity level of a ma­ter­i­al above which hand­ling of this ma­ter­i­al is sub­ject to man­dat­ory li­cens­ing; the val­ues are spe­cified in An­nex 3 Column 10; they do not ap­ply to NORM;

m.

guid­ance value means a value, de­rived from a lim­it, the ex­ceedance of which trig­gers cer­tain meas­ures and com­pli­ance with which also en­sures com­pli­ance with the as­so­ci­ated lim­it; guid­ance val­ues for air­borne activ­ity (CA) and sur­face con­tam­in­a­tion (CS) are spe­cified in An­nex 3 Columns 11 and 12;

n.

ra­di­ation source means a ra­dio­act­ive ma­ter­i­al or in­stall­a­tion cap­able of emit­ting ion­ising ra­di­ation;

o.

ma­ter­i­al is a gen­er­al term cov­er­ing sol­id, li­quid or gaseous sub­stances, mix­tures, raw ma­ter­i­als and fin­ished products and art­icles man­u­fac­tured there­from;

p.

ra­dio­act­ive ma­ter­i­al means a ma­ter­i­al that in­cor­por­ates ra­di­o­nuc­lides, is ac­tiv­ated or con­tam­in­ated with ra­di­o­nuc­lides and which meets the fol­low­ing con­di­tions:

1.

hand­ling there­of is sub­ject to man­dat­ory li­cens­ing and su­per­vi­sion un­der ra­di­olo­gic­al pro­tec­tion or nuc­le­ar en­ergy le­gis­la­tion,

2.

hand­ling there­of is not ex­empt from man­dat­ory li­cens­ing and su­per­vi­sion un­der ra­di­olo­gic­al pro­tec­tion or nuc­le­ar en­ergy le­gis­la­tion;

q.

ra­dio­act­ive sub­stance is syn­onym­ous with ra­dio­act­ive ma­ter­i­al;

r.

ra­dio­act­ive source means ra­dio­act­ive ma­ter­i­al em­ployed for the pur­pose of util­ising its ra­dio­activ­ity;

s.

sealed ra­dio­act­ive source means a ra­dio­act­ive source whose struc­ture is such as to pre­vent, un­der nor­mal con­di­tions of use, the re­lease of ra­dio­act­ive sub­stances and thus ex­clude the risk of con­tam­in­a­tion;

t.

un­sealed ra­dio­act­ive source means a ra­dio­act­ive source that does not meet the re­quire­ments for a sealed ra­dio­act­ive source;

u.

orphan ra­dio­act­ive ma­ter­i­al means ra­dio­act­ive ma­ter­i­al that is no longer un­der the con­trol of the own­er or li­cence hold­er;

v.

in­stall­a­tionsis an ab­bre­vi­ated form of in­stall­a­tions that gen­er­ate ion­ising ra­di­ation; in­stall­a­tions are equip­ment and devices used to gen­er­ate photon or particle ra­di­ation.

2 In ad­di­tion, for this Or­din­ance, the fol­low­ing ap­ply:

the defin­i­tions giv­en in Art­icles 5–7, 26, 49, 51, 80, 85, 96, 108, 122, 149 and 175;

the defin­i­tions of pre­dom­in­antly tech­nic­al terms giv­en in An­nex 1 and the defin­i­tions of dose-re­lated terms giv­en in An­nex 4.

An activ­ity is jus­ti­fied with­in the mean­ing of Art­icle 8 of the Ra­di­olo­gic­al Pro­tec­tion Act (RPA) if:

a.

the as­so­ci­ated be­ne­fits clearly out­weigh the ra­di­ation-re­lated draw­backs; and

b.

over­all, for people and the en­vir­on­ment, no more fa­vour­able al­tern­at­ive is avail­able in­volving no or lower ra­di­ation ex­pos­ure.

1 Ra­di­olo­gic­al pro­tec­tion must be op­tim­ised for all ex­pos­ure situ­ations.

2 Op­tim­isa­tion in­volves re­du­cing as far as pos­sible and reas­on­able:

a.

the like­li­hood of ex­pos­ure;

b.

the num­ber of people ex­posed;

c.

the in­di­vidu­al dose to the per­sons ex­posed.

For planned ex­pos­ure situ­ations, lim­its shall be spe­cified which must not be ex­ceeded by the sum of all ra­di­ation doses ac­cu­mu­lated by a per­son in a cal­en­dar year (dose lim­it). For med­ic­al ex­pos­ures, no such lim­its shall be spe­cified.

1 If in ex­ist­ing ex­pos­ure situ­ations or in emer­gency ex­pos­ure situ­ations the dose lim­its can­not be com­plied with, or if in these situ­ations com­pli­ance with the dose lim­its would in­volve dis­pro­por­tion­ate ef­forts or would be coun­ter­pro­duct­ive, then ref­er­ence levels shall be ap­plied.

2 To en­sure that the ref­er­ence level can be com­plied with, the re­quis­ite meas­ures must be taken.

1 For planned ex­pos­ure situ­ations, the dose re­ceived by a per­son from a single ra­di­ation source or activ­ity shall be spe­cified (dose con­straint). This dose con­straint shall be spe­cified for each ra­di­ation source in such a way that the sum of all doses re­ceived from the vari­ous ra­di­ation sources does not ex­ceed the dose lim­it.

2 The li­cence hold­er shall spe­cify the dose con­straints for the oc­cu­pa­tion­ally ex­posed per­sons with­in the en­ter­prise.

3 The li­cens­ing au­thor­ity (Art. 11) shall de­cide wheth­er source-re­lated dose con­straints are re­quired for the pub­lic and shall spe­cify these in the li­cence. If this has not been done in the case of activ­it­ies already li­censed, the su­per­vis­ory au­thor­ity (Art. 184) may spe­cify source-re­lated dose con­straints.

4 Dose con­straints are op­tim­isa­tion in­stru­ments. When de­fin­ing dose con­straints, the cur­rent state of sci­ence and tech­no­logy must be taken in­to ac­count.

5 If a dose con­straint is ex­ceeded, meas­ures must be taken.

All ra­di­olo­gic­al pro­tec­tion meas­ures must be gradu­ated ac­cord­ing to the un­der­ly­ing risk.

In ad­di­tion to the activ­it­ies spe­cified in Art­icle 28 of the RPA, or by way of cla­ri­fic­a­tion there­of, the fol­low­ing activ­it­ies are sub­ject to man­dat­ory li­cens­ing:

the hand­ling of ma­ter­i­al whose spe­cif­ic activ­ity ex­ceeds the clear­ance lim­it and whose ab­so­lute activ­ity ex­ceeds the li­cens­ing lim­it;

the hand­ling of con­tained gaseous ma­ter­i­al whose ab­so­lute activ­ity ex­ceeds the li­cens­ing lim­it;

the dis­charge to the en­vir­on­ment of ma­ter­i­al whose spe­cif­ic activ­ity ex­ceeds the clear­ance lim­it and whose ab­so­lute activ­ity is great­er than the activ­ity of 1 kg of a ma­ter­i­al whose spe­cif­ic activ­ity is equal to the clear­ance lim­it;

the dis­tri­bu­tion of ma­ter­i­al whose spe­cif­ic activ­ity ex­ceeds the clear­ance lim­it and whose ab­so­lute activ­ity is great­er than the activ­ity of 1 kg of a ma­ter­i­al whose spe­cif­ic activ­ity is equal to the clear­ance lim­it;

e.

the use of ra­di­o­nuc­lides in the hu­man body;

f.

the de­ploy­ment of oc­cu­pa­tion­ally ex­posed per­sons as defined in Art­icle 51 para­graphs 1 and 2 at one’s own or at an­oth­er en­ter­prise in Switzer­land or abroad;

g.

the per­form­ance of qual­ity as­sur­ance meas­ures on in­stall­a­tions, nuc­le­ar medi­cine ima­ging equip­ment and act­i­vi­met­ers, or im­age re­cept­or and dis­play sys­tems used in med­ic­al dia­gnostics;

h.

the fur­ther use of ra­di­olo­gic­al legacies as spe­cified in Art­icle 150 para­graph 2;

i.

activ­it­ies in­volving the hand­ling of NORM, if at least one of the situ­ations spe­cified in Art­icle 168 para­graph 2 let­ters b and c ap­plies;

j.⁴

the de­cay stor­age of ra­dio­act­ive waste from nuc­le­ar in­stall­a­tions out­side nuc­le­ar in­stall­a­tions.

The fol­low­ing are ex­empt from man­dat­ory li­cens­ing:

a.

the trans­port of ra­dio­act­ive ma­ter­i­al which does not ex­ceed the activ­ity con­cen­tra­tion lim­its for ex­empt ma­ter­i­al or the activ­ity lim­its for ex­empt con­sign­ments spe­cified in:

1.

An­nex A, Sub­sec­tion 2.2.7.2, Tables 2.2.7.2.2.1 and 2.2.7.2.2.2, of the European Agree­ment of 30 Septem­ber 1957⁵ con­cern­ing the In­ter­na­tion­al Car­riage of Dan­ger­ous Goods by Road (ADR), and in the Or­din­ance of 29 Novem­ber 2002⁶ on the Car­riage of Dan­ger­ous Goods by Road (SDR), or

2.

the Reg­u­la­tions con­cern­ing the In­ter­na­tion­al Car­riage of Dan­ger­ous Goods by Rail (RID) in ac­cord­ance with Ap­pendix C, Sub­sec­tion 2.2.7.2, Tables 2.2.7.2.2.1 and 2.2.7.2.2.2, to the Pro­tocol of 3 June 1999⁷ modi­fy­ing the Con­ven­tion con­cern­ing In­ter­na­tion­al Car­riage by Rail (COTIF) of 9 May 1980, and in the Or­din­ance of 31 Oc­to­ber 2012⁸ on the Car­riage of Dan­ger­ous Goods by Rail and Cable­way (RSD);

b.

the trans­port of ra­dio­act­ive sub­stances as ex­cep­ted pack­ages:

1.

in ac­cord­ance with An­nex A, Sec­tion 3.2.1, Table A (UN num­bers 2908, 2909, 2910, 2911 and 3507) of the ADR, and the SDR,

2.

in ac­cord­ance with Sec­tion 3.2.1, Table A (UN Num­bers 2908, 2909, 2910, 2911 and 3507) of the RID, and the RSD,

3.

in ac­cord­ance with Art­icle 16 of the Or­din­ance of 17 Au­gust 2005⁹ on Air Trans­port (LTrV),

4.

in ac­cord­ance with the Or­din­ance of 2 March 2010¹⁰ on the Im­ple­ment­a­tion of the European Agree­ment con­cern­ing the In­ter­na­tion­al Car­riage of Dan­ger­ous Goods by In­land Wa­ter­ways;

c.

the trans­port of ra­dio­act­ive sub­stances by air (UN num­bers 2908, 2909, 2910, 2911, 2912, 2913, 2915, 2916, 2978, 3321, 3322, 3332 and 3507) in ac­cord­ance with An­nex 18 to the Con­ven­tion on In­ter­na­tion­al Civil Avi­ation of 7 Decem­ber 1944¹¹ and the as­so­ci­ated Tech­nic­al In­struc­tions¹²;

d.

the dis­tri­bu­tion, use, stor­age and trans­port, as well as the im­port, ex­port and trans­it, of fin­ished timepieces con­tain­ing ra­dio­act­ive sources, provided that they com­ply with the stand­ards ISO¹³ 3157¹⁴ and ISO 4168¹⁵, and of no more than 1000 timepiece com­pon­ents with ra­dio­act­ive tri­ti­um-based lu­min­ous paint;

e.

the hand­ling of stray ra­di­ation sources, where:

the elec­tron ac­cel­er­a­tion voltage does not ex­ceed 30 kV, and

the am­bi­ent dose rate at a dis­tance of 10 cm from the sur­face does not ex­ceed 1 μSv per hour¹⁶;

f.

the hand­ling of min­er­al and rock col­lec­tions with a spe­cif­ic activ­ity be­low the NORM clear­ance lim­its, or if they con­tain less than 10 g nat­ur­al thori­um or 100 g nat­ur­al urani­um;

g.

the hand­ling of ra­di­ation sources, with the ex­cep­tion of dis­tri­bu­tion, for which a type li­cence has been gran­ted;

h.

activ­it­ies and ra­di­ation sources which are sub­ject to man­dat­ory li­cens­ing or a de­com­mis­sion­ing or­der un­der the Nuc­le­ar En­ergy Act of 21 March 2003¹⁷ (NEA);

i.

the de­ploy­ment of oc­cu­pa­tion­ally ex­posed air­crew by air­craft op­er­at­ors.

¹ Without pre­ju­dice to para­graph 2, the Fed­er­al Of­fice of Pub­lic Health (FOPH) is the li­cens­ing au­thor­ity for all activ­it­ies and ra­di­ation sources sub­ject to man­dat­ory li­cens­ing un­der this Or­din­ance.

² The Swiss Fed­er­al Nuc­le­ar Safety In­spect­or­ate (EN­SI) is the li­cens­ing au­thor­ity for:

a.

activ­it­ies at nuc­le­ar in­stall­a­tions which are not sub­ject to man­dat­ory li­cens­ing or a de­com­mis­sion­ing or­der un­der the NEA¹⁸;

b.

ex­per­i­ments in­volving ra­dio­act­ive sub­stances in con­nec­tion with geo­lo­gic­al in­vest­ig­a­tions as spe­cified in Art­icle 35 of the NEA;

c.

the im­port and ex­port of ra­dio­act­ive sub­stances for or from nuc­le­ar in­stall­a­tions;

d.

the trans­port of ra­dio­act­ive sub­stances from and to nuc­le­ar in­stall­a­tions;

e.

the dis­charge of ra­dio­act­ive waste from nuc­le­ar in­stall­a­tions to the en­vir­on­ment;

f.¹⁹

the de­cay stor­age of ra­dio­act­ive waste from nuc­le­ar in­stall­a­tions and all re­lated activ­it­ies.

¹ Ap­plic­a­tions for the grant­ing or re­new­al of a li­cence must be sub­mit­ted to the li­cens­ing au­thor­ity with the ne­ces­sary doc­u­ments.

² In cases of high ra­di­olo­gic­al haz­ard po­ten­tial, the li­cens­ing au­thor­ity shall ad­di­tion­ally re­quest a haz­ard ana­lys­is.

³ Ap­plic­ants from abroad must provide a Swiss postal ad­dress.

⁴The Fed­er­al De­part­ment of Home Af­fairs (FDHA) and EN­SI may is­sue spe­cific­a­tions con­cern­ing the doc­u­ments and evid­ence re­quired in their area of re­spons­ib­il­ity.

1 Without pre­ju­dice to Art­icles 14 and 15, the li­cens­ing au­thor­ity shall as­sess activ­it­ies and ra­di­ation sources sub­ject to man­dat­ory li­cens­ing us­ing a stand­ard pro­ced­ure.

² It shall re­view the ap­plic­a­tion doc­u­ments sub­mit­ted for com­plete­ness, form, con­tent and ex­tent.

³ It shall de­cide wheth­er source-re­lated dose con­straints are re­quired for the pub­lic, and shall spe­cify these in the li­cence.

1 In cases where the haz­ard po­ten­tial for people and the en­vir­on­ment is low, the FOPH may as­sess activ­it­ies sub­ject to man­dat­ory li­cens­ing us­ing a sim­pli­fied pro­ced­ure. This con­cerns in par­tic­u­lar:

a.

med­ic­al ap­plic­a­tions in the low-dose range (Art. 26 let. a);

b.

the op­er­a­tion of in­stall­a­tions with full or par­tial pro­tec­tion sys­tems.

2 In the sim­pli­fied pro­ced­ure, it shall re­view the ap­plic­a­tion doc­u­ments sub­mit­ted solely for com­plete­ness and form.

¹ In the case of ra­di­ation sources with a par­tic­u­larly low haz­ard po­ten­tial for people and the en­vir­on­ment, the FOPH may grant a type li­cence (Art. 29 let. c RPA), in par­tic­u­lar if:

a.

they are de­signed or meas­ures are taken so as to pre­vent in­ad­miss­ible ex­pos­ure or con­tam­in­a­tion of per­sons; and

b.

it is as­sured that, if ne­ces­sary, they will be de­livered to the fed­er­al col­lec­tion centre as ra­dio­act­ive waste at the end of their use­ful life.

² The FOPH shall re­view the ap­plic­a­tion doc­u­ments sub­mit­ted for com­plete­ness, form, con­tent and ex­tent.

³ It shall sub­ject the ra­di­ation sources for which a type li­cence is sought to type test­ing. It may en­gage oth­er bod­ies for this pur­pose.

⁴ When grant­ing a type li­cence, it shall spe­cify:

a.

un­der what con­di­tions the ra­dio­act­ive ma­ter­i­al may be handled;

b.

wheth­er and how ra­dio­act­ive ma­ter­i­al at the end of its use­ful life must be de­livered to the fed­er­al col­lec­tion centre as ra­dio­act­ive waste;

c.

wheth­er and how the ra­di­ation sources must be marked with a sym­bol spe­cified by the FOPH.

¹ The li­cens­ing au­thor­ity shall lim­it the term of the li­cence to a max­im­um of ten years.

² It shall com­mu­nic­ate its de­cision to the ap­plic­ant, the can­tons con­cerned and the su­per­vis­ory au­thor­ity.

¹ If an activ­ity con­cerns both li­cens­ing au­thor­it­ies, the pro­ced­ures may be com­bined.

² The lead au­thor­ity shall be the one deemed to be primar­ily con­cerned on the basis of the ap­plic­a­tion doc­u­ments.

³ The lead au­thor­ity shall define the pro­ced­ure in con­sulta­tion with the oth­er li­cens­ing au­thor­ity.

¹ The FOPH shall main­tain a data­base con­cern­ing the li­cences gran­ted un­der this Or­din­ance.

² The pur­pose of the data­base is:

a.

to make avail­able in­form­a­tion re­quired for the grant­ing of li­cences;

b.

to sim­pli­fy ad­min­is­trat­ive pro­ced­ures for the grant­ing of li­cences;

c.

to fa­cil­it­ate the su­per­vis­ory activ­it­ies of the com­pet­ent au­thor­it­ies.

³The fol­low­ing data con­cern­ing the li­cence hold­er may be stored in the data­base:

a.

for a nat­ur­al per­son: name, first name, former name; for a leg­al per­son: com­pany name of the leg­al per­son;

b.

home or busi­ness ad­dress;

c.

for a nat­ur­al per­son: func­tion and aca­dem­ic title;

d.

tele­phone num­bers;

e.

ad­dresses for elec­tron­ic com­mu­nic­a­tion;

f.

cat­egory of en­ter­prise;

g.

the in­form­a­tion spe­cified in Art­icle 179 para­graph 3 con­cern­ing the ra­di­olo­gic­al pro­tec­tion ex­perts;

h.

en­ter­prise iden­ti­fic­a­tion num­ber (UID) in ac­cord­ance with the Fed­er­al Act of 18 June 2010²⁰ on the En­ter­prise Iden­ti­fic­a­tion Num­ber;

i.

Swiss Ac­ci­dent In­sur­ance Fund (Suva) cus­tom­er num­ber.

^{4In ad­di­tion, tech­nic­al in­form­a­tion on ra­di­ation sources may be stored in the data­base.}

^{5The fol­low­ing in­di­vidu­al ac­cess rights ap­ply:}

a.

The staff of the FOPH Ra­di­olo­gic­al Pro­tec­tion Di­vi­sion, the re­spons­ible EN­SI unit and Suva Phys­ics are en­titled to pro­cess the data in the data­base.

b.

Re­gistered li­cence hold­ers are en­titled, via elec­tron­ic ac­cess, to view their li­cences and the data con­cern­ing them stored in the data­base, and to re­quest amend­ments.

c.

The ap­plic­a­tion man­agers re­spons­ible for main­ten­ance or pro­gram­ming tasks ob­tain ac­cess to data in­so­far as this is re­quired for the ful­fil­ment of their du­ties.

¹ The li­cence hold­er must grant the ra­di­olo­gic­al pro­tec­tion ex­pert the powers re­quired to ful­fil his or her du­ties and make avail­able the ne­ces­sary re­sources.

² In ad­di­tion, the li­cence hold­er must:

a.

is­sue in­tern­al dir­ect­ives con­cern­ing work­ing meth­ods and pro­tect­ive meas­ures and mon­it­or com­pli­ance;

b.

spe­cify in writ­ing the powers of the vari­ous line man­agers and ra­di­olo­gic­al pro­tec­tion ex­perts, and of per­sons hand­ling ra­di­ation sources.

³If the li­cence hold­er de­ploys per­sons from ser­vice or oth­er en­ter­prises as oc­cu­pa­tion­ally ex­posed per­sons, these en­ter­prises must be made aware of the rel­ev­ant ra­di­olo­gic­al pro­tec­tion reg­u­la­tions.

The li­cence hold­er must en­sure that all per­sons with­in the en­ter­prise who may be ex­posed to ra­di­ation are ap­pro­pri­ately in­formed about the health risks which may arise from hand­ling ion­ising ra­di­ation at the work­place.

¹The li­cence hold­er must re­port the fol­low­ing changes to the su­per­vis­ory au­thor­ity be­fore they are ef­fected:

a.

changes to the out­put of an in­stall­a­tion, struc­tur­al and design char­ac­ter­ist­ics, and beam dir­ec­tion (Art. 35 para. 1 let. a RPA);

b.

a change of the ra­di­olo­gic­al pro­tec­tion ex­pert (Art. 32 para. 2 RPA).

² The loss or theft of a ra­dio­act­ive source whose activ­ity ex­ceeds the li­cens­ing lim­it must be re­por­ted to the su­per­vis­ory au­thor­ity without delay.

¹ The ef­fect­ive dose must not ex­ceed the lim­it of 1 mSv per cal­en­dar year.

² The equi­val­ent dose must not ex­ceed the fol­low­ing lim­its:

a.

for the lens of the eye: 15 mSv per cal­en­dar year;

b.

for the skin: 50 mSv per cal­en­dar year.

¹ In the case of en­ter­prises with a li­cence for dis­charge to the en­vir­on­ment in ac­cord­ance with Art­icles 111–116, the li­cens­ing au­thor­ity may re­quest an an­nu­al de­term­in­a­tion of the dose re­ceived by the most ex­posed mem­bers of the pub­lic and spe­cify the re­quire­ments for the de­term­in­a­tion of ra­di­ation doses.

² EN­SI shall is­sue guidelines for the de­term­in­a­tion of ra­di­ation doses for the area un­der its su­per­vi­sion.

¹ Yearly av­er­age air­borne activ­ity con­cen­tra­tions in ac­cess­ible loc­a­tions off-site must not ex­ceed the im­mis­sion lim­its for air (LIA) spe­cified in An­nex 7.

² Weekly av­er­age activ­ity con­cen­tra­tions in pub­licly ac­cess­ible wa­ters must not ex­ceed the im­mis­sion lim­its for wa­ters (LIW) spe­cified in An­nex 7.

3 It must be ad­di­tion­ally en­sured that am­bi­ent doses due to ex­tern­al ra­di­ation in dwell­ings, pub­lic-ac­cess build­ings and work­places are kept at such a low level that, tak­ing in­to ac­count res­id­ence time and all oth­er ex­pos­ure path­ways, they can­not lead to ex­ceedance of the dose lim­its for mem­bers of the pub­lic.

The fol­low­ing activ­it­ies are deemed to be un­jus­ti­fied in ac­cord­ance with Art­icle 8 of the RPA and are there­fore pro­hib­ited:

a.

the de­lib­er­ate ad­di­tion of ra­di­o­nuc­lides in the pro­duc­tion of food­stuffs and feed­ing­stuffs, toys, per­son­al or­na­ments and cos­met­ics;

b.

the ap­plic­a­tion of meth­ods in­volving the ac­tiv­a­tion of ma­ter­i­als used in toys and per­son­al or­na­ments;

c.

the im­port, ex­port and trans­it of products as spe­cified in let­ters a and b.

Med­ic­al ex­pos­ures are:

a.

in the low-dose range if the pa­tient re­ceives an ef­fect­ive dose of less than 1 mSv;

b.

in the me­di­um-dose range if the pa­tient re­ceives an ef­fect­ive dose of between 1 mSv and 5 mSv;

c.

in the high-dose range if the pa­tient re­ceives an ef­fect­ive dose of more than 5 mSv.

Without pre­ju­dice to Art­icles 28 and 29, med­ic­al ex­pos­ures are deemed to be fun­da­ment­ally jus­ti­fied.

¹ Any gen­er­al ap­plic­a­tion of dia­gnost­ic or thera­peut­ic pro­ced­ures must be jus­ti­fied in ad­vance.

² The jus­ti­fic­a­tion of ex­ist­ing dia­gnost­ic or thera­peut­ic pro­ced­ures must be re­viewed as soon as im­port­ant new know­ledge on the ef­fect­ive­ness or con­sequences of such pro­ced­ures be­comes avail­able.

3 In col­lab­or­a­tion with the pro­fes­sion­al bod­ies and sec­tor­al as­so­ci­ations con­cerned, the KSR shall pre­pare and pub­lish re­com­mend­a­tions on the jus­ti­fic­a­tion of pro­ced­ures in ac­cord­ance with para­graphs 1 and 2.²¹

¹ Any per­son who pre­scribes or per­forms pro­ced­ures must take in­to ac­count ex­ist­ing dia­gnost­ic in­form­a­tion and the case his­tory in or­der to avoid un­ne­ces­sary ra­di­ation ex­pos­ures.

² Any per­son who pre­scribes pro­ced­ures must es­tab­lish and doc­u­ment an in­dic­a­tion and for­ward this to the phys­i­cian per­form­ing the pro­ced­ure.

³Hos­pit­als, ra­di­ology centres and re­fer­rers must pre­scribe pro­ced­ures in ac­cord­ance with the cur­rent state of sci­ence and tech­no­logy. This is re­flec­ted in par­tic­u­lar by re­fer­ral guidelines based on na­tion­al or in­ter­na­tion­al guidelines or re­com­mend­a­tions.

⁴Each ap­plic­a­tion must be jus­ti­fied in ad­vance by the phys­i­cian per­form­ing the pro­ced­ure, tak­ing in­to ac­count the cur­rent state of sci­ence and tech­no­logy, the in­dic­a­tion and the char­ac­ter­ist­ics of the in­di­vidu­al in­volved.

⁵A dia­gnost­ic or thera­peut­ic pro­ced­ure which is not jus­ti­fied in ac­cord­ance with Art­icle 28 may non­ethe­less, de­pend­ing on the cir­cum­stances, be jus­ti­fied as a spe­cif­ic, in­di­vidu­al ap­plic­a­tion. This must be doc­u­mented on a case-by-case basis, with the reas­ons stated, by the phys­i­cian per­form­ing the pro­ced­ure.

¹ Ra­di­olo­gic­al screen­ing is a ra­di­olo­gic­al ex­am­in­a­tion per­formed in a spe­cif­ic group of people for the pur­pose of early de­tec­tion of a dis­ease, even though it is not clin­ic­ally sus­pec­ted in the in­di­vidu­als con­cerned. This does not in­clude routine oc­cu­pa­tion­al health ex­am­in­a­tions.

² Ra­di­olo­gic­al screen­ing may only be car­ried out as part of a pro­gramme. It must be in­sti­tuted by a health au­thor­ity.

³ Ra­di­olo­gic­al screen­ing must sat­is­fy the qual­ity re­quire­ments spe­cified for the pro­gramme by the com­pet­ent health au­thor­ity.

¹ Activ­it­ies in­volving ex­pos­ure for non-med­ic­al ima­ging pur­poses must be jus­ti­fied in ad­vance, tak­ing in­to ac­count the spe­cif­ic ob­ject­ives of the pro­ced­ure and the char­ac­ter­ist­ics of the in­di­vidu­al in­volved.

² Ex­pos­ures in the me­di­um-dose or high-dose range for aptitude tests are pro­hib­ited.

³ If an ex­pos­ure is ordered by the crim­in­al in­vest­ig­a­tion, se­cur­ity or cus­toms au­thor­it­ies, the ima­ging pro­ced­ure must be per­formed us­ing the low­est pos­sible dose re­quired to re­solve the ques­tion. If an ex­pos­ure can­not be per­formed in the low-dose range, this must be doc­u­mented, with the reas­ons stated.

⁴ If ex­pos­ures are routinely per­formed for se­cur­ity reas­ons, the in­di­vidu­al ex­amined must be giv­en the op­tion of choos­ing a dif­fer­ent type of ex­am­in­a­tion not in­volving ion­ising ra­di­ation.

¹ In dia­gnost­ic, in­ter­ven­tion­al ra­di­ology and nuc­le­ar medi­cine ex­am­in­a­tions, the li­cence hold­er must keep all ra­di­ation doses as low as achiev­able con­sist­ent with ob­tain­ing the re­quired ima­ging in­form­a­tion.

² For all thera­peut­ic ex­pos­ures, the li­cence hold­er must carry out in­di­vidu­al do­si­met­ric plan­ning. The doses for risk or­gans must be kept as low as is achiev­able and con­sist­ent with the in­ten­ded ra­dio­thera­peut­ic pur­pose.

³ For the pro­tec­tion of pa­tients, the op­tim­isa­tion pro­cess in­volves in par­tic­u­lar:

a.

se­lec­tion of suit­able equip­ment, in­clud­ing soft­ware;

b.

con­sist­ent pro­duc­tion of ad­equate dia­gnost­ic in­form­a­tion or thera­peut­ic out­comes;

c.

the prac­tic­al as­pects of pro­ced­ures;

d.

qual­ity as­sur­ance;

e.

as­sess­ment and eval­u­ation of the pa­tient dose or the ad­min­istered activ­ity;

f.

use of ap­pro­pri­ate set-up para­met­ers or ap­pro­pri­ate ra­di­o­nuc­lides;

g.

use of sens­it­ive de­tect­ors;

h.

for every med­ic­al in­stall­a­tion, use of the ele­ments re­quired for the pro­tec­tion of pa­tients.

⁴ The dose re­ceived by per­son­nel must be taken in­to ac­count in the op­tim­isa­tion pro­cess.

5 The FDHA may is­sue tech­nic­al op­tim­isa­tion pro­vi­sions for the pro­tec­tion of pa­tients.

The li­cence hold­er must doc­u­ment all thera­peut­ic and dia­gnost­ic ex­pos­ures in the me­di­um-dose or high-dose range and in mam­mo­graphy in such a way that the ra­di­ation dose re­ceived by the pa­tient can be de­term­ined at a later date.

¹ The FOPH shall sur­vey on a reg­u­lar basis, but at least every ten years, the ra­di­ation doses re­ceived by the pop­u­la­tion from med­ic­al ex­pos­ures.

² It may re­quest from li­cence hold­ers an­onymised data on thera­peut­ic, dia­gnost­ic, in­ter­ven­tion­al or nuc­le­ar medi­cine ap­plic­a­tions, in par­tic­u­lar:

a.

time and type of ap­plic­a­tion and ana­tom­ic­al re­gion;

b.

ex­pos­ure para­met­ers;

c.

ra­di­ation dose or activ­ity levels;

d.

in­stall­a­tion spe­cific­a­tions;

e.

sex, age, height and weight of pa­tients;

f.

num­ber of in­di­vidu­al ex­pos­ures per ap­plic­a­tion, clas­si­fied by type and ana­tom­ic­al re­gion.

³ It may re­quest third parties to pre­pare stat­ist­ics. For this pur­pose, it shall provide them with the ne­ces­sary data.

¹ The FOPH shall pub­lish re­com­mend­a­tions on ra­di­ation doses for dia­gnost­ic, in­ter­ven­tion­al or nuc­le­ar medi­cine ex­am­in­a­tions in the form of dia­gnost­ic ref­er­ence levels.

² To this end, it shall con­duct na­tion­al sur­veys based on the data spe­cified in Art­icle 34 para­graph 2, take in­ter­na­tion­al re­com­mend­a­tions in­to ac­count and pub­lish the res­ults.

³ Li­cence hold­ers must reg­u­larly re­view their own prac­tices and ac­count for any de­vi­ations from dia­gnost­ic ref­er­ence levels.

¹ The li­cence hold­er must:

a.

closely in­volve a med­ic­al phys­i­cist in thera­peut­ic prac­tices, with the ex­cep­tion of stand­ard­ised nuc­le­ar medi­cine prac­tices;

b.

in­volve a med­ic­al phys­i­cist in stand­ard­ised nuc­le­ar medi­cine prac­tices, in com­puted tomo­graphy, in in­ter­ven­tion­al ra­di­ology prac­tices and in flu­oro­scopy in the me­di­um- and high-dose range;

c.

if so re­ques­ted by the su­per­vis­ory au­thor­ity, in­volve a med­ic­al phys­i­cist in prac­tices of tech­no­lo­gic­ally com­plex ex­am­in­a­tions or new ex­am­in­a­tion tech­niques in the low- and me­di­um-dose range.

² For thera­peut­ic pro­ced­ures, the FDHA may spe­cify the level of in­volve­ment of med­ic­al phys­i­cists.

¹ The li­cence hold­er must en­sure that per­sons help­ing to com­fort and care for pa­tients in a non-pro­fes­sion­al ca­pa­city are in­formed about their ex­pos­ure and the as­so­ci­ated risks.

² For carers and com­fort­ers, a dose con­straint of 5 mSv per year (ef­fect­ive dose) ap­plies.

³ If an ex­ceedance of the dose con­straint is de­term­ined, the li­cence hold­er must in­form the per­son con­cerned.

⁴ The FDHA may define spe­cif­ic dose con­straints for par­tic­u­lar med­ic­al pro­ced­ures.

Pa­tients must be in­formed about the risks and be­ne­fits of med­ic­al ex­pos­ure.

Med­ic­al ex­pos­ures of chil­dren must be per­formed us­ing ex­pos­ure para­met­ers spe­cific­ally op­tim­ised for this pa­tient group. In par­tic­u­lar, the fol­low­ing must be taken in­to ac­count:

a.

physique;

b.

ra­di­o­sensit­iv­ity;

c.

the pos­sib­il­ity of em­ploy­ing spe­cif­ic tech­nic­al aids.

¹ For ex­pos­ures in the me­di­um-dose or high-dose range and for thera­peut­ic ex­pos­ures in fe­male pa­tients, the phys­i­cian per­form­ing the pro­ced­ure must es­tab­lish wheth­er the pa­tient is preg­nant.

² If preg­nancy is de­term­ined or can­not be ruled out, this must be weighed against the need for the ex­pos­ure in the jus­ti­fic­a­tion. In the op­tim­isa­tion, both the dose to the un­born child and that to the moth­er must be taken in­to ac­count.

³ If the uter­us of a preg­nant pa­tient lies with­in the area ex­amined, the dose to the uter­us must be doc­u­mented.

⁴ In the case of nuc­le­ar medi­cine ex­pos­ures, breast­feed­ing pa­tients must be in­formed about the need for and dur­a­tion of a sus­pen­sion of breast­feed­ing on ac­count of the con­tam­in­a­tion of breast milk.

1 The pur­pose of clin­ic­al audits is to en­sure that med­ic­al ex­pos­ures are jus­ti­fied and op­tim­ised in ac­cord­ance with the cur­rent state of sci­ence and tech­no­logy, and that the qual­ity and out­come of pa­tient care are con­tinu­ously im­proved.

² Clin­ic­al audits in­volve sys­tem­at­ic­ally ex­amin­ing pa­tient- and per­son­nel-re­lated pro­cesses for dia­gnost­ic and thera­peut­ic pro­ced­ures in­volving ion­ising ra­di­ation, and com­par­ing them with the cur­rent state of sci­ence and tech­no­logy.

³ The FOPH may re­quire the li­cence hold­er to un­der­go a clin­ic­al audit for the fol­low­ing med­ic­al ra­di­ation ap­plic­a­tions every five years:

a.

com­puted tomo­graphy;

b.

nuc­le­ar medi­cine;

c.

ra­di­ation on­co­logy;

d.

flu­oro­scopy-guided in­ter­ven­tion­al dia­gnost­ic and thera­peut­ic pro­ced­ures.

¹ If the FOPH en­gages third parties for the co­ordin­a­tion and pre­par­a­tion of clin­ic­al audits (Art. 189), they must be ex­perts from vari­ous in­sti­tu­tions and pro­fes­sion­al bod­ies.

²If the FOPH en­gages third parties for the con­duct of clin­ic­al audits (Art. 189), these aud­it­ors must have many years’ pro­fes­sion­al ex­per­i­ence in their field and must be in­de­pend­ent of the audited li­cence hold­ers.

³The FOPH shall make the ne­ces­sary data con­cern­ing li­cence hold­ers avail­able to the third parties en­gaged.

⁴If, in the eval­u­ation of audits, the third parties en­gaged dis­cov­er sig­ni­fic­ant de­vi­ations from the re­quire­ments of this Or­din­ance or from the cur­rent state of sci­ence and tech­no­logy, they shall in­form the FOPH.

¹ All hold­ers of li­cences for ra­di­ation ap­plic­a­tions as spe­cified in Art­icle 41 para­graph 3 shall con­duct an an­nu­al self-eval­u­ation of their pro­cesses.

² They shall pre­pare a qual­ity manu­al and present this at the audit.

3 The qual­ity manu­al must in­clude a de­tailed de­scrip­tion of at least the fol­low­ing points:

a.

com­pet­ences and re­spons­ib­il­it­ies;

b.

equip­ment avail­able for ex­am­in­a­tion and treat­ment;

c.

per­son­nel train­ing;

d.

meas­ures to en­sure com­pli­ance with re­quire­ments con­cern­ing the jus­ti­fic­a­tion of in­di­vidu­al ap­plic­a­tions (Art. 29);

e.

ex­am­in­a­tion and treat­ment pro­to­cols and pa­tient in­form­a­tion;

f.

doc­u­ment­a­tion of ra­di­ation doses (Art. 33);

g.

es­tab­lish­ment and com­mu­nic­a­tion of dia­gnost­ic find­ings or treat­ment mon­it­or­ing, data stor­age and data trans­fer;

h.

qual­ity as­sur­ance;

i.

self-eval­u­ation.

1 The con­duct of hu­man re­search pro­jects in­volving the use of ra­di­ation sources re­quires au­thor­isa­tion in ac­cord­ance with Art­icle 45 of the Hu­man Re­search Act of 30 Septem­ber 2011²² (HRA).

2 In ad­di­tion, the con­duct of clin­ic­al tri­als of thera­peut­ic products cap­able of emit­ting ion­ising ra­di­ation re­quires au­thor­isa­tion in ac­cord­ance with Art­icle 54 of the Thera­peut­ic Products Act of 15 Decem­ber 2000²³ (TPA).

¹ In re­search pro­jects with no ex­pec­ted dir­ect be­ne­fit, a dose con­straint of 5 mSv per year (ef­fect­ive dose) ap­plies to the par­ti­cipants.

2 In ex­cep­tion­al cases, the dose con­straint spe­cified in para­graph 1 may be up to 20 mSv per year (ef­fect­ive dose), with con­sid­er­a­tion be­ing giv­en to age, fer­til­ity, life ex­pect­ancy and health status, provided that this is ab­so­lutely es­sen­tial for meth­od­o­lo­gic­al reas­ons.

³ In the case of com­bined pro­ced­ures, all ra­di­ation sources must be taken in­to ac­count in the cal­cu­la­tion or es­tim­a­tion of the dose to par­ti­cipants.

⁴ In the cal­cu­la­tion or es­tim­a­tion of the dose, the un­cer­tainty factor must be taken in­to ac­count.

¹ For the pla­cing of products on the mar­ket and ad­min­is­tra­tion of ra­dio­phar­ma­ceut­ic­als in hu­mans, the pro­vi­sions of the TPA²⁴ ap­ply.

2 Ap­prov­al is re­quired from the FOPH for:

a.

the mar­ket­ing au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als in ac­cord­ance with Art­icle 9 para­graph 1 of the TPA;

b.

the sim­pli­fied au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als in ac­cord­ance with Art­icle 14 of the TPA;

c.

the au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als for a lim­ited peri­od in ac­cord­ance with Art­icle 9 para­graph 4 of the TPA.

³ The FOPH shall grant ap­prov­al based on the doc­u­ments re­ceived as part of the ap­plic­a­tion for au­thor­isa­tion, and on the as­sess­ment and reas­on­ing of the Ex­pert Com­mis­sion for Ra­dio­phar­ma­ceut­ic­als.

⁴ Ra­dio­phar­ma­ceut­ic­als must be la­belled as such. Their pack­age la­belling must in­clude at least the fol­low­ing ra­di­olo­gic­al pro­tec­tion-re­lated in­form­a­tion:

a.

the pre­par­a­tion name;

b.

the haz­ard warn­ing sym­bol in ac­cord­ance with An­nex 8;

c.

the ra­di­o­nuc­lides and their activ­ity at the time of cal­ib­ra­tion;

d.

the cal­ib­ra­tion time and the ex­piry time.

⁵For the la­belling, the pro­vi­sions of the medi­cin­al products le­gis­la­tion also ap­ply.

6 Long-lived ra­di­o­nuc­lide im­pur­it­ies rel­ev­ant to dis­pos­al must be in­dic­ated in the ac­com­pa­ny­ing doc­u­ments.

¹ Any per­son who pre­pares ra­dio­phar­ma­ceut­ic­als must carry out the qual­ity con­trols de­scribed in the product in­form­a­tion.

²The FOPH may take samples at any time in or­der to de­term­ine wheth­er the re­quire­ments spe­cified in Art­icle 46 are still be­ing met. For this pur­pose, it may en­gage spe­cial­ised labor­at­or­ies.

³ The FDHA may spe­cify re­quire­ments for the pre­par­a­tion and use of ra­dio­phar­ma­ceut­ic­als; it shall take in­to ac­count na­tion­al and in­ter­na­tion­al guidelines and the re­com­mend­a­tions of pro­fes­sion­al bod­ies, in par­tic­u­lar those is­sued by the European As­so­ci­ation of Nuc­le­ar Medi­cine (EANM)²⁵ or the Swiss So­ci­ety of Ra­dio­phar­macy/Ra­dio­phar­ma­ceut­ic­al Chem­istry (SGRRC)²⁶.

¹ The Ex­pert Com­mis­sion for Ra­dio­phar­ma­ceut­ic­als (ECRP) is a stand­ing ad­vis­ory com­mis­sion with­in the mean­ing of Art­icle 8a para­graph 2 of the Gov­ern­ment and Ad­min­is­tra­tion Or­gan­isa­tion Or­din­ance of 25 Novem­ber 1998²⁷ (GAOO).

2 It shall ad­vise the Fed­er­al De­part­ment of Home Af­fairs (FDHA), Swiss­med­ic and the FOPH on ra­dio­phar­ma­ceut­ic­al mat­ters. In par­tic­u­lar, it has the fol­low­ing tasks:

a.

it pre­pares re­ports on ap­plic­a­tions for the mar­ket­ing au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als;

b.

it pre­pares re­ports on safety-re­lated ques­tions con­nec­ted with ra­dio­phar­ma­ceut­ic­als;

c.

it ad­vises the FH­HA on the amend­ment of An­nex 1 to the Thera­peut­ic Products Or­din­ance of 21 Septem­ber 2018²⁸.²⁹

It is com­prises spe­cial­ists from the fields of nuc­le­ar medi­cine, phar­ma­ceut­ics, chem­istry and ra­di­olo­gic­al pro­tec­tion.

A med­ic­al ra­di­ation in­cid­ent is an un­planned event in the form of a care­less or in­ap­pro­pri­ate ac­tion, with or without ac­tu­al con­sequences, which, as a res­ult of de­fi­cien­cies in the qual­ity as­sur­ance pro­gramme, tech­nic­al mal­func­tions, op­er­at­or er­ror or oth­er in­cor­rect be­ha­viour, led or could have led to un­in­ten­ded ex­pos­ures of pa­tients.

¹ Li­cence hold­ers must keep a re­cord of med­ic­al ra­di­ation in­cid­ents.

² They must, with an in­ter­dis­cip­lin­ary work­ing group, reg­u­larly ana­lyse any in­cid­ents which have oc­curred and make the op­er­a­tion­al ad­just­ments re­quired to pre­vent sim­il­ar in­cid­ents.

³ They must re­port the fol­low­ing med­ic­al ra­di­ation in­cid­ents to the su­per­vis­ory au­thor­ity with­in 30 days:

a.

un­planned ex­pos­ures which led or could have led to mod­er­ate or­gan dam­age, mod­er­ate func­tion­al impair­ment or more ser­i­ous dam­age in the pa­tient;

b.

con­fu­sion of pa­tients or or­gans in thera­peut­ic ex­pos­ures or in dia­gnost­ic ex­pos­ures in the high-dose range;

c.

un­planned ex­pos­ures where the pa­tient re­ceived an ef­fect­ive dose of more than 100 mSv.

⁴ In the case of med­ic­al ra­di­ation in­cid­ents as spe­cified in para­graph 3, the li­cence hold­er must con­duct an in­vest­ig­a­tion and sub­mit a re­port in ac­cord­ance with Art­icle 129.

¹ Oc­cu­pa­tion­ally ex­posed per­sons means per­sons who:

a.

in the course of their oc­cu­pa­tion­al activ­it­ies or train­ing may in­cur ex­pos­ure which ex­ceeds a dose lim­it for mem­bers of the pub­lic as spe­cified in Art­icle 22; this is without pre­ju­dice to para­graph 2;

b.

work or un­der­go train­ing at least once a week in con­trolled areas as defined in Art­icle 80; or

c.

work or un­der­go train­ing at least once a week in su­per­vised areas as defined in Art­icle 85 and may thus be ex­posed to an in­creased am­bi­ent dose rate.

2 Per­sons who are sub­ject solely to radon ex­pos­ure at their work­place are only deemed to be oc­cu­pa­tion­ally ex­posed if they may thereby ac­cu­mu­late an ef­fect­ive dose of more than 10 mSv per year (Art. 167 para. 3).

3 The li­cence hold­er, or in the case of air­crew the air­craft op­er­at­or, shall des­ig­nate all oc­cu­pa­tion­ally ex­posed per­sons with­in the en­ter­prise.

4 Li­cence hold­ers, or in the case of air­crew the air­craft op­er­at­or, shall in­form the oc­cu­pa­tion­ally ex­posed per­sons reg­u­larly of:

a.

the ra­di­ation doses to be ex­pec­ted in the course of their work;

b.

the dose lim­its ap­plic­able for them;

c.

the health risks as­so­ci­ated with their work;

d.

the ra­di­olo­gic­al pro­tec­tion meas­ures which must be ob­served for their work;

e.

the risks of ra­di­ation ex­pos­ure for the un­born child.

¹ For pur­poses of mon­it­or­ing, li­cence hold­ers shall clas­si­fy the oc­cu­pa­tion­ally ex­posed per­sons in­to cat­egor­ies A and B in ac­cord­ance with para­graphs 2–4.

2 Cat­egory A com­prises per­sons who:

a.

may ac­cu­mu­late the fol­low­ing doses per cal­en­dar year in the course of their work:

1.

an ef­fect­ive dose great­er than 6 mSv,

2.

an equi­val­ent dose for the lens of the eye great­er than 15 mSv, or

3.

an equi­val­ent dose for the skin, hands or feet great­er than 150 mSv;

b.

as a res­ult of radon ex­pos­ure at the work­place re­ceive an ef­fect­ive dose great­er than 10 mSv per cal­en­dar year; or

c.

work as in­tern­al per­son­nel at a nuc­le­ar in­stall­a­tion.

3 Cat­egory B com­prises all oc­cu­pa­tion­ally ex­posed per­sons not be­long­ing to cat­egory A.

⁴ Per­sons en­gaged in activ­it­ies where the risk of ac­cu­mu­lat­ing doses as spe­cified in para­graph 2 let­ter a is neg­li­gible shall be as­signed to cat­egory B for the per­form­ance of these activ­it­ies. This in­cludes in par­tic­u­lar activ­it­ies:

a.

in­volving the op­er­a­tion of dia­gnost­ic X-ray sys­tems in med­ic­al, dent­al and veter­in­ary prac­tices, ex­cept in the high-dose range;

b.

as oc­cu­pa­tion­ally ex­posed air­crew.

⁵ If ap­plic­ants or li­cence hold­ers demon­strate that an activ­ity does not ful­fil any of the con­di­tions spe­cified in para­graph 2, they may re­quest the su­per­vis­ory au­thor­ity to as­sign the per­sons per­form­ing this activ­ity to cat­egory B.

¹ Per­sons aged un­der 16 years must not be oc­cu­pa­tion­ally ex­posed.

² For per­sons aged between 16 and 18 years and for preg­nant wo­men, the dose lim­its spe­cified in Art­icle 57 ap­ply.

³ From the time when a preg­nancy be­comes known un­til its com­ple­tion, the ra­di­ation ex­pos­ure of the preg­nant wo­man must be de­term­ined monthly.

⁴ The FDHA shall spe­cify, in con­sulta­tion with EN­SI, when preg­nant wo­men must be ad­di­tion­ally equipped with an act­ive per­son­al do­si­met­er.

⁵ Preg­nant wo­men must, if they so re­quest, be ex­emp­ted from the fol­low­ing activ­it­ies:

a.

from flight du­ties;

b.

from any work with ra­dio­act­ive ma­ter­i­al in­volving a risk of in­takes or con­tam­in­a­tion;

c.

from activ­it­ies which may only be per­formed by an oc­cu­pa­tion­ally ex­posed per­son in cat­egory A.

⁶ Breast­feed­ing wo­men must not per­form any work with ra­dio­act­ive ma­ter­i­al in­volving an in­creased risk of in­takes.

For oc­cu­pa­tion­ally ex­posed air­crew, ra­di­ation ex­pos­ure must be op­tim­ised when es­tab­lish­ing work plans.

1 The li­cence hold­er must have med­ic­al as­sess­ments con­duc­ted in ac­cord­ance with Art­icle 11a of the Or­din­ance of 19 Decem­ber 1983³⁰ on Ac­ci­dent Pre­ven­tion (APO).

2 Suva may sub­ject em­ploy­ees to the pre­vent­ive oc­cu­pa­tion­al medi­cine pro­vi­sions spe­cified in Art­icles 70–89 APO.

¹ For oc­cu­pa­tion­ally ex­posed per­sons, the ef­fect­ive dose must not ex­ceed the lim­it of 20 mSv per cal­en­dar year.

² For such per­sons, by way of ex­cep­tion and with the ap­prov­al of the su­per­vis­ory au­thor­ity, the lim­it for the ef­fect­ive dose may be up to 50 mSv per cal­en­dar year, provided that the cu­mu­lat­ive dose over five con­sec­ut­ive years, in­clud­ing the cur­rent year, is less than 100 mSv.

³ For such per­sons, the equi­val­ent dose must not ex­ceed the fol­low­ing lim­its:

a.

for the lens of the eye: 20 mSv per cal­en­dar year or a cu­mu­lat­ive dose of 100 mSv over five con­sec­ut­ive cal­en­dar years, sub­ject to a max­im­um dose of 50 mSv in a single cal­en­dar year;

b.

for the skin, hands and feet: 500 mSv per cal­en­dar year.

⁴ Oc­cu­pa­tion­ally ex­posed per­sons from abroad must, in Switzer­land, only ac­cu­mu­late an ef­fect­ive dose of 20 mSv per cal­en­dar year, al­low­ing for the dose already re­ceived in the cur­rent cal­en­dar year.

¹ For per­sons aged 16–18 years, the ef­fect­ive dose must not ex­ceed the lim­it of 6 mSv per cal­en­dar year.

² Preg­nant wo­men may only be de­ployed as oc­cu­pa­tion­ally ex­posed per­sons if it is as­sured that, from the time when a preg­nancy be­comes known un­til its com­ple­tion, the ef­fect­ive dose to the un­born child does not ex­ceed 1 mSv.

1 If a dose lim­it as spe­cified in Art­icle 56 para­graphs 1–3 and Art­icle 57 para­graph 1 is ex­ceeded in an oc­cu­pa­tion­ally ex­posed per­son, then, for the rest of the cal­en­dar year, the per­son con­cerned may ac­cu­mu­late no more than:

a.

an ef­fect­ive dose of 1 mSv;

b.

an equi­val­ent dose of 15 mSv for the lens of the eye, and of 50 mSv for the skin, hands and feet.

2 The right of the su­per­vis­ory au­thor­ity to grant ap­prov­al in ac­cord­ance with Art­icle 56 para­graph 2 is re­served.

3 If the dose lim­it spe­cified in Art­icle 57 para­graph 2 is ex­ceeded, the wo­men con­cerned must not, for the re­mainder of their preg­nancy, be de­ployed in con­trolled or su­per­vised areas as defined in Art­icles 80 and 85.

¹ If a dose lim­it spe­cified in Art­icle 56 or 57 is ex­ceeded, the su­per­vis­ory au­thor­ity shall de­cide wheth­er the per­son con­cerned must be placed un­der med­ic­al sur­veil­lance.

² The phys­i­cian shall in­form the per­son con­cerned and the su­per­vis­ory au­thor­ity of the res­ults of his or her in­vest­ig­a­tion and pro­pose meas­ures to be ad­op­ted. If the per­son con­cerned is an em­ploy­ee, the phys­i­cian shall also in­form Suva.

³ The phys­i­cian shall re­port to the su­per­vis­ory au­thor­ity:

a.

data con­cern­ing any early ef­fects de­tec­ted;

b.

data con­cern­ing ill­nesses or spe­cial pre­dis­pos­i­tions mak­ing it ne­ces­sary to de­clare the per­son un­fit for ra­di­ation work;

c.

bio­lo­gic­al do­si­metry data.

⁴ If the per­son con­cerned is an em­ploy­ee, the phys­i­cian shall also re­port the data to Suva.

⁵ Suva, or the su­per­vis­ory au­thor­ity in the case of per­sons not in em­ploy­ment, shall take the ne­ces­sary meas­ures. It may or­der a tem­por­ary or per­man­ent ex­clu­sion from activ­it­ies in­volving oc­cu­pa­tion­al ex­pos­ure.

¹ For the pur­pose of op­tim­ising ra­di­olo­gic­al pro­tec­tion, the li­cence hold­er, or in the case of air­crew the air­craft op­er­at­or, shall spe­cify dose con­straints for oc­cu­pa­tion­ally ex­posed per­sons.

² The prin­ciple of op­tim­isa­tion is deemed to be sat­is­fied where activ­it­ies do not lead to an ef­fect­ive dose of more than 100 µSv per cal­en­dar year for oc­cu­pa­tion­ally ex­posed per­sons.

³ If a dose con­straint is ex­ceeded, the work­ing prac­tice must be re­viewed and ra­di­olo­gic­al pro­tec­tion im­proved.

¹ In oc­cu­pa­tion­ally ex­posed per­sons, ra­di­ation ex­pos­ure must be de­term­ined in­di­vidu­ally in ac­cord­ance with An­nex 4 (in­di­vidu­al mon­it­or­ing).

² Ex­tern­al ex­pos­ure must be de­term­ined every month.

³ The su­per­vis­ory au­thor­ity may grant ex­emp­tions from para­graphs 1 and 2 if:

a.

an ad­di­tion­al or an­oth­er ap­pro­pri­ate dose mon­it­or­ing sys­tem is avail­able;

b.

no ap­pro­pri­ate dose mon­it­or­ing sys­tem is avail­able, but en­hanced ra­di­olo­gic­al pro­tec­tion meas­ures are taken.

⁴ The FDHA shall spe­cify, in con­sulta­tion with EN­SI, how and at what in­ter­vals in­tern­al ra­di­ation ex­pos­ure is to be de­term­ined. In do­ing so, it shall take in­to ac­count the work­ing con­di­tions and the type of ra­di­o­nuc­lides used.

⁵ It shall spe­cify, in con­sulta­tion with EN­SI, when a second, in­de­pend­ent do­si­metry sys­tem ful­filling an ad­di­tion­al func­tion must be used.

¹ In cases where in­di­vidu­al dose meas­ure­ment is not suit­able, the li­cence hold­er must de­term­ine the ra­di­ation dose by cal­cu­la­tion; this re­quires the ap­prov­al of the su­per­vis­ory au­thor­ity.

² The FDHA, in con­sulta­tion with EN­SI, shall is­sue pro­vi­sions con­cern­ing the de­term­in­a­tion of ra­di­ation doses by cal­cu­la­tion.

³ In the case of air­crew, air­craft op­er­at­ors may them­selves de­term­ine ra­di­ation doses by cal­cu­la­tion. The soft­ware used for this pur­pose must re­flect the state of the art.

1 For oc­cu­pa­tion­ally ex­posed per­sons at en­ter­prises li­censed by the FOPH, the fol­low­ing re­port­ing thresholds per do­si­met­ric mon­it­or­ing peri­od ap­ply:

a.

2 mSv for the ef­fect­ive dose;

b.

2 mSv for the equi­val­ent dose for the lens of the eye;

c.

50 mSv for the equi­val­ent dose for the skin, hands or feet.

2 When a re­port­ing threshold is reached, the re­port­ing du­ties spe­cified in Art­icle 65 para­graph 1 let­ter c and Art­icle 69 let­ter b arise.

¹ Li­cence hold­ers, or, in the case of air­crew, air­craft op­er­at­ors, must have the ra­di­ation ex­pos­ure of all oc­cu­pa­tion­ally ex­posed per­sons with­in the en­ter­prise de­term­ined by an ap­proved per­son­al do­si­metry ser­vice. They may also them­selves de­term­ine doses by cal­cu­la­tion as spe­cified in Art­icle 62 or carry out triage meas­ure­ments to de­tect in­tern­al ra­di­ation ex­pos­ure.

² They shall bear the costs of do­si­metry.

³ They must:

a.

in­form the per­sons con­cerned of the res­ults of do­si­metry;

b.

fur­nish them with a writ­ten sum­mary of all doses:

1.

upon ter­min­a­tion of em­ploy­ment,

2.

pri­or to de­ploy­ment at an­oth­er en­ter­prise;

c.

provide Suva with the op­er­a­tion­al, per­son­al and do­si­metry data re­quired for pre­vent­ive oc­cu­pa­tion­al medi­cine;

d.

when a re­port­ing threshold as spe­cified in Art­icle 63 is reached, provide the su­per­vis­ory au­thor­ity, if so re­ques­ted, with an ex­plan­a­tion of the cause of the dose; the ex­plan­a­tion must be provided in writ­ing with­in two weeks;

e.

com­mu­nic­ate to the ap­poin­ted per­son­al do­si­metry ser­vice the data spe­cified in Art­icle 73 para­graph 1 let­ters a–e and g–i for all oc­cu­pa­tion­ally ex­posed per­sons with­in the en­ter­prise;

f.

re­port dir­ectly to the Cent­ral Dose Re­gistry doses ac­cu­mu­lated by oc­cu­pa­tion­ally ex­posed per­sons work­ing abroad which were not de­term­ined by a Swiss per­son­al do­si­metry ser­vice; the re­port must be sub­mit­ted with­in a month after the end of the as­sign­ment in a form pre­scribed by the FOPH.

¹ If ra­di­ation doses are de­term­ined by cal­cu­la­tion with­in the en­ter­prise as spe­cified in Art­icle 62, li­cence hold­ers, or, in the case of air­crew, air­craft op­er­at­ors, must re­port:

a.

the data spe­cified in Art­icle 73: to the Cent­ral Dose Re­gistry (Art. 72);

b.

the ra­di­ation doses de­term­ined by cal­cu­la­tion: to the Cent­ral Dose Re­gistry with­in a peri­od spe­cified by the FOPH in a form pre­scribed by the FOPH;

c.

the reach­ing of a re­port­ing threshold as spe­cified in Art­icle 63: to the su­per­vis­ory au­thor­ity no later than ten days after the ra­di­ation dose has been cal­cu­lated;

d.

a sus­pec­ted ex­ceedance of a dose lim­it: with­in one work­ing day, to the su­per­vis­ory au­thor­ity and, if the per­son con­cerned is an em­ploy­ee, to Suva.

2 For en­ter­prises with­in the area su­per­vised by EN­SI, this au­thor­ity shall is­sue ad­di­tion­al guidelines con­cern­ing the re­port­ing of ra­di­ation doses de­term­ined by cal­cu­la­tion.

¹ A per­son­al do­si­metry ser­vice must be ap­proved by the com­pet­ent au­thor­ity (Art. 68).

² It shall be ap­proved if the fol­low­ing re­quire­ments are met:

a.

It is dom­i­ciled in Switzer­land.

b.

It has an ap­pro­pri­ate or­gan­isa­tion and suf­fi­cient staff, in par­tic­u­lar an ad­equate num­ber of per­sons with a prac­tic­al know­ledge of the rel­ev­ant meas­ure­ment tech­nique and of ra­di­olo­gic­al pro­tec­tion.

c.

It demon­strates to the com­pet­ent au­thor­ity that it has, and im­ple­ments, a qual­ity as­sur­ance pro­gramme.

d.

The meas­ure­ment sys­tem re­flects the state of the art and can be re­lated to ap­pro­pri­ate stand­ards through an un­broken chain of com­par­is­ons.

³ If a per­son­al do­si­metry ser­vice is ac­cred­ited for per­son­al do­si­metry, the re­quire­ments spe­cified in para­graph 2 let­ters c and d are deemed to be met.

¹ The com­pet­ent au­thor­ity shall de­term­ine, by means of an in­spec­tion and a tech­nic­al re­view, wheth­er a per­son­al do­si­metry ser­vice meets the re­quire­ments for ap­prov­al. It may en­gage third parties for this pur­pose.

² Ap­prov­al may be gran­ted for a max­im­um of five years.

¹ The fol­low­ing au­thor­it­ies are re­spons­ible for ap­prov­al:

the FOPH, in cases where a per­son­al do­si­metry ser­vice wishes to op­er­ate wholly or largely with­in the area su­per­vised by the FOPH or by Suva;

b.

EN­SI, in cases where a per­son­al do­si­metry ser­vice wishes to op­er­ate wholly or largely with­in the area su­per­vised by this au­thor­ity

² In cases where a per­son­al do­si­metry ser­vice wishes to op­er­ate in vari­ous areas, the com­pet­ent au­thor­it­ies shall jointly de­cide which of them is to be re­spons­ible for ap­prov­al.

³ The com­pet­ent au­thor­it­ies must not op­er­ate any per­son­al do­si­metry ser­vices them­selves.

The per­son­al do­si­metry ser­vice has the fol­low­ing re­port­ing du­ties:

a.

With­in a month after the end of the mon­it­or­ing peri­od, it shall re­port the data spe­cified in Art­icle 73 to the fol­low­ing:

1.

the li­cence hold­er or, in the case of air­crew, the air­craft op­er­at­or;

2.

the Cent­ral Dose Re­gistry (Art. 72), in a form pre­scribed by the FOPH;

3.

in the case of data from the area su­per­vised by EN­SI: also dir­ectly to EN­SI.

b.

If a re­port­ing threshold per mon­it­or­ing peri­od as spe­cified in Art­icle 63 is reached, the per­son­al do­si­metry ser­vice shall no­ti­fy the li­cence hold­er and the su­per­vis­ory au­thor­ity no later than ten work­ing days after re­ceipt of the do­si­met­er.

c.

In the event of a sus­pec­ted ex­ceedance of a dose lim­it, the per­son­al do­si­metry ser­vice shall re­port the res­ult to the li­cence hold­er, or, in the case of air­crew, to the air­craft op­er­at­or, and to the su­per­vis­ory au­thor­ity with­in one work­ing day. If the per­son con­cerned is an em­ploy­ee, it shall also in­form Suva.

d.

For per­son­al do­si­metry ser­vices ap­proved by EN­SI, this au­thor­ity shall is­sue re­port­ing guidelines.

¹ The per­son­al do­si­metry ser­vice must re­tain the dose val­ues and per­son­al de­tails, as well as all the raw data re­quired for cal­cu­la­tion of the doses to be re­por­ted at a later date, for a peri­od of two years after sub­mis­sion to the Cent­ral Dose Re­gistry.

² In ac­cord­ance with the in­struc­tions of the com­pet­ent au­thor­ity, it must par­ti­cip­ate at its own ex­pense in in­ter­com­par­is­on ex­er­cises.

³ If a per­son­al do­si­metry ser­vice wishes to cease its activ­it­ies, it must give the com­pet­ent au­thor­ity, its cli­ents and the su­per­vis­ory au­thor­it­ies re­spons­ible for its cli­ents at least six months’ ad­vance no­tice.

⁴ The per­son­al do­si­metry ser­vice ceas­ing its activ­it­ies shall trans­fer its archived data to the new per­son­al do­si­metry ser­vices des­ig­nated by its cli­ents.

⁵ In ex­cep­tion­al cases, the com­pet­ent au­thor­ity shall de­term­ine the steps to be taken.

⁶ If a cli­ent ter­min­ates its con­trac­tu­al re­la­tion­ship with the per­son­al do­si­metry ser­vice, the lat­ter must draw the cli­ent’s at­ten­tion to its du­ties as a li­cence hold­er as spe­cified in Art­icle 64 and in­form the su­per­vis­ory au­thor­ity of the ter­min­a­tion.

The per­son­al do­si­metry ser­vice may only dis­close per­son­al de­tails and the res­ults of do­si­metry:

a.

to the in­di­vidu­al con­cerned;

b.

to the li­cence hold­er or, in the case of air­crew, the air­craft op­er­at­or;

c.

to the su­per­vis­ory au­thor­ity;

d.

to the li­cens­ing au­thor­ity;

e.

to the Cent­ral Dose Re­gistry.

¹ The FOPH shall main­tain a Cent­ral Dose Re­gistry.

² The pur­pose of the Re­gistry is to re­cord the doses de­term­ined throughout the peri­od dur­ing which a per­son is oc­cu­pa­tion­ally ex­posed, in or­der to as­sess pos­sible in­sur­ance claims on this basis.

3 In ad­di­tion, the Re­gistry en­ables the su­per­vis­ory au­thor­it­ies:

a.

to re­view at any time the doses ac­cu­mu­lated per mon­it­or­ing peri­od for each oc­cu­pa­tion­ally ex­posed per­son in Switzer­land;

b.

to con­duct stat­ist­ic­al ana­lyses and eval­u­ate the ef­fect­ive­ness of the pro­vi­sions of this Or­din­ance;

c.

to en­sure data re­ten­tion.

¹ The fol­low­ing data con­cern­ing oc­cu­pa­tion­ally ex­posed per­sons shall be stored in the Cent­ral Dose Re­gistry:

a.

name, first name and former names;

b.

date of birth;

c.³¹

OASI num­ber;

d.

sex;

e.

name, ad­dress and UID of the en­ter­prise;

f.

dose val­ues de­term­ined in Switzer­land and abroad;

g.

oc­cu­pa­tion­al group;

h.

activ­ity;

i.

cat­egory (A or B).

² For per­sons work­ing in Switzer­land only tem­por­ar­ily, the doses de­term­ined in Switzer­land shall be re­cor­ded.

The fol­low­ing shall have dir­ect elec­tron­ic ac­cess to data in the Cent­ral Dose Re­gistry:

the staff of the FOPH Ra­di­olo­gic­al Pro­tec­tion Di­vi­sion;

the Suva Oc­cu­pa­tion­al Medi­cine De­part­ment;

the su­per­vis­ory au­thor­it­ies: the data in the area un­der their su­per­vi­sion;

d.

the Fed­er­al Of­fice of Civil Avi­ation (FO­CA): the data con­cern­ing air­crew.

¹ The su­per­vis­ory au­thor­it­ies shall pro­duce an­nu­al re­ports on the res­ults of per­son­al do­si­metry.

² The re­ports shall be pub­lished by the FOPH. It shall en­sure that the per­sons con­cerned are not iden­ti­fi­able.

¹ The FOPH may use, or make avail­able to third parties on re­quest, the per­son­al data stored in the Cent­ral Dose Re­gistry for re­search pro­jects con­cern­ing the ef­fects of ra­di­ation and ra­di­olo­gic­al pro­tec­tion. The pro­vi­sions of the HRA³² are ap­plic­able.

² The FOPH shall only make the per­son­al data avail­able in an an­onymised form, un­less the ap­plic­ant demon­strates that:

a.

the per­sons con­cerned have con­sen­ted to the dis­clos­ure of their data; or

b.

the ap­plic­ant has been gran­ted au­thor­isa­tion by the re­spons­ible eth­ics com­mit­tee in ac­cord­ance with Art­icle 45 of the HRA.

¹ The FDHA, in con­sulta­tion with EN­SI and after a hear­ing with the Fed­er­al In­sti­tute of Met­ro­logy (METAS), shall is­sue tech­nic­al pro­vi­sions for per­son­al do­si­metry.

² The tech­nic­al pro­vi­sions shall spe­cify in par­tic­u­lar:

a.

min­im­um re­quire­ments for meas­ure­ment sys­tems;

b.

min­im­um re­quire­ments for meas­ure­ment ac­cur­acy in routine op­er­a­tions and for in­ter­com­par­is­on ex­er­cises;

c.

stand­ard mod­els for cal­cu­la­tion of ra­di­ation doses.

¹ In or­der to lim­it and mon­it­or ra­di­ation ex­pos­ure, the li­cence hold­er shall es­tab­lish con­trolled or su­per­vised areas.

² Activ­it­ies in­volving ra­dio­act­ive ma­ter­i­al above the li­cens­ing lim­it, with the ex­cep­tion of sealed ra­dio­act­ive sources, must be car­ried out with­in con­trolled areas in rooms which are de­signed as work­ing areas as spe­cified in Art­icle 81.

³ For rooms and loc­a­tions with­in su­per­vised or con­trolled areas where con­tam­in­a­tion of sur­faces or in­door air or in­creased am­bi­ent dose rates may oc­cur, the su­per­vis­ory au­thor­ity may or­der a clas­si­fic­a­tion in­to zones as spe­cified in Art­icle 82 and dis­pense with the es­tab­lish­ment of work­ing areas.

1 The room or area in which in­stall­a­tions are op­er­ated or ra­dio­act­ive ma­ter­i­al is handled must be de­signed or shiel­ded in such a way that no lim­its are ex­ceeded.

2 At loc­a­tions out­side of con­trolled and su­per­vised areas where mem­bers of the pub­lic may be con­tinu­ously present, the weekly am­bi­ent dose must not ex­ceed 0.02 mSv. At loc­a­tions where people are not con­tinu­ously present, this value may be ex­ceeded by up to a factor of five.

3 If the loc­a­tions spe­cified in para­graph 2 are work­places, the am­bi­ent dose, giv­en an as­sumed work-re­lated pres­ence of 40 hours per week, may be high­er.

⁴ The in­flu­ence of sev­er­al dif­fer­ent ra­di­ation sources on a loc­a­tion to be pro­tec­ted must be taken in­to ac­count.

⁵ The FDHA, in con­sulta­tion with EN­SI, shall spe­cify guid­ance val­ues for the am­bi­ent dose with­in and out­side of con­trolled and su­per­vised areas.

¹ Con­trolled areas means areas which are sub­ject to spe­cif­ic re­quire­ments for the pur­pose of pro­tect­ing against ex­pos­ures to ion­ising ra­di­ation and pre­vent­ing the spread of con­tam­in­a­tion. In the area su­per­vised by EN­SI, the term con­trolled zone may con­tin­ue to be used for con­trolled areas.

2 The fol­low­ing are to be es­tab­lished as con­trolled areas:

a.

work­ing areas as spe­cified in Art­icle 81;

b.

zone types I–IV as spe­cified in An­nex 10;

c.

areas in which air­borne con­tam­in­a­tion may ex­ceed 0.05 CA as spe­cified in An­nex 3 Column 11 or sur­face con­tam­in­a­tion may ex­ceed 1 CS as spe­cified in An­nex 3 Column 12.

3 The su­per­vis­ory au­thor­ity may re­quest that fur­ther areas be es­tab­lished as con­trolled areas if this is ap­pro­pri­ate for or­gan­isa­tion­al reas­ons.

4 The li­cence hold­er must en­sure that ac­cess to con­trolled areas is only pos­sible for au­thor­ised per­sons.

5 Con­trolled areas must be clearly de­lim­ited and marked as spe­cified in An­nex 8.

6 The li­cence hold­er must su­per­vise com­pli­ance with guid­ance val­ues for am­bi­ent dose rates, con­tam­in­a­tion and in­door air activ­ity con­cen­tra­tions, and com­pli­ance with pro­tec­tion meas­ures and safety pro­vi­sions with­in con­trolled areas.

¹ Work­ing areas must be es­tab­lished with­in a con­trolled area in sep­ar­ate rooms re­served for these pur­poses.

² They shall be clas­si­fied in­to the fol­low­ing types, ac­cord­ing to the activ­ity of the ra­dio­act­ive ma­ter­i­als handled per op­er­a­tion or per day:

a.

type C: an activ­ity from 1 to 100 times the li­cens­ing lim­it;

b.

type B: an activ­ity from 1 to 10 000 times the li­cens­ing lim­it;

c.

type A: an activ­ity from 1 times the li­cens­ing lim­it to an up­per lim­it defined in the li­cens­ing pro­ced­ure.

³ For the stor­age of ra­dio­act­ive ma­ter­i­als in work­ing areas, the su­per­vis­ory au­thor­ity may in­crease the val­ues spe­cified in para­graph 2 by up to a factor of 100.

⁴ The su­per­vis­ory au­thor­ity may al­low ex­cep­tions to para­graph 1 on op­er­a­tion­al grounds, provided that ra­di­olo­gic­al pro­tec­tion is as­sured.

⁵ The su­per­vis­ory au­thor­ity may in ex­cep­tion­al cases, where hand­ling in­volves a low risk of in­takes, in­crease the val­ues spe­cified in para­graph 2 by up to a factor of 10, provided that ra­di­olo­gic­al pro­tec­tion is as­sured.

⁶ The su­per­vis­ory au­thor­ity may in in­di­vidu­al cases, tak­ing in­to ac­count the risk of in­takes, as­sign work­ing areas to a dif­fer­ent type from that spe­cified in para­graph 2, provided that only activ­it­ies in­volving a low risk of in­hal­a­tion are car­ried out therein.

⁷ The FDHA, in con­sulta­tion with EN­SI, shall is­sue the ne­ces­sary reg­u­la­tions con­cern­ing pro­tec­tion meas­ures.

¹ Zones shall be clas­si­fied in­to the zone types spe­cified in An­nex 10 ac­cord­ing to the de­gree of con­tam­in­a­tion present or to be ex­pec­ted.

² For the pur­pose of plan­ning and reg­u­la­tion of in­di­vidu­al doses, with­in zones with el­ev­ated am­bi­ent dose rates, areas with max­im­um per­miss­ible am­bi­ent dose rates must be es­tab­lished and des­ig­nated as spe­cified in An­nex 10.

³The su­per­vis­ory au­thor­ity may in ex­cep­tion­al cases ap­prove oth­er zone and area types if ra­di­olo­gic­al pro­tec­tion is equally well or bet­ter as­sured.

⁴The FDHA, in con­sulta­tion with EN­SI, shall is­sue reg­u­la­tions con­cern­ing pro­tec­tion meas­ures for the vari­ous zone and area types.

¹ For con­trolled areas in which the hand­ling of ra­dio­act­ive ma­ter­i­al is dis­con­tin­ued, and if ne­ces­sary also for the sur­round­ing areas, in­clud­ing all in­stall­a­tions and the re­main­ing ma­ter­i­al, the li­cence hold­er must en­sure that the clear­ance meas­ure­ment cri­ter­ia spe­cified in Art­icle 106 are met and the im­mis­sion lim­its spe­cified in Art­icle 24 are not ex­ceeded.

² The li­cence hold­er must demon­strate to the su­per­vis­ory au­thor­ity that the duty spe­cified in para­graph 1 is ful­filled.

³ The li­cence hold­er may only use the con­trolled areas con­cerned for oth­er pur­poses after ap­prov­al has been gran­ted by the su­per­vis­ory au­thor­ity.

¹ Be­fore per­sons leave, or ma­ter­i­als are re­moved from, con­trolled areas, it must be en­sured that the guid­ance value spe­cified in An­nex 3 Column 12 for sur­face con­tam­in­a­tion is not ex­ceeded. For the clear­ance of ma­ter­i­als, the re­quire­ments spe­cified in Art­icle 106 ap­ply.

² If, in con­trolled areas, the con­tam­in­a­tion of ma­ter­i­als and sur­faces is great­er than 10 times the guid­ance value spe­cified in An­nex 3 Column 12, de­con­tam­in­a­tion meas­ures must be im­ple­men­ted or oth­er ap­pro­pri­ate pro­tec­tion meas­ures ad­op­ted.

³ If, in con­trolled areas, part of the con­tam­in­a­tion will re­main at­tached to the sur­face un­der fore­see­able con­di­tions of hand­ling, the guid­ance val­ues spe­cified in An­nex 3 Column 12 shall only ap­ply to the trans­fer­able con­tam­in­a­tion.

¹ Su­per­vised areas means areas which are sub­ject to spe­cif­ic re­quire­ments for the pur­pose of pro­tect­ing against ex­pos­ures to ion­ising ra­di­ation from the op­er­a­tion of in­stall­a­tions or the hand­ling of sealed ra­dio­act­ive sources.

² The fol­low­ing are to be es­tab­lished as su­per­vised areas:

a.

rooms and ad­ja­cent areas in which in­stall­a­tions are op­er­ated without a full or par­tial pro­tec­tion sys­tem;

b.

zones of type 0 as spe­cified in An­nex 10;

c.

areas in which per­sons may ac­cu­mu­late an ef­fect­ive dose of more than 1 mSv per cal­en­dar year from ex­tern­al ra­di­ation ex­pos­ure.

³ The li­cence hold­er must en­sure that, if el­ev­ated am­bi­ent dose rates oc­cur dur­ing the op­er­a­tion of in­stall­a­tions or the hand­ling of sealed ra­dio­act­ive sources, only au­thor­ised per­sons can be present in su­per­vised areas.

⁴ The li­cence hold­er must mon­it­or com­pli­ance with the guid­ance val­ues for am­bi­ent dose rates and com­pli­ance with pro­tec­tion meas­ures and safety pro­vi­sions with­in su­per­vised areas.

5 Su­per­vised areas must be marked as spe­cified in An­nex 8.

⁶ The es­tab­lish­ment of su­per­vised areas is not ne­ces­sary for oc­cu­pa­tion­ally ex­posed air­crew.

⁷In rooms in which only com­pact dent­al X-ray sys­tems are op­er­ated, the es­tab­lish­ment of su­per­vised areas is not ne­ces­sary.

1 When hand­ling sealed ra­dio­act­ive sources, li­cence hold­ers must main­tain an in­vent­ory.

² They must keep re­cords of the pur­chase, use, trans­fer and dis­pos­al of ra­dio­act­ive ma­ter­i­als.

³ They must re­port an­nu­ally to the su­per­vis­ory au­thor­ity on their trade in ra­di­ation sources, provid­ing the fol­low­ing in­form­a­tion:

a.

the name of the ra­di­o­nuc­lides, their activ­ity, the date of activ­ity de­term­in­a­tion, and their chem­ic­al and phys­ic­al form;

b.

the name of the equip­ment or art­icles con­tain­ing ra­dio­act­ive sources, with de­tails of the ra­di­o­nuc­lides, their activ­ity and the date of activ­ity de­term­in­a­tion;

c.

the name of the in­stall­a­tions and the as­so­ci­ated para­met­ers;

d.

the ad­dresses and li­cence num­bers of do­mest­ic cli­ents.

⁴ The li­cens­ing au­thor­ity may spe­cify ad­di­tion­al re­cord-keep­ing and re­port­ing du­ties in the li­cence.

Hold­ers of ra­di­ation sources sub­ject to man­dat­ory li­cens­ing may only sup­ply them to en­ter­prises or per­sons hold­ing the re­quis­ite li­cence.

The EDI, in con­sulta­tion with EN­SI, shall define the re­quire­ments for the hand­ling and the loc­a­tion of ra­di­ation sources. In par­tic­u­lar, it shall spe­cify:

a.

struc­tur­al meas­ures and the basis for cal­cu­la­tions in this re­gard;

b.

the re­quire­ments for ir­ra­di­ation, ad­min­is­tra­tion and re­lax­a­tion rooms, and for rooms for equip­ment used for nuc­le­ar medi­cine ex­am­in­a­tions;

c.

the ra­di­olo­gic­al pro­tec­tion meas­ures for the care and ac­com­mod­a­tion of pa­tients re­ceiv­ing ther­apy;

d.

the type of stor­age and the re­quire­ments for fa­cil­it­ies for the stor­age of ra­dio­act­ive ma­ter­i­als.

¹ Li­cence hold­ers must en­sure that the en­ter­prise has the ne­ces­sary num­ber of suit­able meas­ur­ing in­stru­ments for ion­ising ra­di­ation.

² In rooms or areas where ra­di­ation sources are handled or op­er­ated and a re­lated haz­ard ex­ists, suit­able meas­ur­ing in­stru­ments for ion­ising ra­di­ation must be avail­able at all times to mon­it­or dose rates and sur­face or air­borne con­tam­in­a­tion.

Meas­ur­ing in­stru­ments for ion­ising ra­di­ation are gov­erned by the Meas­ur­ing In­stru­ments Or­din­ance of 15 Feb­ru­ary 2006³³ and the im­ple­ment­ing pro­vi­sions is­sued by the Fed­er­al De­part­ment of Justice and Po­lice (FD­JP) in con­sulta­tion with the FDHA and the Fed­er­al De­part­ment of the En­vir­on­ment, Trans­port, En­ergy and Com­mu­nic­a­tions (DE­TEC).

The FDHA, in con­sulta­tion with EN­SI, shall spe­cify:

a.

the type and the num­ber of in­stru­ments re­quired for meas­ur­ing ion­ising ra­di­ation;

b.

the ex­tent of qual­ity as­sur­ance for the use of meas­ur­ing in­stru­ments for ion­ising ra­di­ation.

¹ Li­cence hold­ers must carry out func­tion­al test­ing of meas­ur­ing in­stru­ments for ion­ising ra­di­ation at ap­pro­pri­ate in­ter­vals, us­ing suit­able ra­di­ation sources.

² The su­per­vis­ory au­thor­ity may re­quire li­cence hold­ers to par­ti­cip­ate in in­ter­com­par­is­on ex­er­cises.

¹ With re­gard to design, sealed ra­dio­act­ive sources must re­flect the state of the art when they are placed on the mar­ket.

² For sealed ra­dio­act­ive sources, the ra­di­o­nuc­lides se­lec­ted must be chem­ic­ally as stable as pos­sible.

³ If sealed ra­dio­act­ive sources are used ex­clus­ively as gamma or neut­ron emit­ters, shield­ing must be provided which pre­vents the es­cape of al­pha or beta ra­di­ation.

¹ Sealed ra­dio­act­ive sources and their con­tain­ers must be marked in such a way as to per­mit iden­ti­fic­a­tion of the source at any time.

² The man­u­fac­turer or sup­pli­er of a high-activ­ity sealed source as defined in Art­icle 96 must en­sure that it can be iden­ti­fied by a unique num­ber. This num­ber must be en­graved or stamped on the source and on the source con­tain­er.

³ The ra­di­o­nuc­lide, activ­ity, date of man­u­fac­ture and meas­ure­ment, and if ap­pro­pri­ate the clas­si­fic­a­tion ac­cord­ing to ISO 2919³⁴, must be im­me­di­ately ap­par­ent or as­cer­tain­able from the mark­ing.

⁴ The su­per­vis­ory au­thor­ity may grant ex­emp­tions from para­graphs 1–3 if mark­ing is not prac­tic­able or if re­usable source con­tain­ers are used.

¹ Be­fore be­ing placed on the mar­ket, every sealed ra­dio­act­ive source must be tested for leak tight­ness and ab­sence of con­tam­in­a­tion. Test­ing must be car­ried out by a body ac­cred­ited for this activ­ity or re­cog­nised by the su­per­vis­ory au­thor­ity.

² The cap­sule of sealed ra­dio­act­ive sources whose activ­ity is great­er than 100 times the li­cens­ing lim­it must com­ply with the re­quire­ments of ISO 2919³⁵ for the in­ten­ded ap­plic­a­tion and be clas­si­fied ac­cord­ingly.

³ In jus­ti­fied cases, the su­per­vis­ory au­thor­ity may grant ex­emp­tions from para­graphs 1 and 2 or re­quire ad­di­tion­al qual­ity tests.

High-activ­ity sealed source means a sealed ra­dio­act­ive source whose activ­ity is great­er than the activ­ity value spe­cified in An­nex 9.

¹ The li­cens­ing au­thor­ity shall main­tain an in­vent­ory of li­cence hold­ers and of the high‑activ­ity sealed sources in their pos­ses­sion.

² The in­vent­ory shall in­clude:

a.

the iden­ti­fic­a­tion num­ber;

b.

the sup­pli­er;

c.

the type and loc­a­tion of the source;

d.

the ra­di­o­nuc­lide in each case;

e.

the activ­ity of the source at the time of pro­duc­tion, first pla­cing on the mar­ket or pur­chase of the source by the li­cence hold­er.

³ The li­cens­ing au­thor­ity shall con­tinu­ously up­date the in­vent­ory.

¹ Be­fore a li­cence is gran­ted for hand­ling high-activ­ity sealed sources, the ap­plic­ant must provide evid­ence that ap­pro­pri­ate pro­vi­sion has been made for sub­sequent dis­pos­al.

² The li­cence hold­er shall veri­fy at least once a year that each high-activ­ity sealed source and, where rel­ev­ant, its pro­tect­ive con­tain­er is in good con­di­tion and is still present at its place of use or stor­age. The li­cence hold­er shall re­port the res­ults of the in­spec­tion to the li­cens­ing au­thor­ity.

¹ For each high-activ­ity sealed source, the li­cence hold­er shall define ad­equate meas­ures and pro­ced­ures aimed at pre­vent­ing un­au­thor­ised ac­cess to or loss or theft of the source or its dam­age by fire, and shall doc­u­ment the meas­ures and pro­ced­ures.

² The FDHA, in con­sulta­tion with EN­SI, shall define the prin­ciples for the struc­tur­al, tech­nic­al, or­gan­isa­tion­al and ad­min­is­trat­ive re­quire­ments for safety and se­cur­ity meas­ures.

¹ The li­cence hold­er must en­sure that ra­di­ation sources:

a.

are sub­jec­ted to test­ing pri­or to their first use;

b.

are reg­u­larly in­spec­ted and main­tained.

²Para­graph 1 also ap­plies to as­so­ci­ated med­ic­al im­age re­cept­or sys­tems, im­age dis­play and im­age doc­u­ment­a­tion equip­ment, nuc­le­ar medi­cine ex­am­in­a­tion sys­tems and act­i­vi­met­ers.

³ The FDHA may, in con­sulta­tion with EN­SI, define the min­im­um scope and the peri­od­icity of test­ing, the min­im­um scope of the qual­ity as­sur­ance pro­gramme and the re­quire­ments for the im­ple­ment­ing bod­ies. It shall take in­to ac­count na­tion­al and in­ter­na­tion­al qual­ity as­sur­ance stand­ards.

¹ Any per­son who trans­ports ra­dio­act­ive ma­ter­i­al, or has it trans­por­ted, off-site must:

a.

com­ply with fed­er­al reg­u­la­tions con­cern­ing the car­riage of dan­ger­ous goods;

b.

provide evid­ence that they have and im­ple­ment an ap­pro­pri­ate qual­ity as­sur­ance pro­gramme.

² The con­signors and trans­port­ers of ra­dio­act­ive ma­ter­i­al must:

a.

each, in ad­vance, des­ig­nate a per­son re­spons­ible for qual­ity as­sur­ance and define qual­ity as­sur­ance meas­ures in writ­ing;

b.

make sure that the trans­port con­tain­ers or pack­aging ma­ter­i­als com­ply with the rel­ev­ant reg­u­la­tions and are prop­erly main­tained.

³ If the con­signors and trans­port­ers have in place a qual­ity as­sur­ance sys­tem for the trans­port of ra­dio­act­ive ma­ter­i­al, cer­ti­fied by an ac­cred­ited body, it shall be as­sumed that they im­ple­ment an ap­pro­pri­ate qual­ity as­sur­ance pro­gramme.

⁴ The con­signors must veri­fy that the con­trac­ted trans­port­er, if ne­ces­sary, has a li­cence for the trans­port of ra­dio­act­ive ma­ter­i­al.

The FDHA, in con­sulta­tion with EN­SI, shall spe­cify the re­quire­ments for on-site trans­port of ra­dio­act­ive ma­ter­i­al.

¹ Ra­dio­act­ive ma­ter­i­al may only be im­por­ted, ex­por­ted or un­der­go trans­it via the cus­toms of­fices des­ig­nated by the Dir­ect­or­ate Gen­er­al of Cus­toms.

² The cus­toms de­clar­a­tion for im­port, ex­port, or trans­it must in­clude the fol­low­ing de­tails:

a.

the pre­cise des­ig­na­tion of the goods;

b.

the ra­di­o­nuc­lides (in the case of nuc­lide mix­tures the three nuc­lides with the low­est li­cens­ing lim­its must be in­dic­ated);

c.

the total activ­ity per ra­di­o­nuc­lide in Bq³⁶;

d.

the li­cence num­ber of the re­cip­i­ent (for im­ports) or the sender (for ex­ports) in Switzer­land.

³ For each in­di­vidu­al stor­age of ra­dio­act­ive ma­ter­i­al in a cus­toms bon­ded ware­house or in a duty-free ware­house, the de­pos­it­or must present to the cus­toms of­fice a li­cence as spe­cified in Art­icle 28 of the RPA.

⁴ The li­cens­ing au­thor­ity may re­quest that a sep­ar­ate li­cence ap­plic­a­tion be sub­mit­ted for each im­port, ex­port and trans­it of high-activ­ity sealed sources.

¹ If there is an in­creased like­li­hood of orphan ra­dio­act­ive ma­ter­i­als be­ing en­countered in re­cyc­lable ma­ter­i­als or wastes, the en­ter­prises con­cerned are re­quired, when man­aging or pre­par­ing these ma­ter­i­als or wastes for ex­port, to in­spect them for the pres­ence of orphan ra­dio­act­ive ma­ter­i­als us­ing ap­pro­pri­ate screen­ing pro­ced­ures and, if such ma­ter­i­als are de­tec­ted, to se­cure the re­cyc­lable ma­ter­i­als or wastes at an ap­pro­pri­ate loc­a­tion. This ap­plies in par­tic­u­lar to:

a.

en­ter­prises where mu­ni­cip­al wastes or wastes of sim­il­ar com­pos­i­tion are in­cin­er­ated;

b.

en­ter­prises which re­cycle scrap metals;

c.

en­ter­prises which pre­pare scrap metals for ex­port.

² The du­ties of the en­ter­prises con­cerned shall be spe­cified in the li­cence.

Hand­ling of the fol­low­ing shall be cleared from man­dat­ory li­cens­ing and su­per­vi­sion:

a.

ma­ter­i­al dis­charged to the en­vir­on­ment in ac­cord­ance with Art­icles 111–116;

b.

ma­ter­i­al cleared or dis­charged to the en­vir­on­ment in ac­cord­ance with the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 22 June 1994³⁷;

c.

ma­ter­i­al from an activ­ity sub­ject to man­dat­ory li­cens­ing cleared in ac­cord­ance with Art­icle 106;

e.

NORM dis­charged to the en­vir­on­ment in ac­cord­ance with Art­icle 169.

1 Li­cence hold­ers may clear the hand­ling of ma­ter­i­al from man­dat­ory li­cens­ing and su­per­vi­sion if they demon­strate by a meas­ure­ment (clear­ance meas­ure­ment) that:

a.

the max­im­um am­bi­ent dose rate at a dis­tance of 10 cm from the sur­face, al­low­ing for nat­ur­al ra­di­ation, is less than 0.1 µSv per hour; and

b.

one of the fol­low­ing re­quire­ments is met:

1.

the spe­cif­ic activ­ity is be­low the clear­ance lim­it,

2.

the ab­so­lute activ­ity is less than the activ­ity of 1 kg of a ma­ter­i­al whose spe­cif­ic activ­ity is equal to the clear­ance lim­it.

2 If per­sons may be con­tam­in­ated when hand­ling ma­ter­i­al cleared in ac­cord­ance with para­graph 1, it must ad­di­tion­ally be en­sured by a meas­ure­ment that the sur­face con­tam­in­a­tion guid­ance value spe­cified in An­nex 3 Column 12 is com­plied with.

3 For the av­er­aging of the val­ues meas­ured in ac­cord­ance with para­graphs 1 and 2 to en­sure non-ex­ceedance of the clear­ance lim­it or the sur­face con­tam­in­a­tion guid­ance val­ues spe­cified in An­nex 3 Column 12, the fol­low­ing quant­it­ies must be com­plied with:

for the meas­ure­ment of activ­ity: 100 kg;

for the meas­ure­ment of sur­face con­tam­in­a­tion: 100 cm2.

4 In jus­ti­fied cases, the su­per­vis­ory au­thor­ity may ap­prove val­ues high­er than those spe­cified in para­graph 3.

5 Hand­ling of sol­id or li­quid ma­ter­i­al may be cleared without meas­ure­ment of activ­ity by tech­nic­al means if:

a.

the max­im­um am­bi­ent dose rate at a dis­tance of 10 cm from the sur­face, al­low­ing for nat­ur­al ra­di­ation, is less than 0.1 µSv per hour;

b.

para­graph 2 is com­plied with; and

c.

one of the fol­low­ing re­quire­ments is met:

1.

it can be demon­strated that the clear­ance lim­it is not ex­ceeded by an as­sess­ment of the ma­ter­i­als used or by ex­clud­ing ac­tiv­a­tion,

2.

the su­per­vis­ory au­thor­ity has ap­proved the mod­els and cal­cu­la­tions used to demon­strate that the clear­ance lim­it is not ex­ceeded.

6 The su­per­vis­ory au­thor­ity may define the con­di­tions un­der which the res­ults of a clear­ance meas­ure­ment must be re­por­ted to it pri­or to the clear­ance of the ma­ter­i­als.

It is not per­miss­ible to mix ra­dio­act­ive ma­ter­i­als with oth­er ma­ter­i­als so that the hand­ling of the mix­ture is not sub­ject to man­dat­ory li­cens­ing and su­per­vi­sion. This is without pre­ju­dice to Art­icles 111–116 and 169.

Ra­dio­act­ive waste means ra­dio­act­ive ma­ter­i­al for which no re­use is fore­seen and which does not con­tain only NORM.

1 A spe­cific­ally planned use of ra­dio­act­ive ma­ter­i­al as part of a li­censed activ­ity, ini­ti­ated with­in three years from the last use, is con­sidered to be re­use. The su­per­vis­ory au­thor­ity may ap­prove an ex­ten­sion of this time lim­it.

² The su­per­vis­ory au­thor­ity may re­quest that ra­dio­act­ive ma­ter­i­al be sub­jec­ted to re­use.

Li­cence hold­ers must:

a.

mon­it­or their ra­dio­act­ive waste hold­ings

b.

doc­u­ment the activ­ity levels rel­ev­ant for sub­sequent treat­ment and the com­pos­i­tion;

c.

keep re­cords of ra­dio­act­ive waste dis­charged to the en­vir­on­ment.

¹ Dis­charge to the en­vir­on­ment com­prises, in par­tic­u­lar, land­filling, dis­pos­al with do­mest­ic waste, dis­charge in ex­haust air and wastewa­ter, in­cin­er­a­tion, re­use or de­liv­ery to a re­cyc­ling fa­cil­ity.

²Only low-level ra­dio­act­ive waste may be dis­charged to the en­vir­on­ment.

³Ra­dio­act­ive waste may only be dis­charged to the en­vir­on­ment with a li­cence and un­der the su­per­vi­sion of the li­cence hold­er.

4 It may only be dis­charged to the en­vir­on­ment by the li­cence hold­er without the ap­prov­al of the li­cens­ing au­thor­ity and without spe­cif­ic li­cens­ing in ac­cord­ance with Art­icle 112 para­graph 2 if:

a.

the max­im­um am­bi­ent dose rate at a dis­tance of 10 cm from the sur­face, al­low­ing for nat­ur­al ra­di­ation, is less than 0.1 µSv per hour;

b.

the re­quire­ment spe­cified in Art­icle 106 para­graph 2 is met; and

c.

the total activ­ity per week and li­cence is not great­er than the activ­ity of 10 kg of a ma­ter­i­al whose spe­cif­ic activ­ity is equal to the clear­ance lim­it.

5 Pri­or to the dis­charge of ra­dio­act­ive waste, la­bels, haz­ard warn­ing sym­bols or oth­er mark­ings in­dic­at­ing ra­dio­activ­ity must be re­moved.

¹ Air­borne or li­quid ra­dio­act­ive sub­stances may be dis­charged in ex­haust air to the at­mo­sphere or in wastewa­ter to sur­face wa­ters.

² The li­cens­ing au­thor­ity shall spe­cify max­im­um per­miss­ible dis­charge rates and, where ap­pro­pri­ate, dis­charge activ­ity con­cen­tra­tions for each dis­charge site on a case-by-case basis.

³ It shall spe­cify the dis­charge rates and dis­charge activ­ity con­cen­tra­tions in such a way that the source-re­lated dose con­straint in ac­cord­ance with Art­icle 13 para­graph 3 and the im­mis­sion lim­its in ac­cord­ance with Art­icle 24 are not ex­ceeded.

⁴ It may in­crease by up to a factor of three the dis­charge activ­ity con­cen­tra­tions in ac­cord­ance with para­graphs 2 and 3 for dis­charges in­to sew­ers if it can be as­sured that ap­pro­pri­ate di­lu­tion is guar­an­teed at all times pri­or to dis­charge in­to pub­licly ac­cess­ible wa­ters.

¹ The li­cens­ing au­thor­ity shall spe­cify the mon­it­or­ing of emis­sions in the li­cence in ac­cord­ance with Art­icle 112 para­graphs 2–4. It may, in the li­cence, provide for man­dat­ory re­port­ing.

² Im­mis­sion mon­it­or­ing is gov­erned by Art­icle 191.

³ The su­per­vis­ory au­thor­ity may re­quire the li­cence hold­er to con­duct ad­di­tion­al or spe­cial meas­ure­ments as part of im­mis­sion mon­it­or­ing and to re­port the res­ults.

⁴ The su­per­vis­ory au­thor­ity may re­quest that a met­eor­o­lo­gic­al as­sess­ment and loc­al back­ground ra­di­ation meas­ure­ments be car­ried out be­fore op­er­a­tions are com­menced.

⁵ The li­cence hold­er may, with the ap­prov­al of the su­per­vis­ory au­thor­ity, en­gage ex­tern­al bod­ies to carry out mon­it­or­ing meas­ure­ments.

¹ Ra­dio­act­ive waste may, in in­di­vidu­al cases, with the ap­prov­al of the li­cens­ing au­thor­ity, be dis­posed of to land­fill if:

a.

over­all, tak­ing in­to ac­count oth­er ma­ter­i­als present in the land­fill, the clear­ance lim­it is not ex­ceeded; or

b.

at no time can an ef­fect­ive dose of 10 µSv per cal­en­dar year be ac­cu­mu­lated as a res­ult of the dis­pos­al.

² The FOPH shall mon­it­or com­pli­ance with the per­miss­ible ef­fect­ive dose via the sampling and meas­ure­ment pro­gramme spe­cified in Art­icle 193.

³ The spe­cif­ic activ­ity of ra­dio­act­ive waste thus dis­posed of must not ex­ceed 100 times the clear­ance lim­it and, for waste con­tain­ing ar­ti­fi­cial ra­di­um, 1000 times the clear­ance lim­it.

⁴ For the dis­pos­al of ra­dio­act­ive waste con­tain­ing tech­nic­ally en­hanced ra­di­um, the fol­low­ing con­di­tions must ad­di­tion­ally be met:

a.

The waste arose be­fore 1 Oc­to­ber 1994.

b.

Dis­pos­al via the usu­al chan­nels would be im­possible or would in­volve dis­pro­por­tion­ate ef­forts.

c.

Re­mov­al rep­res­ents a sig­ni­fic­antly bet­ter op­tion for people and the en­vir­on­ment over­all than main­ten­ance of the status quo.

The li­cens­ing au­thor­ity may spe­cify con­di­tions for re­cyc­ling ra­dio­act­ive waste, in par­tic­u­lar metals, with a spe­cif­ic activ­ity no great­er than 10 times the clear­ance lim­it if it can be as­sured that the ma­ter­i­als arising after the planned re­cyc­ling do not ex­ceed the clear­ance lim­it.

1 Com­bust­ible ra­dio­act­ive waste may, with the ap­prov­al of the li­cens­ing au­thor­ity, be in­cin­er­ated at thermal waste treat­ment plants in ac­cord­ance with the Waste Or­din­ance of 4 Decem­ber 2015³⁸ if:

a.

com­pli­ance with the clear­ance lim­it can be demon­strated by mon­it­or­ing of activ­ity con­cen­tra­tions or cal­cu­la­tion of the pos­sible con­tam­in­a­tion of in­cin­er­a­tion residues;

b.

the ra­dio­act­ive waste only con­tains the ra­di­o­nuc­lides H-3 or C-14; and

c.

the activ­ity ap­proved for in­cin­er­a­tion per week does not ex­ceed 1000 times the li­cens­ing lim­it.

2 In jus­ti­fied cases, the li­cens­ing au­thor­ity may ap­prove the in­cin­er­a­tion of com­bust­ible ra­dio­act­ive waste con­tain­ing ra­di­o­nuc­lides oth­er than those spe­cified in para­graph 1 let­ter b.

¹ Ra­dio­act­ive waste ex­clus­ively con­tain­ing ra­di­o­nuc­lides with a half-life of 100 days or less must, whenev­er pos­sible, be re­tained at the sites where it arises un­til its activ­ity has de­cayed to such an ex­tent that it can be meas­ured for clear­ance in ac­cord­ance with Art­icle 106 or dis­charged with­in the li­censed dis­charge rate in ac­cord­ance with Art­icle 112 para­graph 2.

² In the ab­sence of an al­tern­at­ive that is more fa­vour­able over­all for people and the en­vir­on­ment, ra­dio­act­ive waste whose activ­ity, as a res­ult of ra­dio­act­ive de­cay, will have de­creased no later than 30 years after the end of use of the ori­gin­al ma­ter­i­al to such an ex­tent that it can be meas­ured for clear­ance in ac­cord­ance with Art­icle 106 or re­cycled in ac­cord­ance with Art­icle 115 must be stored un­til this point has been reached. It must be sep­ar­ated from ra­dio­act­ive waste which does not ful­fil this con­di­tion.

³ Dur­ing the de­cay peri­od, waste as spe­cified in para­graphs 1 and 2 must be:

a.

pack­aged and stored in such a way as to pre­vent the un­con­trolled re­lease of ra­dio­act­ive sub­stances and avoid cre­at­ing a fire haz­ard;

b.

marked and provided with doc­u­ment­a­tion in­dic­at­ing the type of waste, activ­ity con­tent and time of pos­sible clear­ance.

⁴ Pri­or to clear­ance, it must be en­sured that Art­icle 106, or Art­icle 112 or 115, is com­plied with.

⁵ The li­cens­ing au­thor­ity shall spe­cify the tech­nic­al re­quire­ments for de­cay stor­age and any re­lated activ­it­ies.³⁹

¹ Ra­dio­act­ive waste in the form of gases, dust or aer­o­sols which may not be dis­charged to the en­vir­on­ment must be re­tained by suit­able tech­nic­al devices.

² Li­quid ra­dio­act­ive waste which may not be dis­charged to the en­vir­on­ment must be con­ver­ted to a chem­ic­ally stable sol­id form.

³ The su­per­vis­ory au­thor­ity may grant ex­emp­tions from para­graphs 1 and 2 or per­mit ad­di­tion­al treat­ment op­tions if an al­tern­at­ive more fa­vour­able for people and the en­vir­on­ment can thereby be real­ised.

¹ Ra­dio­act­ive waste not arising as a res­ult of the use of nuc­le­ar en­ergy must, fol­low­ing any treat­ment which may be re­quired in ac­cord­ance with Art­icle 118, be de­livered to the fed­er­al col­lec­tion centre.

² The fol­low­ing are ex­emp­ted from de­liv­ery to the fed­er­al col­lec­tion centre:

a.

ra­dio­act­ive waste which may be dis­charged to the en­vir­on­ment;

b.

ra­dio­act­ive waste with a short half-life as spe­cified in Art­icle 117.

³ The FDHA shall define the tech­nic­al de­tails for the treat­ment of ra­dio­act­ive waste sub­ject to man­dat­ory de­liv­ery pri­or to its re­ceipt by the fed­er­al col­lec­tion centre.

1 The fed­er­al col­lec­tion centre shall be op­er­ated by the Paul Scher­rer In­sti­tute (PSI).

2 The PSI shall take re­ceipt of ra­dio­act­ive waste sub­ject to man­dat­ory de­liv­ery and be re­spons­ible for stack­ing, treat­ment and in­ter­im stor­age.

A co­ordin­a­tion group com­pris­ing rep­res­ent­at­ives from the FOPH, EN­SI and the PSI shall make re­com­mend­a­tions to the su­per­vis­ory and li­cens­ing au­thor­it­ies on en­sur­ing the safe re­ceipt of ra­dio­act­ive waste sub­ject to man­dat­ory de­liv­ery.

Fail­ure means an event which in­volves the de­vi­ation of an in­stall­a­tion, art­icle or activ­ity from nor­mal op­er­a­tion, and which:

a.

com­prom­ises the safety of the in­stall­a­tion or art­icle;

b.

may lead to the ex­ceedance of an im­mis­sion or emis­sion lim­it; or

c.

has or could have led to the ex­ceedance of a dose lim­it.

¹ The li­cence hold­er must ad­opt ap­pro­pri­ate meas­ures to pre­vent fail­ures.

² The en­ter­prise must be de­signed in such a way that the fol­low­ing re­quire­ments are met:

a.

For fail­ures with an ex­pec­ted fre­quency of more than 10-1 per year, it must be pos­sible for the source-re­lated dose con­straints spe­cified in the li­cence to be com­plied with.

b.

For fail­ures with an ex­pec­ted fre­quency of between 10^–1 and 10^–2 per year, a single such event must not lead to an ad­di­tion­al dose which ex­ceeds the rel­ev­ant source-re­lated dose con­straints.

c.

For fail­ures with an ex­pec­ted fre­quency of between 10-² and 10-⁴ per year, the dose res­ult­ing from a single such event for mem­bers of the pub­lic must not be great­er than 1 mSv.

d.

For fail­ures with an ex­pec­ted fre­quency of between 10-⁴ and 10-⁶ per year, the dose res­ult­ing from a single such event for mem­bers of the pub­lic must not be great­er than 100 mSv; the li­cens­ing au­thor­ity may spe­cify a lower dose in in­di­vidu­al cases.

³ The en­ter­prise must be de­signed in such a way that only a small num­ber of fail­ures as spe­cified in para­graph 2 let­ters c or d can oc­cur.

⁴ For fail­ures as spe­cified in para­graph 2 let­ters c and d and for fail­ures which have an ex­pec­ted fre­quency of less than 10-⁶ per year, but which could have ma­jor im­pacts, the su­per­vis­ory au­thor­ity shall re­quire the en­ter­prise to ad­opt the ne­ces­sary pre­pared­ness meas­ures.

⁵ The su­per­vis­ory au­thor­ity shall spe­cify on a case-by-case basis the meth­od­o­logy and bound­ary con­di­tions for the ana­lys­is of fail­ures and for their as­sign­ment to the fre­quency classes spe­cified in para­graph 2 let­ters b–d. The ef­fect­ive dose or the equi­val­ent doses arising from fail­ure-re­lated ex­pos­ure of per­sons must be de­term­ined in ac­cord­ance with the cur­rent state of sci­ence and tech­no­logy, us­ing the as­sess­ment quant­it­ies and dose coef­fi­cients spe­cified in An­nexes 3, 5 and 6.

⁶ For en­ter­prises where fail­ures as spe­cified in para­graph 2 let­ter d may oc­cur, the su­per­vis­ory au­thor­ity may or­der:

a.

the meas­ure­ment of in­stall­a­tion para­met­ers which are re­quired to mon­it­or the course of an ac­ci­dent, to pro­duce dia­gnoses and fore­casts, and to de­term­ine the meas­ures ne­ces­sary to pro­tect the pub­lic;

b.

the con­tinu­ous trans­mis­sion of the in­stall­a­tion para­met­ers to the su­per­vis­ory au­thor­it­ies via a net­work tol­er­ant of an fail­ure.

¹ The su­per­vis­ory au­thor­ity may re­quire the li­cence hold­er to sub­mit a safety re­port.

² The safety re­port shall in­clude de­scrip­tions of:

a.

the safety sys­tems and equip­ment;

b.

the meas­ures ad­op­ted to en­sure safety;

c.

the en­ter­prise or­gan­isa­tion re­spons­ible for safety and ra­di­olo­gic­al pro­tec­tion;

d.

fail­ures, their ef­fects on the en­ter­prise and the sur­round­ing area, and their ap­prox­im­ate fre­quency;

e.

emer­gency re­sponse plan­ning for pro­tec­tion of the pub­lic, in the case of en­ter­prises as spe­cified in Art­icle 136.

³ The su­per­vis­ory au­thor­ity may re­quest ad­di­tion­al doc­u­ment­a­tion.

¹ Li­cence hold­ers must make the ne­ces­sary in­tern­al pre­par­a­tions so that fail­ures and their ef­fects can be man­aged.

² They must is­sue dir­ect­ives con­cern­ing the emer­gency meas­ures to be ad­op­ted.

³ They must en­sure that ap­pro­pri­ate re­sources are avail­able at all times for the man­age­ment of fail­ures and their ef­fects; in rooms where ra­dio­act­ive ma­ter­i­als are handled, this also ap­plies to fire­fight­ing.

⁴ They must en­sure that staff re­ceive reg­u­lar in­struc­tion on rules of be­ha­viour, are trained in emer­gency meas­ures and are fa­mil­i­ar­ised with the loc­a­tion and use of the rel­ev­ant re­sources.

⁵ They must take ap­pro­pri­ate meas­ures to en­sure that, in a par­tic­u­lar case, the per­sons de­ployed to man­age fail­ures and their ef­fects do not re­ceive an ef­fect­ive dose of more than 50 mSv or, to save hu­man lives, more than 250 mSv.

⁶ They must in­form the com­pet­ent can­ton­al au­thor­it­ies and emer­gency ser­vices of the ra­dio­act­ive ma­ter­i­als present in the en­ter­prise.

⁷ The su­per­vis­ory au­thor­ity may re­quire that ex­er­cises be con­duc­ted to test re­port­ing chan­nels, the func­tion­al­ity of re­sources and the ne­ces­sary skills of staff. It may or­gan­ise ex­er­cises it­self.

¹ Li­cence hold­ers must make every ef­fort to man­age fail­ures and their ef­fects.

² In par­tic­u­lar, they must, without delay:

a.

con­trol the ex­tent of the fail­ure, in par­tic­u­lar by tak­ing meas­ures at source;

b.

en­sure that all per­sons not in­volved in the man­age­ment of the fail­ure do not enter the danger zone or leave it im­me­di­ately;

c.

take meas­ures to pro­tect the staff de­ployed, such as dose mon­it­or­ing and ap­pro­pri­ate in­struc­tion;

d.

en­sure that all those in­volved are re­gistered, mon­itored for con­tam­in­a­tion and in­takes, and if ne­ces­sary de­con­tam­in­ated.

³ They must, as soon as pos­sible:

a.

re­move any con­tam­in­a­tion which has aris­en;

b.

take the meas­ures re­quired to cla­ri­fy the cause of the fail­ure.

Li­cence hold­ers must re­port fail­ures in a timely man­ner, as fol­lows:

a.

every fail­ure: to the su­per­vis­ory au­thor­ity;

b.

fail­ures as spe­cified in Art­icle 122 let­ter b: in ad­di­tion, to the Na­tion­al Emer­gency Op­er­a­tions Centre (NEOC);

c.

fail­ures with­in the area su­per­vised by Suva: in ad­di­tion, to the FOPH;

d.

fail­ures lead­ing to an ex­ceedance of the dose lim­it for oc­cu­pa­tion­ally ex­posed per­sons in the en­ter­prise: to Suva.

1 The su­per­vis­ory au­thor­ity shall as­sess the fail­ure. With­in the area su­per­vised by Suva, the FOPH must be in­formed of the as­sess­ment.

2 The su­per­vis­ory au­thor­ity shall for­ward to the au­thor­it­ies con­cerned any in­form­a­tion on fail­ures which is re­quired for the ful­fil­ment of a re­spons­ib­il­ity.

3 EN­SI shall re­port to the IAEA the rat­ing of a fail­ure on the In­ter­na­tion­al Nuc­le­ar and Ra­di­olo­gic­al Event Scale (INES)⁴⁰ from Level 2 up­wards.

¹ After an fail­ure, li­cence hold­ers must carry out an in­vest­ig­a­tion without delay.

² The res­ults of the in­vest­ig­a­tion must be re­cor­ded in a re­port. The re­port must con­tain:

a.

a de­scrip­tion of the fail­ure, the cause, the ef­fects de­term­ined and oth­er pos­sible ef­fects, and the meas­ures taken;

b.

an ac­count of meas­ures which are planned or have already been taken to pre­vent fur­ther sim­il­ar fail­ures.

³ The li­cence hold­er shall sub­mit the re­port to the su­per­vis­ory au­thor­ity no later than six weeks after the fail­ure.

If the FOPH de­term­ines that an im­mis­sion lim­it has been ex­ceeded, it shall as­cer­tain the cause and take the ne­ces­sary meas­ures.

The su­per­vis­ory au­thor­ity shall en­sure that the per­sons and the can­tons con­cerned and the pub­lic are in­formed about fail­ures in a timely man­ner.

Emer­gency means an fail­ure as defined in Art­icle 122, or an­oth­er event in­volving in­creased ra­dio­activ­ity, which ne­ces­sit­ates im­me­di­ate ac­tion to mit­ig­ate or avert ser­i­ous ad­verse con­sequences for hu­man health and safety, liv­ing con­di­tions and the en­vir­on­ment.

¹ In emer­gency ex­pos­ure situ­ations, a ref­er­ence level of 100 mSv in the first year ap­plies for mem­bers of the pub­lic.

² The Fed­er­al Civil Pro­tec­tion Crisis Man­age­ment Board (CCMB), which is re­spons­ible for deal­ing with in­cid­ents of na­tion­al im­port­ance rel­ev­ant to the pro­tec­tion of the pop­u­la­tion in ac­cord­ance with the Or­din­ance of 2 March 2018⁴¹ on the Fed­er­al Civil Pro­tec­tion Crisis Man­age­ment Board (CCMBO), may re­quest the Fed­er­al Coun­cil to set a lower ref­er­ence level, de­pend­ing on the spe­cif­ic situ­ation.⁴²

¹In emer­gency ex­pos­ure situ­ations, a de­ploy­ment-re­lated ref­er­ence level of 50 mSv per year ap­plies for per­sons with spe­cial re­spons­ib­il­it­ies.

² The CCMB⁴³ may re­quest the Fed­er­al Coun­cil to set lower ref­er­ence levels, de­pend­ing on the spe­cif­ic situ­ation, for par­tic­u­lar activ­it­ies per­formed by per­sons with spe­cial re­spons­ib­il­it­ies.

³ For sav­ing hu­man lives, pre­vent­ing ser­i­ous dam­age to health or avert­ing dis­asters, a ref­er­ence level of 250 mSv per year ap­plies.

¹ The Fed­er­al Of­fice for Civil Pro­tec­tion (FO­CP), to­geth­er with the com­pet­ent au­thor­it­ies and the can­tons, is re­spons­ible for pre­par­ing the na­tion­al emer­gency re­sponse plan.

² The FOPH, in co­oper­a­tion with the FO­CP, shall pre­pare the ra­di­olo­gic­al pro­tec­tion strategy for the na­tion­al emer­gency re­sponse plan. This must be based on ref­er­ence levels. For nuc­le­ar power plant scen­ari­os, EN­SI shall provide the ne­ces­sary found­a­tions.

³The FO­CP, to­geth­er with the FOPH, is re­spons­ible for pre­par­ing the sampling and meas­ur­ing or­gan­isa­tion spe­cified in Art­icle 4a of the Or­din­ance of 17 Oc­to­ber 2007⁴⁴ on the Na­tion­al Emer­gency Op­er­a­tions Centre (ONEOC).

⁴The FOPH is re­spons­ible for pre­par­ing the meas­ures re­quired for the pro­tec­tion of pub­lic health. This is without pre­ju­dice to pre­par­a­tions for pro­tect­ive meas­ures dur­ing the acute phase as spe­cified in the CCMBO⁴⁵.

⁵ The FOPH is re­spons­ible for the main­ten­ance of know­ledge on the treat­ment of severely ir­ra­di­ated per­sons.

⁶ The FOPH and EN­SI, to­geth­er with the NEOC, shall de­vel­op meth­ods and mod­els for de­term­in­ing ra­di­ation doses.

¹ For en­ter­prises where, giv­en the li­censed quant­ity and activ­ity of ra­di­o­nuc­lides, an emer­gency may oc­cur, the li­cens­ing au­thor­ity shall spe­cify on a case-by-case basis to what ex­tent they are re­quired to par­ti­cip­ate in pre­par­ing and im­ple­ment­ing emer­gency re­sponse meas­ures in the sur­round­ing area, or to ad­opt such meas­ures them­selves.

² The li­cens­ing au­thor­ity shall in­volve the com­pet­ent can­ton­al au­thor­it­ies and emer­gency ser­vices in pre­par­ing emer­gency re­sponse meas­ures and in­form them of the meas­ures ad­op­ted.

³For warn­ings and alerts and for pre­par­ing and im­ple­ment­ing meas­ures to pro­tect against in­creased ra­dio­activ­ity in the vi­cin­ity of nuc­le­ar in­stall­a­tions, the Emer­gency Re­sponse Or­din­ance of 20 Oc­to­ber 2010⁴⁶ and the Alerts and Safety Ra­dio Net­work Or­din­ance of 18 Au­gust 2010⁴⁷ ap­ply.

The FOPH shall re­port an emer­gency to the World Health Or­gan­iz­a­tion (WHO) in ac­cord­ance with the In­ter­na­tion­al Health Reg­u­la­tions (2005) ad­op­ted on 23 May 2005⁴⁸.

The su­per­vis­ory au­thor­ity shall en­sure that in­form­a­tion on emer­gen­cies is provided in a timely man­ner to the per­sons con­cerned at the en­ter­prise, the pub­lic and the can­tons con­cerned.

1 The FOPH is re­spons­ible for the cal­cu­la­tion, as­sess­ment and veri­fic­a­tion of ra­di­ation doses to the pub­lic. In the acute phase of a crisis, the NEOC shall as­sume this re­spons­ib­il­ity in ac­cord­ance with the Civil Pro­tec­tion Or­din­ance of 11 Novem­ber 2020⁴⁹.⁵⁰

² For sim­pli­fied dose cal­cu­la­tions, the dose coef­fi­cients spe­cified in An­nexes 5 and 6 ap­ply.

¹In emer­gency ex­pos­ure situ­ations, the CCMB is re­spons­ible for man­age­ment in ac­cord­ance with the CCMBO⁵¹. It shall take in­to ac­count the im­ple­ment­a­tion of emer­gency pre­pared­ness as spe­cified in Art­icle 135.

²In a crisis, the NEOC shall de­ploy the sampling and meas­ur­ing or­gan­isa­tion spe­cified in Art­icle 4a para­graph 4 of the ONEOC⁵².

³ The FOPH shall sup­port the NEOC in pre­par­ing mon­it­or­ing pro­grammes.

⁴The FOPH shall ad­vise the CCMB on or­der­ing meas­ures to pro­tect pub­lic health.

The CCMB, on the basis of the ra­di­olo­gic­al situ­ation, shall re­quest the Fed­er­al Coun­cil to or­der the trans­ition from an emer­gency ex­pos­ure situ­ation to an ex­ist­ing or planned ex­pos­ure situ­ation.

¹ In an emer­gency ex­pos­ure situ­ation, the fol­low­ing are re­quired to as­sume re­spons­ib­il­ity for tasks in ac­cord­ance with Art­icle 20 para­graph 2 let­ter b of the RPA:

a.

mem­bers of au­thor­it­ies and ad­min­is­trat­ive bod­ies;

b.

mem­bers of the po­lice, pro­fes­sion­al fire ser­vices, emer­gency med­ic­al ser­vices, civil pro­tec­tion and army;

c.

per­sons and un­der­tak­ings such as mon­it­or­ing and ra­di­olo­gic­al pro­tec­tion teams, for dir­ect in­ter­ven­tion;

d.

per­sons and un­der­tak­ings in the pub­lic and private trans­port sec­tor, for pas­sen­ger and freight trans­port and evac­u­ations;

e.

per­sons and un­der­tak­ings, for in­dir­ect in­ter­ven­tion, such as at-source meas­ures de­signed to pre­vent fur­ther con­tam­in­a­tion of the sur­round­ing area;

f.

health­care pro­fes­sion­als and med­ic­al staff, for the care of ra­di­ation vic­tims or oth­er per­sons af­fected;

g.

per­sons and un­der­tak­ings re­quired to sus­tain crit­ic­al in­fra­struc­ture;

h.

per­sons and un­der­tak­ings re­quired to sus­tain in­dis­pens­able pub­lic ser­vices.

² For the pro­tec­tion of mem­bers of vol­un­tary fire ser­vices, Art­icles 134 and 143–146 ap­ply.

³ Per­sons un­der 18 years of age and preg­nant wo­men shall be ex­emp­ted from tasks as spe­cified in para­graph 1.

¹ The ra­di­ation ex­pos­ure of per­sons with spe­cial re­spons­ib­il­it­ies must be de­term­ined at ap­pro­pri­ate in­ter­vals by means of suit­able meas­ure­ments.

² If per­sons with spe­cial re­spons­ib­il­it­ies have re­ceived an ef­fect­ive dose of more than 250 mSv, they must be placed un­der med­ic­al sur­veil­lance.

³ The med­ic­al sur­veil­lance and du­ties in the event of an ex­ceedance are gov­erned by Art­icle 59 para­graphs 2–5.

¹ In an emer­gency ex­pos­ure situ­ation, per­sons with spe­cial re­spons­ib­il­it­ies must re­ceive ap­pro­pri­ate in­struc­tion. The FDHA, in con­sulta­tion with EN­SI and the Fed­er­al De­part­ment of De­fence, Civil Pro­tec­tion and Sport (DDPS), shall spe­cify:

a.

the goals of in­struc­tion;

b.

the ra­di­olo­gic­al pro­tec­tion activ­it­ies which the per­sons may per­form on the basis of their in­struc­tion.

² The au­thor­it­ies, ad­min­is­trat­ive bod­ies, or­gan­isa­tions and un­der­tak­ings con­cerned are re­spons­ible for provid­ing in­struc­tion.

¹ The per­sons with spe­cial re­spons­ib­il­it­ies must have the equip­ment re­quired for per­form­ing their tasks and pro­tect­ing their health. The CCMB shall serve a co­ordin­at­ing func­tion with re­gard to equip­ment.

² The re­quired equip­ment shall in­clude in par­tic­u­lar:

a.

an ad­equate num­ber of meas­ur­ing in­stru­ments and do­si­met­ers to de­term­ine ra­di­ation ex­pos­ure;

b.

means of pro­tec­tion against in­takes or con­tam­in­a­tion.

¹ In the event of in­creased ra­dio­activ­ity, per­sons with spe­cial re­spons­ib­il­it­ies are in­sured against ac­ci­dents and ill­ness.

2 If the cov­er provided by com­puls­ory ac­ci­dent in­sur­ance and ex­ist­ing private in­sur­ance is not suf­fi­cient, the Con­fed­er­a­tion shall guar­an­tee be­ne­fits in ac­cord­ance with the pro­vi­sions of the Fed­er­al Act of 19 June 1992⁵³ on Mil­it­ary In­sur­ance. If ne­ces­sary, the mil­it­ary in­sur­ance or­gan­isa­tion may be in­volved for pur­poses of im­ple­ment­a­tion.

³ If, as a res­ult of their activ­it­ies, per­sons and un­der­tak­ings with spe­cial re­spons­ib­il­it­ies in­cur costs that are not covered, they shall re­ceive com­pens­a­tion from the Con­fed­er­a­tion. The DDPS shall reg­u­late the pro­cessing of fin­an­cial claims.

¹If, in an emer­gency ex­pos­ure situ­ation or in the sub­sequent ex­ist­ing ex­pos­ure situ­ation, the can­ton­al en­force­ment au­thor­it­ies de­term­ine an ex­ceedance of a max­im­um con­cen­tra­tion for ra­di­o­nuc­lides in foods in ac­cord­ance with the food le­gis­la­tion, they shall take meas­ures as spe­cified in the food le­gis­la­tion and in­form the Fed­er­al Food Safety and Veter­in­ary Of­fice (FS­VO).

²The FS­VO shall in­form the FOPH and the oth­er can­tons of re­ports re­ceived in ac­cord­ance with para­graph 1.

¹For ex­ist­ing ex­pos­ure situ­ations, a ref­er­ence level of 1 mSv per cal­en­dar year ap­plies. This is without pre­ju­dice to the radon ref­er­ence level spe­cified in Art­icle 155 and the threshold level spe­cified in Art­icle 156.

² The FOPH may re­com­mend to the Fed­er­al Coun­cil, in in­di­vidu­al cases, ref­er­ence levels of up to 20 mSv per cal­en­dar year, in par­tic­u­lar if meas­ures are re­quired in ac­cord­ance with Art­icle 171.