APPLICABLE PARTS OF PNRI REGULATIONS

Safety in the Use of Nuclear Equipment and Devices

Ensuring radiation safety by regulation and control

Relevant laws
REPUBLIC ACTS & EXECUTIVE

ORDER
R.A. 2067 Science Act of 1958 R.A. 5207 Atomic Energy Regulatory ia!ility Act of 1968 E.". #o. 128 $1987% Reorgani&ing 'AE( to ')ili**ine #uclear Re+earc) ,n+titute $'#R,%

The National Regulatory Authorities

Philippine Nuclear Research Institute (PNRI), Department of Science and Technology (DOST) for radioactive materials ureau of !ealth and Technological Devices" Department of !ealth for electrically generated #$ and N#$ (linear accelerator" %&ray machines)

PNRI Organizational tructure

Director Deputy Director

Atomic Research Division Agricultural Research Biomedical Research Health Physics Research Applied Physics Research Chemistry Research Analytical Measurements Research Isotope Techniques Research Nuclear Materials Research

Nuclear "ervices & Training Division Reactor perations !ngineering "ervices Irradiation "ervices Nuclear Training Computer "ervices Radiation Protection "ervices In#ormation "ervices $i%rary "ervices

Nuclear Regulations' $icensing & "a#eguards Division "tandards Development $icensing' Revie( and !valuation Inspection and !n#orcement "a#eguards Radiological Impact Assessment

*inance and Administrative Division Budget )nit Accounting )nit Cash )nit Property and Procurement )nit Personnel )nit Records and Communication )nit Medical )nit Plant "ervices )nit Motorpool )nit

!ode of PNRI Regulations (!PR)

'onsists of (arts
(arts )&*+

(ractice specific
(art ,,& $adiography (art ,*&Teletheraphy (art ,-&$adiopharmaceuticals (art ,.& rachytherapy (art ,/&#rradiator (art ,+&#ndustrial Devices

ases
#nternational 0tomic Energy 0gency (#0E0) safety requirements and standards United Stated Nuclear $egulatory 'ommission (USN$') 'ode of 1ederal

-)e (o.e of '#R, Regulation+

Part 2-

L !ens n" #$ Ra% #a!t ve &ater al' P()l s*e% n O$$ ! al Ga+ette' V#, -.'
N#,2/' 0. 1(l2 0//3

Part 4-

Stan%ar%s $#r Pr#te!t #n A"a nst Ra% at #n' P()l s*e% n O$$ ! al
Ga+ette' V#l, 033' N#,..' . Se5te6)er 2337

Part 7-

R(les an% Re"(lat #ns #n t*e Sa$e Trans5#rt #$ Ra% #a!t ve &ater als n t*e P* l 55 nes P()l s*e% n O$$ ! al Ga+ette'
V#l, 033 N#, 74' 28 O!t#)er 2337

(ontinuation/
Part .- R(le #$ Pr#!e%(re $#r t*e

L !ens n" #$ At#6 ! Ener"2 Fa! l t es n t*e P* l 55 nes0 'u!li+)e. in "fficial 1a&ette0
2ol. 730 #o. 370 12 Se*tem!er 1977

Part 9- L !ens n" #$ At#6 ! Ener"2

220 8 4une 1975

Fa! l t es" 'u!li+)e. in "fficial 1a&ette' 2ol. 700 #o. P*2s !al Pr#te!t #n #$ Plants an% &ater als0 "fficial 1a&ette 2ol. 920 #o.30 15
4anuary 1996

Part /-

(ontinuation/
Part 00- L !enses

$#r In%(str al Ra% #"ra5*2 an% Ra% at #n Sa$et2 Re:( re6ents $#r Ra% #"ra5* ! O5erat #ns' "fficial 1a&ette 2ol. 920 #o.30 15
4anuary 1996

Part 02-L !enses $#r &e% !al Use #$ Part 04-L !enses $#r &e% !al Use #$
1a&ette0 2ol. 1010 #o. 520 26 6ecem!er 2005

Seale% S#(r!es n Telet*era520 'u!li+)e. Ra% #5*ar6a!e(t !als" 'u!li+)e. in "fficial

in t)e "fficial 1a&ette0 2ol900 #o.390 26 Se*tem!er 1995

(ontinuation/
Part 07-L !enses $#r &e% !al Use #$

Seale% Ra%% #a!t ve S#(r!es n Bra!*2t*era52" 'u!li+)e. in t)e "fficial 1a&ette0 2ol.
910 #o. 200 15 7ay 1995

Part 08- L !enses $#r Lar"e Irra% at#rs " Part 0.-L !enses $#r t*e Use #$ Seale%

'u!li+)e. in t)e "fficial 1a&ette0 2ol. 890 #o.560 15 #o8em!er 1993

S#(r!es C#nta ne% n In%(str al Dev !es" 'u!li+)e. in t)e "fficial 1a&ette0 2ol. 900 #o. 290 16
Augu+t 1999

(ontinuation/
Part 23- L !enses t# &an($a!t(re an%

D s5ense Ra% #5*ar6a!e(t !als0 "fficial

1a&ette0 2ol. 980 #o. 260 1 4uly 2002

Part 20- L !ens n" an% Sa$et2

Re:( re6ents #$ Part !le A!!elerat#r Fa! l t es F#r t*e Pr#%(!t #n #$ Ra% # s#t#5es' "fficial 1a&ette0 2ol. 1020 #o. 2 9
4anuary 2006

 Part 22-

Fees $#r &ater als L !enses an% Ot*er Re"(lat#r2 Serv !es0 "fficial 1a&ette0 2ol. 1020 #o. 180 1 7ay 2006 Part 28 ; L !enses $#r C#66er! al Pr#v %ers #$ N(!lear Te!*n !al Serv !es' O$$ ! al Ga+ette0 2ol. 1020 #o.130 27
7arc) 2006

Part 2. ; Se!(r t2 #$ Ra% #a!t ve

S#(r!es0

"fficial 1a&ette0 2ol. 1030 #o. 10 1 4anuary 2007

Pri"ary ob#ecti$esof the !PR

%) Protection ob#ecti$e
to prevent the occurrence of deterministic effects in individuals 2y 3eeping doses 2elo4 the relevant threshold and to ensure that all reasona2le steps are ta3en to reduce the occurrence of stochastic effects in the population at present and in the future

tochastic effects & radiation'induced cancer -y*e or locali&ation of cancer

'o*ulation grou*+ A<!om! +ur8i8or+ Ra<.ial *ainter+ Early ra.iologi+t+ ;<miner+ E:*o+e. in a nuclear acci.ent 9
A.. mo.ule co.e num!er an. le++on 15 title

eu=e< mia 9

-)yroi. glan. 9

ung >rea+t >one S=in 9 9 9 9 9

(eter"inistic health effects

Early appearance (days to 4ee3s5 months to years after e%posure for cataract) E%istence of dose threshold" specific for particular effect elo4 dose thresholds & no effect 02ove threshold the severity depends on level of radiation dose 7o.ule 26

15

!PR Part ) (based on the IAEA * Occupational

Effecti$e dose li"it (+hole body) ,- " $.year a$eraged o$er / years, but not to e0ceed /- " $ in a single year

Indi$idual dose li"its

P()l !
0 6Sv<2r

E1ui$alent dose li"it (" $.yr) 2in, hands and feet /-3ens of the eye %/-

/%/

!ealth effects at various dose levels

(!ealth (hysics 6ournal" 7ol8 9:" No8 /" Nov *))/)

Pri"ary ob#ecti$es of the !PR

,) afety ob#ecti$e
to protect individuals" society and the environment from harm 2y esta2lishing and maintaining effective defenses against radiological ha;ards from sources

Illustration of (efense in depth

Pra!t !e =e,", n%(str al "a(" n"' et!,> ?Source ?S)iel.e. container ?@or= area @ea= *oint+A

Pri"ary ob#ecti$es of the !PR

)) ecurity ob#ecti$e< to prevent theft" unauthori;ed possession and malevolent use of sources 2y terrorists

= because of recent increased concern on terrorism

RELEVANT CODE OF PNRI REGULATIONS =CPR> FOR T?E USE OF NUCLEAR GAUGES

CPR Part 2@ L !ens n" #$ Ra% #a!t ve &ater al =0//3> CPR Part 4@ Stan%ar%s $#r Pr#te!t #n A"a nst Ra% at #n =2337> CPR Part 7@ Sa$e Trans5#rt #$ Ra% #a!t ve &ater als n t*e P* l 55 nes =2337> CPR Part 0.@ L !enses $#r t*e Use #$ Seale% S#(r!es C#nta ne% n In%(str al Dev !es =0///> CPR Part 2.@ Se!(r t2 #$ Ra% #a!t ve S#(r!es =2339>

CPR Part 2
Set+ fort) t)e rule+ an. regulation+

a**lica!le to all *er+on+ in t)e ')ili**ine+ go8erning t)e licen+ing of ra.ioacti8e material !y '#R, Re+olution of conflict Acti8itie+ reBuiring licen+eC manufacture0 *ro.uce0 tran+fer0 +ell0 recei8e0 acBuire0 oDn0 *o++e++0 u+e0 im*ort or e:*ort

CPR Part 2 =!#nt,>

-y*e+ of licen+e+ A**lication for licen+e 1eneral reBuirement+ for i++uance of a

licen+e A..itional reBuirement+ for eac) ty*e of licen+e $Dill !e !a+e. on a**lica!le ('R% ,++uance of a licen+e -erm+ an. con.ition+ of licen+e+

CPR Part 2 =!#nt,>

E:*iration an. reneDal of licen+e+ A**lication for amen.ment of licen+e+ -ermination of a licen+e Recor.+0 re*ort+0 in+*ection+ an. te+t+ Enforcement

('R 'AR- 3
E+ta!li+) t)e +tan.ar.+ for *rotection

again+t ioni&ing ra.iation ari+ing from t)e u+e of ra.ioacti8e material+ an. relate. acti8itie+ con.ucte. un.er licen+e+ i++ue. !y t)e '#R, E+ta!li+) t)e !a+ic reBuirement+ for t)e +afety of ra.iation +ource+

('R 'AR- 3 $(ont.%

Ra.iation 'rotection an. Safety

ReBuirement+
Eormat an. content of ra.iation *rotection an. +afety *rogram 4u+tification of *ractice+ "*timi&ation of *rotection an. +afety 6o+e con+traint+ 6o+e limitation+

('R 'AR- 3 $(ont.%

0dditional

$equirements for Each Type of E%posure

Occupational e%posure 'onditions for pregnant 4omen 'lassification of 4or3 areas (ersonnel monitoring devices and protective equipment >edical e%posure

('R 'AR- 3 $(ont.%

Safety

>easures and 'ontrol of $adioactive >aterial

Transport of radioactive material Storage and control of radioactive material

(recautionary

$equirements

'aution signs" la2els" and posting requirements #nstruction to 4or3ers

('R 'AR- 3 $(ont.%

?aste

>anagement and Disposal of @icensed $adioactive >aterial $ecords" $eports and Notifications E%emptions and 0dditional $equirements Enforcement

CPR PART 7
Esta2lish

standards of safety to protect persons" property and environment from the ha;ardous effects of radiation associated 4ith the transport of radioactive materials # the (hilippines Esta2lish requirements for pac3aging and pac3ages" preparation for shipment and transport of radioactive materials

CPR PART 7 =C#nt,>

Esta2lish

procedures and standards for the control of shipment and for the approval of pac3aging and pac3ages
'ertificate of release 'ertificate of transportA0uthority to Transport

CPR PART 2.

-o *rotect t)e *u!lic again+t t)e u+e of ra.ioacti8e an. a++ociate. facilitie+ for unaut)ori&e. *ur*o+e+ -o ac)ie8e an. maintain )ig) le8el of +ecurity of ra.ioacti8e +ource t)at i+ commen+urate Dit) t)e *otential )a&ar. *o+e. !y t)e +ource -o *re8ent unaut)ori&e. acce++ or .amage to0 an. lo++0 t)eft or unaut)ori&e. tran+fer of ra.ioacti8e +ource+

'($ (0$T ,+
(rescri2es

requirements for the issuance of licenses to possess and use sealed sources contained in industrial devices for the purpose of detecting" measuring" gauging or controlling thic3ness" density" level" or interface location8 'overs sealed sources contained in porta2le gauges and gauges mounted in fi%ed location

E:*iration an. ReneDal of icen+e

Eac) licen+e +)all e:*ire at t)e en. of t)e .ay of t)e e:*iration .ate +tate. in t)e licen+e

E:am*leC icen+e #o.C F05.05012 E:*iration .ateC 28 Ee!ruary 2009 A**lication for reneDal +)all !e file. 30 .ay+ *rior to e:*iration .ate

-ermination of icen+e

A licen+ee may reBue+t for termination of )i+ licen+e at anytime DGin t)e *erio. of licen+e or @)en *rinci*al acti8itie+ un.er t)e licen+e )a8e not !een con.ucte. for a *erio. of 25 mont)+

-ermination of icen+e $2%

Eor t)e *ur*o+e+ of terminating t)e licen+e0 t)e licen+ee +)allC

6i+continue u+e in8ol8ing licen+e. RA7+H -ran+fer of .i+*o+e of all licen+e. material DGc Dere in )i+ *o++e++ion in accor.ance DG t)e reg+. 6etermine t)at no contamination le8el+ in e:ce++ of t)e limit+ for unre+tricte. area+ e:i+t in )i+ facilitie+H A++ure. t)at t)e reBuire. recor.+ are com*lete an. u*<to<.ate.

-ermination of icen+e $3%

-o !e relie8e. of t)e re+*on+i!ility for t)e material I ot)er con.ition+ in )i+ licen+e0 t)e licen+ee +)all +u!mit to '#R,C

Ji+ reBue+t t)at licen+e !e terminate.H A certifie. +tatement t)at )e no longer )a+ in )i+ *o++e++ion any ra.ioacti8e material reBuiring a licen+eH an. A li+ting of t)e RA7 tran+ferre. or .i+*o+e. of I t)e *er+on to D)om t)e material Da+ tran+ferre. or t)e met)o. of .i+*o+al

Amen.ment of icen+e
A licen+ee +)all a**ly for an. mu+t recei8e a licen+e amen.ment !eforeC

recei8e+ I u+e+ +eale. +ource+ ot)er t)an D)at i+ in.icate. in t)e licen+eH it c)ange+ t)e RJS" .e+ignate. in t)e licen+eH it c)ange+ t)e area+ of u+e i.entifie. in t)e licen+eH it im*lement+ any maKor c)ange in t)e a**ro8e. ra.iation +afety *rogramH any +u!+tantial c)ange in any con.ition of t)e licen+e ta=e+ *lace

-raining I E:*erience ReBuirement+ of RJS"

50 )r+. of formal training I in+truction+ in Ra.iation ')y+ic+0 Ra.iation Safety0 #uclear Regulation+ I Safe -ran+*ort of RA7H -)e manufacturerL+ training *rogram on t)e u+e an. o*eration of t)e nuclear gauge .e+cri!e. in t)e a**lication.

Duties and $esponsi2ilities of $!SO

DUTIES AND RESPONSIBILITIES OF R?SO

En+ure t)at licen+e. ra.ioacti8e material

*o++e++e. !y t)e licen+ee i+ limite. to t)e =in.+ an. Buantitie+ of ra.ioacti8e material li+te. in t)e licen+e En+ure t)at in.i8i.ual+ u+ing an. o*erating t)e .e8ice are traine. in accor.ance Dit) Section 25$!% of ('R 'art 16

6utie+ I Re+*on+i!ilitie+/
En+ure t)at *er+onnel monitoring .e8ice+

are u+e. a+ reBuire. an. re*ort+ of *er+onnel e:*o+ure are re8ieDe. in a timely manner En+ure t)at gauge+ are *ro*erly +ecure. again+t unaut)ori&e. remo8al at all time+ D)en gauge+ are not in u+e En+ure t)at *ro*er aut)oritie+ are notifie. in ca+e of acci.ent0 .amage to gauge+0 fire of t)eft

6utie+ an. Re+*on+i!ilitie+ /

En+ure t)at au.it+ are *erforme. at lea+t annually En+ure t)at re+ult+ of au.it+0 i.entification of .eficiencie+0 an. recommen.ation for c)ange for c)ange are .ocumente. En+ure t)at au.it re+ult+ an. correcti8e action+ are communicate. to all *er+onnel D)o u+e licen+e. ra.ioacti8e material En+ure t)at all inci.ent+0 acci.ent+ an. *er+onnel e:*o+ure to ra.iation in e:ce++ of A ARA or ('R 'art 3 limit+ are in8e+tigate. an. re*orte. to '#R,

6utie+ an. Re+*on+i!ilitie+ /

En+ure t)at licen+e. ra.ioacti8e material i+ tran+*orte. in accor.ance Dit) '#R, tran+*ort regulation+ $('R 'art 5% En+ure t)at ra.ioacti8e material i+ .i+*o+e. of *ro*erly En+ure t)at )e )a+ u*<to<.ate co*ie+ of a**lica!le '#R, regulation+0 re8ieD+ neD or amen.e. '#R, regulation+0 an. re8i+e+ licen+ee *roce.ure+0 a+ nee.e.0 to com*ly Dit) '#R, regulation+

6utie+ an. Re+*on+i!ilitie+ /

Ensure

that the license is amended 4henever there are changes in licensed activities" responsi2le individuals" or information or commitments provided to (N$# in the licensing process

RA6,A-,"# SAEE-F 'R"1RA7

6e+cri*tion of t)e "rgani&ation -raining 'rogram 'er+onnel 7onitoring 'rogram Ra.iation 6etection ,n+trument an.

Ra.iation 7onitoring 'rogram ea= -e+ting 7aintenance

Ra.iation Safety 'rogram $2% Transportation of Devices to 1ield @ocations (applica2le only to porta2le gauges) Operating and Emergency (rocedures 0nnual 0udit of $adiation Safety (rogram #nventories $ecord Beeping $equirements SE'U$#TC >E0SU$ES ?0STE >0N0DE>ENT

$0D#0T#ON S01ETC ($OD$0>

RA(IATION

A4ET5 PRO6RA7

The program must include<

Description of the organi;ation E notice to 4or3ers of the programFs e%istence5 Definition of functions E responsi2ilities5 $adiation safety procedures E safety measures5 and 'ontinuing education E training program for all personnel 4ho 4or3 4ith radioactive materials

Pers#nnel &#n t#r n" Pr#"ra6

u+e of monitoring .e8ice+ film !a.ge - 6 *en.o+imeter

,nformation to !e *ro8i.e.C

i.entification of t)e ty*e of monitoring .e8ice t)e name of t)e +u**lier of t)e monitoring .e8ice freBuency Dit) D)ic) t)e film !a.ge Dill !e e:c)ange.

for film !a.geG- 6C e8ery tDo mont)+

 Ra% at #n Dete!t #n Instr(6ent =s> an% Ra% at #n &#n t#r n" Pr#"ra6
'ro8i.e +*ecification+ of t)e ra.iation .etection in+trument $+% to !e u+e.. ty*e of in+trument 7anufacturer 7o.el #o. Serial #o. ra.iation .etecte. +en+iti8ity range Din.oD t)ic=ne++

Eor *orta!le gauge+ C 10 S8 to 10 mS8$1 t)roug) 1000 milliroentgen% *er )our freBuency of cali!ration C e8ery 12 mont)+

Eor fi:e. gauge+C a**ro*riate +ur8ey meter

'ro8i.e Ra.iation 7onitoring 'rogram

(ali!ration of Sur8ey 7eter a8ail of +er8ice+ of '#R, .o oDn cali!ration $*ro8i.e cali!ration *roce.ure%

LeaA Test n"<Sw 5e Test

ReBuirementC +i:<mont)

inter8al

"*tion+C Engage t)e +er8ice+ of a con+ultant or '#R,0 commercial facility0 or t)e gauge manufacturer to ta=e I e8aluate +Di*e +am*le+0 I re*ort t)e re+ult+ to t)e licen+eeH ;+e a commercial lea= te+t =itH icen+ee to *erform entire lea= te+t *roce.ure
(Submit entire procedure)

&a ntenan!e Pr#"ra6

'ro8i.e *roce.ure for maintenance of t)e .e8ice

Trans5#rtat #n #$ F el% Dev !es t# F el% L#!at #n

$for *orta!le gauge+ only% Su!mit t)e *roce.ure for tran+*orting RA7 6e+cri!e )oD you Dill en+ure t)e +afe tran+*ortation I recei*t at t)e aut)ori&e. location $Refer to ('R 'art 5 Rule+ an. Regulation+ on t)e Safe -ran+*ort of Ra.ioacti8e 7aterial in t)e ')ili**ine+%

O5erat n" an% E6er"en!2 Pr#!e%(res

'ro8i.eGSu!mit t)e folloDingC

co*y of t)e gauge o*erating manual

emergency *roce.ure+ to a..re++ emergencie+ +uc) a+ *otential .amage to t)e +ource0 lo++ of +)iel.ing0 +tuc= +ource+ or +u!+tantial acci.ental e:*o+ure of an in.i8i.ual .e+cri*tion of your local rule+ I *roce.ure+ reC in8e+tigation0 *rotecti8e mea+ure+ I +afety *ro8i+ion+0 *ro8i.ing a.eBuate +u*er8i+ion0 *ro8i.ing Dor=er+ information on )ealt) ri+=+ .ue to occu*ational e:*o+ure0 I emergency *lanning in+truction

.e+cri*tion of training *rogram to en+ure t)at all a**ro*riate *er+onnel are a.eBuately traine. in t)e current o*erating *roce.ure+ I )oD t)eir action+ may affect +afety
A copy of the operating and emergency procedures should be provided to the operators of the nuclear gauge and should be available at the job sites.

Ann(al A(% t #$ Ra% at #n Sa$et2 Pr#"ra6

Annual au.it inclu.e+C re8ieD of content+ I im*lementation of t)e *rogram to en+ure com*liance Dit) t)e ('R0 term+ I con.ition+ of t)e licen+e occu*ational .o+e+G.o+e+ to t)e mem!er+ of t)e *u!lic +)oul. !e A ARA
Licensee must maintain records of audit & other reviews of program content & implementation until PN ! authori"es their disposition

Invent#r es
'erio.ically account all +eale. +ource+ G.e8ice+ recei8e. an. *o++e++e. un.er t)e licen+e

in8entorie+ +)oul. !e con.ucte. at inter8al+ not to e:cee. t)ree $3% mont)+ recor.+ +)oul. !e maintaine. for at lea+t 3 year+ ? ? ra.ionucli.e acti8ity

? manufacturerL+ name of +eale. +ource I eBui*ment ? ? ? 7o.el #o. I Serial #o. of eBui*ment location .ate of in8entory

Re!#r% Bee5 n" Re:( re6ent

Sy+tem of recor.+ +)oul. inclu.eC

.i+*o+al of +*ent +ource+ *er+onnel e:*o+ure $i.e. current recor.+ I *rior Dor= )i+tory area +ur8ey+ $i.e. .o+e rate0 contamination% in+trument te+t+ I cali!ration te+t+ for ra.ioacti8e +ource lea=age in8entory I accounta!ility of +ource+ au.it+ I re8ieD+ of ra.iation +afety *rogram inci.entGacci.ent in8e+tigation re*ort maintenance an. re*air Dor= facility mo.ification+ training *ro8i.e. e8i.ence of )ealt) +ur8eillance of Dor=er+ tran+*ortation

@AS-E 7A#A1E7E#-)e a**licantGlicen+ee may eit)erC

tran+fer t)e +ource+ to anot)er aut)ori&e. u+er or licen+ee for u+e at t)e current acti8ity le8elH or return t)e +*ent +eale. +ource+ to t)e *rinci*al +u**lier or manufacturer
Specify which option to ta#e.

Submit certificate of agreement that the depleted$spent source will be accepted by the principal supplier or manufacturer (for t)e 2n. o*tion%

 SA7'

E "E A'' ,(A-,"# E"R7C

#R S6G RE<0070 Re8i+ion 20 Ee!. 2007 A**lication for icen+e for ;+e of Seale. Source (ontaine. in ,n.u+trial 6e8ice Sam*le of Attac)e. formC #R S6G RE<0101 -raining an. E:*erience of 'ro*o+e. Aut)ori&e. ;+erG RJS"

SA7' E "E RA7 ,(E#SE

(o8er letter
're+i.entGmanagerG +u*er8i+or AttentionC RJS"

RA7 licen+e
icen+e num!er E:*iration .ate

Attac)ment<A
RA7 an. Buantitie+0 u+e an. *lace of u+e

Attac)ment<>
1eneral an. +*ecific con.ition+

Than2 you