Pakistan Biosafety Rules, 2005

REGISTERED No. M - JOZ L.-7646 of ·.~ EXTRAORDINARY PUBLISHED BY AUTHORITY ISLAMABAD, TUESDAY, APRIL 26~ 2005 PART II Statutory. Notifications (S: R. 0.) GOVERNMENT OF PAKISTAN MINISTRY OF. ENVI:8.QNMENT NOTIFICATIO.NS Islamabad, the 21.st April, 2005 S~l{.O; .336(1)/2005;-In ex~rcise of the pow~rs conferred by section ·31 of the Pakistan Environmental Protection Act,· 1997' (XX.XIV of 1997)~ the Federal . . .. Government is pleased to make the following mies, namely:~, 1. Short title and commencement.-(l) These rules may be called the Pakistan Biosafety Rules, 2005. (2) They shall come into force at once. 2. Application.- These rules shall be applicable to (a) manufacture, import and storage of ,micro-organisms and gene technological products.for research, whether conducted in lab6ratotie5 ofteaching and research, research and development institutes or private companies involved in the uses and applications of genetically modified organisms and ·products thereof; (975) [2819(05)/Ex. Gaz.] Price: Rs. 10.50. 976 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 (PARTU (b) all work ~nvolved in the field trial of genetically manipuiated plants, animals (including poultry and marine life), micro-organisms and cells; and (c) import, export, sale and purchase of living modifo;:d organisms, substances or cells and products thereof for commercial purposes. 3. Definitions.-(D In these rules, unless there is atiything repugnant in the subject or•context, (a) (b) (c) (d) (f) (g) (Ii) (i) "Act" means the Pakistan Environmental Protection Act, 1997 (XXXIV of 1997}; "applicant" means any person including an artifieial juridical person, seeking licence for activities related w'ithapplication ot"these rules; ''biosa:fety" means the mechanism developed through policy· and procedures to ensure the environmentally safe application of biotechnology; "biosaf-ety guidelines" means the Paldstan Biosafety Guiddmes notified by the Ministry of Environment; "commercial release" means any intentional introduction of living modified organisms into the en\/ironment through sale or purchase; "contained use" means any operation or activity, undertaken within a facility, instaUati on or other physicaLstructure, which involves Jiving modified. organisms, substances or ·cells a:nd: products thereof and con tro11ed ih a inanner,that lirriits their contact with, andth~ir impact on, the external en.vironment and the general population; "deliberaterelease'"means any mte11t1onaltransfer of livingmodifie:c1 or,gan1s~s to the environment or nature; irrespective of t'fi'e way in whkh it is done; "experimental release'' means ;my intentional introduction into the, environment of living IllodifiedQrganisms; wfrh containment measures and which is not used for commercialization: °'export" means the intentional transbounctaiyniovementfrom Pakistan to another country; 978 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 f.PARTil 4. Establishment of National Bio-safety Committee.-(!} The Federal Government shall, by notification in the official G<J.zette, establish a National Biosafe(y Committee consisting of the following members, namely;~ (a) Secretary, Minis.try ofEnvii:onmem Chairperson (b) Member (Biosciences), Pakistan AtoJTiic.Energy Go1ntnission Member (G) Cnaj.lj)ersQJJS of concerne.d)tistitutiorial Bi9"safetyCominittees Members (4) Reptesentativeq 9f'ProviqoiaiGovennnent~ Members (e) Rep·resentafrve of (fove;rnment ofAJK Member (f:t Ch:a;irman; PA~c ~g) t~Jit~~fnWlvt'~iru~1tv:·qcfE:o.oct &, A~culfore (b} ~epr~s('.?nta,.tt\'.e M:inisti;r:·PtI:i.~;iJiif Ci) l{~r,r~;,eoi~.t~V'¢ Mihil'>frj{pf ~ p1spc,f.a,rx~,re¢hri0Jqgy (jJ' ~ep,,t¢;,e,f;lqt~ye;Mb::ifatry:'6f-g~~cati9v,' (k,) plreq6.r~O.eu~i&1{DeparimeJit:otP.1an r Profectfon q 0 f)irectotc<3i;}neta1/.l{akfatiff.Et?A Mr:mbef Member. Member. Member Member Meinber· Member .•. . . . ci) whit Pitei,3tt5t/Gerieti).1,.'P~ist;iii'EPi:. }ihaJfoaq(;M .~et;ref?.I)'., df:th½, Nhti'o@f:Biti:,saf~ty:€◊mtnitte1:f ($) Tille Conhn.{fiee' .infy.-cq~.o"Rf any other i:ti¢ri{5et ''iii' .dtemed nec~s~.@'ry. foiits:func tiQnirig - (4) TJ-ie.,rnernJ:iei:s·oHb.e Ccintmittee;1pllie'r';jhan ;i'f.t.offkio ,in:embers. sl1all l1old .. qf:Qfe,for,ca,'{c;z:'mof.thtee0years.·extenda6le to· anotheri~rtn of thfoe,yea:i's\vith the'~ppro:val:'df.ctbe,•Cfiaimerson ( 5) The ·Coinmittee.,shalHram:e.its own rule$ and,proc&dures, (§). Thei]Omitiitteb ·tb¥!lthoid meel'ings a:s'il.nd.:when .deemed'ne te~sary 'Dtovic!ecl ;that inbtclessi.than.foui\meeting:s,thaUJ;ie held.in. a y e.ar. 5, lfu11ctions• :0L.Natlonal Bios.a(~ty,:Gon:.i.mitte~;-"- (1): Tlie-Nationa} B'iosafeJyQoiti.mitte.e:shi:ll perrornttheiolltlwing;ftift~lions: nam~ly·~ (a) to:.estahlish stantlards'.arid pr<5aedlires· fotrfsk'.,assesstnenta:nd'labeli'iig :lfliving modified organisms· substances br cells and-ptodi:Jcts tliereof. PARTll]' THE GAZETTE OF PAK1STAN, EXTRA., APRIL 26, 2005 979 (b) to consider application(s) for import, export or c~mmercial release of living modified organisms, and on the recommendations of Technical Advisory Committee al)owrelease·or reject applicatio\1s after reviewing the risk assessment c.arried qut iri <1ccorda11ce wHh the biosafety gu1deline~, the procedures established under clause (a) and any other reliable ·inforroation. ( c) to ban or restrict frripor.t, e)f port, salt\ purchase ?i: trading of <J.~Y living modiijed organism caiisin~.or likc;'ly to cause risktopubljc healt~. safety or:e,1vir9{1ment. (d) to develop ·linkages wi1h f pref gri btps~f~ty' committees and relevant lfgeiicies ttY en$µte. thatJ;enetit· mah ipulafiorr .practices hi Pakistan adcitessfotetnat1onal]:!11Jsafety:coiicerns,and,observe uni,vers::tl codes: .ofc,opJli.Ict. to COOP.e.ratbw.hh other releyant- fedtit~l~or prq\r1rici;i1' aut;horHieii 9;;,et.§~i~iig ~t)Jfai(:nport,a~4.iteleJi§e,.cif:flYJbgso(g&µi~rris ~rt.~.'fonrnilate. guidiliqes 0 for tM.\deritifiditibfl;lrisp(Gtion ·an.o ;regg!a.tioh.Af 1:ri:ihsgeo.ic specii3s'-exoii6.1Jrga~1srris•imtl oth~is:, . . (f,) to,restiain on ilie·advke' qf 1.ecb,nig~ ';6:pvlsoi;Y,Cpjnr,riittee'.ap y;pe,rs-oni a(! tli<>:ri tgJjr tnstthi teJn VqlJ ~cl @:itli :~n$W~ tuanipii latib\'l ,~~pei:iments. · :ofi~t?tetidath~atd~, · · · (g) to f1Xc:mta:(e e~qiange o.f.·1eohi#¢i) · ~ip~r-i;i,~~r'.t,b);y9 npus research: ifrstibltions and t;eggJWt!?!-Y'agenci-es-:Sn;. ~etttng up.':·apj:itoptja(~ :extr#ifn¢I;lt;c(lc-qn,qiti ons; :tcffaqtlitafo·~fJ'jt'xel.s·'offa~~tyi~iQU::bf ¥,~Xi~ti~•IDiiQip,ulafio1tworkby. ··aisistint'0JJ:iet tegurn~qry · J:i9.di~s-"il\cl.!1Hig:g·Jrfatifutioii'.aF'l?t{)Iaf.e t§ Ccimrn:ittees; in'e:stabli1slli~~'.:P.~r(iileht't6des'.ctisciplities·ancl•gtifJeudes. 'f oi' the•iipptaJs;:i:l :of:ot6l;iat:atds ;i11rfJhf.mm~g~in.ent$1.fcWiJ~$rif ~g~fir"ds,: ,,· .t9•¢9ord.ip:;:ile•Mforls offustitufi6P~1.8iosafetyJ:~ommiftees;.~riµ:itifofrri. an:d educ.ate{he p.ublib\m hio~afety .is.~utsJi.nd Qrfprpj:ip$ec,1 nit.lo rial 'policies . . G} tq. ~nsui~Jficif ihhoratoty field wort<; ari.p.' cortuner.cial ,rd ease· of 'genetically, niodified'titga.t11sms ·and ·their products·· c;611foiijns 0tci the national biO:s.afety guideliri~:,;; 980 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 (k) to'prepare and provide to Institutional Biosafety Committees me vanous nsitifications an d assess!YJent forms, biosafeiy guidelines, related documents and assorted signs for facilities. (1) (q) to inform the various insfitutfo~s erigaged in genetic inanipulation work about ~ew .developmerits. in biosafety -~o ,;S to. avoid exposure of ;1atwatory. personnel, the co~u'nity qr,tbe envi rqnil)e~t to imdui risks. tCI COQi:d1µ~t¢ effsms. b~twe~n pertinent gov~i-pii)ei1! ·agew::ies .and ptiv~te.cirgruu#tiqnsto)ilain:tsiift~\ife,ty.livels ti;ibiotecqn~lo g ic'al ~qrk: aiictk/piepare tffoni'fo/bfolq'g kru:efuetgfncfos: to;~(ittff1\I#gh: l~y~l,!ahgfat6µe§,·pfa.ti.t :.tli1ss-M11i:;e.s inciJuifu~l Ji9uset. ··jjlt~~dei:l:toflJilJ~:.irthfthfn~llwww.:trr¥!tf~Aiiesf:BJ:fh'6'in~titutlon;'anct a.iJtfil{(!'~iJ:tJi~~{i;g~AYehi,~Q.~i. 't[e.'Nattp:(1'~11B.ios?f~t:Sr'B6rtfrbit'tef ma i: '¥t~P~~!Al~~~fitj;~j:i,d:f{tf:l:~tls~i'.i!cfc¢rt1.ficati{:in./or\e~c'imw~no-;ictd.ifi◊niit :Rttc;~ut10JYs;·:ff~Ieroefirsoftlie::fiiE·nH:w,;-\fell&eriifiited.1:0J;,e-i:h·aaequate ·t9:§i,lpp ◊ilm~,ty.p~~::.§Itt~K.9r,,p~™'9JB9mi:t~ii.£¥ng;\t',~rkre,qu!ntittuch pJttstf;,tlto.ntainfuent: ~0)11$J:l~?:;thrgli:1eveflabora.1;9tief~n~:¢.◊hW.iiH1.tiri;@ipiltp~i:.◊,µ){r:egUii.r; :BMi?.';. Tlie3-;J'attqnal:131b·s~rn1;t::GPm1JhWii:!•, nr,ay;i~lP~ctjJ:~~9f§Jgr,i ¢~, \tf bcl\facikiftfi:§bt:Jf;c.oi,1t?i).1Jf1eij.t'il?vffifZ/fij;2}§~~f.tJ§l:ijt~¢W~'<;!;{ifW.~-­ tirn·$'ilf~uy\gpjt,!~1iri~~tt'~ijiyJ{fnt:~fh'i#he r:at:;a~}':tiffl.tl\'.li b'.s©fti:!{tjt:cto,: '.(imfiG':atjpri~wltlidJ.WP:noiJ16W5t; tq keep inf qrjiiafiq11·-◊.f c;qn:im~tc;i@.~gqifit5{f).sei9nf.ig.i'i#if!.1.ft'.o m p,ul,)11¢: ri?!'i;i./iiififs§/f%fu,¥:sf~Jif:&rjt1~j~Y<~i@Ml~t?iff{s{Jri:{!?:iJ1~Ft~i;Ci9~&r titg@tz;-}i~q1.tf '((} fr1J#}p'rjjt pr··:fu'd'.Jti(~n,;:J§rnfe9.;r,i~it~t1fgf;pp:;g¢Jqg:fii~M¢Il':'PtOJec,ts. ·aud,ai:!h'ievemerltsin961:viir:'. · en'eticaJ.I: :mf r eeied~f 'irrifoms/fi~clous · --·,""·-'!:s'.p,•"···· . ··· , .... •'·"'"'"' .. , g g ,,,. , .,,, ,,.-.Y, .,.K}}L:. . ,g~ •·.,··-· .c.·• .- . ,. . .,. ,, .. fetib${~if!iesfo{c~Ii~/~i\ci:p}oo0.tf$'1hflf bf{ PART II] THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 981 6. Technical Advisory Committee:-(1) The Federal Government shall, by notification in Jhe official Giizeite, ~stablish a Technical ,Advisory Committee consisting,of the following member~, namely :- · (i) Director-General, Pakistan EPA (ii) Director, National Institute for Bio Technology and Genetic Engineering, Faisalabad. (iii) Executive.Dfrector, Pakistan Medical Research Gouncil(fMRC). (iv) Director, Pakistan Council oflndnstrial and · Scientific Research (PC.SIR). (v) -Director, Health Services Academy (HSA) (vi) Executive birector, Nat\onal Institute of Health . (vii) Representative, Pakistan Atomic Energy Commission, Islamabad . . Representative; rentre for Molecular Genetics, lJniversity'of Karachi. . .. (ix) Representative: Centre for Applied and Molec:u1ar . J3iology, Laho~~ Chairperson Vice Chairperson Member Member Member Member Member Member (x) (xi) Repres~ntative; N ationaI Cori:IIU.ission on ~~qtechnolqgy Re.levant technical representative, Animal scrences, PARci · · · · l\lfember Member (xii)· Reieva·nt technical representativ~, Plant.Sciences'. PA~C. (xiii) Director, Pakistan EnYirdnmerttal Protectionl\.'gency; l~larn~b<\d. .. (xiv) Twc'Jexperts from private sector/civilsociety Member Member Members (2) Tne Qifrctoi", Pakistan Environmental Prot~cti6n Agency shall. act as Secretary of the Technical AdvisoryCo~mittee. (3) TheCommitlee niay co(opt any techmcal repr~seri.tative from any province. 7. l?m)ctioµs llCI'echhicall\.dyis()ry· c'b~mitJee.,-"- The following . s11all be the functions of ~he' Techhical Advisory' Committee·; nameiy: (a) tci examine applications and recomi:nend to Nation.al Biosafety Committee on permitting or otherwise iaboratory work)ieiciwork or relecise· of livirig modified oigariism; substances, ceils· and products thereat . 982 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 (b) to review and control of safety measures adopted while handling large scale use of genetic~lly engineered organisms/classified organisms in research, developmental ~nd industrial production activities; (c) to review research methodologies in genetic engineering and recombinant DNA work at the- international level and assess the associated risks to guide relevant institutions; (d) (e) {f) to. monitor~release of engineered organisms or products into environment and to oversee field applications and experimental field tli.als; to provide info):mation or data inputs to National J3iosafety Committee upon sutveilfo.nce ofapproved projects under industrial pr~d~ction, and in case of environmental releases witll respect to smety risks anci accidents;· and to supervise directly or through aIJY person authorized in.this behalf the imJ?lernentation of the terms and cond~ti;ns laid d9wn in connection with the approv~ls accorded by the N~tional 1:liosafety Commlttee. 8. Institutional Biosafety Comrilittees.-,.:.:cJ) The h,ead of the institution related to biotechnology sh;i H notify Institutio~al Biosafet{Cornmittee ~ith the following miniii-lum compositibri: .. . (a) Head of the instJtutio (b) Subject expert(s) (c) Social Scientist/economist (for social impact) (d) Represenhtive ofdvil:society Chairperson M~mbers 'f)Jember Meniber 9 ·Fgnctions .of Institutional Biosafety Committee .-(1)- The Committee shall perform the follo~ingf1.1ncti.ons, namely:-· '( a) to ·assist in the activities ofN ational Biosafety Committee and Technical Advisory Committee; (b) to ass}st researchers in,undertakirig ri,sk-assessment, qrganizing training p'rog~ammes and harmonizing experimental c::on"ditio~s with hiosafety . gurdeltnes; (c) to detennine additional safeguards anq draft i,;upplementary operating instruction~ f~r work at the institution, inJiii.e witp. and addressfog the specific risks and concerns uncovered; PART II] (d) (e). (t) (g) (i) (j) (k) (l) (m) (n) THE GAZETTE OF PAKISTAN, EXTRA, APRIL 26, 2005 983 to evaluate the qualifications of researchers involved in biotechnological projects and assess whether each retains a thorough understanding of good microbiological practices necessary for the supervision of students, assistants and junior peisonnel; to monitor all regulated work under progress within the instit4tion and counsel the proponents on issues ofbjosafyty and on compliance with biosafety guidelines on a regular basis, ·or as requested; to serve, where approp1iate, as a gateway for the flow of information, ideas and opinions between. the-:National' Biosafety Committee and the research teams; · · to' maintain and update a directory of all personnel engaged inactivities at. eve:rybiosafety.level and to instruct r,iew personnei on the correct laboratory or field pr~ctices, emergency procedures and ~quipment operatio11 at the relevanflevel; . . to ensure health of laboratory and field personnel 'as may deem necessary. from medical recol'ds; t9 liaise \1/itli NationalBiosaf~ty Comtri.ittee and Tei;:hnical Advisory Comtri.ittee ori import, export;• i:nanufac tiire; process:, use or sale of any geneticaily modified oi-gariisms/subst~nces or celis and products thereof f9r the-purpose of rese·arch: to withhold funds and 6t use administfative authority, tO irnfuediately refrain'programmes if biosafety: guidelines are violated: to prepare ,and implerrient the institutional emergency .and response plan according to the 'details provided in the'manual§ a:nd guidelines prepared by NatioI.J.al .!3iosafety Committee; to assess .allprojects referred to it, and on the,basis of the information ' ' . , : \ i c.. . ·~ prov~dec! .and the risks forecast deter.mini; under -which cru,egory of work the proposals fall and whether to endorse the work piopos~d; to 11;aintain records of approved project propµsals for laboratory genetic . mahipu!atiqn work (including notification for. project exemption) and the assessments; t9 foi:ward summades of all P.r<?ject pr(!posals submitted for IBC n'ot1fication, and the asseisment~ to the Tech~ica\Adyi~ory Coimn}ttee for records and inforniation,or lor tev,iew and reco,mmendation fo'the · case of proposai:a;: for Risk Category 2 and J work; . . . , 984 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 [ PART II (oJ to und~rtak~ risk assessment, in cooperation with the research teams as necessary, to determine the appropriate containment and biosafety conditions, operating procedures and emergency safeguards for Risk Cqtegory 2 an:d 3 genetic manipulation work, and for the 'housing, storage or movement .of regulated material and aho the waste; {p) · to prepare, in,conjunction with the research teams, specific contingency plans after undertaking risk· assessments and. reviey.,ing project proposals; (q} to enforce, with particular empha:iis bn Risk Category 3 work, all· recommendations, and ensure that the conditions of }fational Biosafety Committee.have been acknowledged and promptly addressed; (r) to inspect and certify; before use in geneticmaniplilation work; Cl leyel laboratories;'cdnventiortal animal ho.~ses~ PH r pfant glass houses, and qi.rnr~ntine and inedical faciliti~s fo; ihfected'.animaJs; an4 (s) t0 monitor and assess the :containmehtleatt.ires of ~nd the working 'coriditions',0ithin,all labora,tories, plM.{glMS h9use~ and animal houses sµppcn\ingtl1f' institutiqn's y.,ork, to eristir~hat the vatiousfaciliti,es are: rnafotaine.d .. at .the standards ahd .requirements delirie:ated in /4ppenciices 4 .thI"Q,Ugh]l of biof afety' guidelin~s.: . l 0. · 'fhe Bfo~Safety Officer (l,JSO).:-- (i) fostitution1., .arid organizations ·. •. , . • : ~ • ·,. . . .,,, ; . . . . . I -. ., , ' j eqgaged in bjotectmoJogy or1g~1w,tifmal).ipul~tij'.m '.W()rk sl}~Jappoint ordesigpate a Bio~Safyty Qfficer Cs) Wen cqnv~rsant with Qio-safety issues and erriergency.cquntcir measures to perform the foU6'vdng functioris; namely:"--· ' ( ~) · to ass.isJ and Iiaif.le with Ir1sti tutio.Qa[ Biosakty Coµunittee·: (b) (c) for.ev1ew m col)Jtinctioriwith the Institutional Bios'afety Committee a~d bi{. a "regula:r basis ~perating ·,proced).ltes · and bi6:Safety records, .. ,,. ..... ' "' ' ' . "' ,.j . ' aridtdassay the integrifyofcontaininent facilities and safety equipment or utilities; an(j to a dvilie on ali matters pertaining to risk and biosafety, 4ealth of personnei; contfogeh~ies at work and infri:ictions 6fbiosafety guidelines. 11. Prohibition ai1d Licence requirementi-(0 No personshail import, eX:jJort,·s~ll;,ptfrchase ortriide 11.vingrrtbdified 8rgariisms, st1bstri.hces or cells. atid'pfoducts thtreoffor,anypurposes, \vith6ut the prior obtaining of 1i~encefrom the' Federal Agen·cy: PA IIT II] THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 985 (2) Applicants seeking li 0 cence for activities shall submit an application prepared in conformity with the requirements of the Biosafety Guidelines to the ·Federal /. ""ency accompanied with a prescribed fee. (3) Any person to whom a licence has been granted shall notify the Federal Agency and the National Biosafety Committee of any change in or addition to the information already submitted. 12. Confidential information.-:-Information desjgnated as cpnfidential by the applicant shall be protected from disclosure in conformity with Article 21 of the Cartage-na Protocol as set forth in the biosafety guidelines,: 13. Risk assessments and risk management.--':-:-(1) The '\',1ational Biosafety Committee shall ensure that riskassessment ts carri~d out in adordance with the biosafety guidelines for a:11 ?Ctivities th at require a.-licence. (2) Risk assessment, mcluding the aµditing of-r:isk assessmet\ts ai:id evaluation of proposed risk managem~nt measures, and fi~ld trials sh allbe Lfried . ~~~i~~ ~-~a::dt:hrt:x ii~i~;i: ~~:::~~:1·i;~f::ci~ :a~;te;~!~-~~c~~:~i~~;~!~ guidelines. · · · · ·' · 14. Decisio~·making imclcoiufo.p.nication·ofdecision;+(l).A fi\al decisioifshall be made and toirimunicated to the applicant within~ (a) sixty days for Rjsk 'Category 2 and 3 :containep use activtties {as, specified in t~e biosafety guidelines); (b) ninety days for;experimentaf releases; an.cf . ; , ( C) {)[le hundred and •t~epty nays for commerdaliza.Udti; (2) Decisions shall be base.<bon informatiog s~t forth in the .application, scien:tific risk U§Sessment and prior fide! ex perience with theJivlng modified organisms ·in P~kistan. · ·· · (3) ·- Final decisions shall be recorded in a decisfori ·ciocument as de$cribed in the bibsafety gu,idelin1;:s. No person shall yaiy the putpos~ of the 1icencedacti'(ity as sd forth-jn--the decision docuIT1ent-unless he obttiins .a licence. (4). 'The. licence granted by the Federal Agen(:y under r(!le'11shall not take effect until the applicant executes an undertaking inwhichtheapplicanhissumes thilega] duty to ~Otnply with applicable provisions of the biqsafetygi;iideline,5 in existence ·as of the date of the licence. 986 THE'GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 [ PARTlI 15. Grant of licence.~(!) All grants of licences under rule '11 shall be subjected to, terms and conditions as to the labeling, control to be exercised by the. applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information or any other cortdition deemed appropriate by the Federal Agency . . ,(2) All approvals of the Federal Agency shall be for a specifie4 period not exdc:eding four years at the first im;ta.nce renewable for two years' at a ti'me. The Federal Ag~~1cy shall have powers to rev9ke,such approval in the followi~g situations; namely:~ . (aD if there is any nev,; iqforrnation as to ~he harmful effects of the genetically engjneered organisms pr cell~; (b) if the genetically engineered organisms or·ce;ills cause such damage to the environment, nature or health as could not hi ~nvisaged when the: approva~ was g1ven, or . ( c) rt on-compliance of any condition stipulated by the federal Agency. 16. Appli:cation for re-examinatwn..-;-:-(1) Any appiicant may file. appi1cation with the Natio.rial Biosafety Copgmttyeforre-examination after a minimµln tih:j/e of six µ10nths if the.,applicant ·considers that,:--,-, (b) a change in circumstan:ce has c;iccurred that may have a l?laterial effect on t~.e outcome of thefiskass·essin~\'lt upon whkh the- decision was based; or . additional scientific or te¢linical inforination has become avajlable thnt "may have:atilaterial effect OD the:q edsion intludingany conditi~ris, limita:ticins or requirementsimposed under an authonzation. 17, Special re'quirements'for import 3hd export oflivfog modified· organisms,~ 1 ). Liv.irtg modified organisms, subs1anyes ~r cells ~nd products th~reor imported for containe~ use, for i ntentional introduction into the environment, or for direct use a; food or feed or for processing sha11 be identified iii atcorda:nce'with the requifementlof -Articte 18 · of the ,Cartagena Protocol as set forth 'in the biosar~ty giiidf'.lines, and such import, where, i;equirtid, shall be in accordance witti these ,n1les and the N aticinal Plant Quar.aritine R<c!gl)latioris :aligned with International 'p] ant ,Protec;tion Convention. NI such imports will als'o be governed by the provision of lrripottTrade; Art<;! l'rocedures Order (IT &PO) and Export Policy and Procedures Oi·der (EPPO). . . . . . PART IT] THE GAZETTE OF PAKISTAN, EX;I'RA., APRIL 26, 2005 987 (2) Any person proposing to export living modified organisms, substances 1 or cells and products thereof shall provide all information inc Judi ng risk assessment and field trials to the exporting country and such export, where required, shall be in accordance with these rules and.the National-Plant Quarantine Regulations aligned with International Plant Prptection Co nvention. All such expor):s w1ll also be governed by the provision o( IT&PO and EPPO. 18. ·Transition and revi ews.-Activities that were ongoing pursuant to the pre-existing regulatory system at the date of the entry into forcv of these rules shall be@bject to the 'revi~w procedure ·set forth in rule 11 but may cqntinue: until such time as·a finai decision is provided fothe applicant: Any appUcatiorrpending at the ~ate cif the entry into force of these rules shall be subject to the provision ;of these rules. 19, . Production:-Prnduction in which iivin·g .rhodified -engineered . "· , . . I . . . . · organ{sms, substances.or cells, or;" product$ thereof or mici:p-organisrn,are·geriera:ted or used shall IlQ~ be commenced' except-y.,itli the c0nsent of Nation.al I}iosafety Committee. This s]:ia]I also apply to .production taking: place in connection with development, te~ting ~nd e'.:(periments. - ·20. Deliberate or unititeritii:m~l. release·, : o) Deliberat~ or unintentioriar reie?se ofhving modified organisms oihazardous .rhicr ocorganrsms, substances or cells and products thereof includingdeliberate release fol' the purpose ofexperiment is !1-otaJibwect: (2) National Biosafety Committee on the recommendations of the Technical Advisory Committee may in special cases give appro.val of ~eliberate ielease. 21: Permission and ;approval for certi,tin: substances.- Substances and prpduc:ts, which :contain "geneth,ally e11gj'neered organisms or cells' or :mici:o-. organisms sl}a11 not be produced, so1d, imported oi- .used except with the appttival of Natiorgtl Biosafety-Committee. ar'id fo · accordance with sub-ru1e (2)-6f rule 20. t ~' . 22. : Permission arid approytd for foodstuffs;~foodstUff$, ingredientE in· foodstuffs arid additi ves°tncludirig pioces'siqg aids containing or consist ing ofliving modified organfsms, subst;m~es or cells arid products thereofslmll not be produced, sqld, irqporled or used except with the approval of the NationalBicisafety Committee and in accordance with ,sub-rule (2) ofnile 20. 2.3; Res porisibHity .to notify interruptions· or accid,ents.~(]) ·Any person,, institutipn, or 'organization wJ:iether has obtained licence under rule 11 or not shall immediately notify the, Techhica) Advisory Committee ofany interruption of operations or a,cdderits that may lead to-disc harges of geneticaHy engineered ·organisms or cells which may be harmful to t he eriyironmen't, nature or health or ·. iiwoJve any ·aanger thereto. 988 THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 [ PARTil (2) Any notice given\mder sub-rule (1) above shall not lessen the duty of the person who is responsible'to try effectively to:minimize or prevent the effects of interruptions of operations of accidents. 24. Prep~rntion of off-site emergency plan by the Technical Advisory Committee.-(1) The Technical Advisqry Committee rriay prepare· an off-site ernergi:ncy plan for emergencies relating to a pbssible majbr accident and prepare a plan of action in consultatio n with all concerned. •. (2) For the purpose of enabling the Techn ical Advisory Ccimmit~ee to prepare lhe emerg<?ncy plan required u~der sub-rule (l); the person, instftl!te or organiiatiori shall provide· the Technic~lAdvisory Committee with such information relating to th~ handling 9f hazardous micrcic-9rganisms/genetitally en.gi~ee-red ·organisms under his. control a~ the Technical Advisory Committee may require including the nature; ex ten( and likt;:1/ off-site effe.ds bf a po~sible major accident . and the :techriic~l. Advisory Cdmqrittee sha!Cprovide the person:, institute or tirganization'with any information related to off-site emergen 9y blan. . 25. Information and ipspr.ctim;1s; -{I) A'..rty person seeking Iicenc·e o~ :- vho has ()btained li~ence uhdenule 1 J sh-aU iifthe directio~ 9f Technkal Advisory. Corrimitfe.e s1,1bn1it all such informa:tfoh deemed fieces~mj,°fohts f~ncti6nihg. (?): The'National Biosafety Committee or its iutl-joriied: officer 'inay a~· any reasonable time inspect or verify compliance of ariy conditi6n Jaiddownfo the licehce issued· updetrule It. :26. 'Fee.:-:-:- The Technical Adviso ry Committee may fix fe¢", with the , appi;oval 9f N at[onafBio~afety C<:lmmit,te9; fo c,6YJ:r, in ·whole or: in part, the expenses· iri.cutred by the aiithodties in ·co'n:nection with approvals, ~xamiriat[ons, superyision anct control. . . . . . , . . , . . . . . · · ... · 27.. PQwers to giye directions~ ~ m. The Federal Governrnentmay giye any ,o/ritte~ direction whichsfrallb~.bi1{ding Qn the Nqti9nal Jliosf!foty Comttlittee · or"the Tech~ical,Adviso-ry Commitlee·qcthe Institutional Biosafety Committees to comply with. File [2(7)/9,f Bio,] . Sdl:- . NOORtAMAN; Section OJji~er (Admn-l). PART II] . THE GAZETTE OF PAKISTAN, EXTRA., APRIL 26, 2005 989 MINISTRY OF WATER AND POWER Islamabad, the 21st April,. 2005 S.R.O. 337(1)/2005.~In exercise ofth,e powers confen:ed by sub-sec(ion (2) of the se;cti~n 10 ofFaktstan Engineering Council Aq, 1975 (V of 1976), the Pa)dstari Engineering Council· is pleas~d to inake the f oJlqwing furth~r arnendment in the Schedule I to the said Act, namely.,- . . fo~fie µ f'?t:esaid sc~e~4Ie, in ru:~ ei,istingentry f;3t:N'~.33, the Words· 'Jauhar' Ca,nipus' be repl,!.ced. by the \y6td~ "Jsl;1mabad Cflfllptfo": i'½q(P~~iri~,sl~t "Ba~is tar(~1igirzJieri1Jk•.:<;l'd~rit;il.: •-' . '- ' ' " ' '.,.-,' ;