Genetically Modified Organisms Amendment Act
This section amends and adds definitions for GMO-related terms such as accident, activity, release, contained use, and user.
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- South Africa
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- Act 23 of 2006
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About this statute
This section amends and adds definitions for GMO-related terms such as accident, activity, release, contained use, and user. This section sets up the Executive Council for Genetically Modified Organisms and lets the Minister appoint its members and alternates. This section says section 4 of the principal Act is being substituted, but the replacement text is not included here. The Council must advise the Minister on genetically modified organisms and ensure related activities comply with this Act. The Council is given wide powers and duties for GMO permit applications, accident response, notifications, coordination, and guidelines.
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Provisions of Genetically Modified Organisms Amendment Act
Showing 130 of 130
- 1 Verify source ↗
Section I of the Geiietically Modifid Organisnls Acl, 1997 (Act No. I5 of 1997).
AI-assisted research summary: This section amends and adds definitions for GMO-related terms such as accident, activity, release, contained use, and user.
1. Section I of the Geiietically Modifid Organisnls Acl, 1997 (Act No. I5 of 1997). [iiereinafler referred to as the principal Act). is liereby amended- 5 ( a ) by the subsiitution for tlie definition of "accident" of the following dcfinitioii: '' 'accident' means any= (IJ incidenl involving an [unintended general] uninteiilional eiiviron- mental release of genelically modified organisnls [which ceuld] __ tlial is likelv to have nn immediate or delayed adverse inipact on the 10 m\vonment or on Iiurnan or minial health within the Republic, or (ii) unintentional transhoundzy movement of zencticallv modified organisms that IS likely lv have an iiiiiiidiate or a delayed adversc impaci on the environinrnt or on hunmi or animal lhealtl~."; f b ) by the inseriioii after the definition of "accidenl" of !he following definition: " 'activity' means my activity with ewetically mcdilied tyganisms liut is not limited tn the ini!iirlatioii. exportatioii. uaiisit, develi)pnient, production, release, disirihulion, use, S I O J : ~ ~ ~ and applicatimi ot Feiieti- callv inodilicd orgaiiisins nnly;"; 15 i c ) by thc uiserlioi! afier the definition of "applicant" of lhe following definilioii: 20 'hiosafety' means the level of safety when risk rn~mageintnl measures ~~ planting of a genetically nioditied organism as a release into thc environment; ‘conditional general releaw’ nieims a release of a genetically modified organism under specific imposed conditions to replate or monitor the use of that genetically modified organism for a specified period ol time;”: by the suhstitution for the definition of “cmlained use” of the lollowing dkfinilion: “‘conhintd use’ means Ienr HCtiVitY in nhich orziinicms R r e 10 15 i n ” barriers or hotl; [are used tn li&t], [thereofl of the eenetically modified organisms with huni<ms. animals 25 aid the external environment md thelr milact on humans, animals and the that eNectivel\, limit cuntact environment;”; (si by the inseruon after the definition of “conrained use” of the following delinilion: ” ‘Convention’ means the Convention on Bialogicd Diversilv;”: 30 ih) hy the uisertion a i m the definilion of “environinent” of the lbllowing defini tinns: - orgkising, analysing, interpreUng and communicating information on I 35 suih activity; ‘extension ocrmit’ means a nerrmt issued for activities relaliiiz t o genetically inodiiied organism; for which a permit had been issued 1 previously;”; ~~ ~~ ~ (il by the sulistitulioii for the definition of “general release” of the Following 40 delinition: ”‘general release’ meaiis the [intrduction] reiease of genetically modi fied [nrgwnbms] organism inlo the environmelil by whatever means, where thc [organisms are] or!zaiiism is no longer conl:iiiied iby any system o f harriers [and AIY no longer under any person’s rontrnl, 45 so that the organism is likely to survive and be disseminated]."; by the insertion after the definition of “prescribed” of the lollowing definition: ( j ) “ ‘Pmtocol’ meaiis the Cartagena Protocol on Biosafety to the Conveii- tion. thal has Ibcen negotialed aid adopted by the Pmks to the 50 Convention, acceded t n hv the Republic oil 14 Au:ust the Prntocol is atlaclied ior iiiiomiaoon purposes i n the Annexure;”; 2003; A copy or ,~ ik) hy the insertion after thedefinition of “repu1ation”ofthe following dzfinition: “‘relcuse’ means release into the environment. and includes a trial release, conditional general release and general release;”: and . , ~ , ~, ~~ ill ~ ~~~~~ h\, the insertion after the definition of “this Act” of the followine defnition: ’, ‘transbsundary movement’ means the movement of ii genetically modilied organism from iiie Repuhlic to another countq or frnm amdier c(~untrv to the Republic;” (rn) by the substitution for the definition of “user” of the followiiig definition: 5 5 60 ‘’ ‘user’ means a person who cvnducts an activity with a genetically modified organism,”. hmendment of section 3 of Act ! 5 of l W 7 - 2 Verify source ↗
Section 3 of the principal Act ;s herd?!. amended-
AI-assisted research summary: This section sets up the Executive Council for Genetically Modified Organisms and lets the Minister appoint its members and alternates.
2. Section 3 of the principal Act ;s herd?!. amended- ( a ] hy Uie suhsttiution for r.ubsecIiCxi ( i ) of !he fo!iowing suhseclion. “ ( I ) There is hcrehy estddishrd a [cttuncil] !unsilc n e n s to t x known as tile Executive C:>uiicii i3r Gencncdliy Ivldilied Organisns, which shall consist of not more than [eight] members appointed by the Mmisler.”; ibl bv the insertion of the following suhsection: “(IA) For each member of the Couicrl referred to in suhsecliun (11, the Miimier iilay appoint an alternate. who may attend and vote at the meetlnp of the Council on behall OS the member if that member is unable toattend ”, and i c J hv the suhmtiition for parapaph f u ) of subsection (2) of the following . . . 5 10 pnra&rrdph: “ f a ) siiall he one officer of eazh of tlie fdlowii-.g nntional departinenis of 1 .i Staie. notmaled 1.v the re;evani drpar!ment: (i) The Departmcnt of AgriculLure; (ii) the Department of [Artc, Culture,] Science ;md Techtidog).: (iiij Uie Deparment of Environmental kBam and Tourism. (iv) the Department of I-leallh; (v) the Department of Labour; [and] (vi) die Denariment of Trade and Industry liie Departmen1 of Arts and Culture; -and (viii (viii) h e Department of Water Afidlrs and Foreslry, who shall have knouAedpe of modified organism? with regard io the sector represented 13). his or her department, includin: any existinc mhcies aid lepislali(in applicable wiUim that stctI)r.” the implications of genetically 15 30 Substitution of section 4 of Act 15 of 1997 - 3 Verify source ↗
The following section is hereby suhstituted Sor section 4 of the principal Act:
AI-assisted research summary: This section says section 4 of the principal Act is being substituted, but the replacement text is not included here.
3. The following section is hereby suhstituted Sor section 4 of the principal Act: 30 “Objwtives of Council - 4 Verify source ↗
The Council shall advise tlie Minister on all aspets concerning [the
AI-assisted research summary: The Council must advise the Minister on genetically modified organisms and ensure related activities comply with this Act.
4. The Council shall advise tlie Minister on all aspets concerning [the development, priduction, use, upplicntion nnd relence ofl relating to genetically mtrdified organisms, and [to] ensure thaf [nil nctivities with regard to the development, production, use, npplicntion 35 niid relcnse of] such activities [genetically modified orgnnisnis] arc perforined in accordance with [the provisions ofl this Act.”. Substitution uf section 5 of Act 15 of 1997 - 4 Verify source ↗
The following section is hereby substituted for section 5 OS the principal Act:
AI-assisted research summary: The Council is given wide powers and duties for GMO permit applications, accident response, notifications, coordination, and guidelines.
4. The following section is hereby substituted for section 5 OS the principal Act: “Powers nnd duties of Council 5. (1 ) The Council slid!- faj where an applicant applies in the prescrihed mainer for a pernui to in respect of genetically modlfied orgnnisn”’s conduct activities deterimjne whether that applicant must, in addition to his or her 40 application, subnut ai assessmeii~ in accordance wi!h tiit. I-elrvnni provisions of k k Kational Enviro~iniental Management Aci, 2998 (Act 'ton the environmenl and an assxmcnl No. 107 of 1998). of h e i cratioils of such a:ti\'iiies; of the socio-economic cc f h ) in consultation wiln the C o i m t t e e . uecide whether lo appmvr :in application- (i) Cii) for the use of facilities to conduct activities in respec1 oi genetically modified organisms; or to conduct any activity, except an actitity Sor which an extension pernul is required; ( c ) in considering an apilicatioii have regard to the iollowing factors Scientifically based risk assessments: and (i) (ii) proposed risk manageiiient mrasures; rd) deterrmne, in the event or- (i) (ii) an intentional change i n the use of a facility or an activity for which approval was p n l e d : arid being notified by lile user of ally inteiiiied chdngr. whether that user must re-;q'pI~ for approval: i c ) evaluate whelher the user irrplemented the iirescnhed iiotification (' prccedures in accordance wilh article 8 gf the ?rotoco!; in the eveiit of an accidenr. cklrrnune tile mruiiier of notilication a n i the infomation to he snhiilltled by a user as required in terms of t h i s Act; (I?) (8) advise the Minister on ways In avoid accidents in the Suture and OP measures to minimise any adverse impact on the conservation and snstninahle use of biological diversity including risks Lo hurnai and animal health; irnplcment appmpriate rneasurs regarding the manner of notification that must be given to an alTected or polcntially affectcu Sale. the Biosafety Clermng-House aid, wlicre appropriate. any rclewnl inteni:ttional organisa~ions. nf an uninrentional traiislxluiidv move. ment that is likely to have an adverse irtlp;ict on- (i) the conservalion and the sustainable use of biological diver- sity; or (ii) human and animal health, iij ( j J in such an affected or potentially affected State; provide an affected or potenlially atrected State with the prescrikc iiiformaticm in the iiotification referred to in paragraph ih); cnnsull with an affected or potentially alTected State imiediately aftei notifying that State of ai uiintentionnl transhoundar). niovenienl referred to in paragraph ( h ) , to enable that State lo Lake lhe necessarj actions, including emergency measures: 5 10 15 10 15 30 35 40 f k j satisfy itself prior to the Repnhlic entering into a bilateral, regional or niultilateral agreement or arrangement. including an a$reemeiit or mangemeiit on regarding uniiiieiitional transboundary mvemeiils, that the levcl of protection of human a i d animal heallh and the environment IS nnt lower than Ihe level of protection providei for in the Prolocol, and shall advise the Minister accordingly; inJorm the Minister- contingency plans (1) 45 50 (i) (ii) (iii) of any approval to conduct an activity contemplated in this Act arid to exercisr control over such an activity; of any notification received of an unintentional transbunday movement, and relevant such transboundary movement: in lhe event of an accident, of the propsed contml nieasures tn be implcniented to contain that accident; and information on any 55 (iv) of any other matler will1 regard tu gmetically modified f m ) make recommendations to the Minister on :he qi'~ (ill1 3f organisms: members to the Commllee; in) where the Couiicil has ixen iniornled LI!~ the rrgisrrar tnat there i s :I reas<mahle suspici.~n that 811 8ctivr:y is cc>nductrd mintrag to this Act or tic a condition conlamed in a perniil issued wider this Acl, determine- (i) (ii) a place or facilily whereto a geiietically modified organism used in such a activity or any niaterial or suhstaice used, affected or potentially affected by such activity n i u l be removed; and appropriate measures for the disposal or repalnation of m y geiietically modified organism used iii such activily or any matenal or substance used. rafected or potentially affected hy such activity. ( 2 ) The Council may- i n ) before miking a decision regarding an a;ydiiation subnxlled iii terms of' this section coiisider [he fullowing fac (i) Puhliz input. (11) (iii) the environriirntal imp:icl assessinciil; or the ptenliiil sxio-econoinjc impact of such aaivilies; ( h ) if the Council is satisfied Lhat the application coilforms wiih the factors in suhsection (1)ic) or pamydpli in), authnnse the registrar, in writing. to issue a permil on such term? and conditions as the Council considers necessary: i c ) in the event or ilfl accident, iiistruct the registrar to qyioinl ii panel tc enquire i n k <and report on the causes u i such accident, id) where an applicant applies for an entensioii perilill. consult witli the Committee on such issues as the Council may cmsider necessary tc come to a decision, l e ) promote co-operntion hetween the Republic and any other country with regard to research, development and lechnology transfer in t h t field of geiieiic modificalion of organisms and biosafety; with the consent of the Minister, approve and issue guidelines Soi activities with genetically mdified organisms and make such guidelines availahle to the public; (,fl ( g J if the Council receives new and relrvmit scientific or technological evidence a h u l activities coi~duclrd in term? of tlus Acl, which inay have an impact on h e factors reSerred to in suhsectioii (l)fc) or paragraph in), reconsider any decision taken by it: (h) co-opt any person knowledgeable in a specific field of scieiice to sen'e on the Couicil in order t o advise the Council on matters where the Couiicil considers i t necessw: invite witt.en coinnienls imni any person knowledgeable in a specific field of science on any aspecl of genelic modification which falls within (he Council's functions.". fi) Amendment of section 7 of Act 15 of 1997 - 5 Verify source ↗
Section 7 o l Uie principal Acl is hereby aniended-
AI-assisted research summary: Council decisions must be made by consensus, and the Council must call a special meeting when required by the specified triggers.
5. Section 7 o l Uie principal Acl is hereby aniended- fa) hy the substitution for subsection (3) of the Sollowing subsection: "(3) faJ A decision of the Council shall be reached on lhe basis ol consensus bv all memliers of the Council. i 10 15 30 25 3c 35 40 45 50 (11) In tlie event diat tile Council fails to reach consensus o n a dcc:sion such decision shall he considertit as havinp been rehusrd:’: ( b ) by the insertion of the following subsectim “(3A) The Council shall convenc a mecia! meetin: at such mx .- and p1,liice aid 01% wch uilte as detcrnuned i.i, tiit- cliain-.rrson- iai on ieceivt of a written requcst n); i i i t hlinis:er. Lbj on receip OS a written request signed ny a! least two membcrs; or icJ in the even1 of an accident conteinplatrd iii sectioii S( l)if).”, and fc) hy the deletion of suhsections ( 5 ) and (6). Substitution of section 9 of Act 15 of 1 9 7 - 6 Verify source ↗
The following section is herehy suhstituled for Section ? or tlie principal Act:
AI-assisted research summary: The registrar must check applications, manage permits, keep a register, arrange inspections, stop non-compliant activities, send permit applications and documents to the Council, and share specified information with the Biosafety Clearing-House.
6 . The following section is herehy suhstituled for Section ? or tlie principal Act: 5 10 “Functions of registrar 9. (l,’! The repisirashall. sul>jeci lo the instructions c r l and conditions laid down hy the Ccunci!- la) enamine whether an ap!iiicat!on conform to tlic requiremcms of ihis Act; i b ) issue a permit or an extension perrmt in the mimner prescrihed: f c j amend or withdraw a ~-.ermiC or an extension perrmt issued under tins l i i I Act; id) satisfy himelf or herself that all users apply ihe appropriale measures to protect the environment and human nnd animal hedth during the exercise of any activity with genetically m(dified organism: and attend to any nther niatter with regard l o hiosafely of geiietically modified orgainsms. (2) The registrar shall- ( e ) ia) having regard io section 18, maii!;ain a regisler of- (i) iii) (iii) all the facilities i l i a are used ior contained use; a11 the trial release sites; and the names and addresses ( i f the persons involved with such contained use or trial release; (0) mange for an inspection by an inspector, in the mmner contemplated in section 15, of any activities or facilities where such activtties are undertaken: ic) where the registrar has ascertained or suspects on reasonahle pmunds thal an activity is conducted contrary tc\ ths Act or to a conchon contained in a prmit or an extension prrmt issued under tllls Act require the cessation of m y such activity: (dl submit to the Council the application ror a permit together with all the prescribed documents and ;my other documentation the Council may require to make its decision; and i e j communicate to the Biosaiety Clezuing-House tlie inionnation s p c i - 20 ?i 30 15 10 fied 111 the regulations. ( 3 ) The registrar m y , subjecl to such tern< and conditions laid down hy the Council, issue an extension permit for an activity in respect of genetically modified organisms for which a pemiit had heeri ~ssued previously.” 15 Amendment of section 10 of Act 15 of 1997 - 7 Verify source ↗
Sectim 10 of the principal Act i s herehy amended by the suhstitution for paragraph
AI-assisted research summary: This section amends section 10 so that two persons must be from the public sector, with one knowledgeable about ecological matters and genetically modified organisms and the other knowledgeable about the potential impact of genetically modified organisms on human and animal health.
7. Sectim 10 of the principal Act i s herehy amended by the suhstitution for paragraph = . . , ibj of subsection ( 1 ) oi the followinc naramauh: “(hi two persons shall he from the public sector [nndl, of which one person shall 50 have kiowledpe of ecolopical matters and genetically iiiodified orcmisms. and the other- person shall have knowled& of the potential iiipact (1: genetically rnodilied o r t a i i s m oii hunun and antii~:il licalth.” Amendment uf section 11 of Act 15 of 1991 - 8 Verify source ↗
Section 11 of the principal Act is iierel2y anmxied-
AI-assisted research summary: The Committee may advise officials and bodies on organism modification matters, and may seek input from knowledgeable scientists on genetic modification issues.
8. Section 11 of the principal Act is iierel2y anmxied- fi;) ly the suhstilution 111 p a r a p p l i / h J oi subseaim (I) for the words ;Ireceding suhparagr:!ph (1 ! of the inlkwing words: advise:, on request or OS its own accord. the Minister. the Council, & repistrar, other Ministries and appropriate bodies. on matters concerning modification oi organisnx and. rnrer alia. advise L h e n t ' . : -tic and ( h ) by the suhstilution for paragraph id) of suhsection ( 1 ) of the following p a r a p p h : " i d ) co-opt or invite written cnmments from knowledgeable persons specific fields of science nil any aspect of the genetic modificalion 01 organisms which lies wiiiiin the Coinnuttee's IhieS. 10 assist the Cnrmiutke in performini. its Iuictions." Amenclment of section 12 nfAc1 I5 of lW7 5 10 15 - 9 Verify source ↗
Section 12 of the principal 2 c t is liereby mended hy the subsitutioii for subsectim
AI-assisted research summary: The Minister, with the concurrence of the Minister of Finance, may determine the remuneration paid to committee and subcommittee members and certain other members.
9. Section 12 of the principal 2 c t is liereby mended hy the subsitutioii for subsectim ( I ) oS the following suhsectlon: " ( I ) Tu nizmkrs oilhe Conunittee. suhcommittre rnernkrs and the [meniberl members reSeiTcd to in [section] seaions 3(2)fr)- shall he paid such reinuneration 3s the Minister, with the concurrence of the Minister ot Finance, imy determine." 20 Amendment of section 15 of Act 15 of 1997 - 10 Verify source ↗
Section I S OS the pnncipal Act is hertby amended-
AI-assisted research summary: This section amends the principal Act by replacing paragraph text about seizure of items, notice to owners or controllers, and removal of seized items at the person's cost.
10. Section I S OS the pnncipal Act is hertby amended- f a ) by the ruhstitutton for paragraphs 111, and id of subsection (4) of the following paragraphs: " ( c ) lo seize any appliance, hook, stalrrnent [or]l docuiiient or ~eiieticall\; modified o r p i i s m aid take sampirs of material or suI>s(iiiices which a p p a r to provide proof of a contravention oi any provisioil oS this Act: id) to give notice to the owner of any material, suhslaalce. genetically modified organism appliance. hook. statement or document seized under )xaragrqih ic) or to the person who had control over it immediately hesore any Seizure under [ s u b p ~ r a ~ w p h ] paramaaph fci to remove the seizrd ikms a1 such person's nun cos[ within a period and to a place specified in wch nolice." and ihl bv the addition to subsection (4) oi tile Sollowine naramanh Amendment of scrtion 17 of Act 15 of 1W7 - 11 Verify source ↗
Section 17 of the principal Act is hereby mended-
AI-assisted research summary: Users must take appropriate measures to avoid harmful impacts from genetically modified organisms, and users are generally liable for damage caused by GMO-related activities.
11. Section 17 of the principal Act is hereby mended- i n ) hy the substitution for suhsection ( I ) o1 the following subsection: " ( I ) Users shall ensure that appropriate measures are taken to avoid an adverse tmlxict on the erivironmenl and human atid animal health uztlich m.iy arise froin the use of genetically modilicd organisms."; i h ) by the insertion of the following subsection: registrar of thc daixige and i n coiisultation with the registrar invesugatc. assess ,and evaluate the ildmage caused hy the activity (in the environ- ment and human 'and animal health and impleinent nieasures incluchng hut not limited tc- 25 30 35 40 4s 50 fh) minimise, contain or yrevent the move:nent of w y gcnetically modified orp~iilsmn? causmg the damage ir, the even! that an activity clannoi reasrmably he avoided or diipped; f c j eliminate ail? source of !he damage; or id! reinedv the effects of lii: damace caused l b v the a c t i v . ~ ~ . ” : and 5 i c j by the suhslitution for subsection ( 3 ) oi‘ the following subsection: “(2) The lirlhility for damage caused by [the use or relensr ofl aclivities relatiny to a geneiically modified orgaiism shall he home IT? the user concerned: Provided Uiat when such an ormnism was in the possession of an inspector as sei out in section 1.5 (4), the user concerned 10 at the time of such [use or relrese] aCtlYlly shall not be held liable for uiy d;mlage unless such user foresaw or should have foreseen such damage and could or should have prevented Uie daniafe hut failed to lake reasonable action to urevent such darnace. - lnscrtion of scction 17A in Act IS of 1997 - 12 Verify source ↗
Tlic follou7ing section is herehy iirserled In the principal Act ;iiles szciion 1::
AI-assisted research summary: The Council may recover costs, and affected people may appeal a costs order.
12. Tlic follou7ing section is herehy iirserled In the principal Act ;iiles szciion 1:: “Recovery of costs 17A. 11) Suhject to subsection (2), the Council may recover all costs incurred as a result d i t acting under section 17(3) or sectiori S(1)inJ. (2) The Council m y 111 respecl or the recovery of coslc under suhsection (11, claim pmprirtioiially from any other person u-nc txnelited t‘roin the measures undertakeii under scctioi? l i ( 3 ) or Yecction 5(1jtn). 13) The costs claimed under suhsecrions 11) and (2) must he reasonable and m y include, without heing liiiuied to, Ialmur, adminisiralive and overhead costs. (4) If inure than one person is liable under subsectiuii (21, the Council IlluSt, at the request of any of those persolis, and after having given the others an opportuniiy to he heard. apprtion the liahiiity, hut such apportionment does not relieve any of them of their joint and several liabilities for the rull atnoun! of the costs. ( 5 ) Any urder referred 10 in suhsectiuns (1) and ( 2 ) sliall have the effect of civil judgment in a inagis!rate’s court. (6) Any person afiected hy a11 order for costs awarded under this section may l d g e an appeal lo the appeal hoard in the manner contemplated in section 19.” hmendment of section 18 of Act 15 of 1 9 7 - 12 Verify source ↗
Section 18 of the principal Act is hereby amended-
AI-assisted research summary: The section amends application-content requirements for genetically modified organism matters.
12. Section 18 of the principal Act is hereby amended- f a ) by the suixtitution for paragraph (a) of subsectioii (21 of the foilowirig ‘ i n ) the peneral description of the genetically mdified organisms, the name and address of the applicant, and the puqnise afthe contained use or release and the locat~ot~ of use:”; aid ib) by the suhstitulii~n for paragraph fc) of suhsection (2) of the following 20 35 30 35 40 45 paragraph: paragraph: fc) [the evnluation of fomswable impactv, in particulnr any pathogenic or ecolo&illy disruptive imparts] the s u i n n ~ w ~ of the scientificallv bused nsk a ~ ~ e ~ ~ i i i e i i l environment a i d human and animal hedth.” of the impact on the SO Amendment of section :9 of Act 15 of 1997 - 13 Verify source ↗
Section 19 of the principal Act is hereby ai~iended-
AI-assisted research summary: This section changes appeal-board procedure, including appointment timing, ministerial designation of a chairperson, the board’s decision-making powers, and publication of decisions.
13. Section 19 of the principal Act is hereby ai~iended- ra) by the stihsii~uiion for paragraphs i m ] and ( b ) of suhscclion ( 3 ) of t!le iollowin~ naragraiihs resuecti\ e!% - L . j “rni An spptal l&rd ~1x1~1 he appointed within 60 days rronr the date of receipt of the appeal hy the rreisisar, providcd thar the Minister may. if he or she considers i t necessml: extend the pencd IT another 70 davs and sh:dl consist of rthe n e r s ~ n or1 ixrsons who. in the ot>inion of the Minister, [hns or] liave expert knowledge of the matter on a p p a l axd who [is or] are otherwise suitahle to [decide on the issues ofl decision on the appeal concerned. ~.~ _ I . I ~~~~~ ~ 5 10 ih) [IF an nppwl board consistinx of more thnn one person is appointtd, the] E MiuisLer mall d e s i p t e one or the iirrinl-ers & appeal lxlaid as chs~qxrson or thni appeal board.”: 15 of the foliowinf sulmctlon: i b J by the suhstitution for suhsection (:) “(4) An appeal h o d . n x - fa) confirm, set aside. suixiirug or amend Uie decisim or aclion concerned, whicb is ti:: suiT!cct of the ap!wll: (h) refer the relevant mttzr back to U x regstrar for reconsideralioi; by the Councll; For1 ~. ( c ) alter due consjderation of the potential risks and ptenlial henefits related lo the matter of appeal, make such other order M i t may [deem] - fit in order to miiiimise a significant negative impact on the enviroiimmt or humin and animal hcalth: (dl in niakinE a decision- 9 oiik follow tlic iire:;criLxd procedures; and (ii) consider i i w scieiitific o: ieduiicnl evidence or any other inloriniatioii that is, in the oi7iiiion of tile apileai hoard, directly applicable to thr appeal.^'; and fc) by the substitution for suhsec.Iion (6) of the following subsection. “(6) The fuli decision of an appeal board, together with l k reasons therefor. shall he reduced to writing[,] a1d [copies therwf shall bel furnished to the Minister, the repistrar aid all pnrtics directly involved in the appeal. and made availalile to the public. wthm 30 days ;liter the final decision has heen taken [whereupon]: Prnvided that the Minister may necessq.’. take such further action as he or she may [deem] 20 2s 30 15 Amendment of section 20 of Act 15 of 1997 - 14 Verify source ↗
Section 20 of the principal Act is hereby amended-
AI-assisted research summary: This section amends section 20 of the principal Act by changing permit-related wording and adding topics about risk assessments, environmental impact assessments, accident-notification information, and the Biosafety Clearing-House.
14. Section 20 of the principal Act is hereby amended- ( a ) by lhe sulistituuon for paragraphs iaj arid f h ) of suhsection ( 1 ) of the following paragraphs respectively: “ i d regarding the applications for and [the issue of pcrmiL~1 the period within which a decision on an application must be takeii in tenns of this Act. 40 ( b ) prescribing the pmcdure to ix followed hy an applicant for the purpose of drawing up scientifically hased risk assessinents, [and] environmental impact assessineiits, smio-economic consideratioils and risk manage- men1 measures, Tor submssion to tile Council i n terms 01 this A d ; ” ; auld ib) hy the inserlirin in suhsection (1) of the following p a a p p h s after paragraph 45 (Pj “(PA) regarding the content of Ihe information that a user, in the event of any SO accident involving genetically niodilied org:uiisn~s, is required to 1 supply to the registrx; regarding the rnaiiiier and content of the information that must he contained in the notification contemplated in section S(l)ih); regarding matlers concerning the Biosaiety Cle‘xing-House; 55 (pBJ (pC J 20 K”. m o i Arl :he. 2 . ZOlG GOVFIIWCIT i:/rzr.rn.. i i A P K I L ? ~ ~ ~ ___I_-_ C;FNEi’lCAI.LY MOI1II:lEI.~ OK(;AYISMS AhIL~\DMEh”I AX. 20W Amendment of section 21 of hct 15 of 1997 - 15 Verify source ↗
Sectinn 21 of the principal Act is herehy m e n d e d by the sulWitulion in suIY.ecIIiIn
AI-assisted research summary: This section replaces rules so that a person must not break the Act or any rule made under it, must respond to lawful questions from specified officials, and must not give false or misleading information.
15. Sectinn 21 of the principal Act is herehy m e n d e d by the sulWitulion in suIY.ecIIiIn ( I ) for para-pphs fa) nnd fc) of the SoJIL>wing paraFraphs. resnecti\,ely: “ i n ) contravenes or Sails to coriimlv wiii tlus Act. a::\ condtcon. restriction, prohihition, res-wa!ion or dirdixve i i n ~ x e a or issued in term oi tins Act: 5 fc) refuses or fails to furnish iniormatioii or give ill) expicmation o r to reply 10 the hes! of his or her [ability] knowledge 10 a question lawfully deinanded from or put to him or her hy h e registrar, CommitLee, Couicil or any inspectirr I n the performance OS his or her lunclions in t e r m OS this Act. or furnishes infomtion, an explxnation or areply to the regstrar, Conunitlee. Council or any inspector which is false or Iiiisleadmg. knowing that it i s lalse or misleadmg; or” Substitution of lnng title of Act 15 of 1997 - 16 Verify source ↗
The following long title is iierehy sulistituied for the Ion? tille of the prii~cipal Act:
AI-assisted research summary: This section substitutes the long title of the principal Act with a title about measures for genetically modified organisms, including responsible development, protection of the environment and health, risk evaluation, and notification procedures.
16. The following long title is iierehy sulistituied for the Ion? tille of the prii~cipal Act: ‘.ACT I O 15 Tc provide for iiieasures to promote the responsihle developinent. production, use and application OS genetically modified orpinism; to [ensure that] provide Tor an adequate level of protection durin.e all activities involving [the use ofl genetically modified organisms [(includ- ing importation, production. relcase and distribution) shall he carried 20 out in such a W R Y as to limit aossible harmful cnnst‘quences tu the mvimnment] that may have an adverse impact on Uie coiise~viiti~~& sus1;iinahie use ol hioioyical &versi:y human aid animal hzaltk l c i ylvr attetiiion to the prevenlion of accidents and the efieclivt managenlent of waste. to establish cormnon measures fur the evaluation and rwIi~ctJon of 25 the poteiitial risks arising out of activities involving tlie use of :meiically nioditied oreanisms; to lay down the necessary requirements aid criteria that genetically niodihed organisms a e appropriate and do not present il hazard to the environment; and to establish appropriate procedures for lhe notification of specific activities invoiviiig Ux use of genetically mcidified organisms; a i d to provide for matters connected therewith.” Short title 35 - 17 Verify source ↗
This Act is called the Gmetically Modilied OrFanismsAmrndrnenrAc(. 2006. arid
AI-assisted research summary: This section says the Act starts on a date fixed by the President through a proclamation in the Gazette.
17. This Act is called the Gmetically Modilied OrFanismsAmrndrnenrAc(. 2006. arid comes into operation on a date fixed by the President l y proclanation in the Gizulrc. ANNEX URI? CARTAGCNA PROTOCOL ON RIOSAIXTY to the Convcntion on Biological Diversity The Parties to this Protocol. 5 Being Parties to the Convention 011 Biological Diversity. hereinafter refemd to as "the Convention", Recalling Aniclr 19, paragraphs 3 311d 4, and Articles gig) aid 17 of Uie Coiiveiiti(m, Recalling alsu decision I1/5 of 17 Noveiiiher 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosaiety. specifically Socusing on 10 transboundcry movement of any living imdified orpnism rrsultmg ircm modern biotcchnolop ilia1 may have advcrse eifeci vn the conservaiioii an(! suslainalde use of l?ioIii,oical diversity. serting nut iur consideralion. in particular, appropriak pmxdures Sur 3dv;ince iiifornied agrcenieni. Reaffirming the precautionan, approacli cnnt;i:ned in Principle :5 vf the Rio 15 1kcl:uation 011 Environment and De\riopT:itnt, Aware of the rapid expansion of modern hiotechnolo~y and tiie emuing puhlic concern over its potential adverse effects on biological diversity~ laking also imo account risks to human health, Recognizing tkat mdem biotechnology has great potential for human well-being 20 i i developed and used with adequate safely measures ior the environment and human health, Recomizing also die crucial imptance til humankind of centres of origin aid centres oi griietic diversily. 'Inkinl: into account the limited caphilities of many cnuutries. particularly 15 developing countries. to cope with t h r iiaturc and scale of known and poteniii:l risks associated with living modified orpmisms. Recognizing that trade and environinent agreements should he mutually suppnrt- ive with a view to achieving sustainable development, Emphesizing that this Protocol shall not he mterpreted as implying a change in the 30 rights and obligations of a Party under any exlsting international agreements, Understanding lhal the above recital is not intended to suhordinate this Protocol to other intemational agreements, Have agreed as Sollows: Article 1 OBJECTIVE 35 In amnrdance wilh the precautionary approach contaiiied in F'nnciple 15 of the Rio Declaration on Environment and Development, the objective of this Proloco1 is to contribute to ensuring an adequate level of prntectitm in the iield of lhe safe transfer, handling and use of living modified organism? resultinp Smm modem biotecluiology 40 that may have adverse erects on the conservation and susiainalde use of hiolopical diversity. taking also into account risk to human health, and speciiically i ~ u s i ~ g on lranshoundq movements. Article 2 GENERAL PRO\'ISIONS 45 - 1 Verify source ↗
Each Party shell take necessary and qyropriate le@, adininistrative and other
AI-assisted research summary: Each Party must take necessary and appropriate legal, administrative, and other measures to implement its obligations under this Protocol.
1. Each Party shell take necessary and qyropriate le@, adininistrative and other measures to implement its obligations under this Protocol. - 2 Verify source ↗
The Parties shall ensure that the develvpnienl, handling, transport, use, vansier and
AI-assisted research summary: The Parties must ensure activities involving living modified organisms reduce or prevent risks to biological diversity and consider risks to human health.
2. The Parties shall ensure that the develvpnienl, handling, transport, use, vansier and release oi any living minlifird orp;misnis are undertaken in a manner that prevents or reduces the risks to hiolopical divcrsity, laking also intii account risks to human health. 50 - 3 Verify source ↗
Nothing in t t u s Protocol shall an'ecc in a i y way the sovereignty of States m e r thcir
AI-assisted research summary: This provision says the Protocol does not change states’ sovereignty and related maritime rights, or navigation freedoms under international law.
3. Nothing in t t u s Protocol shall an'ecc in a i y way the sovereignty of States m e r thcir terntorial sea es1;iblisIied in accordance with international l a u . and Oie sovereign riglits and h e jurisdiction which Slates have in their excluive economic zoiies and their continental shelves in accordance with intenWionnl l : ~ , and the exercse 11y ships mid aircraft of all States of navigational righ!s aiid Sreedonis a6 provided lor i n iiirtrnnliiliin! law and as reilested in relewnt iiitemniioiuil iiislrunxnls. - 4 Verify source ↗
Nothing in ths Prolwol s h d ixmierpreted a restricting thenFht c’f a P u t y 10 kike
AI-assisted research summary: A Party may take more protective action for biodiversity conservation and sustainable use than the Protocol requires, if the action fits the Protocol’s objective and provisions and complies with other international law obligations.
4. Nothing in ths Prolwol s h d ixmierpreted a restricting thenFht c’f a P u t y 10 kike aciion thal is more protective of the consemailon and su<taiu&ilc u t of iiioloycal dsvcrsity than that called for in this Proiocal. prwidcd that such action is consisteni wit!i the ohjective nnd ttir provisions of tiis Protocol and is in accordance with thal Paris’s other obligations under international Iau. 5 - 5 Verify source ↗
The Parties are encouraged to take into account, as appropriate. available expeitist‘.
AI-assisted research summary: The Parties are encouraged to consider available expertise, instruments, and work from international forums on risks to human health. The section also defines key terms and says the Protocol does not apply to human pharmaceuticals covered by other international agreements or organizations.
5. The Parties are encouraged to take into account, as appropriate. available expeitist‘. instmmnls and work undertaken in international iorums will1 competence in the area of 10 risks to human health. Article 3 1lSE OF TERMS For the purpoqea of this P r o t ~ o I 20 the i5 “Conference uf the Pariier” mcms b e Conference of thc Pmies LO Convention; “Contained use” means m y opera!ion, undertaken within n facility. iiistalla- tion or other physical structure. which Involves iiving midified orgnnisnls thal are controlled by specific measures that effectively limit tlieir coiltact with, cmd their impact on, the external environment: “Export” me‘ms intentional uansboundar). movement from one Party to another Party: “Exporter” means any lepal or natural pason, under the jurisdiction of the Party of export. who manges for a living rnodilied nrgnnisin 1:) ix exported “lnipori” nirrms intentional traishoundary iiiovemrnt iiito one Party from 35 another Party; “lmpoiler” means any legal or natural person. under the jurisdichrm of the Party of import. who ;irr:inges fix- a living modified organism 10 he impcwteii; “Living modified organism” means any living organism that possesses a novel combination of genetic malerid obtained t h r o u j tlie use of iiiodern 30 hiolechnology; “Living organism” means any hiological entity capable of transferring or replicating genetic material. including sterile organisms, viruses and viroids; “Modern biotechnology” means tlie ilpplicatiim of: a. iiucleic acid teclmiques. including recornl%nnit dcoxyrihe 35 nucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or reprmiuctive or recoml>inatioii harriers h. Fusion of cells kyond the taxonomic family, that overcome natural ~ ~ l i y ~ i ~ l ~ g i c a l ancl that are not tec!iniques used in traditioiid breeding and selection; “Regional economic integration orgaiiization” means an orsanization consti- tuted by sovereign States OS a given region, to which its rnrmber Staitx h a w transferred competence in respect of rnattem governed hy this Protocol and which has heen duly authorized, in accordance with its internal procedures, to sign. ratify, accept, approve or accede to it. “Transl~nund‘ay movement” means the movtment of a living niodified organism from one Party to another Party, save that Cor the p q m s e s of Articles 17 aid 24 transhoundary niovemen! extends to rnovriiienl het.ween Parties mid non-Parties. Article 4 SCOPE 40 45 50 This Protocol shall apply to the transhoundary mo\wnent, transit, handling and use of all living mcidiiied organisms that may have adverse effects on the conservation aiid sustainable use of hiological diversity. taking also into account risks lo human health Article 5 PHARMACEUTICALS Notwi!hstaiidiiiFArliclr 4 and without prejudice 10 any right or: Part) to subjirci ;ill living modificd orgmisms to nsk ilssessment ]xior ii’ the making oi Litcisions 011 import, inis Protncol shnll not apply LO the trcmsbouir~lary niwement of living moditied organisms whch are pharmaceuticals for humans that are addressed by other relevant international ageements or organisations. 5 Article 6 TIMNSITAND CONTAINED USE - 1 Verify source ↗
Notwithslanding Article 4 and without prejudice to any naht ol a Party of tritllsil to
AI-assisted research summary: The advance informed agreement procedure does not apply to living modified organisms that are in transit.
1 . Notwithslanding Article 4 and without prejudice to any naht ol a Party of tritllsil to rebwlate ilir IriLnspfxt of living modified orpmisnrs through 11s territory and make available to the Biosafety Clearing-House. any decision nf thal Part 2, paragraph 3, regarding thz lral)s~t lhrough its terriln?. of a spec orpnisni. the provisions of this Proiocol with respect to ine adviince infcxmed agrrenieTi! pincedure shnll not npply to livinx modified orxnnisms in transit. I O 15 - 2 Verify source ↗
Noiwitlxtanding Article 4 and without prejudice io m y right of it Party Lo sui,j!ect
AI-assisted research summary: The Party may risk-assess living modified organisms before import decisions and set contained-use standards within its jurisdiction. The advance informed agreement procedure does not apply to transboundary movement of living modified organisms for contained use if it follows the Party of import’s standards.
2. Noiwitlxtanding Article 4 and without prejudice io m y right of it Party Lo sui,j!ect all living mociilied organisms to risk assessment prior to decisions 011 import and lo sei standards for contained use within ils junsdction. the provisions of this Prolocol with respect to the advance informed agreement procedure shall not apply to the transhoundivy movement of living moditied organisim destined for contained use 20 undertakeii in accordance with the standards of the Party of imlion. Article 7 APPLICATION OF THE AIWANCE INFORMED AGREEMENT PROCE- 1)URE - 1 Verify source ↗
Subject to Articles 5 and 6, the advance informed aFeement procedure in Articles 25
AI-assisted research summary: The advance informed agreement procedure applies before the first intentional transboundary movement of living modified organisms for intentional introduction into the environment, subject to Articles 5 and 6.
1 . Subject to Articles 5 and 6, the advance informed aFeement procedure in Articles 25 8 to 10 and 12 shall apply prior to the first intentional transboundq movement of living modified organisms for inlentional introduction into the envirnnment of the Party of import. 2. “lnlentional introduction into Lhe environment” in paragraph 1 almve, does irot refer Lo living iiiodilied organisms intended for &rect u‘e as food or feed, or for 30 prrxessing. - 3 Verify source ↗
Article I1 shall apply prior to the firs1 transboundary movement of liviiig modified
AI-assisted research summary: This provision says Article I1 applies before the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.
3 . Article I1 shall apply prior to the firs1 transboundary movement of liviiig modified organisms intended lor direct use as lod or Iced, or for processing. - 4 Verify source ↗
The advance inlormd agreemeirc procedure shall no1 apply lo the intentiix~al
AI-assisted research summary: The advance informed agreement procedure does not apply to certain intentional transboundary movements of living modified organisms, and the Party of export must notify the Party of import’s competent national authority in writing before such movement.
4. The advance inlormd agreemeirc procedure shall no1 apply lo the intentiix~al transhoundivy niovemem of living inodiiied orFanisms identified in a decisim of the 35 CoirTerriice 01 the Parties serving a lhe mcetinf of the Parties to this Protocol as being not likely to have adverse eflects on lhc wnst‘natioii ;ind susiainahle use 01 l ~ i n l o ~ i c a l diversity, laking also into accounl risks LO human health. Article 8 NOTIFICATION 1 The Party of exporl shall notify, or require the exporter to ensure notification to, in writing, the competent national authority of the Party of impori prior to Uie intentional Wnnshoundary movemeiil of a living modified organism that falls within the scope of Article 7, paragraph 1. The notilicauon shall coirtain. at a imninium, the informition spedied in Annex 1. - 2 Verify source ↗
The Party of export shall ensure that there is a legal requirement for the accuracy
AI-assisted research summary: The Party of export must ensure there is a legal requirement for the accuracy of information provided by the exporter.
2. The Party of export shall ensure that there is a legal requirement for the accuracy of informalion providd by the exporter. 40 45 Article 9 A C K N O W L E I ~ G ~ h 1 E ~ l O F I 1 E C E r P T O F N O T ~ l C A ~ 1 0 N - 1 Verify source ↗
The Party of import slid1 acknowledge receipt of the notification. in writing. to the
AI-assisted research summary: The Party of import must acknowledge receipt of the notification in writing to the notifier within 90 days of receiving it.
1 . The Party of import slid1 acknowledge receipt of the notification. in writing. to the notifier wilhin iiinety dzys of its receipt. - 2 Verify source ↗
The achowled~ement shall state:
AI-assisted research summary: The acknowledgement must state the date of receipt, whether the notification appears to contain the Article 8 information, and whether to proceed under the domestic regulatory framework or Article 10.
2. The achowled~ement shall state: 5 fnj The date of receipl of the notification: ( b ) Whether the notificatioii, prima facie. contains the infummation referred lo in Article 8; (c) Whether to proceed accordmg to the domestic rcplalory framework of the Party of impiin or according lo the procedure spzcified in Article 10. - 3 Verify source ↗
The domestic regulatory framework referred to in parapapli 2fci akwe, shall he
AI-assisted research summary: The domestic regulatory framework referred to here must be consistent with this Protocol.
3. The domestic regulatory framework referred to in parapapli 2fci akwe, shall he 10 ~ ~ n s i s l e n t with this Protocol. - 4 Verify source ↗
A failure by the Party of import to acknowledge receipt of a notification shall not
AI-assisted research summary: If the Party of import fails to acknowledge receipt of a notification, that failure does not count as consent to an intentional transboundary movement.
4. A failure by the Party of import to acknowledge receipt of a notification shall not imply its consent to an intentional tra~isl~omdary niovmient. Article 10 DECISION PKOCEDIJRE - 1 Verify source ↗
Decisions taken I y the Party of i m p r t shall be in accordance with Article 15.
AI-assisted research summary: Decisions taken by the Party of i m p r t must be in accordance with Article 15.
1. Decisions taken I y the Party of i m p r t shall be in accordance with Article 15. - 2 Verify source ↗
The Party of import shall. within the period of time referred to in Article 9, inform
AI-assisted research summary: The Party of import must inform the notifier, within the period referred to in Article 9, whether the intentional transboundary movement may proceed.
2. The Party of import shall. within the period of time referred to in Article 9, inform the notitier, in witin:, whether the intentional trmshoundary niovenienl may proceed: in) Only after the Party of iniport has given its written consent; or ( b ) After no lex$ than ninety days without a subsequent written consent. - 3 Verify source ↗
Wiltun twohundred and seventy davs ofthe date ofreccipt ofnotificlilion. thePnrty
AI-assisted research summary: The Party of import must send its decision in writing to the notifier and the Biosafety Clearing-House.
3. Wiltun twohundred and seventy davs ofthe date ofreccipt ofnotificlilion. thePnrty of iniprt shall communicate, in wntinp, to Uie notilier and LO the Blosaiety Clearing-House Uie decisivn referred to in p;rra~rapIi 2r a1 alxive: Approving the import, with or M,itiiou;condilions. inchiding how the decision will apply 10 suhsequent imports of the same liviiif niudiiid organism. Prohibiting the import; Requesting additional relevant infurmalion in accordance with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is to respond, the numlwr of days i t has tn wait for additional relevant informalion shall not be taken into account: or Inforning the notiiier that the period specified in this paragraph is extended hy a defined m n o d of time. - 4 Verify source ↗
Except in a case in whch consenl is unconditional. ii decision under paragraph 3
AI-assisted research summary: A decision under paragraph 3 must state the reasons on which it is based, except where consent is unconditional.
4. Except in a case in whch consenl is unconditional. ii decision under paragraph 3 above, shall set out the reasons on which it is hased - 5 Verify source ↗
A failure hy the Party of impart to c~mmunicate its decision within two hundred
AI-assisted research summary: If the Party does not communicate its decision within 270 days after receipt of the notification, that failure does not count as consent to the intentional transboundary movement.
5. A failure hy the Party of impart to c~mmunicate its decision within two hundred and seventy days of the dale of receipt of lhe notification shiill no! imply its consent to an intentional transhoundary movement. - 6 Verify source ↗
Lack or scientific certainty due to insufficient relevant scientific information and
AI-assisted research summary: If scientific certainty is lacking, that does not stop the Party of import from deciding on the import of the living modified organism.
6. Lack or scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse efecls of a living modiiied organism on the conservation and sustainahle use of hiolopical diversity in thy Party of import, taking also into account risks to human liealth, shall not prevent that Party Fnom laking a decision, as appropnale, with regard to Uie iinport of lhe living modilied organism in question as referred to in p:uagraph 3 above, in order t o avoid or nunimiw such potential adverse effrcts. I . The Conference of the Parties scrviiif as the meeting of the Parties shall, at its lirst meeting, decide upon appropriate prccedures and niechrinisrns to lacilitate decision- malung by Parlies of inlport. Article 11 15 20 25 30 3s 40 45 PROCEDURI;. FOR LIVING MODIFW,D ORGANISMS IN'I'ENDEI) FOR DlRECT (ISE AS FOOD OR FEED, OR FOR PROCESSING 50 - 1 Verify source ↗
AParLy that makes a final decision r e y d i n g domestic use. including placing on the
AI-assisted research summary: A Party must inform the Parties through the Biosafety Clearing-House within 15 days after making a final decision on domestic use or placing on the market of a living modified organism in the stated cases.
1. AParLy that makes a final decision r e y d i n g domestic use. including placing on the market, of a living modified organism that may he sulijecc to cranshoundim; moveinrnt I,r direct use as food or feed. or for processing shall, within fifteen days of making that decision, inform the Pnrties through the Bitsafety Clcaring-House. This informa- 55 - 30 Verify source ↗
No. 2YXfl3
AI-assisted research summary: The Party must provide a written copy of the information to the national focal point of each Party that has told the Secretariat it does not have access to the Biosafety Clearing-House.
30 No. 2YXfl3 Art Yo. 23, 3306 GCIVERNMErUT GAT-TTE, 17 APRI!. 2007 tion shitll contain, at a minimum the inforin:ition spec.ified in Aiinex TI. The Party shall provide a copy of the infonnatioii, in wnting. to the ii:rtional focal pcmt of each Part)> that informs the Secretariat in advance that i t does not have access to the Binsafety Clewing-House. This provision shall not apply to decisions regzding field trials. - 2 Verify source ↗
The Party making a decision under p m q a p h 1 ahove. shall eiisure h a t there is a
AI-assisted research summary: The decision-making party under paragraph 1 must ensure there is a legal requirement that the applicant’s information is accurate.
2. The Party making a decision under p m q a p h 1 ahove. shall eiisure h a t there is a 5 legal requirement for the accuracy of infoi-mation provided hy the applic:in!. - 3 Verify source ↗
Any Party may request additional iiifonnalion from the authority identified in
AI-assisted research summary: Any Party may request additional information from the authority identified in paragraph (b) of Annex 11.
3 Any Party may request additional iiifonnalion from the authority identified in p m q a p h ib) of Annex 11. I O - 4 Verify source ↗
A Party may take a decisionon the import of living modified orgaiisms intended for
AI-assisted research summary: A Party may decide on imports of certain living modified organisms, if its domestic rules are consistent with the Protocol’s objective.
4. A Party may take a decisionon the import of living modified orgaiisms intended for direct use as fmd or feed. or for processing. under its doineslic regulatory franiework (hat is consistent with the objective of tlus Protocol. - 5 Verify source ↗
Each Pany sh:iIl make available to the BiosaTety Clearing-House copies of my
AI-assisted research summary: Each Pany must make available certain national laws, regulations, and guidelines to the Biosafety Clearing-House, if available.
5. Each Pany sh:iIl make available to the BiosaTety Clearing-House copies of my national laws, regulations and pldelines applicable to the import of living modified organisms intended for direct use as lood or leed. or for processing. if available. - 6 Verify source ↗
A developing country Party or a Party with an economy in transillon may. in the 15
AI-assisted research summary: A developing country Party or a Party with an economy in transition may declare, through the Biosafety Clearing-House, that certain pre-import decisions will follow a risk assessment and be made within 270 days.
6. A developing country Party or a Party with an economy in transillon may. in the 15 ahseuce of the donxstic regulatory franiewcvk referred to i n paragraph 4 above. and ill exercise oi i l s domestic jurisdiction, dcclare through the Binsalery Clearing-!-louse that its decision pnor to the firs1 import of a living modilietl organism inteiided for drec! use as ihod or feed, or for processing. on which ~nformation has been providcd wider parn:rapii I above, will 1% taken accnrding to the foilowin:: 20 f a ) A risk assessment undertaken in accordance with Annex III; and (bi A decision made within a ;)redictahie limeframe, iiot exceeding two hundred seventy days. - 7 Verify source ↗
Failure by a Party Lo communicate its decision according IC) pangraph 6 above,
AI-assisted research summary: If a Party does not communicate its decision, that silence does not count as consent or refusal for the import of a living modified organism for food, feed, or processing, unless the Party says otherwise.
7 . Failure by a Party Lo communicate its decision according IC) pangraph 6 above, shall not imply its consent or refusal to Ihe imlxlrt of R living modtied organism 7-5 intended for direct use as lood or ked. or Tor processing, unless otheiwise specified by the Party: - 8 Verify source ↗
Lack of scientific certainty due to insuficient relwant scientific information and
AI-assisted research summary: A lack of scientific certainty does not stop a Party from deciding whether to allow import of a living modified organism for direct use as food or feed, or for processing.
8 Lack of scientific certainty due to insuficient relwant scientific information and knowledge regardin8 the extent of the potential adverse eflects of a living m~dified organism on the conservation and sustmahle use of biological diversity in the Party of 30 iinport, tiiking also into accounl risks to humar health. shall 1101 prevent that Party from lakin: a decision, as appropriate. with regard to the imlmrt of that living modified orgaiisni inlended for direct use as food or fced, or i w processing, in order to avoid or minimize such ptential adverse effects. - 9 Verify source ↗
A Party may indicate its needs Cor limancial and technical assistance and 35
AI-assisted research summary: A Party may state its need for financial and technical assistance and capacity-building for certain living modified organisms, and the Parties must cooperate to meet those needs.
9. A Party may indicate its needs Cor limancial and technical assistance and 35 capacity-building with respect to living modified organisins intended for direct use as food or feed, or lor processing. Partirs shall conperate to m e t these needs in accordance with Articles 32 aid 28. Article 12 REVIEW OF DECISIONS 40 - 1 Verify source ↗
A Party of inlporl may, at any time, in light of new scieiilific informalion 01:
AI-assisted research summary: A Party may review and change a transboundary movement decision when new scientific information or potential adverse effects justify it, while considering human health risks.
1. A Party of inlporl may, at any time, in light of new scieiilific informalion 01: polential adverse cNects 011 the conservetion mid su~tainable use of bioliigical diversit),. taking also into account the risks to human health. review and change a decision regarding an inlentioiiril transhoundani movement. In such c a r , the Party shall. within thirty days, inform any notifier that has previously notified movenieiits of the living 45 nnxlified organism referred to in such decision. as well as the Biosafety Clearing-House, and shall set out the reasons for its decision. - 2 Verify source ↗
A Party of export or a notilier may request the Party of import to review a decision
AI-assisted research summary: The Party of export or the notifier may ask the Party of import to review a decision under Article 10 if circumstances have changed or new relevant scientific or technical information is available.
2. A Party of export or a notilier may request the Party of import to review a decision i t Iim made in respect of i t under Article 10 where the Party of export or the notilier considers that: 50 io) A chanre in circumstances ha occurred that inay influence thc outcome of the nsk assessment upon which the decision was hased. or ib) Additional relevant scientific or technical inlormation has become nvailahle. - 3 Verify source ↗
The Party of iinport shall respond in writing to such a request wilhin ninety days
AI-assisted research summary: The Party of iinport must reply in writing to the request within 90 days and explain its decision.
3. The Party of iinport shall respond in writing to such a request wilhin ninety days and set out h e reasons for i k decision. 55 - 4 Verify source ↗
The Party of import may. at its discretion, require a n s k assessment for suhsequent
AI-assisted research summary: The party of import may, at its discretion, require an assessment for subsequent imports.
4. The Party of import may. at its discretion, require a n s k assessment for suhsequent imports. Article 13 SlMI'LFIED PROCEDURE - 1 Verify source ↗
A Party of im:mrl may. provided that adequate measures arc a p ~ l i r d to ensure the
AI-assisted research summary: A Party may, if adequate safety measures are in place, pre-notify the Biosafety Clearing-House of certain intentional cross-border movements and exempt some living modified organism imports from the advance informed agreement procedure.
1. A Party of im:mrl may. provided that adequate measures arc a p ~ l i r d to ensure the safe intentional transboundary inovemenf of living modified o r p isins i n accordawe with the objecuve of this Rolocol, specify in advance to the Biosdety Clexinp-House: ( a ) Cases in which intent~ciiial transboundary movement to i t may take pbcc at the same time as the movement is notified to the Party of import; and ( 6 ) Imports of living mahfied organisms to i t to be exempted from the advance informed agreement procedure. 5 Notifications under subparagraph (a) above, may apply to subsequent similar movements to the same Party. IO - 2 Verify source ↗
The i n f o n a t i m relating to 'm intentional translwundq mwement that is lo be
AI-assisted research summary: Notifications under paragraph 1 must use the information specified in Annex 1.
2. The i n f o n a t i m relating to 'm intentional translwundq mwement that is lo be provided in the notifications referred to in paragraph I ial abnve. shall he the inrorination specified in Annex 1. Article 14 15 RILATERAL, REGIONAL ANI) hllTLTILATERAL AGREEMENTS A N ) ARRANGEMENTS - 1 Verify source ↗
Parties may enter into bilateral, regional and multilateral agreements and
AI-assisted research summary: Parties may make certain bilateral, regional, or multilateral agreements and arrangements about international transboundary movements of living modified organisms, if they fit the Protocol’s objective and do not reduce protection below the Protocol level.
1. Parties may enter into bilateral, regional and multilateral agreements and arrangements regardmg inttntional transboundary movements of livinp modified organism, consistent with the objective of this prolocol and provided that such 20 agreements and arrrui~ements do not result in a lower level or protection than that provikd for by the Protocol. - 2 Verify source ↗
The Parties shall inform each other, through the Biosafety Clexing-House, of ;my
AI-assisted research summary: The Parties must inform each other, through the Biosafety Clexing-House, about certain bilateral, regional, and multilateral agreements and arrangements they entered into.
2. The Parties shall inform each other, through the Biosafety Clexing-House, of ;my such bilateral, regional and mu1;ilateral agreements :ind anangeniciits that they have entered into befni-e or after the date of entry into rorce or this Protocol - 3 Verify source ↗
The propisions of
AI-assisted research summary: This provision says the Protocol does not affect certain movements made under agreements or arrangements between the parties to those agreements or arrangements.
3. The propisions of this Protocol shall not affect intentional trcmshund:u). movements that take place pursuant to such agreements and :irraiFements as hetween the parties Lo those agreements or arranpemcnts. 25 - 4 Verify source ↗
Any Party may determine that its domestic regulations shall apply with respect to
AI-assisted research summary: Any Party may decide that its domestic regulations apply to specific imports, and must notify the Biosafety Clearing-House of that decision.
4. Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clexing-House of its decision. 30 Article 15 RlSK ASSESSMENT 1. msk assessments undertaken pursuant to this F'rotoci~l shall he carted out in a scientifically sound mrtnner, in accordance with Annex iII and taking into account recognized risk a s s e s s n m ~ tecluiiques. Such risk assessments shall he bayed, at a 35 mininium, on inTornlatioii provided in accordance with Article 8 and other available scicniific evidence in order to idcnlify r i n d evaluate the possible adverse effects of living modified organisms on the conservation aid sustainable use of biological diversity, taking also into account risks to huiiian health. - 2 Verify source ↗
The Party or import shall ensurc that risk assessments are camed out For decisions 40
AI-assisted research summary: The Party or import must ensure risk assessments are carried out for decisions made under Article 10.
2. The Party or import shall ensurc that risk assessments are camed out For decisions 40 taken under Arlicle IO. It m q rtquire the exporter to c a m on1 the risk assessment. - 3 Verify source ↗
The cost or risk assrssment shall he h m e by the notifier if the Party of i m p t so
AI-assisted research summary: The notifier must make the cost or risk assessment if the party of impact requires it.
3. The cost or risk assrssment shall he h m e by the notifier if the Party of i m p t so requires. Article 16 RlSK MANAGEMENT 45 - 1 Verify source ↗
The Parties shall, taking into account Article Si,?) of the Convention, establish and
AI-assisted research summary: The Parties must establish and maintain mechanisms, measures, and strategies to regulate, manage, and control risks linked to living modified organisms.
1. The Parties shall, taking into account Article Si,?) of the Convention, establish and maintain appropriate mechanisms, i u e a s u ~ s aid strategies to regulate, manage and control risks identitied in the risk assessment provisions of this Protocol associated with the use, handling and transboundary mrivemiil of 11ving mcntficd organisms. - 2 Verify source ↗
Measures based on nsk assessmenl shall be imposed to die exlent necessary to SO
AI-assisted research summary: Measures based on risk assessment must be imposed as necessary to prevent adverse effects of a living modified organism on conservation and sustainable use of biological diversity, while also considering risks to human health, in the territory of the Party of import.
2. Measures based on nsk assessmenl shall be imposed to die exlent necessary to SO prevent adverse effects of the living nmhfied organism on the ccnservatioii and -Jo. 2989.3 14 _____ A C l h. 23, 2owi - c VERUMFNI cIP;’rrc. i i AWIL 2007 __ GEXT1G’L.Y \43DlFl’L!) (!RGA\IIShlS AM€hDhlEhT A C . 20M sustainable use of hiological diversity, talung also into account risks to human healUi, within the territory of the Party OS import. - 3 Verify source ↗
Each Party shall take appropriate measures lc p:-cvenl iminleniioiial I;
AI-assisted research summary: Each Party must take appropriate measures to prevent international movements of living modified organisms.
3. Each Party shall take appropriate measures lc p:-cvenl iminleniioiial I; movements of living modified org,misms. includng such measures as requirine a risk nssessmeiit lo Lx cmid out prior to tho tirst relecse of a livm: mndifitd orgmsm. 5 - 4 Verify source ↗
Without prejudice to paraGph 2 ahove, each Pan! shall endewou: to ensare that
AI-assisted research summary: Each Party should ensure living modified organisms are observed for an appropriate period before intended use.
4. Without prejudice to paraGph 2 ahove, each Pan! shall endewou: to ensare that any living modified organism. whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time M o r e ii is put to its intended use. - 5 Verify source ↗
Parties shall cooperate with a view to:
AI-assisted research summary: Parties must cooperate to identify living modified organisms or traits that may harm biodiversity and human health, and to take appropriate treatment measures.
5 . Parties shall cooperate with a view to: (n) Identifyiiig living modified organisms or specific traits of living modificd organism that may have adverse effects on the conservation and suscainable use of biological dwersity, taking also into account nsks to human health; and (h) T&ng appropate measures regarding the treatment of such living modified organism or sixcific traits. 10 15 Article i? LWINI‘ENTIQNAI, TRANSBOIJN1’T)ARY MOVEhENTS AND EMERGSNCX ME.4SIIRES - 1 Verify source ↗
Each Party shall take appropriale measures to notify arectedor potentially atYecled
AI-assisted research summary: Each Party must take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House, and sometimes relevant international organizations, after certain releases involving a living modified organism.
1. Each Party shall take appropriale measures to notify arectedor potentially atYecled States, the BiosaFety Clraring-House aid, where appropriate, relevdiit inteniational 20 organizations, when it knows of an occurrence under its jurisdiction resullmg in a release that leads, or may lead, to an unintentional transhoundary movement of a living niodified organism that is likely to have significant adverse effects on Ih- roiihervation and sustainable uqe of biological diversity. takiiig also into account risks to human liealth in such States. The notification shall he providtd as soon a.5 the P;uty knows of Ihe 7-5 above situatioii. ’~ - 2 Verify source ↗
Each Party shalt, no later than the date of riitN into force oi this Protocol For it.
AI-assisted research summary: Each Party must provide the Biosafety Clearing-House with its contact-point details for receiving notifications under this Article.
2. Each Party shalt, no later than the date of riitN into force oi this Protocol For it. make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purposes of receiving iiotitications under this Ariicle. - 3 Verify source ↗
Any notification wisin: from p a r q ~ a p h 1 almve, should include:
AI-assisted research summary: A notification under paragraph 1 must include specified information about the living modified organism, the release, possible adverse effects, other relevant information, and a contact point.
3. Any notification wisin: from p a r q ~ a p h 1 almve, should include: 30 ( a ) Available relevant information on the estimated quantities and relevant characteristics and/or waits of the liviiig intxiified organism; ib) lnformation on the circumstances and estimated date of the release. and on the use of the living modified orpanism in the originating Party: i c ) Any available ininmiation about the possible adverse effects on the 35 coiisewation and sustainable use of biological diversity, laking also into account risks to human health, as well as availahle information about possiRle risk management measures; i d ) Any other relevant information; and ( e ) A point of contact for iurther information. 40 - 4 Verify source ↗
In order to Mninuze any significant adverse effects on the conservation and
AI-assisted research summary: Each Party must immediately consult affected or potentially affected States after a release, and must require safe handling, packaging, and transport of certain living modified organisms.
4. In order to Mninuze any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living mdified organism referred to in paragraph 1 above. occurs, shall inniiediately consult the atrecled or potentially affected States to enable them Io determine appropnale respnses and iruliate necessary 45 action, including emergency measures. Article 18 IIANDLING, TRANSPORT, PACKAGPJIG AND U)ENTIFICATION I . In order to avoid adverse effects on the conservation aid sustainable use of hiological diversity, taking also into account risks to humm health, each Party shall take 50 necessary measum to require that living. niodifieil organism< that are suhjecl to intentional t r a n s h m n d q inovenient within the scope of this Protocol are haridled, packaged and transported under conditions of safety, Laking into consideration relevant international rules and standards. - 2 Verify source ↗
Each Party shall take memures to require that documeiitation accompanying:
AI-assisted research summary: Each Party must require documentation for certain living modified organisms to clearly identify them and include specified handling and contact information.
2. Each Party shall take memures to require that documeiitation accompanying: 55 i n ) Living modilied orpiiisms that are intended for direct use as fciod or feed. or for processing, clearly idenlifies that they “may conlam” Iiviii; modified : y p n i s m and are not intended i3r intentional introductior, into tlie eiiviroiinieiit, as well as a coiitx: p i n 1 for further inSonnation. Tiiz Conference of the Parties serviag its !I-,$ meeting of the Fartie: 10 C I S Protocol shall take a decism on Ihe detaili-: :L..~u~rw;;eiits far this purpose, including specification of their identi!). and ;ir?!' s l q u e ideutificaiion. n o later than two years after the date o f e n y i n k fiwx of h i s Pr.;xol; Living modified orfatiisms that m destined for contained use clearly identifies them as living modified organisms; and spcifies any requirements for the safe handling, storage, transport and use, the contact poinl for further information, includ~ng tlir name and address of the individual and institution to whom the livins mdified orpinisms are consigned; and Living modified organism$ thal are intended for inteiitional introduction into the environment of the Party of import and any ollier living modified organisms within the scope of the Protocol. clearly identifies them as llving modified organisms; slxcilies thr idciitity and relevant trnits andor chwac- teristics. any requirements for the s; handling, storage. t:ail:sport and use. tlie contact point for ruriho- informatic. iir d, as appropriate, the nnmc anJ a d w x of the importer aid exporter; ani! a . :ins a ~ecliuation that tlir inovew:; :s iii conformity with thr requixirmts of tins Protocol applicable to the exnorter. 1 - 3 Verify source ↗
The Conference of the Paties serviiiz as :hc meeting of the Prties to ths Pi-otocol
AI-assisted research summary: The Conference of the Parties must consider whether to develop standards for identification, handling, packaging, and transport practices, and do so in consultation with other relevant international bodies.
3. The Conference of the Paties serviiiz as :hc meeting of the Prties to ths Pi-otocol shd! consider the need for and modalities of developing staiidards with regard to identification, handling, packaging and transport practices, in consultation with other relevant international bodies. Article 19 COMPETENT NATIONAI. AIJTHOWI'ES AND NAT'JONAL FOCAL POINTS - 1 Verify source ↗
Each Party shall designale one national focal p i n 1 10 be responsildr on its behalf
AI-assisted research summary: Each Party must designate a national focal point and one or more competent national authorities; it may use one entity for both roles.
1. Each Party shall designale one national focal p i n 1 10 be responsildr on its behalf for liaison with the Secretanat. Each Pa1y shall also designate one or more competent national authorities, which shall be responsihle for prrfomiing the adininistrative functioiis required by this Protocol and which shall he authorized to act on its behalf wilh respect to those functions. A Parly niay designate a single entity to fulfil tlie functions of hoth focal point and coinpetent national authority. - 2 Verify source ↗
Each Party shall, no later than the date of entry into force of t h s Protocol for it,
AI-assisted research summary: Each Party must tell the Secretariat who its focal point and competent national authority are, and update that information when it changes.
2. Each Party shall, no later than the date of entry into force of t h s Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities. Where a Party designates more than one competent national authority, it shall convey to the Secretanat, with i t s nolificatioii thereof. relevanl information on tlie respective rcsponsihilities of those authorities. Where applicable, such inSormntion shall, at a minimum specify which competent authority is responsihle for which type of living niodified organism. Each Party shdl forthwith notify the Secretanat of any changes in the designation OS its national f x a l point or in the name and address or mponsibilities of its competent national authorily or authorities. - 3 Verify source ↗
The Secretariat shall forthwith inform the Parties of the notifications il receives
AI-assisted research summary: The Secretariat must promptly tell the Parties about certain notifications it receives and make that information available through the Biosafety Clearing-House.
3. The Secretariat shall forthwith inform the Parties of the notifications il receives under paragraph 2 ahove, and shall also make such informalion available through the Biosafety Clearing-House. 5 10 1s 20 7-5 30 35 40 45 Article 20 MOKMATION SIIARING AND THE RIOSAFETY CLEARING-IJOUSE I . A Biosafety Clearing-House is hereby established as par! of Uie clearing-house mechanism under Article 18, p a r a p p h 3, of the Convention, in order to: (u) Facilitate the exc1ian:e of scientific, technical. environmental and legnl information on, and experience with, living modified orpanism?; and 50 ib) Assist Parties to implement the Protocol, taking into account the special needs of developing country Parties, in particular the least developed and small island developing States among then% and countries with economies in transition as well as countries hat are centres of origin and centres of genetic diversity. 55 - 1 Verify source ↗
Tnt 3iosaCe;y Clearing-Iiouse shall sewe
AI-assisted research summary: The Clearing-House must act as the means for making information available and provide access to relevant Parties and, where possible, other biosafety information exchange mechanisms.
1. Tnt 3iosaCe;y Clearing-Iiouse shall sewe m-ans Liiraugh wliict, :nSoriiialimi is made availalile for the piuliosss of pwapaph I a!xwe. It shall provide access to the Parties re:e~;mt io the irni~lenien~ation of he information niade nvaiiahle b!, Protocol. It shall also provide access, where possibir, io other in~em;iCxaI biosaiety iiifomiatioil exchange niechanis:ns. - 3 Verify source ↗
Without prejudice ( o tile irroLectinii o f c.xifidential miomatjon. each Par:?. shall
AI-assisted research summary: Each Party must provide specified information to the Biosafety Clearing-House, subject to protection of confidential information.
3. Without prejudice ( o tile irroLectinii o f c.xifidential miomatjon. each Par:?. shall make available 10 the Blosafety Cleannp-House any mfmmalion required to he made - available to the Biosafetv Clearinr-House under this Protocol, and: Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the Parlies for the advance informed a p e m e n t procedure; Any bilateral, regional and multilateral agreements and arrangements: Sumianes of its risk assessments or environmental reviews of living modified organisms generated hy its re~mlatow process, and carried out in accordance with Article 15, including. where appropriate, relevant inloriim- 1.ion regardine priductj thereof, namely, pxxessed miiirnals that :ui of hviiiz modihed organism ongin, coiitainuie detectable novel comlir!ations ol replicable genetic material ob:ained ihe use or modem bi ot tcholog y: Its final decisions reparding the ipmrtatioii or relense of living modified orpnisms; and Reports submitted by it pursuant to Article 33. including those on impleinen- Lati@n of the advance informed ameemenl urocedure. through - 4 Verify source ↗
The modalities of the operation of the Biosafety'Cleatin~-House, including reports
AI-assisted research summary: The Conference of the Parties, acting as the meeting of the Parties to the Protocol, must consider and decide the Biosafety'Cleatin~-House operating arrangements at its first meeting and keep them under review afterward.
4. The modalities of the operation of the Biosafety'Cleatin~-House, including reports on its activities, shall be considered and decided upon b?' the Coni'erence of the Parties scrving as the meeting or the Parties to this Protocol at its firs1 meeting, and kept under review hereafter. Article 31 CONFIDENTIAL INFOKXlATION - 1 Verify source ↗
The Party of import shall permit he notifier to idenrify iiirormalion suhniitled
AI-assisted research summary: The Party of import must let the notifier identify confidential information submitted under the Protocol procedures or required for the advance informed agreement procedure, and must give a justification on request in such cases.
1. The Party of import shall permit he notifier to idenrify iiirormalion suhniitled under the procedures of this Prolocol or required by the Party of import as part of the advance informed agreement procedure of the Protwol that i s to he treated 3s confidential. Justification shali he given in such caqes upon request. - 1 Verify source ↗
The Party of import shall cnnsull the nolifier if i t decides that inlormation identified
AI-assisted research summary: The Party of import must consult the notifier and, before disclosing the information, tell the notifier of its decision and give reasons on request, plus an opportunity for consultation and internal review.
1. The Party of import shall cnnsull the nolifier if i t decides that inlormation identified by the notifier as confidentid does not qualify lor such treatment and shall, prior to any disclosure, informthenotifier ofits decision, providingreasons on request, as well as an opportunity for consultation m d for an internal review of the decisioii prior to disclosure. - 3 Verify source ↗
Each Party shall protect confidential information received under this Protcxol.
AI-assisted research summary: Each Party must protect confidential information received under the Protocol.
3. Each Party shall protect confidential information received under this Protcxol. iiicludiny any confidential inforniation received in the contexl of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information aid sliall protect the confidentiality oi such infomution in a manner no less favourable than its treatment of confidential information in connectioii with domestically produced living modified organisms. - 4 Verify source ↗
The Party of import shall not use such inforination For a commemial purpose,
AI-assisted research summary: The party of import must not use the information for a commercial purpose unless the notifier gives written consent.
4. The Party of import shall not use such inforination For a commemial purpose, except with h e written consent oi the notifier - 5 Verify source ↗
If a notifier withdraws or has withdrawn a notification, the Party of import shall
AI-assisted research summary: If a notifier withdraws a notification, the Party of import must keep commercial and industrial information confidential.
5 . If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the confidentiality of commercial and industrial information, incruding research and development ittormation as well as intormation on which the Party and the notifier disagree as to its confidentiality. - 6 Verify source ↗
Without p~%jUdiCe to paragraph 5 above, the following information shall not he
AI-assisted research summary: Some information is not confidential, including the notifier’s name and address, a general description of the living modified organism, the risk-assessment summary, and emergency-response methods and plans.
6. Without p~%jUdiCe to paragraph 5 above, the following information shall not he considered confidential: i n ) The nwme and address of the notifier. f D ) A general description of lhr IivJng modified organism or organisms; f c j A sunmar?; of the risk assessment of lhe effecls on the conservation and sustainable use of biological diversity, taking also into account risks to liuman health; arid i d ) Any methods and plans for emergency response. 5 10 15 '0 25 30 3s 40 45 50 55 Act "lo. 23, L O M GF..I\ETICAI,t.Y MO!jlFIED CCl! hrticlc 22 5 - 1 Verify source ↗
Tne Paities shall coopemt'r in th:: developiiient miNor at:elgiheniii:
AI-assisted research summary: The Parties must cooperate to build biosafety-related human and institutional capacity, including biotechnology where needed, to help implement the protocol.
1. Tne Paities shall coopemt'r in th:: developiiient miNor at:elgiheniii: of humac resources and ~nslitutional cqiacities in hicsafety. ini;uding hiotecl~~iol~~gy to the extent that it is rquired for biosafety, for the purpose of the eiTeclive in~plen~envalioii or this piotocol, in developing country Parties, in particular the least de\doped nod small island developing States among them, and in Parties will? economies in lransilioll, including through existing global, regional, subregional aiid nalmnal institutions arid organizations and, as appropriale, through kicilitatiiig private Sector involvement. - 2 Verify source ↗
For the purposes of iniplenienting paragraph 1 above, in relation to cooperation, the IO
AI-assisted research summary: In cooperation on biosafety capacity-building, the parties must take the needs of developing countries, especially least developed countries and small island developing States, fully into account.
2. For the purposes of iniplenienting paragraph 1 above, in relation to cooperation, the IO needs of developing c o u n o Parties, in particular the leas1 developed and small islaid developing States among them for financial resourczs aiid access to and transfer oi tecluiology and know-how in accordnnce with !he relevant previsions OS tile Convention, shall be taken fully inlc xcvmt fur caimcity-building iii hiurafety. Cmperation ii: capacity-huiidiri: shall, suujeujf-t to the dilfcreiit s u a i o i ! . canabiilil-s aid iI? tile p r q w aid requirements of each Party. include scienkfic aid kc:;nical train safe management of hiott.clmology, and in tile use of risk essmeiit and risk management for hiosafety, and the enhaicement of tshnolc~ical and ins!itutional capacities in biosafety. The needs of Parties witli economes in transitloii shall also he taken fully into account Tor such capacityluildmg in hiosafety. 15 20 Article 23 PITBLIC AWAREh;ESS AND PARTlCIPATION - 1 Verify source ↗
Tne Psrties shall:
AI-assisted research summary: The Parties must promote public awareness, education, and participation about the safe transfer, handling, and use of living modified organisms, and cooperate with other States and international bodies as appropriate.
1. Tne Psrties shall: (ai Pronioie and iacilitnte public awareness. educalion and participation concern- ing the safe transfer. haiidlmg and use of living mcditied orpiisms in relation 25 to the conservation and suslwinable use of hiological diversity. iakiiig also into aaount risks to human health. In doing so, the Parties shall cooperate, as appropriate. with other States aid inteniational hodies; (b) Endeavour to ensure that puhlic awareness and education encompass access to information on living mdified organisnx identified in accordance with this 30 Protocol that may he imported. - 2 Verify source ↗
The Parties shall. in accordance with their respctive laws and regulations. consult
AI-assisted research summary: The Parties must consult the public on decisions about living modified organisms and make the results public, while respecting confidential information under Article 21.
2. The Parties shall. in accordance with their respctive laws and regulations. consult the public in the decision-making process regarding living modified organisms arid shall make the results of such decisions available to the public, while respecting confidential inrorination in accordance with Article 21. - 3 Verify source ↗
Each P m y shall endeavour to inform its public aboul the means of public access to
AI-assisted research summary: Each P m y should try to inform the public about how to access the Biosafety Clearing-House.
3. Each P m y shall endeavour to inform its public aboul the means of public access to 35 the Biosafety Clearing-House. Article 24 NON-PARTIES - 1 Verify source ↗
Transboundary movemeiiis oi living modified oryanisnis hetween Parties and 40
AI-assisted research summary: Transboundary movements of living modified organisms must be consistent with the Protocol’s objective, and Parties may make bilateral, regional, or multilateral agreements about those movements.
1. Transboundary movemeiiis oi living modified oryanisnis hetween Parties and 40 non-Parties shall be consistent with lhe objective of this Protocol. The Parties may enter into hilateral, regional and multilateral agreements and arrangements wilh noii-Parues r e p d i n g such trnnsboundary movements. - 2 Verify source ↗
The Parties shall encourage non-Parties to adhere to this Pro10col and to contribute
AI-assisted research summary: The Parties must encourage non-Parties to follow this Protocol and provide appropriate information to the Biosafety Clearing-House about certain living modified organisms.
2. The Parties shall encourage non-Parties to adhere to this Pro10col and to contribute approiiriate infommtion to the Biosafety Clearing-House on living modified organisms 45 released in, or moved into or out of, areas within their national jurisdictions. Article 25 ILLEGAL TRANSBOUNJ)ARY MOVEMENlS - 1 Verify source ↗
Each Party shall adopt appropriate domestic ineasures aimed at preventing arid. i r
AI-assisted research summary: Each Party must adopt domestic measures to prevent, and where appropriate minimize, illegal transboundary movements of living modified organisms.
1. Each Party shall adopt appropriate domestic ineasures aimed at preventing arid. i r appropnate, iwiaiizing transhouiidary movements of living niohfied orpnisms carried 50 out 111 contravention or its domestic measures to in$ernent movements shall Ix deemed illegal transhouiidary movements. this Protocol. Such Act No. 23, 1u06 - 2 Verify source ↗
In tlie case of m illegal tr;ursi?ound
AI-assisted research summary: In an illegal transit case, the party of origin is to dispose of the matter, apparently by repatriation or destruction, at its request.
2. In tlie case of m illegal tr;ursi?ound the Pdrty of origin to dispse, at its questioii hy repatriation or destiuctio - 3 Verify source ↗
Each ?arty shall in;,ke avail
AI-assisted research summary: Each Party must make available information about cases of illegal transboundary movements that relate to it.
3. Each ?arty shall in;,ke avail ' c m n t . the airected Party may request e. o f the living nicwiilicd orsanism in ty Clearin:-House infornia~:oii concerning cases of illegal transhouudary nio\mnients pcrtai:i:ng to it 5 Article 26 SOCIO-ECONOMIC CONSIDERATIONS - 1 Verify source ↗
The Parties, in reaching a decision on import uider this Protocol or under its
AI-assisted research summary: The Parties may consider certain non-economic impacts when deciding on imports under the Protocol or related domestic measures, as long as they act consistently with international obligations.
1. The Parties, in reaching a decision on import uider this Protocol or under its domestic measures implementing iiie Prolocol, may take into account, consistent with their international obligations, ~(x~o-ecoiiomic considerations arising from the impact 10 of living mcdified organisms on the conservation 'and sustainable use of hiolopx! diversity. especially with regard to tlie value of biologkal diversity to indigenous and local communities. - 2 Verify source ↗
The Partics are encouraged to cmpcrale on research and mfomwtioii exchanee on
AI-assisted research summary: The Parties are encouraged to cooperate on research and information exchange about the socio-economic impacts of living modified organisms, especially for indigenous and local communities.
2. The Partics are encouraged to cmpcrale on research and mfomwtioii exchanee on any socio-economic Impacts of living i n d i f k d organism. especially on indigenoius and 15 local communities. Articlc 27 LIABIIJTY AND KEDKESS T!ie Conference of the Parties serving as the meeting of the Parties to t h s Protocol shall, at its first meeting, adopt a process with respect lo the appropriale elaboration of 20 in~eniationnl rules and prmedures in the field of liahility and redress for damage resulting from transboundaq movements 01 iiving modified organisms, aialysing and taking due account of ihe ongoing processes in nitemafmnal law oil these niatters, and siiall endeavour Lo compiete this process within four years. L4rliclr 28 25 FINANCML iMECIIANISM AND RICSOImRCES - 1 Verify source ↗
In considering financial resources for the ~mplemeiitation of this Protocol, the
AI-assisted research summary: When considering financial resources for implementing this Protocol, the Parties must take into account Article 20 of the Convention.
1. In considering financial resources for the ~mplemeiitation of this Protocol, the Parties shall take into account the provisions of Article 20 of Uie Convention. - 2 Verify source ↗
The financial mechanismestablished :nArlicle 21 ofthe Convention shall. tivough
AI-assisted research summary: The financial mechanism under Article 21 of the Convention is the financial mechanism for this Protocol, operating through the institutional structure assigned to it.
2. The financial mechanismestablished :nArlicle 21 ofthe Convention shall. tivough the institutional structure entrusted with its operation. be the financial mechmism lor 30 uus Pr11Locol. - 3 Verify source ↗
Regarding tlie capacity-huilding referred to in Article 22 of !his Protocol, the
AI-assisted research summary: When giving guidance on the financial mechanism, the Conference of the Parties serving as the meeting of the Parties must take developing-country financial needs into account, especially for least developed and small island developing States.
3. Regarding tlie capacity-huilding referred to in Article 22 of !his Protocol, the Confcrence of the Parlies serving as Ihe meelin& of the Parties to this Protocol, i n providing puidance with respect lo lhe financial mechnnisni referred Lo in paragraph 2 almve, for consideration by the Conference of the Parties, shall take inlo account tlie 35 need for financial resources l>y developing country Parties, in particular tlie least developed and tlie small island developing States among them - 4 Verify source ↗
In the context of paragraph 1 ahove, the Parties shall also lake into a c c ~ u i t the
AI-assisted research summary: Parties must take into account the needs of developing country Parties, especially least developed and small island developing States, and Parties with economies in transition, when identifying and implementing capacity-building requirements for implementing the Protocol.
4. In the context of paragraph 1 ahove, the Parties shall also lake into a c c ~ u i t the needs of the developing counvy Parties, in particular the least develqxd and Uie small island developing States among them, mid of the Parties with econ~niies in transition, in 40 their efforts to identify and implement their capacity-buildins requirements for the purposes of tlie impleinentation of this Protocol. - 5 Verify source ↗
The guidance to the financial mechanism ofthe Convenlion ir relevant decisions of
AI-assisted research summary: Guidance to the financial mechanism and relevant Conference of the Parties decisions applies, as adapted as necessary, to this Article.
5. The guidance to the financial mechanism ofthe Convenlion ir relevant decisions of the Conference of the Parties. includins those agreed before the adoption oi tlus Protocol, shall apply, mutatis murnndis, to the provisions of this Article. - 6 Verify source ↗
The developed couutry Parties may also pro\zidc, and tlie developing country
AI-assisted research summary: Developed country Parties may provide financial and technological resources, and developing country Parties and Parties with economies in transition may avail themselves of such resources, through bilateral, regional, or multilateral channels.
6. The developed couutry Parties may also pro\zidc, and tlie developing country Parties aid the Parties with economies in transiiion avail themselves of, tinancial and techiiological resources for the impiementation 01 the provisions of this Protocol through bilateral, regional and multilateral channels. 45 Article 29 CONFEKEENCF: OF iTW, PARTIES SERVING A S T I E MEETWG OF THE i’AI<TES TO TlfiS I’I~Ct’I’OCOL - 1 Verify source ↗
The Conference of the Parties shall sen’e as the nieeting of !he Parties to this
AI-assisted research summary: The Conference of the Parties must serve as the meeting of the Parties to this Protocol.
1. The Conference of the Parties shall sen’e as the nieeting of !he Parties to this Protocol - 2 Verify source ↗
Parties to the Convention lhat are not Parties to this Pmtocol may participate as
AI-assisted research summary: Non-Parties to the Protocol that are Parties to the Convention may attend meetings as observers.
2. Parties to the Convention lhat are not Parties to this Pmtocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting oi the Parties to this Protocol. When lhe Conference of the Parties senw as the meeting of the Parties to this Protocol, decisions under Uus Protocol shall he taken only by those that are Parties to it. - 3 Verify source ↗
When the Conference of the Parties serves as the meeting of the Parties Lo h
AI-assisted research summary: If the Conference of the Parties is acting as the meeting of the Parties to the Protocol, a bureau member representing a Convention party that is not yet a Protocol party must be replaced by a member elected from among the Protocol parties.
3. When the Conference of the Parties serves as the meeting of the Parties Lo h s Protocol, my memkr of the bureau of the Conkrence of the Parties representing a Party to Ihe Convention bui. at thal time. not a Part.. tc this Protocol, shall he culislituted by a nieniber to be elected by mind from among the Parties lo this Protocol. - 4 Verify source ↗
The Conierencr 01 the Parties serving a i th: meetin: 01 the Parties Lo this Protocol
AI-assisted research summary: The Protocol’s meeting of Parties must review implementation, make needed decisions, and carry out the functions assigned to it.
4. The Conierencr 01 the Parties serving a i th: meetin: 01 the Parties Lo this Protocol shall keep under regu!ar review the impleme tior of iitis R~it~xol and shall make, ‘e in~plementatinn. It within its m i d a t e , the decisions necessary to i>romote its efie shall perform the functions assimed tn it hy ttus Prolocol aid Make recottunendations on any matters neczsszy for lhe jinplemeiit.ation of this Protocol; Establish such subsidiary bodies as are deemed necessary Tor the implemen- tation of this Protocol: Seek and utilize, where appropriate, the services and cooperatioil of, and information provided by, competent intemaiional organizations and intergov- ernmental and non-govemmental todies; Establish the form arid the intends for transmitting the ;ninrination to he sulimlted in accordaice wilh Article 33 of this Protocoi and consider such information as well as reprts sul,mitted b y m y suhsidiary hody; Consider aid adopt, as required. amendments to this Protocol and its annexes, as well as any additional aimexes to this Protocol. that are deeinrd riecessary for the implementation of l h i s Protocol; and Exercise such other l’unclions as m q he required for the irril~lenientation of this Protocol ~~~ ~~ ~ ~ - 5 Verify source ↗
The rules of prwedure of the Conierence of the Parties ‘md finnncial rules of the
AI-assisted research summary: The Convention’s rules of procedure and financial rules apply to this Protocol, except where the Parties decide otherwise by consensus.
5 . The rules of prwedure of the Conierence of the Parties ‘md finnncial rules of the Convention slid1 hr applied. nrrrinris murnndi.r, under t h s Protixol. except as m i y b~ otherwise decided by consensus by the Conference of the Parties serving as Uie meeting of the Parties to this Protocol. - 6 Verify source ↗
The first n ~ e l i n g of the Conference of the P,artIes serving as the meeting of the
AI-assisted research summary: The Secretariat must convene the first meeting, and later ordinary meetings must be held together with ordinary meetings of the Conference of the Parties unless the Parties decide אחרת.
6. The first n ~ e l i n g of the Conference of the P,artIes serving as the meeting of the Parties to Uus Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that 1s scheduled after the dale oi the entry into force of t h s F’rotwol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protwol shall be held in corijunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting oi the Parties to this Protocol. - 7 Verify source ↗
Extraordinary meetings of the Conierence of the Parties serving as the meeting or
AI-assisted research summary: Extraordinary meetings must be held when the body deems them necessary or when a Party requests one in writing and the request is supported by at least one third of the Parties within six months.
7 . Extraordinary meetings of the Conierence of the Parties serving as the meeting or the Parties to this Protocol shall be held at such other tinies as may be deemed necessary hy the Conference of the Parties serving a the meeting of the Parties to h Protocol, or at the wntten request of any Party, provided that, wittiin six months of the q u e s t being communicated to thc Parties Iiy the Secretaiat, it is supported by at least one thud of the Parties. s - 8 Verify source ↗
The United Nations, its specialized agencies and the International Atomk Energy
AI-assisted research summary: Certain international and qualified bodies may attend as observers at the relevant meetings, and observer admission/participation is subject to the rules of procedure and possible objection by one third of Parties present.
8. The United Nations, its specialized agencies and the International Atomk Energy Agency, as well as any State member thercof or observers thereto not party to the Convention, may be represented as observers at meetings of the Confereiice of the Parties serving as the meeting of the Partjes to this Protocol. Any hod? or agency, whether national or international. govemnimtal or noii-govemniental, that is qualilied in matters covered by this Protocol and thnl has infnrnied the Secretariat of its wish tn he represenled at a meetmg of the Confereiice of the Parties serving as a meeting oi the Parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object. Except as otherwise provided in this Article, the adiiiissioit and participation of observers shall IR subject to !he rules of procedure, as referred tci in paragraph 5 almve. 5 10 15 20 25 30 15 40 4s 50 55 60 Article 30 SIIBSTDIARY n i > D E S - 1 Verify source ↗
Any suhsidiap body established hy or unezr the Zoiiventinii may. illion 3 decision
AI-assisted research summary: A subsidiary body established by or under the Convention may serve the Protocol, if the Parties acting as the meeting of the Parties decide so.
1. Any suhsidiap body established hy or unezr the Zoiiventinii may. illion 3 decision by the Conference of the Parties serving as the meetiiig of the Farties to this Prolccol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise. - 2 Verify source ↗
Parties to the Convention that are not Parties to this Protocol I N V narticlmte as
AI-assisted research summary: Non-Parties to the Protocol may attend relevant subsidiary-body meetings as observers, and Protocol decisions are made only by Protocol Parties.
2 Parties to the Convention that are not Parties to this Protocol I N V narticlmte as - ~ ~ . . . . ~ ~ . ~~~ observers in b e proceedings o i any meeting oi any such subsidiary bodies. When a sulxidiary body oithe Convention serves as a subsidiary Imdy to this Prolocol. decisions under the Prolocol shall he idken only hy the Parues to the Prc~tocol. _ I ~~~ - 3 Verify source ↗
When a subsidiary body of the Convention exercises its functions with regard to
AI-assisted research summary: If the subsidiary body is acting on matters concerning this Protocol, a bureau member representing a Convention Party that is not a Protocol Party must be replaced by a member elected from among the Protocol Parties.
3. When a subsidiary body of the Convention exercises its functions with regard to mattcrs concerning this Protocol, any meinher of the bureau of that suhsidiav lwdy representing a Plut!? to the Coiiventioii but. at t h ~ i time, not a Party 10 the Protocol. shall he suvstituted hy a member to be elected by and from among thc Parties Loth- Protocol. - 1 Verify source ↗
The secretariat established by Article 24 of the Convenlion shall serve as the
AI-assisted research summary: The secretariat established by Article 24 of the Convention must serve as the secretariat for this Protocol.
1. The secretariat established by Article 24 of the Convenlion shall serve as the secretariat to his Protocol. - 2 Verify source ↗
Aflicle 24, paragraph 1. of the Coiiventim on the functions of the Secretanat shall
AI-assisted research summary: Article 24(1) of the Convention on the functions of the Secretariat applies, mutatis mutandis, to this Protocol.
2. Aflicle 24, paragraph 1. of the Coiiventim on the functions of the Secretanat shall apply. wiirmti,y mutandis. to this Protocol. - 3 Verify source ↗
To the extent that they are distinct, the costs of the secretariat services ior this
AI-assisted research summary: Parties must pay the distinct secretariat costs, monitor implementation, and report to the Conference of the Parties; the Conference must also set up compliance procedures and budget arrangements at its first meeting.
3. To the extent that they are distinct, the costs of the secretariat services ior this Protocol shall k met by the P'arlies lierrto. The Conierence of the Parties scrving as the meeting of tk Parties to this Protocol shall, at its lirsl meeting. decide on [ne necessary budgetary arrangements to this end. Article 32 RElATIONSI~ID' WITH THE CONVENTION Except as othenvise provided in this Protocol, tlie provisions of the Convention relating to its protocols shall apply to thi< Protocol Article 33 MONITORING AM> REPORTING Each Party shall monitor the implementation of its obligations under this Protocol. and shall. at intervals to he detennined by the Conierence of thc Parties serving 11s tlie meeting of the Parties to this Prolocol, report to the Conference of the Parties sen'ing as the meeting of the Parties 10 this Prolocol on measures that it has taken to inlplement the Protocol. Article .74 COMPLIANCE 5 IO 15 20 25 30 35 The Conference of the Parties serving as the meeting of the Parties to t h s Protocol shall, at its first meeting, consider and approve coopentive procedures and inslitulional mechanisms to promote compliance with the provisions of this Protocol and to address 40 cases oinon-complirlnce. Tnese procedures and mechanisms shall include pmvisions to offer advice or nssistrmce, where appropriale. They shall be separate from and without prejudice to, the dispute settleiiient procedures a i d mechanisms est.ahlished hy Article 27 of the Convenlion. ilPt N". 23, mfi - 1C Verify source ↗
A. r .LY M m F i 3 ORS!iKlSr\lS
AI-assisted research summary: The Conference of the Parties must review the Protocol’s effectiveness five years after it enters into force, and then at least every five years.
1C.A. r .LY M m F i 3 ORS!iKlSr\lS AhEI\?)MEYT A.7.2OC6 Article 35 ASSESShENT A N T REVTEW Tne Conference of the Parties seninf as L;ic I-eting ol the Parties to tics Protocol shall undertake. five years after the miry into i . ~ ~ c r of Uu? Frotcxol and at least eve? five years thereafter, an evaluation of the efiectiveness of the Protocol, includmg an assessinent of its procedures and annexes. 5 Article .% SlGNATlJKE This Protocol shall he open for sipature at the United Nations Office at Nairobi by Stales and regional economic integation organizations from 15 to 26 May 2000, and at 10 ;liiited Nations Headquaners in New Yor!; from 5 June 2000 to 4 June 2001. Article 37 ENTRY mro FORCE - 1 Verify source ↗
This Protocnl shall enter into force on the ninetieth day after the date of deposit of
AI-assisted research summary: This Protocol enters into force 90 days after the fiftieth instrument of ratification, acceptance, approval, or accession is deposited.
1. This Protocnl shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance. approval or accession by States or 15 regional economic integration organizations that are Parties to the Convention. - 2 Verify source ↗
TlUs Protmol shall enter into force for a State or regional economic integration
AI-assisted research summary: This Protocol enters into force for a ratifying, accepting, approving, or acceding State or regional economic integration organization on the later of 90 days after deposit of its instrument or the date the Convention enters into force for it.
2. TlUs Protmol shall enter into force for a State or regional economic integration orpamzation that ralifies, accepts or appro\'es this Protocol or accedes thereto after its e n t n into force pursuant to paragraph 1 above, oil the ninetieth day after the dale on which Uiat State or repional econonlic mtegratiim organization &posits 11s insirumtni of 20 ratification. acceptance, approval or accession. or on tile dale oii which the Convention enters into force lor that State or regimal rconoinic integration orgaization, whichever shall he the later. - 3 Verify source ↗
For the puq7oses of paragraphs 1 and 1- ahove, any instrument deposited hy ii
AI-assisted research summary: An instrument deposited by a regional economic integration organization is not counted as additional to the 25 instruments deposited by member States.
3 . For the puq7oses of paragraphs 1 and 1- ahove, any instrument deposited hy ii regional economic integratiiiii organization shall not he counted as additional to tliosr 25 deposited by ineniber Slates of such organization. Article 38 RESEIWATIONS No reservations may be made to this Protocol. Article 39 H'ITID)KA\VAL 30 - 1 Verify source ↗
At any time after two years from the date on which this Frotc~~ol has entered into
AI-assisted research summary: A Party may withdraw from the Protocol after two years from the date it entered into force for that Party, by notifying the Depositary.
1. At any time after two years from the date on which this Frotc~~ol has entered into force for a Party, that Party may withdraw from the F~otocol by giving u m t m notification to tlie Depositary - 2 Verify source ↗
Any such withdrawal shdl take placr upon expiry or one year after the date of its 35
AI-assisted research summary: A withdrawal takes effect on expiry, one year after the Depositary receives it, or later if the notification says so.
2. Any such withdrawal shdl take placr upon expiry or one year after the date of its 35 receipt hy the Depositary, or on such later date as may be specified in the notification of Ihr withdrawal. Article 40 AUTIIENTIC TEXTS The original of this Prnlocol, of which tlie Arabic, Chinese. English. French Russian 40 and Spanish texts are equally authentic, shall be deposited wilh the Secretq-General of the United Nations. I N WITNESS WITEREOF the undersigned., being duly authorized to that effect, have s i p e d this Protocol. DONE at Montreal on Lhis twenty-nmth day of January, two thousand 45 AMEhTIME\T A 7 , 3 0 0 ( 1 Annex I INFORMATION IWQLTmED IN WYFIF!CATJONS LWDER AKTICLES 8, : < I i W D 1.3 5 1s Name, addrcss and contact details of the exporter. Kame, address and contact delails 01 the importer. Name and identity of the living modified organism, as well 3s the domestic classification, if m y , of lhe hosafety level of the living nindified organism in the Slate of export. Intended date or dates of the transhoundar), mnvement. if known Taxoiioinic statns, conmion name, point of collection or acquisilion, and 10 charactenstics of recipient orgmism or parental organisns related tn biosafety. Centres of origin and centres of genctic diversitv, if knowi. of the recipient organism and/or the parental organisn~ and a description of the liabilats where the organisnx may p s i s t or proliferate. Taxonomic status, common namr, p i n t oi cnlleciioii or ac.c:]uisitinn, and charactenstics or the donor organism or orpnnisrns rrlait? I C hiosafe ' Description of ciie nucieic acid io; used, nnd the resuhing characreristizs of the living moaikd irpnisiii. Intended uce of the living modified organism or products ttiereoi, namely, 20 processed matenals that are of living modified organism origin. containing detectable novel conihinations of replicable genetic malenal obtained thrnugh the use of mrxlem biolechnology. Quantity or volume of the living modified organism lo be transferred. A previous and existing risk assessniml report Consisleiit w ~ l h Annex 111. Suggested methods (or the safe hann;iling. smrage, tramport a i d use. including packaging, lahellin:, documentatifin, ~ S ~ O S Z I and cunt~iigcncy imxxdures. where appropriate. Regulator). stalus of the livin; iilodified organism ulthiil ihe Stale of e x p r t (for example, whether ii is prohibited in the Stale of export, whether there ,me 30 other restrictions. or whether it has been approved for general release) and, if' the living m&Gd organism is banned in the State of export, the reason or reasons for the han. Result and purpose of my notification by lhe exporler to other StRtes regardng the living modified organism 10 he transferred. A declaration that the above-mentioned infornlatioti I S factually correct. iiie modiiicatioii lnlrci!uwd, :he tt 35 25 Annex !I OR FOR PROCESSING I%EEI< AliTIC1.E 11 The name and contact details of <!le appiicmt for a dx-isim for doiiiei.tic use. The name and contact details OS the autlionty responsible for h e decision. Name and identiry of the living modified organism. Description of the gene inodificaiion, tire technique used, and the resulting characteristics of the living modlied organism. Any unique identification or the liviiis modified organism. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parentd orpanism? related to biosafety. Centres of orimn and centres or genetic divers~iy, if h-niwn. of the recipient organism and/or ine parental or@sin? where the organism? may persist or pioliferaie. Tanoiiomic stalus, common name, p n t or cdle-tion or acquisition. and Characteristics of the donor organism or o::anisms Approvd uses of the living modified ~qxmisrn. A risk a.sessnien1 report consistent wilh Annex IJJ. Suggested methods for the safe handhng, sttirage, transport anduse, including packaging. Inhelling, documentation, disposal and contingency prwedures, where appropriate. relaitd to hiosaiety. 5 10 10 and ii descnpiicin of the hnbilats 15 Annex' III RISK ASSESShEXl Objective - 1 Verify source ↗
The objective of risk assessment, uiider this Protocol. is 10 idmtify and evaluate the
AI-assisted research summary: This provision says risk assessment under the Protocol is meant to identify and evaluate possible adverse effects of living modified organisms on biodiversity and human health.
1. The objective of risk assessment, uiider this Protocol. is 10 idmtify and evaluate the potential adverse effects of living niodified organism? on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into accnunt risks to human health. 5 Use of risk assessment 2. fisk assessment is, intvr alia, used by competent authorities to make informed decisions regarding living modified organism?. 10 GenerRi principles - 3 Verify source ↗
Risk assessmmt should he camed out in a scimtifically suind xid trnnspareiit
AI-assisted research summary: Risk assessment should be carried out in a scientifically sound and transparent manner.
3. Risk assessmmt should he camed out in a scimtifically suind xid trnnspareiit m:~imer. and can take iiito account expert advice of; and guidelines d e v e l o p l hy, relevant international organizations - 4 Verify source ↗
Lack of scientific knowledge or scientific consensus should i'ot necessarily be 15
AI-assisted research summary: Lack of scientific knowledge or consensus should not be treated as meaning there is a particular level of risk, no risk, or an acceptable risk.
4. Lack of scientific knowledge or scientific consensus should i'ot necessarily be 15 interpreted as indcaung a particular level of risk, an absence of risk, or an acceptable nsk. S . Risks associated with living modified organisms or products thereof, namely. prcessed materials that are or living modified organism origin. containing detectable novel combinations of replicable genetic iiiiiterial obtainxi t h u p h the use of inodeni 20 hiotechnolo,7i, should he considered in Ihe context of the risks posed hy the nm-mndified recipients or parenpal organisms in the likely potenual receiving environment. - 6 Verify source ↗
Risk assessment should he carried out on a case-by-case bayis. The required
AI-assisted research summary: Risk assessment should be done case by case, and the information needed can vary depending on the organism, its intended use, and the receiving environment.
6. Risk assessment should he carried out on a case-by-case bayis. The required information may vary in nature and level of deiail from case to case. depending oii the 25 living modified organism concerned, its intended use and the likely potential receiving environnient. Methndolngy - 7 Verify source ↗
The process of risk assessment may on the one h,md give rise to a need for further
AI-assisted research summary: During risk assessment, additional information about specific subjects may be needed and requested.
7. The process of risk assessment may on the one h,md give rise to a need for further information about speciiic subjects, whcli may Lx identified and requested during the 30 assessment process, whle on the other hand information on other subjects may not be relevant in some instances. - 8 Verify source ↗
To fulfil its objective. risk assessment entails. as appropriate. the following steps:
AI-assisted research summary: This provision lists the steps for risk assessment of a living modified organism, including checking characteristics, likelihood, consequences, overall risk, and possible risk management or monitoring.
8. To fulfil its objective. risk assessment entails. as appropriate. the following steps: (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse eflects on 35 biological diversity in the likely potential receivins environment. taking also into account risks to humcan health; f h ) An evaluation of the likelihood o r these adverse efects k i n g realized. takiiig into account the level and kind of expsure of the likely potential receiving eiivironment to tlie living modified organism: ic) An evaluation of the consequences should these adverse effects hr realized; id) An estimation of the overall risk posed hy the living modified organism hased on liie evaiuation of the likelihood and consequences of the identified adverse effects being realized; 40 i ~ ) A recommendation as to whrther or not the risks are acceptahle or 45 manageable, including, where necessary, identification of strategies to manage these risks; and il) Where there is uncertainty reganling tlie level of risk, it may he addressed hy requesting fudier information on the specific issues of concern or b y implementing appropriate risk nianageinenl strategies andlor nionitoring the 50 living modified organism in the receiving environiiient. nCi ss. 23, z m Points to consider GESETICA~LY MoLmEr.t ORGAYISMS AW:NDMEVT x r . mx. - 9 Verify source ↗
Depending on the case:. risk assessment mkes into account the rel-;vnnt technical
AI-assisted research summary: Risk assessment must take account of the relevant technical and scientific details for the listed biological subjects and the receiving environment.
9. Depending on the case:. risk assessment mkes into account the rel-;vnnt technical and saentific details regmiin: Ihz cliarnctenslics 0: the ;oIlowiiig suiqrc!s: i n j Recipient organism or pnrentn! cqaniims. Tli: biolo$icai cn:irxleristiis 0: <ne recipent organism or parental or!anicms. including ~dor:iiatio:i oil taxonomic status, c~nmion nanie, origin, centres of origin and centres of genetic diversity if known, and a description of thc habitat where the organisins may persist or proliferate; (ti) Donor orgnnism or organisms Taxonomic Status and cornnlou iiaine, source, and the rrlevant hiolofical characteristics of the donor organisnx: i c ) Vector. Charactenstics of tlie vector, including its identity, if any. and its source or origin, and its host range; 5 10 ( d ) Insert or insert< andor chnrnctcridics of modification. Genetic character- islics of the inserled nuclric acid and lhe funclim it specifies, and/or characterist!cs of (ne modification introduced; 15 l r ) Living modified organism. Identity of the living modified orpnism. an3 the uifSel-cnces between tlie hiolofical characteristics 0: :he In in: modified orfanism and those of !he recipient orpanism or piirtnta! o:p:fflisrns: Detection and identification of the living modified orcanism. Suggested detection and ide~itification methods and their speciiicilj;, sensitivity ?did 20 rzli ahilily; (0 ig) Information relating to the intended use. Information relating to [he intended use of the living modified organism including new or chnngrd use compared to the recipient organism or parental organisms; and VI) Reccivinx environment. Information on the location, geogapliical, climatic 15 and ecoiogical characteristics, including rzlevariI iufonnalicin on biological diversity and centres of origin of thc likely potential receiving envirimment.
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Genetically Modified Organisms Amendment Act
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