----~ -------------- -~----_.
SPECIAL ISSUE
KenyaGazetteSupplement No.10(ActsNo.2)
REPUBLIC OFKENYA
KENYA GAZETTE SUPPLEMENT
ACTS,2009
NAIROBI, 13thFebruary, 2009
CONTENT
Act-
PAGE
TheBiosafety Act,2009 81
27FEB20ng
PRINTED ANDPUBLISHED BYTHEGOVERNMENT I'RINTER. NAIROBI
ij
------.--.
8]
THEBIOSAFETY ACT
No.2of2009
Date0/Assent:12thFebruary. 2009
Datea/Commencement: ByNotice
ARRANGEME~T OFSECTIO:\TS
Section
PARTI-PRELIMINARY
I-Short titleandcommencement.
2-Interpretation.
3-Scope oftheAct.
4-0bjects oftheAct.
PARTII-ESTABLISHMENT, POWERS ANDFUNCTIONS OF
THEAUTHORITY
5-Establishment oftheAuthority.
6-Board oftheAuthority.
7-Functions oftheAuthority.
8-Powers oftheBoard.
9-Conduct ofbusinessandaffairsoftheBoard.
IO-Delegation bytheBoard.
II-Remuneration ofmembers oftheBoard.
12-TheChiefExecutive Officer.
I3-Functions oftheChiefExecutive Officer.
]4-Staff oftheAuthority.
I5-The common sealoftheAuthority.
I6-Protection frompersonal liability.
I7-Liability fordamages.
-.----- ----
82
No.2 Biosafety
PARTIII-APPLICATIONS FORAPPROVAL ANDRISK
ASSESSMENT
18-Application forcontained useactivity.
19-Application tointroduce intotheenvironment.
20-Application forimportation.
2I-Application forplacingonthemarket.
22-Genetically modified organisms intransit.
23-Application forexport.
24-Withdrawal ofapplication.
25-Confidential information
26-Acknowledgement ofapplication
27-Ris~ assessment andriskmanagement.
28-Non-assessment ofrisks.
29-Determination ofapplication.
30-Communication ofdecision.
3I-Suspension orrevocation ofanapproval.
32-Register.
PARTIV-REVIEWS ANDAPPEALS
33-Review ofdecision.
34-0ffence ofwithholding information.
35-Establishment oftheAppealsBoard.
36-Powers oftheAppealsBoard.
37-Provisions astotheAppealsBoard.2009
83
2009 Biosafefy
PARTV-REGULA TORYAGENCIES
38-Consultation withregulatory agencies.
39-Unintentional releaseintotheenvironment.
PARTVI-RESTORA TIONANDCESSATIONORDERS
40-Environmental restoration order.
4I-Contents ofrestoration order.
42-Cessation orders.
PARTVII-INSPECTION ANDMONITORING
43-Appointment ofbiosafety inspectors.
44;-Functions ofbiosafety inspectors.
45-Powers ofbiosafety inspectors.
PARTVIII-FINANCIAL PROVISIONS
4~Funds oftheAuthority.
47-Annual estimates.
48-Accounts andaudit.
49-Investment offunds.No.2
84
No.2 Biosafety 2009
PARTIX-MISCELLANEOUS
50-Packaging andlabelling ofgenetically modified organisms.
51-Regulations.
52-Offences andpenalties.
53-Restriction oninstitution ofproceedings.
54-Public awareness andparticipation.
55-Transitional provisions.
FIRSTSCHEDULE REGULA TORYAGENCIES
SECOND SCHEDULE PROVISIONS ASTOTHE
CONDUCT OFBUSINESS ANDAFFAIRS OFTHEBOARD.
THIRDSCHEDULE INFORMA TIONREQUIRED IN
APPLICATIONS FORAPPROVAL OFCONTAINED USE
ACTIVITY
FOURTH SCHEDULE -INFORMA TION REQUIRED IN
APPLICA TlONS FOR APPROVAL OFRELEASE,
IMPORTA TION ORPLACING ONTHEMARKET OF
GENETICALL YMODIFIED ORGANISMS
FIFTHSCHEDULE -PROVISIONS ONRISKASSESSMENT
SIXTH SCHEDULE-PROVISIONS ASTOTHECONDUCT OF
BUSINESS ANDAFFAIRS OFTHEAPPEALS BOARD
85
2009 Biosafety
ANACTofParliament toregulate activities in
genetically modified organisms, toestablish the
National Biosafety Authority, andforconnected
purposes
ENACTED BYtheParliament ofKenya,asfollows-
PARTI-PRELIMINARY
1.ThisActmaybecitedastheBiosafety Act,200~
andshallcomeintooperation onsuchdateastheMinister
may,bynoticeintheGazette,appoint.
2.InthisAct,unlessthecontextotherwise requires-
"applicant" meansapersonsubmitting anapplication
pursuant totheprovisions ofthisAct;
"Authority" meanstheNational Biosafety Authority
established undersection5;
"biosafety" meanstheavoidance ofrisktohuman
healthandsafety,andtheconservation oftheenvironment, as
aresultoftheuseofgenetically modified organisms;
"contained use"meansanyactivityundertaken within
afacility, installation orotherphysical structure which
involves genetically modified organisms thatarecontrolled by
specificmeasures;
"environment" includes thephysical factors
surroundings ofhuman beings, including land,
atmosphere, soil,vegetation, climate, sound,
aesthestics, fishandwildlife;ofthe
water,
odour,
"financial year"meanstheperiodoftwelvemonths
endingonthethirtieth Juneineachyear;
--~-,-------No.2
ShorttitleanJ
commencement.
Interprctation.
No.2
ScopcorAct.
Ohjects ortheAct.86
Bio.\"{~fefY 2009
"genetically modified organism" meansanyorganism
thatpossesses anovelcombination ofgeneticmaterial
obtained throughtheuseofmodernbiotechnology techniques~
"intentional introduction intotheenvironment" means
anydeliberate useofgenetically modified organisms other
thannotcontained use:
"Minister" meanstheMinister forthetimebeing
responsible formattersrelatingtoscienceandtechnology.
"modern biotechnology" includestheapplication of-
(a)in-vitro nucleic acidtechniques
including theuseofrecombinant
deoxyribonucleic acid(DNA)anddirect
injection ofnucleicacidintocellsor
organelles; or
(b)fusionofcellsbeyond thetaxonomic
family. thatovercome natural
physiological, reproductive and
recombination barriers andwhichare
nottechniques usedIntraditional
breeding andselection:
"placing onthemarket" meansmakingagenetically
modified organism available forsale;and
"regulatory agency" meansaregulatory agencyasset
outintheFirstSchedule totheAct,orsuchotheragencyas
theMinistermay.byOrderintheGazette.determine.
3.(1)There.quirements ofthisActareinaddition to
therequirements imposedbyanyotherAct.
(2)ThisActshallnotapplytogenetically modified
organisms thatarepharmaceuticals forhumanuse.
4.TheobjectsofthisActare-.
200987
Biosafety
(a)tofacilitate responsible research into,
and .minimize therisksthatmaybe
posed by,genetically modified
orgamsms;No.2
(b)toensureanadequate levelofprotection
forthesafetransfer,handling anduseof
genetically modified organisms that
mayhaveanadverse effectonthe
health ofthepeople andthe
environment; and
(c)toestablish atransparent, science-based
andpredictable processforreviewing
andmakingdecisions onthetransfer,
handling anduseofgenetically
modified organisms andrelated
activities.
PARTII-ESTABLISHMENT, POWERS AND
FUNCTIONS OFTHEAUTHORITY
5.(1)Thereisestablished anAuthority tobeknownasEstablishment of
theNational Biosafety Authority.theAuthority.
(2)TheAuthority isabodycorporate withperpetual
succession andacommon sealandshall,initscorporate name,
becapableof-
(a)suingandbeingsued;
(b)taking, purchasing orotherwise
acquiring, holding, charging or
disposing ofmoveable andimmovable
property;
(c)enteringintocontract~; and
(d)doingorperforming allotherthingsor
actsnecessary fortheproper
No.2
Boardofthe
Authorny.88
Biosafety 2009
performance ofitsfunctions underthis
Act,whichmaylawfully bedoneor
performed byabodycorporate.
6.(I)TheAuthority shallbemanaged byaBoard
comprising of-
(a)achairperson, whoshallbeaneminent
scientist, appointed bytheMinister;
(b)thePermanent Secretary intheMinistry
forthetimebeingresponsible for
scienceandtechnology;
(c)thePermanent Secretary intheministry
forthetimebeingresponsible for
finance;
(d)thePermanent Secretary oftheMinistry
forthetimebeingresponsible for
agriculture;
(e)theDirector-General oftheNational
Environment Management Authority;
(f)theManaging Director oftheKenya
BureauofStandards;
(g)theManaging Director oftheKenya
PlantHealthInspectorate Services;
(h)theDirector oftheDepartment of
Veterinary Services;
(i)theSecretary oftheNational Council
forScience andTechnology;
U>theChiefPublicHealthOfficer;
(k)sixotherpersons appointed bythe
Minister; ofwhomatleasttwoshallbe
89
2009 Biosafery
ofeithergenderandofwhom-
(i)threeshallbeexperts inthe
following respective sciences~
namely biological.
environmental andsocial
sCIences;
(ii)oneshallrepresent interests of
consumers;
(iii)oneshallrepresent theinterests
offarmers;
(iv)oneshallrepresent theinterests
ofthebiotechnology industry;
and
(I)aChiefExecutive officerappointed
undersection12.whoshallbethe
Secretary totheBoard.
(2)Themembers oftheBoardappointed under
paragraphs (b)toU>ofsubsection (1)mayattendinpersonor
designate arepresentative toattendontheirbehalf.
(3)Theappointment ofthechairperson andthe
members underparagraphs (k)and(I)ofsubsection (1)shall
bebynameandbynoticeintheGazette.
(4)Thechairman andmembers oftheBoard.other
thantheexofficiomembers, shallholdofficeforaperiodof
threeyearsbutshallbeeligibleforreappointment forafurther
termofthreeyears.
7.(1)TheobjectandpurposeforwhichtheAuthority
isestablished istoexercise generalsupervision andcontrol
overthetransfer, handling a"1duseofgenetically modified
organisms withaviewtoensuring-
(a)safetyofhumanandanimalhealth;
----No.2
Obj.:ctsand
fUnc'l1l)nS"rlh.:
AUlhorny
No.290
Biosafety 2009
(b)provision ofanadequate levelof
protection oftheenvironment.
(2)Without prejudice tothegenerality ofsubsection (1),
theAuthority shall-
(a)consider anddetennine applications for
approval forthetransfer, handling and
useofgenetically modified organisms,
andrelatedactivities inaccordance with
theprovisions ofthisAct;
(b)co-ordinate, monitor andassess
activities relatingtothesafetransfer,
handling anduseofgenetically
modified organisms inordertoensure
thatsuchactivities donothaveadverse
effectonhuman healthandthe
environment;
(c)co-ordinate research andsurveys in
matters relating tothesafe
development, transfer, handling anduse
ofgenetically modified organisms, and
tocollect, collateanddisseminate
infonnation aboutthefindings ofsuch
research, investigation orsurvey;
(d)identify national requirements for
manpower development andcapacity
building inbiosafety;
(e)advisetheGovernment onlegislative
andothermeasures relatingtothesafe
transfer,handling anduseofgenetically
modified organisms;
(f)promote awareness and
among thegeneral public
relatingtobiosafety; andeducation
inmatters
200991
Biosafety
(g)establish andmaintain abiosafety
clearing housetoserveasameans
through whichinformation ismade
available facilitate theexchange of
scientific, technical, environmental and
legalinformation! on,andexperience
with,livingmodified organisms:
(h)perform anyotherfunction whichis
incidental totheperformance ofanyof
theforegoing functions.
8.TheBoardshallhaveallthepowersnecessary for
theproperperformance ofthefunctions oftheAuthority under
thisActand,inparticular butwithout prejudice tothe
generality oftheforegoing, theBoardshallhavepowerto-
(a)enterintocontracts;
(b)manage, control andadminister the
assetsoftheAuthority insuchmanner
andforsuchpurposes asbestpromote
thepurposeforwhichtheAuthority is
established;
(c)receiveanygifts,grants,donations or
endowments madetotheAuthority or
anyothermoneys inrespectofthe
Authority andmakedisbursements
therefrom inaccordance withthe
provisions ofthisAct;
(d)enterintoassociation withsuchother
bodiesororganizations withinor
outside Kenyaasitmayconsider
desirable orappropriate aqdin
furtherance ofthepurposes forwhich
theAuthority isestablished;
(e)openabanking account orbanking
-----No.2
Powers ofthe
Board.
No.2
Conduct of
business and
affairsofthe
Board.
Delegation bythe
Board.
Remuneration of
members ofthe
Board.
TheChief
ExecutiveOfficer.
Functions ofthe
ChiefExecutive
Officer.92
Biosafety 2009
accounts forthefundsoftheAuthority;
and
(0offerservicestoanypersonuponsuch
termsastheBoardmayfromtimeto
timedetermine.
9.Thebusiness andaffairsoftheBoardshallbe
conducted inaccordance withtheSecondSchedule.
10.TheBoardmay,byresolution eithergenerally orin
anyparticular case,delegate toacommittee oranyofficer,
memberofstafforagentoftheBoard,theexercise ofanyof
thepowersortheperformance ofanyofthefunctions or
dutiesoftheBoardunderthisAct.
11.Themembers oftheBoardshallbepaidsuch
remuneration, fees,allowances anddisbursements for
expenses asmaybeapproved bytheMinister.
12.(1)ThereshallbeaChiefExecutiveOfficerofthe
Boardwhoshallbeappointed bytheBoard.
(2)TheChiefExecutive Officershallholdofficefor
suchperiodandonsuchtermsandconditions ofemployment
astheBoardmaydetermine.
(3)TheChiefExecutive Officershallbeanex-officio
member oftheBoardbutshallhavenorighttovoteatany
meetingoftheBoard.
(4)TheChiefExecutive Officershall,subjecttothe
direction oftheBoard,beresponsible forthedaytoday
management oftheAuthority.
13.(1)TheChiefExecutive Officershall,subjectto
thedirections oftheBoard,beresponsible forthemanagement
oftheaffairsandtransactions oftheAuthority, theexercise,
discharge andperformance ofitsobjectives, functions and
duties.
93
2009 Biosafety
(2)TheChiefExecutive Officershall-No.2
(a)ensurethemaintenance
anddiscipline byall
Authority;ofefficiency
staffofthe
(b)managethebudgetoftheAuthority to
ensurethatitsfundsareproperly
expended andaccounted for;
(c)perform suchother
Authority may,from
assign.dutiesasthe
timetotime,
14.TheBoardmayappointsuchofficers, agentsandStaffofthe
otherstaffoftheAuthority asarenecessary fortheproperandAuthority.
efficient discharge ofthefunctions oftheAuthority underthis
Act,uponsuchtermsandconditions ofserviceastheBoard
maydetermine.
15.(1)Thecommon sealoftheAuthority shallbekeptThecommonseal
inthecustody oftheChiefExecutive OfficerorofsuchotheroftheAuthority.
personastheBoardmaydirect,andshallnotbeusedexcept
fupontheorderoftheBoard.
(2)Thecommon sealoftheAuthority, whenaffixedto
adocument anddulyauthenticated, shallbejudicially and
officially noticed, andunlessthecontrary isproved,any
necessary orderorauthorisation bytheBoardunderthis
sectionshallbepresumed tohavebeendulygiven.
(3)Thecommon sealoftheAuthority shallbe
authenticated bythesignature ofthechairperson oftheBoard
andtheChiefExecutive Officer:
Provided thattheBoardshall,intheabsenceofeithet
thechairperson ortheChiefExecutive Officer, inany
particular matter,nominate onemember oftheBoardto
authenticate thesealoftheAuthority onbehalfofeitherthe
chairperson ortheChiefExecutive Officer.
-
No.2
Protection from
personal liability.
Liability for
damages.
Application for
contained use
activity.-------
94
Biosf}fety 2009
16.NomatterorthingdonebyamemberoftheBoard
orbyanyofficer,member ofstaff,oragentoftheAuthority
shall,ifthematterorthingisdonebonafideforexecuting the
functions, powersordutiesoftheAuthority underthisAct,
renderthemember, officer,employee oragentoranyperson
actingontheirdirections personally liabletoanyaction,claim
ordemandwhatsoever.
17.Theprovisions ofsection16shallnotrelievethe
Authority oftheliabilitytopaycompensation ordamages to
any~rsonforanyinjurytohim,hisproperty oranyofhis
interestscausedbytheexerciseofanypowerconferred bythis
Actoranyotherwrittenlaworbythefailure,whollyor
partially, ofanyworks.
PARTIII-APPLICATIONS FORAPPROVAL AND
RISKASSESSMENT
18.(1)Apersonshallnotconduct anyactivity
involving genetically modified organisms withoutthewritten
approval oftheAuthority.
(2)Anapplication forapproval toconductacontained
useactivityshall-
(a)beintheprescribed manner;and
(b)contain-
(i)theinformation setoutinthe
ThirdSchedule tothisAct;and
(ii)suchotherinformation thatthe
applicant ortheAuthority may
consider necessary forthe
assessment ofthepotential risk
orbenefits oftheparticular
contained useactivity.
200995
Biosafety
19.(1)Apersonshallnotintroduce intothe
environment agenetically modified organism without the
writtenapproval oftheAuthority.
(2)Apersonwishing tointroduce agenetically
modified organism intotheenvironment shallsubmittothe
Authority anapplication describing theactivityforwhichthe
approval issought.
(3)Anapplication tointroduce agenetically modified
organism intotheenvironment shall-
(a)beintheprescribed manner;
(b)contain-
(i)theinformation setoutInthe
FourthSchedule; and
(ii)suchotherinformation thatthe
applicant ortheAuthority may
consider necessary forthe
assessment ofthepotential risk
orbenefitsoftheintroduction of
theparticular genetically
modified. organism intothe
environment.
(4)TheAuthority shallpublishintheGazette, atleast
twonewspapers withnationwide circulation, andinan
appropriate electronic media, noticeconcerning any
application forreleaseintotheenvironment ofagenetically
modified organism, forthegeneralinformation ofthepublic.
(5)Anypersonmay,withinthirtydaysfromthedate
ofpublication ofthenotice,makerepresentations tothe
Authority regarding suchanapplication, andtheAuthority
shalladdressappropriately anyrelevant concerns raisedby
suchaperson.
--No.2
Application to
introduce intothe
enVIronment.
No.2
Applicationfor
importation.
Application for
placing onthe
market.96
Biosafety 2009
20.(1)ApersonshallnotimportintoKenyaa
genetically modified organism withoutthewrittenapproval of
theAuthority.
(2)Anapplication forimportation ofagenetically
modified organism shall-
(a)beintheprescribed manner;
(b)contain-
(i)theinformation setoutInthe
FourthSchedule;
(ii)suchotherinformation thatthe
applicant ortheAuthority may
consider necessary forthe
assessment ofthepotential risk
orbenefitsofimportation ofthe
particular genetically modified
organism.
21.(l)Apersonshallnotplaceonthemarketa
genetically modified organism withoutthewrittenapproval of
theAuthority.
(2)Anapplication toplaceonthemarketagenetically
modified organism shall-
(a)beintheprescribed manner;
(b)contain-
(i)theinformation setoutInthe
FourthSchedule; and
(ii)suchotherinformation thatthe
applicant ortheAuthority may
consider necessary forthe
assessment ofthepotential risk
orbenefits oftheplacement of
200997
Biosafety
theparticular genetically
modified organism onthe
market.
22.(1)Aperson transporting through Kenya
genetically modified organisms, whicharenotdestinedforuse
il1Kenyashall-
(a)applyforawrittenapproval ofsuch
transportation fromtheAuthority; and
(b)ensurethatthegenetically modified
organisms being transported are
properly packaged andtransported in
accordance withsuchregulations as
maybeprescribed andanyapplicable
international standards.
(2)Anapplication totransport genetically modified
organisms throughKenyashallbeintheprescribed manner.
23.Apersonintending toexportagenetically modified
organism fromKenyashallprovidetheAuthority withan
advancewrittenconsentgrantedbyarelevantauthority ofthe
country towhichthegenetically modified organism is
destined, totheeffectthatsuchrelevant authority hasno
objection totheintended exportation.
24.Apersonapplying foranyapproval maywithdraw
hisapplication atanytimepriortotheissuance ofafinal
decisionbytheAuthority.
25.(1)TheAuthority shall-
(a)allow anapplicant toidentify
information provided totheAuthority in
accordance withtherequirements of
thisActandanyregulations made
hereunde.., thatistobetreated as
confidential, withjustification for
claimsofconfidentiality tobeprovided
uponrequest;
----No.2
Genetically
modified
organIsms In
transit.
Application to
export.
Withdrawal of
application.
Confidential
information.
No.2
Acknowledgement
ofapplication.
Riskassessment
andrisk
management.98
Biosafety 2009
(b)decidewhetheritacceptsasconfidential
theinformation designated bythe
applicant;
(c)informtheapplicant ofanyrejection of
theclaimofconfidentiality, providing
reasons onrequest, aswellasan
opportunity"for consultation;and
(d)intheeventthatanapplicant withdraws
anapplication inaccordance with
section 24,respect theapplicant's
claimsofconfidentiality.
(2)TheAuthority shallnotuseconfidential
information foranypurposenotauthorized underthisAct,and
shallensurethatsuchinformation isprotected byanyperson
involved inhandling applications underthisAct.
26.(1)Uponreceiptofanapplication, theAuthority
shallscreentheapplication forcompleteness andshall,within
thirtydaysfromthedateofreceipt,acknowledge receiptofthe
application inwriting.
(2)Where anapplication isnotcomplete, theAuthority
shallrequesttheapplicant tosubmitadditional information.
(3)Where theAuthority requests foradditional
information fromtheapplicant, thetimetakenbeforegetting
theinformation shallnotbereckoned bytheAuthority in
calculating thetimetakenpriortomakingafinaldecision on
theapplication.
27.(1)Wheretheapplication forapproval underthis
Acthasbeenscreened andfoundtobecomplete, theAuthority
shall-
(a)subjecttosection28,undertake arisk
assessment intermsoftheprovisions of
theFifthSchedule; and
200999
Biosafety
(b)auditriskassessment information
submitted bytheapplicant, ifany.No.2
(2)Riskassessment underthissectionshallbecarried
outtakingintoaccountavailable information concerning any
knownriskposedbypotential exposure toagenetically
modified organism.
(3)Uponcompletion oftheriskassessment, the
Authority shallmakeareportofitsfindings, andshallindicate
anymeasures tobetakentoensurethesafeuseofa
genetically modified organism.
(4)TheAuthority shallliaisewiththeappropriate
regulatory agencytoensurethatappropriate measures arein
placetomanageandcontrolrisksidentified duringtherisk
assessment process.
28.TheAuthority mayoptnottoundertake ariskNon-assessment
assessment forpurposes ofsections 18,19and20,whereitofrisks.
determines thatsufficient experience orinformation existsto
conclude thatthegenetically modified organism orcontained
useactivityconcerned donotposeasignificant risk.
29.(1)Indetermining anapplication, theAuthority DeterminatIOn of
shalltakeintoaccount- anapplication.
(a)theinformation submitted bythe
applicant;
(b)suchinformation andconditions asmay
besubmitted bytherelevantregulatory
agency;
(c)theriskassessment report;
(d)anyrelevant representations submitted
bymembers ofthepublic;and
No.2
Communication of
decision.
Suspension or
revocatIon ofan
approval.100
Biosafety 2009
(e)socio-economic considerations arising
fromtheimpactofthegenetically
modified organism ontheenvironment,
wherethedecision relates toan
application undersection19ofthisAct.
(2)TheAuthority shall,priortodetermining an
application, liaisewiththerelevant regulatory agency,and
suchregulatory agencyshallsubmittotheAuthority any
conditions thattheregulatory agencyconsiders appropriate to
beattachedtotheapproval.
30.(1)TheAuthority shalIcommunicate itsfinal
decision ofapproval orrejection oftheapplic..tion tothe
applicant, withinonehundred andfiftydaysofthereceiptof
theapplication butnotearlierthanninetydaysofsuchreceipt.
(2)Anapproval-
(a)shall'bespecific totheactivity
authorized; and
(b)itgranted subject tosomeconditions,
including suchconditions asmaybe
givenbyanappropriate regulatory
agency, shallclearly statesuch
conditions.
(3)Whereanapplication forapproval isrejected, the
reasonsforsuchrejection shalIbeclearlystated.
31.(1)TheAuthority maysuspend orrevokeany
approval givenunderthisActwherethepersonwhohasbeen
granted suchapproval isincontravention ofanyofthe
conditions imposed onthegrantoftheapproval, orthe
provisions ofthisAct.
(2)TheAuthority shall,beforesuspending orrevoking
anapproval, giveawrittennoticeofitsintention tosuspendor
revoketheapproval tothepersonuponwhomitisgiven,and
shalIaccordingly invitesuchpersontomakerepresentations
withinthirtydaysfromthedateofsuchnotice.
101
2009 Biosafety
(3)WheretheAuthority suspends orrevokes an
approval, itshallpublishtheordersuspending orrevoking the
approval intheGazette, atleasttwonewspapers with
nationwide circulation, andinanappropriate electronic media.
32.TheAuthority shallmaintain aregister,whichshall
contain-
(a)acopyof-
(i)everyapplication received;
(ii)theriskassessment report;
(iii)thedecision document;
(iv)theapproval; and
(b)anyotherinformation theAuthority
mayconsider neces.sary.
PARTIV-REVIEW ANDAPPEALS
33.(1)TheAuthority mayreview adecision made
undersection 29ofthisActatanytimeuponobtaining
significant newscientific information relating tobiosafety of
thegenetically modified organism orcontained useactivity
involved.
(2)Aregulatory agencyoranapplicant mayrequest
theAuthority toreviewitsdecision withrespecttoanactivity
conducted bytheapplicant wheretheregulatory agencyorthe
applicant considers that-
(a)achangeincircumstances hasoccurred
thatmayhaveamaterial effectonthe
outcome oftheriskassessment upon
-.------.-----No.2
Register.
Reviewof
decision.
No.2
Offenceof
withholding
information.
Establishment of'
theAppeals
Board.102
Biosafety
whichthedecision wasbased;or
(b)additional scientific ortechnical
information hasbecomeavailable that
mayhaveamaterial effectonthe
decision oranyconditions, limitations
orrequirements imposed undera
decision.2009
(3)IfuponreviewtheAuthority i:>satisfied thata
changeiswarranted, theAuthority shallsubstitute itsearlier
approval withanotherapproval whichshalltakeintoaccount
thechangedcircumstances.
(4)TheAuthority shallmakeadecision onareview
withinonehundred daysfromthedateofrequestforthe
reviewandshallstateclearlythereasonsforitsdecision.
(5)WheretheAuthority hasknowledge thatanactivity
posesathreattobiosafety, theAuthority shalltakeimmediate
actiontoputnecessary safetymeasures inplace.
(6)TheAuthority shallgivespecialconsideration for
reviewrequestsfromaregulatory agency.
34.Whereapet'8onuponwhomapproval hasbeen
grantedwithholds information thatbecomes available tohim
beforeandaftertheapproval ofhisapplication, andthe
information couldreasonably beexpected tochangethe
evaluation oftheriskposedbytheperson's intended activity,
suchpersoncommits anoffenceandisliableonconviction to
afinenotexceeding twomillionshillings, orimprisonment for
atermnotexceeding tenyears,orboth.
35.(1)Thereisherebyestablished anAppeals Board
whichshallconsistof-
(a)achairperson whoshallbeanadvocate
oftheHighCourtqualified for
appointment asajudgeoftheHigh
CourtofKenya, appointed bythe
Minister;
103
2009 Biosafety
fourotherpersons, each-ofwhomshall
beanexpertineitherbiological,
environmental orsocialsciences,
appointed bytheMinister.(b)
(2)Appointments totheAppeals Boardshallbeby
noticeintheGazette.
(3)Amember oftheAppeals Boardshallholdoffice
forthreeyears.
(4)Anypersonwhoisaggrieved by-
(a)arefusaltograntanapproval;
(b)theimposition ofanyconditions onan
approval;
(c)therevocation, suspension orvariation
ofanapproval;
(d)arefusaltotreatanapplication as
confidential;
(e)adecisionofabiosafety inspector;
(f)anyotherdecision oftheAuthority
underthisAct,
may,withinthirtydaysofbeingnotified oftherelevant
decision oftheAuthority, appealtotheAppeals Boardinthe
prescribed manner.
(5)Anypersonaggrieved byadecision oftheAppeals
Boardmay,withinthirtydaysofthem~kingofthedecision,
appealagainstthedecisiontotheHighCourt.
(6)ThedecisionoftheHighCourtonanyappealunder
thissectionshallbefinal.
----No.2
No.2
Powersofthe
AppealsBoard.]04
Biosafety 2009
(7)Subject tosubsection (8).theAppeals Boardshall
regulate itsownprocedure.
(8)TheMinister maymakerules-
(a)prescribing themanner inwhichan
appealshallbemadetotheAppeals
Boardandthefeestobepaidinrespect
ofanappeal;
(b)prescribing ascaleofcostswhichmay
beawarded bytheAppealsBoard;and
(c)generally forthebettercarrying outof
theprovisions ofthisActrelatingtothe
AppealsBoardandappealsthereto.
(9)TheAppeals Boardshallcommunicate itsfinal
decision totheappellant withinninetydaysfromthedatethe
appealwasmade.
36.(1)Onhearinganappeal,theAppeals Boardshall
havethepowersofacourttosummon witnesses, take
evidence uponoathoraffirmation, andtocallforthe
production ofbooksandotherdocuments.
(2)WheretheAppealsBoardconsiders itdesirable for
thepurposeofavoiding expenseordelayoranyotherspecial
reasonsotodo,itmayreceiveevidence byaffidavit and
administer interrogatories andrequirethepersontowhom
interogatories areadministered tomakeafullandtruereplyto
theinterogatories withinthetimespecified bytheAppeals
Board.
(3)Inthedetermination ofanymatter,theAppeals
Boardmaytakeintoconsideration anyevidence whichit
considers relevant tothesubjectofanappealbeforeit,
notwithstanding thatsuchevidence wouldnototherwise be
admissible underthelawrelatingtoevidence.
105
2009 Biosafety No.2
(4)TheAppealsBoardshallhavethepowertoaward
thecostsofanyproceedings beforeitandtodirectthatcosts
shallbetaxedinaccordance withanyscaleprescribed.
(5)Allsummonses, noticesorotherdocuments issued
underthehandofthechairperson oftheAppeals Boardshall
bedeemedtobeissuedbytheAppealsBoard.
(6)Anyinterested partymayberepresented beforethe
Appeals Boardbyanadvocate orbyanyotherpersonwhom
theAppeals Boardmayadmittobeheardonbehalfofthe
party.
37.Theprov~sions oftheSixthSchedule shallapplyto
theAppealsBoard.
PARTV-REGULA TORYAGENCIES
38.(1)TheAuthority shallcoordinate allactivities
involving genetically modified organisms andincarrying out
itsroleofcoordination, theAuthority mayconsultwiththe
relevantregulatory agency.
(2)Regulatory agencies shall,whereappropriate,
monitoranyactivityforwhichapproval hasbeengrantedby
theAuthority toensurethatsuchanactivitycomplies with
conditions imposed, ifany,onthegrantofanapproval.
(3)Wherearegulatory agency,incarrying outits
mandate, becomes awareofanysignificant newscientific
information indicating thatapproved activities withgenetically
modified organisms mayposepotential biosafety risksnot
previously known,theregulatory agencyshallimmediately
informtheAuthority ofthenewinformati~n andofthe
measures proposed tobeputinplacetoensurethecontinued
safeuseofthegenetically modified organism.
39.(1)Aregulatory agencywithknowledge ofan
unintentional orunapproved introduction intotheenvironment
ofagenetically modified organism thatislikelytopose
-- --Provisions asto
theAppeals
Board.
Consultation with
regulatory
agencies.
Unintentional
releaseintothe
environment.
No.2
Environmental
restoration order.
Contentsof
restoration order.-----
106
Biosafety 2009
biosafety risksshall,withintwenty-four hoursofknowledge
oftheintroduction, notifytheAuthority oftheoccurrence.
(2)Anotification underthissectionshallincludesuch
adequate information aswouldenabletheAuthority to
mitigate anyadverseeffectstobothhumanbeingsandthe
environment.
(3)TheAuthority shall,inconsultation withthe
regulatory agencyconcerned, determine whetheranyactionis
necessary tominimize anybiosafety risks.
PARTVI-RESTORA TIONANDCESSATION
ORDERS
40.(1)TheAuthority mayissueandserveonany
personarestoration orderinrespectofanymatterrelatingto
release ofagenetically modified organism intothe
environment.
(2)Anenvironmental restoration orderissuedunder
subsection (1)shallbeissuedto-
(a)requirethepersononwhomitisserved
torestoretheenvironment asnearasit
maybetothestateinwhichitwas
beforethereleaseofagenetically
modified organism;
(b)levyachargeonthepersononwhomit
isservedwhich,intheopinionofthe
Authority, represents areasonable
estimate ofthecostsofanyactiontaken
byanauthorized personororganization
torestoretheenvironment tothestatein
whichitwasbeforethereleaseofa
genetically modified organism.
41.Anenvironmental restoration ordershallspecify
clearlyandinamannerwhichmaybe23:sily understood-
2009107
Biosafety
(a)theactivitytowhichitrelates;No.2
(b)thepersontowhomitisaddressed;
(c)thetimeatwhichitcomesintoeffect;
(d)theactionwhichshouldbetakento
remedytheharmtotheenvironment
andthetime,beingnotmorethatthirty
daysorsuchfurtherperiodasmaybe
prescribed intheorder,withinwhich
theactionshouldbetaken;and
(e)thepenaltywhichmaybeimposed if
theactionspecifiedisnotundertaken..
42.(1)TheAuthority, inconsultation withtherelevant Cessationorders.
regulatory agency, mayissueanorderfortheimmediate
cessation ofanapproved activity, orfortheimmediate
imposition ofadditional riskmanagement measures with
respecttosuchactivity,iftheAuthority, inconsultation with
therelevant regulatory agency,determines thatthereisan
imminent dangerposedtotheconservation andsustainable use
ofbiological diversity, takingintoaccountriskstothehuman
healthonthebasisof-
(a)oneormoretestsconducted and
evaluated inamannerconsistent with
acceptable scientific procedures;
(b)othervalidated scientific evidence.
(2)TheAuthority mayissueacessation order-
(a)uponthefailureofanypersonissued
withanapproval todemonstrate
compliance withsuchapproval aftera
reasonable periodoftime;or
(b)intheeventofnon-compliance withthe
No.2
Appointment of
biosafety
inspectors.
Functions of
biosafety
inspectors.
Powersof
biosafety
inspectors.-'--
108
Biosafety 2009
provisions ofthisActorregulations
madethereunder.
(3)Acessation orderissuedunderthisActmaybe
withdrawn oncetheAuthority determines thatsufficient
information existstopermittheactivityconcerned toresume,
ortoresumeinthepresence ofadditional riskmanagement
measures, withoutposingasignificant risktohumanhealth
andtheenvironment.
PARTVII-INSPECTION ANDMONITORING
43.TheMinister may,ontherecommendation ofthe
Authority, andbynoticeintheGazette,appointdulyqualified
personswhetherbynameorbytitleofoffice,tobebiosafety
inspectors oftheAuthority, forsuchjurisdictional unitsas
maybespecified inthenoticeofappointment.
44.Abiosafety inspector shall-
(a)monitor compliance withthisActand
regulations madethereunder;
(b)undertake inspections andsubmit
reportsthereoftotheAuthority;
(c)perform suchotherfunctions asthe
Authority maydeemnecessary.
45.(1)Abiosafety inspector may,intheperformance
ofhisdutiesunderthisAct,atallreasonable timesandwithout
awarrant-
(a)enteranypremises, facility, vesselor
property whichtheinspector hasreason
tobelieveitisnecessary forhimto
enterinordertoascertain whether the
requirements ofthisActoranyapproval
underthisActarebeingcomplied with,
andmaytakewithhimanypersonduly
authorized bytheAuthority;
109
2009 Biosafety
(b)takewithhimanyequipment or
material required foranypurpose for
whichthepowerofentryisbeing
exercised;
(c)carryoutsuchtestsandinspections, and
makesuchrecordings asmaybe
necessary inthecircumstances;
(d)directthatanypartofpremises which
hehaspowertoenter,oranything in
suchpremises, shallbeleftundisturbed
forsplongasisreasonably necessary
forthepurposeofanytestorinspection;
(e)takeappropriate samples ofany
organisms, articlesorsubstances found
inanypremises whichhehaspowerto
enterforanalysisoranyotherrelevant
purposeunderthisAct;
(f)inthecaseofanything foundinthe
premises whichhehaspowertoenter,
whichappears tohimtocontain
genetically modified organisms which
posebiosafety risk,causeittobe
dismantled orsubjected toanyprocess
ortestbutnotsoastodamage or
destroyit,unlessitisnecessary;
(g)requiretheproduction ofanyrecords
whichmayberequired tobekeptunder
thisAct.
(2)Whenexercising hispowers underthisAct,a
biosafety inspector shallsuitably identify himself.No.2
suchgiftsasmaybegiventothe
Authority; and
allmoneys fromanyothersource
provided, donated orlenttothe
Authority.No.2110
Biosafety
PARTVIII-FINANCIAL PROVISIONS2009
Fundsofthe
Authority.46.ThefundsandassetsoftheAuthority shallconsist
of-
(a)suchmoneysasmaybeappropriated by
Parliament forthepurposes ofthe
Authority;
(b)suchmoneysorassetsasmayaccrueto
orvestintheAuthority inthecourseof
theexercise ofitspowers orthe
performance ofitsfunctions underthis
Act;
(c)suchmoneysasmaybepayabletothe
Authority pursuant tothisActorany
otherwrittenlaw;
(d)
(e)
Annualestimates. 47.(1)Atleastthreemonthsbeforethecommencement
ofeachfinancial year,theBoardshallcausetobeprepared
estimates oftherevenueandexpenditure oftheAuthority for
thatfinancial year.
(2)Theannualestimates shallmakeprovision forall
estimated expenditure oftheAuthority forthefinancial year
concerned, andinparticular shallprovidefor-.
(a)thepayment ofthesalaries, allowances
andothercharges inrespectofthe
officers, members ofstaff,oragentsof
theAuthority;
2009III
Biosafety
thepayment ofthepensions, gratuities
andothercharges inrespect of
retirement benefits payable tothe
members ofstaffoftheAuthority;(b)
(c)thepropermaintenance ofthebuildings
andgroundsoftheAuthority;
(d)thepropermaintenance, repairand
replacement oftheequipment andother
movable property oftheAuthority; and
(e)thecreation ofsuchreservefundsto
meetfutureorcontingent liabilities in
respect ofretirement benefits,
insurance, replacement ofbuildings or
equipment, orinrespectofsuchother
mattersastheBoardmaydeemfit.
(3)Theannualestimates shallbeapproved bythe
Boardbeforethecommencement ofthefinancial yearto
whichtheyrelateand,onceapproved, thesumprovided inthe
estimates shallbesubmitted totheMinister forapproval.
(4)Noexpenditure shallbeincurred forthepurposes
oftheAuthority exceptinaccordance withtheannual
estimates approved undersubsectior. (3),orinpursuance ofan
authorisation oftheBoardgivenwithpriorwrittenapproval of
theMinister, andthePermanent Secretary totheTreasury.
48.(1)TheBoardshallcausetobekeptproperbooks
andotherrecordsofaccounts oftheincome, expenditure,
assetsandliabilities oftheAuthority.
(2)Withinaperiodofthreemoqthsaftertheendof
eachfinancial year,theBoardshallsubmittotheController
andAuditor-General theaccounts oftheAuthority, inrespect
ofthatyear,togetherwith-
(a)astatement ofincomeandexpenditure
duringthatfinancial year;andNo.2
Accounts and
audit.
No.2
No.12of2003
Investment of
funds.
Handling
packaging, etc,of
genetically
modifIed
organisms.
Regulations.112
Biosafety 2009
(b)astatement oftheassetsandliabilities
oftheAuthority onthelastdayofthat
financial year.
(3)Theaccounts oftheAuthority shallbeexamined,
auditedandreported uponannually bytheController and
Auditor-General inaccordance withtheprovisions ofthe
PublicAuditAct,2003.
49.TheBoardmay-
(a)investanyofthefundsoftheAuthority
insecurities inwhichtheBoardmayby
lawinvesttrustfunds,orinanyother
securities whichtheTreasury may,from
timetotime,approve;
(b)placeondeposit, withsuchbankor
banksasitmaydetermine, anymoneys
notimmediately required forthe
purposes oftheAuthority.
PARTIX-MISCELLANEOUS
50.Anypersonmanufacturing orimporting any
genetically modified organisms shallensurethatthehandling,
packaging, identification andtransportation ofgenetically
modified organisms isdoneintheprescribed manner.
51.TheMinister may,inconsultation withthe
Authority, makeregulations forthebettercarrying intoeffect
theprovisions ofthisAct,andinparticular forprescribing-
(a)anything required bythisActtobe
prescribed;
(b)procedures forconducting contained use
activities involving genetically modified
orgamsms;
2009113
Biosafety
(c)procedures forreleaseofgenetically
modified organisms intothe
environment;
(d)procedures
exportation
organisms;forimportation and
ofgenetically modified
(e)procedures forgenetically modified
organisms intransit;
(f)procedure forhandling,
transporting andlabelling
Tl}odified organisms;packaging,
genetically
(g)formstobeusedforapplications for
approvals;
(h)schedules offees
administrative costsof
applications andnotices.tocover
processmg
52.Anypersonwho-
(a)makescontained useof,releases into
theenvironment, placesonthemarket,
imports orexports agenetically
modified organism withouttheapproval
oftheAuthority;
(b)contravenes anyconditions attached to
anapproval underthisAct;
(c)failstofurnish anyinformation as
requiredbythisAct;
(d)usesanyconfidential information for
anypurpose notauthorized underthis
Act;No.2
Offences and
penalties.
No.2
Restriction on
institution of
proceedings.
Publicawareness
andparticipation.--~--
114
Biosafety 2009
(e)usesagenetically modified organism in
amannerinconsistent withtheapproval
granted bytheAuthority orfor
unethical purposes;
(f)obstructs orfailstoassisttheAuthority
orofficers oftheAuthority inthe
performance oftheirdutiesunderthis
Act;.
(g)contravenes anyoftheprovisions ofthis
Act,
commits anoffenceandisliableonconviction toafinenot
exceeding twentymillionshillings, ortoimprisonment fora
termnotexceeding tenyears,orboth.
53.Noproceedings foranoffenceunderthisActshall
beinstituted withoutapriorwrittenconsentoftheAttorney-
General.
54.(1)TheAuthority shallpromote publicawareness
andeducation ofthepublicandthoseconducting theactivities
subjecttotheAct,concerning biosafety matters,throughthe
publication ofguidance documents andothermaterials aimed
atimproving theunderstanding ofbiosafety.
(2)TheAuthority shallgivenoticeintheGazetteofall
decisions maderegarding applications forapproval.
(3)Uponrequest,theAuthority shall,uponpayment of
theprescribed fee,availtoanypersoncopiesofrecordskept
undersection32!including detailsofanyapplication thatdo
notqualifyasconfidential information.
(4)Anypersonmaysubmitwrittencomments ona
.proposeddecisionforanyapplication forplacingagenetically
modified organism onthemarket,withinthirtydaysfromthe
datethenoticeisposted.
FIRSTSCHEDULE (s.2)
REGULA TORYAGENCIES
1.Department ofPublicHealth.
2.Department ofVeterinary Service$.
3.KenyaBureauofStandards.
4.KenyaPlantHealthInspectorate Services.
5.KenyaIndustrial Property Institute.
6.KenyaWildlifeService.
7.PestControlProducts Board.
8.National Environment Management Authority.2009115
Biosafety
55.(1)Anyapplication forapproval toundertake an
activityinvolving genetically modified organisms, whichhad
beenmadetotheNational Council forScience and
Technology inaccordance withtheScienceandTechnology
Act,andwhichhadnotbeenfinallydetermined onthedateon
whichthisActcameintoforce,shallbedeemedtobean
application forapproval madeunderthisActandshallbedealt
withaccordingly.
(2)Anyapproval toundertake anactivityinvolving
genetically modified organisms whichhadbeengrantedbythe
National CouncilforScienceandTechnology inaccordance
withtheScienceandTechnology Act,andwhichwasinforce
onthedateonwhichthisActcameintoforce,shallbedeemed
tobeanapproval oftheAuthority underthisAct.No.2
Transitional
provisions.
Cap.250
Cap.250
No.2
Committees and
co-opted
advisors.
Meetings ofthe
Board',
Vacation of
ofhce.116
Biosafety 2009
SECOND SCHEDULE (s.9)
PROVISIONS ASTOTHECONDUCT OFBUSINESS
ANDAFFAIRS OFTHEBOARD
1.(1)TheBoardmayestablish suchcommittees asit
mayconsider appropriate toperform suchfunctions and
responsibilities asitshalldetermine, butallfindings ofsuch
committees shallbepresented totheBoardforits
consideration anddetermination.
(2)TheBoardmay,atanytimeandforanylengthof
time,inviteanypersontoattendanyofitsdeliberations but
suchpersonshallnotbeentitledtovoteonanymatteratany
meetingoftheBoard.
2.(1)TheBoardshallmeetatleastfourtimesinevery
financial year.
(2)Thechairperson shallpresideateverymeetingof
theBoardatwhichheispresent, butinhisabsence, the
members shallelectoneoftheirnumber whoshall,with
respecttothatmeeting andthebusiness transacted thereat,
haveallthepowersofachairperson.
(3)Unlessaunanimous decision isreached, adecision
onanymatterbeforetheBoardshallbebyamajority ofvotes
ofthemembers presentandinthecaseofanequalityofvotes,
thechairperson shallhaveacastingaswellasadeliberative
vote.
3.(1)Amember oftheBoard,o~herthananex-officio
member, shallvacateofficeonanyofthefollowing grounds-
(a)upontheexpiryofhisappointment;
(b)uponhisdeath;
(c)ifheisadjudged bankrupt;
(d)ifheissentenced foranyoffence
117
2009 Biosafety
againstanywrittenlawtoatermof
imprisonment ofsixmonthsormore;
(e)ifheisconvicted ofanoffence
involving fraud,dishonesty ormoral
turpitude;
(f)ifheisabsent,withoutpermission ofthe
chairperson oftheBoard,fromthree
successive meetings oftheBoardof
whichhehasreceived notice;
(g)uponnoticeinwritingofhisintention to
resignhisoffice,
(h)ifintheopinion oftheBoard,he
becomes byreasonofmentalorphysical
infirmity incapable ofperforming his
dutiesasamemberoftheBoard;or
(i)uponthecommission ofanoffence
underthisAct.
4.IfamemberoftheBoardhasanyinterestdirector
indirectinanyapplication orothermatterwhichisthesubject
ofconsideration atameetingoftheBoard,themember shall,
atthemeeting, disclosethefacttotheBoardandshalltakeno
partintheconsideration ordiscussion oforvoteonany
question withrespecttotheapplication ortheothermatter.
THIRDSCHEDULE (s.18)
INFORMA TIONREQUIRED INAPPLICATIONS
FORAPPROVAL OFCONTAINED USEACTIVITY
1.Thenameandcontactaddressoftheapplicant.
2.Thelocation wherecontained useactivities aretobe
undertaken.No.2
Disclosure of
interest
No.2118
Biosafety 2009
3.Thenatureandidentityofgenetically modified organisms
tobeinvolved.
4.Thenatureandpurpose oftheactivities including such
activities asstoring,transporting, producing, processing,
disposing orusingthegenetically modified organisms in
anyotherway..
5.Adescription ofthecontainment measures tobeprovided
andthesuitability ofthosemeasures forthegenetically
modified organisms andactivities tobeundertaken.
6.Adescription ofanypotential risksassociated withthe
genetically modified organisms ortheactivities tobe
undertaken, and
7.Adescription ofremedial measures tobeundertaken inthe
eventofanyaccident.
8.Asworndeclaration bytheapplicant thattheabove
information isfactually correct.
.FOURTH SCHEDULE (s.19,20,21)
INFORMA TIONREQUIRED INAPPLICATIONS
FORAPPROVAL OFRELEASE INTOTHE
ENVIRONMENT, IMPORTATION ANDPLACING ON
THEMARKET OFGENETICALLY MODIFIED
ORGANISMS
1.Narne,addressandcontactdetailsoftheapplicant.
2.Nameandidentity ofthegenetically modified
organism aswellasthedomestic classification, if.any,
oftheBiosafety levelofthegenetically modified
organism inthecountryofexport.
3.Intended datesofthetrans-boundary movement.
119
2009 Biosafety
4.Taxonomic status,common name,pointofcollection
oracquisition andcharacteristics oftherecipient
organism orparentalorganism relatedtoBiosafety.
5.Centeroforiginandcenterofgeneticdiversity if
known,oftherecipient organism andtheparental
organism andthedescription ofthehabitatwherethe
organism maypersist.
6.Taxonomic status,common name,pointofcollection
oracquisition andcharacteristics ofthemodification
introduced, thetechnique usedandtheresulting
characteristics ofthegenetically modified organism.
7.Intended useofthegenetically modified organism.
8.Quantity orvolume ofthegenetically modified
organism tobetransferred.
9.Suggested methods forthesafehandling, storage,
transport anduse.
10.Asworndeclaration oftheapplicantthattheabove
mentioned information isfactually correct.
FIFTHSCHEDULE (s.27)
PROVISIONS ONRISKASSESSMENT
1.Theobjective ofth~riskassessment istoidentify
andevaluate thepotential adverse effectsofgenetically
modified organisms onhumanhealthandtheenvironment.
2.Theriskassessment shallbeusedbytheAuthority to
makeinformed decisions regarding ienetically modified
orgamsms.
3.Thegeneralprinciples guidingriskassessment are-
(a)riskassessment shallbecarriedoutinaNo.2
Objective of
risk
assessment.
Useofrisk
assessment.
General
principle~.
No.2
MClhOlh)lo[!) .120
Biosafety 2009
scientifically soundandtransparent
manner andmaytakeintoaccount
expertadviceandguiding principles
developed byrelevantorganizations.
(b)lackofscientific knowledge orscientific
consensus shallnotnecessarily be
interpreted toindicate aparticular level
ofrisk,anabsence ofriskoran
acceptable risk.
(c)riskassociated withgenetically
modified organisms shallbeconsidered
inthecontext oftherisksposedbythe
genetically modified organisms
recipient ortheparental organisms in
thelikely potential receiving
environment.
4.Tofulfillitsobjective, ariskassessment shallentail
thefollowing steps-
(a)anidentification ofanygenotype and
phenotypic characteristics associated
withthegenetically modified organisms
thatmayhaveadverse effectsonthe
environment andonhumanhealth
(b)anevalu~\tion ofthelikelihood ofthese
adverse l'ffects beingrl'alil.ed, taking
intoaccount thl'kvdandthl'kindof
exposure of'helikely potential
receiving l'nvironml'nt ofthl'gl'ndically
modifil'd organisms,
(c) anevaluation oftheconSl'l\Ul'llces
shouldthl'seeffects berealil.l'd,
(d)alll'stimation ofthl'overallriskposl'd
bythl'gl'netically modified organisms
basedontheevaluation ofthelikelihood
121
2009 Biosafety No.2
andconsequences oftheidentified
adverseeffectsbeingrealized,
(e)arecommendation astowhether ornot
therisksareacceptable ormanageable,
including identification ofstrategies to
manage theserisks,and
([)wherethereisuncertainty regarding the
levelofrisk,theAuthority mayrequest
forfurtherinformation onthespecific
issuesofconcern ormayrecommend
implementing appropriate risk
management strategies andmonitoring
thegenetically modified organisms in
thereceiving environment.
5.Riskassessment shalltakeintoaccount therelevant P"intsI"
technical andscientific detailsregarding thecharacteristics ofc"nslJcr
thefollowing subjects-
(a)Recipient organism orparental organism.
Thebiological characteristics oftherecipient organism
orparental organism including taxonomic status,common
name,origin,centersoforiginandcentersofgeneticdiversity
andadescription ofthehabitat\vheretheorganism persists
(h)Donororganism
Taxonomic status<.1ndcommon name,sourceandthe
rekvant biological characlL'ristics ofthedonororganisms.
(c)Vector
Characteristics ofthevectorincluding itsidentity and
thesourcesoforiginandhostrange.
(d)Insertandcharacteristics ofmodification.
Geneticcharacteristics oftheinsertednucleicacidand
No.2
Vacation of
office.--~- --
122
Biosafety 2009
thefunction itspecifies andcharacteristics ofthemodification
introduced.
(e)Genetically modified organisms.
Identityofthegenetically modified organisms andthe
differences between thebiological characteristics ofthe
genetically modified organisms andthoseoftherecipient
organism orparentalorganism.
(0Detection andidentification ofgenetically modified
organisms.
Suggested detection andidentification methods andthe
specificity, sensitivity andreliability.
(g)Information relatingtotheintended use.
Information relatedtotheintended useofthe
genetically modified organisms including neworchanged use
compared totherecipient organism orparentalorganism.
(h)Receiving environment.
Information onthelocation, geographical, climaticand
ecological characteristics including relevant information on
biological diversity andcentersoforiginofthelikelypotential
receiving environment.
SIXTHSCHEDULE (s.37)
PROVISIONS ASTOTHEAPPEALS BOARD
1.(1)Amember.oftheAppeals Boardmayvacate
officeonanyofthefollowing grounds-
(a)upontheexpiryofhisappointment;
(b)uponhisdeath;
(c)ifheisadjudged bankrupt;
123
2009 Biosa/ery No.2
(d)ifheissentenced foranyoffence
againstanywrittenlawtoatermof
imprisonment ofsixmonthsormore;
(e)ifheisconvicted ofanoffence
involving fraud,dishonesty ormoral
turpitude;
(f)ifheisabsent,withoutpermission ofthe
chairperson oftheAppeals Boardfrom
threesucces,sive sittingsoftheAppeals
Boardofwhichhehasreceived notice;
(g)upongivingnoticeinwritingofhis
intention toresignhisoffice,
(h)ifhebecomes, byreasonofmentalor
physical .infirmity, incapable of
performing hisdutiesasamember of
theAppealsBoard;or
(i)uponthecommission ofanoffence
underthisAct.
2.IfamemberoftheAppealsBoardhasanyinterest Disclosure of
directorindirectinanyapplication orothermatterwhichisinterest.
thesubjectofconsideration atasittingoftheAppeals Board,
themembershallatthesitting,disclosethefacttotheAppeals
Boardandshalltakenopartintheconsideration ordiscussion
oforvoteonanyquestion withrespecttotheapplication orthe
othermatter.
3.Wheretheofficeofanymember becomes vacant, Vacancy.
whether bydeathorotherwise, theMinister mayappoint
anotherpersontobeamember oftheAppeals Boardforthe
remainder ofthetermofthemember whosevacancy caused
theappointment.
4.Thedecision oftheAppeals BoardshallbethatofMajority
themajority andshallbesignedbythemembers thereof decisions.
agreeing thereto.
---..----..-
r
No.2
Venue.
Proofof
documents.-------
124
Biosafety 2009
5.TheAppealsBoardshallsitatsuchplaceasitmay
consider mostconvenient having regard toallthe
circumstances oftheparticular proceedings.
6.Adocument purporting tobeacopyofanyorderof
theAppealsBoard,andcertified bythechairperson tobeatrue
copythereof,shallinanylegalproceedings beprimafacie
evidence oftheorder.