STS Final - Basal Paciente Romano Valiente

8/19/2019 STS Final - Basal Paciente Romano Valiente

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Understanding BiosafetyUnderstanding Biosafety

Biosafety: The need to protecthuman health and environmentfrom the possible adverse eects ofthe products of modernbiotechnology.

The concept of biosafetyencompasses a range of measures,policies and procedures forminimizing potential risks thatbiotechnology may pose to theenvironment and human health.

Establishing credible and eectivesafeguards for !"s is critical forma#imizing the bene$ts of

biotechnology %hile minimizing itsrisks.


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Unit "b&ectivesUnit "b&ectives

'. E#plain the scope and intention of the(artagena )rotocol

*. +istinguish bet%een the categories ofiving !odi$ed "rganisms - !"s

/. +iscuss the trans0boundary !ovements of!"s

1. 2llustrate the 3dvance informed agreement

-323 procedure4. 5efer to the Biodiversity (learing 6ouse

7. +etermine the role of (ustoms and bordercontrol in implementing the (B+ )rotocol


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)rinciple '4 of the 5io)rinciple '4 of the 5io

+eclaration+eclaration2n order to protect the environment,the precautionary approach shall be%idely applied by 8tates according

to their capabilities. 9here there arethreats of serious or irreversibledamage, lack of full scienti$ccertainty shall not be used as areason for postponing cost0eectivemeasures to prevent environmentaldegradation.


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"b&ective of the (artagena"b&ective of the (artagena

)rotocol)rotocol2n accordance %ith the precautionary approachcontained in )rinciple '4 of the 5io +eclarationon Environment and +evelopment, theob&ective of this )rotocol is to contribute to

ensuring an adequate level of protectionin the eld of the safe transfer, handlingand use of living modied organisms resulting from modern biotechnology that mayhave adverse eects on the conservation and

sustainable use of biological diversity, takingalso into account risks to human health,and specically focusing ontransboundary movements.


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8cope of the (artagena8cope of the (artagena

)rotocol)rotocol

This )rotocol shall apply tothe transboundary movement,transit, handling and use of all

living modi$ed organisms thatmay have adverse eects onthe conservation andsustainable use of biologicaldiversity, taking also intoaccount risks to humanhealth. 2n accordance %ith the precautionaryapproach ;ocuses speci$cally on trans0boundary

movements

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The 5oad to (artagena The 5oad to (artagena

)rotocol)rotocolPhase 1: 's and 's -problemidenti$cationPhase 2: late 's and beginning of'


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'>. The negotiation

phase'. Elements de$nition phase '


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"n *< Aanuary *>>>, the (onference of

the )arties to the (onvention on

Biological +iversity adopted a

supplementary agreement to the

(onvention kno%n as the (artagena

)rotocol on Biosafety.

The )rotocol entered into force on ''

8eptember *>>/, ninety days after the

deposit of the $ftieth instrument of

rati$cation.

8tatus of )rotocol


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+e$nition of !"+e$nition of !"

3 living modi$ed

organism -!" is any

living organism that

possesses a novel

combination of genetic

material obtained

through the use of

modern biotechnology.3lso freuently referred to as geneticallymodi$ed organisms -!"s


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(ategories of !"s(ategories of !"s

!"s for intentionalintroduction into theenvironment -e.g. seeds, live$sh

!"s intended for direct useas food or feed, or forprocessing -e.g. agriculturalcommodities @ corn, canola,cotton

!"s for contained use -e.g.bacteria for laboratory

scienti$c e#periment


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(ategories of !"s(ategories of !"s

These dierent categories of !"sunder the )rotocol have dierentreuirements for their handling,

transport, packaging andidenti$cation.

3rticle '? of the )rotocol -Crelated (")0!") decisions set outthose reuirements.


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9hat is the $rst !9hat is the $rst !

3nimalD3nimalD

3 genetically modi$ed mouse in%hich a gene aecting hair gro%thhas been knocked out -left, sho%nne#t to a normal lab mouse.


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Examples of genetic

modication

GM bacteria a strain of

Rhizobium meliloti, containedgenes from $ve dierent speciesand %as genetically altered to

enhance its ability to providenitrogen to alfalfa plants onfarmland

GM agric!lt!ral crops )apayahas been modi$ed to provideresistance to papaya ringspotvirus. 5ice yello% mottle virusattacks rice in 3frica @ modernbiotechnology has produced a rice

resistant to the virus. Faccinesagainst diseases of the gastro0

intestinal tract have beenproduced in bananas andpotatoes.


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Examples of genetic

modication

GM "rees since '


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Examples of genetic

modication GM $ish The 3tlantic and

)aci$c salmon has receivedmost media attention,

particularly those thatcontain an additional genefor gro%th hormoneproduction and an anti0

freeze gene.

GM %nsects The fruitGyDrosophila melanogast er

%as one of the $rst

organisms to be geneticallyengineered over *> yearsago, and has been regularlyused in medical and

scienti$c research.


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!"s: )otential 5isks and!"s: )otential 5isks and

(oncerns(oncerns &ealth: 8afety of food for humans and livestock

He% allergens, to#ins

2ncreased resistance to antibiotics

En'ironment: 2mpact on biodiversity

(hanges in agricultural inputsene0Go%, gene introgression2mpact on centers of origin2mpact on ecosystem

(ocioeconomic: ack of access to proprietarytechnologies ;ood and consumer choice2mpact on seed sector and onresource0poor farmers


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!ain )illars of the )rotocol!ain )illars of the )rotocol

SAFE HANDLING, TRANSPORT AND ID

RISK MANAGEMENT

RISK ASSESSMENT

BIOSAFETY CLEARING HOUSE

AIA PROCEDURE


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M#%) P%**#+( ,$ "&E P+,",-,*

323 )rocedure

5isk 3ssessment5isk !anagement

Bio0safety (learing 6ouse


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#d'anced %nformed#d'anced %nformed

#greement#greement

+ierentiated procedures for !"s for intentionalintroduction into the environment and !"s fordirect use as food, feed or for processing -!"0;;)s

323I)rior 2nformed (onsent -)2(◦ ;or $rst movement of !"s for intentional introduction into

environment◦ E#porter must provide detailed information in advance of

$rst shipment

◦ 2mporter may then authorizeJrefuse shipment, depending on53

323 )rocedure -3rticles =0'>, '*:◦ Hoti$cation

◦ 3ckno%ledgement by importer - days

◦ +ecision procedure and revie% of decisions


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323323 )rocedures)rocedures

The advance informed agreement or 323procedure is designed to ensure that before an!" is imported into a country for the $rst timefor intentional introduction into the environment,the )arty of import:

a) Is notifed about the proposed import

b) Receives ull inormation about the LMO andits intended use

c) Has an opportunit to assess the ris!sassociated "ith that LMO and to decide "hetheror not to allo" the import


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The 323 procedure includes -' communication and -*decision making processes bet%een the )arties:

1. -omm!nication process:

a) #he $art o e%port or the e%porter must noti the$art o import o the proposed transboundarmovement in advance o the frst shipment& providing detailed& "ritten inormation about theLMO and its intended use'

b) #he $art o import is to ac!no"ledge receipt othis inormation "ithin ( das'

c) #hen& "ithin *+ das o the date o receipt onotifcation& the $art o import must ma!e adecision and communicate it to the notifer and the,-H'


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2. /ecisionma0ing process:

a) #he decision o the $art o import must be basedon a ris! assessment'

b) $arties ma also ta!e into account certain socio.economic considerations in ma!ing a decision"hether or not to allo" the import o an LMO'

c) #he $rotocol allo"s $arties to ta!e decisions basedon the precautionar approach "here there is a lac!

o scientifc certaint due to insu/cient scientifcinormation and !no"ledge regarding the e%tent o possible adverse e0ects o an LMO'


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5isk 3ssessment5isk 3ssessment

2denti$cation of potential environmentaladverse eects or hazards, anddetermining, %hen a hazard is identi$ed,the probability of it occurring

2n accordance %ith principles,methodologies C details in 3nne# 222

2dentifyJevaluate potential adverseeectsKscienti$cally, case by case

!inimum information, 3nne# ':

Ensured by importer, cost by e#porter


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5isk !anagement5isk !anagement

5isk management is the process ofcombining a risk assessment %ith decisionson ho% to address that risk, and doing so in%ays that consider the technical and social

aspects of the risk assessment.• !ethods applied to minimize potential

hazards or adverse eects identi$ed by theassessment

!easures to manage and control risks )revent unintentional !" movement

Ensure that !"s are observed for anappropriate period before use


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Bio08afety (learing houseBio08afety (learing house

The Biosafety (learing06ouse -B(6 is aninformation e#change mechanismestablished by the (artagena )rotocol on

Biosafety to assist )arties to implement itsprovisions and to facilitate sharing ofinformation on, and e#perience %ith, livingmodi$ed organisms -!"s.


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!andate of Bio08afety!andate of Bio08afety

(learing 6ouse(learing 6ouse

-a;acilitate the e#change of scienti$c, technical,environmental and legal information on, ande#perience %ith, living modi$ed organismsL and

-b 3ssist )arties to implement the )rotocol,taking into account the special needs ofdeveloping country )arties, in particular theleast developed and small island developing8tates among them, and countries %itheconomies in transition as %ell as countriesthat are centres of origin and centres of geneticdiversity.


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2mportance of B(62mportance of B(6

2t assists )arties and other stakeholders indierent %ays in the implementation of the)rotocol.

;osters greater transparency in theimplementation of the )rotocol .

;acilitates scienti$c and technical cooperation

bet%een )arties and other relevant stakeholders.

The B(6 allo%s easy access to information vitalto their activities

T b d ! f


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Transboundary movements of !"s intended forintentional introduction into the environment ofthe )arty

of import are sub&ect to the advance informed

agreement -323 procedure, %hich applies beforethe $rst intentional trans0boundary movement ofthe !" in uestion.

8tep ' @ Hoti$cation by E#porter

8tep * @ 3ckno%ledgement of receipt ofnoti$cation by 2mporter

8tep / @ +ecision !aking

Transboundary !ovement of Transboundary !ovement of

!"s!"s


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Transboundary movements of !"s0;;) aresub&ect to the follo%ing t%o0step procedure:

(tep 1: 2nforming the Biosafety (learing06ouse

about the $nal decision on domestic use.

(tep 2: +ecision making by a potential importing)arty.

3 )arty may take a decision on the import of an!"0;;) under its domestic regulatory frame%ork.

Transboundary !ovement of !"s0 Transboundary !ovement of !"s0

;;);;)


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&andling "ransport&andling "ransport

Pac0aging %denticationPac0aging %dentication

8hipments of dierent categories of !"s %ill beaccompanied by documentation %ith varyingdetails:◦ LMO.11$s2 %ill identify them as Mmay containN !"s, not

intended for introduction into the environment andcontact details of consignee -details to be de$ned by (")0!")

◦ -ontained use2 clearly identi$es them as !"s, speci$esconditions for safe handling, storageJuse and contactdetails of consignee

◦ 1or introduction into environment2 clearly identi$es themas !"s, speci$es the identity and relevant traits andJorcharacteristics, along %ith any reuirements for their safehandling, storage, transport and use, contact informationand declaration that the movement conforms to the

reuirements of the )rotocol


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)recautionary 3pproach)recautionary 3pproach

The )rotocol reGects a fundamental concept kno%nas the )recautionary 3pproach %hich means that agovernment may decide not to permit a particular!" to be imported across its borders.

This is the case even if there is insuOcient scienti$cevidence about the !"Ns potential adverse eects.

(oncerns could include the risk that imports ofgenetically engineered foods may replace traditionalcrops, undermine local cultures and traditions orreduce the value of biodiversity to indigenouscommunities.


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Precautionary

ApproachObjective: afe transfer, handling and

use of !"Os

#andling,transport,

packaging,identication:

$%ocumentation

for shipments$ tandards

Ris! 3ssessment

P

Ris!Management

.Inormation sharing

.

3"areness 4 participation

• 5ules Cprocedures

+ecisionmaking

(ompetentHational3uthorities Q

3dvisors

(ustoms Q(ompetentHational3uthorities

8ociety-public Qprivate

entities


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P!blic #areness and Participation #rP!blic #areness and Participation #r

2323

)romote C facilitate public a%areness concerning thesafe transfer, handling and use of !"s in relation to theconservation and sustainable use of biological diversity,taking also into account risks to human health.

Endeavour to ensure that public a%areness andeducation encompass access to information.

(onsult the public in the decision0making processregarding living modi$ed organisms and shall make theresults of such decisions available to the public, %hilerespecting con$dential information in accordance %ith3rticle *'.

Endeavour to inform its public about the means of publicaccess to the Biosafety (learing06ouse.


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The 5ole of (ustoms "Ocials The 5ole of (ustoms "Ocials

2n implementing the Biosafety )rotocolcustoms oOcials are reuired to:

Ensure !" imports have prior approval-decisions

Ensure !" shipments are accompanied%ith proper documentation

Ferify that contents of shipments match

accompanying documentation+etect illegal !" imports

Take appropriate measures


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These information requirements can be provided in different types ofdocumentation such as:

3 commercial invoiceL

3 document reuired or utilized bye#isting documentation systemsL or

"ther documentation as reuired bydomestic regulatoryJadministrativeframe%orks



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When a shipment of LMOs arrives at a port ofentry, the role of customs is to:

'. Ferify if shipment has proper importapprovals C if there are any conditions on its

import◦ This information can be obtained from

(ompetent Hational 3uthority C B(6

*. Ferify that documentation is complete

/. Ensure that contents of shipment correspondto information in accompanying documentation

◦ ;ollo% national procedures on sampling Cdetection


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When a shipment of LMOs arrives at a port

of entry, the role of customs is to (cont.):

1 a. 3dmit shipment to country of importof !" has been approved Cdocumentation is complete

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1 b. ;ollo% domestic rules andprocedures for refusing import if importof !" has not been approved andJordocumentation is incomplete


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Other eneral responsibilities:5egular communication %ith

the (ompetent Hational3uthority regarding !"sarriving at the ports of entry

;or%arding !" importdocuments to relevant nationalauthorities

+etecting and alerting relevant

authorities aboutpossible illegalimports and unintentional trans0boundary movements of !"s

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