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Biotecnologie ambientali aa 2012-2013 Rischi ambientali e Protocollo di Cartagena.

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Presentazione sul tema: "Biotecnologie ambientali aa 2012-2013 Rischi ambientali e Protocollo di Cartagena."— Transcript della presentazione:

1 Biotecnologie ambientali aa Rischi ambientali e Protocollo di Cartagena

2 Le piante coltivate e la sindrome da domesticazione: shattering e dormienza Rischi e benefici ambientali delle piante transgeniche in paragone a quelle convenzionali. Convenzione di Rio, Protocollo di Cartagena e normativa sulle piante create tramite ingegneria genetica Piante per una maggiore sostenibilità ambientale (es. plastiche biodegradabili), per il risanamento (fitodepurazione) e come biosensori di contaminazione. Interazione pianta-microrganismo: le risposte di difesa delle piante e generazione di specie resistenti. Interazione simbiotiche pianta-microrganismo: fissazione dellazoto (batteri azoto fissatori) PROGRAMMA

3 La convenzione di Rio o sulla Biodiversità (CBD) The Convention on Biological Diversity is an international treaty to sustain the rich diversity of life on Earth. 42 articoli e 2 annex in ita:

4 Article 2. Use of Terms "Biotechnology" means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. Article 8. In-situ Conservation (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health: (h) Prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species: Its objectives are: the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising out of the utilization of genetic resources.

5 1. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, to provide for the effective participation in biotechnological research activities by those Contracting Parties, especially developing countries, which provide the genetic resources for such research, and where feasible in such Contracting Parties. 2. Each Contracting Party shall take all practicable measures to promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies based upon genetic resources provided by those Contracting Parties. Such access shall be on mutually agreed terms. 3. The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. 4. Each Contracting Party shall, directly or by requiring any natural or legal person under its jurisdiction providing the organisms referred to in paragraph 3 above, provide any available information about the use and safety regulations required by that Contracting Party in handling such organisms, as well as any available information on the potential adverse impact of the specific organisms concerned to the Contracting Party into which those organisms are to be introduced. Article 19. Handling of Biotechnology and Distribution of its Benefits Nasce il Protocollo di Cartagena

6 Conference of the Parties (COP)Conference of the Parties (COP) : governing body of the Convention The governing body: Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol (COP-MOP) Storia della CBD e del Protocollo di Cartagena

7 1700 M$ in 12 years from GEF in cofinancing of biodiversity projects. GEF=Global Environment Facility

8 An additional protocol to the Convention of Biological Diversity è frutto delle decisioni prese allinterno della CBD The Cartagena Protocol on Biosafety to the Convention on Biological Diversity It was adopted on 29 January 2000 and entered into force on 11 September 2003.

9 Eventuale testo in italiano (non necessariamente corretto)

10 The Cartagena Protocol on Biosafety to the Convention on Biological Diversity An international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs, with specific focus on transboundary movements of LMOs. It features a set of procedures including one for LMOs that are to be intentionally introduced into the environment called the advance informed agreement procedure, and one for LMOs that are intended to be used directly as food or feed or for processing.advance informed agreementLMOs that are intended to be used directly as food or feed or for processing

11 Preamble The Parties to this Protocol, Being Parties to the Convention on Biological Diversity, … Recalling Article 19, paragraphs 3 and 4, and Articles 8 (g) and 17 Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement, Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health, Il Protocollo di Cartagena A Protocol is a binding international instrument, separate from, but related to, another treaty.

12 Recognizing that modern biotechnology has great potential for human well- being if developed and used with adequate safety measures for the environment and human health, Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity, Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms, Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development, Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, Understanding that the above recital is not intended to subordinate this Protocol to other international agreements, Have agreed as follows:

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14 Paragonate con CBD Article 8. In-situ Conservation (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health: (h) Prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species: but Article 19 …may have adverse effects

15 I virus normalmente NON sono considerati living organisms

16 AIA The Primary focus of the Cartagena Protocol is the regulation of transboundary movement of living modified organisms. The main instrument is the Advanced Informed Agreement (AIA) - pharmaceuticals - in transit - destined for contained use (research) This Protocol shall not apply to the transboundary movement of living modified organisms which are: Separate AIAs apply to: - LMOs intended for direct use as food or feed, or for processing - LMOs for deliberate release (= cultivation)

17 The "Advance Informed Agreement" (AIA) procedure applies to the first intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import. It includes four components: -notification by the Party of export or the exporter, -acknowledgment of receipt of notification by the Party of import, -the decision procedure, and -opportunity for review of decisions. The purpose of this procedure is to ensure that importing countries have both the opportunity and the capacity to assess risks that may be associated with the LMO before agreeing to its import. The Party of import must indicate the reasons on which its decisions are based (unless consent is unconditional). A Party of import may, at any time, in light of new scientific information, review and change a decision. A Party of export or a notifier may also request the Party of import to review its decisions. Art.8 Art.9 Art.10 & 11 (food, feed, processing) Art.12 There is a simplified procedure (Art.13) - Immissione contemporanea alla notifica - Esenzioni MAI USATA

18 ANNEX I Informazioni richieste dallAIA per il rilascio ambientale

19 ANNEX II Informazioni richieste dallAIA uso per Food, feed, processing

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22 Valutazione del rischio

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24 Tante parole, ma come si fa in pratica una valutazione del rischio? Rischio = Pericolo Probabilità di conseguenze negative x Risk is defined as the probability that exposure to a hazard will lead to a negative consequence, or more simply, Risk = Hazard x Dose (Exposure)

25 Transgenic crops expressing Bacillus thuringiensis toxins and biological control Romeis (2006) Nature Biotech. 24:63-71 doi: /nbt1180 Tiered approach Tiered – sequenziale? Gerarchica? Decision tree to determine nontarget effects of Bt plants on natural enemies (parasitoids and predators) feeding on either host/prey species or directly on plant material (e.g. pollen) in studies under confined conditions.

26 In the case of nontarget risk assessment of insecticidal transgenic crops, early tier (laboratory) tests are conducted to determine whether an organism is susceptible to the toxin under worst case conditions, that is, organisms are directly exposed to high doses of the toxin. These tests are relatively simple in design, easy to standardize, repeatable and the results are easy to interpret. The risk assessment can stop here if risks under these worst case conditions are considered negligible or acceptable. However, if risks have been identified or cannot be ruled out with some certainty, higher tier tests will follow that expose nontarget organisms to the toxin under more realistic conditions.

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30 Conclusions and recommendations Although the effects of Bt plants have been investigated for a limited number of predator and parasitoid species under confined conditions, two general trends are evident: first, there is no indication of direct effects of Bt plants on natural enemies, either in direct plant feeding assays or when natural enemies have been provided with unsusceptible hosts/prey containing the Cry toxin; second, adverse effects on natural enemies have been observed only in studies with susceptible herbivores as hosts/prey. These effects are most likely due to reduced host/prey quality. One exception to this is the reported impact of Bt potatoes on an aphid parasitoid, which was probably due to affected aphid hosts. In contrast, applications of conventional insecticides have usually resulted in negative impacts on biological control organisms. Because Bt-transgenic varieties can lead to substantial reductions in insecticide use in some crops, they can contribute to integrated pest management systems with a strong biological control component. David A. Andow et al. (2006) Ecological risk assessment for Bt crops. Nature Biotechnology 24: doi: /nbt Jörg Romeis et al.(2006) Reply to Ecological risk assessment for Bt crops. Nature Biotechnology 24: doi: /nbt

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35 Solo approvazioni a livello europeo

36 Risk assessment

37 Laws and regulations

38 17 su 23 sono di tipo EU Le rimanenti sono queste In realtà mancano una serie di norme

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42 Sito Italiano (in inglese)

43 Normativa nazionale

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45 Tutti queste buone intenzioni e articoli si scontrano con una concezione viziata della transgenesi

46 Mackenzie (2003) FAQs,

47 Mito: I transgenici sono innaturali mentre le piante convenzionali sono naturali e non sono modificate dal punto di vista genetico Nuovi geni vengono continuamente creati. In riso hanno identificato 898 retrogeni, 55% sembrano funzionanti e 35% sono chimere (costruiti a partire da geni diversi). Sono meglio i geni creati consciamente o quelli creati inconsciamente (dalla natura)? La mutazione Wp in soia ha semi più grandi (22%), più proteine (4%) e i fiori rosa pallido. La mutazione è dovuta a un retrotransposone, inserito in una calcone sintasi, che ha catturato 5 esoni da 4 geni differenti fusi in un nuovo gene Relazione di W. Parrott alla PAS

48 Organizzazione della regione che contiene il gene bronze (bz) in 7 diverse linee di mais gene bz 5 linee inbred 2 razze locali i diversi trasposoni sono rappresentati da triangoli colorati Wang e Dooner (2006) PNAS 103:

49 (a) (b) (c) Esempi di variegazione indotta da trasposoni nei semi di mais

50 Il mais Bt contaminerà la biodiversità nel centro di origine mettendo a rischio la sovranità alimentare di centinaia di milioni di persone Pannocchie di mais bianco, nero e giallo stese ad asciugare sui tetti delle case di San Juan Ostuncalco, Guatemala. I contadini sanno come mantenere lidentità delle diverse varietà Foto: cortesia di Eduardo Roesch Il Grande Mito del mais:

51 Pannocchie raccolte nei campi in Guatemala; le varietà locali si incrociano Foto: cortesia di W. Parrott, Università della Georgia, AL (USA) Non per questo le varietà hanno perso la loro identità i contadini sanno bene come mantenere lidentità delle diverse varietà Il genoma del Palomero Toluqueno (varietà indigena) è 78% del B73

52 Arca di Noé - S. Maurizio al Corso (Mi)

53 Relazione di J. Gressel e M. Qaim Mais Mais infestato da Striga hermonthica I transgenici sono utili per i PVS?

54 THE BIOSAFETY PROTOCOL WILL ENABLE PEOPLE EVERYWHERE TO ENJOY THE BENEFITS OF BIOTECHNOLOGY WHILE AVOIDING UNNECESSARY RISKS. Biosafety and the environment (An Introduction to the Cartagena Protocol on Biosafety) Il desiderio: Risultato????

55 Per la coltivazione occorre un permesso sulla base di documentazione scientifica Varietà convenzionale Varietà transgenica La realtà:

56 Cartagena countries-- which includes the EU-- do not regulated GMOs as such. They regulate the products of modern biotechnology, defined as a crop obtained by injecting nucleic acids into a cell. Nothing says the nucleic acid has to stay there. Thus, all products from genome editing are GMOs unless they change the definition or make an exception. USDA does not regulate transgenes as such, either. They regulate plant and animal pests. Thus in the US it depends on the presence or absence of pathogen-derived sequences and whether transformation is done with the gun or with agro. Canadian regulatory trigger is based on novelty of the trait. It is the only current regulatory trigger compatible with OECD, NAS, ACRE science- based regulatory trigger recommendations. Regulatory frameworks

57 Focus on product risks, not on method used * Allergen inactivation (soybean) * Toxin inactivation (cotton ) *... Two methods, one result Same result using different methods: is one evil and the others benign? Sunflower Herbicide tolerant sunflower mutagenesis transgenesis Herbicide tolerant sunflower Any loss of function… spont. mutation Morandini (2010) New Biotechnol.

58 Nel frattempo... ZFNs, TALENs, CRISPS

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62 Tutti questi nuovi metodi (e la mutagenesi classica...) pongono seri problemi ai regolatori!

63 Avvistati extraterrestri nel Nord-Italia Segnalato predone Tusken Scene di panico a Milano Qual è la credibilità di un protocollo che dovrebbe normare una tecnologia di cui non comprende i fondamenti?

64 In Reports 1 and 2 we conclude that the framework for controlling GMOs in the EU is out-dated and not fit for purpose. Regulatory frameworks need to evolve along with the evidence, especially when dealing with novel technology. This includes the EUs legislation for controlling GMOs. ACREs recommendation is that the current framework should be replaced by a system that regulates organisms based on the novelty of their characteristics rather than on how they are produced. It should also take benefits, as well as risks, into account to allow for more informed decision-making.

65 Refreshing the vocabulary 3 stamen 1 sepal 2 petal 4 carpel

66 Identity crisis Petal flower Sepal leaf Mutant: Apetala

67 More problems Agamous stamen petal stamen carpel PistillataApetala3 stami carpelli petal sepal carpel flower petal sepal Images courtesy of L. Colombo (Unimi)

68 and Cauliflower… …as well as Arabidopsis

69 Female cucumber flower Even cucumbers have problems Images courtesy of M. Kater (Unimi) One of the most aggressive insects damaging cucumbers in greenhouses in Canada & USA Western flower thrips Frankliniella occidentalis

70 Life cycle of Frankliniella occidentalis larva egg Pupa Adult meeting place mating place Female flower Images courtesy of M. Kater (Unimi)

71 Mutante Green petals: B (CUM26) AC B S S --- C cum Petal sepal Images courtesy of M. Kater (Unimi)

72 total damage mm 2 thrips larvae total damage mm 2 thrips larvae wtgp mutant wtgp mutant CD Basal leaves Apical leaves Wild-type Green petals mutant Take home message: genetic engineering is a more predictable, more precise, faster and less expensive method to introduce a character Images courtesy of M. Kater (Unimi)

73 Bibliografia Nicholas Kalaitzandonakes (2004) The Potential Impacts of the Biosafety Protocol on Agricultural Commodity Trade PRRI (2005) Guide for notifications and risk assessments for releases into the environment of genetically modified organisms Mackenzie (2003) An Explanatory Guide to the Cartagena Protocol on Biosafety. IUCN Environmental Law Centre (www.iucn.org/bookstore)www.iucn.org/bookstore PRRI(2003) Introductory seminar for the participation of public research scientists in the second meeting of the parties to the Cartagena protocol on biosafety Biosafety and the environment (An Introduction to the Cartagena Protocol on Biosafety)

74 TALENs are pathogen derived. ZFNs and CRISPRs could be embodied without pathogen sequences, but the research community first needs to break its dependance on 35S promoters, SV40 nuclear target sequences, and NOS terminators. The USDA has indicated that once pathogen derived sequences are segregated out, the item is not regulated, which I interpret to say ZFN and CRISPR-modified plants should be exempt. However, there have been a couple of cases now where the plants with no pathogen-derived sequences were regulated anyway b/c Agro was used. So, my take is ZFN and CRISPR derived plants should be exempt as along as Agro is not used, and as long as they are not used to add pathogen-derived sequences. I am hopeful USDA will give a blanket exception even if Agro is used. Altri problemi allorizzonte


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