WEBVTT Kind: captions Language: en 00:00:28.000 --> 00:00:33.680 Hello. Welcome back to the course again. So, this is in continuation with our earlier 00:00:33.680 --> 00:00:39.280 discussion for the Regulatory framework for GM crops. So, in this discussion we would 00:00:40.240 --> 00:00:45.280 discuss about the Cartagena Protocol which is one of the international obligations for 00:00:45.280 --> 00:00:52.000 India to adopt different mechanisms where the trans boundary movement of the living organism 00:00:52.000 --> 00:00:58.480 can be regulated and safely assessed. So, so, this 00:00:59.840 --> 00:01:07.280 ok we can stop here I think will be cut that. So, this is the current set of legislation. So, I said 00:01:07.280 --> 00:01:13.920 ok from 1976 onwards we have lot of development we have lot of regulations guidelines everything in 00:01:13.920 --> 00:01:20.880 place to now control, but how did it started? So, one of the international obligation which India 00:01:20.880 --> 00:01:28.240 also followed was the obligation with respect to the Biosafety Protocol or adopting Biosafety 00:01:28.240 --> 00:01:34.880 guidelines is because of this protocol which is known as the Cartagena Protocol on Biosafety. 00:01:35.760 --> 00:01:42.960 So, this Cartagena Protocol on the Biosafety; is is basically is is a 00:01:43.520 --> 00:01:48.480 part to the Convention of the Biological Diversity which is an international treaty. 00:01:50.080 --> 00:01:56.160 And this Cartagena Protocol on the Biosafety basically governs the movement of the living 00:01:56.160 --> 00:02:03.600 modified organisms or the LMOs resulting from the modern biotechnology from one country to other. 00:02:03.600 --> 00:02:12.240 So, initially when the research started being international when you wanted to bring certain 00:02:12.240 --> 00:02:18.400 genetic resources to your country or give it to other country. Then there was need of this 00:02:18.400 --> 00:02:23.040 movement of the living modified organism and the inherent risk was also there. 00:02:23.600 --> 00:02:30.960 Suppose if there is a loss of the organism or if it is by accident released into the environment. 00:02:30.960 --> 00:02:36.720 So, who will be held responsible? And if you do not get the intended one and there is certain 00:02:36.720 --> 00:02:44.640 other like negative results or so, there may be lot of consequences. So, depending on so, for that 00:02:44.640 --> 00:02:53.200 reason in order to have a controlled movement and an informed decision on whether or not to bring 00:02:53.200 --> 00:02:58.640 any genetically modified organism to own country. we needed certain Biosafety assessment. 00:02:59.360 --> 00:03:05.920 So, under this Cartagena Protocol. So, this basically this Cartagena Protocol was enacted 00:03:05.920 --> 00:03:14.160 for that reason only and this protocol was adopted on 29th January 2000 as a supplementary agreement 00:03:14.160 --> 00:03:21.200 to the convention of the biological diversity and it entered into force on 11th of September 2003. 00:03:24.080 --> 00:03:31.840 So, so, if you see the development of this Cartagena Protocol on the Biosafety the it is 00:03:31.840 --> 00:03:39.520 named based on the place on which that treaty was signed Cartagena place Cartagena in the Columbia. 00:03:40.080 --> 00:03:49.280 So, as per the Article 19 of paragraph 3 of this Convention of the Biological Diversity the member 00:03:49.280 --> 00:03:56.080 countries they established an Open-ended Ad Hoc Working Group on the Biosafety Biosafety to 00:03:56.080 --> 00:04:02.480 draft the protocol on the Biosafety particularly focusing on the trans boundary movement of the 00:04:03.040 --> 00:04:08.080 genetically modified organisms deriving from derived from the biotechnological process. 00:04:08.080 --> 00:04:13.680 And which may have adverse effect on the conservation as well as the sustainable 00:04:13.680 --> 00:04:21.760 use of the biological diversity. So, so, that finally, that gave us this Cartagena Protocol 00:04:21.760 --> 00:04:31.280 and by 2018 nearly 171 countries have ratified this protocol so far. India is also a party to 00:04:31.280 --> 00:04:37.920 the convention of the biological diversity like this Cartagena Protocol from the year 2003. 00:04:40.720 --> 00:04:46.880 So, what is this all protocol is about? So, this protocol is basically as I mentioned for 00:04:46.880 --> 00:04:52.400 the transboundary movement of the genetically modified organism or living modified organism 00:04:52.400 --> 00:04:58.320 as defined in that protocol LMOs. And so, depending on the risk 00:04:58.880 --> 00:05:06.240 associated with the different kinds of the product. So, this they have classified this whole 00:05:06.240 --> 00:05:13.680 LMOs into three categories and they have tried to place certain Biosafety measures or how to 00:05:14.320 --> 00:05:21.600 control this movement in these three categories. So, first categories category is the LMOs or the 00:05:21.600 --> 00:05:30.720 living modified organisms intended for direct use as food or feed or for processing FFP, 00:05:30.720 --> 00:05:37.680 food or feed or for processing. And there is a second category LMOs for a destined for contained 00:05:37.680 --> 00:05:42.960 use means the bacterias or any other modified organism which will be generally used in the 00:05:42.960 --> 00:05:50.240 laboratory scale of experiments in the laboratory scale. Then we have the third categories LMOs for 00:05:51.120 --> 00:05:56.000 intentional introduction into the environment. For example this Bt cotton or any other 00:05:56.000 --> 00:06:02.160 genetically modified plant which have the intention to be introduced into the environment. 00:06:02.160 --> 00:06:05.840 So, there are three different levels of or three different categories of the 00:06:06.480 --> 00:06:13.360 modified substances which can be used. So, all these are regulated under this 00:06:13.360 --> 00:06:19.520 Cartagena Protocol. However, there are certain exemptions so, for something like 00:06:19.520 --> 00:06:25.680 for the pharmaceuticals which are derived from the living modified organism. You know different 00:06:26.720 --> 00:06:32.320 proteins or different antibodies are also being derived from the genetically modified plants. 00:06:32.320 --> 00:06:39.040 So, all those pharmaceutical substances developed by the living modified organisms are exempted from 00:06:39.040 --> 00:06:45.600 this for which already relevant guidelines or relevant provisions are there which is 00:06:46.720 --> 00:06:52.800 managing the Biosafety aspect or managing the risk assessment. So, those are exempted from 00:06:52.800 --> 00:06:58.800 this Cartagena Protocol further the products derived from the living modified organism 00:06:58.800 --> 00:07:03.920 such as the processed food are also exempted from this Cartagena Protocol. 00:07:05.120 --> 00:07:09.680 Only those three listed varieties which I mentioned earlier are regulated under the 00:07:09.680 --> 00:07:14.480 Cartagena Protocol. So, under this 00:07:15.120 --> 00:07:20.000 protocol the protocol as I mentioned. So, it regulates the transboundary movement. 00:07:20.000 --> 00:07:26.800 So, it acts on the precautionary as approach as well. So, basic objective is that that ensure 00:07:26.800 --> 00:07:33.120 safe transfer or ensure safe handling or ensure the proper use of the living modified organism. 00:07:33.680 --> 00:07:41.680 So, for to have overall effect or or to achieve the aim of this Cartagena Protocol. So, if you go 00:07:41.680 --> 00:07:48.640 through this protocol it has nearly 40 articles and these 40 articles you see. So, basically it 00:07:50.240 --> 00:07:58.640 deals with the advanced information of approval procedures, it have the elements of the risk 00:07:58.640 --> 00:08:04.560 assessment or risk management, it laid down certain procedures for the safe handling 00:08:04.560 --> 00:08:10.720 transport and packaging and the identification of the micro genetically modified organisms. And 00:08:11.600 --> 00:08:17.600 how to transfer through the shipments and what should be the documentation procedure. 00:08:19.040 --> 00:08:24.880 And what should be the standards adopted for the transportation procedure then also it 00:08:25.600 --> 00:08:31.200 has the elements for information sharing and public awareness and participation program. 00:08:31.200 --> 00:08:40.720 So, overall by placing certain proper regulation or proper procedure for the transport or handling 00:08:40.720 --> 00:08:46.560 of this thing. By aiming at capacity building, by taking into consideration the socioeconomic 00:08:47.440 --> 00:08:50.640 consideration, then different compliance procedure. 00:08:50.640 --> 00:08:58.640 So, this has this protocol has tried to achieve the this achieve the objective of 00:08:58.640 --> 00:09:05.680 the safe transfer or or handling of the living modified organism. So, India being a party to 00:09:05.680 --> 00:09:11.200 this Cartagena Protocol also have adopted the standards and they have also adopted the 00:09:11.200 --> 00:09:18.000 different principle or the measures which are a guided which are provided in the protocol. 00:09:18.960 --> 00:09:25.600 So, I will just talk about regarding two important provisions under this. So, first 00:09:26.160 --> 00:09:32.160 the important one of the important points with which the Cartagena Protocol has introduced is 00:09:32.160 --> 00:09:39.520 the advanced informed agreement or the AIA procedure. So, basically this AIA procedure 00:09:39.520 --> 00:09:47.280 ensures that the countries are provided with the all the necessary information which is required to 00:09:47.280 --> 00:09:53.600 make an informed decision before agreeing to import of such organisms into the territory. 00:09:53.600 --> 00:09:58.560 So, if India wants to import certain genetically modified organism, they should know about 00:09:58.560 --> 00:10:04.080 the inherent risk associated with that how it operates in the environment or other 00:10:04.080 --> 00:10:10.400 hazards associated with that. So, through this an advance informed agreement this can be possible. 00:10:12.000 --> 00:10:19.120 So, basically subject to the Article 5 and 6, the advance informed agreement procedure in given in 00:10:19.120 --> 00:10:25.200 Article 8 to 10 and 12 shall apply prior to the first international transboundary movement of the 00:10:25.200 --> 00:10:34.080 living modified organism and for the intentional introduction into the intentional introduction 00:10:34.080 --> 00:10:40.880 into the environment of the importing country. And it contains the reference for the 00:10:40.880 --> 00:10:45.120 precautionary approach and the reaffirms the precaution language in the principle 15 00:10:45.680 --> 00:10:48.880 of the Rio Declaration of the environment and the development. 00:10:51.280 --> 00:10:56.960 So, as I mentioned; so, this is basically to know about the inherent risk associated 00:10:56.960 --> 00:11:02.880 with the modified organism which you are importing. So, it it ensures that you have 00:11:02.880 --> 00:11:08.560 sufficient information. So, that you are you can make an informed decisions means you know 00:11:08.560 --> 00:11:13.280 about the risk associated with the thing. So, there are basically four components 00:11:13.280 --> 00:11:18.720 of this advance informed agreement; first, the notification by the exporter. 00:11:18.720 --> 00:11:24.160 So, miss that is a detailed written description of this living modified organism by the exporter 00:11:24.160 --> 00:11:28.800 well in advance of the first shipment. So, you have you will be given all the 00:11:28.800 --> 00:11:34.560 information well in advanced. And after that you as an importer country have to acknowledge 00:11:34.560 --> 00:11:43.840 the notification by the by the importing country. And then you have to take a decision. So, there is 00:11:43.840 --> 00:11:49.840 a duration through which in which you can take the decisions its I think varies from 90 to 70 days 00:11:49.840 --> 00:11:55.360 anyway. So, the decision procedure means whether you want to approve it or prohibit or you do not 00:11:55.360 --> 00:12:00.880 want to import those things or you know you want to know more information. So, those decisions 00:12:00.880 --> 00:12:06.560 you can give back to the country, then finally, there will be the review of the decision. So, 00:12:06.560 --> 00:12:10.160 these are the four steps through which the advance informed agreement take place. 00:12:12.160 --> 00:12:17.760 And the second most important aspect which is mentioned in this Cartagena Protocol is 00:12:17.760 --> 00:12:25.200 the establishment of a clearing-house mechanism or which is known as the Biosafety Clearing-House and 00:12:25.200 --> 00:12:32.960 information sharing mechanism. So, with respect to this Biosafety information Article 20 of paragraph 00:12:32.960 --> 00:12:39.360 1; the Cartagena Protocol on the Biosafety, they have established this Biosafety Clearing-House as 00:12:39.360 --> 00:12:46.480 a part of the clearing house mechanism. And basically this is a what you call 00:12:46.480 --> 00:12:51.920 information exchange procedure where you can exchange the scientific technical 00:12:51.920 --> 00:12:57.600 environmental and other legal information regarding the living modified organisms 00:12:57.600 --> 00:13:03.600 and this is very helpful in terms that it assists the parties in implementing the different protocol 00:13:03.600 --> 00:13:11.440 and you can take into account the special need for the developing part in developing country means 00:13:12.800 --> 00:13:16.800 all the relevant information regarding different traits different organisms different 00:13:18.400 --> 00:13:23.040 LMOs are given under this Biosafety clearinghouse mechanism. 00:13:23.040 --> 00:13:29.840 So, we they have a dynamic platform where the information is registered by different management 00:13:29.840 --> 00:13:40.000 center and you can search the related information and you can accordingly conduct your thing. So, 00:13:40.800 --> 00:13:45.200 it requires that one national focal point has to be established. So, as I mentioned so, 00:13:45.200 --> 00:13:52.000 in India also we have a Biosafety Clearing-House under this DBT biosafety body. So, they if you 00:13:52.000 --> 00:13:58.400 visit that site so, it has a platform where all the information has been provided. 00:13:59.440 --> 00:14:06.560 So, if you see the Biosafety Clearing-House has two kinds of records; first is the national record 00:14:07.920 --> 00:14:14.560 where basically all the data related to the what you called whatever is being 00:14:14.560 --> 00:14:20.000 developed there or information is with the national body are what are the bodies other 00:14:20.000 --> 00:14:27.200 information are given in the portal. And other data are the known known as the reference record. 00:14:27.920 --> 00:14:34.480 So, and as per this UN Mandate these informations are available also in six languages like; 00:14:34.480 --> 00:14:40.240 English, Russian, Spanish, French, Arabic and Chinese and the you can find the LMOs 00:14:40.800 --> 00:14:45.600 for the unique identifier registry which basically provides you the summary information on 00:14:45.600 --> 00:14:51.520 all the living organisms registered in that BCH portal including the transformation event the 00:14:51.520 --> 00:14:57.840 genetic modification, the unique identification code whatever is available the trade details. 00:14:58.720 --> 00:15:03.280 Then we have the gene registry which provides the summary information on the different gene inserts 00:15:03.280 --> 00:15:08.480 and characteristics of the genetic modification. And the organism registry which provides the 00:15:08.480 --> 00:15:13.840 summary information on the parental line use or the recipient or the donor organisms related to 00:15:13.840 --> 00:15:19.360 the LMO all these are registered in this Biosafety Clearing House mechanism. So, this is a good 00:15:20.080 --> 00:15:25.840 interactive portal where you can search and find the different details. 00:15:26.880 --> 00:15:31.840 So, India as I mentioned. So, India also became a party to this thing and according to that we 00:15:31.840 --> 00:15:37.680 have developed all this portal of this BCH act as the BCH management portal is there, 00:15:37.680 --> 00:15:42.880 but all information are being exchanged. So, why should one be become party to this? So, 00:15:42.880 --> 00:15:47.680 what is the benefit which a country might get by being a party to such protocol? 00:15:48.320 --> 00:15:55.120 So, if you see there are number of benefits being a party to this kind of protocol. So, 00:15:55.120 --> 00:16:02.080 India is a member of CBD and we also respect the principles of sustainability access benefit 00:16:02.080 --> 00:16:09.440 sharing and protection of the bio resource bio resources. So, but if being a party to this kind 00:16:09.440 --> 00:16:16.880 of the protocol gives you further advantage in terms of it gives you an enhanced visibility 00:16:16.880 --> 00:16:21.840 and credibility of the national systems for regulating Biosafety within the global community. 00:16:22.960 --> 00:16:29.680 And it also allows you to contribute to the harmonized rules procedures or the practices 00:16:30.320 --> 00:16:36.960 in managing the transboundary movement of the LMOs. And it also facilitates different mechanisms 00:16:36.960 --> 00:16:40.880 and opportunities for the governments to collaborate with other governments 00:16:40.880 --> 00:16:44.560 and the private sector civil society for strengthening the Biosafety. 00:16:45.200 --> 00:16:49.760 And we have the improved access to relevant technologies and data and 00:16:49.760 --> 00:16:55.360 which is like we can get through regular exchange of information and the expertise. 00:16:56.080 --> 00:17:01.200 And it helps in demonstrating the commitment for conservation and sustainable use 00:17:01.200 --> 00:17:05.520 of the biological diversity through the implementation of this Biosafety measures. 00:17:07.040 --> 00:17:13.600 Further it gives us the ability to influence the implementation of the protocol and shape 00:17:13.600 --> 00:17:19.600 the further shape the future development through this participation in the decision making process 00:17:19.600 --> 00:17:23.760 of the conference of the parties and serving as meeting of the parties of the protocol. 00:17:24.320 --> 00:17:28.800 And developing country parties and parties with the economies in transitions are 00:17:28.800 --> 00:17:33.280 eligible for financial support from the global environment facilities as well. 00:17:33.280 --> 00:17:39.440 So, it helps in capacity building and also in supporting other implementation of the protocol 00:17:39.440 --> 00:17:46.640 and participation process. So, there are number of benefits associated with associated with the being 00:17:46.640 --> 00:17:53.920 a member to this protocol and India has successful India is successfully a being implementing all 00:17:53.920 --> 00:18:01.520 these protocol throughout this time period from when it has joined. So, it is not only giving 00:18:01.520 --> 00:18:07.200 the visibility to India, but also enhancing our research credential in the area of the GM crops. 00:18:07.200 --> 00:18:14.960 Though we haves only so far only one plant approved, but if you see the scale in which 00:18:14.960 --> 00:18:20.880 this is cultivated they particular DBT cotton crop it is highly commendable. And hopefully 00:18:20.880 --> 00:18:25.280 we have many there are many transgenic varieties which are under different 00:18:26.160 --> 00:18:33.360 phases of the trial they might be released soon as soon as they get all the Biosafety clearances. 00:18:33.360 --> 00:18:37.200 And that would be helpful over overall helpful not only 00:18:37.840 --> 00:18:43.120 from the environmental point of view from the health as well as the food safety point of view. 00:18:44.160 --> 00:18:47.680 So, this Cartagena Protocol is an important instrument 00:18:50.080 --> 00:18:55.360 which is related to our GM crop because you know all this Biosafety requirement or movement of this 00:18:55.360 --> 00:19:00.080 not only GM crops also other genetically modified organisms because it is one of the protocol 00:19:00.720 --> 00:19:06.480 which regulates the movement of the living organism more genetically modified organisms. 00:19:06.480 --> 00:19:13.040 So, it is also applicable for the development of the recombinant drugs sector also. So, 00:19:13.040 --> 00:19:18.960 which we will study in the next segments . So, this is all about the development of 00:19:18.960 --> 00:19:24.080 the genetically modified plants and its regulatory framework. So, you can get 00:19:24.080 --> 00:19:31.280 more information in the DBT Biosafety site. So, more information is provided in the references. 00:19:31.280 --> 00:19:34.880 So, thank you for being with me. So, we will meet again in our next 00:19:34.880 --> 00:19:37.840 chapter. Thank you.