1. Modification of order withholding approvals for field trials of genetically modified plants. (Para 1 )
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2007 Supreme(SC) 1883
SUPREME COURT OF INDIA
K.G. Balakrishnan, CJI., Tarun Chatterjee and D.K. Jain, JJ.
Aurna Rodrigues and Ors. - Petitioner
Versus
Union of India and Ors - Respondent
W.P.(C)No. 260 of 2005 with W.P.(C) No. 115 of 2004.
Decided On : 8-5-2007
The court established safety protocols for GM crop field trials, requiring a 200-meter buffer zone and validated detection protocols to prevent pollen contamination, while permitting commercial use of approved varieties subject to toxicity and allergenicity verification.
Headnote:(A) Biotechnology Regulation - Genetically Modified (GM) crops - Field trials and commercial approval - Prevention of pollen flow contamination - Requirements for buffer zones, scientific accountability, and validated test protocols (Para 3).
(B) Genetically Modified (GM) crops - Commercial use of specific varieties - Conditional permission - Verification against further genetic modification, toxicity, and allergenicity (Para 4).
Facts of the case:
A request was made to modify a previous order that had halted approvals for genetically modified crops. The regulatory authority noted that multiple applications for field trials were pending. Concerns were raised regarding potential pollen flow contamination of neighboring fields during these trials.
Findings of Court:
To prevent contamination, field trials must maintain a distance of at least 200 meters from neighboring fields of the same type. Details of the scientists responsible for the trials must be reported to the regulatory authority for regular supervision. Before open field trials, a validated event-specific test protocol with a detection limit of at least 0.01% must be submitted to confirm the absence of contamination. Commercial use of specific cotton varieties is permitted provided they are not further modified and are verified to be non-toxic and non-allergenic.
Issues: Whether the stay on GM crop approvals should be modified to allow field trials and commercial use, and if so, under what safety and environmental guidelines.
Ratio Decidendi: Environmental safety in GM crop trials necessitates strict spatial isolation and rigorous scientific testing to prevent contamination. Commercial approval is contingent upon the stability of the genetic event and the verified absence of toxicity or allergenicity to users.
Result: I.As. are disposed of accordingly.
Legal Category Hierarchy
Table of Contents
2. Union sought modification to allow approvals; petitioner argued risk of contamination from field trials. (Para 1 , 2 )
3. Field trials risk contamination; sufficient precautions including distance and supervision required. (Para 3 , 4 )
4. Approval for GM field trials requires precautions including distance, supervision, and contamination testing. (Para 3 , 4 )
5. I.As. disposed with directions for field trial precautions and commercial use of Bt cotton subject to conditions. (Para 3 , 4 , 5 )
6. What precautions are required for field trials of genetically modified crops?
Court required 200 meters distance from similar crops, supervision by named scientist, and contamination testing protocol at 0.01% limit of detection. (Para 3 )
7. Can GEAC grant commercial use approval for existing Bt cotton varieties?
Yes, subject to verification of no further genetic modification and testing for toxicity or allergenicity, with data to be provided to the court. (Para 4 )
8. What conditions apply to commercial use of Bt cotton?
GEAC must verify no further genetic modification and assess toxicity or allergenicity; usual conditions apply. (Para 4 )
ORDER :
K.G. Balakrishnan, CJI., Tarun Chatterjee and D.K. Jain, JJ. - I.A.No.4,14 & 15
1. Union of India is seeking modification of the order passed by this Court on 22.9.2006. By the said order, this Court had directed the Genetic Engineering Approval Committee (GEAC) to withhold approvals till further instructions to be issued by this Court on hearing of all concerned. The learned ASG submits that in view of the order passed by this Court, GEAC is not in a position to grant approval to various applications which are pending with the said authority. All these application are for conducting field trials on various varieties of plants. GEAC, during the period 2.5.2006 to 22.9.2006, granted approvals in respect of 24 items in respect of Bt cotton, Bt Cauli flower, Bt Brinjal, Bt rice, Transgenic rice, Bt Castor, Ground nut, Transgenic tomato, potato, and other items. The field trials are going on in respect of these items and this Court in the said order also noticed that 91 field testings have been going on.
2. Mr. Prashant Bhushan, learned counsel for the petitioner submits that as regards these field trials sufficient precautions are not being taken and it is likely that there would be serious Polan Flow contamination to the plants of similar species of the neighboring fields.
3. The GEAC shall take sufficient precautions to see that these trials are not causing any contamination to the cultivation of neighboring fields. There should be at least 200 meters distance from the trial fields from the neighboring field having same type of cultivations. All the trials which are being conducted, the name of the scientist and other details who will be responsible for all aspects of the trials should be reported to GEAC and they should be regular supervision by them. Prior to bringing out the GM material from the green house for conduct of open field trials, the approved institution should submit a validated event specific test protocol at an LOD of at least 0.01% to detect and confirm that there has been no contamination.
4. As regards Bt cotton, we are told that GEAC has already granted approval for commercial use of Bt. cotton Cry 1 Ac MON 531, Cry 1 Ac & Cry 2 Ab MON, GFM Cry 1A gene and Cry 1AC gene (Event 1). Several applicants sought for permission to use Bt cotton for commercially. The applications are pending with the GEAC. As regards these four species of Bt cotton varieties, the GEAC may give permission for commercial use, subject to the usual conditions imposed. GEAC should also satisfy itself that these events are not further genetically modified so that no further species are created by such modification. GEAC should also verify whether these species by commercial use create any toxicity or allergen city to any of the users in organic conducted with these varieties of Bt cotton. If any such test has been conducted, the data should be made available to this Court.
5. I.As. are disposed of accordingly.
6. Post the matter in August, 2007.
