2. The appellant filed the RTI application seeking copy of biosafety document of GM Mustard being experimented in fields for trial in India along with raw data of studies conducted. The CPIO said information could not be given as it was under process. The appellant filed appeal before the first appellate authority (FAA). FAA upheld the response of CPIO stating that the information is covered under section 8(1)(d) which will breach commercial confidence of a third party Centre for Genetic Manipulation of Crop Plants. They also claimed that the trial is premature and thus information cannot be given. Dissatisfied, the appellant filed second appeal. Contentions
3. Both the parties made elaborate submissions. Ms.Kavitha disputed contention of Public Authority that information sought is confidential, of the third party. She CIC/SA/A/2015/901798 Page 1 cited that there were administrative precedents of disclosure in such circumstances, where information was in large scale trials was given. The 7 page submission of grounds of second appeal filed by appellant is added to this order, Annexure 1.
4. Respondents contended: that they would give entire information after clinical trials proved correct to avoid disclosure of piecemeal information; that part disclosure would not give holistic view of experiment; that the patent right is in favour of inventor; that they gave gist of minutes of the meeting of Genetic Engineering Appraisal Committee (GEAC); that it has provided an opportunity to the appellant to participate in the public hearing, which was proved by email print out dated March 3, 2016, inviting appellant. Ms Madhumitha Biswas, the member secretary of GEAC has also invited the appellant and her team for discussions on the matter.
5. Appellant contended that the Bt. brinjal dossier came out on the regulators website only after the Supreme Court order. In the case of GM mustard, regulatory opaqueness is apparent from the fact that even minutes of the meeting in which the decision to approve BRL II trials took place, are not being shared proactively.
6. Dr Madhumitha Biswas of MoEF has submitted a detailed note dated 8.3.2016 in response to second appeal, which is Annexure II.
7. After hearing day, the appellant Ms. Kavitha Kuruganti submitted following points to justify her demand for sharing the data:
a) There are both Supreme Court and CIC 2009 Orders which have already adjudicated on this matter. The CIC in 2009 concluded conclusively that this is a matter of overriding public interest, and also settled the issue of third party confidential information at that time itself. It asked for all existing data to be shared before any massive trial. CIC/SA/A/2015/901798 Page 2
b) There are administrative precedents within the transgenic regulatory institutions in India which have in the past not only shared information, but had sought public feedback and consulted the public before large scale trials /Biosafety Research Level II (BRL II) trials were allowed.
c) It was only such data sharing followed by public scrutiny including of not just nonexperts but many experts in their respective fields that pointed out to biosafety issues and gaps in the Bt Brinjal dossier in the past, which was put on an indefinite moratorium later on due to lack of conclusive proof of safety, including many tests not conducted. Years later, one Supreme Court Technical Expert Committee in its majority report reanalysed submitted biosafety data and concluded that the regulators were wrong in concluding that the GMOs in question were safe. It is therefore important that public scrutiny take place. This is a subject of farreaching implications given that transgenics affect health and environment and this is a matter of public interest.
d) In this case, my RTI application was preceded by the GEAC having a meeting in July 2014 where they minute that biosafety data was received and circulated and also place on record appreciation for the way the biosafety dossier has been created by the crop developer/applicant.
e) This particular meeting decided on allowing the next stage of trials based on the biosafety data being in order and everything being safe, it is presumed. Which means that safety data was presented, assessed and safety was concluded. Data should have been shared at that stage itself, before giving next stage permission. However, in reality this is not the case and no scrutiny of the kind required would have actually taken place. They allow every application to proceed till the very last stage of commercialisation without any rigorous scrutiny and that is why we are asking for full data to be released at each stage. If something is unsafe about that GMO, it should not proceed into the next stage at all. Be that as it may, my application was after data related to biosafety was received and considered by the regulators and after they permitted the BRL II trials. CIC/SA/A/2015/901798 Page 3
f) This information cannot be confidential since this is data pertaining to results of testing the safety of a GMO. These are safety assessment test results. There are no grounds on which these can become confidential.
g) A regulator dismissing the expertise in society is unhealthy and to think that they have all the expertise is wrong. This is a matter that affects all citizens, and transparent regulation is a must, especially given that conflict of interest is prevalent in the regulatory bodies.
8. The appellant sought the following information be shared in the public domain and with her: a. The entire biosafety dossier submitted by the crop developer so far, in 2014, and now in 2015 when the "environmental release" application came in; b. Raw data submitted by the crop developer, and if he has not submitted raw data and the regulators are only going by the summary of findings of various studies, for the same data to be obtained from the crop developer and shared with the public, and also used for the review by the regulators if they are not doing so; c. Full notice and agenda for all meetings of the regulators since the public needs to know what is under review, and the full meeting minutes which will inform the public about decisions and the basis of the same; d. And, all biosafety data pertaining to all other GMOs in the pipeline.
9. In response to this, Ms. Ranjini Warrior submitted a detailed note which is Annexure III. Analysis
10. The excuses forwarded by the respondents appear to be not based on any reasoning or exceptions under RTI Act.
a) If respondents approve that gist of minutes could be shared, as no exception under RTI Act prevents disclosure, same should permit the disclosure of entire CIC/SA/A/2015/901798 Page 4 text. Nothing stops disclosure of text of minutes of GEAC. The public authority has no authority to limit the disclosure to gist and refusing the rest.
b) The claim information can be given only after clinical trials were proved correct is another wrongful proposition. Does it mean that they are refusing to give information if the clinical trials are not proved correct? Right to Information of citizen about clinical trial does not depend on its success or failure. The authority has to share irrespective of the outcome.
c) The officers of the respondent authority could not substantiate what kind of confidence it was, and how? The PIO cannot simply say that confidence will be breached without substantiating it. The burden of proof is on the PIO or public authority, which was not discharged.
d) Denial of information on the pretext that it was under process is similarly unreasonable. No exception permits such a denial.
e) It was stated in response by Dr. Warrier in Annexure 3, that the application for environmental release of transgenic mustard hybrid DMH 11 by CGMCP, University of Delhi (South Campus) was under review of GEAC and when completed, it would be shared except confidential information having IPR implication). Research and Development of GM crops is a long drawn process taking about seven to ten years and therefore piecemeal posting of information may lead to misinterpretation of scientific facts and creating a wrong perception on the technology. Finally Ms. Madhumitha contended that they would give when complete information is ready that too only after taking final decision. She also maintained that appellant has alternate remedy and matter was already in subjudice in Supreme Court and prayed for dismissal of second appeal. The Commission cannot accept these excuses information could be given only after complete information is ready and could not be given because matter was subjudice, as RTI Act has provided for no such exceptions. CIC/SA/A/2015/901798 Page 5
11. The public authority should understand that the information sought by appellant is supposed to be disclosed on their own as per the mandate under Section 4. The decision making process should be told, along with information about whether such process is adopted, minutes of the meetings, results of clinical trial, and entire information about GM mustard etc. This is in public interest. The people should know how and why GM mustard is being permitted or denied because they have to consume that food or feed and face consequences. It is a policy decision by the public authority which needs to be revealed to the public in general as mandated by S4 because they are going to be affected if GM mustard is marked.
12. As per the minutes of 127th meeting of GEAC, Chair of the Sub Committee also informed that the outcome of the review of the Biosafety Dossier submitted by the Biosafety Support Unit setup by DBT was also deliberated in detail. It was further informed that the SubCommittee recommended revision of the Biosafety Dossier by incorporating the additional information/clarifications/gaps identified by the SubCommittee and the Bio safety Support Unit. After detailed deliberations, the GEAC adopted the recommendation of the Subcommittee and decided to send all comments of the Subcommittee and points listed by the Biosafety Support Unit of the DBT to CGMCP, with a direction that the DOSSIER be revised as per the comments/suggestions for further review by the Subcommittee and to prepare the Risk Assessment and Risk Management (RARM) document for consideration of the GEAC. In addition, CGMCP may also send a detailed response on the relevant points. All documents relating to GEAC recommendation, Subcommittee report, revised Dossier as recommended and CIC/SA/A/2015/901798 Page 6 to prepare RARM need to be furnished to the public in general in public interest. Its denial to appellant is not legal.
13. Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells have been made in connection with the application of gene technology and microorganisms, on which the Central Government has made rules on
Genetically Engineered Organisms or Cells Text of Rule 7 is:
1. No person shall import, export, transport, manufacture, process, use or sell any hazardous microorganisms of genetically engineered organism/substances or cells except with the approval of the Genetic Engineering Approval Committee.
2. Use of pathogenic microorganisms or any genetically engineered organisms or cells for the purpose of research shall only be allowed in laboratories or inside laboratory area notified by the Ministry of Environment and Forests for this purpose under the Environment (Protection) Act, 1986.
3. The Genetic Engineering Approval Committee shall give directions to the occupier to determine or take measures concerning the discharge of micro organism / genetically engineered organisms or cells mentioned in the Schedule from the laboratories, hospitals and other areas including prohibition of such discharges and laying down measures to be taken to prevent such discharges.
4. Any person operating or using genetically engineered organisms / microorganisms mentioned in the schedule for scale up or pilot operations shall have to obtain licence issued by the Genetic Engineering Approval Committee for any such activity. The possessor shall have to apply for licence in prescribed proforma.
5. Certain experiments for the purpose of education within the field of gene technology or micro organism may be carried out outside the laboratories and laboratory areas mentioned in sub rule (2) and will be looked after by the Institutional Biosafety Committee.
Text of Rule 13 is:
1. In connection with the granting of approval under rules 8 to 11 above, terms and conditions shall be stipulated, including terms and conditions as to the control to be exercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the State Biotechnology Coordination Committee or to the District Level Committee. CIC/SA/A/2015/901798 Page 7
2. All approvals of the Genetic Engineering Approval Committee shall be for a specific period not exceeding four year at the first instance renewable for 2 years at a time. The Genetic Engineering Approval Committee shall have powers to revoke such approval in the following situations Text of Rule 14 is:
1. The Genetic Engineering Approval Committee may supervise the implementation of the terms and conditions laid down in connection with the approvals accorded by it.
2. The Genetic Engineering Approval Committee may carry out this supervision through the State Biotechnology Coordination Committee or the State Pollution Control Boards/District Level Committee or through any person authorized in this behalf.
14. From a perusal of these rules it is quite clear that genetically engineered organism or cells are recognized by government as an item potentially hazardous to public health. It automatically follows that full compliance with these rules is a matter of public interest. Sec. 8(1) of Right to Information Act, 2005 says: (d) information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information;
15. However, both in this sub clause of sec. 8(1) and in sub clause (2) of sec. 8, access may be allowed to information if public interest in disclosure outweighs the harm to the protected interests.
16. The authority has a duty to enunciate the requirement of such public interest in disclosure. Even if they claim exception under section 8(1)(d), they have to justify the same by substantiating how it will breach the commercial confidence of third party. If so, they can separate the same and give rest of the information to the appellant. CIC/SA/A/2015/901798 Page 8
17. It is quite relevant to discuss the international agreement and the conditions regarding confidentiality on this subject. The Cartagena Protocol on Biosafety is the first international agreement to regulate the transboundary movements of genetically engineered (GE) organism that resulted from the mobilisation of the international community, to place precaution at the core of decisionmaking related to such movements. This contains a precautionary principle, which is at the heart of this agreement. This means that countries have the right to ban or restrict the import and use of GE organisms when there is a lack of scientific knowledge or consensus regarding their safety.
18. The protocol requires that countries are informed and agree in advance to imports of GE crops. This is called the Advance Informed Agreement (AIA). Before countries are allowed to export any genetically engineered organisms destined for intentional introduction into the environment, they must first obtain the importing country's explicit consent.
19. Article 1 of the Cartagena Protocol on Biosafety explained the objective as follows: In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.
20. Article 21 (3) secures commercial confidential information. It says: CIC/SA/A/2015/901798 Page 9
3. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms.
4. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.
5. If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Party and the notifier disagree as to its confidentiality.
21. However, (6) of Article 21 provides an explanation regarding what should not be considered as Confidential:
6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential: (a) The name and address of the notifier; (b) A general description of the living modified organism or organisms; (c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; (d) Any methods and plans for emergency response.
22. The submission of Dr Warrier, in Annexure III mentioned above rules and assured to adhere to these norms and provide information accordingly. She disputed the appellants statement that Technical Expert Committee TEC has reanalyzed the biosafety data and concluded that regulators were wrong. She CIC/SA/A/2015/901798 Page 10 stated that Union of India represented by MoEF, Ministry of Agriculture and Dept of Biotechnology have filed a joint affidavit in response to TEC Report. The Commission directs the MoEF to furnish the certified copy of TEC report and joint affidavit filed by MoEF and MoA in response to the TEC report.
23. Ms Warrier submitted that the main bone of contention was whether toxicity and allergenicity data are confidential information as stated by the the 3rd party. The CIC in Divya Raghunandan case has rightly indicated that data on safety issues which is matter of overriding public interest cannot be considered as confidential information. Dr. Warrier said that GEAC was in full agreement with this and was never denied information related to the safety aspect. She also claimed that India was fully compliant of the requirement under Article 21(6) and such information was posted on the website (http;//www.moef.gov.in/majorinitiatives/geacclearances). She claimed that uploading of the confidential information without giving an opportunity to the 3rd party to represent their case would be unfair in the principles of natural justice as the researchers in the country are also one of the stakeholders and their views cannot be neglected in the national interest. The Commission finds reason in this point, that is requirement under RTI Act also, and directs the public authority to issue notice to 3rd party to represent their case and take an independent decision as to whether the information would constitute confidential information as claimed by 3rd party and communicate the same before 30th April 2016.
24. Dr. Warrier promised to post all agenda and minutes of GEAC on website as per the current practice. Though this appears to be a reasonable assurance, the Commission is reminded of the contention that MoEF would give CIC/SA/A/2015/901798 Page 11 only gist of the agenda and minutes and thus directs the MoEF put on website complete agenda on website along with its circulation among stakeholders and complete minutes also immediately within 24 hours of the approval. She also assured Commission to post Biosafety dossier as and when received by GEAC.
25. The public authority, thus, shall disclose the information as explained under Article 21(6) which cannot be considered as confidential, and after avoiding other confidential information, if any. In fact, according to this protocol, the public authority has a duty to check up whether information required in notifications under articles 8, 10 and 13, and information required concerning living modified organism intended for direct use as food or feed, or for processing under article 11, which were explained under Annexures I and II of the protocol and publish such information in public interest under proactive disclosure provision in section 4 of rti act. The MoEF & CC scientists have a duty to separate confidential information, if any as per the guidelines available in protocol and disclose the rest as explained above. The Commission directs the public authority to verify and provide such information which could be given as per the Protocol, more specifically the biosafety dossier as submitted by the crop developer in 2014 and in 2015, and any other material submitted by them and under review, after separating confidential information if any, as per their independent decision. The Commission also directs all biosafety data pertaining to all other GMOs in pipeline as that is part of voluntary disclosure under section 4 of rti act. All directions shall be complied before 30th April, 2016. CIC/SA/A/2015/901798 Page 12
26. The appeal is disposed of accordingly. (M. Sridhar Acharyulu) Information Commissioner Authenticated true copy (Babu Lal) Deputy Registrar Addresses of the parties:
1. The CPIO under the RTI Act, Govt of India Ministry of Environment & Forests, RTI Cell, CS Division Indira Paryavaran Bhavan, Jor Bagh Road, Lodi Road PO New Delhi1100032. 2.Ms. Kavitha, 302, Santhome Apartments No.33/1, 1st ACross, Indira Nagar, IStage, Bngalore560038 CIC/SA/A/2015/901798 Page 13