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Core Purpose

Proposes amendments to the 1989 rules regarding hazardous micro-organisms and genetically engineered organisms, introducing a code on conflict of interest for expert committee members.

Detailed Summary

This notification from the Ministry of Environment, Forest and Climate Change proposes amendments to the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells Rules, 1989. The key amendment introduces a "Code on Conflict of Interest for Expert Members" participating in decision-making within committees under Rule 4. This code mandates disclosure of potential conflicts, ensuring these do not affect committee decisions. It outlines procedures for conflict disclosure, management, and includes declaration forms (Form-I and Form-II). This amendment follows a Supreme Court directive in the "Gene Campaign & Anr. Vs. Union of India" case, emphasizing expert credential verification and conflict of interest mitigation. The draft is open for public comments for sixty days post-gazette publication.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-02012025-259846 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 5227] NEW DELHI, TUESDAY, DECEMBER 31, 2024/PAUSHA 10, 1946 8495GI/2024 MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE NOTIFICATION New Delhi, the 31st December, 2024 (To be notified under the EP Act, 1986) S.O. 5647 (E)—Whereas, the Central Government proposes to issue following amendment in the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells Rules, 1989 in exercise of the power conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986). Accordingly, the draft amendment notification is hereby published for the information of public likely to be affected thereby and notice is hereby given that the said draft amendment shall be taken into consideration on or after the expiry of a period of sixty days from the date on which copies of the gazette containing this amendment notification are made available to the public; Any person interested in making any objections or suggestions on the proposal contained in the draft amendment notification may forward the same in writing for consideration of the Central Government within the period so specified to the Secretary, Ministry of Environment, Forest and Climate Change, Indira Paryavaran Bhawan, Jor Bagh road, New Delhi 110003, and may be sent to e-mail id: geac.secretariat@gov.in on or before sixty days after the publication of this notification. Draft Notification WHEREAS, the Central Government vide G.S.R.1037(E) dated 05.12.1989 issued Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells Rules, 1989 with a view to protect the environment, nature and health, in connection with the application of gene technology and micro-organism. AND WHEREAS, judgement in Writ Petition No. 115 of 2004 titled as "Gene Campaign & Anr. Vs. UOI & Ors." and its connected matters collectively relating to environmental release of Genetically Modified Organisms(GMOs), was pronounced by the Hon'ble Supreme Court of India on 23.07.2024. AND WHEREAS, the Hon'ble Supreme Court in the consensus part of order dated 23.07.2024 in WP(C) No. 115 of 2004 titled as "Gene Campaign & Anr Vs. Union of India" and its connected matters has directed that Union of India must ensure that all credentials and past records of any expert who participates in the decision-making process should be scrupulously verified and conflict of interest, if any, should be declared and suitably mitigated by ensuring representation to wide range of interests. Rules on this regard may be formulated having a statutory force. NOW, THEREFORE, in exercise of the powers conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), the Central Government hereby makes the following further amendments in Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells Rules, 1989. These rules shall be called as the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells (Amendment) Rules, 2024 and shall come into force from the date of its publication in official gazette :- In the said rules :- 1. In rule (3), after sub-rule (v) following shall be inserted :- (vi) "Conflict of interest” means any personal interest or association of a Member, which is likely to influence the decision of the Committee in a matter, as viewed by an independent third party. 2. After rule 4 the following shall be inserted :- 4(A) Code On Conflict Of Interest For Expert Members The Expert member of the committees, as specified at Rule 4, whoparticipate in any decision making process, shall abide by the code onconflict of interest as specified in schedule II. 3. Wherever the word 'Schedule' is mentioned in principal notification, it shall be read as Schedule-I. 4. Schedule-II shall be inserted, after the Schedule-I. SCHEDULE-II [See Rule 4(A)] CODE ON CONFLICT OF INTEREST FOR EXPERT MEMBER(S) OF THE COMMITTEES SPECIFIED IN RULE 4A A. General Principles 1. Expert member shall disclose his/her interest, which may conflict with his/her duties. 2. Further, the Expert member shall take all steps necessary to ensure that any conflict of interest to which he/she may be subject to, does not affect any decision of the Committee. B. Conflict in respect of agenda 1. An Expert member, who has any direct or indirect association with an Agenda coming up for consideration in the meeting of the Committee, shall disclose the nature of their interest prior to the meeting. 2. An Expert member shall not participate in any deliberation or discussion of the committee regarding such matters, except to provide professional advice if specifically requested by the Committee. C. Procedure for managing the conflict 1. Every Expert Member shall immediately after his/her appointment as an Expert Member in the Committee, submit a declaration in Form-I of this schedule. 2. The declaration submitted in Form-I will be retained in the records of the concerned Committee. 3. Expert Member shall disclose a conflict of interest at the earliest possible opportunity in Form-II to the Chairman of the concerned Committee. 4. Expert Member shall seek determination from the Chairman of the concerned Committee, if he/she has doubt whether there is a of interest or not, conflict through the Member Secretary/Convenor of the Committee. 5. In case Chairman of the Committee determines that conflict of interest has arisen in respect of participation of an expert member in a particular agenda item, he may allow such Expert Member to recuse from that particular agenda item. Form-I Declaration at the time of Appointment as Expert Member of the committee 1. I, hereby submit that in the last 10 years, I have worked in the below mentioned institutions/organizations: +---------+--------------------------+-----------+-----------+ | Sr. No. | Name of the | From Date | Upto | | | institution/organization | | | +---------+--------------------------+-----------+-----------+ | | | | | | | | | | | | | | | | | | | | | | | | | +---------+--------------------------+-----------+-----------+ 2. I hereby undertake that I will provide impartial and objective decisions, drawing solely from my professional expertise. I hereby undertake that, if a conflict arises during my tenure, I will immediately inform the Chairperson of the committee and refrain from participating in the decision-making process related to the concerned matter. Name: Designation: Institutional Affiliation: Date: Place: Signature Form-II Declaration Form for any conflict of Interest I hereby state that, I have the following conflict of interest in respect of agenda item 1. ........... 2. ........... 3. ........... In light of the above-mentioned conflict of interest, I may be allowed to recuse myself from the meeting. Name: Designation: Institutional Affiliation: Date: Place: Signature [F. No. C-12015/3/2022-CS-III] RAGHU KUMAR KODALI, Scientist 'G' Note - The Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/ Genetically Engineered Organisms or Cells Rules, 1989 were published in the Gazette of India, Extraordinary, vide number G.S.R. 1037(E), dated the 5th December, 1989, which came into force vide notification number S.O. 677(E), dated 13th September, 1993, and subsequently were amended vide notification numbers G.S.R. 493(E), dated the 14th July, 2005, G.S.R. 616 (E), dated the 20th September, 2006, S.O. 1519(E), dated 23-8-2007, S.O. 411(E), dated 25-2-2008, S.O. 2519(E), dated 3-10-2008, S.O. 800(E), dated 17-3- 2009, S.O. 2884(E), dated 9-11-2009, S.O. 828(E), dated 5-4-2010, S.O. 2478(E), dated 4-10-2010, G.S.R. 613(E), dated the 16th July, 2010, G.S.R. 1(E), dated the 23rd December, 2010, S.O. 2312(E), dated 30-9- 2011, S.O.2303(E), dated 26-9-2012, S.O.953(E), dated 05-4-2013, S.O. 3113(E), dated 14-10-2013, S.O. 999(E), dated 01-4-2014, S.O. 2634(E), dated 09.10.2014, S.O. 940(E), dated 26-3-2015 Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. GORAKHA NATH YADAVA Digitally signed by GORAKHA NATH YADAVA Date: 2025.01.02 15:37:06+05'30'

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