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Rules For Hazardous Micro Organisms
(To be notified under the EP Act, 1986)

G.S.R. 1037(E). – In exercise of the powers conferred by sections 6, 8 and 25 of the Environmental (Protection) Act, 1986 (29 of 1986) and with a view to protecting the environment, nature and health, in connection with the application of genetechnology and micro-organisms, the Central Government hereby makes the following rules, namely :-

1. (i) These rules may be called the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous micro-organisms Genetically engineered organisms or cells.

(ii) These rules shall come into operation on the date to be notified for the purpose in the Official Gazette.

2. (i) These rules are applicable to the manufacture import and storage of micro-organisms and Gene-Technological products.

(ii) These shall apply to genetically engineered organisms micro-organisms and cells and correspondingly to any substances and products and food stuffs, etc. of which such cells, organisms or tissues hereof form part.

(iii) These rules shall also apply to new genetechnologies apart from those referred to in clauses (ii) and (iv) of rule 3 and these rules shall apply to organisms / micro-organisms and cells generated by the utilisation of such other gene-technologies and to substances and products of which such organisms and cells form part.

(iv) These rules shall be applicable in the following specific cases ;

a.

sale, offers for sale, storage for the purpose of sale, offers and any kind of handling over with or without a consideration;

b.

exportation and importation of genetically engineered cells or organisms;

c.

production, manufacturing, processing, storage, import, drawing off, packaging and repacking of the Genetically Engineered Products;

d.

Production, manufacture etc of drugs and pharmaceuticals and food stuffs distilleries and tanneries, etc. which make use of micro-organisms genetically engineered micro-organisms one way or the other.

(v) These rules shall be applicable to the whole of India.

3. In these rules unless the context requires,

(i) “Biotechnology” means the application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services;

(ii) “Cell hybridisation” means the formation of live cells with new combinations of genetic material through the fusion of two or more cells by means of methods which do not occur naturally;

(iii) “Gene Technology” means the application of the gene technique called genetic engineering, include self cloning and deletion as well as cell hybridisation;

(iv) “Genetic engineering” means the technique by which heritable material, which does not usually occur or will occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material;

(v) “microorganisms” shall include all the bacteria, viruses, fungi, mycoplasma, cells lines, algae, protodones and nematotes indicated in the schedule and those that have not been presently known to exist in the country or not have been discovered so far.

4. (i) Recombination DNA Advisory Committee (RDAC)
This committee shall review developments in Biotechnology at national and international levels and shall recommend suitable and appropriate safety regulations for India in recombinant research, use and applications from time to time. The committee shall function in the Department of Biotechnology.

(ii) Review Committee on Genetic Manipulation (RCGM).
This committee shall function in the Department of Biotechnology to monitor the safety related aspect in respect of on-going research projects and activities involving genetically engineered organisms / hazardous microorganisms. The Review Committee on Genetic Manipulation shall include representatives of

(a) Department of Biotechnology

(b) Indian Council of Medical Research

(c) Indian Council of Agricultural Research

(d) Council of Scientific and Industrial Research

(e) other experts in their individual capacity.

Review Committee on Genetic Manipulation may appoint sub groups.

It shall bring out Manuals of guidelines specifying procedures for regulatory process with respect to activities involving genetically engineered organisms in research, use and applications including industry with a view to ensure environmental safety. All ongoing projects involving high risk category and controlled field experiments shall be reviewed to ensure that adequate precautions and containment conditions are followed as per the guidelines.

The Review Committee on Genetic Manipulation shall lay down procedures restricting or prohibiting production, sale, importation and use of such genetically engineered organisms of cells as are mentioned in the Schedule.

(iii) Institutional Biosafety Committee (IBSC).

This committee shall be constituted by an occupier or any person including, research institutions handling microorganisms / genetically engineered organisms. The Committee shall comprise the Head of the Institution, Scientists engaged in DNA work, a medical expert and a nominee of the Department of Bioechology. The occupier or any person including research institutions handling microorganisms / gentically engineered organisms shall prepare with the assistance of the Institutional Biosafety Committee (IBSC) an uptodate on site emergency plan according to the manual / guidelines of the RCGM and make available copies to the District Level Committee / State Biotechnology Co-ordinating Committee and the Genetic Engineering Approval Committee.

(iv) Genetic Engineering Approval Committee (GEAC)

This committee shall function as a body under the Department of Environment, Forests and Wildlife for approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. The Committee shall also be responsible for approval of proposals relating to release of genetically engineered organisms and products into the environment including experimental field trials.

5. Microorganisms laid down in the Schedule are divided into the following :-

  1. Bacterial Agents;
  2. Fungal Agents;
  3. Parasitic Agents;
  4. Viral, Rickettsial and Chlamydial Agents;
  5. Special Category.

6. (i) No person shall import, export, transport, manufacture, process, use or sell any hazardous microorganisms of genetically engineered organisms / substances or cells except with the approval of the Genetic Engineering Approved Committee.

(ii) 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.

(iii) The Genetic Engineering Approval Committee shall give directions to the occupier to determine or take measures concerning the discharge of microorganisms / 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.

(iv) 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.

(v) Certain experiments for the purpose of education within the field of genetechnology or microorganisms may be carried out outside the laboratories and laboratory areas mentioned in sub-rule (2) and will be looked after by the Institutional Bioasafety Committee.

7. Production in which genetically engineered organisms or cells or microorganisms are generated or used shall not be commenced except with the consent of Genetic Engineering Approval Committee with respect of discharge of genetically engineered organisms or cells into the environment. This shall also apply to production taking place in connection with development, testing and experiments where such production, etc., is not subject to rule 7.

8. (1) Deliberate or unintentional release of genetically engineered organism / hazardous microorganisms or cells, including deliberate release for the purpose of experiments shall not be allowed.

9. Substances and products, which contain genetically engineered organisms or cells microorganisms or cells or microorganisms shall not be produced, solid, imported or used except with the approval of Genetic Engineering Approval Committee.

10. Food stuffs, ingredients in food stuffs and additives including processing and containing or consisting of genetically engineered organisms or cells, shall not be produced, sold, imported or used except with the approval of the Genetic Engineering Approval Committee.

11. (i) Any person who applies for approval under rules 8 – 11 shall, as determined by the Genetic Engineering Approval Committee submit information and make examinations or cause examinations to be made to eradicate the case, including examinations according to specific directions and at specific laboratories. He shall also make available an on-site emergency plan to GEAC before obtaining the approval. If the authority makes examination itself, it may order the applicant to delay the expenses incurred by it in so doing.

(ii) Any person to whom an approval has been granted under rules 8 – 11 above shall notify the Genetic Engineering Approval Committee of any change in or addition to the information already submitted.

12. (i) 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 Co-ordination Committee or to the District Level Committee.

(ii) The Genetic Engineering Approval Committe shall have powers to revoke such approval in the following situations:-

If there is any new information as to the harmful effects of the genetically engineered organisms or cells.
If the genetically engineered organisms or cells cause such damage to the environment, nature or health as could not be envisaged when the approval was given, or
Non compliance of any condition stipulated by Genetic Engineering Approval Committee.

13. (i) The Genetic Engineering Approval Committee may supervise the implementation of the terms and conditions laid down in connection with the approval accorded by it.

(ii) 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 authorised in this behalf.

14. (i) If any order is not complied with, the District Level Committee or State Biotechnology Co-ordination Committee may take measures at the expense of the person who is responsible.

(ii) In case where immediate intervention is required in order to prevent any damage to the environment, nature or health, the District Level Committee or State Biotechnology Co-ordination Committee may take the necessary steps without issuing any order or notice. The expenses incurred for this purpose will be repayable by the person responsible for such damage.

(iii) The State Biotechnology Co-ordination Committee / District Leval Committee may take samples for a more detailed examination of organisms and cells.

(iv) The State Biotechnology Co-ordination Committee / District Level Committee shall be competent to ask for assistance from any other government authority to carry out its instructions.

15. (i) Any person who under rule 7-11 is responsible for conditions or arrangements shall immediately notify the District Level Committee / State Biotechnology Co-ordination Committee and the State Medical Officer of any interruption of operations or accidents that may lead to discharges of genetically engineered organisms or cells which may be harmful to the environment, nature or health or involve nay danger thereto.

(ii) Any notice given under sub-rule (1) above shall not lessen the duty of the person who is responsible to try effectively to minimise or prevent the effects of interruptions of operations or accidents.

16. (i) It shall be the duty of the DLC to prepare an off-site emergency plan detailing how emergencies relating to a possible major accident at a site will be dealt with and in preparing the plan, the DLC shall consult the occupier and such other person as it may deem necessary.

(ii) For the purpose of enabling the DLC to prepare the emergency plan required under sub-rule (1), the occupier shall provide the DLC with such information relating to the handling of hazardous microorganisms / genetically engineered organisms under his control as the DLC may required including the nature, extent and likely off-site affects of a possible major accident and the DLC shall provide the occupier with any information from the off-site emergency plan which relates to this duties under rule 16.

17. (i) The State Biotechnology Co-ordination Committee or the Genetic Engineering Approval Committee / the DLC or any person with special knowledge duly authorised by the State Biotechnology Co-Ordination Committee or the Genetic Engineering Approval Committee or the DLC where it is deemed necessary, at any time on due production of identity be admitted to public as well as to private premises and localities for the purpose of carrying out supervision.

(ii) Any person who is responsible for activities subject to rules 7-11 above shall at the request of District Level Committee or State Biotechnology Coordination Committee or the GEAC submit all such information including information relating to financial conditions and accounts, as is essential to the authority’s administration under these rules. He shall also allow supervision or inspection by the authorities or persons indicated in sub-rule (1).

(iii) The Genetic Engineering Approval Committee may fix fees to cover, in whole or in part, the expenses incurred by the authorities in connection with approvals, examinations, supervisions in sub-rule (1).

18. (1) Any person aggrieved by a decision made by Genetic Engineering Approval Committee / State Biotechnology Co-ordination Committee in pursuance of these rules may within thirty days from the date on which the decision is communicated to him, prefer an appeal to such authority as may be appointed by Ministry of Environment and Forests provided that the appellate authority may entertain the appeal after the expiry of the said period of thirty days if such authority is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.

19. The Ministry of Environment and Forests shall, wherever necessary, exempt an occupier handling a particular microorganism / genetically engineered organism from rule 7-11.