18 The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous micro- organisms, Genetically engineered organisms or cells, 1989

Dr. Shruti Goyal

Learning Outcomes

• To understand the scope of Rules
• To understand the mechanism developed for implementation of the Rules.
• To understand the procedure for grant of approval envisaged under the Rules.

Introduction

Biosafety concerns have led to the development of regulatory regimes in various countries for research, testing, safe use and handling of genetically modified organisms and products thereof. India is one of the earliest countries to establish a biosafety system for regulation of genetically modified organisms. The Ministry of Environment, Forest & Climate Change has framed rules for the manufacture, use, import, export and storage of hazardous micro-organisms/genetically engineered organisms or cells. These rules have been framed in exercise of the powers conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986.

There are twenty Rules in total and a Schedule is attached to the Rules. These rules are commonly referred as “Rules 1989”. The Rules are supported by a number of biosafety guidelines which have been developed through a consultative approach and following the international norms prescribed by the Organisation for Economic Co-operation and Development, CODEX Alimentarius Commission and International Plant Protection Convention (IPPC) etc. For example, Recombinant DNA (rDNA) Safety Guidelines, 1990 and 1994; Guidelines for Generating Preclinical and Clinical Data for rDNA Vaccines, Diagnostics and other Biological,

1989; Guidelines and Handbooks for Institutional Biosafety Committee 2011 and Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012.

Objective of the Rules

The Rules have been framed with a view to protect the environment, nature and health in connection with the application of gene technology and micro-organisms. The Rules cover areas of research as well as large scale applications of genetically modified organisms and their products including experimental field trials and seed production.

Commencement and Territorial Applicability [Rule 1]

Rule 1 talk about the short title, extent and commencement of the Rules. The Rules have come into operation by notification No. S.O. 677 (E) in 1993 and are applicable to the whole of India.

Scope of the Rules

The Rules are applicable to micro-organisms; gene-technological products; 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 form part of; new gene-technologies. [Rule 2(1), 2(2) and 2(3)]. The rules cover the areas of research as well as large scale applications of genetically modified organisms and products made there from throughout India. They also cover the application of hazardous microorganisms which may not be genetically modified. Hazardous microorganisms include those which are pathogenic to human beings animals as well as plants

The Rules are also applicable in the following specific cases:

• sale, offer for sale, storage for the purpose of sale, offers and any kind of handling over with or without a consideration;
• exportation and importation of genetically engineered cells or organisms;
• production, manufacturing, processing, storage, import, drawing off, packaging and replacing of the genetically engineered products;
• production, manufacture etc. of drugs and pharmaceuticals and food stuffs, distilleries and tanneries etc. which make use of genetically engineered micro-organisms in one way or other [Rule 2(4)].

Regulatory Institutions established for Implementation of Rules [Rule 4]

The Rules are implemented by Ministry of Environment and Forests, the Department of Biotechnology, Ministry of Science and Technology and the state Governments through the six competent authorities notified under the Rules which are as follows:

1. Recombinant DNA Advisory Committee (RDAC)
2. Institutional Biosafety Committee (IBSC)
3. Review Committee on Genetic Manipulation (RCGM)
4. Genetic Engineering Appraisal Committee (GEAC)
5. State Biotechnology Coordination Committee (SBCC)
6. District Level Committee (DLC).

The Rules describe the hierarchy of these committees, their constitution and functions.

1. Recombinant DNA Advisory Committee [Rule 4(1)]As the name suggests, the Recombinant DNA Advisory Committee is of advisory character. It reviews the developments in biotechnology at the national and international levels and recommends appropriate safety regulations for India in recombinant deoxyribonucleic acid (r-DNA) research works. The Committee functions under the Department of Biotechnology.

Functions of the Committee:

• To review developments in biotechnology at national and international levels.
• To recommend suitable and appropriate safety regulations for India in r-DNA research, use and applications.

2. Review Committee on Genetic Manipulation [Rule 4 (2)]

The Review Committee on Genetic Manipulation monitors safety related aspect in respect of on-going research projects and activities (including small scale field trials). The Review Committee on Genetic Manipulation functions under the Department of Biotechnology. It comprises of representatives of (i) Department of Biotechnology; (ii) Indian Council for Medical Research; (iii) Indian Council for Agricultural Research; (iv) Council for Scientific and Industrial Research; and (v) other experts in their individual capacity. The Review Committee may appoint sub-groups.

Functions of Review Committee on Genetic Manipulation

• To monitor the safety related aspect in respect of on-going research projects and activities involving genetically engineered organisms/ hazardous microorganisms.
• To bring out manuals and guidelines specifying procedure 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.
• To lay down procedures restricting or prohibiting production, sale, importation and use of such genetically engineered organisms of cells as are mentioned in the Schedule

3. Institutional Bio-safety Committee [Rule 4(3)]

Institutional Biosafety Committee is the nodal point for interaction within an organisation for implementation of the bio-safety regulatory framework. An Institutional Bio-safety Committee is to be constituted by every organisation engaged in research, handling and production activities related to genetically modified organisms. The role of this committee is extremely important as it is a statutory committee that operates from premises of respective organisation.

The committee shall comprise of the (i) head of the institution, (ii) scientists engaged in DNA work, (iii) a medical expert and (iv) a nominee of the Department of Biotechnology.

Functions of the Committee

• The occupier or any person including research institutions handling microorganisms/genetically engineered organisms shall prepare with the assistance of the Institutional Biosafety Committee an up-to-date on-site emergency plan according to the manuals/guidelines of the RCGM.
• The copies of this plan shall be made available to the District Level Committee/State Biotechnology Co-ordinating Committee and the Genetic Engineering Approval Committee.

4. Genetic Engineering Appraisal Committee [Rule 4 (4)]

The Genetic Engineering Appraisal Committee was originally named as the Genetic Engineering Approval Committee. It was renamed in 2010 by the Ministry of Environment and Forests through an amendment in the Rules called as Rules for the Manufacture, use, import, export and storage of hazardous micro-organisms/genetically engineered organisms or cells (Amendment) Rules, 2010.

The Genetic Engineering Appraisal Committee functions under the Department of Environment, Forests and Wildlife. The Committee is the apex body under the Rules which shall give 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..

The Committee shall consist of (i) Additional Secretary, Department of Environment, Forests and Wild life; (He shall be the Chairman of the committee) (ii) representative of Department of Bio-technology; (iii) representatives of concerned agencies and departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy. The Committee shall also consist of expert members such as (i) Director General, Indian Council of Agricultural Research; (ii) Director General, Indian Council of Medical Research; (iii) Director General, Council of Scientific and Industrial Research; (iv) Director General, Health Services; (v) Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage; (vi) Chairman, Central Pollution Control Board or their representatives not below the rank of Joint Secretary and three outside experts in individual capacity. The Committee shall also consist of an official of the Department of Environment, Forest and Wildlife who shall be the Member Secretary of the Committee. The Committee may co-opt other members/experts as necessary.

Function of the Committee

The committee or any person/s authorized by it shall have powers to take actions under the Environment (Protection) Act. (For details, see authority for grant of approval

5. State Biotechnology Coordination Committee [Rule 4 (5)]

The State Biotechnology Coordination Committee shall be constituted in the States where necessary. The Committee shall play a major role in monitoring. The Committee shall comprise of Chief Secretary and Secretaries from the Department of Environment, Health, Agriculture, Industries and Commerce, Forests, Public Works/Chief Engineer of the Department of Public Health Engineering. In addition to it, it shall consist of state microbiologists and pathologists and chairman of State Pollution Control Board. The Committee may co-opt other members/experts as necessary.

Main functions

• Powers to inspect, investigate and to take punitive action in case of violations of statutory provisions through the State Pollution Control Board or the Directorate of Health etc.
• To review periodically the safety and control measures in various institutions handling genetically engineered organisms/hazardous microorganisms.

The Committee coordinates the activities related to genetically engineered organisms in the State with the Central Ministries. This committee also nominates State Government representatives in the activities requiring field inspection of activities concerning genetically engineered organisms.

6. District Level Committee [Rule 4 (6)]

There shall be a District Level Biotechnology Committee (DLC) in the districts wherever necessary. The District Level Committee shall comprise of (i) District Collector; (ii) factory inspector; (iii) a representative of the Pollution Control Board; (iv) Chief Medical Officer (District Health Officer); (v) District Agricultural Officer; (vi) a representative of the Public Health Engineering department; (vii) District Microbiologists/Pathologist (technical expert); and (viii) Commissioner Municipal Corporation. The committee may co-opt other members/experts as necessary. The District Collector shall be the chairman of the committee and the Chief Medical Officer shall be the convener of the committee.

Functions

• To monitor the safety regulations in installations engaged in activity involving genetically engineered organisms/ hazardous microorganisms and its applications in the environment.
• The Committee or any other persons authorised in this behalf can visit the installation engaged in activity involving genetically engineered organisms, hazardous microorganisms.
• To formulate information chart, find out hazards and risks associated with each of the installationengaged in activity involving genetically engineered organisms, hazardous microorganisms. To coordinate activities with a view to meet any emergency.
• To prepare an off-site emergency plan. It shall be the duty of the Committee 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 Committee shall consult the occupier and such other person as it may deem necessary. The occupier shall provide the Committee with such information relating to the handling of hazardous microorganisms/genetically engineered organisms as may be required including the nature, extent and likely off-site effects of a possible major accident.[Rule 17]

To sum up, Recombinant DNA Advisory Committee has advisory function whereas Institutional Biosafety Committee, Review Committee on Genetic Manipulation and Genetic Engineering Appraisal Committee are involved in regulatory functions. State Biotechnology Coordination Committee and District Level Committee are responsible for monitoring the activities related to genetically modified organisms in state/district level. Recombinant DNA Advisory Committee, Review Committee on Genetic Manipulation and Genetic Manipulation and Genetic Engineering Appraisal Committee are constituted at the central level by the Department of Biotechnology and Ministry of Environment and Forests. Institutional Biosafety Committee is constituted in all organizations working in the area of genetically modified organisms. State Biotechnology Coordination Committee and District Level Committee are constituted in states and districts respectively, wherever necessary.

Requirement of Approval

The Rules envisages that prior approval or consent is to be taken for certain activities carried out in connection with the application of gene technology and micro-organisms from committees established under the Rules. The cases are:

• Approvals to individuals on the import, export, transport, manufacture, process, use or sale of genetically modified organisms and use of genetically modified organisms for research – 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 Appraisal Committee. [Rule 7(1)].
• Any person operating or using genetically engineered organisms/microorganisms mentioned in the schedule for scale up or pilot operations shall have to obtain license issued by the Genetic Engineering Appraisal Committee for any such activity.
• Authorization for production of genetically modified microorganisms, plants and animals-Production in which genetically engineered organisms or cells or micro-organisms are generated or used shall not be commenced except with the consent of Genetic Engineering Appraisal Committee with respect to 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. [Rule 8]
• Approval for deliberate or unintentional release of GMOs into the open environment-Deliberate or unintentional release of genetically engineered organisms/hazardous microorganisms or cells (including deliberate release for the purpose of experiment) shall not be allowed. However, in special cases the Genetic Engineering Appraisal Committee may give approval of deliberate release. Deliberate release shall mean any intentional transfer of genetically engineered organisms/hazardous, microorganisms or cells to the environment or nature irrespective of the way in which it is done. [Rule 9]
• Approval for production, sale and import of substances and products which may contain GMOs or cells- Substances and products which contain genetically engineered organisms or cells or microorganisms shall not be produced, sold, imported or used except with the approval of Genetic Engineering Appraisal Committee.[Rule 10]
• Approval for production, sale and import of foodstuff, ingredients in foodstuff including processing aid which may contain genetically modified organisms or cells- 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 Appraisal Committee. [Rule 11] For the purpose of research, use of genetically modified organisms or micro-organisms shall be allowed in laboratories or inside laboratory areas as notified by the Ministry of Environment and Forest for this purpose under the Environment (Protection) Act, 1986. [Rule 7(2)] Educational experiments within the field of gene technology or microorganism may be performed outside the notified laboratories and areas provided they are overseen by the Institutional Biosafety Committee. [Rule 7(5)]

Authority for grant of approval

The approval for certain activities carried out in connection with the application of gene technology and micro-organisms is to be obtained from Genetic Engineering Appraisal Committee established under the Rules. Any person who wants to apply for approval shall submit application to the Committee in the prescribed form. The Committee may fix fees to cover (in whole or in part) the expenses incurred by the authorities in connection with approvals, examinations, supervisions and control. [Rule 18]

The person shall make examinations or cause examinations to be made including examinations according to specific directions and at specific laboratories. He shall also make available an on-site emergency plan to the Committee before obtaining the approval. The Committee shall lay down terms and conditions for the grant of approval. [Rule 13(1)] the project proponents / NGO’s / other stakeholders are given an opportunity for personal hearing by the committee on request.

The meetings of the committee are convened on every second Wednesday of the month. All proposals received in the Ministry 30 days prior to the meeting are placed in the agenda for consideration of the committee. Information regarding the agenda items for the meeting, decisions taken therein and other relevant documents (like policy issues, sub-committee / expert committee reports etc.) are posted on the website of the committee.

The Committee shall prohibit discharge or give directions to the occupier to determine or take measures regarding discharge of microorganisms/genetically engineered organisms or cells from the laboratories, hospitals and other areas into the environment. [Rule 7(3)]

Any person to whom an approval has been granted shall notify the Committee of any change in or addition to the information already submitted. [ Rule 12]

Period of Approval [Rule 13 (2)]

All approvals granted by the Genetic Engineering Appraisal Committee are for a specific period not exceeding four years at the first instance. The approval can be renewed after that for two years at a time. This means, the approval is initially granted for a maximum period of four years and after that it has got to be renewed after every two years.

Revocation of Approval [Rule 13 (2)]

The Genetic Engineering Appraisal Committee shall have the powers to revoke the approval given by it. The approval can be revoked in the following situations:-

• if there is any new information as to the harmful effects of the genetically engineered organisms or cells, or
• 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.

Mechanism for Supervision [Rule 14]

The Genetic Engineering Appraisal Committee may supervise the implementation of the terms and conditions laid down in connection with the approvals given by it. It may also carry out this supervision through the State Bio-technology Coordination Committee or the State Pollution Control Boards/District Level Committee or through any person authorized in this behalf.

Penalties [Rule 15]

The State Biotechnology Co-ordination Committee or the District Level Committee shall have the powers to take measures against a person who has not complied with the orders. In cases, where immediate intervention is required in order to prevent any damage to the environment, nature or health the State Biotechnology Co-ordination Committee or the District Level 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.

The State Bio-technology Co-ordination Committee or the District Level Committee also has the powers to take samples for a more detailed examination of organisms and cells. Both the committees are competent to ask for assistance from any other government authority to carry out its instructions.

Responsibility to notify interruptions or accidents [Rule 16]

In case of any interruption of operations or accidents that may lead to discharge of genetically engineered organisms or cells which may be harmful to the environment, nature or health, the person who is responsible for conditions or arrangements shall immediately notify the same to the State Biotechnology Co-ordination Committee or the District Level Committee and the state

medical officer. However, this shall not lessen the duty of the person to try effectively to minimize or prevent the effects of interruptions of operations or accidents.

Appeal [Rule 19]

Any person aggrieved by a decision made by the Genetic Engineering Appraisal Committee or the State Biotechnology Co-ordination Committee in pursuance of these rules may prefer an appeal to such authority as may be appointed by the Ministry of Environment and Forests. The appeal shall be filed within thirty days from the date on which the decision was communicated. However, the appellate authority may entertain the appeal even after the expiry of thirty days, if such authority is satisfied that there is sufficient cause for not filing the appeal in time.

Exemption [Rule 20]

Under the Rules, every person dealing with microorganisms/genetically modified organisms has to seek approval before handling it. However, under Rule 20 the Ministry of Environment and Forests have been empowered to exempt an occupier handling a particular microorganism/genetically engineered organism from seeking such approval. For example, the Ministry has exempted the processed food derived from living modified organisms.

REFERENCES

1. The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous micro-organisms, Genetically engineered organisms or cells, 1989
2. Recombinant DNA Safety Guidelines,1990.
3. Rajkumar Dubey Biotechnology-Destination India, Journal of Business and Law, Vol 1 I 2004,Pg 205
4. Bhuvan Bhaskar Jha & Ashutosh Shankar Evaluating the Law on Regulation of Genetically Modified Crops in India , Jamia Law Journal, Vol 2, 2017, Pg 119- 137
5. Guidelines and Handbook for Institutional Biosafety Committees (IBSCs) , Department of Biotechnology, Government of India, may 2011