ORDER

The Issue

1. Substantial question relating to environment raised in this application is the effectiveness of regulatory regime on the subject of safe and scientific disposal of waste generated from recombinant-DNA (Deoxyribo Nucleic Acid) research. Though particular grievance in this application is in the context of disposal of such waste by Anna University, Chennai and Pondicherry University, Puducherry, the same is relevant for all similar research organisations throughout the country.

2. We have gone through the record and considered the matter. We proceed to consider the question in the light of material on record.

Pleadings – Applicant’s case

3. Case of the applicant is that in the process of research on DNA, different bacteria and virus or other organism are made to react with the enzymes to form Ribonucleic Acid (RNA) which forms protein. To prevent multiplication of virus affected protein, vaccines are developed using DNA molecules - having active and dormant component. In the process various combinations are worked out in the laboratories. If safety precautions are not taken in disposal of combinations, there is potential threat to environment and public health by the bio-hazard involved. Microscopic cells are not visible to naked eyes. All educational institutions and research laboratories that deal with DNA, recombinant DNA, microorganisms, pathogenic bacteria, viruses etc., have to ensure that the wastes are destroyed through process of incineration, as the wastes may contain live DNA molecules which may react to form a potential bio-hazard resulting in unknown diseases. "Recombinant DNA Safety Guidelines and Regulations" were introduced in 1990 but in view of subsequent research and "Guidelines for the use and Safety of Genetic Engineering Techniques or Recombinant DNA Technology" issued by the World Health Organization (WHO), the said regulations need to be revised. The applicant has relied upon a scholarly article on the subject published on 26.05.2016 under the heading "Horizontal Gene Transfer".

4. According to the applicant, the waste generated from recombinant DNA research needs incinerators for safety. The applicant sought information from Anna University and Pondicherry University about the process followed for disposal of waste generated from recombinant DNA research. Similar requests were made also to Centre for Cellular and Molecular Biology (CCMB) and National Institute for Research in Tuberculosis (NIRT). The said institutions admitted that they do not have incineration facility. Questions posed by the applicant to the Anna University (similar questions posed to others as mentioned above) are reproduced below:

“i. Kindly provide the information on whether your institution deals with research on recombinant-DNA involving pathogenic genes? - The Centre deals with recombinant - DNA research involving genes in pathogenic organisms.

ii. Whether you have installed incinerators at your Institution? -

There are no incinerators installed at the Centre.

iii. Whether the incinerators are in working condition? - Not Applicable (since there are no incinerators installed).

iv. What is the method used for disposal of waste generated from recombinant-DNA research? - The waste generated from recombinant -DNA research is disposed using Heat and Chemical sterilization.

v. What are the safety guidelines followed for disposal of recombinant-DNA by your institute? - The disposal of recombinant-DNA at the Centre is as per the Department of Biotechnology (DBT), Government of India Biosafety Guidelines.

vi. if not disposed through incinerator. whether DNA will be alive in normal course? - The DNA will not be alive after Heat and Chemical sterilization.

vii. Whether autoclaving is a sufficient mechanism to dispose the DNA used for research? - Yes, autoclaving is a sufficient mechanism for disposal viii. What is the procedure followed by your Institution to ensure decontamination, if the disposal of DNA is done after autoclaving? - Th