MEDICAL POLLUTION CONTROL COMMITTEE

Now, therefore, in exercise of the powers conferred by section 6.8 and 25 of the Environment (Protection) Act. 1986 the Central Government hereby notifies the rules for the management and handling of bio-medical waste.

1    SHORT TITLE AND COMMENCEMENT :

(1) These rule may be called the Bio-Medical Waste (Management and Handling) Rules, 1998
(2) They shall come into force on the date of their publication in the official Gazette.

These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle biomedical waste in any form.

3.  DEFINITIONS : In these rules unless the context otherwise requires :-

(1) "Act" means the Environment (Protection) Act, 1986 (29 of 1986),
(2) "Animal House" means a place where animals are reared/kept for experiments or testing purpose
(3) "Authorisation" means permission granted by the prescribed authority for the generation,
      collection. reception, storage, transportation, treatment, disposal and/or any other form of
      handling of bio-medical-waste in accordance with these rules and any guidelines issued by the
      Central Government. 
(4) "Authorised person"  means an occupier or operator authorised by the prescribed authority to
     generate collect, receive, store, transport, treat, dispose and/or handle bio-medical waste in
     accordance with these rules and any guidelines issued by the Central Government; 
(5) "Bio-medical waste" means any waste, which is generated during the diagnosis, treatment or
     immunisation of human beings or animals or in research activities pertaining thereto or in the
     production of testing of biological. and including categories mentioned in Schedule I,
(6) "Biologicals" means any preparation made from organisms or micro-organisms or product or
     metabolism and biochemical reactions intended for use in the diagnosis. immunisation or the
     treatment of human beings or animals or in research activities pertaining there to;
(7) "Bio-medical waste treatment facility" means any facility wherein treatments disposal of bio-
     medical waste or processes incidental to such treatment or disposal is carried out;
(7) "Form" means Form appended to these rules;
(8) "Occupier" in relation to any institution generating biomedical waste, which includes a hospital,
     nursing home. clinic dispensary, veterinary institution, animal house, pathological laboratory,
     blood bank by whatever name called, means a person who has control over that institution and/or
     its premises:
(9) "Operator of a bio-medical waste facility" means a person who owns or controls or operates a
     facility for the collection, reception, storage, transport, treatment, disposal or any other form of
     handling of bio-medical waste;
(10) "Schedule" means schedule appended to these rules;

4.  DUTY OF OCCUPIER:

It shall be the duty of every occupier of an institution generating bio-medical waste which includes a hospital, nursing, home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment.

5.  TREATMENT AND DISPOSAL

(1) Bio-medical waste shall be treated and disposed of in accordance with Schedule 1. and in
     compliance with the standards prescribed in Schedule V.

(2) Every occupier, where required, shall set up in accordance with the time-schedule in Schedule
     VI. requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system
     for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment
     facility or any oilier waste treatment facility.

6.  SEGREGATION. PACKAGING. TRANSPORTATION AND STORAGE

(1) Bio-medical waste shall not be mixed with other wastes.

(2) Bio-medical waste shall be segregated into containers/bags at the point of generation in
     accordance with  Schedule II prior to its storage, transportation, treatment and disposal. The
     containers shall be labeled according to Schedule III. 

(3) If a container is transported from the premises where biomedical waste is generated to any waste
     treatment facility outside the premises, the container shall, apart from the label prescribed in
     Schedule III, also carry information prescribed in Schedule IV.

(1) Every occupier of an institution generating, collecting, receiving, storing, transporting, treating,
     disposing and/or handling bio-medical waste in any other manner, except such occupier of
     clinics, dispensaries, patho-logical laboratories, blood banks providing treatment/service to less
     than 1000 (one thousand) patients per month, shall make an application in Form I to the
     prescribed authority for grant of authorisation. 
(2) Every operator of a bio-medical waste facility shall make an application in Form I to the
     prescribed authority for grant of authorisation.
(3) Every application in Form I for grant of authorisation shall be accompanied by a fee as may be
     prescribed by the Government of the State or Union Territory.
(4) The authorisation to operate a facility shall be issued in Form IV, subject to conditions laid 
     therein and such other condition, as the prescribed authority, may consider it necessary.

9. ADVISORY COMMITTEE

The Government of every State/Union Territory shall constitute an advisory committee. The committee will include experts in the Field of medical and health, animal husbandry and veterinary sciences, environmental management, municipal administration, and any other related department or organisation including non-governmental organisations. As and when required, the committee shall advise the Government of the State/Union Territory and the prescribed authority about matters related to the implementation of these rules.

10. ANNUAL REPORT

Every occupier/operator shall submit an annual report to the prescribed authority in Form II by 31 January every year, to include information about the categories and quantities of bio-medical wastes handled during the preceding year. The prescribed authority shall send this information in a compiled form to the Central Pollution Control Board by 31 March every year.

11. MAINTENANCE OF RECORDS

(1) Every authorised person shall maintain records related to the generation, collection, reception,
     storage, transpiration, treatment, disposal and/or any form of handling of bio-medical waste in
     accordance with these rules and any guidelines issued. 

(2) All records shall be subject to inspection and verification by the prescribed authority at any time.

12. ACCIDENT REPORTING

When any accident occurs at any institution or facility or any other site where bio-medical waste is handled or during transportation of such waste, the authorised person shall report the accident in Form III to the prescribed authority forth with.

13. APPEAL

Any person aggrieved by an order made by the prescribed authority under these rules may, within thirty days from the date on which the order is communicated to him, prefer an appeal to such authority as the Government of State/Union Territory may think fit to constitute :

Provided that the authority may entertain the appeal after the expiry of the said period of thirty days if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.

14. COMMON DISPOSAL/INCINERATION SITES
Without prejudice to rule 5 of the these rules, the Municipal Corporations, Municipal Boards or Urban Local Bodies, as the case may be, shall be responsible for providing suitable common disposal / incineration sites for the biomedical wastes generated in the area under their jurisdication and in areas outside the jurisdiction of any municipal body, it shall be the responsibility of the occupier generating bio-medical waste/operator of a bio-medical waste treatment facility to arrange for suitable sites individually or in association, so as to comply with the provisions of these rules.