BIO MEDICAL WASTE ( MANAGEMENT AND HANDLING ) RULES ,1998 MINISTRY OF ENVIORNMENT AND FORESTS NOTIFICATION NEW DELHI 20 TH JULY 1998.
 

S.O 630(E) - whereas a notification in exercise of the powers conferred by Section 6, 8 and 25 of the Environment (Protection) Act, 1986 ( 29 of 1986) was published in the gazette vide S.O.746(E) dated 16 October, 1997 inviting objections from the public within 60 days from the date of the publication of the said notification on the bio-medical waste (Management and handling) Rules,1998 and whereas all objections received were duly considered.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 rules may be called the bio-medical waste (Management and Handling) Rules,1998.
  (2) They shall come into force on the sake of their publication in the official gazette.
2. Application -
 

These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio- medical 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 purposes;
  (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) "Authorized person" means an occupier or operator authorized 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 immunization of the human beings or animals or in research activity pertaining thereto or in the production or testing of biologicals, and include categories mentioned in Schedule I;
  (6) "Biologicals" means any preparation made from organisms or micro-organisms or product of metabolism and biochemical reactions entended for use in the diagnosis, immunisation or the treatment of human beings or animals or in research activities pertaining thereto;
  (7) "Bio-Medical waste treatment facility" means any facility wherein treatment disposal of bio-medical waste or processes incidental to such treatment or disposal is carried out [and includes comman treatment facility];
  [(7A) "Form" means Form appended to these rules;]
  (8) "Occupier" in relation to any institution generating bio-medical waste, which includes a hospital, nursing home, clinic dispensary veterinary institution, animal house, pathalogical laboratory, blood bank, by whatever name called, means a person who has control over that institution and/or its premises;
  (9) "Operator of the 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, pathalogical 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 I, and in compliance with the standards prescribed in Schedule V.
  (2) Every occupier, where required, shall set up in accordance with the time schedule VI, requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system for the treatment of waste, or,ensure requsite treatment of waste at a comman waste treatment facility or any other waste treatment facility.
6. Segregation, packaging, transportation and storage -
  (1) Bio-Medical waste shall not be fixed 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 labelled according to schedule III.
  (3) If a container is transported from the premises where bio-medical 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.
  (4) Notwithstanding anything contained in the motor Vehicle Act,1988 or rules thereunder, untreated bio-medical waste shall be transported only in such vehicles as may be authorised for the purpose by the competent authority as specified by the government .
  (5) No untreated bio-medical waste shall be kept stored beyond a period of 48 hours.
  [(6) The municipal body of the area shall continue to pick up and transport segregated non bio-medical solid waste generated in hospitals and nursing homes, as well as duly treated bio-medical wastes for the disposal at municipal dump site.]
  Provided that if for any reason it became neccessary to store the waste beyond such period, the authorised person must take permission of the prescribed authority and take measures to ensure that the waste does not adversely affect human health and environment.
7. Prescribed authority-
  [(1) The prescribed authority for enforcement of the provisions of these rules shall be the state pollution control boards in respect of states and the pollution control committees in respect of the union territories and all pending cases with a prescribed authority appointed earlier shall stand transferred to the concerned state pollution control board, or as the case may be, the pollution control commitees.]
  (2) The prescribed authority for the state or the union territory shall be appointed within one month of the coming into force of these rules.
  (3) The prescribed authority shall function under the supervision and control of the respective Government of the state or union territory.
  (4) The prescribed authority shall on receipt of Form I make such enquiry as it deems fit and if it is satisfied that the applicant possesses the necessary capacity to handle bio-medical waste in accordance with these rules, grant or renew an authorisation as the case may be.
  (5) An authorisation shall be granted for a period of three years, including an initial trial period of one year from the date of issue. Thereafter, an application shall be made by the occupier/operator for renewal. All such subsequent authorisation shall be for a period of three years .A provisional authorisation will be granted for the trial period, enables the occupier/operator to demonstrate the capacity of the facility.
  (6) The prescribed authority may after giving reasonable opportunity of being heard to the applicant and for reasons thereof to be recorded in writing, refuse to grant or renew authorisation.
  (7) Every application for authorisation shall be disposed of by the prescribed authority within ninety days from the date of receipt of the application.
  (8) The prescribed authority may cancel or suspend an authorisation, if for reasons, to be recorded in writing, the occupier/operator has failed to comply with any provisions of the Act or these rules. Provided that no authorisation shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard.
8. Authorisation -
  (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, pathalogical laboratories , blood bank, providing treatment/services to less than 1000 (one thousand) patients per month, shall make an application in Form I to the prescribed authority for the grant of authorisation.
  (2) Every operator of a bio-medical 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 husbandary and veterinary sciences, enviornmental management, municipal administration, and any other related department or organisation including non-governmental organisations. As and when required, the commitee shall advise the government of the state/union terriory 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 31st January every year, to include information about the catagories 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 31st march every year.
11. Maintenance of records -
  (1) Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, 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 forthwith.
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 [in Form V] 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 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 bio-medical wastes generated in the area under their jurisdiction 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.]
  SCHEDULE II (see Rules 6)
  COLOUR CODING AND TYPE OF CONTAINER FOR DISPOSAL OF BIO-MEDICAL WASTES
  Color Coding Type of Container Waste Category Treatment Options as per Schedule I
Yellow Plastic Bag Cat.1, Cat.2 and Cat 3, Cat.6 Incineration /Deep Burial
Red Disinfected Container/Plastic Bag Cat.3, Cat.6, Cat.7 Autoclaving, Microwaving/Chemical Treatment
Blue/White Translucent Plastic Bag/Puncture Proof Container Cat.4, Cat7. Autoclaving, Microwaving/Chemical Treatment and Destruction/Shreading
Black Plastic Bag Cat.5 and Cat.9 and Cat.10 (solid) Disposal in secured fill
  Notes:
  1. Colour coding of waste categories with multiple treatment options as declared in Schedule 1, shall be selected depending on treatment option chosen, which shall be specified in Schedule 1.
  2. Waste collection bags for waste types needing incineration shall not be made of chlorinated pastes.
  3. Categories 8 and 10 (liquid) do not require containers/bags.
  4. Category 3, if disinfected locally need not be put in container/bags.
  SCHEDULE VI (see Rules 5)
  SCHEDULE FOR WASTE MANAGEMENT FACILITIES LIKE INCINERATOR/AUTOCLAVE/MICROWAVE SYSTEM.
  A. Hospitals and nursing homes in towns with population of 30 Lakhs and above by 30th June 2000 or earlier
  B. Hospital and nursing homes in towns with population of below 30 Lakhs,
  a) with 500 beds and above by 30th June 2000 or earlier
b) with 200 beds and above but less than 500 beds by 31st December 2000 or earlier
c) with 50 beds and above but less than 200 beds by 31st December 2001 or earlier
d) with less than 50 beds by 31st December 2002 or earlier
  C. All other institutions generating biomedical waste not included in A and B above, by 31st December 2002 or earlier