BIO-MEDICAL WASTE MANAGEMENT RULES 1998


SHORT TITLE AND COMMENCEMENT


(1) These rules may be called the bio-medical waste (management and handling) rules, 1998.
(2) They shall come in to force on the date of their publication in the official gazette


APPLICATION

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


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. Authorization - means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal and/or handle biomedical 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 biomedical waste in accordance with these rules and any guidelines issued by the central government;
  5. Biomedical waste" means any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining thereto or in the production or testing biological and including categories mentioned in schedule 1;
  6. Biologicals" means any preparation made from organisms or micro-organisms or product of metabolism and biochemical reactions intended for use in the diagnosis, immunization 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;
  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, dispose or any other form of handling of bio-medical waste;
    (10)"Schedule" means schedule appended to these rules;


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 steps to ensure that such waste is handled without any adverse affect to human health and the environment.


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, wherever required shall set up in accordance with the time-schedule in schedule VI, requisite bio-medical waste treatment facilities like incinerator, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.


SEGREGATION, PACKING, TRANSPORTATION AND STORAGE

  1. Biomedical 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 bio-medical waste is generate 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 vehicles act, 1988, or rules hereunder, untreated bio-medical waste shall be transported only in such vehicle as may be authorized 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:

Provided that if for any reason it becomes necessary to store the waste beyond such period, the authorized person must take permission of the prescribed authority and take measures to ensure that the waste does not adversely affect human health and the environment.


PRESCRIBED AUTHORITY
  1. The government of every state and union territory shall establish a prescribed authority with such members as may be specified for granting authorization and implementing these rules. If the prescribed authority which such members as may be specified for granting authorization and implementing these rules. If the prescribed authority comprises of more than one member, a chairperson of r the authority shall be designated.
  2. The prescribed authority for the state or union shall be appointed within one month of the coming into force to 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 in receipt of form I make such Enquirer as it deems fit and if satisfied that the applicant possesses the necessary capacity to handle bio-medical waste in accordance with these rules, grant or renew an authorization as the case may be
  5. An authorization 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 authorization shall be for a period of three years. A provisional authorization will be granted for the trial period, to enable 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 the reasons thereof to the recorded in writing, refuse the grant or renew authorization
  7. Every application for authorization 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 authorization, if for reason, to be recorded in writing provided that no authorization shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard.


AUTHORIZATION

  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, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per moth shall make an application in form I to the prescribed authority for grant of authorization for grant of authorization.
  2. Every application in Form I for grant of authorization shall be accompanied by a fee as may be prescribed by the government of state or union territory.


ADVISORY COMMITTEE

The Government of very 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 organization including non-governmental organizations. The state pollution control board/pollution control committee shall be represented. As and when required, the committee shall advise the government of the state/union. Territory and the prescribed authority on matters related to the implementation of these rules.


ANNUAL REPORT

Every occupier/operator shall submit an annual report to the prescribed authority in formII 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 complied form to the central pollution control board by 31 march every year.


MAINTENANCE OF RECORDS

  1. Every authorized 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 rule s and any guidelines issued.
  2. All records shall be subjected to inspection and verification by the prescribed authority at any time.


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 authorized person shall report the accident in form iii to the prescribed authority forthwith.


APPEAL

Any person aggrieved by an order made by the prescribed authority under these rules may, within thirty days form 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 the satisfied that the appellant was prevented by sufficient cause from filling the appeal in time.