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TAMIL NADU POLLUTION CONTROL BOARD

 
 

THE BIO-MEDICAL WASTE MANAGEMENT RULES, 2016

Salient Features

Rule 2

Application :-

These rules shall apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, ayush hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and research labs.

Rule 3

Definitions :-

Definitions.-"bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or research activities pertaining thereto or in the production or testing of biological or in health camps, including the categories mentioned in Schedule I appended to these rules;

“health care facility” means a place where diagnosis, treatment or immunisation of human beings or animals is provided irrespective of type and size of health treatment system, and research activity pertaining thereto;

"occupier" means a person having administrative control over the institution and the premises generating bio-medical waste, which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank, health care facility and clinical establishment, irrespective of their system of medicine and by whatever name they are called; 

"bio-medical waste treatment and disposal facility" means any facility wherein treatment, disposal of bio-medical waste or processes incidental to such treatment and disposal is carried out, and includes common bio-medical waste treatment facilities;

"authorisation" means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, processing, disposal or any other form of handling of bio-medical waste in accordance with these rules and guidelines issued by the Central Government or Central Pollution Control Board as the case may be;

Rule 4

Duties of the Occupier:-

(1)  The occupier shall take all necessary steps to ensure that bio-medical waste is handled without any adverse effect to human health and the environment and in accordance with these rules;

(2)  The occupier shall make a provision within the premises for a safe, ventilated and secured location for storage of segregated biomedical waste in colored bags or containers in the manner as specified in Schedule I, to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals and the bio-medical waste from such place or premises shall be directly transported in the manner as prescribed in these rules to the common bio-medical waste treatment facility or for the appropriate treatment and disposal, as the case may be, in the manner as prescribed in Schedule I

(3)  The occupier shall pre-treat the laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation on-site in the manner as prescribed by the World Health Organisation (WHO) or National AIDs Control Organisation (NACO) guidelines and then sent to the common bio-medical waste treatment facility for final disposal;

(4)  The occupier shall phase out use of chlorinated plastic bags, gloves and blood bags within two years from the date of notification of these rules;

(5)  The occupier shall not give treated bio-medical waste with municipal solid waste;

(6)   The occupier shall ensure segregation of liquid chemical waste at source and ensure pre-treatment or neutralisation prior to mixing with other effluent generated from health care facilities;

(7)  The occupier shall maintain and update on day to day basis the bio-medical waste management register and display the monthly record on its website according to the bio-medical waste generated in terms of category and colour coding as specified in Schedule I;

(8)  The occupier shall make available the annual report on its web-site and all health care facilities shall make own website within two years from the date of notification of these rules;

Rule 5

Duties of the operator of a common bio-medical waste treatment and disposal facility:-

(1)  The operator shall take all necessary steps to ensure that the bio-medical waste collected from the occupier is transported, handled, stored, treated and disposed of, without any adverse effect to the human health and the environment, in accordance with these rules and guidelines issued by the Central Government or, as the case may be, the central pollution control board from time to time;

(2)  The operator shall ensure timely collection of bio-medical waste from the occupier as prescribed under these rules;

(3)  The operator shall establish bar coding and global positioning system for handling of bio- medical waste within one year;

(4)  The operator shall ensure occupational safety of all its workers involved in handling of bio-medical waste by providing appropriate and adequate personal protective equipment;

(5)  The operator shall maintain a log book for each of its treatment equipment according to weight of batch; categories of waste treated; time, date and duration of treatment cycle and total hours of operation;

(6) The operator of the common bio-medical waste treatment facility shall ensure collection of biomedical waste on holidays also;

Rule 6

Duties of authorities :-

The Authority specified in column (2) of Schedule-III shall perform the duties as specified in column (3) thereof in accordance with the provisions of these rules.

Rule 7

Treatment and disposal :-

(a)  Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards provided in Schedule-II by the health care facilities and common bio-medical waste treatment facility.

(b)   The occupier shall hand over segregated waste as per the Schedule-I to common bio-medical waste treatment facility for treatment, processing and final disposal:

(c)  Every operator of common bio-medical waste treatment facility shall set up requisite biomedical waste treatment equipments like incinerator, autoclave or microwave, shredder and effluent treatment plant as a part of treatment, prior to commencement of its operation.

(d)   The Occupier or Operator of a common bio-medical waste treatment facility shall maintain a record of recyclable wastes referred to in sub-rule (9) which are auctioned or sold and the same shall be submitted to the prescribed authority as part of its annual report. The record shall be open for inspection by the prescribed authorities.

(e)   After ensuring treatment by autoclaving or microwaving followed by mutilation or shredding, whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and glass shall be given to such recyclers having valid authorisation or registration from the respective prescribed authority.

(f)  The handling and disposal of all the mercury waste and lead waste shall be in accordance with the respective rules and regulations.

Rule 8

Segregation, packaging, transportation and storage :-

(1)     No untreated bio-medical waste shall be mixed with other wastes.

(2)    The bio-medical waste shall be segregated into containers or bags at the point of generation in accordance with Schedule I prior to its storage, transportation, treatment and disposal.

(3)   The containers or bags referred to in sub-rule (2) shall be labelled as specified in Schedule IV

(4)  The operator of common bio-medical waste treatment facility shall transport the bio-medical waste from the premises of an occupier to any off-site bio-medical waste treatment facility only in the vehicles having label as provided in part ‘A’ of the Schedule IV along with necessary information as specified in part ‘B’ of the Schedule IV.

(5)   The vehicles used for transportation of bio-medical waste shall comply with the conditions if any stipulated by the State Pollution Control Board or Pollution Control Committee in addition to the requirement contained in the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there under for transportation of such infectious waste.

(6)  Untreated human anatomical waste, animal anatomical waste, soiled waste and, biotechnology waste shall not be stored beyond a period of forty –eight hours:

(7)  Microbiology waste and all other clinical laboratory waste shall be pre-treated by sterilisation to Log 6 or disinfection to Log 4, as per the World Health Organisation guidelines before packing and sending to the common bio-medical waste treatment facility.

Rule 9

Prescribed authority :-

(a)    The prescribed authority for implementation of the provisions of these rules shall be the State Pollution Control Boards in respect of States and Pollution Control Committees in respect of Union territories.

(b)    The prescribed authority for enforcement of the provisions of these rules in respect of all health care establishments of the Armed Forces under the Ministry of Defence shall be the Director General, Armed Forces Medical Services, who shall function under the supervision and control of the Ministry of Defence.

(c) The prescribed authorities shall comply with the responsibilities as stipulated in Schedule III of these rules.

Rule 10

Procedure for authorisation :-

(1)   Every occupier or operator handling bio-medical waste, irrespective of the quantity shall make an application in Form II to the prescribed authority i.e. State Pollution Control Board for grant of authorisation and the prescribed authority shall grant the provisional authorisation in Form III and the validity of such authorisation for bedded health care facility and operator of a common facility shall be synchronised with the validity of the consents.

(2)  The authorisation shall be one time for non-bedded occupiers and the authorisation in such cases shall be deemed to have been granted, if not objected by the prescribed authority within a period of ninety days from the date of receipt of duly completed application along with such necessary documents.

(3)  In case of refusal of renewal, cancellation or suspension of the authorisation by the prescribed authority, the reasons shall be recorded in writing after giving an opportunity of being heard to the applicant before such refusal of the authorisation.

(4)  Every application for authorisation shall be disposed of by the prescribed authority within a period of ninety days from the date of receipt of duly completed application along with such necessary documents, failing which it shall be deemed that the authorisation is granted under these rules.

(5)  In case of any change in the bio-medical waste generation, handling, treatment and disposal for which authorisation was earlier granted, the occupier or operator shall intimate to the prescribed authority about the change or variation in the activity and shall submit a fresh application in Form II for modification of the conditions of authorisation.

Rule 11

Advisory Committee :-

(1)   Every State Government or Union territory Administration shall constitute an Advisory Committee for the respective State or Union territory under the chairmanship of the respective health secretary to oversee the implementation of the rules in the respective state and to advice any improvements

(2) The Advisory Committee constituted under sub-rule (1) and (2) shall meet at least once in six months and review all matters related to implementation of the provisions of these rules in the State and Armed Forces Health Care Facilities, as the case may be.

Rule 12

Monitoring of implementation of the rules in health care facilities :-  

(1)  The Ministry of Environment, Forest and Climate Change shall review the implementation of the rules in the country once in a year through the State Health Secretaries and Chairmen or Member Secretary of State Pollution Control Boards and Central Pollution Control Board.

(2)   The Central Pollution Control Board shall monitor the implementation of these rules in respect of all the Armed Forces health care establishments under the Ministry of Defence. 

(3)  Every State Government or Union territory Administration shall constitute District Level Monitoring Committee in the districts under the chairmanship of District Collector or District Magistrate or Deputy Commissioner or Additional District Magistrate to monitor the compliance of the provisions of these rules in the health care facilities generating bio-medical waste and in the common bio-medical waste treatment and disposal facilities, where the bio-medical waste is treated and disposed of.

Rule 13

Annual report :-

(a)  Every occupier or operator of common bio-medical waste treatment facility shall submit an annual report to the prescribed authority in Form-IV, on or before the 30th June of every year.

(b) The Annual Reports shall also be available online on the websites of Occupiers, State Pollution Control Boards and Central Pollution Control Board.

Rule 14

Maintenance of records :-

Every authorized person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling of bio-medical waste, for a period of five years, in accordance with these rules and guidelines issued by the Central Government or the Central Pollution Control Board or the prescribed authority as the case may be.

Rule 15

Accident reporting :-

In case of any major accident at any institution or facility or any other site while handling bio-medical waste, the authorised person shall intimate immediately to the prescribed authority about such accident and forward a report within twenty-four hours in writing regarding the remedial steps taken in Form I.

Rule 16

Appeal :-

(1)  Any person aggrieved by an order made by the prescribed authority under these rules may, within a period of thirty days from the date on which the order is communicated to him, prefer an appeal in Form V to the Secretary (Environment) of the State Government or Union territory administration.

(2)  The appeal shall be disposed of within a period of ninety days from the date of its filing.

Rule 17

Site for common bio-medical waste treatment and disposal facility :-

The selection of site for setting up of such facility shall be made in consultation with the prescribed authority, other stakeholders and in accordance with guidelines published by the Ministry of Environment, Forest and Climate Change or Central Pollution Control Board.

Rule 18

Liability of the occupier, operator of a facility :-

The occupier or operator of common bio-medical waste treatment facility shall be liable for action under section 5 and section 15 of these Act, in case of any violation.

Schedule I

Accident reporting :-

In case of any major accident at any institution or facility or any other site while handling bio-medical waste, the authorised person shall intimate immediately to the prescribed authority about such accident and forward a report within twenty-four hours in writing regarding the remedial steps taken in Form I.

Schedule II

Maintenance of records :-

Every authorized person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling of bio-medical waste, for a period of five years, in accordance with these rules and guidelines issued by the Central Government or the Central Pollution Control Board or the prescribed authority as the case may be.

Schedule III

Accident reporting :-

In case of any major accident at any institution or facility or any other site while handling bio-medical waste, the authorised person shall intimate immediately to the prescribed authority about such accident and forward a report within twenty-four hours in writing regarding the remedial steps taken in Form I.

Schedule IV

Maintenance of records :-

Every authorized person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling of bio-medical waste, for a period of five years, in accordance with these rules and guidelines issued by the Central Government or the Central Pollution Control Board or the prescribed authority as the case may be.

Form - 1

Accident Reporting

Form - 2

Application form for Authorisation or Renewal of Authorisation

Form - 3

Authorisation Format

Form - 4

Annual Report

Form - 5

Application for filing appeal against order passed by the prescribed authority

 

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