Bio-Medical Waste Rules 2016

The Bio-Medical Waste (Management and Handling) Rules, 2016 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, animals 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, ferensic laboratories and research labs.

DUTIES OF THE OCCUPIER

It shall be the duty of every occupier to-

1. take all necessary steps to ensure that bio-medical waste in handle without any adverse effect to human health and the environment and in accordance with these rule;

2. 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 manners as specified in Schedule I, to ensure that there shall be ...Read More

DUTIES OF THE OPERATOR OF A COMMON BIO-MEDICAL WASTE TREATMENT AND DISPOSAL FACILITY

It shall be the duty of every operator to-

1. 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 board from time to time;
2. ensure timely collection of bio-medical waste from the occupier as prescribed under these rules;
3. establish bar coding and global positioning system for handling of bio-medical waste within one year; ...Read More

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.

PROCEDURE FOR AUTHORISATION

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 and Pollution Control Committee, as the case may be, 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.

1. 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.
2. In case of refusal of renewal, cancellation or suspension of the authorisation by the prescribed authority, the reasons shall be recorded in writing...Read More

MANAGEMENT OF BIO-MEDICAL WASTE

A. SEGREGATION, PACKING, 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....Read More

B. TREATMENT AND DISPOSAL

1. 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.
2. Occupier shall hand over segregated waste as per the Schedule – I to common bio-medical waste treatment facility for treatment, processing and final disposal: ...Read More

ANNUAL REPORT

1. 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.
2. The prescribed authority shall compile, review and analyse the information received and send this information to the Central Pollution Control Board on or before the 31st July of every year.
3. The Central Pollution Control Board shall compile, review and analyse the information received and send this information, along with the comments or suggestions or observations to the Ministry of Environment, Forest and Climate Change on or before 31st August every year.
4. The annual Reports shall also be available online on the websites of Occupiers, State Pollution Control Boards and Central Pollution Control Board.

MAINTENANCE OF RECORDS

1. Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, 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.
2. All records shall be subject to inspection and verification by the prescribed authority or the Ministry of Environment, Forest and Climate Change at any time.

ACCIDENT REPORTING

1. 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.
2. Information regarding all other accidents and remedial steps taken shall be provided in the annual report in accordance with rule 13 by the occupier.

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 the Union territory administration.
2. Any person aggrieved by an order of the Director General Armed Forces Medical Services 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 the Secretary, Ministry of Environment, Forest and Climate Change.
3. The authority referred to in sub-para (1) and (2) as the case may be, 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.
4. The appeal shall be disposed of within a period of ninety days from the date of its filing.

SITE FOR COMMON BIO-MEDICAL WASTE TREATMENT AND DISPOSAL FACILITY

1. Without prejudice to rule 5 of these rules, the department in the business allocation of land assignment shall be responsible for providing suitable site for setting up of common biomedical waste treatment and disposal facility in the State Government or Union territory Administration.
2. 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.

LIABILITY OF THE OCCUPIER, OPERATOR OF A FACILITY

1. The occupier or an operator of a common bio-medical waste treatment facility shall be liable for all the damages caused to the environment or the public due to improper handling of bio-medical wastes.
2. The occupier or operator of common bio-medical waste treatment facility shall be liable for action under section 5 and section 15 of the Act, in case of any violation.