(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.
SCHEDULE I [See rules 3 (e), 4(b), 7(1), 7(2), 7(5), 7 (6) and 8(2)] Part-1 Biomedical wastes categories and their segregation, collection, treatment, processing and disposal options Category Type of Waste Type of Bag or Container to be used Treatment and Disposal options
(1) (2) (3) (4) Yellow (a) Human Anatomical Waste:
Human tissues, organs, body parts and fetus below the viability period (as per the Medical Termination of Pregnancy Act 1971, amended from time to time).
Yellow coloured non-chlorinated plastic bags Incineration or Plasma Pyrolysis or deep burial*
(b)Animal Anatomical Waste :
Experimental animal carcasses, body parts, organs, tissues, including the waste generated from animals used in experiments or testing in veterinary hospitals or colleges or animal houses.
(c) Soiled Waste:
Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and Incineration or Plasma Pyrolysis or deep burial* In absence of above facilities, autoclaving or micro-waving/ 12 bags containing residual or discarded blood and blood components.
hydroclaving followed by shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent for energy recovery.
(d) Expired or Discarded Medicines:
Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials etc.
Yellow coloured non-chlorinated plastic bags or containers Expired 'cytotoxic drugs and items contaminated with cytotoxic drugs to be returned back to the manufacturer or supplier for incineration at temperature >1200 0C or to common bio-medical waste treatment facility or hazardous waste treatment, storage and disposal facility for incineration at >12000C Or Encapsulation or Plasma Pyrolysis at >12000C.
All other discarded medicines shall be either sent back to manufacturer or disposed by incineration.
(e) Chemical Waste:
Chemicals used in production of biological and used or discarded disinfectants.
Yellow coloured containers or non-chlorinated plastic bags Disposed of by incineration or Plasma Pyrolysis or Encapsulation in hazardous waste treatment, storage and disposal facility.
(f) Chemical Liquid Waste :
Liquid waste generated due to use of chemicals in production of biological and used or discarded disinfectants, Silver X-ray film developing liquid, discarded Formalin, infected secretions, aspirated body fluids, liquid from laboratories and floor washings, cleaning, house-keeping and disinfecting activities etc.
Separate collection system leading to effluent treatment system After resource recovery, the chemical liquid waste shall be pre-treated before mixing with other wastewater. The combined discharge shall conform to the discharge norms given in Schedule- III.
(g) Discarded linen, mattresses, beddings contaminated with blood or body fluid.
Non-chlorinated yellow plastic bags or suitable packing material Non- chlorinated chemical disinfection followed by incineration or Plazma Pyrolysis or for energy recovery.
In absence of above facilities, shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent for energy recovery or incineration or Plazma Pyrolysis.
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(h) Microbiology, Biotechnology and other clinical laboratory waste:
Blood bags, Laboratory cultures, stocks or specimens of micro organisms, live or attenuated vaccines, human and animal cell cultures used in research, industrial laboratories, production of biological, residual toxins, dishes and devices used for cultures.
Autoclave safe plastic bags or containers Pre-treat to sterilize with non chlorinated chemicals on-site as per National AIDS Control Organisation or World Health Organisation guidelines thereafter for Incineration.
Red Contaminated Waste (Recyclable)
(a) Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vaccutainers with their needles cut) and gloves.
Red coloured non-chlorinated plastic bags or containers Autoclaving or micro-waving/ hydroclaving followed by shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent to registered or authorized recyclers or for energy recovery or plastics to diesel or fuel oil or for road making, whichever is possible.
Plastic waste should not be sent to landfill sites.
White (Translucent) Waste sharps including Metals:
Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes both used, discarded and contaminated metal sharps Puncture proof, Leak proof, tamper proof containers Autoclaving or Dry Heat Sterilization followed by shredding or mutilation or encapsulation in metal container or cement concrete; combination of shredding cum autoclaving; and sent for final disposal to iron foundries (having consent to operate from the State Pollution Control Boards or Pollution Control Committees) or sanitary landfill or designated concrete waste sharp pit.
Blue (a) Glassware:
Broken or discarded and contaminated glass including medicine vials and ampoules except those contaminated with cytotoxic wastes.
Cardboard boxes with blue colored marking Disinfection (by soaking the washed glass waste after cleaning with detergent and Sodium Hypochlorite treatment) or through autoclaving or microwaving or hydroclaving and then sent for recycling.
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(b) Metallic Body Implants Cardboard boxes with blue colored marking *Disposal by deep burial is permitted only in rural or remote areas where there is no access to common bio-medical waste treatment facility. This will be carried out with prior approval from the prescribed authority and as per the Standards specified in Schedule-III. The deep burial facility shall be located as per the provisions and guidelines issued by Central Pollution Control Board from time to time.
Part -2
(1) All plastic bags shall be as per BIS standards as and when published, till then the prevailing Plastic Waste Management Rules shall be applicable.
(2) Chemical treatment using at least 10% Sodium Hypochlorite having 30% residual chlorine for twenty minutesor any other equivalent chemical reagent that should demonstrate Log104 reduction efficiency for microorganisms as given in Schedule- III.
(3) Mutilation or shredding must be to an extent to prevent unauthorized reuse.
(4) There will be no chemical pretreatment before incineration, except for microbiological, lab and highly infectious waste.
(5) Incineration ash (ash from incineration of any bio-medical waste) shall be disposed through hazardous waste treatment, storage and disposal facility, if toxic or hazardous constituents are present beyond the prescribed limits as given in the Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 2008 or as revised from time to time.
(6) Dead Fetus below the viability period (as per the Medical Termination of Pregnancy Act 1971, amended from time to time) can be considered as human anatomical waste. Such waste should be handed over to the operator of common bio-medical waste treatment and disposal facility in yellow bag with a copy of the official Medical Termination of Pregnancy certificate from the Obstetrician or the Medical Superintendent of hospital or healthcare establishment.
(7) Cytotoxic drug vials shall not be handed over to unauthorised person under any circumstances.
These shall be sent back to the manufactures for necessary disposal at a single point. As a second option, these may be sent for incineration at common bio-medical waste treatment and disposal facility or TSDFs or plasma pyrolys is at temperature >1200 0C.
(8) Residual or discarded chemical wastes, used or discarded disinfectants and chemical sludge can be disposed at hazardous waste treatment, storage and disposal facility. In such case, the waste should be sent to hazardous waste treatment, storage and disposal facility through operator of common bio-medical waste treatment and disposal facility only.
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(9) On-site pre-treatment of laboratory waste, microbiological waste, blood samples, blood bags should be disinfected or sterilized as per the Guidelines of World Health Organisation or National AIDS Control Organisation and then given to the common bio-medical waste treatment and disposal facility.
(10) Installation of in-house incinerator is not allowed. However in case there is no common biomedical facility nearby, the same may be installed by the occupier after taking authorisation from the State Pollution Control Board.
(11) Syringes should be either mutilated or needles should be cut and or stored in tamper proof, leak proof and puncture proof containers for sharps storage. Wherever the occupier is not linked to a disposal facility it shall be the responsibility of the occupier to sterilize and dispose in the manner prescribed.
(12) Bio-medical waste generated in households during healthcare activities shall be segregated as per these rules and handed over in separate bags or containers to municipal waste collectors. Urban Local Bodies shall have tie up with the common bio-medical waste treatment and disposal facility to pickup this waste from the Material Recovery Facility (MRF) or from the house hold directly, for final disposal in the manner as prescribed in this Schedule.
SCHEDULE II [See rule 4(t), 7(1) and 7(6)] STANDARDS FOR TREATMENT AND DISPOSAL OF BIO-MEDICALWASTES
1. STANDARDS FOR INCINERATION.- All incinerators shall meet the following operating and emission standards- A. Operating Standards 1) . Combustion efficiency (CE) shall be at least 99.00%.
2) . The Combustion efficiency is computed as follows:
%C02 C.E. = ------------ X 100 %C02 + % CO 3) . The temperature of the primary chamber shall be a minimum of 800 0C and the secondary chamber shall be minimum of 10500C + or - 500C.
4) . The secondary chamber gas residence time shall be at least two seconds.
B. Emission Standards 16 Sl.
No.
Parameter Standards
(1) (2) (3) (4) Limiting concentration in mg Nm3 unless stated Sampling Duration in minutes, unless stated
1. Particulate matter 50 30 or 1NM3 of sample volume, whichever is more
2. Nitrogen Oxides NO and NO2 expressed asNO2 400 30 for online sampling or grab sample
3. HCl 50 30 or 1NM3 of sample volume, whichever is more
4. Total Dioxins and Furans 0.1ngTEQ/Nm3 (at 11% O2) 8 hours or 5NM3 of sample volume, whichever is more
5. Hg and its compounds 0.05 2 hours or 1NM3 of sample volume, whichever is more C. Stack Height: Minimum stack height shall be 30 meters above the ground and shall be attached with the necessary monitoring facilities as per requirement of monitoring of ‘general parameters' as notified under the Environment (Protection) Act, 1986 and in accordance with the Central Pollution Control Board Guidelines of Emission Regulation Part-III.
Note:
(a) The existing incinerators shall comply with the above within a period of two years from the date of the notification.
(b) The existing incinerators shall comply with the standards for Dioxins and Furans of 0.1ngTEQ/Nm3, as given below within two years from the date of commencement of these rules.
(c) All upcoming common bio-medical waste treatment facilities having incineration facility or captive incinerator shall comply with standards for Dioxins and Furans.
(d) The existing secondary combustion chambers of the incinerator and the pollution control devices shall be suitably retrofitted, if necessary, to achieve the emission limits.
(e) Wastes to be incinerated shall not be chemically treated with any chlorinated disinfectants.
(f) Ash from incineration of biomedical waste shall be disposed of at common hazardous waste treatment and disposal facility. However, it may be disposed of in municipal landfill, if the toxic metals in incineration ash are within the regulatory quantities as defined under the Hazardous Waste (Management and Handling and Transboundary Movement) Rules, 2008 as amended from time to time.
(g) Only low Sulphur fuel like Light Diesel Oil or Low Sulphur Heavy Stock or Diesel, Compressed Natural Gas, Liquefied Natural Gas or Liquefied Petroleum Gas shall be used as fuel in the incinerator.
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(h) The occupier or operator of a common bio-medical waste treatment facility shall monitor the stack gaseous emissions (under optimum capacity of the incinerator) once in three months through a laboratory approved under the Environment (Protection) Act, 1986 and record of such analysis results shall be maintained and submitted to the prescribed authority. In case of dioxins and furans, monitoring should be done once in a year.
(i) The occupier or operator of the common bio-medical waste treatment facility shall install continuous emission monitoring system for the parameters as stipulated by State Pollution Control Board or Pollution Control Committees in authorisation and transmit the data real time to the servers at State Pollution Control Board or Pollution Control Committees and Central Pollution Control Board.
(j) All monitored values shall be corrected to 11% Oxygen on dry basis.
(k) Incinerators (combustion chambers) shall be operated with such temperature, retention time and turbulence, as to achieve Total Organic Carbon content in the slag and bottom ashes less than 3% or their loss on ignition shall be less than 5% of the dry weight.
(l) The occupier or operator of a common bio-medical waste incinerator shall use combustion gas analyzer to measure CO2, CO and O2.
2. Operating and Emission Standards for Disposal by Plasma Pyrolysis or Gasification:
A. Operating Standards:
All the operators of the Plasma Pyrolysis or Gasification shall meet the following operating and emission standards:
1) Combustion Efficiency (CE) shall be at least 99.99%.
2) The Combustion Efficiency is computed as follows.
% CO2 C.E = .................................. X 100 (% CO2 + % CO) 3) The temperature of the combustion chamber after plasma gasification shall be 1050 ± 50 o C with gas residence time of at least 2(two) second, with minimum 3 % Oxygen in the stack gas.
4) The Stack height should be minimum of 30 m above ground level and shall be attached with the necessary monitoring facilities as per requirement of monitoring of ‘general parameters' as notified under the Environment (Protection) Act, 1986 and in accordance with the CPCB Guidelines of Emission Regulation Part-III.
B. Air Emission Standards and Air Pollution Control Measures
(i) Emission standards for incinerator, notified at Sl No.1 above in this Schedule, and revised from time to time, shall be applicable for the Plasma Pyrolysis or Gasification also.
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(ii) Suitably designed air pollution control devices shall be installed or retrofitted with the ‘Plasma Pyrolysis or Gasification to achieve the above emission limits, if necessary.
(iii) Wastes to be treated using Plasma Pyrolysis or Gasification shall not be chemically treated with any chlorinated disinfectants and chlorinated plastics shall not be treated in the system.
C. Disposal of Ash Vitrified Material: The ash or vitrified material generated from the ‘Plasma Pyrolysis or Gasification shall be disposed off in accordance with the Hazardous Waste (Management, Handling and Transboundary Movement) Rules 2008 and revisions made thereafter in case the constituents exceed the limits prescribed under Schedule II of the said Rules or else in accordance with the provisions of the Environment (Protection) Act, 1986, whichever is applicable.
3. STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL WASTE.- The autoclave should be dedicated for the purposes of disinfecting and treating bio-medical waste.
(1) When operating a gravity flow autoclave, medical waste shall be subjected to:
(i) a temperature of not less than 121° C and pressure of 15 pounds per square inch (psi) for an autoclave residence time of not less than 60 minutes; or
(ii) a temperature of not less than 135° C and a pressure of 31 psi for an autoclave residence time of not less than 45 minutes; or
(iii) a temperature of not less than 149° C and a pressure of 52 psi for an autoclave residence time of not less than 30 minutes.
(2) When operating a vacuum autoclave, medical waste shall be subjected to a minimum of three pre-vacuum pulse to purge the autoclave of all air. The air removed during the pre-vacuum, cycle should be decontaminated by means of HEPA and activated carbon filtration, steam treatment, or any other method to prevent release of pathogen. The waste shall be subjected to the following:
(i) a temperature of not less than 121°C and pressure of 15 psi per an autoclave residence time of not less than 45 minutes; or
(ii) a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of not less than 30 minutes;
(3) Medical waste shall not be considered as properly treated unless the time, temperature and pressure indicators indicate that the required time, temperature and pressure were reached during the autoclave process. If for any reasons, time temperature or pressure indicator indicates that the required temperature, pressure or residence time was not reached, the entire load of medical waste must be autoclaved again until the proper temperature, pressure and residence time were achieved.
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(4) Recording of operational parameters: Each autoclave shall have graphic or computer recording devices which will automatically and continuously monitor and record dates, time of day, load identification number and operating parameters throughout the entire length of the autoclave cycle.
(5) Validation test for autoclave: The validation test shall use four biological indicator strips, one shall be used as a control and left at room temperature, and three shall be placed in the approximate center of three containers with the waste. Personal protective equipment (gloves, face mask and coveralls) shall be used when opening containers for the purpose of placing the biological indicators. At least one of the containers with a biological indicator should be placed in the most difficult location for steam to penetrate, generally the bottom center of the waste pile. The occupier or operator shall conduct this test three consecutive times to define the minimum operating conditions. The temperature, pressure and residence time at which all biological indicator vials or strips for three consecutive tests show complete inactivation of the spores shall define the minimum operating conditions for the autoclave. After determining the minimum temperature, pressure and residence time, the occupier or operator of a common biomedical waste treatment facility shall conduct this test once in three months and records in this regard shall be maintained.
(6) Routine Test: A chemical indicator strip or tape that changes colour when a certain temperature is reached can be used to verify that a specific temperature has been achieved. It may be necessary to use more than one strip over the waste package at different locations to ensure that the inner content of the package has been adequately autoclaved. The occupier or operator of a common bio medical waste treatment facility shall conduct this test during autoclaving of each batch and records in this regard shall be maintained.
(7) Spore testing: The autoclave should completely and consistently kill the approved biological indicator at the maximum design capacity of each autoclave unit. Biological indicator for autoclave shall be Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X106 spores. Under no circumstances will an autoclave have minimum operating parameters less than a residence time of 30 minutes, a temperature less than 121o C or a pressure less than 15 psi. The occupier or operator of a common bio medical waste treatment and disposal facility shall conduct this test at least once in every week and records in this regard shall be maintained.
4. STANDARDS OF MICROWAVING.-
(1) Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated animal carcasses, body parts and large metal items.
(2) The microwave system shall comply with the efficacy test or routine tests and a performance guarantee may be provided by the supplier before operation of the limit.
(3) The microwave should completely and consistently kill the bacteria and other pathogenic organisms that are ensured by approved biological indicator at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus atrophaeusspores using vials or spore strips with at least 1 x 104sporesper detachable strip. The biological indicator shall be placed with waste and exposed to same conditions as the waste during a normal treatment cycle.
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5. STANDARDS FOR DEEP BURIAL.- (1) A pit or trench should be dug about two meters deep.
It should be half filled with waste, then covered with lime within 50 cm of the surface, before filling the rest of the pit with soil.
(2) It must be ensured that animals do not have any access to burial sites. Covers of galvanised iron or wire meshes may be used.
(3) On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall be added to cover the wastes.
(4) Burial must be performed under close and dedicated supervision.
(5) The deep burial site should be relatively impermeable and no shallow well should be close to the site.
(6) The pits should be distant from habitation, and located so as to ensure that no contamination occurs to surface water or ground water. The area should not be prone to flooding or erosion.
(7) The location of the deep burial site shall be authorised by the prescribed authority.
(8) The institution shall maintain a record of all pits used for deep burial.
(9) The ground water table level should be a minimum of six meters below the lower level of deep burial pit.
6. STANDARDS FOR EFFICACY OF CHEMICAL DISINFECTION Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the difference between the logarithms of number of test microorganisms before and after chemical treatment. Chemical disinfection methods shall demonstrate a 4 Log10 reduction or greater for Bacillus Subtilis (ATCC 19659) in chemical treatment systems.
7. STANDARDS FOR DRY HEAT STERILIZATION Waste sharps can be treated by dry heat sterilization at a temperature not less than 1850C, at least for a residence period of 150 minutes in each cycle, which sterilization period of 90 minutes. There should be automatic recording system to monitor operating parameters.
(i) Validation test for Shaprs sterilization unit Waste shaprs sterilization unit should completely and consistently kill the biological indicator GeobacillusStearothermophillus or Bacillus Atropheausspoers using vials with at least log10 6 spores per ml. The test shall be carried out once in three months
(ii) Routine test 21 A chemical indicator strip or tape that changes colour when a certain temperature is reached can be used to verify that a specific temperature has been achieved. It may be necessary to use more than one strip over the waste to ensure that the inner content of the sharps has been adequately disinfected. This test shall be performed once in week and records in this regard shall be maintained.
8. STANDARDS FOR LIQUID WASTE.-
(1) The effluent generated or treated from the premises of occupier or operator of a common bio medical waste treatment and disposal facility, before discharge into the sewer should conform to the following limits PARAMETERS PERMISSIBLE LIMITS pH Suspended solids Oil and grease BOD COD Bio-assay test
6.5-9.0 100 mg/l 10 mg/l 30 mg/l 250 mg/l 90% survival of fish after 96 hours in 100% effluent.
(2) Sludge from Effluent Treatment Plant shall be given to common bio-medical waste treatment facility for incineration or to hazardous waste treatment, storage and disposal facility for disposal.
Schedule III [See rule 6 and 9(3)] List of Prescribed Authorities and the Corresponding Duties Sl.
No Authority
(2) Corresponding Duties
(3)
(1) 1 Ministry of Environment, Forest and Climate Change, Government of India
(i) Making Policies concerning bio-medical waste Management in the Country including notification of Rules and amendments to the Rules as and when required.
(ii) Providing financial assistance for training and awareness programmes on bio-medical waste management related activities to for the State Pollution Control Boards or Pollution Control Committees.
(iii) Facilitating financial assistance for setting up or up-gradation of common bio-medical waste treatment facilities.
(iv) Undertake or support operational research and assessment with reference to risks to environment and health due to bio-medical waste and 22 previously unknown disposables and wastes from new types of equipment.
(v) Constitution of Monitoring Committee for implementation of the rules.
(vi) Hearing Appeals and give decision made in Form- V against order passed by the prescribed authorities.
(vii) Develop Standard manual for Trainers and Training.
(viii) Notify the standards or operating parameters for new technologies for treatment of bio medical waste other than those listed in Schedule- I.
2 Central or State Ministry of Health and Family Welfare, Central Ministry for Animal Husbandry and Veterinary or State Department of Animal Husbandry and Veterinary.
(i) Grant of license to health care facilities or nursing homes or veterinary establishments with a condition to obtain authorisation from the prescribed authority for bio-medical waste management.
(ii) Monitoring, Refusal or Cancellation of license for health care facilities or nursing homes or veterinary establishments for violations of conditions of authorisation or provisions under these Rules.
(iii) Publication of list of registered health care facilities with regard to bio-medical waste generation, treatment and disposal.
(iv) Undertake or support operational research and assessment with reference to risks to environment and health due to bio-medical waste and previously unknown disposables and wastes from new types of equipment.
(v) Coordinate with State Pollution Control Boards for organizing training programmes to staff of health care facilities and municipal workers on bio-medical waste.
(vi) Constitution of Expert Committees at National or State level for overall review and promotion of clean or new technologies for bio-medical waste management.
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(vii) Organizing or Sponsoring of trainings for the regulatory authorities and health care facilities on bio-medical waste management related activities.
(viii) Sponsoring of mass awareness campaigns in electronic media and print media.
3 Ministry of Defence (i) Grant and renewal of authorisation to Armed Forces health care facilities or common bio-medical waste treatment facilities (Rule 9).
(ii) Conduct training courses for authorities dealing with management of bio-medical wastes in Armed Forces health care facilities or treatment facilities in association with State Pollution Control Boards or Pollution Control Committees or Central Pollution Control Board or Ministry of Environment, Forest and Climate Change.
(iii) Publication of inventory of occupiers and bio medical waste generation from Armed Forces health care facilities or occupiers
(iv) Constitution of Advisory Committee for implementation of the rules.
(v) Review of management of bio-medical waste generation in the Armed Forces health care facilities through its Advisory Committee (Rule 11).
(vi) Submission of annual report to Central Pollution Control Board within the stipulated time period (Rule 13).
4. Central Pollution Control Board (i) Prepare Guidelines on bio-medical waste Management and submit to the Ministry of Environment, Forest and Climate Change.
(ii) Co-ordination of activities of State Pollution Control Boards or Pollution Control Committees on bio medical waste.
(iii) Conduct training courses for authorities dealing with management of bio-medical waste.
(iv) Lay down standards for new technologies for 24 treatment and disposal of bio-medical waste (Rule 7) and prescribe specifications for treatment and disposal of bio-medical wastes (Rule 7).
(v) Lay down Criteria for establishing common bio medical waste treatment facilities in the Country.
(vi) Random inspection or monitoring of health care facilities and common bio-medical waste treatment facilities.
(vii) Review and analysis of data submitted by the State Pollution Control Boards on bio-medical waste and submission of compiled information in the form of annual report along with its observations to Ministry of Environment, Forest and Climate Change .
(viii) Inspection and monitoring of health care facilities operated by the Director General, Armed Forces Medical Services (Rule 9).
(ix) Undertake or support research or operational research regarding bio-medical waste.
5. State Government of Health or Union Territory Government or Administration
(i) To ensure implementation of the rule in all health care facilities or occupiers.
(ii) Allocation of adequate funds to Government health care facilities for bio-medical waste management.
(iii) Procurement and allocation of treatment equipments and make provision for consumables for bio-medical waste management in Government health care facilities.
(iv) Constitute State or District Level Advisory Committees under the District Magistrate or Additional District Magistrate to oversee the bio medical waste management in the Districts.
(v) Advise State Pollution Control Boards or Pollution Control Committees on implementation of these Rules.
(vi) Implementation of recommendations of the Advisory Committee in all the health care facilities.
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6. State Pollution Control Boards or Pollution Control Committees
(i) Inventorisation of Occupiers and data on bio-medical waste generation, treatment & disposal.
(ii) Compilation of data and submission of the same in annual report to Central Pollution Control Board within the stipulated time period.
(iii) Grant and renewal, suspension or refusal cancellation or of authorisation under these rules (Rule 7, 8 and 10).
(iv) Monitoring of compliance of various provisions and conditions of authorisation.
(v) Action against health care facilities or common bio medical waste treatment facilities for violation of these rules (Rule 18).
(vi) Organizing training programmes to staff of health care facilities and common bio-medical waste treatment facilities and State Pollution Control Boards or Pollution Control Committees Staff on segregation, collection, storage, transportation, treatment and disposal of bio-medical wastes.
(vii) Undertake or support research or operational research regarding bio-medical waste management.
(viii) Any other function under these rules assigned by Ministry of Environment, Forest and Climate Change or Central Pollution Control Board from time to time.
(ix) Implementation of recommendations of the Advisory Committee.
(x) Publish the list of Registered or Authorised (or give consent) Recyclers.
(xi) Undertake and support third party audits of the common bio-medical waste treatment facilities in their State.
7 Municipalities or Corporations, Urban Local Bodies and Gram Panchayats
(i) Provide or allocate suitable land for development of common bio-medical waste treatment facilities in their respective jurisdictions as per the guidelines of 26 Central Pollution Control Board.
(ii) Collect other solid waste (other than the bio medical waste) from the health care facilities as per the Municipal Solid Waste ( Management and handling) Rules, 2000 or as amended time to time.
(iii) Any other function stipulated under these Rules.
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SCHEDULE IV [See rule 8(3) and (5)] Part A LABEL FOR BIO-MEDICAL WASTE CONTAINERS or BAGS CYTOTOXIC HAZARDSYMBOL HANDLE WITH CARE HANDLE WITH CARE Part B LABEL FOR TRANSPORTING BIO-MEDICAL WASTE BAGS OR CONTAINERS Waste category Number .......
Waste quantity..............
Sender's Name and Address Phone Number .......
Fax Number..............
Contact Person .......
In case of emergency please contact :
Name and Address :
Day ...........Month .............
Year ..........
Date of generation ..................
Receiver's Name and Address:
Phone Number ..............
Fax Number ................
Contact Person ........
Phone No.
Note :Label shall be non-washable and prominently visible.
FORM - I [ (See rule 4(o), 5(i) and 15 (2)] ACCIDENT REPORTING
1. Date and time of accident :
2. Type of Accident :
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3. Sequence of events leading to accident :
4. Has the Authority been informed immediately :
5. The type of waste involved in accident :
6. Assessment of the effects of the accidents on human health and the environment:
7. Emergency measures taken :
8. Steps taken to alleviate the effects of accidents :
9. Steps taken to prevent the recurrence of such an accident :
10. Does you facility has an Emergency Control policy? If yes give details:
Date : .............................. Signature................................
Place: .............................. Designation.............................
FORM - II (See rule10) APPLICATION FOR AUTHORISATION OR RENEWAL OF AUTHORISATION (To be submitted by occupier of health care facility or common bio-medical waste treatment facility) To The Prescribed Authority (Name of the State or UT Administration) Address.
1. Particulars of Applicant:
(i) Name of the Applicant:
(In block letters & in full)
(ii) Name of the health care facility (HCF) or common bio-medical waste treatment facility (CBWTF) :
(iii) Address for correspondence:
(iv) Tele No., Fax No.:
29
(v) Email:
(vi) Website Address:
2. Activity for which authorisation is sought:
Activity Please tick Generation, segregation Collection, Storage packaging Reception Transportation Treatment or processing or conversion Recycling Disposal or destruction use offering for sale, transfer Any other form of handling
3. Application for □ fresh or □ renewal of authorisation (please tick whatever is applicable):
(i) Applied for CTO/CTE Yes/No
(ii) In case of renewal previous authorisation number and date:
(iii) Status of Consents:
(a) under the Water (Prevention and Control of Pollution) Act, 1974
(b) under the Air (Prevention and Control of Pollution) Act, 1981:
4. (i) Address of the health care facility (HCF) or common bio-medical waste treatment facility (CBWTF):
(ii) GPS coordinates of health care facility (HCF) or common bio-medical waste treatment facility (CBWTF):
5. Details of health care facility (HCF) or common bio-medical waste treatment facility (CBWTF):
(i) Number of beds of HCF:
(ii) Number of patients treated per month by HCF:
(iii) Number healthcare facilities covered by CBMWTF: ______
(iv) No of beds covered by CBMWTF: _____
(v) Installed treatment and disposal capacity of CBMWTF:_______ Kg per day
(vi) Quantity of biomedical waste treated or disposed by CBMWTF:_____ Kg/ day
(vii) Area or distance covered by CBMWTF:______________ 30 (pl. attach map a map with GPS locations of CBMWTF and area of coverage)
(viii) Quantity of Biomedical waste handled, treated or disposed:
Category Type of Waste Quantity Generated or Collected, kg/day Method of Treatment and Disposal (Refer Schedule- I)
(1) (2) (3) (4) Yellow
(a) Human Anatomical Waste:
(b)Animal Anatomical Waste :
(c) Soiled Waste:
(d) Expired or Discarded Medicines:
(e) Chemical Solid Waste:
(f) Chemical Liquid Waste :
(g) Discarded linen, mattresses, beddings contaminated with blood or body fluid.
(h) Microbiology, Biotechnology and other clinical laboratory waste:
Red Contaminated Waste (Recyclable) White (Translucen t) Waste sharps including Metals:
Blue Glassware:
Metallic Body Implants
6. Brief description of arrangements for handling of biomedical waste (attach details):
(i) Mode of transportation (if any) of bio-medical waste:
(ii) Details of treatment equipment (please give details such as the number, type & capacity of each unit) No of units Capacity of each unit Incinerators :
Plasma Pyrolysis:
Autoclaves:
Microwave:
Hydroclave:
Shredder:
Needle tip cutter or destroyer Sharps encapsulation or concrete pit:
Deep burial pits:
Chemical disinfection:
Any other treatment equipment:
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7. Contingency plan of common bio-medical waste treatment facility (CBWTF)(attach documents):
8. Details of directions or notices or legal actions if any during the period of earlier authorisation
9. Declaration I do hereby declare that the statements made and information given above are true to the best of my knowledge and belief and that I have not concealed any information.
I do also hereby undertake to provide any further information sought by the prescribed authority in relation to these rules and to fulfill any conditions stipulated by the prescribed authority.
Date : Signature of the Applicant Place : Designation of the Applicant FORM -III (See rule 10) AUTHORISATION (Authorisation for operating a facility for generation, collection, reception, treatment, storage, transport and disposal of biomedical wastes)
1. File number of authorisation and date of issue............................................................
2. M/s __________________ an occupier or operator of the facility located at ______________________ is hereby granted an authorisation for;
Activity Please tick Generation, segregation Collection, Storage packaging Reception Transportation Treatment or processing or conversion Recycling Disposal or destruction use offering for sale, transfer Any other form of handling
3. M/s _____________________________ is hereby authorized for handling of biomedical waste as per the capacity given below;
(i) Number of beds of HCF:
(ii) Number healthcare facilities covered by CBMWTF: ______ 32
(iii) Installed treatment and disposal capacity:_______ Kg per day
(iv) Area or distance covered by CBMWTF:______________
(v) Quantity of Biomedical waste handled, treated or disposed:
Type of Waste Category Quantity permitted for Handling Yellow Red White (Translucent) Blue
3. This authorisation shall be in force for a period of................Years from the date of issue.
4. This authorisation is subject to the conditions stated below and to such other conditions as may be specified in the rules for the time being in force under the Environment (Protection) Act, 1986.
Date................... Signature.................................
Place: ......................... Designation..............................
Terms and conditions of authorisation *
1. The authorisation shall comply with the provisions of the Environment (Protection) Act, 1986 and the rules made there under.
2. The authorisation or its renewal shall be produced for inspection at the request of an officer authorised by the prescribed authority.
3. The person authorized shall not rent, lend, sell, transfer or otherwise transport the biomedical wastes without obtaining prior permission of the prescribed authority.
4. Any unauthorised change in personnel, equipment or working conditions as mentioned in the application by the person authorised shall constitute a breach of his authorisation.
5. It is the duty of the authorised person to take prior permission of the prescribed authority to close down the facility and such other terms and conditions may be stipulated by the prescribed authority.
Form - IV (See rule 13) ANNUAL REPORT [To be submitted to the prescribed authority on or before 30th June every year for the period from January to December of the preceding year, by the occupier of health care facility (HCF) or common bio-medical waste treatment facility (CBWTF)] Sl.
No.
Particulars 1 . Particulars of the Occupier
(i) Name of the authorised person (occupier or operator of facility) 33
(ii) Name of HCF or CBMWTF
(iii) Address for Correspondence
(iv) Address of Facility
(v)Tel. No, Fax. No
(vi) E-mail ID
(vii) URL of Website
(viii) GPS coordinates of HCF or CBMWTF
(ix) Ownership of HCF or CBMWTF (State Government or Private or Semi Govt. or any other)
(x). Status of Authorisation under the Bio-Medical Waste (Management and Handling) Rules Authorisation No.:
......................... valid up to.............
(xi). Status of Consents under Water Act and Air Act Valid up to:
2. Type of Health Care Facility
(i) Bedded Hospital No. of Beds:.....
(ii) Non-bedded hospital (Clinic or Blood Bank or Clinical Laboratory or Research Institute or Veterinary Hospital or any other)
(iii) License number and its date of expiry
3. Details of CBMWTF
(i) Number healthcare facilities covered by CBMWTF
(ii) No of beds covered by CBMWTF
(iii) Installed treatment and disposal capacity of CBMWTF:
_______ Kg per day
(iv) Quantity of biomedical waste treated or disposed by CBMWTF _____ Kg/day
4. Quantity of waste generated or disposed in Kg per annum (on monthly average basis) Yellow Category :
Red Category :
White:
Blue Category :
General Solid waste:
5 Details of the Storage, treatment, transportation, processing and Disposal Facility
(i) Details of the on-site storage facility Size :
Capacity :
Provision of on-site storage : (cold storage or any other provision) 34 disposal facilities Type of treatment No Cap Quantity equipment of acit treatedo unit y r s Kg/ disposed day in kg per annum Incinerators Plasma Pyrolysis Autoclaves Microwave Hydroclave Shredder Needle tip cutter or destroyer Sharps encapsulation or - concrete pit Deep burial pits:
Chemical disinfection:
Any other treatment equipment:
(iii) Quantity of recyclable wastes sold to authorized recyclers after treatment in kg per annum.
Red Category (like plastic, glass etc.)
(iv) No of vehicles used for collection and transportation of biomedical waste
(v) Details of incineration ash and ETP sludge generated and disposed during the treatment of wastes in Kg per annum Quantity Where generated disposed Incineration Ash ETP Sludge
(vi) Name of the Common Bio Medical Waste Treatment Facility Operator through which wastes are disposed of
(vii) List of member HCF not handed over bio-medical waste.
6 Do you have bio-medical waste management committee? If yes, attach minutes of the meetings held during the reporting period 7 Details trainings conducted on BMW
(i) Number of trainings conducted on BMW Management.
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(ii) number of personnel trained
(iii) number of personnel trained at the time of induction
(iv) number of personnel not undergone any training so far
(v) whether standard manual for training is available?
(vi) any other information) 8 Details of the accident occurred during the year
(i) Number of Accidents occurred
(ii) Number of the persons affected
(iii) Remedial Action taken (Please attach details if any)
(iv) Any Fatality occurred, details.
9. Are you meeting the standards of air Pollution from the incinerator? How many times in last year could not met the standards?
Details of Continuous online emission monitoring systems installed 10 Liquid waste generated and treatment methods in place. How many times you have not met the standards in a year?
11 Is the disinfection method or sterilization meeting the log 4 standards? How many times you have not met the standards in a year?
12 Any other relevant information (Air Pollution Control Devices attached with the Incinerator) Certified that the above report is for the period from Name and Signature of the Head of the Institution Date:
Place FORM -V 36 (See rule 16) Application for filing appeal against order passed by the prescribed authority
1. Name and address of the person applying for appeal :
2. Number, date of order and address of the authority which passed the order, against which appeal is being made (certified copy of order to be attached):
3. Ground on which the appeal is being made:
4. List of enclosures other than the order referred in para 2 against which appeal is being filed:
Signature.................................
Date : Name and Address.................................
[F. No. 3-1/2000-HSMD] (Bishwanath Sinha) Joint secretary to the Government of India 37