National Green Tribunal
Ms Hlg Memorial Hospital Pvt Ltd vs West Bengal Pollution Control Board on 9 October, 2023
BEFORE THE NATIONAL GREEN TRIBUNAL
EASTERN ZONE BENCH,
KOLKATA
............
APPEAL No.21/2023/EZ
IN THE MATTER OF:
1. M/s HLG Memorial Hospital (P) Ltd.,
Through its Administrator,
Vivekanand Sarani, Sen Raleigh Road,
Post Office-Asansol, P.S.-Asansol (North),
District-Paschim Bardhaman,
Pin - 713305,
2. The Administrator,
M/s HLG Memorial Hospital (P) Ltd.,
Vivekanand Sarani, Sen Raleigh Road,
Post Office-Asansol, P.S.-Asansol (North),
District-Paschim Bardhaman,
Pin - 713305,
.... Appellant(s)
Versus
1. West Bengal Pollution Control Board,
Through its Member Secretary,
Department of Environment, Govt. of West Bengal,
Paribesh Bhavan, Block-LA, Building 10A, Sector-III,
Salt Lake, Kolkata, P.S.-Bidhannagar,
Pin - 700106,
2. Chief Engineer, Operation and Execution Cell,
West Bengal Pollution Control Board,
Department of Environment, Govt. of West Bengal,
Paribesh Bhavan, Block-LA, Building 10A, Sector-III,
Salt Lake, Kolkata, P.S.-Bidhannagar,
Pin - 700106,
3. Inspecting Officer,
West Bengal Pollution Control Board,
Department of Environment, Govt. of West Bengal,
Paribesh Bhavan, Block-LA, Building 10A, Sector-III,
Salt Lake, Kolkata, P.S.-Bidhannagar,
Pin - 700106,
.... Respondent(s)
1
COUNSEL FOR APPELLANT(S):
Ms. Arpita Saha, Advocate
COUNSEL FOR RESPONDENT(S):
Mr. Prithwish Basu, Advocate for R-1 to 3,
JUDGMENT
PRESENT:
HON'BLE MR. JUSTICE B. AMIT STHALEKAR (JUDICIAL MEMBER) HON'BLE DR. ARUN KUMAR VERMA (EXPERT MEMBER) __________________________________________________________________ Reserved On:- October 04th, 2023 Pronounce On:- October 9th, 2023 __________________________________________________________________
1. Whether the Judgment is allowed to be published on the net? Yes
2. Whether the Judgment is allowed to be published in the NGT Reporter? Yes JUSTICE B. AMIT STHALEKAR (JUDICIAL MEMBER) Heard the learned Counsel for the parties and perused the documents on record.
2. The Appellants in the present Appeal are seeking quashing of the order dated 29.05.2023 passed by the Chief Engineer, Operation and Execution Cell, West Bengal Pollution Control Board, imposing a penalty of Rs. 2,00,000/- (Rupees Two Lakhs only) against the Appellants and further directing the Appellants to execute a Bank Guarantee of Rs. 5,00,000/- (Rupees Five Lakhs only).
23. It is stated that the Appellant's Unit is a 101 Bedded Private Super Speciality Hospital located in a G+3 storeyed building at Sen Raleigh Road, Asansol, and is providing medical services to indoor and outdoor patients and is stated to be operational for more than 10 years.
4. It is stated that the Appellants' Hospital has also been requisitioned by the Government of West Bengal as a COVID Hospital for management of COVID-19 patients.
5. It is further stated that on 30.11.2012, an Inspector from the West Bengal Pollution Control Board inspected the Appellants' Hospital and made certain observations that the Hospital in question was operating in violation of environmental norms.
6. It is stated that the Appellants' Hospital was called for hearing on 28.03.2023 for violation of the Bio-medical Waste Rules, 2016, and thereafter the impugned order was passed.
7. The findings recorded by the West Bengal Pollution Control Board are mentioned in the impugned order itself and have been quoted in para 7 of the Memo of Appeal which read as under:-
"(a) Waste bins were not observed under any bed in any sections.
(b) The BMW bins were observed to be provided with wrongcoloured plastic bags in many cases.
(c) The bins were also observed to be filled with the wrong type of BMW.3
(d) Proper segregation of BMW at the source is not followed by the unit.
(e) No proper storage place for storage of BMW was observed during inspection.
(f) The storage place which is used to store BMW was observed to have large openings on the upper side. The place had no floor washing facility.
(g) Plastic bags full of BMW were found to be scattered in front of the BMW storage place of the unit. Plastic bags full of BMW were also found to be lying in other open places in the said area. Dried up stains of blood/body fluid were also noticed on road near the said place.
(h) In many cases, needles were observed discarded without destruction, one needle cutter (electrical) was observed in the entire hospital.
(i) No covered and levelled trolleys are used for intramural transportation of BMW from the source of generation.
(j) No proper cell has been allotted for the proper management of BMW. Staffs are not properly aware regarding segregation of BMW. No record of training of the staff could be shown during inspection.
(k) The unit has no Effluent Treatment Plant (ETP).
Effluent is directly discharged into municipal drain.
(l) Proper records are not maintained by the unit for BMW generation and disposal.
(m) Annual report & Monthly report could not be shown during inspection.
(n) The Consent to Operate and the Bio-Medical Waste Authorization of the HCU is valid upto 31.12.2026.
4(o) The unit has started construction for its 3rd floor for additional ICCU & Cabins without obtaining Consent to Establish from the State Board."
8. The Inspection Report reads as under:-
"Inspection Report-cum-Checklist"
Name of the industry M/s. HLG Memorial Hospital Pvt. Ltd.
Address Sen Releigh Road, PO-Asansol, PS-Asansol (N), Paschim Bardhaman-713304.
Category of industry Bio-Medical Date and Time of inspection 30.11.2022, 02.00 pm - 03.00 pm Inspecting Officer R. Chakraborty, AEE Persons met during inspection Suvobrata Chatterjee, Administrator Cess paying industry - Observation Cleaning and washing in Pathology,
(A) Sources of generation of liquid Polyclinic, Procedure etc. section waste (B) Facility available for Nil treatment (C) Generation of sewage and its -
treatment/disposal (D) Observation and comments on Effluent is directly discharged into Municipal performance of treatment Drain.
facility of liquid waste-
(E) Sources of generation of 02 nos Silent Type DG Set
gaseous emission- (125KVA&140KVA)
(F) Facility available for No proper stack was provided.
treatment of gaseous
emission-
(G) Observation and comments on DG Set was not operating during the
5
performance of treatment inspection
facility for gaseous emission-
(H) Observation on noise pollution NA
generated from industrial
process along with measured
level (if measurement
required)-
(I) Information regarding solid Solid waste is disposed of in Municipal Vat.
waste generation and
disposal/storing facility-
(J) Information regarding Almost all type of Biomedical waste is
hazardous waste generation generated. Rules for onsite storing are not and on site storing facility followed properly.
(K) Status of hazardous waste Bio-Medical Waste Authorisation is valid up (M&H) authorization to 31.12.2026 (L) Storing of hazardous -
chemicals under MS & I (HC) Rules.
(M) Status of consent to establish Possesses valid NOC-Yes At present whether NOC required-No (N) Status of Consent Possesses valid consent to operate-Yes Valid period up to 31.12.2026.
(O) Any other relevant information:
• The unit is a 101 bedded full-fledged private hospital located in a G+3 storied building. It caters for a large range of medical services to outpatients as well as inpatients and thus generates almost all types of biomedical waste.
• The building housing the following sections as follows --
1. Ground Floor -- Reception + OPD + Emergency + Pathological Laboratory + Radiology + Eye (OPD) + OT
2. 1St Floor -- General OT (02 nos) + ICCU + Cabins + General Ward
3. 2nd Floor -- CCU + Cath Lab + CTVS + Paediatric Ward + NICU + 6 Dialysis + General Ward + Cabin
4. 3rd Floor -- Under construction • During the inspection, most of the sections on each floor were observed provided with waste bins with colour-coded plastic bags on the floor passages. However, Bins were not observed under any bed in any sections.
• The bins in the passages were observed provided with wrong-coloured plastic in many cases. The bins were also observed filled with the wrong type of BMW. It appeared that proper segregation of BMW at the source is not followed.
• Sharp wastes were kept in puncture-proof containers. In many cases, needles were observed discarded without destruction. It may be mentioned here that only one Needle Cutter (electrical) was observed in the entire hospital.
• Bins from the passages are carried to the ground floor by hand. No covered and levelled trolleys are used for intramural transportation of BMW from the source of generation.
• No separate cell has been allotted for the proper management of biomedical waste. Staffs were not properly aware of the segregation practices of biomedical waste. No record of training of the staff could be shown either.
• No quantification of wastewater generation is carried out. No treatment of effluent, not even basic disinfection, is carried out. Effluent is directly discharged into Municipal Drain.
• No proper storage place for storage of BMW was observed during the inspection. The storage place which is used to store BMW was observed to have large openings on the upper side. The place had no floor washing facility. Plastic bags full of BMW was found scattered in front of the said storage place. Plastic bags full of BMW was also observed lying in other open places in the said area. Dried-up stains of blood/body fluid were also noticed on road near the said place.
• Proper records are not maintained for biomedical waste generation and disposal. Annual & Monthly reports could not be shown during the inspection.
7(P) Remarks:-
• The unit as observed during the inspection is violating the BMW Rules 2016 and subsequent Amendments. It has also started construction for its 3rd floor for additional ICCUs & Cabins without obtaining CTE from the Board.
• Keeping in view of the above, stern action may be taken against the Unit.
9. The Appellants in their reply affidavit dated 03.10.2023 have denied the allegations and the findings recorded in the Report of the West Bengal Pollution Control Board. The case of the Appellants as made out in para 4 of their reply affidavit is as under:-
"(a) There is ward wise bins in all sections.
(b) All the bins are provided with colored plastic bags as per norms only if there were any deficiency found it would have been one of odd case due to deficiency from group D staff which the appellants have already taken care. Corrective majors were taken.
(c) proper segregation of BMW is done at all sources and necessary follow up is done.
(d) The storage place for storing of BMW was done as per NABH guideline and appellants are following other industry leaders. Washing is done through flexible pipe.
(e) The plastic bags that were found lying was kept for shifting to storage place. There is less chance of stains of blood/body fluid as appellants transport BMW through proper care.8
(f) Appellants have manual needle cutter as well as electrical needle cutter. No needles were discarded without needle cutter.
(g) Allegations made in paragraphs 4(g) are already rectified.
(h) Training records are with HR department and inspecting authority didn't ask for any record.
(i) First one vendor was appointed for commissioning of ETP and provided two advance payments (details attached along with issuing of work order but the vendor didn't turn up so new vendor was appointed. All material has been dispatched by them and work is in progress details attached).
(j) Records were maintained manually which appellants have shown but inspecting authority asked for electronic data, for which appellants have purchased new software and updated regularly.
(k) Appellants are maintaining records manually. We have tied up with MEDICARE ENVIRONMENTAL AGENCY for collection of our bio-medical waste who is maintaining annual and monthly reports. The file could not be shown as the inspection was done all of a sudden and was lying with the filing department.
(l) There is no additional ICCU or cabins constructed at 3rd floor, it was undergoing renovation work. The number of beds remains same as per CE license which was submitted to the authority at the time of inspection."
10. With regard to the allegations in para 4(g) as outlined in the reply, it is stated that the allegations therein have already been rectified. However, para 4 of the Memo of Appeal does not have any sub-para (g). Para 7 of the Memo of Appeal, on the other hand, has para (g) which is the findings of the Inspection Team which records 9 that the plastic bags full of Bio-medical Waste (BMW) were found scattered in front of the BMW storage place of the Unit; the plastic bags full of BMW were also found lying in other open places in the said area; dried up stains of blood/body fluid were also noticed on the passage near the said place.
11. The fact that the Appellants state that these findings have been rectified confirms that Bio-medical Waste had not been properly kept or maintained or disposed of and there were blood stains and body fluid all over the place. Though the Appellants have denied the findings of the Inspection Team, however, the findings of the Inspection Team are matter of record and the inspection was carried out on 30.11.2022.
12. The Inspection Report mentions that Bio-medical Waste Authorisation is valid upto 31.12.2026 and almost all types of bio-
medical waste is generated but rules for onsite storing have not been followed.
13. The Inspection Report further mentions that waste bins were not observed under any bed in any section and the bins in the passages were observed to be provided with wrong-colored plastic in many cases; the bins were also observed to be filled with wrong type of Bio-medical Waste which showed that proper segregation of Bio-
medical Waste at source was not being followed; sharp wastes were kept in puncture-proof containers but in many cases needles were observed discarded without destruction; only one Needle Cutter (electrical) was observed in the entire Hospital.
1014. The Inspection Team further noted that the bins from the passages are carried out to the ground floor by hand and no covered and levelled trolleys are used for intramural transportation of Bio-medical Waste from the source of generation.
15. It was also noted by the Inspection Team that no separate cell has been allotted for proper management of Bio-medical Waste and hospital staff were not properly aware of the segregation practices of Bio-medical Waste and during inspection no record of training of staff could be shown.
16. The Inspection Team further noted that there was no quantification of waste water generation, not even basic disinfection was being carried out; and effluent was being directly discharged into the Municipal Drain.
17. It was further noted by the Inspection Team that no proper storage place for storage of Bio-medical Waste was observed during inspection; the storage place which is used to store Bio-medical Waste was observed to have large openings on the upper side; the place had no floor washing facility; plastic bags full of Bio-medical Waste were found scattered in front of the said storage place;
plastic bags full of Bio-medical Waste were also observed lying in other open places in the said area; and dried-up stains of blood/body fluid were also noticed on the passage near the said place.
1118. The Report further noted that proper records are not maintained for Bio-medical Waste generation and its disposal and annual and monthly reports could not be shown during inspection.
19. The Inspection Team, therefore, confirms that the Unit of the Appellants was carrying on its operations in violation of the Bio-
medical Waste Management Rules, 2016, as amended from time to time. It was also noted that the Appellants' Hospital had started construction of its third floor for additional ICCUs and Cabins without obtaining Consent to Establish from the West Bengal Pollution Control Board.
20. Photographs in support of the findings have also been filed by the West Bengal Pollution Control Board along with its affidavit dated 28.08.2023.
21. In the affidavit, it is further stated that the Appellants' Healthcare Unit was provided an opportunity of hearing on 28.03.2023 in respect of the findings regarding violation of the Bio-
medical Waste Management Rules, 2016, during which representative of the Hospital appeared and submitted that they would obtain 'Consent to Establish' for expansion and assured that no construction work of additional floors would be carried out till Consent to Establish is obtained. The representative of the Appellant's Unit also assured that the Hospital would comply the Bio-medical Waste Management Rules, 2016, as amended from time to time, within one month and they were in the process of installation of Effluent Treatment Plant.
1222. It is also stated that the State Board waited for almost two months for the compliance report to be filed by the Appellants' Unit but in the absence of the same, following the findings recorded in the Inspection Report and the discussion during hearing at the State board, the impugned order directing the Appellants' Unit to pay penalty of Rs.2,00,000/- (Rupees Two Lakhs only) for violation of Bio-medical Waste Management Rules, 2016, with a further direction to the Appellant's Hospital to execute a bank guarantee of Rs.5,00,000/- (Rupees Five Lakhs only) was made.
23. With regard to the non-setting up of Effluent Treatment Plant (ETP), the stand of the Appellants in their reply affidavit is that the first vendor was appointed for commissioning of ETP and provided two advance payments but he did not turn-up so a new vendor was appointed and all material has been dispatched by them and work of construction of ETP is in progress.
24. This confirms that on the date of inspection the Appellants' Hospital had not set-up any ETP.
25. Regarding non-production of documents by the Appellants' Hospital during inspection, it is stated by the Appellants that one Medicare Environmental Agency for collection of Bio-medical Waste has been authorized by the Hospital for collection of Bio-medical Waste and they are maintaining annual and monthly reports but file could not be shown during inspection since it was a surprise 13 inspection and the file documents were lying with the filing department.
26. In our opinion, this is not a satisfactory reply, since all requisite documents ought to have been in possession of the Appellants' Hospital and provided to the Inspection Team. Even otherwise, such inspections are always carried out as surprise inspection otherwise the inspection itself would be a futile exercise.
27. With regard to ICCU and Cabins construction, it is stated by the Appellants that there is no additional ICCU or Cabins constructed on the third floor and, in fact, it was renovation work being carried out.
28. In our opinion, this reply of the Appellants is wholly unsatisfactory, since the relevant documents to that effect would have been provided by the Appellants' Hospital to the West Bengal Pollution Control Board during hearing or at least documents would have been provided to show that the Hospital was in possession of Consent to Establish for expansion with regard to the construction of ICCU and Cabins on the third floor.
29. Rule 5 of the Bio-medical Waste Management Rules, 2016, lays down the duties of the operator of a common bio-medical waste treatment and disposal facility which reads as under:-
"5. Duties of the operator of a common bio-medical waste treatment and disposal facility.- It shall be the duty of every operator to-14
(a) 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;
(b) ensure timely collection of bio-medical waste from the occupier as prescribed under these rules;
(c) establish bar coding and global positioning system for handling of bio- medical waste within one year;
(d) inform the prescribed authority immediately regarding the occupiers which are not handing over the segregated bio-medical waste in accordance with these rules;
(e) provide training for all its workers involved in handling of bio-medical waste at the time of induction and at least once a year thereafter;
(f) assist the occupier in training conducted by them for bio-medical waste management;
(g) undertake appropriate medical examination at the time of induction and at least once in a year and immunise all its workers involved in handling of bio-
medical waste for protection against diseases, including Hepatitis B and Tetanus, that are likely to be transmitted while handling bio-medical waste and maintain the records for the same;
(h) ensure occupational safety of all its workers involved in handling of bio-medical waste by providing appropriate and adequate personal protective equipment;
15(i) report major accidents including accidents caused by fire hazards, blasts during handling of biomedical waste and the remedial action taken and the records relevant thereto, (including nil report) in Form I to the prescribed authority and also along with the annual report;
(j) 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;
(k) allow occupier , who are giving waste for treatment to the operator, to see whether the treatment is carried out as per the rules;
(l) shall display details of authorisation, treatment, annual report etc on its web-site;
(m) 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 recyclers having valid consent or authorisation or registration from the respective State Pollution Control Board or Pollution Control Committee;
(n) supply non-chlorinated plastic coloured bags to the occupier on chargeable basis, if required;
(o) common bio-medical waste treatment facility shall ensure collection of biomedical waste on holidays also;
(p) maintain all record for operation of incineration, hydroor autoclaving for a period of five years; and
(q) upgrade existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin 16 and Furans within two years from the date of this notification."
30. Rule 7 of the Rules, 2016, provides for treatment and disposal of Bio-medical Waste which reads as under:-
"7. 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 healthcare 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:
Provided that the lab and highly infectious bio-medical waste generated shall be pre-treated by equipment like autoclave or microwave.
(3) No occupier shall establish on-site treatment and disposal facility, if a service of ` common biomedical waste treatment facility is available at a distance of seventy-five kilometer.
(4) In cases where service of the common bio-medical waste treatment facility is not available, the Occupiers shall set up requisite biomedical waste treatment equipment like incinerator, autoclave or microwave, shredder prior to commencement of its operation, as per the authorisation given by the prescribed authority.
(5) Any person including an occupier or operator of a common bio medical waste treatment facility, intending to use new technologies for treatment of bio medical waste other than those listed in Schedule I shall request the Central Government for laying down the standards or operating parameters. (6) On receipt of a request referred to in sub-rule (5), the Central Government may determine the standards 17 and operating parameters for new technology which may be published in Gazette by the Central Government.
(7) 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.
(8) Every occupier shall phase out use of non-chlorinated plastic bags within two years from the date of publication of these rules and after two years from such publication of these rules, the chlorinated plastic bags shall not be used for storing and transporting of bio-medical waste and the occupier or operator of a common bio-medical waste treatment facility shall not dispose of such plastics by incineration and the bags used for storing and transporting biomedical waste shall be in compliance with the Bureau of Indian Standards. Till the Standards are published, the carry bags shall be as per the Plastic Waste Management Rules, 2016.
(9) 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.
(10) 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.
18(11) The handling and disposal of all the mercury waste and lead waste shall be in accordance with the respective rules and regulations."
31. Rule 8 of the Rules, 2016, provides for segregation, packaging, transportation and storage of Bio-medical Waste which reads as under:-
"8. Segregation, packaging, transportation and storage.-(1) Non treated 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 labeled as specified in Schedule IV. (4) Bar code and global positioning system shall be added by the Occupier and common bio-medical waste treatment facility in one year time.
(5) 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.
(6) 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.
(7) Untreated human anatomical waste, animal anatomical waste, soiled waste and, biotechnology waste shall not be stored beyond a period of forty -eight hours:19
Provided that in case for any reason it becomes necessary to store such waste beyond such a period, the occupier shall take appropriate measures to ensure that the waste does not adversely affect human health and the environment and inform the prescribed authority along with the reasons for doing so.
(8) 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."
32. Schedule-I to the Rules, 2016, provides for bio-medical wastes categories and their segregation, collection, treatment, processing and disposal which reads as under:-
"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 Treatment and disposal Container to be options used (1) (2) (3) (4) Yellow (a) Human Anatomical Yellow coloured Incineration or Plasma Waste: non-chlorinated Pyrolysis or deep burial* Human tissues, organs, plastic bags body parts and fetus below the viability period (as per the Medical Termination of Pregnancy Act, 1971, amended from time to time).
(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
20
colleges or animal houses.
(c) Soiled Waste: Incineration or Plasma
Items contaminated with Pyrolysis or deep burial* In
blood, body fluids like absence of above facilities,
dressings, plaster casts, autoclaving or micro-waving/
cotton swabs and bags hydroclaving followed by
containing residual or shredding or mutilation or
discarded blood and blood combination of sterilization
components. and shredding. Treated
waste to be sent for energy
recovery.
(d) Expired or Discarded Yellow coloured Expired cytotoxic drugs and
Medicines: non-chlorinated items contaminated with
Pharmaceutical waste plastic bags or cytotoxic drugs to be
like antibiotics, cytotoxic containers returned back to the
drugs including all items manufacturer or supplier for
contaminated with incineration at
cytotoxic drugs alogn temperature>1200 ºC or to
with glass or plastic common bio-medical waste
ampoules, vials etc. treatment facility or
hazardous waste treatment,
storage and disposal facility
for incineration at >1200 ºC
Or Encapsulation or Plasma
Pyrolysis at >1200 ºC. All
other discarded medicines
shall be either sent back to
manufacturer or disposed by
incineration.
(e) Chemical Waste: Yellow coloured Disposed of by incineration
Chemicals used in containers or or Plasma Encapsulation or
production of biological and non-chlorinated hazardous in treatment,
used or discarded plastic bags storage and disposal facility.
disinfectants.
(f) Chemical Liquid Separate After resource recovery, the
Waste: collection system chemical liquid waste shall
Liquid waste generated due leading to be pre-treated before mixing
to use of chemicals in effluent with other wastewater. The
production of biological and treatment combined discharge shall
used or discarded system conforms to the discharge
disinfectants, Silver X-ray norms given in Schedule-III.
film developing liquid,
discarded Formalin,
infected secretions,
aspirated body fluids, liquid
from Laboratories and floor
washings, cleaning, house-
keeping and disinfecting
21
activities etc.
(g) Discarded linen, Non-chlorinated Non-chlorinated chemical
mattresses, beddings yellow plastic disinfection followed by
contaminated with blood bags or suitable incineration or Plazma
or body fluid [routine packing material Pyrolysis or for energy
mask and gown]. 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.
111 (h) Microbiology, [Autoclave or Pre-treat to sterilize with
Biotechnology and other Microwave or non-chlorinated chemicals
clinical laboratory waste: Hydroclave safe on-site [as per World Health
Blood bags, Laboratory plastic bags or Orgnaisation guidelines on
cultures, stocks or containers] Safe management of wastes
specimens of micro- from health care activities
organisms, live or and WHO Blue Book, 2014
attenuated vaccines, human and thereafter sent for
animal cell cultures used in incineration]
research, industrial
laboratories, production of
biological, residual toxins,
dishes and devices used for
cultures.
Red Contaminated Waste Red coloured Autoclaving or micor-
(Recyclable) non-chlorinated waving/ hydroclaving
(a) Waste generated from plastic bags or followed by shredding or
disposable items such containers mutilation or combination of
as tubing, bottles, sterilization and shredding.
intravenous tubes and Treated waste to be sent to
sets, catheters, urine registered or authorized
bags, syringes (without recyclers or for energy
needles and fixed recovery or plastics to diesel
needle syringes) and or fuel oil or for road making,
vaccutainers with their whichever is possible. plastic
needles cut) and gloves. waste should not be sent to
landfill sites.
White Waste Sharps including Puncture proof, Autoclaving or Dry Heat
(Translucent) Metals: Leak proof, Sterilization followed by
Needles, syringes with fixed tamper proof shredding or mutilation or
needles, needles from containers encapsulation in metal
needle tip cutter or burner, container or cement concrete;
scalpels, blades, or any combination of shredding
other contaminated sharp cum autoclaving; and sent
22
object that may cause for final disposal to iron
puncture and cuts. This foundries (having consent to
includes both used, operate from the State
discarded and Pollution Control Boards or
contaminated metal sharps Pollution Control Committees)
or sanitary landfill or
designated concrete waste
sharp pit.
Blue (a) Glassware: [Puncture proof Disinfection (by soaking the
Broken or discarded and and leak proof washed glass waste after
contaminated glass boxes or cleaning with detergent and
including medicine vials containers with Sodium Hypochlorite
and ampoules except blue colored treatment) or through
those contaminated with marking] autoclaving or microwaving
cytotoxic wastes. or hydroclaving and then
sent for recycling.
*
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.
23(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.
(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.
24(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."
33. Schedule-II to the Rules, 2016, lays down the standards for treatment and disposal of Bio-Medical Wastes such as - Standards for Incineration, Operating and Emission Standards for Disposal by Plasma Pyrolysis or Gasification, Standards for Autoclaving of Bio-
Medical Waste, Standards of Microwaving, Standards for Deep Burial, Standards for Efficacy of Chemical Disinfection, Standards for Dry Heat Sterilization, Standards for Liquid Waste, which reads as under:-
"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 25
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
Sl. Parameter Standards
No.
(1) (2) (3) (4)
Limiting Sampling Duration
concentration in minutes, unless
[in mg/Nm3 ] unless stated
stated
1. Particulate matter 50 30 or 1[NM3] of sample volume,
whichever is more
2. Nitrogen Oxides NO and 400 30 for online sampling or grab
NO2 expressed asNO2 sample
3. HCl 50 30 or 1NM3 of sample volume,
whichever is more
4. Total Dioxins and Furans 0.1ng TEQ/Nm3 (at 8 hours or 5NM3 of sample
11% O2) 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.26
(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.
(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 27 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.=------------------------------X100 (%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.
28B. 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.
(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 29 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;
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 till proper temperature, pressure and residence time were achieved. (3) 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 30 identification number and operating parameters throughout the entire length of the autoclave cycle. (4) 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.
(5) 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.
31(6) 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.
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 32 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.
337. 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 log106 spores per ml. The test shall be carried out once in three months.
(ii) 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 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 6.5-9.0
Suspended solids 100 mg/l
Oil and grease 10 mg/l
BOD 30 mg/l
COD 250 mg/l
34
Bio-assay test 90% survival of fish after 96 hours in
100% effluent.
["Note-
1. Above limits are applicable to the occupiers of Health Care Facilities (bedded) which are either connected with sewerage network without terminal sewage treatment plant or not connected to public sewers.
2. For discharge into public sewers with terminal facilities, the general standards as notified under the Environment (Protection) Act, 1986 (29 of 1986) shall be applicable.
3. {Health Care Facilities having less than ten beds shall have to comply with the output discharge standards for liquid waste by 31st December, 2019}.
4. Non-bedded occupiers shall dispose infectious liquid wastes only after treatment by disinfection as per Schedule-II (6) of the principal rules."] (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."
34. The Inspection Report further notes that no proper stack was provided; solid waste was being disposed of in the Municipal Vat;
and rules for onsite storing were also not being followed.
35. In view of the above, we find that the Appellants have been operating their Hospital clearly in violation of the Bio-medical Waste Management Rules, 2016.
36. For reasons aforesaid, we do not find any illegality or infirmity in the impugned order dated 29.05.2023. The Appeal lacks merit and is accordingly dismissed.
37. I.As. if any, stand disposed of accordingly.
3538. There shall be no order as to costs.
......................................... B. AMIT STHALEKAR, JM ................................................. DR. ARUN KUMAR VERMA, EM Kolkata, October 09th, 2023, APPEAL No.21/2023/EZ AK 36